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Pharmacy and Poisons Act

LAWS OF FIJI


REVISED 1985


CHAPTER 115
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PHARMACY AND POISONS
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TABLE OF PROVISIONS
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PART I - PRELIMINARY

SECTION


1. Short title
2. Interpretation
2A. Meaning of "medicine" and related expressions
2B. Certain substances or articles to be treated as medicines
3. Meaning of "sale"
4. Meaning of "adulteration"


PART II - ADMINISTRATION


5. The Pharmacy and Poisons Board
6. Members of Board
7. Meetings of the Board
8. Board may summon person to attend and give evidence
9. Chairman may administer oath
10. Person failing to appear when summoned
11. Person refusing to make oath or affirmation
12. False testimony
13. Liability of members
14. Fees
15. Power of search
16. Secretary. Inspectors
17. Persons eligible for appointment as inspectors
18. Powers of inspectors
19. Certificate of Government analyst


PART III - PHARMACISTS


20. Register of Pharmacists
21. Pharmacists how registered
22. Persons eligible for registration
23. Board may direct examination of applicant
24. Registration of applicants
25. Appeal against refusal of Board to register
26. Copy of register to be published
27. Fraudulent representation
28. Amendments may be made in register
29. Notification of change of address or death
30. Correction of register
31. Corporate body may carry on business of pharmacist
32. Restriction on number of pharmacies
32A. Establishment of Fiji Pharmaceutical Society
32B. Objects of Fiji Pharmaceutical Society
32C. Former Fiji Pharmaceutical Society


PART IV - CONDUCT OF BUSINESS AS PHARMACIST


33. Grounds of cancellation of registration
34. Removal of name from register
35. Surrender of certificate of registration
36. Persons other than registered pharmacists not to carry on business
37. Death, unsoundness of mind or bankruptcy of pharmacist
38. Name of pharmacist to be exhibited
39. Pharmacists only to dispense
40. Temporary licence
41. Prescriptions to be signed
42. Record of prescriptions
43. Conduct of business by pharmacist
44. Medical practitioners, etc., may dispense
45. Automatic machines for vending medicines prohibited
46. Restrictions on supply of certain medicines
47. False or misleading advertisements
47A. Prohibition of certain advertisements
47B. Meaning of "advertisement" in sections 47 and 47A
48. British Pharmacopoeia


PART V - MANUFACTURE, SALE AND SUPPLY OF MEDICINES


48A. Licensing of manufacture and wholesale dealing
48B. Exemptions from licensing
48C. Application for manufacturer's or wholesale licence
48D. Factors relevant to determination of application
48E. Persons qualified for grant of manufacturer's licences
48F. Grant or refusal of licence
48G. Duration and renewal of licence
48H. Suspension, variation and revocation of manufacturer's or wholesale licences
48I. Variation of manufacturer's or wholesale licence on application of holder
48J. Appeals
48K. Inspection and search of premises, etc.
48L. Offences
49. Sale of medicines
50. Medicine Licence
51. Animal Medicine Licence
52. Police to be notified of issue of licence
53. Only medicines mentioned in licence may be sold
54. (Repealed)
55. Adulteration of medicines
56. Sale of adulterated medicines
57. Offence in relation to sales
58. Reliance on written warranty a good defence
59. Importation of medicines
60. Labels on medicines imported
61. Importation of certain medicines may be prohibited


PART VI - POISONS


62. Importation and sale of poisons
63. Pharmacists to be authorised sellers of poisons
64. Poisons Licence
65. Register of Premises
66. Prohibition and regulations with respect to the sale of poisons
67. Exemption with respect to medicines
68. Exemption with respect to certain sales
69. Use of titles, emblems and descriptions
70. Prohibition of sale of poisons by means of automatic machine


PART VII - MISCELLANEOUS


71. Regulations
72. General penalty
73. Application of Customs law
First Schedule-Countries, etc., Specified for the Purpose of Section 22
Second Schedule-Exempted Articles
Third Schedule-The Poisons List
Fourth Schedule-Animal Medicines

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Ordinances Nos. 30 of 1937, 22 of 1938, Order in Council No. 4 of 1938, Ordinances Nos. 2 of 1945, 1 of 1951, 9 of 1955, Order 12 September 1957, Ordinance No. 5 of 1958, Order 31 March 1959, Ordinances Nos. 20 of 1960, 32 of 1962, Order 22 March 1965, Ordinances Nos. 37 of 1966, 52 of 1968, 11 of 1970, Legal Notices Nos. 112 of 1970, 118 of 1970, 58 of 1971, 104 of 1971, 59 of 1973, 28 of 1975, Acts Nos. 14 of 1975, 24 of 1976, Legal Notice No. 124 of 1977, Acts Nos. 2 of 1980, 18 of 1984, Legal Notices Nos. 155 of 1980, 180 of1980, 12 of 1981, 35 of 1983, 36 of 1983


AN ACT TO PROVIDE FOR THE REGISTRATION OF PHARMACISTS AND TO CONTROL THE PRACTICE OF PHARMACY AND THE SALE AND DISTRIBUTION OF DRUGS AND POISONS AND FOR PURPOSES CONSEQUENTIAL THEREON


[1 January 1938]


PART I - PRELIMINARY


Short title

1. This Act may be cited as the Pharmacy and Poisons Act.


Interpretation

2.-(1) In this Act, unless the context otherwise requires -


"administer" in relation to any substance or article means administer it either in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with, some other substance used as a vehicle;


"assembly" in relation to a medicine, means the process of enclosing the medicine in a container which is labelled before the medicine is sold or offered for sale, or where the medicine is already enclosed in the container in which it is to be sold or offered for sale, labelling the container before the medicine is sold or offered for sale in it;


"Board" means the Pharmacy and Poisons Board appointed under this Act;


"chairman" means the chairman of the Board appointed under this Act;


"manufacture" in relation to a medicine, includes any process carried out in the course of making the medicine including the assembly thereof, but does not include dissolving or dispersing the medicine in, or diluting or mixing it with, some other substance used as a vehicle for the purpose of administering it and does not include the incorporation of the medicine in any animal feeding stuff;


"medicine" and "medicinal purpose" have the meanings assigned to them by section 2A;


"member" means a member of the Board constituted under this Act;


"Permanent Secretary" means the Permanent Secretary for Health;


"poison" includes the several substances mentioned in the Poisons List in the Third Schedule;


"qualified veterinary surgeon" means any veterinary surgeon registered under the provisions of the Veterinary Surgeons Act; (Cap. 257.)


"register" means the Register of Pharmacists registered under this Act;


"registered dentist" means a dentist registered under the Medical and

Dental Practitioners Act; (Cap. 255.)


"registered medical practitioner" or "medical practitioner" or "duly qualified practitioner" means a medical practitioner registered under the Medical and Dental Practitioners Act; (Cap. 255.)


"registered pharmacist" means a person registered under the provisions of this Act.

(Amended by Ordinance 5 of 1958, s. 2; 32 of 1962, s. 2; 37 of 1966, s. 39; Act 14 of 1975, s. 26; 2 of 1980, s. 2.)


(2) In this Act any reference to selling anything by way of wholesale dealing is a reference to selling it to a person who buys it for the purpose of -


(a) selling or supplying it; or


(b) administering it or causing it to be administered to one or more human beings,


in the course of a business carried on by that person, except that it does not include any such sale by the person who manufactured it under and in accordance with a manufacturer's licence. (Inserted by Act 2 of 1980, s. 2.)


Meaning of "medicine" and related expressions

2A.-(1) In this Act -


(a) "medicine" means any substance or article (not being an instrument, apparatus or appliance) which is manufactured, sold or offered for sale for use wholly or mainly in either or both of the following ways:


(i) use by being administered to human beings or animals for a medicinal purpose;


(ii) use, in circumstances specified in subsection (2), as an ingredient in the preparation of a substance or article which is to be administered to human beings or animals for a medicinal purpose, but, except as provided in section 2B, medicine does not include a substance or article the sole or principal use of which is, or ordinarily is, a cosmetic use, or which is represented to be, or might reasonably be taken to be, for cosmetic use;


(b) "medicinal purpose" means any one or more of the following purposes:


(i) treating or preventing a disease;


(ii) diagnosing disease or ascertaining the existence, degree or extent of a physiological condition;


(iii) contraception;


(iv) inducing anaesthesia;


(v) otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating, reducing or postponing, or increasing or accelerating, the operation of that function or in any other way.


(2) The circumstances referred to in subsection (1) (a) (ii) are -


(a) use in a pharmacy or in a hospital, clinic, nursing home or similar institution;


(b) use by a medical practitioner, registered dentist, registered pharmacist or a qualified veterinary surgeon;


(c) use in the course of a business which consists of or includes the retail sale of herbal remedies.


(3) In subsection (2)(c) "herbal remedy" means a medicine consisting of a substance produced by subjecting a plant to drying, crushing or any other process, or of a mixture whose sole ingredients are two or more substances so produced, or of a mixture whose sole ingredients are one or more substances so produced and water or some other inert substance. (Inserted by Act 2 of 1980, s. 3.)


Certain substances or articles to be treated as medicines


2B.-(1) Where in the course of trade or business any substance or article is manufactured, sold or offered for sale as a medicine or is described as a medicine or recommended in any manner to be used for a medicinal purpose that substance or article shall be treated as a medicine for the purposes of this Act.


(2) Without prejudice to the generality of subsection (1) a substance or article shall be taken to be described as a medicine or recommended to be used for a medicinal purpose if any description of that substance on any container, label, carton or wrapping, or in any advertisement, display material or poster, or in any brochure, leaflet or other material supplied with or in connection with such substance is likely or calculated to be taken as an indication that the substance or article is suitable to be used for a medicinal purpose.


(3) For the avoidance of doubt it is hereby declared that subsections (1) and (2) shall apply to any substance or article notwithstanding that the sole or principal use thereof is, or ordinarily is, a cosmetic use, or which is represented to be, or might be reasonably taken to be for cosmetic use, as they apply to any other substance or article. (Inserted by Act 2 of 1980, s. 3.)


Meaning of "sale"

3. In this Act, unless the context otherwise requires, "sale" includes barter, and also includes offering or attempting to sell, or receiving for sale, or having in possession for sale, or exposing for sale, or sending or delivering for sale, or causing or allowing to be sold, offered, or exposed for sale; and "sell" has a corresponding meaning.

(Inserted by Ordinance 5 of 1958, s. 3; amended by Act 2 of 1980, s. 9 and Sched.)

[(2) * * * * * (Repealed by Act 2 of 1980, s. 9 and Sched.)]

[(3) * * * * * (Repealed by Act 2 of 1980, s. 9 and Sched.)]

[(4) * * * * * (Repealed by Act 2 of 1980, s. 9 and Sched.)]


Meaning of "adulteration"

4. For the purposes of this Act, any medicine shall be deemed to be adulterated -


(a) if it contains or is mixed or diluted with any substance which diminishes in any manner its beneficial properties as compared with the medicine in a pure and normal state and in an undeteriorated and sound condition, or which in any other manner operates or may operate to the prejudice or disadvantage of the purchaser or consumer;


(b) if it contains or is mixed or diluted with any substance of a commercial value lower than that of a medicine in a pure and normal state and in an undeteriorated and sound condition;


(c) if any substance or ingredient has been extracted or omitted therefrom, and by reason of such extraction or omission the beneficial properties of the medicine as sold are less than those of the medicine and its pure and normal state, or the purchaser or consumer is or may be in any other manner prejudiced. (Inserted by Ordinance 5 of 1958, s. 3, amended by Act 2 of 1980, s. 9 and Sched.)


PART II - ADMINISTRATION


The Pharmacy and Poisons Board

5.-(1) For the purposes of this Act, there is hereby constituted an authority to be called the "Pharmacy and Poisons Board".


(2) The Board shall be a body corporate with perpetual succession and a common seal and shall be capable of suing and being sued.


(3) All courts, judges and persons acting judicially shall take judicial notice of the seal of the Board affixed to any document and shall deem that it was duly affixed.


Members of the Board

6.-(1) The Board shall consist of the Permanent Secretary and of three members who shall be appointed annually by the Minister:


Provided that one member shall be a registered pharmacist who is in business in Fiji on his own account. (Amended by Ordinance 52 of 1968, s. 2; Legal Notice 112 of 1970.)


(2) The Permanent Secretary shall be ex officio chairman of the Board.


(3) The chairman and one member shall form a quorum.


(4) The chairman shall have an original vote and in the event of equality of voting a second or casting vote.


Meetings of the Board

7. All meetings of the Board shall be convened by the chairman by notice in writing to the other members of the Board specifying the time and place of meeting.


Board may summon person to attend and give evidence

8.-(1) For the purposes of this Act, the Board may by writing under the hand of the chairman summon any person to attend the meeting of the Board at a time and place named in the summons and then and there to give evidence and to produce any books, documents or writings in his custody or control which he is required by the summons to produce.


(2) The Board may in its discretion on the application of any party to any proceedings before the Board by writing under the hand of the chairman summon any person to appear as a witness before the Board.


Chairman may administer oath

9. The chairman of the Board may administer an oath to any person appearing before the Board, whether the witness has been summoned or appears without being summoned before the Board, and may examine the witness upon oath.


Person failing to appear when summoned

10. If any person served with a summons to attend the Board fails without reasonable cause to attend the Board or to produce any documents, books or writings in his custody or control which he was required by the summons to produce, he shall be guilty of an offence and shall be liable to a fine not exceeding $100. (Amended by Ordinance 2 of 1945, s. 112.)


Person refusing to make oath or affirmation

11. If any person appearing as a witness before the Board refuses to be sworn or to make an affirmation or to answer any question relevant to the proceedings before the Board put to him by any member thereof, he shall be guilty of an offence and shall be liable to a fine not exceeding $100:


Provided that nothing contained in this section shall render any person compellable to answer any question in respect of any matter which would have been protected from disclosure on the ground of privilege if the proceedings had been held in any court. (Amended by Ordinance 22 of 1938, s. 3; 2 of 1945, s. 112.)


False testimony

12. Any witness before the Board who knowingly gives false testimony touching any matter material to any inquiry shall be guilty of an offence and shall be liable to a fine not exceeding $200 or to imprisonment for any period not exceeding 12 months. (Amended by Ordinance 2 of 1945, s. 112.)


Liability of members

13. The members of the Board shall not be personally liable for any act or default of the Board done or omitted to be done in good faith in administering this Act.


Fees

14.-(1) The Board may demand and in advance collect such fees as are prescribed.


(2) Such fees and all penalties and other moneys received or realized under this Act or under any regulations made hereunder shall be paid into the Consolidated Fund.


Power of search

15. Any person thereto authorised in writing by the chairman may enter into premises in which any pharmacist or licensed seller of poisons or medicines is carrying on business and may examine any books, papers, records or writings, medicines, or any article stored or offered for sale or used in the business. (Amended by Act 2 of 1980, s. 9 and Sched.)


Secretary

16.-(1) The Minister may appoint from time to time a secretary to the Board.


Inspectors

(2) The Minister may appoint inspectors for the purposes of enforcing the provisions of this Act or any regulations made thereunder. (Amended by Legal Notice 112 of 1970.)


Persons eligible for appointment as inspectors

17. No person who is not a registered medical practitioner or a registered pharmacist shall be eligible for appointment as an inspector under this Act.


Powers of inspectors

18. For the purposes of enforcing the provisions of this Act or regulations made thereunder any inspector so appointed shall have the power at all reasonable times to enter upon the premises of any registered pharmacist or licensed seller of poisons or holder of a manufacturer's or wholesale licence and to inspect any books, papers, records or writings, medicines, or any article stored or offered for sale or used in the business, and shall have the power at all reasonable times to enter any premises in which he has reasonable cause to suspect that a breach of the law has been or is being committed and to make such examination and inquiry and to do such other things (including the taking on payment therefor of samples) for the purpose of ascertaining whether the provisions aforesaid are being complied with. (Amended by Act 2 of 1980, s. 9 and Sched.)


Certificate of Government analyst

19. In any proceedings under this Act a document purporting to be a certificate signed by the Government analyst stating results of an analysis made by him shall be admissible as prima facie evidence of the matters stated by him.


PART III - PHARMACISTS


Register of Pharmacists

20. The Board shall keep a register to be called the "Register of Pharmacists".


Pharmacists how registered

21.-(1) A person shall be registered by the entry in the register of his name and such other particulars relating to him as are prescribed.


(2) Every such entry in the register shall be signed by the registrar of the Board.


(3) The Permanent Secretary shall be the registrar.


Persons eligible for registration

22. Any person who is of good fame and character and who has passed the final examination of the Pharmaceutical Society of Great Britain or Northern Ireland or of any Pharmacy Board, Society or College of any country, state or territory of the Commonwealth mentioned in the First Schedule may be registered under the provisions of this Act. (Amended by Ordinance 22 of 1938, s. 4; 37 of 1966, s. 39.)


Board may direct examination of applicant

23.-(1) The Board may direct that any pharmacist applying for registration as a pharmacist shall pass an examination and for that purpose may appoint an examination board consisting of the Permanent Secretary as chairman and of two members who shall be registered pharmacists.


(2) The Board may prescribe fees for such examination not exceeding $10.


Registration of applicants

24. When any person has applied to be registered and has proved to the satisfaction of the Board that -


(a) he has attained the age of twenty-one years;


(b) he is entitled to be registered by virtue of compliance with the requirements mentioned in section 22; and


(c) that the certificate or diploma testifying to his qualification was after examination duly obtained by him from such a Society, Board or College as is specified in section 22 and in the period in which he has held the certificate or diploma his name has not been removed from the register of any country, state or territory for any cause which would on its happening disqualify him from being registered under this Act and has not been removed from the register of persons entitled to practise pharmacy in the country, state or territory concerned, the Board may cause the person to be registered by entering in the register his name and such other particulars as may be prescribed and issue to him upon payment of the prescribed fee, a certificate in the prescribed form. (Amended by Ordinance 37 of 1966, s. 39.)


Appeal against refusal of Board to register

25.-(1) If the Board refuses to register any person under this Act, the Board shall, if required by such person, state in writing the reasons for such refusal.


(2) Such person may thereupon appeal to the Supreme Court.


(3) An appeal under this section shall be by way of special case in the same manner as provided for under section 31 and the Board shall, if the Supreme Court so orders, register the said person.


Copy of register to be published

26.-(1) During the month of January in each year the Board shall cause to be published in the Gazette a true copy of the register.


(2) A copy of the register so published shall be prima facie evidence of the registration of the persons named therein.


Fraudulent representation

27. Any person who procures himself to be registered under this Act by means of any false or fraudulent representations or by the production of any false certificate or diploma shall be guilty of an offence and shall be liable to a fine not exceeding $200 or, to imprisonment for any period not exceeding twelve months. (Amended by Ordinance 2 of 1945, s. 112.)


Amendments may be made in register

28. Any registered pharmacist who obtains or already possesses any higher degree or any qualification other than the one qualification in respect of which he is registered may have such higher degree or additional qualification inserted in the register without payment of any additional fee.


Notification of change of address or death

29.-(1) Any registered pharmacist who changes his professional address shall forthwith give notice of the fact in writing to the chairman of the Board.


(2) The Registrar-General on registering the death of any pharmacist shall forthwith give notice in writing thereof to the chairman of the Board.


Correction of register

30.-(1) The Board shall remove from the register the name of any registered pharmacist who has died, and may make such alterations and amendments in the register as it thinks fit.


(2) The Board may by notice in writing to any registered pharmacist addressed to him by registered post according to his address in the register inquire whether he has changed his address or residence, and, if an answer is not returned to such notice within six months after the date of the posting thereof, the Board may remove the name of such person from the register.


(3) The name of any registered pharmacist removed from the register under this Part may be restored by the Board. (Amended by Ordinance 22 of 1938, s. 5.)


Corporate body may carry on business of pharmacist

31.-(1) Subject to the provisions of this section a body corporate carrying on a business which comprises the retail sale of medicines shall be an authorised seller of poisons within the meaning of this Act if the following conditions are complied with:-


(a) the business shall, so far as concerns the keeping, dispensing and compounding of medicines and poisons, be under the management of a superintendent in relation to whom the following requirements are fulfilled -


(i) he shall be a registered pharmacist;


(ii) a statement in writing signed by him on behalf of the body corporate stating his name and stating whether or not he is a member of the board of directors shall have been sent to the registrar;


(iii) he shall not be acting at the time in a similar capacity for any other body corporate; and


(b) in each set of premises where the business is carried on the business shall, so far as concerns the retail sale of medicines if not under the personal control of the superintendent, be carried on subject to the directions of the superintendent under the personal control of a manager or assistant who is a registered pharmacist; and


(c) the name and the certificate of registration of the person having the control of the business as aforesaid, whether he is the superintendent or some other person, shall be conspicuously exhibited in the premises; and


(d) all the share capital of the body corporate is owned by registered pharmacists:


Provided that the provisions of this paragraph shall not apply to any body corporate which was, on 19 November 1968, lawfully carrying on any business which comprised the retail sale of medicines for the purposes of this subsection.

(Amended by Ordinance 52 of 1968, s.3; Act 2 of 1980, s. 9 and Sched.)


(2) Notwithstanding the restrictions imposed by the provisions of this Act on the use of certain titles, emblems and descriptions, a body corporate which is an authorised seller of poisons may, if all the members of the board of directors are registered pharmacists use the description of "chemist and druggist" or of "chemist" or of "druggist" or of "dispensing chemist" or of "dispensing druggist" and may use the description of "pharmacy" in connection with the business:


Provided that nothing in this subsection shall authorise the use of any of the said descriptions in or upon any premises which are for the time being disqualified under this section from being registered in the Register of Premises or in connection with any business so far as it is carried on in any premises so disqualified.


(3) If -


(a) a body corporate which is an authorised seller of poisons has been convicted of any offence under this Act; or


(b) any member of the board of directors or any officer of that body or any person employed by that body in carrying on the business has been convicted of any such criminal offence or been guilty of any such misconduct as in the opinion of the Board renders him or would, if he were a registered pharmacist, render him unfit to be on the register,


the Board may inquire into the case and may, subject to the provisions of this Act, direct -


(i) that the body corporate shall cease to be an authorised seller of poisons and be disqualified for such period as may be specified in the direction from being an authorised seller of poisons; or


(ii) that any or all of the premises of the body corporate shall be removed from the Register of Premises and be disqualified for such period as may be specified in the direction from being registered therein.


(4) If the Board thinks fit in any case so to do it may either on its own motion or on the application of the body corporate concerned direct that any disqualification imposed under this section shall cease:


Provided that where an appeal has been brought to the Supreme Court against a direction involving a period of disqualification a direction under this subsection for a cesser of any disqualification subsisting by virtue of any direction as originally given shall not take effect unless approved by the Minister. (Amended by Legal Notice 112 of 1970.)


(5) Any body corporate which has been disqualified in pursuance of this section may appeal by way of special case to the Supreme Court on any question of fact or law affecting the aforesaid disqualification, and the Board shall, if the Supreme Court so orders, set aside the disqualification.


Restriction on number of pharmacies

32.-(1) Except as otherwise provided by this Act -


(a) no body corporate, either alone or in partnership, shall, without the consent of the Board, establish or carry on in more than one set of premises any business which comprises the retail sale of medicines for the purposes of section 31; and


(b) no pharmacist or other person, either alone or in partnership, shall, without the consent of the Board, establish or carry on the business of a pharmacist in more than one set of premises:


Provided that any body corporate or any pharmacist who was, on 19 November 1968, either alone or in partnership, lawfully carrying on such business in more than one set of premises may, subject to the provisions of this Act, carry on such business in those premises.


(2) The Board may, where it considers it to be in the public interest, give its consent to a body corporate or to a pharmacist, either alone or in partnership, to establish or carry on such business as aforesaid in two, but not more than two, sets of premises.

(Inserted by Ordinance 52 of 1968, s. 4; amended by Act 2 of 1980, s. 9 and Sched.)


Establishment of Fiji Pharmaceutical Society

32A.-(1) There is hereby established a society under the name of the Fiji Pharmaceutical Society, which shall be a body corporate with perpetual succession and a common seal.


(2) The Fiji Pharmaceutical Society shall have power to hold real and personal property and may sue and be sued in matters whether relating to contract or tort or otherwise in connection with the exercise of its powers or the carrying out of its functions under this Act.


(3) Membership of the Fiji Pharmaceutical Society shall be open to every person who is a registered pharmacist.


(4) The Fiji Pharmaceutical Society may make rules for the election of officers of the Society, the summoning of meetings of the Society, the regulation and conduct of meetings and the proceedings thereat, the terms and conditions of membership and for all such matters as may be deemed necessary and proper to ensure the efficient functioning of the Society.

(Inserted by Act 2 of 1980, s. 4.)


Objects of Fiji Pharmaceutical Society

32B. The objects for which the Fiji Pharmaceutical Society is established are -


(a) to maintain and improve the standards of conduct and learning of the pharmaceutical profession in Fiji;


(b) to promote the welfare and to preserve and maintain the integrity and status of the pharmaceutical profession;


(c) to represent the views, interests and wishes of the pharmaceutical profession;


(d) to represent, protect and assist members of the pharmaceutical profession in Fiji as regards conditions of practice and otherwise;


(e) to settle points of practice and to provide means for the amicable settlement of professional differences;


(f) to protect and assist the public and the pharmaceutical profession in all matters touching, ancillary or incidental to the practice of pharmacy;


(g) to assist needy members and former members of the Fiji Pharmaceutical Society or their relatives and the relatives of deceased members;


(h) to acquire, hold, develop or dipose of property of all kinds, whether real or personal, and to apply capital or income therefrom, for all or any of the foregoing objects;


(i) to raise or borrow money for all or any of the foregoing objects in such manner and upon such security as may from time to time be determined by the Fiji Pharmaceutical Society including a mortgage or charge of the property or assets of the Society;


(j) to invest and deal with moneys of the Fiji Pharmaceutical Society not immediately required in such manner as may from time to time be determined by the said Society;


(k) to pay the whole or any part of the expenses incurred by members in attending meetings of the Fiji Pharmaceutical Society or of any committee appointed by the said Society;


(l) to pay all costs and other payments incidental to or connected with the discharge of any function of the Fiji Pharmaceutical Society;


(m) to cultivate a generous professional spirit among pharmacists by encouraging meetings of members of the Fiji Pharmaceutical Society and persons connected with matters of pharmaceutical interest;


(n) to do all such other things as are incidental or conducive to the attainment of the foregoing objects or any of them.

(Inserted by Act 2 of 1980, s. 4.)


Former Fiji Pharmaceutical Society

32C.-(1) The persons who immediately before 2 May 1980 were members and officers of the body previously known as the Fiji Pharmaceutical Society (in this section referred to as "the former Society") shall be deemed to be members and officers of the Fiji Pharmaceutical Society established by section 32A (in this section referred to as "the incorporated Society") upon the same terms and conditions as those on which they were members and officers of the former society until those terms and conditions are varied or superseded by other terms and conditions under rules made by the incorporated Society pursuant to section 32A (4).


(2) The rules of the former Society in force immediately before 2 May 1980 shall be deemed to be the rules of the incorporated Society until they are amended or revoked by rules made by the incorporated Society under section 32A (4).


(3) All rights, property and assets of the former Society existing at 2 May 1980, shall as from that date be vested in the incorporated Society without further assurance and all liabilities of the former Society shall, as from that date be transferred to and discharged by the incorporated Society, subject however to all defences and remedies which were previously available to the former Society in respect thereof; and as from the said date the former Society is dissolved.

(Inserted by Act 2 of 1980, s. 4.)


PART IV - CONDUCT OF BUSINESS AS PHARMACIST


Grounds of cancellation of registration

33.-(1) The Board shall remove from the register the name of any person -


(a) whose registration has been obtained by fraud or misrepresentation;


(b) who has ceased to possess or does not possess the qualifications in respect of which he was registered;


(c) who has been convicted whether in Fiji or elsewhere of an indictable offence or of any other offence which in the opinion of the Board renders him unfit to practise;


(d) who has been certified to be of unsound mind; or


(e) who is deemed by the Board guilty of -


(i) habitual drunkenness or habitual addiction to any drug;


(ii) such improper conduct as in the opinion of the Board renders him unfit to be allowed to continue to practise as a pharmacist.


(2) If the Board removes the name of any person from the register it shall, if so required by him, state in writing the reason for the removal.


(3) Any person whose name has been removed from the register in pursuance of this section may appeal by way of special case as aforesaid to the Supreme Court to have his name restored to the register, and the Board shall, if the Supreme Court so orders, restore his name to the register.


Removal of name from register

34.-(1) Before removing from the register the name of any person the Board shall make due inquiry, and such person may be represented by a barrister and solicitor or agent who may examine witnesses and address the Board on his behalf.


(2) Pending the hearing of a charge against any person the Board may suspend the registration of that person who shall thereupon cease to practise.


Surrender of certificate of registration

35. Any person whose name is removed from the register under section 33 shall, within fourteen days after the posting of a notice demanding the return of his certificate of registration, surrender his certificate to the Board for cancellation, and any person who fails so to do shall be liable to a fine not exceeding $10 for every day after the period of fourteen days during which the certificate is not returned.

(Amended by Ordinance 2 of 1945, s. 112.)


Persons other than registered pharmacists not to carry on business

36.-(1) Subject to the provisions of subsection (2), any person other than a registered pharmacist who carries on or attempts to carry on in any place or on any occasion the business of a pharmacist or pretends to be a pharmacist or assumes or uses the title of pharmaceutical chemist, pharmacist, druggist, homeopathic chemist, dispensing chemist or of member of any Pharmaceutical Society or Board or takes or uses in connection with the sale of goods the title of chemist shall be guilty of an offence. (Amended by Ordinance 52 of 1968, s. 5.)


(2) Any person other than a registered pharmacist who, either alone or in partnership with a registered pharmacist, is the owner or part owner of the business of a pharmacist, shall be guilty of an offence:


Provided that the provisions of this subsection shall not apply to any person who was, on 19 November 1968, the owner or part owner of such a business in respect of one set of premises within a radius of one mile from the place where the business of that pharmacy was at that date being carried on.

(Inserted by Ordinance 52 of 1968, s. 5.)


(3) No person shall use in connection with any business any title, emblem or description reasonably calculated to suggest that he or anyone employed in the business possesses any qualification with respect to the selling, dispensing or compounding of medicines or poisons other than the qualification which he in fact possesses. (Amended by Act 2 of 1980, s. 9 and Sched.)


For the purposes of this subsection the use of the description "pharmacy" in connection with a business carried on on any premises shall be deemed to be reasonably calculated to suggest that the owner of the business and the person having the control of the business on those premises are registered pharmacists.


(4) If any person acts in contravention of the foregoing provisions of this section he shall be liable in respect of each offence to a fine not exceeding $1,000 and in the case of a continuing offence to a further fine not exceeding $50 for every day subsequent to the day on which he is convicted of the offence during which the offence continues.


Death, unsoundness of mind or bankruptcy of pharmacist

37.-(1) Subject to the provisions of this section if a registered pharmacist who is an authorised seller of poisons dies or becomes of unsound mind or is adjudicated bankrupt or enters into any arrangement with his creditors, any representatives who thereafter carry on his business in accordance with the conditions hereinafter specified and are persons in relation to whom the requirements of this section are satisfied shall, for the purposes of that business and during the period specified in subsection (4), be authorised sellers of poisons within the meaning of this Act and be entitled to use in conjunction with the business name of the pharmacist such titles, emblems and descriptions as might have been used by the pharmacist.


(2) The conditions referred to in subsection (1) are as follows:


(a) in each set of premises where the business is carried on, the business, so far as concerns the retail sale of medicines, shall be under the personal control of a registered pharmacist; and


(b) the name and certificate of registration of the person having the control of the business as aforesaid shall be conspicuously exhibited in the premises.

(Amended by Act 2 of 1980, s. 9 and Sched.)


(3) The requirements to be satisfied under the provisions of subsection (1) in relation to the representatives are that their names and addresses shall be registered with the registrar together with a statement of the name of the pharmacist whose representatives they are.


(4) The period referred to in subsection (1) shall be -


(a) in the case of the death of a pharmacist, a period of five years from the date thereof;


(b) in the case of the unsoundness of mind or bankruptcy of a pharmacist, a period of three years from the date when he became of unsound mind or was adjudicated bankrupt;


(c) in the case of an arrangement with the creditors of a pharmacist, a period of three years from the date when the representatives became entitled thereunder to carry on his business;


or such longer period as on the application of the representatives the Board may, having regard to all the circumstances of the case, think fit to direct.


(5) If a representative or a person employed by the representatives in the carrying on of the business has been convicted of any such criminal offence or been guilty of any such misconduct as in the opinion of the Board renders him or would, if he were a registered pharmacist, render him unfit to be on the register, the Board, after making inquiry into the case, may, subject to the provisions of this Act, direct that the representatives shall cease to be authorised sellers of poisons and cease to be entitled to use the titles, emblems and descriptions which might have been used by the pharmacist.


(6) In this section the expression "representative" means an executor, administrator, trustee or committee or a person authorised to exercise in relation to a person of unsound mind not so found by inquisition any of the powers of a committee and includes, in respect of the period of three months after the death of a pharmacist leaving no executor who is entitled and willing to carry on his business, any person beneficially interested in the estate of the pharmacist.


Name of pharmacist to be exhibited

38. Every pharmacist and every person or assistant under whose conduct or management the business of a pharmacist is carried on shall have his name legibly painted or written and continually so maintained on a conspicuous place on the front of the building where the business is carried on.


Pharmacists only to dispense

39. Save as hereinafter provided no person other than a registered pharmacist or a bona fide assistant to a registered pharmacist under the immediate and personal supervision and control of a registered pharmacist shall dispense or compound for fee or reward any medicine:


Provided always that this section shall not apply to the employment of medical practitioners in public hospitals or dispensaries.

(Amended by Ordinance 9 of 1955, s. 14, 37 of 1966, s. 39; Act 14 of 1975, s. 26; 24 of 1976,

s. 7; 2 of 1980, s. 9 and Sched.)
[(2) * * * * * (Repealed by Act 24 of 1976, s. 7.)]


Temporary licence

40.-(1) The Board may upon the application of any registered pharmacist issue a temporary permit to a pharmacist who possesses the qualifications mentioned in section 22 to act as locum tenens for such registered pharmacist for a period of three calendar months from the date of issue of the permit.


(2) The Board may renew any such permit for a further period of three months but not for any longer period.


(3) The Board shall prescribe fees for such permit.


Prescriptions to be signed

41.-(1) A medical practitioner shall not issue a prescription unless the prescription is signed by him with his usual signature or is written on paper on which is printed his surname and the initials of his Christian names and bears the date on which the prescription was issued.

(Amended by Ordinance 32 of 1962, s. 3; Act 14 of 1975, s. 26.)


(2) A prescription issued by a qualified veterinary surgeon shall, in addition to fulfilling the conditions laid down in subsection (1), bear the words "for veterinary purposes only".


(3) A prescription issued by a registered dentist shall, in addition to fulfilling the conditions laid down in subsection (1), bear the words "for dental purposes only".


Record of prescriptions

42.-(1) Every pharmacist shall as prescribed record in a book, hereinafter called the "prescription book", to be kept by him for that purpose every prescription of any medical practitioner or medical officer dispensed, compounded or made up or supplied by him. (Amended by Ordinance 32 of 1962, s. 4.)


(2) Every prescription whether issued by a registered medical practitioner, qualified veterinary surgeon or registered dentist containing any of the drugs as are prescribed in the Dangerous Drugs Act shall be retained in the custody of the pharmacist dispensing the same for a period of 2 years and filed in the pharmacy as prescribed by the said Act. (Cap. 114.)


(3) The prescription book shall be open for inspection by any inspector appointed under section 16.


Conduct of business by pharmacist

43. A pharmacist shall not -


(a) keep or maintain any shop for selling or supplying medicines or for dispensing or compounding prescriptions unless such shop is while open for business constantly under his own control or that of some other registered pharmacist as an assistant or agent of a registered pharmacist;


(b) permit any person other than a bona fide assistant or apprentice in the course of his employment and under the actual personal supervision of a registered pharmacist to sell or supply medicines or compound or dispense medicines;


(c) permit any person other than a registered pharmacist to dispense or compound any prescription or supply any medicine containing any of the dangerous drugs as prescribed in the Dangerous Drugs Act; (Cap. 114.)


(d) carry on business except under the actual personal supervision of himself or some other registered pharmacist;


(e) practise pharmacy except under his own name;


(f) adopt the title "consulting chemist";


(g) give medical or surgical advice or aid except in his place of business and -


(i) in the case of simple ailments of common occurrence;


(ii) in the administration of antidotes in the case of acute poisoning;


(iii) in the application of immediate aid in cases of accident or injury; or


(iv) in urgent or emergent cases under the direct instructions of a registered medical practitioner or medical officer;


(h) allow his name to be used in connection with the practice of pharmacy at any premises at which there is not a registered pharmacist in continual attendance; or


(i) aid or assist any person other than a registered pharmacist to practice pharmacy except in accordance with the provisions of this Act.

(Amended by Ordinance 32 of 1962, s. 6; Act 2 of 1980, s. 9 and Sched.)


Medical practitioners, etc., may dispense

44.-(1) Subject to subsection (2), a registered medical practitioner may dispense or compound any medicine or drugs for patients without being a registered pharmacist.


(2) Notwithstanding subsection (1), a registered medical practitioner whose place of practice is within five kilometres of a place of practice of a registered pharmacist shall not dispense or compound any medicine or drugs except -


(a) where it is necessary to do so in connection with -


(i) the application of a dressing; or


(ii) the administration of a medicine or drug, in the surgery of the medical practitioner;


(b) in an emergency; or


(c) at a time when the medicine or drug cannot reasonably be obtained from the place of practice of a registered pharmacist situated within five kilometres of the place of practice of the registered medical practitioner.


(3) A qualified veterinary surgeon may dispense or compound a medicine or drug without being a registered pharmacist if the medicine or drug is to be used for the purpose of treating an animal.


(4) A registered medical practitioner or a qualified veterinary surgeon shall keep a record of all medicines or drugs dispensed by him.


(5) A record kept for the purposes of subsection (4) shall be made available for inspection by an inspector or by a person approved for the purpose by the Board.

(Substituted by Act 18 of 1984; s. 3.)


Automatic machines for vending medicines prohibited

45.-(1) Any person who -


(a) instals any automatic machine for the sale or supply of any medicine or device for preventing conception or allows, permits or suffers any such automatic machine to be so installed;


(b) sells or supplies any medicine by means of any such automatic machine;


(c) allows, permits or suffers any person to purchase or be supplied with or otherwise obtain any medicine or device for preventing conception by means of any automatic machine,


shall be guilty of an offence and shall be liable to a fine not exceeding $40 and, in the case of a continuing offence, to a further fine of $10 for every day subsequent to the day on which he is convicted of the offence during which the offence continues. (Amended by Ordinance 2 of 1945, s. 112; 52 of 1968, s. 6; Act 2 of 1980, s. 9 and Sched.)


(2) For the purpose of subsection (1) "automatic machine" means any machine or mechanical device used or capable of being used for the purpose of selling or supplying goods without the personal manipulation or attention of the seller or of his employee or other agent at the time of the sale or supply.


Restrictions on supply of certain medicines

46.-(1) Any person other than a registered medical practitioner or a person acting under the direct instructions of such medical practitioner who attends upon, prescribes for or supplies any article as a medicine to any person for the alleviation, cure or treatment of any venereal disease, whether in fact such person is suffering from such disease or not, or of any disease affecting the generative organs or functions or of sexual impotence or of any complaint or infirmity arising or relating to sexual intercourse or of female or menstrual irregularities or for the purpose of terminating pregnancy or of influencing the course of pregnancy shall be guilty of an offence and shall be liable to a fine not exceeding $200. (Amended by Ordinance 2 of 1945, s. 112; Act 14 of 1975, s. 26; 2 of 1980, s. 9 and Sched.)


(2) Nothing in this section shall apply to -


(a) a registered pharmacist who dispenses to the patient of a registered medical practitioner the prescription of such medical practitioner if the prescription is dated and bears the address and the usual signature (including the surname) of the practitioner; or


(b) a registered pharmacist who in the ordinary course of his business sells or supplies any medicine (except such medicine as may be prescribed for the purpose of this subsection) provided such medicine is sold or supplied by the pharmacist for purposes other than those prescribed by this section; or


(c) a registered nurse in the public service who, in the course of her duties, sells or supplies any medicine in accordance with the instructions of the Permanent Secretary, registered dentists, registered veterinary surgeons, registered pharmacists, registered nurses or midwives. (Amended by Ordinance 52 of 1968, s. 7; Acts Nos. 14 of 1975, s. 26; 2 of 1980, ss. 5, 9 and Sched.)


False or misleading advertisements

47.-(1) Subject to subsections (2) and (3) any person who issues, or causes another person to issue, a false or misleading advertisement relating to medicines of any description shall be guilty of an offence and liable to a fine not exceeding $500 or to imprisonment for a term not exceeding one year or to both such fine and imprisonment.


(2) Where a person is charged with an offence under subsection (1), it shall be a defence for him to prove that he did not know, and could not with reasonable diligence have discovered, that the advertisement was false or misleading.


(3) Without prejudice to subsection (2), where a person is charged with an offence under subsection (1), it shall be a defence for him to prove that he is a person whose business it is to issue or arrange for the issue of advertisements, and that either -


(a) he received the advertisement for issue in the ordinary course of business and issued it, or arranged for it to be issued, either unaltered or without any alteration except in respect of lettering or lay-out; or


(b) not being concerned with manufacture of or dealing in medicines, he received from a person so concerned the information on which the advertisement was based and in the ordinary course of business prepared the advertisement in accordance with that information at the request of that person,


and (in either case) that he did not know and had no reason to suspect that the issue of the advertisement would amount to an offence under subsection (1).

(Substituted by Act 2 of 1980, s. 6.)


Prohibition of certain advertisements

47A.-(1) Subject to subsections (3) and (4) no person shall issue, or cause another person to issue, any advertisement relating to any medicine for treatment or prevention or termination of a disease, complaint, infirmity or condition of any description prescribed by regulations under section 71.


(2) Any person who contravenes any of the provisions of subsection (1) or of any regulation made thereunder shall be guilty of an offence and liable to a fine not exceeding $200 or to imprisonment for a term not exceeding six months or to both such fine and imprisonment.


(3) Where a person is charged with an offence under subsection (1) it shall be a defence for him to prove -


(a) that the advertisement was issued only in so far as it was necessary to bring it to the notice of medical practitioners or registered pharmacists or persons undergoing training with a view to becoming medical practitioners or registered pharmacists;


(b) that the advertisement was issued only in publications of a technical character intended for circulation mainly among medical practitioners or registered pharmacists; or


(c) that the advertisement was issued in such circumstances that he did not know and had no reason to believe that he was taking part in the issue thereof.


(4) Nothing in this section shall apply in respect of any advertisement issued by the Government or a local authority or by any person acting with a written permission of the Minister.

(Inserted by Act 2 of 1980, s. 6.)


Meaning of advertisement in sections 47 and 47A

47B.-(1) Subject to subsections (2) and (3), "advertisement" in sections 47 and 47A includes any form of advertising, whether in a publication, or by the display of any notice, or by means of any catalogue, price list, letter (whether circular or addressed to a particular person) or other document, or by words inscribed on any article, or by the exhibition of a photograph or a cinematograph film, or by way of sound recording, sound broadcasting or television, or in any other way, and any reference to the issue of an advertisement shall be construed accordingly.


(2) Notwithstanding anything contained in subsection (1) "advertisement" does not include spoken words except -


(a) words forming part of a sound recording or embodied in a sound track associated with a cinematograph film; and


(b) words broadcast by way of sound broadcasting or television or transmitted to subscribers to a diffusion service.


(3) For the purposes of subsection (1) neither of the following shall constitute the issue of an advertisement -


(a) the sale or supply, or offer or exposure for sale or supply, of a medicine in a labelled container or package;


(b) the supply, with a medicine of any description, of a leaflet relating solely to medicines of that description.

(Inserted by Act 2 of 1980, s. 6.)


British Pharmacopoeia

48.-(1) Unless and until it is superseded or varied in pursuance of the power hereinafter contained, the British Pharmacopoeia as published in England under the direction of the General Council of Medical Education and Registration of the United Kingdom in the edition for the time being in force shall be the pharmacopoeia in force in Fiji as the standard of quality or composition for all medicines and for the method of preparation of all medicines and of compounding of all mixtures thereof, and for the purposes of this Act the metre and the gram shall be accepted respectively as legal units of measure and weight.

(Amended by Ordinance 5 of 1958, s. 4; Act 2 of 1980, s. 9 and Sched.)


(2) The Board may from time to time prescribe variations of the standards or methods contained in the British Pharmacopoeia or that the same be superseded by such other standards and methods as the Board may prescribe. (Inserted by Ordinance 5 of 1958, s. 4.)


PART V-MANUFACTURE, SALE AND SUPPLY OF MEDICINES
(Amended by Act 2 of 1980, s. 7.)


Licensing of manufacture and wholesale dealing

48A.-(1) Subject to section 48B no person shall, in the course of business carried on by him, manufacture any medicine except in accordance with a licence granted for the purposes of this subsection (in this Act referred to as a "manufacturer's licence").


(2) Subject to section 48B no person shall, in the course of business carried on by him, sell or offer for sale, any medicine by way of wholesale dealing, or import any medicine for such purpose, except in accordance with a licence granted for the purpose of this subsection (in this Act referred to as a "wholesale licence").

(Inserted by Act 2 of 1980, s. 7.)


Exemptions from licensing

48B.-(1) Section 48A shall not apply to anything done by a medical practitioner or a registered dentist which -


(a) relates to a medicine specially prepared, or specially imported by him or to his order, for administration to a particular patient of his, and consists of manufacturing the product or of selling or supplying it to that patient or to a person under whose care that patient is; or


(b) relates to a medicine specially prepared at the request of another medical practitioner or registered dentist, or specially imported by him or to his order at the request of another medical practitioner or registered dentist, for administration to a particular patient of his and consist of manufacturing the product or of selling or supplying it to that other practitioner or dentist or to that patient or to a person under whose care that patient is.


(2) Section 48A shall not apply to anything which is done by a registered pharmacist, in the course of his business as such, or at a hospital, clinic, nursing home or similar institution, and is done there by or under the supervision of a registered pharmacist, and consists of manufacturing a medicine in accordance with a prescription given by a medical practitioner for administration to a particular person or description of persons.


(3) Section 48A shall not apply to anything done by a qualified veterinary surgeon which -


(a) relates to a medicine specially prepared for administration to a particular animal or herd which is under his care, and consists of manufacturing the medicine or of selling or supplying it to a person having the possession or control of that animal or herd;


(b) relates to a medicine specially prepared at the request of another qualified veterinary surgeon for administration to a particular animal or herd which is under the care of that other surgeon, and consists of manufacturing the medicine or of selling or supplying it to that other surgeon or to a person having the possession or control of that animal or herd.


(4) Section 48A shall not apply to the assembly of any medicine by a person in the course of that person's profession as a nurse or midwife registered under the Nurses and Midwives Act.(Cap. 256.)

(Inserted by Act 2 of 1980, s. 7.)


Application for manufacturer's or wholesale licence

48c.-(1) An application for a manufacturer's or a wholesale licence shall be made to the Board and shall be made in such form and manner, and shall contain, or be accompanied by, such information, documents, samples and other materials as may be prescribed.


(2) Any such application shall indicate the descriptions of medicines in respect of which the licence is required, either by specifying the descriptions of the medicines in question or by way of an appropriate general classification.

(Inserted by Act 2 of 1980, s. 7.)


Factors relevant to determination of application

48D.-(1) In dealing with an application for a manufacturer's or wholesale licence the Board shall in particular take into consideration -


(a) the safety of medicines of each description to which the application relates;


(b) the efficacy of medicines of each such description for the purposes for which the medicines are proposed to be administered; and


(c) the quality of medicines of each such description, according to the specification and the method or the proposed method of manufacture, and the provisions proposed for securing that the medicines sold or supplied will be of that quality.


(2) In taking into consideration the efficacy for a particular purpose of a medicine of a description to which the application relates, the Board shall leave out of account any question whether a medicine of another description would or might be equally or more efficacious for that purpose;


Provided that nothing in this subsection shall be construed as requiring the Board, in considering the safety of medicines of a particular description, in relation to a purpose for which they are proposed to be administered, to leave out of account any question whether a medicine of another description, being equally or more efficacious for that purpose, would or might be safer in relation to that purpose.


(3) In dealing with an application for a manufacturer's licence the Board shall in particular take into consideration -


(a) the operations proposed to be carried out in pursuance of the licence;


(b) the premises in which those operations are to be carried out;


(c) the equipment which is or will be available for carrying out those operations;


(d) the qualifications of the persons under whose supervision the manufacture will be carried on; and


(e) the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicines manufactured in pursuance of the licence.


(4) In dealing with an application for a wholesale licence the Board shall in particular take into consideration -


(a) the premises on which the medicines of the descriptions to which the licence relates will be stored;


(b) the equipment which is or will be available for storing medicines on those premises;


(c) the equipment and facilities which are or will be available for distributing medicines from those premises; and


(d) the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicines stored on or distributed from those premises.

(Inserted by Act 2 of 1980, s. 7.)


Persons qualified for grant of manufacturer's licences

48E.-(1) A manufacturer's licence may only be granted to a registered pharmacist or to a body corporate in respect of which the requirements specified in subsection (2) are fulfilled.


(2) The requirements referred to in subsection (1) are that the business of the body corporate, so far as it relates to manufacture of medicines, is under the management of a superintendent who is a registered pharmacist and does not act in a similar capacity for any other body corporate.


(3) Where an application for a manufacturer's licence is made by a body corporate there shall be furnished to the Board a statement signed by the superintendent and signed on behalf of the body corporate specifying his name and address and stating whether he is a member of that body or not.

(Inserted by Act 2 of 1980, s. 7.)


Grant or refusal of licence

48F.-(1) Subject to sections 48D and 48E on any application for a manufacturer's or wholesale licence -


(a) the Board may grant a licence containing such provisions as it considers appropriate; or


(b) if, having regard to the provisions of this Act, the Board considers it necessary or expedient to do so, it may refuse to grant a licence.


(2) The Board shall not refuse to grant such a licence on any ground relating to the price of a medicine, and shall not insert in any such licence any provisions as to the price at which a medicine may be sold, supplied, imported or exported.


(3) Where, on an application for such a licence, the Board -


(a) refuses to grant a licence; or


(b) grants a licence otherwise than in accordance with the application; the Board shall, if requested by the applicant to do so, serve on him a notice stating the reasons for its decision.

(Inserted by Act 2 of 1980, s. 7.)


Duration and renewal of licence

48G.-(1) Subject to this section a manufacturer's or wholesale licence, unless previously renewed or revoked, shall expire at the end of the period of five years from the date on which it was granted or the date as from which it was last renewed, as the case may be, or at the end of such shorter period from that date as may be specified in the licence as granted or last renewed.


(2) Any such licence, if it has not been revoked, may, on the application of the holder of the licence, be renewed by the Board for a further period of five years from the date on which it would otherwise expire or such shorter period from that date as the Board may determine.


(3) On an application to the Board for the renewal of a manufacturer's or wholesale licence, the Board -


(a) may renew the licence, with or without modifications, for such further period as is mentioned in subsection (2); or


(b) may grant to the applicant a new licence containing such provisions as the Board considers appropriate; or


(c) if, having regard to the provisions of this Act, the Board considers it necessary or expedient to do so, it may refuse to renew the licence or grant a new licence.


(4) In relation to any application for the renewal of any such licence sections 48C, 48D, 48E and 48F (2) and (3) shall have effect as if in those sections any reference to refusing a licence included a reference to refusing to renew a licence and any reference to granting a licence included a reference to renewing it.

(Inserted by Act 2 of 1980, s. 7.)


Suspension, variation and revocation of manufacturer's or wholesale licences

48H.-(1) Subject to this section the Board may suspend a manufacturer's licence or a wholesale licence for such period as the Board may determine or may revoke, or vary the provisions of, any such licence.


(2) The powers conferred by subsection (1) shall not be exercised except on one or more of the following grounds:


(a) that the matters stated in the application on which the licence was granted were false or incomplete in a material particular;


(b) that a material change of circumstances has occurred in relation to any of those matters;


(c) that any of the provisions of the licence has to a material extent been contravened by the holder of the licence;


(d) that the holder of the licence has without reasonable excuse failed to furnish such information with respect to medicines of a description to which the licence relates as is required of him by the Board.


(3) In relation to a manufacturer's licence, the powers conferred by subsection (1) shall be exercisable on the ground in addition to those specified in subsection (2), that the holder of the licence does not have the requisite facilities for carrying out properly processes of manufacture authorised by the licence.


(4) In relation to a wholesale licence the powers conferred by subsection (1) shall be exercisable on the grounds, in addition to those specified in subsection (2), that the equipment and facilities for storing and distributing medicines which are available to the holder of the licence are inadequate to maintain the quality of medicines of one or more descriptions to which the application for the licence related.


(5) Where in the exercise of its powers under subsection (1) the Board suspends, revokes, or varies the provisions of a licence it shall serve on the holder of the licence a notice giving the particulars of the suspension, revocation or variation and of the reasons therefor.

(Inserted by Act 2 of 1980, s. 7.)


Variation of manufacturer's or wholesale licence on application of holder

48I. Without prejudice to any power exercisable under section 48H, the Board may, on the application of the holder of a manufacturer's or wholesale licence, vary the provisions of the licence in accordance with any proposals contained in the application, if the Board is satisfied that the variation will not adversely affect the safety, quality or efficacy of medicines of any description to which the licence relates.

(Inserted by Act 2 of 1980, s. 7.)


Appeals

48J.-(1) Any applicant for the grant or renewal of a wholesale licence or a manufacturer's licence, or for variation of the provisions of any such licence, may appeal to the Minister against a decision of the Board to refuse his application; and any holder of such a licence may appeal to the Minister against a decision of the Board to revoke or suspend the licence or vary its provisions.


(2) Such appeal shall be made by notice in writing addressed to the Minister and the Board and served on them by post within fourteen days of the communication to the appellant of the decision against which the appeal is made.


(3) Upon receipt of a notice of appeal the Minister shall consider any written representations made to him in respect of the appeal by the appellant and the Board, and any oral representations so made with his permission, and shall thereafter determine the appeal.


(4) In the exercise of his powers to determine an appeal the Minister may dismiss the appeal or may give such directions in the matter as may appear to him to be appropriate and it shall be the duty of the appellant and the Board to comply with any such directions.


(5) The decision of the Minister on an appeal shall be final.

(Inserted by Act 2 of 1980, s. 7.)


Inspection and search of premises, etc.

48K.-(1) Sections 15 and 18 of this Act shall apply in relation to the premises of a holder of a manufacturer's licence or wholesale licence and to any substance or article found thereon as they apply in relation to the premises of a registered pharmacist or licensed seller of poisons and medicines and to anything which an inspector or a person authorised by the Chairman of the Board has power to inspect, examine or do.


(2) Where in the course of exercising his powers under subsection (1) an inspector or a person authorised by the Chairman of the Board requires a sample of a substance or article appearing to him to be a medicine he shall have a right to take a sample of such substance or article.


(3) Any person who -


(a) wilfully obstructs a person acting in the exercise of his functions under this section; or


(b) wilfully fails to comply with any requirement properly made to him by a person so acting; or


(c) without reasonable excuse fails to give to a person so acting any other assistance or information which that person may reasonably require of him for the purpose of the performance of his function under this section,


shall be liable to a fine not exceeding $540.

(Inserted by Act 2 of 1980, s. 7.)


Offences

48L. Any person who contravenes any of the provisions of section 48A or who is in possession of any medicine for the purpose of selling or supplying it in contravention of that section shall be liable to a fine not exceeding $1,000.

(Inserted by Act 2 of 1980, s. 7.)


Sale of medicines

49.-(1) It shall not be lawful for any person who is not a registered pharmacist or the assistant, manager or bona fide apprentice of a registered pharmacist to sell by retail any medicines whatsoever, whether protected by letters patent whether Imperial or of Fiji or not, except as prescribed by this Act.

(Amended by Act 2 of 1980, s. 9 and Sched.)


(2) Nothing in this Act contained shall be construed to prohibit any licensed storekeeper from selling any of the articles mentioned in the Second Schedule.


(3) The Minister may on the advice of the Board by order add to or delete from the articles mentioned in the Second Schedule. (Amended by Legal Notice 112 of 1970.)


Medicine Licence

50.-(1) The Board may on the application of any licensed storekeeper grant such person a licence, called a "Medicine Licence", to sell such articles as the Board deems fit:


Provided that -


(a) where the premises of a licensed storekeeper are reasonably accessible by road no such licence shall be granted if such premises are less than five miles by the shortest available route by road from the place of business of a registered pharmacist;


(b) no such licence shall be granted to sell any of the medicines to which the provisions of the Dangerous Drugs Act apply.

(Amended by Ordinance 22 of 1938, s.6; 20 of 1960, s.2 of 1980, s.9 and Sched)


(2) Such licence shall be granted for a period not exceeding six months and may be renewed.


(3) The Board shall prescribe fee for such licence.


(4) The licence shall be in the form prescribed by regulations made under the provisions of this Act and shall state clearly the names of all articles which the licensee is permitted to sell.


(5) Every application for a licence under this section shall be accompanied by a report by the Commissioner of the Division in which the business is carried on.


Animal Medicine Licence


51.-(1) The board may, on the application of any holder of a Poisons Licence issued under the provision of section 64 granted to such person, in the prescribed form, a licence called an "Animal Medicine Licence" to sell such animal medicines as are specified in the Fourth Schedule subject to such conditions as may be prescribed or as may be imposed by the Board.


(2) The Minister may, at any time, amend the Fourth Schedule.


(3) The provisions of subsections (2) and (3) of section 50 shall apply to licences granted under the provisions of this section.

(Section inserted by Ordinance 11 of 1970, s2;
subsec.(2) amended by Legal Notice 112 of 1970)


Police to be notified of issue of licence

52. Immediately on the granting of a licence the Board shall so inform the Commissioner or officer in charge of police of that Division in which the licence has been granted.


Only medicines mentioned in licence may be sold

53. It shall be lawful for a holder of such licence to sell or supply or cause or suffer to be sold and supplied by his assistant or manager only such medicines as, by virtue of such licence,, he is entitled to sell or supply. Any person acting in contravention of section shall be guilty of any offence and shall be liable to have his licence cancelled and also to a fine not exceeding $40 and in the case of a continuing offence to a further fine not exceeding $10 for every day subsequent to the day on which he is found guilty of such offence during which the offence continues.

(Amendmed by Ordinance 2 of 1945, s, 112; Act 2 of 1980, s.9 and Sched)


[54*****(Repealed by Act 2 of 1980, s.9 and Sched)]


Adulteration of medicines

55. Any person who adulterates any medicine in such manner as to lessen the efficacy of change the operation of such medicine or to make it noxious, intending that it shall be sold or used for, or knowing it to be likely to be sold or used for, any medicinal purpose as if it had not undergone such adulteration shall be guilty of an offence and shall be liable on conviction to imprisonment for a term not exceeding two years.

(Inserted by Ordinance 52 of 1968, s9; amended by Act 2 of 1980, s.9 and Sched.)


Sale of adulterated medicines

56. Any person who, knowing that any medicine has been adulterated in such manner as to lessen its efficacy or change its operation or to render it noxious, sells the same, or offer, exposed it for sale or issues it from any dispensary for medicinal purposes as unadulterated or causes it to be used for medicinal purposes by any person not knowing of the adulteration shall be liable on conviction to imprisonment for a term not exceeding two years.

(Inserted by Ordinance 52 of 1968, s.9; amended by Act 2 of 1980, s.9 and Sched)


Offence in relation to sales

57.-(1) Subject to such exceptions as may be prescribed by regulations made under the provisions of this Act, every person commits an offence who sells any adulterated medicine without fully informing the purchaser, at the time of the sale, of the nature of adulteration, unless the package in which it is sold had conspicuously printed there on a true description of the composition of the medicine so sold.


(2) Every person commits an offence who sells any medicine -


(a) containing any substance of which the addition is prohibited by regulations under this Act or which does not comply with the standard prescribed therefore by this Act or any such regulations;


(b) containing a greater proportion of any substance than is permitted by regulations made under the provisions of this Act


(3) Every person commits an offence who sells any medicine in any package which bears or has attached thereto any false or misleading statement, word, brand, label or mark purporting to indicate the nature, quality, strength, purity, composition, weight, origin, age or proportion of the article contained in the package or of any ingredient thereof.

(Section inserted by Ordinance 5 of 1958, s.5; subsec. (3) amended by Act 14 of 1975, s.26; section amended by Act 2 of 1980, s.9 and Sched.)


Reliance on written warranty a good defence

58.-(1) Subject to the provisions of this section, its hall be a good defence in any prosecution for an offence against the provisions of section 57 if the defendant proves -


(a) that he purchased the article sold by him in reliance on a written warranty or other written statement as to the nature of the article purchased, signed by or on behalf of the person from whom the defendant purchased the article; and


(b) that if the article had truly conformed to the warranty or statement the sale of the article by the defendant would not have constituted the offence charged against him; and


(c) that he had no reason to believe or suspect that the article sold by him did not confirm to the warranty or statement; and


(d) that at the time of the commission of the alleged offence the article was in the same stated as when he purchased it.


(2) No warranty or statement shall be any defence under this section unless -


(a) it was given or made by or on behalf of a person resident in Fiji or a company having a registered office in Fiji or a firm having a place of business in Fiji; and


(b) the signature thereto is written by hand; and


(c) the defendant proves that at the time he received the warranty or statement he took reasonable steps to ascertain, and did in facet believe, that the signature was that of the person from whom he purchased the article, or, as the case may be, of some person purporting to sign on behalf of the person from whom the defendant purchased that article.


(3) No warranty or statement shall be any defence in any prosecution unless the defendant has within seven days after service of the summons delivered to the prosecutor a copy of the warranty or statement, with a written notice stating that he intends to rely thereon and specifying the name and address of the person from whom he received it, and has also within the same time sent by posit a like notice of his intension to that person.


(4) When the defendant is a servant or agent of the person who purchased the article under such a warranty or statement as aforesaid, he shall be entitled to the benefit of this section in the same manner and to the same extent as his employer or principal would have been if he had been the defendant.

(Inserted by Ordinance 5 of 1958, s.5)


Importation of medicines

59. (1) It shall not be lawful for any person to import for sale by retail for any medicine which under his licence he is not entitled to sell or supply

(Amended by Act 2 of 1980m s.9 and Sched.)


(2) Any medicine imported in contravention of this section shall be liable to confiscation and shall be disposed of in such manner as the Comptroller of Customs and Excise may direct. (Amended by Act 2 of 1980, s.9 and Sched.)


(3) Any person importing or attempting to import any medicine in contravention of this section shall be guilty of an offence and shall be liable for a first offence to a fine not exceeding $20 and for a subsequent offence to a fine not exceeding $200 or imprisonment for a term not exceeding twelve months (Amended by Ordinance 2 of 1945, s112; Act 2 of 1980, s.9 and Sched.)


(4) The provisions of the Customs Act shall apply to every suit or proceedings under this section. (Cap. 196)


Labels on medicines imported

60.-(1) Any medicine imported into Fiji shall bear a label affixed to the container specifying legibly in English or in terms used in the British Pharmacopoeia each and every ingredient or such medicine:


Provided that, in the case of any medical preparation or patent medicine listed in the British Pharmacopoeia, the British Pharmaceutical Codex, the Australasian Pharmaceutical Formulary or any other formulary approved and notified in the Gazette by the Permanent Secretary, it shall be sufficient compliance with the provisions of this subsection if the labels bears legibly in English or the language of such formulary the name of such medical preparation or patent medicine.


(2) Where any medicine imported into Fiji contains any poison or poisons the label shall state the proportion which each such poison bears to the total contents. In the case of such proportion being stated as percentage the statement shall indicate whether the percentage is weight in weight, weight in volume or volume in volume.


(3) Where any medicine imported into Fiji contains spirit, the label shall state the percentage by volume of proof spirit in such medicine.


(4) Any medicine imported into Fiji which does not bear a label complying in all respect with the provisions of this section shall be liable to confiscation and to be disposed of in such a manner as the Comptroller of Customs and Excise may direct:


Provided that where the Permanent Secretary, or a person authorised in writing by the Permanent Secretary to inquire into representations in that behalf, is within a period of three months from the date of importation satisfied by the importer that such medicine is not, and is not likely to be, injurious to the health of any person, he may certify in writing to the Comptroller of Customs and Excised his opinion to that effect and thereupon the Comptroller shall release such medicine from confiscation under this section.

(Substituted by Ordinance 1 of 1951, s.2)


Importation of certain medicines may be prohibited

61. If the opinion of the Permanent Secretary any medicine brought into Fiji is or is likely to injurious to the health or well-being of any person he may certify in writing to the Comptroller of Customs and Excise that the same should not be allowed to be imported:


Provided that this section shall not apply to medicines imported by registered medical practitioners, registered pharmacists, qualified veterinary surgeons or registered dentists for bona fide medical, veterinary or dental treatment.

(Amended by Act 2 of 1980, s 9 and Sched)


PART VI - POISONS


Importation and sale of poisons


62.-(1) It shall not be lawful for any person to import any poison except under a licence issued by the Board upon such conditions as the Board may think fit:


Provided that this subsection shall not apply to the importation of poisons by registered medical practitioners, registered pharmacists, qualified veterinary surgeon or registered dentists for bona fide medical, veterinary or dental treatment (Amended by Ordinance 52 of 1968, s.10)


(2) It shall not be lawful for any person to sell or deal in any of the several articles included in the Third Schedule, hereinafter referred to as the "Poisons List" except in the manner prescribed in this Act.


(3) The Minister may from time to time by order add items to or delete items from Part I or Part II of the Poisons List or may substitute a new Part or Parts for either or both such parts. (Substituted by Ordinance 8 of 1958, s.6; amended by Legal Notice 112 of 1970)


(4) Any such order shall be published in the Gazette and on the expiration of three months from the publication thereof the Poisons List shall be deemed to be amended in accordance with such order. (Substituted by Ordinance 8 of 1958, s,6.)


(5) Any person acting in contravention of subsections (1) and (2) or of any condition imposed under subsection (1) shall be liable to a fine of not less than $40 nor more than $200 and in the case of a continuing offence to a further fine of $10 for each day subsequent to the day on which he is convicted during which the offence continues.

(Amended by Ordinance 2 of 1945, s.112; 52 of 1968, s.10.)


Pharmacists to be authorised sellers of poisons

63. For the purposes of this Act all registered pharmacists shall be authorised sellers of poisons and may, subject to the provisions of this Act, sell and deal in poisons.


Poisons Licence

64. On the application of any holder of a retail store licence and on payment of the prescribed fee the Board may issue to such person a licence to sell poisons, hereinafter referred to as a "Poisons Licence", provided that -


(a) such application is accompanied by a report signed by the Commissioner of the Division in which such retail store is situated certifying that the applicant is a fit and proper person to hold such licence;


(b) such licence shall only apply to one place of business;


(c) no licence shall be granted empowering the holder thereof to sell or deal in any poisons included in Part I of the Poisons List;


(d) such licence shall be for a period of six calendar months and may be renewed; and


(e) such licence shall state specifically the poisons or class of poisons which the holder is licensed to sell or deal in.


Register of Premises

65. The Board shall keep a book, to be called the "Register of Premises", which shall be in the form as prescribed by regulations made under this Act and in which shall be entered the addresses of all premises where poisons or medicines are licensed to be sold and such other particulars as may be prescribed by such regulations.

(Amended by Act 2 of 1980, s. 9 and Sched.)


Prohibition and regulations with respect to the sale of poisons

66.-(1) Subject to the provisions of this Part it shall not be lawful -


(a) for a person to sell any poison included in Part I of the Poisons List unless -


(i) he is an authorised seller of poisons; and


(ii) the sale is effected on premises registered under the provisions of section 65; and


(iii) the sale is effected by or under the supervision of a registered pharmacist;


(b) for a person to sell any poison included in Part II of the Poisons List unless either -


(i) he is an authorised seller of poisons and the sale is effected on premises registered under the provisions of section 65, or


(ii) he is the holder of a Poisons Licence and the sale is effected on premises registered under the provisions of section 65;


(c) for a person to sell any poison, whether included in Part I or Part II of the Poisons List, unless the container of the poison is labelled in the prescribed manner -


(i) with the name of the poison; and


(ii) in the case of a preparation which contains a poison as one of the ingredients, with the prescribed particulars as to the proportion which the poison contained in the preparation bears to the total ingredients; and


(iii) with the word "poison" or other prescribed indication of the character of the article; and


(iv) with the name of the seller of the poison and the address of the premises on which it was sold.


(2) Subject to the provisions of this Part and to any regulations made under this Act dispensing with or relaxing any of the requirements of this subsection -


(a) it shall not be lawful to sell any poison in Part I of the Poisons List to any person unless that person is either -


(i) certified in the manner prescribed by regulations and by a person authorised by regulations to give a certificate for the purposes of this section; or


(ii) known by the seller or by some registered pharmacist in the empoyment of the seller at the premises where the sale is effected,


to be a person to whom the poison may properly be sold:


Provided that no poison shall be sold or delivered to any person under the age of twenty-one years;


(b) the seller of any such poison shall not deliver it until -


(i) he has made or has caused to be made an entry in a book to be kept for that purpose, hereinafter called the "Poisons Book", stating in the form prescribed by regulations the date of the sale, the name and address of the purchaser and of the person, if any, by whom the certificate required under paragraph (a) was given, the name and quantity of the article sold and the purpose for which it is stated by the purchaser it is required; and


(ii) the purchaser has affixed his signature to the entry aforesaid.


Exemption with respect to medicines

67.-(1) Nothing in section 66 shall apply -


(a) to a medicine which is supplied by a registered medical practitioner for the purposes of medical treatment, by a registered dentist for the purposes of dental treatment or by a qualified veterinary surgeon for the purposes of animal treatment;


(b) to a medicine which is dispensed by a registered pharmacist at his place of business; or


(c) to a poison forming part of the ingredients of a medicine which is supplied by a registered pharmacist at his place of business:


Provided that the requirements contained in the following provisions of this section shall be satisfied in relation thereto. (Amended by Ordinance 32 of 1962, s. 8; 37 of 1966, s. 39; Act 14 of 1975, s. 26.)


(2) The medicine shall be distinctly labelled with the name and address of the person by whom it was supplied or dispensed.


(3) On the day on which the medicine was supplied or dispensed or, if that be not reasonably practicable, on the day next following that day, there shall be entered in the prescription book the following particulars -


(a) the date on which the medicine was supplied or dispensed;


(b) the ingredients of the medicine and the quantity thereof supplied;


(c) if the medicine was dispensed by a registered pharmacist, the name or initials and, if it is known, the address of the person by whom and the name and, if it is known, the address of the person to whom, and the date on which, the prescription was given;


(d) if the medicine was not so dispensed, the name and address of the person to whom it was supplied:


Provided that the provisions of this subsection shall in the case of a medicine supplied on a prescription on which the medicine has been supplied by the seller on a previous occasion be deemed to be complied with if the day on which the medicine is supplied and the quantity thereof supplied are entered in the prescription book on that day or, if that is not reasonably practicable, on the day next following that day, together with a sufficient reference to an entry in that book duly recording the dispensing of the medicine on the previous occasion.


(4) In the case of a medicine which is supplied or dispensed by a registered pharmacist and is compounded by the person supplying or dispensing it or by a person in his employment, the medicine shall have been compounded or dispensed by or under the immediate and personal supervision of a registered pharmacist.


(5) In the case of a medicine which is supplied or dispensed by a registered pharmacist, the supplying or dispensing of the medicine shall be effected by or under the immediate and personal supervision of a registered pharmacist.


Exemption with respect to certain sales

68. Except as provided by regulations made under this Act nothing in the foregoing provisions of this Part shall extend to or interfere with -


(a) the sale of poisons by the holder of a manufacturer's or wholesale licence under and in accordance with such licence:


Provided that -


(i) such sale is to a registered pharmacist or to a holder of a Poisons Licence; or


(ii) such sale is to a person who requires the article -


(aa) for the purposes of his trade or business; or


(bb) for the purposes of enabling him to comply with any requirements made by or in pursuance of any Act with respect to the medical treatment of persons employed by that person in any trade or business carried on by him; or


(b) the sale of an article to a registered medical practitioner, registered dentist or qualified veterinary surgeon for the purposes of his profession.

(Amended by Act 2 of 1980, s. 8.)


Use of titles, emblems and descriptions

69. It shall not be lawful for any holder of a Poisons Licence to use in connection with his business any title, emblem or description reasonably calculated to suggest that he is entitled to sell any poison other than a poison which he is under this Act entitled to sell, and if any person acts in contravention of this section he shall be liable in respect of each offence to a fine of not less than $40 or greater than $100 and in the case of a continuing offence to a further fine of $10 for each day subsequent to the day on which he was convicted of the offence during which the offence continues.

(Amended by Ordinance 2 of 1945, s. 112.)


Prohibition of sale of poisons by means of automatic machine

70. It shall not be lawful for a poison to be exposed for sale in or offered for sale by means of an automatic machine, and any person acting in contravention of this section shall be liable to a fine of not less than $40 nor more than $200 and in the case of a continuing offence to a further fine of $10 for each day subsequent to the day on which he is convicted during which the offence continues. (Amended by Ordinance 2 of 1945, s. 112.)


PART VII - MISCELLANEOUS


Regulations

71.-(1) The Board, subject to the approval of the Minister, may make regulations with respect to any of the following matters or for any of the following purposes:-


(a) the manufacture of pharmaceutical preparations containing poisons;


(b) the sale, whether wholesale or retail, or the supply of poisons by or to any person or classes of persons and in particular but without prejudice to the generality of the foregoing provisions -


(i) for regulating or restricting the sale or supply of poisons by holders of a Poisons Licence and for prohibiting the sale of any specified or class of poisons by any class of such licensed sellers of poisons;


(ii) for prohibiting the sale by retail of poisons (being poisons included in Part I of the Poisons List in the Third Schedule) except on a prescription duly given by a duly qualified medical practitioner, registered dentist or qualified veterinary surgeon and for prescribing the form and regulating the use of prescriptions given for the purposes of regulations made under this paragraph;


(iii) for dispensing with or relaxing with respect to poisons any of the provisions contained in Part VI relating to the sale of poisons;


(c) the storage, transport and labelling of poisons;


(d) the containers in which poisons may be sold or supplied;


(e) the additions to poisons of specified ingredients for the purpose of rendering them readily distinguishable as poisons;


(f) the manufacture, compounding and dispensing of medicines and poisons;


(g) the period for which any books required to be kept for the purposes of this Act are to be preserved;


(h) the period for which any certificate given under Part VI is to remain in force;


(i) for requiring persons in charge of the manufacture of pharmaceutical preparations containing poisons to be registered pharmacists;


(j) the meetings and proceedings of the Board and the conduct of the business thereof and the duties of its officers;


(k) the forms to be used in pursuance of this Act;


(1) the manner of keeping the registers and the particulars to be entered therein;


(m) the scale of fees to be charged and paid in respect of any application, registration, certificate or other proceedings, act or thing provided or required under this Act;


(n) the control of the professional conduct of registered pharmacists and the practice of the profession;


(o) for prescribing the standards or quality or composition of medicines and the methods or preparations of medicines and of compounding all mixtures thereof;


(p) for prohibiting the sale by retail of any medicine except pursuant to the order or prescription of a medical practitioner, dentist or veterinary surgeon;


(q) the qualifications of apprentices and assistants and the conditions under which apprentices or assistants may be employed;


(r) the conditions (including the keeping of records) to be observed in the use of poisons for industrial or agricultural purposes;


(s) for prescribing anything which by this Act is to be prescribed by regulations.


(2) The power to make regulations under this section with respect to poisons includes the power to make regulations with respect to any class of poisons or any particular poison.
(Section substituted by Ordinance 5 of 1958, s. 7, amended by Legal Notice 112 of 1970; Act 14 of 1975, s. 26; 2 of 1980, s. 9 and Sched.)


General penalty

72.-(1) A person who acts in contravention of or fails to comply with any of the provisions of this Act or any regulations made thereunder for which no specific penalty is prescribed shall be liable to a fine not exceeding $100 and in the case of a continuing offence to a further fine not exceeding $20 for every day subsequent to the day on which he is convicted of the offence during which the offence continues.

(Amended by Ordinances 22 of 1938, s. 8; 2 of 1945, s. 112.)


(2) In the case of proceedings against a person under this section for or in connection with the sale, exposure for sale or supply of a poison effected by an employee -


(a) it shall not be a defence that the employee acted without the authority of the employer; and


(b) any material fact known to the employee shall be deemed to have been known to the employer.


(3) Notwithstanding any provisions in any Act prescribing the period within which summary proceedings may be commenced proceedings for an offence under this Act may be commenced at any time within the period of twelve months next after the date of the commission of the offence or, in the case of proceedings instituted by or by the direction of the Director of Public Prosecutions, either within the period aforesaid or within the period of three months next after the date on which evidence sufficient in the opinion of the Director of Public Prosecutions to justify a prosecution for the offence comes to his knowledge, whichsoever period ends on the later date. For the purposes of this subsection a certificate purporting to be signed by the Director of Public Prosecutions as to the date on which such evidence as aforesaid came to his knowledge shall be conclusive evidence thereof. (Amended by Act 14 of 1975, s. 26.)


Application of Customs law

73. Articles prohibited to be imported or of which the importation is restricted by virtue of this Act shall be deemed to be included among the goods the importation of which is prohibited or restricted under the provisions of any Act for the time being in force relating to the Customs and the provisions of such Act shall apply accordingly. (Substituted by Ordinance 37 of 1966, s. 39.)

______


FIRST SCHEDULE
(Section 22)


(Amended by Ordinance 22 of 1938, s. 9.)


COUNTRIES, ETC., SPECIFIED FOR THE PURPOSES OF SECTION 22


New Zealand
Canada
New South Wales
Victoria
Western Australia
South Australia
Queensland
Tasmania
South Africa
The Republic of Ireland

______


SECOND SCHEDULE
(Section 49 (2))


(Amended by Order in Council 4 of 1938, Orders 12 September 1957; 31 March 1959; 22 March 1965; Legal Notices 58 of 1971, 28 of 1975, 155 of 1980, 12 of 1981, 36 of 1983.)


EXEMPTED ARTICLES


Epsom Salts
Glauber Salts
Castor Oil
Sulphur
Alum
Saltpetre
Bicarbonate of soda
Soda Crystals (Washing Soda)
Cod Liver Oil
Eucalyptus Oil
Fluid Magnesia
Lucca Oil
Cream of Tartar
Glycerine

Articles purporting to be of medicinal or dietetic value produced or manufactured in China or India and used as such solely by the indigenous inhabitants of those countries provided that -


(a) they contain no dangerous drugs;


(b) they contain no poisons;


(c) they contain no substance the use of which is prohibited by section 61;


(d) they contain no animal substance; and


(e) each container has affixed to it a label stating clearly in the English language the nature of its contents.


Tincture of Iodine (Liquor Iodi Mitis BPC).

Zinc Oxide Ointment.

Boracic Eye Lotion.

Soaps and dusting powders used for toilet purposes.
Aspirin Tablets and Powders. Compound tablets and powders containing aspirin in formulation with one or more of the following substances, caffeine, paracetamol, and salicylamide, and such formulations to be in dosage combinations consistent with the British Pharmacopoeia Codex.
Effervescent Saline Powders, and granules providing an antacid or laxative action.
Vapourising Ointments consisting of menthol and volatile oils in a soft paraffin base.

Infant Feeding Formulas.

Paracetamol Tablets.

Dettol Liquid Antiseptic.

Savlon Liquid Antiseptic.


Any preparations solely for use on the skin and containing not more than two per cent by weight in weight or by weight in volume of hydroquinone.

______


THIRD SCHEDULE
(Section 62 (2))


(Substituted by Legal Notice 124 of 1977; amended by Legal Notice 35 of 1983.)


THE POISONS LIST


PART I


Acepromazine; its salts.
Aceprometazine.
Acetanilide, alkyl acetanilides.
Acetcarbromal.
Acetohexamide.
Acetophenazine; its salts.
Acetorphine; its salts; its esters and ethers; their salts.
Acetylcarbromal.
Acetyldihydrocodeine and its salt.
Acetyldihydrocodeinone; its salts.
Acetylpromazine; its salts.
Acetylstrophanthidin.
Adrenaline; its salts.
African Tea.
Alcuronium chloride.
Aletamine hydrochloride.
Alimemazine.
Alkali Fluorides, other than those specified in Part II of this list.
Alkaloids, the following; their salts, simple or complex; their quarternary
compounds.-

Acetyldihydrocodeinone; its esters.

Aconite, alkaloids of.

Apomorphine.

Atropine.


Belladonna, alkaloids.

Benzoylmorphine.

Benzylmorphine.

Brucine.


Calabar bean, alkaloids of.

Coca, alkaloids of.

Cocaine.

Codeine.

Colchicum, alkaloids of.

Coniine.

Cotarnine.

Curare, alkaloids of; curare bases.


Diacetylmorphine.

Dihydrocodeine.

Dihydrocodeinone; its esters.

Dihydrodesoxymorphine.

Dihydrohydroxycodeinone; its esters.

Dihydromorphine; its esters.

Dihydromorphinone; its esters.


Ecgonine; its esters.

Emetine.

Ephedra, alkaloids of.

Ergot, alkaloids of.

Ethylmorphine.


Gelsemium, alkaloids of.


Homatropine.

Hyoscine.

Hyoscyamine.


Jaborandi, alkaloids of.


Lobelia, alkaloids of.


Morphine.


Papaverine.

Pomegranate, alkaloids.


Quebracho, alkaloids of, other than the alkaloids of red quebracho.


Rauwolfia, alkaloids of, their derivatives, their salts.


Sabadilla, alkaloids of.

Solanaccous alkaloids not otherwise specified in this List.

Stavesacre, alkaloids of.

Strychnine.

Thebaine.

Veratrurn, alkaloids of.

Yohimba, alkaloids of.


Allnortoxiferin chloride.
Allylisoperopylactylurea.
Allyprodine and its salts.
Alphacetylmethadol and its salts.
Alphadolone acetate.
Alphameprodine; its salts.
Alphamethadol; its salts; its esters and ethers; their salts.
Alphaprodine and its salts.
Alphaxolone.
Alprenolol hydrochloride.
Alseroxylon.
Aluminium Phosphide.
Amantadine Hydrochloride.
Ambutonium Bromide.
Amfecloral; its salts.
Amidofebrin.
Amidopyrine; its salts, amindopyrine sulphonates; their salts.
Aminazin.
Amino-alcohols, esterified with benzoic acid, phenylacetic acid phenylproprionic acid, cinnamic acid or derivatives of these acids their salts.
Aminobenz.
p-Aminobenzoic acid, esters of; their salts.
Aminocaproic acid.
Aminomercaptopurine.
Aminomercuric chloride.
Aminophenazonc.
Aminopyrine.
Aminorex; its salts.
Amitriptyline; its salts.
Ammoniated mercury.
Amoxyciliin.
Amphetamine and its salts.
Amphomycin and its salts, its esters and salts of such esters; or any substance, the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Amphotericins; their salts and preparations or any substance, the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which are produced by means other than by living organisms.
Ampicillin; its salts derivatives and preparations.
Amyl nitrite.
Androgenic, oestrogenic and progestational substances, the following:-

Benzoestrol,

derivatives of stilbene, dibenzyl or naphathalene with oestrogenic activity; their esters,

steroid compounds with androgenic or oestrogenic or progestational activity; their esters.
Anileridine; its salts.
Antihistamine substances; the following; their salts; their molecular compounds:-

Antazoline.


Bromodiphenhydramine.

Buclizine.


Carbinoxamine.

Cinnarizine.

Cyproheptadine.

Chlorcyclizine. (p-Chlorophenylpyrid-2-ylmethyl) 2-dimethylaminoethyl ether.

Chlorpheniramine.

Clemizole.

Cyclizine.


3-Di-n-butylaminomethy1-4:5:6-trihydroxyphthalide.

Diphenhydramine.

Diphenylpyraline.

Doxylamine.


Isothepindy1.


Mebhydrolin.

Meclozine.


Phenyltoloxamine.

Phenindamine.

Pheniramine.

Promethazine.

Pyrrobutamine.


Thenalidine.

Tolpropamine.

Tripolidine.


Substances being tetra-substituted N derivatives of ethylenediamine or propylenediamine.


Antimony, chlorides; oxides of antimony; sulphides of antimony; antimonates; antimonites; organic compounds of antimony.


Arsenical substances, the following, except those specified in Part II of this list:


halides of arsenic.

oxides of arsenic.

arsenates.

arsenites.


organic compound of arsenic.


Azocyclonal; its salts.
Azathroprine; its salts.


Barbituric acid; its salts; derivatives of barbituric acid; their salts; compounds of barbituric acid; its salts; its derivatives; their salts, with any other substance.
Barium, salts of, other than barium sulphate and salts of barium specified in Part II of this list.
Benactyzine; its salts.
Benapryzine hydrochloride.
Bencurine iodide.
Bendrofluazide.
Bendroflumethiazide.
Benzathidine and its salts.
Benzbromarone.
Benzhexol; its salts.
Benzoctamine; its salts.
Benzoylmorphine and its salts.
Benzoylpseudotropine.
Benzphetamine and its salts.
Benzthiazide.
Benzethidine; its salts.
Benztropine; its salts.
Benzydroflumethiazide.
Benzyl, phenethyl or phenoxyethyl hydrazines, their x-methyl derivatives; acyl derivatives of any of the foregoing; salts of any compounds comprised in this heading.
Benzylmethylamine; its salts and quaternary compounds.
Benzylmorphine; its salts; its esters and ethers; their salts.
Beta-aminopropylbenzene; its salts; its N-alkyl derivatives; their salts.
Beta-aminoisopropylbenzene; its salts; its N-alkyl derivatives; their salts.
Betacetylmethadol and its salts.
Beta-Chloralose.
Betahistine dihydrochloride.
Beta-hypophamine.
Betameprodine; its salts.
Betaprodine; its salts.
Betamethadol; its salts; its esters and ethers; their salts.
Betaprodine; its salts.
Bezitramide and its salts.
Bistropamide.
Bleomycin sulphate.
Bretylium tosylate.
Bromisovalerylurea.
Bromisovalum.
4-Bromo 2, 5 Dimethoxy-x-methyl Phenethylamide (Bromo-stp).
Bromomethane.
Bromvaletone; its salts.
Bumetanide.
Busulphan; its salts.
Butylehloral hydrate.
Butaperazine; its salts.
Buthalital sodium.
Buthalitone sodium.
Butyl aminobenzoate.


Cacodylic acid.
Calcitonin.
Calcium novobiocin.
Candicidin; its salts, its esters; their salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Cannabis (the dried flowerings tops of Cannabis Sativa Linn); the resin of cannabis; tinctures of cannabis; cannabin tannat.
Cantharidates.
Cantharidin; cantharidates.
Capreomycin and its salts; its esters and salts of such esters.
Capreomycin and its salts; its salts; its esters and salts of such esters.
Captodiame; its salts.
Caramiphen; its salts.
Carbachol.
Carbacholine.
Carbamazepine.
Carbamoylcholine chloride.
Carbarsone.
Carbenicillin and preparations.
Carbazotic acid.
Carbethoxysyringoylmethylreserpate; its salts.
Carbochoral.
Carbostibamide.
Carbromal.
Carfenazine; its salts.
Carisoprodol.
Carperidine; its salts.
Carphenazine; its salts.
Cathine.
Cavalose.
Centrophenoxine hydrochloride.
Cephaloridine; its salts; its esters and salts of such esters or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Cephalosporins, that is to say, antimicrobial substances containing in their chemical structure a fused dihydrothiazine B-lactam nucleus; their salts; their esters and their salts or any substances the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Cevadine.
Chloral.
Chloral formamide.
Chloral hydrate.
Chloralurethane.
Chlorambucil; its salts.
Chloramphenicol and antimicrobial substances derived therefrom including homologues, substitution products and esterified compounds and preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Chlordiazepoxide; its salts.
Chlorethazine hydrochloride.
Chlorglypropamide; its salts.
Chlorhexadol.
Chlormerodrin.
Chlormeroprin.
Chlormethiazole.
Chlormethine; its salts.
Chlormethylencycline and preparations.
2-P-chlorophenyl-3-methylbutane-2:3-diol.
Chloropicrin.
Chlorothiazide and other derivatives of benzo-1:2:4-thiadiazine 7-sulphonamide 1:1-dioxide,
whether hydrogenated or not.
Chlorphenoxamine; its salts.
Chlorphentermine and its salts.
Chlorproethazine; its salts.
Chlorpropamide; its salts.
Chlorprothixan.
Chlorprothixene and other derivatives of 9-methylenethiaxanthen; their salts.
Chloroform.
Chlortetracycline and preparations.
Chlorthalidone and other derivatives of o-chlorobenzene sulphonamide.
Choline chloride carbamate.
Cinchocaine.
Cinchophen.
Clofazimine.
Clomiphene.
Clomipramine hydrochloride.
Clomocycline and preparations.
Clonidine hydrochloride.
Clonitazene and its salts.
Clopamide.
Clopenthixol.
Cloperphenthixan.
Clorprenaline; its salts.
Clotixamide.
Clotrimazole.
Cloxacillin and preparations.
Cocculin.
Cocculus indicus.
Colchamine; its salts.
Colchicine; its salts.
Colistin; its salts and preparations.
Corpus luteum extracts.
Cortexolone; its salts; its esters, their salts; any acetal derivative and its salts.
Corticosteriods, that is to say, any substance which contains the chemical structure of pregn-

4-ene-3, 20-dione, or of pregna-1, 4-diene-3, 20-dione and has the 11-carbon atom directly linked to oxygen, with the exception of flugestone; their esters and their salts; any acetal derivative of a corticosteriod and its salts.


Corticotrophins, natural and preparations.
Corticotrophins, synthetic and preparations.
Corticotropin and preparations.
Corynine.
Cotarnine; its salts and quaternary compounds.
Co-trimoxazole.
Creosote obtained from wood.
Cresols and preparations containing 60% w/w or more.
Cresylic acid and preparations containing 60% w/w or more.
Crotethamide.
Croton, oil of.
Cyanides other than ferrocyanides.
4-Cyano-2-dimethylamino-4: 4-diphenylbutane; its salts.
4-Cyano-l-methyl-4-phenylpiperidine; its salts.
Cyclarbamate.
Cyclofenil.
Cyclopenthiazide.
Cyclophosphamide; its salts.
Cycloserine; its salts and preparations.
d-Cycloserine.
Cyclothiazide.
Cycrimine; its salts.
Cypenamine; its salts.
Cytarabine.


Daturine.
Daunomycin Hydrochloride.
Daunorubicin Hydrochloride.
Deacetyl-lanatoside C.
Deanol 4-chlorophenoxyacetate hydrochloride.
Decamethonium iodide.
Dehydrobenzperidol.
1:2 Dehydrocortisone; its esters and preparations.
Dehydroemetine; its salts.
Demecarium Bromide.
Demecolcine; its salts.
Demeclocycline; its salts and preparations.
Demethoxyreserpine; its salts.
Demethylchortetracycline; its salts or any substance, the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which are produced by means other than by living organisms.
Desacetyl-lanatoside C.
Deserpidine; its salts.
Desipramine; its salts.
Deslanside.
Deslanoside.
Desmethylimipramine.
Desomorphine; its salts.
Dexamphetamine and its salts.
Dextromethorphan; its salts.
Dextromoramide; its salts.
Dextropropoxyphene; its salts.
Dextrophan; its salts.
Diacetylnalorphine; its salts.
Diacetyl N-allynormorphine; its salts.
Diallynortoxferine dichloride.
Diallymalonylurea.
Diallytoxiferine dichloride.
Diamethine.
Diamethine.
Diamorphine and its salts.
Diampromide and its salts.
Di-p-anisyl-p-phenetyl guanidine.
Diazepam and other compounds containing the chemical structure of dihydro-1:4-Benzodiazepine substituted to any degree; their salts.
Diazoxide.
Dibenzepin; its salts.
Dibenzyl derivatives with oestrogenic activity, their esters.
Dibucaine; its salts.
Dibucaine hydrochloride.
Dichoralphenazone.
Di-(2-chloroethyl) amine, N-substituted derivatives of.
Dichlorphenamide.
Dichlorphenarsine Hydrochlorides.
Dicloxacillin sodium.
Diethanolamine fusidate.
Diethazine; its salts.
Diethazine hydrochloride.
Diethylproprion; its salts.
N-Diethyoaminoethylephedrine; its salts.
Diethylmalonylurea.
Diethylthiambutene and its salts.
N, N-Diethyltryptamine and its salts.
Difenoxin.
Digitalis, glycosides of; other active principles of digitalis.
Diguanidines, polymethylene.
Diguanil.
Dihydro-1: 4-benzodiazepine compounds substituted to any degree, their salts. Dihydrocodeine and its salts.
Dihydrocodeinone-O-Carboxymethyloxime; its salts; its esters; their salts. Dihydromethylmorphine; its salts; its esters and ethers; their salts.
Dihydromorphine; its salts; its esters and others; their salts.
Dihydrostreptomycin; its salts and preparations.
Dihydrotheelin; its esters.
3-(3,4-Dihydroxyphenyl) alanine; its salts.
Diiodotyrosine.
Di-isopropyl fluorophosphate.
Di-isopropyl fluorophosphanate.
Dimenoxadole and its salts.
Dimepheptanol.
Dimepropion.
1:4-Dimethanesulphonoxybutane; its salts.
2, 5-Dimethoxy-4, x-dimethlyphenethylamine and its salts.
Dimethylaminoantipyrine; its salts.
Dimethylaminophenazone; its salts.
Dimethyl 4-sulphamoylphenyl phosphorothionate.
Dimethylthiambutene and its salts.
N, N-Dimethyltryptamine and its salts.
Dimethltubocurarine salts.
Dinitronaphthols.
Dinitro-orthocresols.
Dinitrothymols.
Dinitrophenols; dinitronaphtols, dinitrothymols.
Dioxaphetyl butyrate and its salts.
Dipara-anisylphenetyl guanidine.
Diperocaine; its salts.
Diperodon; its salts.
Diphenoxylate and its salts.
Diphenylhydantoin sodium.
Dipipanone; its salts.
Disopyramide.
Distigmine Bromide.
Disulfiram.
Dithienylallylamine compounds; their salts.
Dixyraxine; its salts.
DOPA; its salts.
Dothiepin; its salts.
Doxapram; its salts.
Doxorubicin.
Doxycycline; its salts and preparations.
Droperidol.
Drotebanol; its salts; its esters and ethers, their salts.
Dyflos.


Eazamine hydrochloride.
Ecothiopate iodide.
Ectylcarbamide.
Ectylurea.
Elaterin.
Embutramide.
Emetic tartar.
Emylcamate.
Ephedrine; its optical isomers; their salts; their quaternary compounds; their salts, simple or complex.
Epinephrine; its salts.
Epirenamine; its salts.
Epithiazide.
Ergomonamine; its salts.
Ergonovine.
Ergot (the sclerotia of any species of Claviceps); extracts of ergot; tinctures of ergot.
Ergot alkaloids of whether hydrogenated or not; their homologues any salt of any substance falling within this item.
Erythritol tetranitrate.
Erythrityl tetranitrate.
Erythromycin; its salts; its esters; their salts and preparations containing any of them; any substance, the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Erythrotetranitral.
Eserine; its salts and quaternary compounds.
Estrogenic substances conjugated.
Ethacrynic acid; its salts.
Ethafedrine; its salts.
Ethaminal sodium.
Ethamycin.
Ethchlorvynol.
Ethinamate.
Ethionamide.
Ethoheptazine; its salts.
Ethopropazine; its salts.
Ethybenztropine; its salts.
Ethyl-aminobenzoate.
Ethyl-alcohol.
Ethylephedrine; its salts.
Ethylmethylthiambutene and its salts.
Ethylmorphine and its salts.
Ethylnoradrenaline; its salts.
Ethylstibamine.
Etonitazene and its salts.
Etophylate.
Etorphine; its salts; its esters and ethers; their salts.
Etoxeridine; its salts; its esters and ethers; their salts.
Euphoramin.


Fencamfamin; its salts.
Fenethylline; its salts.
Fenfluramine; its salts.
Fenmetramide; its salts.
Fenoprofen calcium salt.
Fenpipramide; its salts.
Fentanyl and its salts.
Ferruginous neurasthenic serum.
Flamazine.
Flavomycin; its salts; its esters and their salts.
Flavoxate; its salts.
Fluanisone.
Flucloxacillin and its preparations.
Flucytosine.
Flufenamic acid; its salts; its esters; their salts.
Flumethiazide.
Fluopromazine; its salts.
Fluorides, alkali except potassium and sodium.
Fluorouracil.
Flupenthixol; its salts.
Fluphenazine; its salts.
Flurazepam.
Formyl terchloride.
Fouadin.
Framomycin or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Framycetin and its salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Furaltadone; its esters; its salts and their salts.
Furazolidone; its salts; its esters and their salts.
Furethidine and its salts.
Fusidic acid; its salts its esters and salts of such esters.


Gallamine; its salts and its quaternary compounds.
Galenomycin.
Gentamicin; its salts; its esters and salts of such esters or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Glibenclamide.
Glucophage.
Glutethimide; its salts.
Glybutamide.
Glyceryl trinitrate.
Glyceryl aminobenzoate; its salts.
Glyceryal trinitrate.
Glycobiarsol.
Glycodiazine.
Glykresin; its esters.
Glymidine.
Griseofulvin.
Guamecyline; its salts and preparations.
Guanidines, the following -

Polymethylene diguanidines; dipara-anisyiphenetyl guanidine.

Hydrocyanic acid; cyanides; double cyanides of mercury and zinc.


Hachimycin; its salts; its esters; their salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Haloperiodol and other 4-substituted derivatives of N-(3-p-fluo-robenzoylpropyl) piperidine.
Heparin calcium.
Hexachlorophane.
Hexamethone salts.
Hexamethonium salts.
Hexamine phenylcinchoninate.
Hexapropymate.
Hexamium salts.
Hydrazines, benzyl, phenethyl and phenoxyethyl; their x-methyl derivatives; acyl derivatives of any of the foregoing substances comprised in this item; salts of any compounds comprised in this item.
Hydrochlorothiazide.
Hydrocodone and its salts.
Hydrocortamate hydrochloride.
Hydrocyanic acid.
Hydroflumethiazide.
Hydromorphinol; its salts; esters and ethers; their salts.
Hydromorphone; its salts; its esters and ethers; their salts.
Hydroquinone; preparations containing more than two per cent by weight in weight or by weight in volume of hydroquinone.
Hydroxycarbamide.
Hydroxycinchoninic acids; derivatives of; their salts and their esters.
4-Hydroxymethyl-2:2-di-isopropyl 1-1:3-dioxolan.
14-Hydroxydihydromorphine; its salts; its esters and ethers; their salts.
Hydroxy-N: N-dimethyltryptamines; their esters or ethers; any salt of any substance falling within this item except bufotenine and psilocin.
Hydroxyurea.
Hydroxypethidine; its salts.
Hydroxyzine; its salts.


Ibenzmethyzine.
Ibuprofen.
Idoxuridine.
Imipramine.
Indomethacin; its salts.
Insulin.
Iprindole; its salts.
Iron cacodylate.
Iproveratril; its salts.
Isoaminile; its salts.
Isobutyl aminobenzoate.
Isocarboxazid; its salts.
Isomethadone (isoamidone); its salts.
Isoniazid, its salts; its derivatives, their salts.
Isoprenaline; its salts.
Isoprophenamine; its salts.
Isopropylatrerenol; its salts.
Isopropyl meprobamate.
N-Isopropylethylnoradrenaline; its salts.
Isopropylnorandrenaline; its salts.
Isoproterenol; its salts.


Kanamycin and its salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Ketamine Hydrochloride.
Ketobemidone; its salts.
Ketoprofin.


Laudexium; its salts.
L-Dopa; its salts.
Lead acetates; compounds of lead with acids from fixed oils.
Levisoprenaline; its salts.
Levodopa; its salts.
Levomethorphan; its salts.
Levomoramide; its salts.
Levorphan; its salts.
Levophenacylmorphan; its salts; its esters and ethers; their salts.
Levopropoxyphene; its salts.
Levorphanol; its salts; its esters and ethers; their salts.


Lincomycins that is the S-Alkyl derivatives of 6-8 Dideoxy-6-trans (4-alkyl-1-2 Pyrollidine-Carboxamide)-1 Thio-D-erythro-2-D-Calacto-Octo-Pyranoside, and N-methylpyrollidine analogues thereof; salts of any of these; their esters and salts of these.
Liothyronine.
Liothyronine sodium.
Lithium Fluoride.
Loperamide hydrochloride.
Lorazepam.
Lymecycline.
Lysergamide and its salts.
Lysergide and other N-alkyl derivatives of lysergamide; their salts.


Mannityl hexanitrate.
Mannomustine; its salts.
Mazindol.
Mebanazine.
Mebezonium iodide.
Mebutamate.
Meclofenoxate; its salts.
Medazepam.
Medocodene.
Mefenamic acid; its salts esters; their salts.
Melarsonyl Potassium.
Melarsoprol.
Melphalan.
Mepazine hydrochloride.
Mephenesin; its esters.
Mephentermine; its salts.
Meprobamate.
Mephenetoin; its salts.
Mephenytoin, its salts.
Meralluride.
Merbromin.
6-Mercaptopurine.
Mercaptopurine; its salts; derivatives of mercaptopurine; their salts.
Mercuderamide.
Mercuhydrin.
Mercuric cyanide.
Mercuric sulphocyanide.
Mercurochrome.
Mercurophylline sodium.
Mercury ammoniated.
Mercury oleated.
Mercury organic compounds in aerosols.
Mercury, oxides of; nitrates of mercury; mercuric ammonium chlorides Potassiomercuric iodides; organic compounds of mercury which contain a methyl (CH3) group directly linked to the mercury atom; mercuric oxycyanides; mercuric thiocyanate
Mercuzanthin.
Mersalyl.
Merthiolate.
Mescaline and its salts.
Mesoridazine; its salts.
Mesuridazine; its salts.
Methacortandracin.
Metanitrophenol; orthonitrophenol; paranitrophenol.
Metazocine; its salts; its esters and ethers; their salts.
Metformin; its salts.
Methacycline; its salts and preparations.
Methadol; its salts.
Methadone (amidone) its salts.
Methampyrone.
Methagyalone; its salts.
Methantheiinium bromide.
Methcarbomal.
Methdilazine.
Methadyl acetate; its salts.
Methicillin sodium.
Methixene; its salts.
Methocarbamol.
Methoin; its salts.
Methoserpidine; its salts.
Methotrimeprazine; its salts.
Methoxophenadein; its salts.
Methoxsalen.
10-Methoxydeserpidine; its salts.
Methoxyphenamine; its salts.
Methscopolamine bromide.
Methyclothiazide.
Methylacetanilide.
Methylamoniheptane.
Methylamphetamine and its salts.
Methylatropine bromide.
Methylbenzylhydrazine.
N-Methyl-2-(2-Methylbenzhydryloxy)-ethylamine; its salts.
Methyl bromide.
Methyldesomorphine; its salts.
Methyldihydromorphine; its salts.
9-Methylenethiaxanthen derivatives; their salts.
Methylpentynol; its salts.
Methylephedrine.
Methylphenidate; its salts.
2-Methylpentynol; its esters and other derivatives.
2-Methyl-3-morpholino-1: 1-diphenylpropane carboxylic acid; its salts; its esters; their salts.
1-Methyl-4-phenylpiperidine-4-carboxylic acid; esters of; their salts.
Methylphenidate; its salts.
Methylprylone.
Methysuiphonal.
Methysergide; its salts.
Metiguanide.
Metoclopramide; its salts.
Metolazone.
Metopimazine; its salts.
Metopon; its salts.
Mithramycin.
Mitoclomine; its salts.
Mitomen.
Mitopodozide; its salts.
Molindone hydrochloride.
Monofluroracetic acid; its salts.
Morazone.
Morpheridine; its salts.
Morphine; its salts; its esters and ethers; their salts; its pentavalent nitrogen derivatives; their esters and ethers.
Morpholinylethylmorphine; its salts.
Mustine; its salts.
Myelobromol.
Myrophine; its salts.


Naepine Hydrochloride.
Nafcillin; its salts and preparations.
Naftidrofuryl oxalate.
Nalidixic acid; its salts and esters.
Nalorphine; its salts.
Naloxone hydrochloride.
Natamycin.
Neomycin; its salts and preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Nialamide.
Niridazole.
Nitrazepam; its salts.
Nitrofurazone; its salts; its esters and their salts.
Nitrofurantoin; its salts; its esters and their salts.
Nitroglycerin.
Nitromin.
m-Nitrophenol.
p-Nitrophenol.
p-Nitrosulphathiazole.
o-Nitrophenol.
Noradrenaline; its salts.
Noramidopyrine methanesulphonate sodium.
Noracymethadol; its salts.
Norcodeine; its salts.
Normethadone and its salts.
Norlevorphanol; its salts; its esters and ethers; their salts.
Normorphine; its salts.
Nortriptyline; its salts.
Norethynodrel and ethinyloestradiol 3-methyl ether.
Norpipanone; its salts.
Novobiocin; its salts or any substance, the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Nux vomica.
Nystatin; its salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.


Oestrogenic substance conjugated.
Oleandomycin; its salts; its esters and salts of such esters and their preparations or any substance, the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Opium.
Oropramol hydrochloride.
Orciprenaline; its salts.
Orphenadrine; its salts.
Orthocaine; its salts.
Orthonitrophenol.
Ouabain.
Oxaminiquine.
Oxalic acid.
Oxazepam; its salts.
Oxethazaine.
Oxolinic acid.
Oxprenolol hydrochloride.
Oxycinchoninic acid, derivatives of; their salts; their esters.
Oxycinchophen.
Oxycodone; its salts; its esters; their salts.
Oxypertine hydrochloride.
Oxyphenbutazone.
Oxytetracycline; its salts and preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Oxytocins natural and synthetic.
Oxymorphone; its salts.


Pancuronium Bromide.
Paracetaldehyde.
Paraldehyde.
Paramethasone.
Paramomycin; its salts; its esters and salts of such esters.
Para-aminobenzenesulphonamide; its salts; derivatives of paraamino-benezenesul-phonamide having any of the hydrogen atoms in the para-amino group or of the sulphonamide group substituted by another radicle; their salts.
Para-amino-benzoic acid; esters of; their salts.
Para aminosalicyclic acid; its salts; its esters.
Paramethadione.
Pecazine; its salts.
Pemoline; its salts.
Penethamate hydriodide.
Penicillin and Streptomycin or any preparation thereof or such other antimicrobial organic substances the chemical properties of which are identical with others similar to those of the substances so described but not produced by living organisms.
Penicillamine; its salts.
Pentamethonium salts.
Pentazocin; its salts.
Pentresamide.
Perhexiline hydrogen maleate.
Pericyazine.
Perphenazine.
Pethidine; its salts.
Phenacaine hydrochloride.
Phenactropinium chloride.
Phenacemide.
Phenampromide; its salts.
Phenadoxoneits salts.
Phenatine; its salts.
Phenadoxone; its salts.
Phenazocin; its salts.
Phenbutrazate.
Phenclzine; its salts.
Phencyclidine; its salts.
Phendimetrazine; its salts.
Phenethylamine derivatives substituted in the aromatic ring (other than mescaline); their salts.
Phenetidylphenacetin.
Phenformin; its salts.
Pheniprazinc; its salts.
Phenothiazine, derivatives of their salts; except dimethoxanate; its salts and promethazine; its salts and molecular compounds.
1-Phenyl-2-pyrrolidinopentane; its salts.
Phenols (any member of the series of phenols of which the first member is phenol and of which the molecular composition varies from member to member by one atom of carbon and two atoms of hydrogen) except in substances containing less than sixty per cent weight in weight of phenols; compounds of phenol with a metal except in substances containing less than the equivalent of sixty per cent weight in weight of phenols.
Phenoperidine; its salts; its esters and ethers; their salts.
Phenomorphan; its salts.
Phenothiazine derivatives of their salts, except dimethoxanate; its salts and promethazine; its salts and molecular compounds.
3-(10-Phenothiazinyl) propane, substituted in the 1 position; its salts derivatives of 3-(10-Phenothiazinyl) propane substituted in the 1 position; their salts.
Phenoxypropazine; its salts.
Phenylbutazone; its salts.
Phentermine; its salts.
Phenylacetamide; its salts.
Phenylcinchoninic acid; salicylcinchoninic acid; their salts; their salts.
Phenylacetylcarbamide.
Phenylethydantoin; its salts; its acyl derivatives; their salts.
Phenylacetylurea.
5-Phenylhydantoin; its alkyl and aryl derivatives; their salts.
Phenylpropanolamine; its salts.
Phenylpropylmethylamine; its salts.
Pholcodeine; its salts.
Phospholine iodide.
Phosphorous yellow.
Physostigmine; its salts and quaternary compounds.
Picric acid.
Picrotoxin.
Pimafucin.
Piminodine and its salts.
Pimozide; its salts.
Pipamazine.
Pipradol; its salts.
Piritramide; its salts.
Pituitary gland, the active principles of.
Pivhydrazine; its salts.
Pizotyline.
Podophyllum.
Polymethylenebistrimethylammonium salts.
Polymyxins; their salts and preparations or any substance, the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Polythiazide.
Potassium cyanide.
Practolol.
Pramindole; its salts.
Praxilene.
Prazitone; its salts.
Prozosin hydrochloride.
Procainamide; its salts.
Procarbazine; its salts.
Proycyclidine; its salts.
Profenamine.
Prolintane; its salts.
Propheptazine; its salts.
Propantheline bromide.
Propoxyphene; its salts.
Properidine and its salts.
Propiomazine and its preparations.
Propylhexedrine; its salts.
Propynylcyclohexanol carbamate.
Proquamezine; its salts.
Proseptasine.
Prostaglandin E2.
Prostaglandin F2.
Prothionamide.
Prostin F2.
Prothipendyl; its salts.
Prothixene; its salts.
Protriptyline; its salts.
Pseudoephedrine; its salts; its quaternary compounds; their salts simple or complex.
Pyranisamine.
Pyrathiazine.
Pyrazine-2-Carboxyamide; its salts (Procainamide)
L-Pyroglutamyl-L-histidyl-L-proline amide.


Quinethazone.
Quinine; its salts except in preparations containing less than 10% of quinine or its salts (P1 only); S3 preparations containing not more than 1%, also soft drinks, wines or tonic wines and in preparations containing not more than 15% for use in manufacture of soft drinks, wines, tonic wines or confectionery.


Racemethorphan; its salts.
Racemoramide; its salts.
Racemorphan; its salts.
Rescinnamine.
Reserpine.
Rifamycins, that is to say a group of related anitmicrobial macrolactams, either produced by the growth of Streptomyces mediterranei or by modification of such products, and containing the chemical structure of 11-acetoxy-7, 9, 15-trihydroxy-13-metboxy-2, 6, 8, 10, 12-pentamethylpentadeca-2, 4, 12 trienoic acid amide, attached by the nitrogen atom and by the oxygen atom in the 15-position respectively to the 7-and 2-positions of A 5, 6, 9-trioxygenated 2, 4-dimethyl-l-oxanophto (2, 1-b) furan; any salt or ester of a substance comprised in this entry and any salt of such ester or any substance comprised in this entry and any salt of such ester or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Ristocetins and their salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Rolitetracycline; its salts and preparations.
Rimiterol hydrobromide.


Salazopyrin.
Salazosulphadimidine.
Salbutamol; its salts.
2-Salicylcinchoninic acid; its Savin, oil of.
Sensibamine; its salts.
Sodium cacodylate.
Sodium cromoglycate.
Sodium cyanide.
Sodium 4-(dimethyleamino) benezenediazo-sulphonate.
Sodium fusidate and preparations
Sodium Glymidine.
Sodium monofluoroacetate.
Sodium moramidopyrine methansulphonate.
Sodium stibogluconate.
Sodium valproate.
Sotalol hydrochloride.
Spectinomycin; its salts; its esters; their salts or any substances the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Spiramycin; its salts and preparations or any substance the chemical and biological properties of which are identical or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Stilbamine glucoside.
Streptomycin; its salts derivatives and salts of such derivatives and their preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other then living organisms.
Stropanthus; glycosides of.
Strychnine; its salts and quaternary compounds.
Styramate.
Sulphaquinoxalline.
Sulphonal, alkyl sulphonals.
Sulphomyxin sodium.
Suprarenal gland medulla, the active principles of their salts.
Suxamethonium; its salts.
Syrosingopine.


Tamoxifen citrate.
Tartar emetic.
Teclothiazide.
Terbutaline; its salts.
Tetrabenazine; its salts.
Tetracosactrin.
Tetracycline; that is to say, the antimicrobial substance containing the chemical structure Napthalene-2-carboxymide, hydrogenated to any extent and having in each of the positions 1, 3, 10, 11 and 12 substituted by a hydroxyl or an oxo group and their salts.
Tetraethylthiuram disulphide.
Thalidomide; its salts.
Thebaine and its salts.
Thallium salts of.
Thiazinamium methyl sulphate.
Thebacon; its salts; its esters; their salts.
Thiethylperazine; its salts.
Thiocarlide; its salts.
Thioguanine; its salts.
Thioproperazine; its salts.
Thioridazine; its salts.
Thiosemicarbozone.
Thyrocalcitonin.
Thyroid Gland, the active principles of; their salts.
Thyroglobulin.
Tigloidine.
Timolol maleate.
Tiocarlide; its salts.
Tobramycin sulphate.
Tofenacin; its salts.
Tolbutamide; its salts.
Tranexamic acid.
Tranylcypromine; its salts.
Tretamine; its salts.
Triacetyloleanodomycin and preparations.
Triamterene.
Tribromethyl alcohol.
Tribromoethyl alcohol.
Tribromoethanol.
Trichlorbutylodene glycol.
Trichomycin.
Triclofos; its salts.
Triethanomelamine; its salts.
Trifluoperazine; its salts.
Tri-(2-Chloroethyl) amine; its salts.
Trifluoperiodol.
Tribexphenidyl; its salts.
Trimeperidine; its salts.
Trimeprazine; its salts.
Trimethadione.
Trimipramine; its salts.
Trimustine; its salts.
Trinitrogylcerin.
Trinitrophenol.
Trinuride.
Trophenium.
Tropicamide.
Tropine diphenylmethyl ether.
Troxidone.
Tybamate.
Tylosin; its salts; its esters and their salts.


Vancomycin, its salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Vasopressins; natural and synthetic.
Verapamil; its salts.
Viomycin; its salts and preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Viocin sulphate.
Virginiamycin and preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.


Xylylanthranilic acid; its salts; its esters; their salts.


Zoxazolamine; its salts.


PART II


Accumulator acid.
Aldicarb.
Algimycin.
Alkali metal fluorides.
Alpha-chloralose.
Ammonia.
Ammonium Biflouride.
Ammonium flouride.
Arsenical substances, the following:

Arsenic pentoxides.

Arsenic sulphides.

Arsenious oxide.


Calcium arsenates.

Calcium arsenates.

Copper acetoarsenites.

Copper arsenates.

Copper arsenites.

Lead arsenates.

Potassium arsenites.

Sodium arsenites.

Sodium thiorsenates.


Barium carbonate.
Barium silicoflouride.
Benzophenol and its homologues in preparations containing below 60% w/w benzophenol or equivalent.


Ceresol.
Cerium oxalate.
Copper Diagnostic solution-tablets.
Creasote (obtained from wood).
Creosote (obtained from wood).
Cresols in preparations containing less than 60% w/w.
Cresylic acid in preparations containing less than 60% w/w.


Diamines, the following, their salts -

Phenylene diamines, tolylene diamines; other alkylated benzine diamines.
Dinitrocresols (DNC); their compounds with a metal or a base.
Dinosam; its compounds with a metal or a base.
Dinoseb; its compounds with a metal or a base.
B-(2-"3, 5-Dimethyl-2-oxocyclohexyl" -2-Hydroxyethly) Glutarimide.
Drazoxolon; its salts.


Endothal; its salts.
Endrin.


Fluhydric acid.
Fluoroacetamide.
Flouacetanilide.
Formaldehyde.
Formic acid.


Hydrochloric acid.
Hydroflouric acid; potassium flouride; sodium flouride; sodium silicofluoride.


Lysol.
Mercuric chloride; mercuric iodine; organic compounds of mercury except compounds which contain amethyl (CH3) group directly linked to the mercury atom.
Metallic oxalates.
Metaphenylenediamines; their salts.
Methidathion.
Methomyl.
Nicotine; its salts.
Nicotine dusts.
Nitric acid.
Nitrobenzol.
Nitrobenzene.


Organo-tin compounds, the following: Fentin compounds Oxalates, metallic.


Paraquat; salts.
Phenols as defined in Part I of this list containing less than sixty per cent weight of phenols, compounds of phenol with a metal in substances containing less than the equivalent of sixty per cent weight in weight of phenols.


Phenylene diamines; tolylene diamines, other alkylated benzine; their salts.
Phenylmercuric salts.
Phosphorus acids.
Phosphorus compounds: -

Amiton.

Aninphos-methyl.

Demeton-O.

Demeton-S.

Demeton-O-methyl.

Demeton-S-methyl.

Diethyl 4-methyl-7-coumarinyl phosphorothionate.

Diethyl p-nitrophenyl phosphate.

Dimefox.

Ethion.

Ethyl p-nitrophenyl phenyl-phosphorothionate.

Mecarbam.

Mevinphos.

Mipafox.

Phenkapton.

Pirimiphos-ethyl.

Mazidox 2-methoxycarbonyl-l-methyl-vinyl dimethyl phosphate.
2-methoxycarbonyl-l-methyl-vinyl dimethyl phosphate.

Parathion.

Phosphamidon.

Schradan.

Sulfotepp.

Tepp (HETP).

triphosphoric pentadimethylamide.

Vamidothion.
Phosphorus compounds:

Chlorfenvinphos.

Demephion.

Demeton-methyl.

Demeton-S-methyl sulphone.

Dioxathion.

Omethoate.

Primiphos-ethyl.

Thiometon.

Dichlorvos.

Disulfoton.

dvfonate.

Fonofos.

Oxydemeton-methyl.

Phorate.

Thionazin.
Potassium fluoride.
Potassium hydroxide.
Potassium quadroxalate.
Potassium tetroxalate.
Sodium fluoride.
Sodium fluosilicate.
Sodium hydroxie.
Sodium nitrite.
Sudol.
Sulphuric acid.
Tolylene diamines; their salts.
Zinc Phosphide.

______


FOURTH SCHEDULE
(Section 51)
(Substituted by Legal Notice 180 of 1980.)
______


ANIMAL MEDICINES


Avian encephalomyclitis vaccine
Bacitracin preparations for addition to food Boracic and iodoform powder.
Centrimide
Chlorhexidine
Coccidiostats
Cresylic acid
Formalin
Fowl cholera vaccine
Fowl coryza bacterin
Fowl paratyphoid bacterin
Fowl pox vaccine
Furazolidone preparations for addition to food or water
Intramammary injections of penicillin, not exceeding 100,000 units per tube
Marek's disease vaccine
Oral anthelmintics
Sulphadimine tablets, 5 gramme, in packs not exceeding 10 tablets
Tiamulin preparations for addition to food or water
Tylosin preparations for addition to food or water
Vitamin food and water additives


Provided that the abovementioned remedies may be sold only in the original manufacturers' or wholesalers' packs.


Controlled by Ministry of Health


Subsidiary Legislation
__________________________________________________________________________________________


CHAPTER 115


PHARMACY AND POISONS
______


SECTION 71 - PHARMACY AND POISONS (ANIMAL MEDICINE LICENCES) REGULATIONS
______


TABLE OF PROVISIONS
______


REGULATION


1. Short title
2. Form of Animal Medicine Licence
3. Returns of sales of certain medicines
4. Revocation


Schedule - Form of Animal Medicine Licence

______


Legal Notice No. 122 of 1982


Short title

1. These Regulations may be cited as the Pharmacy and Poisons (Animal Medicine Licences) Regulations.


Form of Animal Medicine Licence

2.-(1) An Animal Medicine Licence shall be in the form set out in the Schedule.


Returns of sales of certain medicines

3. The holder of an Animal Medicine Licence shall, for so long as he is required so to do by the Board by notice in writing, make a return to the Board as soon as may be after the expiration of each month, in such form as shall be approved by the Board, in respect of the animal medicines which he shall have sold during that month, being animal medicines of the descriptions included in the Fourth Schedule to the Act which are specified by the Board in the notice.


Revocation

4. The Pharmacy and Poisons (Animal Medicine Licences) Regulations, 1980 are revoked.

______


SCHEDULE
(Regulation 2)


PHARMACY AND POISONS ACT
(CHAPTER 115)
______


FORM OF ANIMAL MEDICINE LICENCE


To [Name] ...........................................................................................
[Address].............................................................................................


You are hereby licensed by the Pharmacy and Poisons Board, in pursuance of section 51 of the Pharmacy and Poisons Act, to sell the animal medicines specified in the Fourth Schedule to the Act. A copy of that Schedule is attached hereto.


This licence cannot be transferred and is available for one place of business only.


This licence is valid for the period of six months expiring on the ...........day of ............... 19....

.....................................
Secretary of the Board,
for and on behalf of the Board

______


SECTION 71 - PHARMACY AND POISONS (MANUFACTURER'S AND WHOLESALE LICENCES) REGULATIONS
______


TABLE OF PROVISIONS
______


REGULATION
1. Short title
2. Interpretation
3. Particulars to be contained in or to accompany an application for a manufacturer's licence or for a wholesale licence
4. Additional particulars to be contained in or to accompany an application for a manufacturer's licence or for a wholesale licence in certain cases
5. Supplementary provisions as to applications
6. Forms of manufacturer's and wholesale licences


First Schedule - Particulars Required on an Application for the Grant of a Manufacturer's Licence


Second Schedule - Particular Requirements on an Application for the Grant of a Wholesale Licence


Third Schedule - Additional Particulars Required on certain Applications


Fourth Schedule - Standard Provisions for a Manufacturer's Licence


Fifth Schedule - Standard Provisions for a Wholesale Licence


Sixth Schedule - Additional Standard Provisions for Manufacturer's and Wholesale Licence

______


Legal Notice No. 164 of 1980


Short title

1. These Regulations may be cited as the Pharmacy and Poisons (Manufacturer's and Wholesale Licences) Regulations.


Interpretation

2. In these Regulations, unless the context otherwise requires -


"application" means a request for the grant of a manufacturer's licence or a wholesale licence, as the case may be, together with the particulars required by regulation 3 or regulation 4, but does not include a request to renew any such licence;


"approved name", in relation to a constituent, means the name of the substance or article which appears in the current edition of one or other of the lists published under section 100 of the Medicines Act of the United Kingdom;


"import" means to bring or cause to be brought into Fiji by sea or air; "monograph" means a monograph in the current edition of the European Pharmacopoeia, any compendium published under section 99 of the said Medicines Act, the British Pharmacopoeia, the British Pharmaceutical Codex or the British Veterinary Codex;


"monograph name" means, in relation to a constituent, the name which appears at the head of the relevant monograph;


"proprietary designation" means a word or words used or proposed to be used in connection with the sale of a medicine or constituent for the purpose of indicating that they are goods of a particular person by virtue of manufacture, selection, certification, dealing with or offering for sale;


"substance" means any natural or artificial substance, whether in solid or liquid form or in the form of a gas or vapour.


Particulars to be contained in or to accompany an application for a manufacturer's licence or for a wholesale licence

3.-(1) Except where the Board otherwise directs, an application for the grant of a manufacturer's licence shall contain or be accompanied by the particulars specified in the First Schedule.


(2) Except where the Board otherwise directs, an application for the grant of a wholesale licence shall contain or be accompanied by the particulars specified in the Second Schedule.


Additional particulars to be contained in or to accompany an application for a manufacturer's licence or for a wholesale licence in certain cases

4.-(1) Except where the Board otherwise directs, where, in the case of an application for a manufacturer's licence, the proposed licencee is to be responsible for the composition of the medicine to which the application relates, the application shall contain or be accompanied by, in addition to the particulars specified in the First Schedule, the particulars specified in Part I of the Third Schedule.


(2) For the purposes of paragraph (1), a person shall be taken to be responsible for the composition of a medicine if, in the course of a business carried on by him, he manufactures the medicine: otherwise than for the purpose of assembly only, whether or not to the order of another person.


(3) Except where the Board otherwise directs, where, in the case of an application for a wholesale licence, the medicine to which the application relates is proposed to be imported-by the proposed licensee, the application shall contain or be accompanied by, in addition to the particulars specified in the Second Schedule, the particulars specified in Part I and Part 11 of the Third Schedule.


Supplementary provisions as to applications

5.-(1) An application for the grant of a manufacturer's licence shall specify -


(a) which, if any, of the standard provisions set out in the Fourth Schedule it is desired should be excluded or modified in relation to the grant of the licence; and


(b) if the application is one to which paragraph (1) of regulation 4 applies, which, if any, of the additional standard provisions set out in the Sixth Schedule it is desired should be so excluded or modified.


(2) An application for the grant of a wholesale licence shall specify -


(a) which, if any, of the standard provisions set out in the Fifth Schedule it is desired should be excluded or modified in relation to the grant of the licence; and


(b) if the application is one to which paragraph (3) of regulation 4 applies, which, if any, of the additional standard provisions set out in the Sixth Schedule should be so excluded or modified.


(3) Except where the Board otherwise directs, an applicant for a manufacturer's licence or for a wholesale licence shall furnish to the Board -


(a) a separate application in respect of each medicine of a particular description;


(b) six copies in the English language of his application and of the accompanying particulars, with the pages serially numbered;


(c) where the application or the accompanying particulars have been translated from another language, one copy of the application or accompanying particulars, as the case may be, in their original language.


(4) Where an application for a manufacturer's licence is an application to which paragraph (1) of regulation 4 applies or an application for a wholesale licence is one to which paragraph (3) of that regulation applies -


(a) the applicant shall submit each part of the accompanying particulars relating to the chemical and pharmaceutical studies, to the experimental and biological studies and to the clinical studies, in a separate section or volume with the pages of each section or volume serially numbered separately and with the first page of each section or volume bearing a reference for identification purposes to the application of which it is a part; and


(b) if the Board so directs, the applicant shall furnish to the Board -


(i) additional copies of the application and any accompanying particulars;


(ii) a sample of the medicine to which the application relates; and


(iii) authenticated copies of licences, certificates and other relevant documents, relating to the medicine to which the application relates, which may have been issued under legislation of any other country corresponding to the provisions of Part V of the Act.


(5) Every application to the Board shall be signed by the applicant, and, where the application is made by a person other than the proposed licensee, shall be signed also by the proposed licensee.


(6) Where the applicant for a manufacturer's licence is a body corporate, the application shall be accompanied by a statement signed by the Superintendent (who shall be a registered pharmacist) who shall be responsible for the management of the business of the body corporate, so far as it relates to the manufacture of medicines, specifying his name and address and stating whether or not he is a member of the body corporate and whether or not he acts in a similar capacity for any other body corporate.


(7) Where, in the case of any application to the Board, any of the required particulars are not furnished, the application shall state -


(a) that the required particulars are not applicable; or


(b) any other reason for their absence.


Forms of manufacturer's and wholesale licence

6.-(1) A manufacturer's licence shall be in such form as shall be approved by the Board and shall contain such provisions as the Board considers appropriate, including (with or without modifications) -


(a) the standard provisions set out in the Fourth Schedule; and


(b) if the application for the licence is one to which paragraph (1) of regulation 4 applies, the additional standard provisions set out in the Sixth Schedule.


(2) A wholesale licence shall be in such form as shall be approved by the Board and shall contain such provisions as the Board considers appropriate, including (with or without modifications) -


(a) the standard provisions set out in the Fifth Schedule; and


(b) if the application for the licence is one to which paragraph (3) of regulation 4 applies, the additional standard provisions set out in Sixth Schedule.

______


FIRST SCHEDULE
(Regulation 3(1))
______


PARTICULARS REQUIRED ON AN APPLICATION FOR THE GRANT OF A MANUFACTURER'S LICENCE


1. The name and address of the applicant, and, where the applicant is not the proposed licensee, the name and address of the proposed licensee.


2. The period for which the licence is desired, where it is for less than 5 years.


3. A statement of the manufacturing or assembling operations to which the licence is to relate, including a statement whether they include one or both of the following -


(a) the manufacture of medicines; or


(b) the assembly of medicines.


4. A statement of the use for which the medicines are or are proposed to be manufactured or assembled, and whether the use is as stated in one or more of the following sub-paragraphs -


(a) for use by being administered to human beings;


(b) for use by being administered to animals;


(c) for use in the form of an ingredient in the preparation of a substance or article which is to be administered to human beings or animals for a medicinal purpose; or


(d) for use by incorporation in any animal feeding stuff.


5.-(1) The address of each of the premises where the manufacturing or assembling operations to which the application relates, or both operations, including any testing associated with manufacture or assembly, are or are to be carried out.


(2) The address of each of the premises if different from those referred to in sub-paragraph (1) -


(a) on which are to be kept any living animals; or


(b) on which are to be kept or from which are to be obtained any materials of animal origin,


from which, in either case, are to be derived any substance or substances used in the production of the medicine, whether human or veterinary, to which the application relates.


(3) The address of each of the premises where the proposed licensee proposes to store medicines or from which he proposes to distribute them.


(4) A statement indicating the facilities and equipment available at each of the premises for storing the medicines on, and distributing them from or between, such premises.


(5) A separate statement in respect of each of the premises, of the manufacturing or assembling operations capable of being carried out at those premises with their existing facilities; each statement specifying the classes of medicines to which the operations are relevant.


(6) A separate statement in respect of each of the premises, of equipment available at those premises for carrying out each stage of the manufacturing or assembling operations described in sub-paragraph (5).


6. A statement of any manufacturing operations, other than those to which the manufacturing licence is to relate, that are carried on by the proposed licensee on or near each of the premises referred to in paragraph 5, and of the substances or articles which are the subject of any such operation.


7.-(1) The name and address and qualifications and experience of the production manager or other persons whose duty it will be to supervise the production operations at each of the premises referred to in paragraph 5, and the name and function of the person to whom he is responsible.


(2) The name and address and degrees, diplomas or other qualifications and experience of the person to be in charge of quality control over all the premises referred to in paragraph 5, and the extent of the authority to be delegated to him to reject unsatisfactory batches of medicines, and the name and function of the person to whom he is responsible (if ultimate responsibility for quality control is to be exercised by any other person this is to be stated).


(3) The name and address and degrees, diplomas or other qualifications of the person in charge of the animals referred to in sub-paragraph (2) of paragraph 5.


(4) The name and address and degrees, diplomas or other qualifications of the person to be responsible for the culture of any living tissue to be used in the manufacture of medicines.


8. An outline of the arrangements for the identification and storage of materials and ingredients before and during manufacture and for the storage of medicines after manufacture or assembly.


9. An outline of the arrangements for securing the safekeeping of materials and ingredients, before and during manufacture, and of medicines after manufacture or assembly.


10. An outline of the arrangements at each of the premises where the licensee stores or proposes to store medicines for ensuring, so far as practicable, whether by maintaining records or other means, a satisfactory turn-over of stocks of medicines.


11. An outline of the arrangements -


(a) for maintaining production records;


(b) for maintaining records of analytical and other testing procedures applied in the course of manufacture or assembly for ensuring compliance of materials used in the manufacture of any medicines, with the specification of such materials or medicines; and


(c) for keeping reference samples of materials used in the manufacture of any medicinal products and of the medicines.

______


SECOND SCHEDULE
(Regulation 3(2))


PARTICULARS REQUIRED ON AN APPLICATION FOR THE GRANT OF A WHOLESALE LICENCE


1. The name and address of the applicant, and, where the applicant is not the proposed licensee, the name and address of the proposed licensee.


2. The period for which the licence is desired, where it is for less than 5 years.


3. A statement of the wholesale dealings to which the licence is to relate, and whether they consist of -


(a) dealing in many kinds of medicines, and whether this dealing includes herbal remedies;


(b) dealing only in such medicines as may be sold otherwise than at a registered pharmacy, or otherwise than by a practitioner or otherwise than at a hospital;


(c) dealing only in herbal remedies; or


(d) dealing only in particular classes of medicines not mentioned in the above sub-paragraphs, and a description of those classes.


4. Whether in any case mentioned in paragraph 3 the use of the medicines is to be one or more of the following -


(a) for use by being administered to human beings;


(b) for use by being administered to animals;


(c) for use in the form of an ingredient in the preparation of a substance or article which is to be administered to human beings or animals or a medicinal purpose; or


(d) for use by incorporation in any animal feeding stuff.


5. The address of each of the premises where the proposed licensee proposes to store medicines or from which he proposes to distribute them.


6. A statement indicating the general range of medicines to be stored at each of the premises.


7. A statement indicating the facilities (including cold storage facilities) and equipment available at each of the premises for storing the medicines on, and distributing them from or between, such premises.


8. A statement indicating the arrangements for securing the safe keeping of medicines to be stored in or to be distributed from each of the premises.


9. An indication of the arrangements at each of the premises, whether by maintaining records or by other means, for ensuring, so far as practicable, a satisfactory turn-over of stocks of medicines.

______


THIRD SCHEDULE
(Regulation 4(I) and (3))
______


PART I


ADDITIONAL PARTICULARS RELATING TO MEDICINES REQUIRED ON APPLICATION FOR A MANUFACTURER'S LICENCE OR FOR A WHOLESALE LICENCE IN CERTAIN CASES


1. The name or proposed name under which the medicine will be sold, supplied or exported.


2. A statement of the specification of the medicine other than as required by paragraphs 3, 4 and 6 of this Schedule.


3. A description of the pharmaceutical form of the medicine.


4. A statement of the qualitative and quantitative composition of the medicine covering -


(a) all active constituents;


(b) all colouring matter, flavouring agents and perfume; and


(c) all other constituents.


5. In respect of each constituent, whether active or not -


(a) the approved name or the monograph name;


(b) where there is no approved name or monograph name, the non-proprietary designation or other descriptive appellation by which it can be readily identified; or


(c) where there is no name or descriptive appellation as described in subparagraph (a) and (b), the proprietary designation.


6. The specification of all constituents whether active or not (where the constituent is the subject of a monograph, a reference to the monograph name may be given instead of the specification).


7. The chemical structural formula for each active constituent where known (where the active constituent is the subject of a monograph, a reference to the monograph name may be given instead of the formula).


8. A description of the method of manufacture or assembly of the medicine.


9. A description of the method of manufacture of each active constituent (where the active constituent is the subject of a monograph, a reference to the monograph name may be given instead of a description).


10. A statement whether precautions will be taken during manufacture or assembly to control the quality of the medicine, and whether the proposed licensee will be responsible for deciding that any batch of the medicine is of acceptable quality for sale, supply or exportation, and, if not, who will be responsible.


11. In the case of all constituents, whether active or not, a description of the quality control procedures and methods to be applied to ensure compliance with the specification.


12. A description of the procedures or methods to be used to ensure the uniformity of the medicine in the process of manufacture or assembly, and evidence of the stability and the grounds for any proposed shelf-life of the medicine.


13. Particulars of the methods to be employed during manufacture or assembly for determining the identity, purity and potency of the medicine, and the address of the premises where such procedures are to be carried out.


14. A description of the nature of the containers to be used for the medicine and a statement of any special directions necessary for storage and transport.


15. In the case of a licence relating to a medicine to be incorporated in any animal feeding stuff -


(a) a description of the feeding stuff;


(b) data on any relevant compatibilities or incompatibilities of the medicine known to the proposed licensee with other substances or articles, on its stability in animal feeding stuffs, and on methods of incorporation and rates of inclusion in animal feeding stuffs; and


(c) a description of the method of analysis used to determine whether or not the medicine has been correctly incorporated, and to determine the rates of inclusion in animal feeding stuffs.


16. Particulars of the indications suggested by the proposed licensee for the administration of the medicine, whether or not incorporated in an animal feeding stuff.


17. Particulars of the proposed dose or dosage, methods and routes of administration.


18. Any directions, contra-indications and warnings proposed, and the basic particulars of the information proposed to be included on the container label, on the package label and in any leaflet to be inserted in the package, or in other informative literature.


19. Copies of reports and evaluations of any experimental and biological studies and of other preclinical, clinical or laboratory studies carried out with the medicine or its constituents which, in the view of the proposed licensee, are relevant to the assessment of the safety, quality or efficacy of the medicine, together with reference to relevant publications, clinical trials or animal tests.


PART II
______


ADDITIONAL PARTICULARS AS TO PURPOSE OF LICENCE REQUIRED ON APPLICATION FOR A WHOLESALE LICENCE IN CERTAIN CASES


1. A statement of the activities to which the licence is to relate, and whether it is one or more of the following -


(a) to sell or supply the medicine in Fiji;


(b) to procure the sale or supply by another person of the medicine in Fiji;


(c) to export the medicine;


(d) to procure the exportation by another person of the medicine;


(e) to procure the manufacture or assembly by another person of the medicine for the purposes of any of the activities referred to in sub-paragraphs (a), (b), (c) or (d).


2. A statement of the use for which the medicine is to be imported, manufactured, sold, supplied or exported, and whether the use is as stated in one or more of the following sub-paragraphs -


(a) for use by being administered to human beings;


(b) for use by being administered to animals;


(c) for use in the form of an ingredient in the preparation of a substance or article which is to be administered to human beings or animals for a medicinal purpose;


(d) for use by incorporation in any animal feeding stuff.


3. A description of the contemplated method of sale or supply in Fiji.


4.-(1) The name and address of the manufacturer or assembler of the medicine in the form in which it will be imported.


(2) A statement of the manufacturing or assembling operations relating to the medicine carried out or to be carried out in Fiji or elsewhere by the proposed licensee or any other persons.


(3) A statement of the address of each place or proposed place of manufacture or assembly in Fiji.


(4) The name and address of the persons, if any, other than the proposed licensee taking part or proposing to take part in the manufacture or assembly in Fiji or elsewhere and a statement of the operations for which each such person is to be responsible.


5. Where the activity to which the licence is to relate is -


(a) to procure the sale or supply by another person of the medicine in Fiji; or


(b) to procure the exportation by another person of the medicine, the name and address of the person who is to sell, supply or export the medicine.

______


FOURTH SCHEDULE
(Regulation 5(1) (a))
______


STANDARD PROVISIONS FOR A MANUFACTURER'S LICENCE


1. The licence holder shall provide and maintain such staff, premises and plant as are necessary for the carrying out in accordance with his licence of such stages of the manufacture and assembly of the medicines as are undertaken by him, and he shall not carry out any such manufacture or assembly except at the premises specified in his manufacturer's licence.


2. The licence holder shall provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the medicines which he handles, stores or distributes under his licence as are necessary to avoid deterioration of the medicines and he shall not use for such purposes premises other than those specified in the licence or which may be approved from time to time by the Board.


3. The licence holder shall conduct all manufacture and assembly operations in such a way as to ensure that the medicines conform with the standards of strength, quality and purity approved by the Board.


4. The licence holder, where animals are used in the production of any medicines and his licence contains any provisions relating to them, shall arrange for the animals to be housed in premises of such a nature and to be managed in such a way as will facilitate compliance with such provisions.


5. The licence holder shall either -


(a) provide and maintain such staff, premises and plant as are necessary for carrying out any tests of the strength, quality or purity of the medicines that he manufactures under his licence as required by the Board, and when animals are used for such tests they shall be suitably housed and managed; or


(b) make arrangements with a person approved by the Board for such tests to be carried out by that person.


6. The licence holder shall provide such information as may be requested by the Board for the purposes of the Act, about the products currently being manufactured or assembled under his licence and of the operations being carried out in relation to such manufacture or assembly.


7. The licence holder shall inform the Board before making any material alteration in the premises or plant used under his licence, or in the operations for which they are used, and he shall inform the Board of any change that he proposes to make in any personnel named in his licence as respectively -


(a) responsible for supervising the production operations;


(b) responsible for quality control of the medicines being manufactured or assembled;


(c) in charge of the animals from which are derived any substances used in the production of the medicines being manufactured or assembled; or


(d) responsible for the culture of any living tissues used in the manufacture of the medicines being manufactured or assembled.


8. The licence holder shall keep readily available for inspection by a person authorised by the Board durable records of the details of manufacture and assembly of each batch of every medicine being manufactured or assembled under his licence and of the tests carried out thereon, in such a form that the records will be easily identifiable from the number of the batch as shown on each container in which the medicine is sold, supplied or exported, and he shall permit the person authorised to take copies or make extracts from such records; and such records shall not be destroyed for a period of 5 years from the date when the manufacture or assembly of the relevant batch occurred, without the consent in writing of the Board.


9. The licence holder shall keep such documents as will facilitate the withdrawal or recall from sale, supply or exportation of any medicine to which the licence relates.


10. Where the licence holder has been informed by the Board that any batch of any medicines to which his licence relates has been found not to conform as regards, strength, quality or purity with the specification of the relevant product or with the provisions of the Act or of any regulations under the Act that are applicable to the medicine, he shall, if so directed, withhold such batch from sale, supply or exportation, so far as may be reasonably practicable, for such a period as the Board shall determine.


11. The licence holder shall ensure that any tests for determining conformity with the standards and specifications applying to any particular product used in the manufacture shall be applied to samples taken from the medicine after all manufacturing processes have been completed, or at such earlier stage in the manufacture as may be approved by the Board.

______


FIFTH SCHEDULE
(Regulation 5(2)(a))
______


STANDARD PROVISIONS FOR A WHOLESALE LICENCE


1. The licence holder shall provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the medicines which he handles, stores or distributes under his licence, as are necessary to avoid deterioration of the medicines and he shall not use for such purposes premises other than those specified in the licence or which may be approved from time to time by the Board.


2. The licence holder shall provide such information as may be requested by the Board concerning the type and quantity of any medicines which he currently handles, stores or distributes.


3. The licence holder shall inform the Board of any proposed structural alterations to, or discontinuance of use of, premises to which the licence relates or premises which have been approved from time to time by the Board.


4. The licence holder shall keep such documents relating to his transactions by way of the sale of medicines to which the licence relates as will facilitate the withdrawal or recall from sale or exportation of such products.


5. Where the licence holder has been informed by the Board or by the manufacturer that any batch of any medicine to which his licence relates has been found not to conform as regards strength, quality or purity with the specifications of that product or with the provisions of the Act or of any regulation under the Act that are applicable to the medicine, he shall, if so directed, withhold such batch from sale or exportation, so far as may be reasonably practicable, for such period as the Board shall determine.


6. The licence holder shall not sell any medicine by wholesale to any person who does not hold a wholesale licence in respect of that medicine or a licence for the sale by retail of that medicine.

______


SIXTH SCHEDULE
(Regulations 5 and 6)
______


ADDITIONAL STANDARD PROVISIONS FOR MANUFACTURER'S
AND WHOLESALE LICENCES


1. The licence holder shall forthwith report to the Board any change in his name and address and in any address at which there is carried on a business to which the licence relates.


2.-(1) The licence holder shall forthwith inform the Board of any material change that has been made or that he proposes to make, or that he proposes that another person shall make, in the particulars contained in or furnished in connection with his application, in relation to any medicine to which the licence relates, that is to say -


(a) in the specification of the medicine;


(b) in the specification of any of the constituents of the medicine;


(c) in the composition of the medicine or of any of the constituents of the medicine;


(d) in the methods of manufacture or assembly of the medicine or of any of the constituents of the medicine;


(e) in the methods and procedures described in the application for ensuring compliance with such specifications; or


(f) in the arrangements described in the application for storage of the medicine.


(2) Where the particulars of any of the matters mentioned in the licence differ from the particulars relating to the corresponding matters contained in or furnished in connection with the application for the licence, the licence holder shall forthwith inform the Board of any change to a material extent in the matters mentioned in the licence that he proposes to make, or that he proposes that another person shall make.


3. The licence holder shall forthwith inform the Board of any information received by him that casts doubt on the continued validity of the data which was submitted with, or in connection with, the application for the licence for the purpose of being taken into account in assessing the safety, quality or efficacy of any medicine to which the licence relates.


4. The licence holder shall maintain a record of reports of which he is aware of adverse effects in one or more human beings or animals associated in those reports with the use of any medicine to which the licence relates, which shall be open to inspection by a person authorised by the Board who may take copies thereof; and if the Board so directs, the licence holder shall furnish the Board with a copy of any such reports of which he has a record or of which he is or subsequently becomes aware.


5. The licence holder shall keep readily available for inspection by a person authorised by the Board durable records of his arrangements -


(i) for procuring the sale, supply, manufacture, assembly or importation of any medicine to which the licence relates;


(ii) for obtaining materials for the purpose of the manufacture or the assembly by him or on his behalf of any medicine to which the licence relates; and


(iii) for tests to be carried out on the materials used for manufacture or assembly of any medicine and on any medicine to which the licence relates,


and shall permit the person authorised to take copies of, or to make extracts from, such records.


6. Except with the consent in writing of the Board, the records required to be kept by paragraph 5 shall not be destroyed for a period of five years from the date when the sale, supply or exportation of the relevant batch of the medicines was authorised by or on behalf of the licence holder.


7. The licence holder shall notify the Board forthwith of any decision to withdraw from sale, supply or exportation of any medicine to which the licence relates, and shall state the reason for that decision.

______


SECTION 71 - POISONS (INDUSTRIAL AND AGRICULTURAL)
REGULATIONS
______


TABLE OF PROVISIONS
______


REGULATION
1. Short title
2. Interpretation
3. Form of licence
4. Use of poisons for control of pests
5. Register
6. Storage of poisons
7. Cupboards, etc., to be kept locked
8. Containers


First Schedule
-
Licence to Import Poisons
Second Schedule
-
Register of Receipts and Issues
Third Schedule
-
Poisons for Controlling Noxious Weeds or Pests

______


Regulations 23 May 1962, 25 March 1964


Short title

1. These Regulations may be cited as the Poisons (Industrial and Agricultural) Regulations.


Interpretation

2. In these Regulations, unless the context otherwise requires, "agricultural" includes "horticultural".


Form of licence

3. The form of licence to import poisons required by subsection (1) of section 62 of the Act shall be as set out in the First Schedule.


Use of poisons for control of pests

4. The Permanent Secretary for Primary Industries* or his duly authorised officer may use or issue to agriculturists the poisons set out in the Third Schedule for the purpose of controlling noxious weeds or pests.


Register

5. A Register of Receipts and Issues of all poisons used for industrial or agricultural purposes shall be kept by the person responsible for the custody of the poison in the form as set out in the Second Schedule.


Storage of poisons

6. When it is necessary to store poisons for industrial or agricultural purposes the following conditions shall apply. They shall be stored -


(a) in a cupboard or drawer which is used solely for that purpose; or


(b) in a room or building used solely for that purpose.


Cupboards, etc., to be kept locked

7.-(1) All cupboards, drawers, rooms or buildings used for the storage of poisons as aforesaid shall be kept locked and the key shall be in the sole possession of some responsible person who shall be acquainted with the nature of the poison and who is capable of recognizing the symptoms peculiar to that poison and is aware of and is capable of administering the appropriate antidote.


(2) The front external part of a drawer or the external side of any door or cupboards, rooms and buildings used solely for such purpose as aforesaid shall bear a notice in a prominent position with the word "POISON" thereon in the English, Fijian and Hindi languages, the letters of which -


(a) on a notice on the front external part of any drawer shall be at least 1½ inches in height; and


(b) on a notice on the doors of cupboards, rooms and buildings shall be at least 3 inches in height.


Containers

8. No poison shall be issued unless in a container impervious to the poison, and distinctly labelled "POISON" with the name of the poison and the purpose for which it is to be used.

______


FIRST SCHEDULE
(Regulation 3)
______


PHARMACY AND POISONS ACT


LICENCE TO IMPORT POISONS


To the Collector of Customs,


This is to certify that permission has been granted to ..................... of .............. to import the several poisons which are enumerated on the back hereof into Fiji.


Suva, ............... 19......


Secretary, Pharmacy and Poisons Board


This licence is to be produced to the Collector of Customs at the port through which the poisons are to be imported.


This licence is for one consignment only.


This licence is to be retained by the Collector of Customs and returned by him after endorsement to the Secretary, Pharmacy and Poisons Board, Suva.


Name of Poison
Quantity



This is to certify that the poisons named above have been duly delivered to ...................... 19.......

Collector of Customs

______


SECOND SCHEDULE
(Regulation 5)
______


(One separate page for each separate poison or class of poison)


Name of Poison:



RECEIPTS

ISSUES
Date
From
Quantity
Date
To
Quantity
For what purpose








______


THIRD SCHEDULE
(Regulation 4)
______

Arsenical subs. -


Arsenic trioxide
Alkali and alkaline earth fluoride (e.g. Cryelite, etc).
Arsenic pentoxide
Alakili cyanides.
Arsenic sulphides
Alkali chlorates.
Calcium arsenates
Barium carbonate.
Calcium arsenites
Lead acetate.
Copper acetates
Mercurial subs. -
Copper acetoarsenites
Mercuric chloride.
Copper arsenites
Mercuric iodide.
Lead arsenates
Organic compound of mercury.
Potasssium arsenites.
Nicotine Salts.
Sodium arsenites.
Phosphorous (yellow).
Sodium arsenates.
Rotenone and other preparations of derris.
Sodium thioarsenates

Zinc arsenites.


______


SECTION 71 - POISONS REGULATIONS


TABLE OF PROVISIONS
______


REGULATION


1. Short title
2. Interpretation
3. Sale of Poisons
4. Application of provisions as to labelling of poisons
5. Application of section 66(2) of Act
6. Sales under section 68 of Act
7. Exemptions from section 67(3) of Act
8. Applications of Regulations to transactions exempted by section 67 of Act
9. Exemptions from application of Regulations and Part VI of Act
10. Further exemptions
11. Restriction on sale of poisons listed in Fourth Schedule
12. Restriction on sale of poisons listed in First Schedule
13. Further restrictions on sale of poisons
14. Labelling
15. Name of poison
16. Particulars to be specified on label
17. Labelling with word "poison"
18. Warnings on labels
19. Provisions as to name and address on label
20. Containers for sale of poison
21. Storage of poisons
22. Transport of poisons
23. Transport of poisons listed in Eighth Schedule
24. Manufacture of preparations containing poison
25. Form of application for licence
26. Licence to sell poison
27. Fees
28. Form of Certificate of Registration
29. Form of Register of Pharmacists
30. Form of Register of Premises
31. Form of application for licence to sell
32. Licence to sell
33. Application for Animal Medicine Licence
34. (Superseded)
35. Certificate
36. Form of entries
37. Preservation of books


First Schedule
-
Substances Falling within the Poisons List to which Special Restrictions Apply (List "A")
Second Schedule
-
Poisons Exempted by Regulation 4(2) from Labelling Provisions When Sold in Certain Circumstances (List "B")
Third Schedule
-
Poisons Exempted by Regulation 10 from the provisions of the Act and of these Regulations (List "C")
Fourth Schedule
-
Substances Required by Regulation 11 to be Sold only on a Prescription Given by a Registered Medical Practitioner, Registered Dentist or Registered Veterinary Surgeon (List "D")
Fifth Schedule
-
Form to which the Substances Specified are Restricted when Sold by Licensed Sellers of Part II Poisons (List "E")
Sixth Schedule
-
Statement of Particulars as to Proportion of the Poison in Certain Cases Permitted by Regulation 16(2)
Seventh Schedule
-
Indication of Character Prescribed by Regulation 17(1) for the Purpose of Section 66(1) (c)(iii) of the Act (List "F")
Eighth Schedule
-
Poisons to which Regulation 23 (Transport) Applies (Lists "G")
Ninth Schedule
-
Form of Application by a Licensed Storekeeper for a License to Sell Part II Poisons
Tenth Schedule
-
Form of Licence to Sell Certain Part II Poisons
Eleventh Schedule
-
Fees
Twelfth Schedule
-
Form of Certificate of Registration as Pharmacist
Thirteenth Schedule
-
Form of Register of Pharmacists
Fourteenth Schedule
-
Form of Register of Premises
Fifteenth Schedule
-
Form of Application for Licence to Sell Medicines
Sixteenth Schedule
-
Form of Licence to Sell Medicines
Seventeenth Schedule
-
Certificate for the Purchase of a Poison
Eighteenth Schedule
-
Form of Entry to be Made under Regulation 36
Nineteenth Schedule
-
Form of Licence to Purchase Arsenical Poison
Twentieth Schedule
-
Form of Application for Licence to Sell Animal Medicine
Twenty-first Schedule
-
(Superseded)

______


Regulations 23 May 1962, 28 November 1962, 7 May 1963, 29 January 1964,
7 November 1964, Legal Notices Nos. 8 of 1970, 87 of 1970, 96 of 1971, 103
of 1971, 109 of 1972, 58 of 1973, 33 of 1976, 154 of 1977, 168 of 1977, 120 of
1979, 7 of 1981, 45 of 1984


Short title

1. These Regulations may be cited as the Poisons Regulations.


Interpretation

2.-(1) In these Regulations, unless the context otherwise requires -


"animal" includes poultry;


"animal feed supplement" means a processed substance fed to animals with a view to promoting and sustaining growth.


"antimonial poisons" means chlorides of antimony, oxides of antimony, sulphides of antimony, antimonates, antimonites, and organic compounds of antimony;


"arsenical poisons" means halides of arsenic, oxides of arsenic, sulphides of arsenic, arsenates, arsenites, copper acetoarsenites, sodium thioarsenates, and organic compounds of arsenic;


"British Pharmacopoeia" and "British Pharmaceutical Codex" include supplements;


"food" includes a beverage;


"licensed seller of poisons" means a person entitled under Part VI of the Act to sell poisons included in Part II of the Poisons List;


"medicines for the internal treatment of human ailments" includes any medicine to be administered by hypodermic injection but does not include any mouth-wash, eye-drops, eye-lotion, ear-drops, douche or similar article;


"Poisons List" means the Poisons List contained in the Third Schedule to the Act;


"sale exempted by section 68 of the Act" means a sale made in such circumstances as to be entitled, except as provided by these Regulations, to exemption under section 68 of the Act from the foregoing provisions of Part VI of the Act;


"transaction exempted by section 67 of the Act" means the supply of a medicine in such circumstances as to be entitled to exemption under section 67 of the Act from the provisions of section 66 of the Act.


(2) In these Regulations any reference to any alkaloid shall include a reference to any salt of that alkaloid and in the case where the esters of an alkaloid are included in the Poisons List by virtue of the words "its esters" to any esters of that alkaloid.


(3) Any reference in the Schedules to the percentage of a poison contained in any substance or preparation shall, unless otherwise expressly provided, be construed in the following manner, that is to say, a reference to a substance or preparation containing one per cent of any poison means -


(a) in the case of a solid that one gram of the poison is contained in every hundred grams of the substance or preparation;


(b) in the case of a liquid that one millilitre of the poison or if the poison itself is a solid one gram of the poison is contained in every hundred millilitres of the substance or preparation;


and so on in proportion for any greater or less percentage.


Sale of poisons

3. It shall not be lawful for any person to sell any poisons on any premises used for or in connection with his retail business notwithstanding that the sale is exempted by section 68 of the Act unless he complies with the provisions of paragraph (a) or paragraph (b) as the case may be subsection (1) of section 66 of the Act.


Application of provisions as to labelling of poisons

4.-(1) Subject as hereinafter provided, the provisions of paragraph (c) of subsection (1) of section 66 of the Act and of regulations 14 to 19 (which provisions relate to the labelling of poisons) shall apply to sales exempted by section 68 of the Act and shall also apply to the supply of poisons (otherwise than on sale) in like manner as if references in the said provisions to the sale and seller of poisons included references to the supply and supplier of poisons respectively.


(2) The said provisions except the provisions of regulation 18 and of sub-paragraph (iv) of paragraph (c) of subsection (1) of section 66 of the Act as modified by regulation 19 shall not apply to the sale or supply of any of the poisons included in the Second Schedule to a person who requires the poison for the purpose of his trade or business if the outside of the package in which the poison is sold or supplied is labelled conspicuously with words indicating the dangerous properties of the poison.


Application of section 66 (2) of Act

5. The provisions of subsection (2) of section 66 (which makes provision as to persons to whom poisons may be sold and to the keeping of records of sales) shall apply to all substances included in the First Schedule, whether or not the poison sold is a poison included in Part I of the Poisons List, and shall not apply with respect to any other substance:


Provided that paragraph (a) of the said subsection shall in its application to sales by authorised sellers of Part II poisons be deemed to be satisfied if the person to whom the poison is sold is known by the person in charge of the premises on which the poison is sold or of the department of the business in which the sale is effected to be a person to whom the poison may properly be sold.


Sales under section 68 of Act

6.-(1) The provisions of subsection (2) of section 66 of the Act as modified by regulation 5 shall apply to sales exempted by section 68 of the Act and shall also apply to the supply in the form of a commercial sample otherwise than on sale of any substance included in the First Schedule in the like manner as if references in the said provisions to the sale and seller of poisons respectively included references to the supply and supplier of poisons in the form of commercial samples.


(2) Paragraph (a) of subsection (2) of section 66 of the Act shall in its application to sales exempted by section 68 of the Act and to the supply in the form of commercial samples of substances included in the First Schedule be deemed to be satisfied if the person to whom the poison or sample is sold or supplied is known by the person in charge of the department of the business through which the sale or supply is effected to be a person to whom the poison or sample may properly be sold or supplied.


(3) So much of paragraph (b) of subsection (2) of section 66 of the Act as requires an entry in a book to be signed by the purchaser of a poison shall not, as respects the sale of a poison to a person for the purposes of his trade, business or profession, apply if the following requirements are satisfied:-


(a) the seller must obtain before the completion of the sale an order in writing signed by the purchaser stating his name and address, trade, business or profession, the name and quantity of the article to be purchased and the purpose for which it is required;


(b) the seller must be reasonably satisfied that the signature is that of the person purporting to have signed the order and that that person carries on the trade, business or profession stated in the order being one in which the poison to be purchased is used;


(c) If the article is sent by post it must be sent by registered post;


(d) the seller must insert in the entry prescribed by regulation 36 the words "signed order" and a reference number by which the order can be identified:


Provided that where a person represents that he urgently requires a poison for the purpose of his trade, business or profession the seller may if he is reasonably satisfied that the person so requires the poison and is by reason of some emergency unable before delivery either to furnish to the seller an order in writing duly signed or to attend and sign the entry in the book deliver the poison to the purchaser on an undertaking by the purchaser to furnish such an order within the twenty-four hours next following.


If any purchaser by whom any such undertaking has been given fails to deliver to the seller a signed order in accordance with the undertaking or if any person for the purpose of obtaining delivery of any poison under the foregoing proviso makes a statement which is to his knowledge false he shall be deemed to have contravened the provisions of this regulation.


Exemptions from section 67 (3) of Act

7. The requirements mentioned in subsection (3) of section 67 of the Act (which requires particulars of medicines supplied or dispensed under that section to be entered in a book) need not be satisfied in the case of any medicine not being a substance included in the First Schedule which is supplied by -


(a) a registered medical practitioner or qualified veterinary surgeon for the purpose of medical or animal treatment; or


(b) a registered pharmacist on and in accordance with a prescription given by a registered medical practitioner.


Application of Regulations to transactions exempted by section 67 of Act

8. Nothing in these Regulations shall apply except as is expressly provided therein to transactions exempted by section 67 of the Act.


Exemptions from application of Regulations and Part V1 of Act

9. Such of the provisions of these Regulations and of Part VI of the Act as modified by these Regulations as apply solely with respect to the substances included in the First Schedule shall not apply with respect to -


(a) machine spread plasters; or


(b) surgical dressings; or


(c) articles containing barium carbonate and prepared for the destruction of rats and mice; or


(d) corn paints in which the only poison is a poison included in the Poisons List under the head of "Cannabis".


Further exemptions

10. Nothing in Part VI of the Act or these Regulations shall apply -


(a) with respect to any article included in Group I of the Third Schedule; or


(b) so far as any poison specified in the first column of Group II of that Schedule is concerned with respect to any of the articles or substances specified in the second column opposite the description of the poison.


Restriction on sale of poisons listed in Fourth Schedule

11.-(1) It shall not be lawful to sell any poison included in the Fourth Schedule except on and in accordance with a prescription given by a registered medical practitioner, registered dentist or a qualified veterinary surgeon in the form provided by this regulation.


(2) This regulation shall apply to the sale of such poison notwithstanding that it is a transaction exempted by section 67 of the Act, but shall not apply to any sale exempted by section 68 of the Act.


(3) For the purposes of this regulation a prescription shall -


(a) be in writing and be signed by the person giving it with his usual signature and be dated by him;


(b) specify the address of the person giving it;


(c) specify the name and address of the person for whose treatment it is given or if the prescription is given by a qualified veterinary surgeon of the person to whom the medicine is to be delivered;


(d) have written thereon if given by a dentist the words "for dental treatment only" or if given by a qualified veterinary surgeon the words "for animal treatment only";


(e) indicate the total amount of the medicine to be supplied and the dose to be administered or injected;


(f) indicate the number of times upon which the prescription is to be dispensed if more than once and indicate also the interval between the dates of dispensing. (Amended by Legal Notice 87 of 1970.)


(4) The person dispensing the prescription shall comply with the following requirements:-


(a) the prescription must not be dispensed more than once unless the prescriber has stated thereon that it may be dispensed more than once;


(b) if the prescription contains a direction that it may be dispensed a stated number of times or at stated intervals it must not be dispensed otherwise than in accordance with the directions;


(c) at the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed;


(d) except in the case of a prescription which may be dispensed again the prescription must for a period of two years be retained and kept on the premises on which it was dispensed in such manner as to be readily available for inspection;


(e) no prescription shall be dispensed after six months have elapsed from the date thereof. (Amended by Legal Notice 87 of 1970.)


(4A) The following conditions apply, in addition to the requirements of the preceding provisions of this regulation, to and in relation to the dispensing and use of silver sulphadiazine (in this paragraph referred to as the preparation):-


(a) the preparation shall be dispensed only to a medical practitioner or to a member of the nursing staff of a hospital who is responsible for the treatment of the patient to whom it is to be administered;


(b) the preparation shall be dispensed only for use, and shall only be used -


(i) in a hospital or the surgery of a medical practitioner; and


(ii) for the treatment of major burns or of conditions in which full-thickness loss of skin has occured.

(Inserted by Legal Notice No. 45 of 1984.)


(5) Nothing in this regulation shall apply to the sale of P-anminobenzenesulphonamide, sulphanilamide or analogous compounds or derivatives contained in preparations for the treatment of bovine mastitis by intramammary injection labelled "For Veterinary Use Only".
(Amended by Legal Notice 33 of 1976.)


Restriction on sale of poisons listed in First Schedule

12. It shall not be lawful for a registered pharmacist to sell any substance included in the First Schedule notwithstanding that the poison is a poison included in Part II of the Poisons List unless the sale is effected by or under the supervision of a registered pharmacist.


Further restrictions on sale of poisons

13.-(1) No licensed seller of poisons shall be entitled by virtue of being a licensed seller of Part II poisons to sell -


(a) any poison other than ammonia, hydrochloric acid, nitric acid, potassium quadroxalate, and sulphuric acid except in a closed container as closed by the manufacturer or other person from whom the poison was obtained;


(b) any substance included in the First Schedule unless the sale is effected by himself or by a responsible deputy.


In this paragraph, "responsible deputy" means a person nominated as a deputy on the seller's form of application as hereinafter prescribed for licence as a licensed seller of Part II poisons or any person substituted by notice in writing to the Pharmacy and Poisons Board for a person so nominated and not more than two deputies shall be nominated at one time in respect of one set of premises.


(2) No person shall be entitled by virtue of being a licensed seller of poisons to sell -


(a) any poison included in Part A of the Fifth Schedule unless the article or substance is in the form and for the purpose specified in that Schedule and the container of the substance is, in addition to any other direction of the Act or of these Regulations with respect to labelling, labelled clearly with a notice of the special purpose for which the article or substance is intended and a warning that it is only to be used for that purpose;


(b) any of the poisons included in Part B of the Fifth Schedule unless the purchaser thereof is engaged in the trade or business of agriculture or horticulture and requires the poison for the purpose of that trade or business;


(c) any of the substances included in Part C of the Fifth Schedule for use in agriculture or horticulture unless it is of a distinctive colour or there has been added thereto a dye or other substance which, in the case of a poison in solution, renders it a distinctive colour or, in the case of any other poison, renders it a distinctive colour whether dry or wet or in solution;


(d) any arsenical poison other than lead arsenates, calcium arsenates, and copper acetoarsenites, any mercuric chloride, mercuric iodide or any organic compound of mercury unless, the purchaser thereof is engaged in the trade or business of timber treatment, horticulture or agriculture and requires the poison for the purpose of that trade or business and in addition produces a licence issued by the Pharmacy and Poisons Board in the form as set out in the Nineteenth Schedule.
(Amended by Regulations 29 January 1964; Legal Notice 154 of 1977.)


(3) It shall not be lawful to sell or supply strychnine except as an ingredient in medicine:
Provided that this regulation shall not apply to the sale of strychnine -


(a) by way of wholesale dealing;


(b) for the purpose of being compounded in medicines prescribed or administered by a registered medical practitioner or qualified veterinary surgeon;


(c) to a person or institution concerned with scientific education or research or chemical analysis for the purposes of that education, research or analysis.


Labelling

14.-(1) Subject to the provisions of these Regulations, the particulars with which the container of a poison is required to be labelled under paragraph (c) of subsection (1) of section 66 of the Act and under these Regulations must appear in a conspicuous position on the container in which the poison is sold and on every box or other covering of whatsoever nature enclosing the container and the particulars must be clearly and distinctly set out and not in any way obscured or obliterated.


(2) Where the poison is contained in an ampoule, cachet or similar article it shall not be necessary to label the article itself if every box or other covering in which the article is enclosed is duly labelled.


(3) Nothing in the said paragraph (c) or in regulations 14 to 19 shall require the labelling of any transparent cover or any wrapper, hamper, packing case, crate or other covering sold solely for the purpose of transport or delivery.


Name of poison

15.-(1) Subject as hereinafter provided for the purpose of sub-paragraph (i) of paragraph (c) of subsection (1) of section 66 of the Act the name of a poison shall be the term under which it is included in the Poisons List:


Provided that when the said term describes a group of poisons and not the poison specifically the name of the poison shall be -


(a) if the poison is the subject of a monograph in either the British Pharmacopoeia or the British Pharmaceutical Codex one or other of the name or synonyms or abbreviated names set out at the head of the monograph; and


(b) in any other case the accepted scientific name or name descriptive of the true nature and origin of the poison.


(2) For the purposes of the foregoing it shall in the case of a preparation in the British Pharmacopoeia or the Formulary to the British Pharmaceutical Codex or any dilution or admixture of such a preparation or any surgical dressing for which a standard is described in the British Pharmaceutical Codex be sufficient notwithstanding anything in paragraph (1) to state the name, synonym or abbreviated name used to describe the preparation or surgical dressing in the British Pharmacopoeia or the Formulary to the British Pharmaceutical Codex with the addition of the letters B.P. or B.P.C. as the case may be.


Particulars to be specified on label

16.-(1) For the purposes of sub-paragraph (ii) of paragraph (c) of subsection (1) of section 66 of the Act (which requires preparations containing poisons to be labelled with the prescribed particulars as to the proportions of poisons therein) the label of the container of any preparation containing a poison as one of its ingredients shall subject as hereinafter provided include a statement of the proportion which the poison bears to the total ingredients of the preparation.


(2) In the case of a preparation containing a poison specified in the first column of the Sixth Schedule it shall be sufficient to state on the label the particulars specified in the second column of that Schedule against the description of the poison.


(3) In the case of a preparation or surgical dressing which is named in accordance with paragraph (2) of regulation 15 it shall not be necessary to state on the label the proportion of the poison contained in the preparation and in the case of any dilution or admixture of such a preparation it shall be sufficient to state the proportion which the preparation bears to the total ingredients of the dilution or admixture.


(4) Where the poison is in tablets, pills, capsules, cachets, lozenges or similar articles or in ampoules it shall be sufficient to state on the label of the box or other covering in which the articles are enclosed the number of the articles and the amount of the poison or in the case of such a preparation as is mentioned in paragraph (3) the amount of the preparation contained in each article.


(5) Where any proportion is stated as a percentage the statement shall indicate whether the percentage is calculated on the basis of weight in weight, weight in volume, or volume in volume.


Labelling with word "poison"

17.-(1) In pursuance of sub-paragraph (iii) of paragraph (c) of subsection (1) of section 66 of the Act (which requires the containers of poisons to be labelled with the word "poison" or other prescribed indication of character) the container of any article specified in the Seventh Schedule shall instead of being labelled with the word "poison" be labelled with the words specified in the said Schedule as applicable to that article.


(2) The said words or the word "poison" as the case may be must not be modified in meaning by the addition of any other words or marks, and -


(a) in the case of a substance included in the First Schedule must either be in red lettering or be set against a red background; and


(b) in all cases must either be on a separate label or be surrounded by a line within which there must be no other words except words with which the container of the poison is required to be labelled under the Act or these Regulations.


Warnings on labels

18.-(1) It shall not be lawful to sell or supply any poison -


(a) in the case of a liquid other than a medicine contained in a bottle of a capacity of not more than one hundred and twenty fluid ounces unless the bottle is labelled with the words "not to be taken";


(b) in the case of an embrocation, liniment, lotion, liquid antiseptic or other liquid medicine for external application, unless the container is labelled with the name of the article and the words "for external use only".


(2) It shall not be lawful to sell or supply any compressed hydrocyanic acid unless the container is labelled with the words "Warning. This container holds poisonous gas and should only be opened and used by persons having expert knowledge of the precautions to be taken in its use".


(3) This regulation shall be in addition to the other requirements of the Act and these Regulations with respect to labelling and shall apply to transactions exempted by section 67 of the Act.


Provisions as to name and address on label

19.-(1) The provisions of sub-paragraph (iv) of paragraph (c) of subsection (1) of section 66 of the Act (which requires the container of a poison to be labelled with the name of the seller and the address of the premises on which it was sold) shall not apply in the case of an article sold for the purpose of being sold again in the same container.


(2) The requirements of the said sub-paragraph shall be deemed to be satisfied in the case of a poison supplied from a warehouse or depot if the container of the poison is labelled with the address of the supplier's principal place of business or in the case of a limited company of the registered office of the company.


(3) When any poison (other than a substance included in the First Schedule) is sold in a container and outer covering, being the container and covering in which it was obtained by the seller, it shall be sufficient if the name of the seller and the address of the premises on which it was sold appear only on the outer covering.


(4) Where the names of more than one person or more than one address appear on any label there must also be words on the label indicating clearly which person is the seller and at which of the addresses the poison was sold.


Containers for sale of poison

20.-(1) It shall not be lawful to sell, whether by wholesale or retail, or supply any poison unless -


(a) it is contained in a container impervious to the poison and sufficiently stout to prevent leakage arising from the ordinary risks of handling and transport; and


(b) in the case of a liquid contained in a glass or plastic bottle of a capacity of not more than one hundred and twenty fluid ounces, not being a medicine made up ready to be taken for the internal treatment of human ailments, the outer surface of the bottle is fluted vertically with ribs or grooves recognisable by touch.

(Amended by Legal Notice 109 of 1972.)


(2) Sub-paragraph (b) of paragraph (1) shall apply to transactions exempted by section 67 of the Act.


Storage of poisons

21.-(1) It shall not be lawful to store any poison except in a container impervious to the poison and sufficiently stout to prevent leakage from the container arising from the ordinary risks of handling.


(2) It shall not be lawful to store any substance included in the First Schedule in any retail shop or premises used in connection therewith unless the substance is stored -


(a) in a cupboard or drawer reserved solely for the storage of poisons;


(b) in a part of the premises which is partitioned off or otherwise separated from the remainder of the premises and to which customers are not permitted to have access;


(c) on a shelf reserved solely for the storage of poisons and -


(i) no food is kept directly under the shelf; and


(ii) the container of the substance is rendered distinguishable by touch from the containers of articles and substances other than poisons stored upon the same premises:


Provided that in the case of any such substance to be used in agriculture or horticulture, it shall not be lawful to store the substance in any such part of the premises as aforesaid if food is kept in that part, or in any cupboard or drawer unless the cupboard or drawer is reserved solely for the storage of poisons to be used as aforesaid.


Transport of poisons

22. It shall not be lawful to consign any poison for transport unless it is sufficiently stoutly packed to avoid leakage arising from the ordinary risks of handling and transport.


Transport of poisons listed in Eighth Schedule

23.-(1) It shall not be lawful to consign for transport by carrier any poison included in the Eighth Schedule unless the outside of the package containing the article is labelled conspicuously with the name or description of the poison as set forth in the said Schedule and a notice indicating that it is to be kept separate from food and from empty containers in which food has been contained.


(2) It shall not be lawful for any person knowingly to transport any such poison as aforesaid either on his own behalf or for another person in any vehicle in which food is being transported unless the food is carried in a part of the vehicle effectively separated from that containing the poison or is otherwise adequately protected from the risk of contamination.


(3) This regulation shall not apply with respect to medicines.


Manufacture of preparations containing poison

24. In all establishments in which pharmaceutical preparations containing any poison are manufactured for the purpose of the internal treatment of human ailments the preparation must be manufactured by or under the supervision of a registered pharmacist:


Provided that this regulation shall not apply to the manufacture by or under the supervision of a registered medical practitioner of preparations containing pituitary, suprarenal or thyroid glands, the active principles of any of those glands or the salts of the active principles of thyroid gland.


Form of application for licence

25. Every application for a licence to sell poisons included in Part II of the Poisons List shall be as set out in the Ninth Schedule.


Licence to sell poison

26. Every licence to a storekeeper to sell such Part II poison as is permitted by these Regulations shall be as set out in the Tenth Schedule.


Fees

27. The fee payable in respect of any application, licence or registration shall be as set out in the Eleventh Schedule.


Form of Certificate of Registration

28. The form of Certificate of Registration as a Pharmacist shall be as set out in the Twelfth Schedule.


Form of Register of Pharmacists

29. The Register of Pharmacists shall be as set out in the Thirteenth Schedule.


Form of Register of Premises

30. The Register of Premises where drugs, poisons or medicines are authorised or licensed to be sold shall be as set out in the Fourteenth Schedule.


Form of application for licence to sell

31. The form of application for a licence to sell medicines shall be as set out in the Fifteenth Schedule.


Licence to sell

32. The licence to sell medicines shall be as set out in the Sixteenth Schedule.


Application for Animal Medicine Licence

33. The form of application for a licence to sell animal medicine shall be as set out in the Twentieth Schedule. (Inserted by Legal Notice 87 of 1970.)


Form of Animal Medicine Licence

34. (Superseded)**


Certificate

35.-(1) A certificate given for the purposes of paragraph (a) of subsection (2) of section 66 of the Act being a certificate certifying a person to be a person to whom a poison may properly be sold shall be in the form and shall contain the particulars set out in the Seventeenth Schedule.


(2) All householders are hereby authorised to give such certificates as aforesaid:


Provided that a certificate given by a householder who is not known to the seller of the poison to be a responsible person of good character shall not be a sufficient certificate for the purposes of the said paragraph unless it is endorsed in the manner specified in the Seventeenth Schedule by a police officer.

(Amended by Legal Notice 168 of 1977.)


(3) On any sale of a poison on such a certificate as aforesaid the certificate shall be retained by the seller.


Form of entries

36. The particulars of sales of poisons which are required by paragraph (b) of subsection (2) of section 66 of the Act to be entered in a book shall be entered in the form set out in the Eighteenth Schedule.


Preservation of books

37. All books kept for the purpose of Part VI of the Act shall be preserved on the premises on which the sales recorded therein were made for a period of two years from the date on which the last entry was made therein.


______


FIRST SCHEDULE
(Regulations 5, 6, 7, 9, 12, 17, 19 and 21)
(Substituted by Legal Notice 154 of 1977.)
______


SUBSTANCES FALLING WITHIN THE POISONS LIST TO WHICH SPECIAL RESTRICTIONS APPLY
______


LIST "A"


Acetorphine; its salts; its esters and ethers; their salts
Acetyldihydrocodeine and its salts.
Acetyldihydrocodeinone; its salts.
Acetylstrophanthidin.
Alcuronium chloride.
Algimycin.
Alkaloids, the following, their salts quaternary compounds; any salt, simple or complex, of any substance falling within the following:

Aconite, alkaloids of, except substances containing less than 0.02% of the alkaloids of aconite.

Atropine except substances containing less than 0.15% of atropine or not more than 1 % of atropine methonitrate.

Belladonna, alkaloids of, except substances containing less than 0.15% of the alkaloids of belladonna calculated as hyoscyamine.

Brucine except substances containing less than 0.2% of brucine.

Calabar bean, alkaloids of.coca, alkaloids of, except substances containing less than 0.1% of the alkaloids of coca.

Cocaine except substances containing less than 0.1% of cocaine.

Codeine; its esters and ethers; except substances containing less than 1.5% of codeine.

Confine except substances containing less than 0.1% of confine.

Cotarnine except substances containing less than 0.2% of cotarnine.

Curare, alkaloids of; curare bases.

Ecgonine; its esters and ethers; except substances containing less than the equivalent of 0.1% of ecgonine.

Emetine except substances containing less than 1% of emetine.

Ephedrine; its optical isomers; except when contained in liquid preparations or preparations not intended for the internal treatment of human ailments and except solid preparations containing less than 10% of ephedrine or its optical isomers otherwise in an inert diluent.

Gelsemium alkaloids of except substances containing less than 0.1% of the alkaloids of gelsemium.

Homatropine except substances containing less than 0.15% of homatropine.

Hyoscine except substances containing less than 0.15% of hyoscine.

Hyoscyamine except substances containing less than 0.15% of hyoscamine.

Jaborandi alkaloids of except substances containing less than 0.5% of the alkaloids of jaborandi.

Lobelia, alkaloids of except substances containing less than 0.5% of the alkaloids of lobelia.

Morphine; its esters and ethers except substances containing less than 0.2% of morphine calculated as anhydrous morphine.

Nicotine.

Papaverine except substances containing less than 1% of papaverine.

Pomegranate, alkaloids of except substances containing less than 0.5% of the alkaloids of pomegranate.

Quebracho, alkaloids of.

Sabadilla, alkaloids of except substances containing less than 1% of the alkaloids of sabadilla.

Stavesacre, alkaloids of except substances containing less than 0.2% of the alkaloids of stavesacre.

Solanaceous alkaloids not otherwise included in this schedule except substances containing less than 0.15% of solanaceous alkaloids calculated as hyoscyamine.

Strychnine except substances containing less than 0.2% of strychnine.

Thebaine except substances containing less than 1% of the alkaloids of veratrum.

Veratrum, alkaloids of except substances containing less than 1% of the alkaloids of veratrum.

Yohimba, alkaloids of.
Allnortoxiferin chloride.
Allylisopropylacetylurea.
Allyprodine; its salts.
Alphameprodine; its salts.
Alphaprodine; its salts.
Aluminium phosphide.
Amino-alcohols esterified with benzoic acid, phenylacetic acid phenylpropionic acid, cinnamic acid or the derivatives of these acids, except substances containing less than ten per cent of esterified amino-alcohols and except procain when in a preparation containing any substance to which Part 11 of the Therapeutic Substances Act 1956 (a) for the time being applies; their salts.
Amphetamine; its salts.
Anileridine; its salts.
Antimonial poisons except substances containing less than the equivalent of one per cent of antimony trioxide.
Apomorphine; its salts; except substances containing less than 0.2% of apomorphine.
Arsenical poisons except:-

(a) Substances containing less than 0.222% of arsenilic acid and not containing any other arsenical poison;

(b) (i) Poultry feeding stuffs containing not more than 0.0375% of carbarsone and not containing any other arsenical poison and

(ii) any other substances containing less than 0.0263% of carbarsone and not containing any other arsenical poison;

(c) substances containing less than 0.0133% of 4-hydroxy-3-nitro-phenyl-arsonic acid and not containing any other arsenical poison;

(d) dentifrices containing less than 0.5% of acetarsol.

(e) other substances containing less than the equivalent of 0.0075% of arsenic (As).
Barbituric acid; its salts; derivatives of barbituric acid; their salts; compounds of barbituric acid, its salts derivatives, their salts, with any other substance.
Barium, salts of.
Barium carbonate unless for destruction of rats and mice.
Bencurine iodide.
Benzphetamine; it salts.
Benzethidine; its salts.
Benzylmorphine; its salts; its esters and ethers; their salts.
Betameprodine; its salts.
Betaprodine; its salts.
Bezitramide and its salts.
4-Bromo 2, 5 Dimethoxy-2-methyl phenethylamine (Bromo-stp).
Bromomethane.
Susulphan; its salts.
Buthalital sodium.
Buthalitone sodium.
Cacodylic acid unless diluted below 0.015%.
Cannabionol and its tetrahydro derivatives, prepared wholly or partly by synthesis; their 3-alkyl homologues; any ester or ether of any substance falling within this item.
Cannabis; the resin of cannabis; extracts of cannabis; tinctures of cannabis; cannabin tannate.
Cantharidin except substances containing less than 0.01% of cantharidin.
Cantharidates except substances containing less than the equivalent of 0.01% of cantharidin.
Carbachol.
Carbacholine.
Carbamoycholine chloride.
Carbarsone unless diluted more than 1 in 38,000 or below 0.0263%.
Carbostibamide unless diluted more than 1 in 50.25 or below 1.99%.
Carperidine; its salts.
Cevadine; its salts and quaternary compounds unless diluted below 1%.
Chlorethazine hydrochloride.
Chlormeroprin.
Chlormethine its salts.
Chloroform unless diluted to 5% or below or unless contained in preparations not intended for internal treatment of human ailments.
Chlorphentermine; its salts.
Chloropicrin.
Choline chloride carbanate.
Cinchocaine; its salts unless diluted below 3%.
Cinchophen.
Clonitazene and its salts.
Cocculin.
Cocculus lndicus.
Corynine.
Cotarnine; its salts and quaternary compounds unless diluted below 0.2%.
Cyanides other than ferrocyanides unless diluted below equivalent of 0.1% w/w HCN.
4-Cyano-2-dimethylamino-4; 4-diphenylbutane; its salts.
4-Cyano-l-methyl-4-phenylpiperidine; its salts.
Daturin unless diluted below 0.15%.
Deacetyl-lanatoside C.
Decamethonium iodide.
Dehydroemetine; its salts.
Demecarium bromide.
Desacetyl-lanatoside C.
Deslanoside.
Desomorphine; its salts; its esters and ethers; their salts.
Dexamphetarnine and its salts.
Dextromethorphan; its salts; except substances containing less than 1.5% of dextromethorphan.
Dextromoramide; its salts.
Dextrorphan; its salts.
Dextropropoxyphene; its salts.
Diacetylmorphine; its salts.
Diacetylnalorphine; its salts.
Diallylmalonylurea.
Diallynortoxiferine dichloride.
Diallytoxiferine dichloride.
Diallytoxiferine dischloride.
Diamethine.
Diamorphine and its salts.
Diampromide and its salts.
Di-p-anisyl-p-phenetyl guanidine.
Dibucaine; its salts unless diluted below 3%.
Dibucaine hydrochloride unless diluted below 3%.
Di-(2-chloroethyl) amine, N-substituted derivatives of.
Dichlorphenarsine Hydrochlorides unless diluted below 0.029%.
Diethylmalonylurea.
Diethylthiambutene and its salts.
Difenoxin.
Digitalis, glycosides and other active principles of, except substances containing less than one unit of activity (as defined in the British Pharmacopoeia) in ten grammes of the substances.
Diguanidines polymethylene.
Dihydrocodeine and its salts; its esters and ethers; their salts.
Dihydrocodeinone; its salts.
Dihydrocodeinone-O-carboxymethyloxime; its salts; its esters; their salts.
Dihydromethylmorphine; its salts; its esters and ethers; their salts.
Dihydromorphine; its salts; its esters and ethers; their salts.
Dimenoxadile and its salts.
B-(2-"3, 5-Dimethyl-2-Oxocyclohexy"-2-Hydroxyethyl) Glutarimide.
Dimepheptanol; its salts; its esters and ethers; their salts.
Dimethylthiambutene and its salts.
Dimethyltubocurarine salts.
Dinitrocresols (DNOC); their compounds with a metal or a base; except winter washes containing not more than the equivalent of 5% of dinitrocresols.
Dinitronaphthols.
Dinitrophenols.
Dinitrothymols.
Dinosam.
Dinoseb.
Dioxaphetyl butyrate and its salts.
Dipara-anisylphenetyl guanidine.
Diphenoxylate and its salts except in preparations containing not more than 2.5mg diphenoxylate calculated as base and a quantity of atropine sulphate equivalent to at least 1% of the dose of diphenoxylate.
Dipipanone; its salts.
Disulfiram.
Dithienylallylamines; dithienylalkylallylamines; their salts.
Drazoxolon; its salts.
Dyflos.
Ecgonine; its salts; its esters and ethers; their salts; any derivatives of ecgonine which is convertible to ecogonine or to cocaine.
Echothiopate iodide.
Embutramide.
Emetic tartar unless diluted more than 1 in 45.
Endosulfan.
Endothal, its salts.
Endrin.
Ephedrine; its opticalisomers; their salts; their quaternary compounds; their salts, simple or complex unless contained in aeresol dispensers.
Eserine; its salts and quaternary compounds.
Ethaminal sodium.
Ethylmethylthiambutene and its salts.
Ethylmorphine; its salts; its esters and ethers; their salts; except substances containing less than 0.2% of ethylmorphine.
Ethylstibamine.
Etonitazene and its salts.
Etophylate.
Etorphine; its salts; its esters and ethers; their salts.
Etoxeridine; its salts; its esters and ethers; their salts.
Euphoramin.
Fenazaflor.
Fencamfamin, its salts.
Fentanyl and its salts;
Ferruginous Neurasthenic serum.
Fluanisone.
Fluoroacetamide; fluoroacetanilide.
Formetanate.
Fouadin.
Furethidine and its salts.
Glyeobiarsol unless diluted below 0.050%.
Gallamine; its salts; its quaternary compounds.
Guanidines, the following:

polymethylene diguanidines.

di-p-anisyl-p-phenetylguanidine.
Hexamethone salts.
Hexamethonium salts.
Hexamine phenylcinchoninate.
Hexonium salts.
Hydrocodone and its salts.
Hydrocyanic acid except substances containing less that 0.15%, weight in weight, of hydrocyanic acid (HCN): cyanides, other than ferrocyanides and ferricyanides, except substances containing less than the equivalent of 0.1%, weight in weight, of hydrocyanic acid (HCN).
Hydromorphinol; its salts; its esters and ethers; their salts.
Hydromorphone; its salts; its esters and ethers; their salts.
Hydroxycarbamide.
Hydroxycinchoninic acids; derivatives of; their salts; except substances containing less than 3% of a hydroxycinchoninic acid or a derivative thereof.
Hydroxypethidine; its salts; its esters and ethers; their salts.
14-Hydroxydihydromorphine; its salts; its esters and ethers; their salts.
Hydroxyurea.
Iron cacodylate unless diluted below 0.016%.
Isomethadone (isoamidone); its salts.
Ketobemidone; its salts, its esters and ethers: their salts.
Laudexium; its salts.
Lead compounds of, with acids from fixed oils.
Levamphetamine; its salts.
Levomethorphan; its salts.
Levomoramide; its salts.
Levophenacylmorphan; its salts; its esters and ethers; their salts.
Levopropoxyphene; its salts.
Levorphanoi; its salts; its esters and ethers; their salts.
Mannomustine; its salts.
Mebezonium iodide.
Melarsonyl Potassium.
Melaroprol.
Melphalan.
Mephentermine; its salts.
Meralluride unless diluted below 0.65% w/w.
Merbromin unless diluted below 0.75% w/w.
Mercaptopurine; its salts; derivatives of mercaptopurine; their salts.
Mereuderamide unless diluted below 0.46%.
Mercuyhydrin unless diluted below 0.65% w/w.
Mercuric chloride except substances containing less than 1% of mercuric chloride; mercuric iodide except substances containing less than 2% of mercuric iodide; nitrates of mercury except substances containing less than the equivalent of 3%, weight in weight of mercury (Hg); potassio-mercuric iodides except substances containing less than the equivalent of one per cent of mercuric iodide; organic compounds of mercury except substances not being aerosols, containing less than the equivalent of 0.2% weight in weight of mercury (Hg).
Mercuric chloride unless diluted below 1%.
Mercuric cyanide unless diluted below 0.47% w/w.
Mercuric iodide (red) unless diluted below 2%.
Mercurochrome unless diluted below 0.75% w/w.
Mercurophylline sodium unless diluted below 0.2% w/w Hg.
Mercury organic compounds except those in previous entry except substances not being aerosols diluted below the equivalent of 0.2% w/w Hg.
Mercury organic compounds which contain a methyl (CH3) group directly linked to the mercury atom, except substances, not being aerosols, diluted below the equivalent of 0.2% w/w Hg.
Mercury organic compounds in aerosols.
Mercuzanthin unless diluted below 0.2% w/w Hg.
Mersalyl unless diluted below 0.5% w/w.
Merthiolate unless diluted below 0.4% w/w.
Mescaline and other derivatives of phenethylamine formed by substitution in the aromatic; their salts.
Methidathion.
Methdyl acetate; its salts.
Methomyl.
Methscopolamine bromide unless diluted below 0.15%.
Methylamphetamine and its salts.
Methylatropine bromide unless diluted below 0.15%.
Methyldesorphine; its salts; its esters and ethers; their salts.
Methyl bromide.
Methyldihydromorphine; its salts; its esters and ethers; their salts.
2-methy-3-morpholino-1:1-diphenylpropane carboxylic acid; its salts; its esters; their salts.
Methylphenidate; its salts.
1-Methyl-4-phenylpiperidine-4-carboxylic acid; esters of; their salts.
Metopon; its salts; its esters and ethers; their salts.
Mitobronitol.
Mitoclomine; its salts.
Mitomen.
Monofluoroacetic acid; its salts.
Morphine; its salts; its esters and ethers; their salts; its pentavalent nitrogen derivatives; their esters and ethers.
Morpheridine; its salts.
Mustine and any other N-substituted derivative of di-(2-chloroethyl) amine; their salts.
Myelobromol.
Myrophine; its salts.
Naepine hydrochloride unless diluted below 10%.
Nalorphine its salts.
Nicotine; dusts unless containing not more than 4% nicotine and intended for agricultural or horticultural use; label "Poison" in red but no register entry needed.
Niclofolan.
Nicocodine; its salts.
Nitromin.
m-Nitrophenol o-Nitrophenol p-Nitrophenol.
Noracymethadol; its salts.
Norcodeine, its salts, its esters and ethers; their salts.
Norlevorphanol; its salts; its esters and ethers; their salts.
Normethadone and its salts.
Normorphine; its salts, its esters and ethers; their salts.
Norpipanone; its salts.
Nux Vomica except substances containing less than 0.2% of strychnine.
Opium except substances containing less than 0.2% of morphine calculated anhydrous morphine.
Organo-tin compounds, the following: Fentin compounds.
Orthonitrophenol.
Ouabain.
Oxycinchophen.
Oxycodone; its salts; its esters and ethers; their salts.
Oxymorphone; its salts; its esters and ethers; their salts.
Paraquat; salts.
Pemoline its salts.
Phenacemide.
Phenampromide; its salts.
Phencyclidine: its salts.
Phenadoxone; its salts.
Phenazocin; its salts; its esters and ethers; their salts.
Phendimetrazine; its salts.
Phenethylamine derivatives substituted in the aromatic ring (other than mescaline); their salts.
Phenomorphan; its salts; its esters and ethers; their salts.
Phenoperidine; its salts; its esters and ethers; their salts.
Phentermine; its salts.
Phenylacetylearbamide.
Phenylacetylurea.
Phospholine iodide. 2-Phenyleinchoninic acid; acid; their salts; their esters. cid ethyl ester; its salts.
Pholcodine; its salts; its esters and ethers; their salts; except substances containing less than 1.5% of pholcodine.
Phosphorus compounds, the following:

Amiton.

Azinphos-ethyl.

Azinphos-methyl.

Chlorfenvinphos except sheep dips containing not more than 10% weight in weight of chlorfenvinphos.

Demeton-methyl.

Demephion.

Demeton-O.

Demeton.-S

Demeton-O-methyl.

Demeton-S-methyl.

Demeton-S-methyl sulphone.

Dichlorvos.

Diethyl 4-methyl-7-coumarinyl phosphorothionate.

Diethyl p-nitrophenyl phosphate.

Dimefox.

Dioxathion.

Disulfoton.

Dyfonate.

Ethion.

Ethyl-p-nitrophenyl phenylphosphorothionate.

Fonofos.

Mazidox.

Mecarbam.

Mevinphos.

Mipafox.

Omethoote.

Oxydemeton-methyl.

Parathion.

Phenkapton.

Phorate.

Phosphamidon.

Schradan.

Sulfotep.

TEPP (HETP).

Thiometon.

Thionazin.

Triphosphoric pentadimethylamide.
Physostigmine; its salts and quaternary compounds.
Picrotoxin.
Piminodine and its salts.
Pipradol; its salts, its esters.
Piritramide; its salts.
Polymethylenebistrimethylammoniumsalts.
Potassium cyanide unless below 0.2% w/w KCN.
Prazitone; its salts.
Proheptazine; its salts.
Propoxyphene; its salts.
Properidine; its salts.
Pseudoephedrine; its salts; its quaternary compounds; their salts simple or complex unless contained in aerosol dispensers.
Racemethorphan; its salts.
Racemoramide; its salts.
Racemorphan; its salts; its esters and ethers; their salts.
Savin, oil of.
Sodium 4-(dimethylamin) benzenediazosulphonate.
Strophanthus, glycosides of.
2-salicvlcinchoninic acid; its salts and esters.
Sodium cacodylate unless diluted below 0.022%.
Sodium stibogluconate unless diluted more than 1 in 40.
Stibamine glucoside.
Strychnine; its salts and quaternary compounds unless diluted below 0.29.
Tartar emetic unless diluted more than I in 45.
Tetraethylthiuram disulphide.
Thallium salts of.
Thebacon; its salts.
Thioguanine; its salts.
Tigloidine unless diluted below 0.159.
Triethanomelamine; its salts.
Tretamine; its salts.
Trimeperidine; its salts.
Trinuride.
Triaziquone.
Trophenium.
Zinc phosphide.

______


SECOND SCHEDULE
(Regulation 4)
(Substituted by Legal Notice 154 of 1977.)
______


POISONS EXEMPTED BY REGULATION 4(2) FROM LABELLING PROVISIONS WHEN SOLD IN CERTAIN CIRCUMSTANCES
______


LIST "B"


Alkali fluorides; alkali metal bifluorides, ammonium bifluoride
Ammonia.
Antimony, chlorides of, antimonates; antimonites.
Chloroform.
Dinitrocresols (DNOC).
Dinitronaphthols; dinitrophenols.
Formaldehyde.
Formic acid.
Glyceryl trinitrate.
Hydrochloric acid.
Hydrofluoric acid; sodium silicofluoride.
Lead acetates; compounds of lead with acids from fixed oils.
Mercuric chloride, mercuric iodide, organic compounds of mercury,
Mercury oxides of; nitrates of mercury.
Nitric acid.
Nitrobenzene.
m-Nitrophenol; o-nitrophenol; p-nitrophenol.
Oxalic acid; metallic oxalates
Phenols; compounds of phenol with a metal.
Phosphorus yellow.
Picric acid.
Potassium hydroxide.
Sodium hydroxide.
Sulphuric acid.

______


THIRD SCHEDULE
(Regulation 10)
(Substituted by Legal Notice 154 of 1977; amended by Legal Notice 120 of 1979.)
______


POISONS EXEMPTED BY REGULATION 10 FROM THE PROVISIONS OF THE ACT AND OF THESE REGULATIONS
______


LIST "C"


Group I - General Exemptions
Adhesives; anti-fouling; builders' materials; ceramics; distempers; electrical valves; enamels; explosives; fillers; fireworks; fluorescent lamps; glazes; glue; inks; lacquer solvents; loading materials; matches; motor fuels and lubricants; paints other than pharmaceutical paints; photographic paper; pigments; plastics; propellants; rubber varnishes; vascular plants and their seeds.


Group II - Special Exemptions
Acetanilide; alkyl acetanilides; substances not being preparations for the treatment of human ailments.
Alkaloids, the following:

Brucine; Surgical spirit containing not more than 0.015% of brucine.

Emetine, Ipecauanha; extracts and tinctures of ipecacuanha; substances containing less than 0.05% of emetine.

Ephedra, alkaloids of; substances containing less than 1% of the alkaloids of ephedra.

Jaborandi alkaloids of; substances containing less than 0.025% of the alkaloids of jaborandi; preparations containing not more than 2% weight in weight of the sulphatesalt of trans-pilosine.

Lobelia, alkaloids of; preparations for the relief of asthma in the form of cigarettes, smoking mixtures or fumagants; substances containing less than 0.1% of the alkaloids of lobelia.

Nicotine; Tobacco; preparations in aerosols dispensers containing not more than 0.2% of nicotine, weight in weight; other liquid preparations and solid preparations with a soap base, containing not more than 7.5% of nicotine weight in weight.
Pomegranate, alkaloids of; Pomegranate bark.
Solanaceous alkaloids; Stramonium contained in preparations for the relief of asthma in the form of cigarettes, smoking mixtures or fumigants.
Stavesacre alkaloids of; soaps; ointment; lotions for external use.
p-Aminobenzenesulphonamide; its salts; derivatives of p-amino-benzenesulphonamide having any of the hydrogen atoms of the p-amino group or of the sulphonamide group substituted by another radical; their salts; Feeding stuffs containing not more than 0.5% of total sulphonamides; sulphaquinoxaline when contained to a concentration not exceeding 0.5% in preparations for the destruction of rats and mice.
Ammonia; Substances not being solutions of ammonia or preparations containing solutions of ammonia; substances containing less than 5%, weight in weight of ammonia (NH3); refrigerators; smelling bottles.
Androgenic, oestrogenic and progestational substances, the following:-

Preparations intended for external application only, except preparations containing more than four milligrammes of oestrogenic substance per hundred grammes of inert substance; feeding stuffs containing hexoestrol or stilboestrol or both and not containing any other androgenic, oestrogenic or progestational substance.

Benzoestrol.

Derivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; their esters.

Steroid compounds with androgenic or oestrogenic or progestational activity; their esters.
Anti-histamine substances, the following; their salts; their molecular compounds:

Preparations intended for external application only and preparations containing not more than one per cent of anti-histamine substances for application in the nose or eye.

Antazoline.

Bromodiphenhydramine.

Buclizine.

Carbinoxamine.

Chlorpheniramine.

Cinnarizine.

Clemizole.

Cyclizine.

3-Di-n-butylaminomethyl-4, 5, 6-trihydroxyphthalide.

Diphenhydramine.

Diphenylpyraline.

Doxylamine.

Isothipendyl.

Mebhydrolin.

Meclozine.

Phenindamine.

Pheniramine.

Phenyltoloxamine.

Promethazine.

Pyrrobutamine.

Thenalidine.

Tolpropamine.

Triprolidine.

Substances being tetra-N-substituted derivatives of ehylene-diamine or propylenediamine.
Antimony, Chlorides of; polishes


Arsenical poisons; Pyrites ores or sulphuric acid containing arsenical poisons as natural impurities; poultry or pig feeding stuffs containing not more than 0.005% of 4-hydroxy-3-nitrophenylarsonic acid and not containing any other arsenical poison; animal feeding stuffs containing not more than 0.01% of arsanilic acid and not containing any arsenical poison; poultry feeding stuffs containing not more than 0.0375% of carbarsone and not containing any other arsenical poison; liquid preparations intended for agricultural use containing not more than 0.9% of anhydrous sodium arsanilatc.


Barbituric acid; its salts; derivatives of barbituric acid, self heating preparations, in aerosol dispensers, intended for external application only containing 1, 5-diethyl-2-thio-4, 6-pyrimidinedione and not containing any other substance included in this entry.


Barium, salts of; Witherite other than finely ground witherite; barium carbenate bonded to charcoal for case hardening; fire extinguishers containing barium chloride.


Bromomethane; fire extinguishers.


Chloroform; Substances containing less than 1% of chloroform; solid preparations; toothpaste.


Cresols in preparations containing less than 60% w/w below 1 % in medicines; below 2.5% in nasal sprays, mouth washes, pastilles, lozenges, capsules, pessaries, ointments, or suppositories, below 60% in other solids also in smelling bottles or soaps for washing.


Cresylic acid below 1% in medicines; below 2.5% in nasal sprays, mouth washes, pastilles, lozenges capsules, pessaries, ointment or suppositories; below 60% in other solids; also in smelling bottles or soaps for washing.


Diperdon; its salts preparations intended for external application only, containing not more than 1% of diperodon calculated as anhydrous base.


Diamines, the following; their salts:-phenylene diamines; tolylene diamines; other alkylated-benzene diamines; Substances other than preparations for the dyeing of hair.


Dinitrophenols; Substances not being preparations for the treatment of human ailments.


Diperodon; its salts; preparations intended for external application only, containing not more than one per cent of diperodon, calculated as anhydrous base.


Disulfiram; substances not being preparations for the treatment of human ailments.


Drazoxolon; its salts; dressings on seeds.


Formaldehyde; Substances containing less than 5%; weight in weight of for madehyde (H.CHO); photographic glazing or hardening solutions.


Formic acid; substances containing less than 5% weight in weight of formic acid (H.C00H).


Formyl terchloride if diluted below 10%.


Hydrochloric acid; substances containing less than 9% weight in weight of hydrochloric acid

(HC1).


Hydrocyanic acid; preparations of wild cherry; in reagent kits supplied for medical or veterinary purposes, substances containing less than the equivalent of 0.1 %, weight, in weight of hydrocyanic acid (HCN).


Hydroxycinchoninic acids; derivatives of their salts and their esters. Poultry or pig feeding stuffs containing not more than 0.005% and no other arsenical poison.


Lead, compounds of; Machine-spread plasters.
Lysol in solids and soaps for washing.
Mercuric chloride; batteries.
Mercuric chloride; mercuric iodide; organic compounds of mercury; Dressings on seeds or bulbs.


Mercury, nitrates of; ointment containing less than the equivalent of 3% weight in weight of mercury (Hg).


Mercury, oxides of Canker and wound paints (for trees) containing not more than three per cent weight in weight of yellow mercuric oxide.


Methyl bromide in fire extinguishers.
Mescaline; its salts; living plants.
Nicotine; its salts preparations containing not more than 0.2% w/w if packed in aerosol dispensers, and other liquid preparations, as well as dispensers, and other liquid preparations, as well as solid preparations with a soap base, which contains not more than 7.5% w/w.


Nitric acid; substances containing less than 9% weight in weight of nitric acid (HNO).


Nitrobenzene; Substances containing less than 0.1% of nitrobenzene; soaps containing less than 1% of nitrobenzene polishes.

p-Nitrobenzyl cyanide; Photographic solutions containing less than the equivalent of 0.1% weight in weight of hydrocyanic acid (HCN).


p-Nitrophenol; Preparations for use in agriculture or horticulture containing not more than 0.5% of p-nitrophenol as preservative.


Oxalic acid; metallic oxalates; Laundry blue; polishes; cleaning powders or scouring products, containing the equivalent of not more than 10% of oxalic acid dihydrate.


Paraquat; preparations in pellet form containing not more than 5% of salts of paraquat calculated as paraquat ion.


Paraquat; preparations in liquid form containing not more than 20% of salts of paraquat calculated as paraquat ion, and a suitable emetic that will induce vomitting in the majority of cases if 10 mls is swallowed and an agent giving the preparation a characteristic stench such that it may readily be distinguished by smell,


Phenols; Butylated hydroxytoluene; carvacrol, creosote obtained from coal tar; essential oils in which phenols occur naturally; liquid disinfectants or antiseptics not containing phenol and containing less than 2.5% of other phenols; medicines than 1% of phenols; nasal sprays, mouth washes, pastilles, lozenges, capsules, pessaries, ointment or suppositories containing less than 2.5% of phenols; in reagent kits supplies for medical or veterinary purposes; smelling bottles; soaps for washing; solid substances, other than pastilles, lozenges, capsules, pessaries ointments and suppositories, containing less than 60% of phenols; tar (coal or wood), crude or refined; p-tertiary-amylphenol; p-tertiary-butylcresol; tertiary-butylcresol; p-(1, 1, 3, 3 tetramethylbutyl) phenol; thymol.


Phenyl mercuric salts; Toilet, cosmetic and therapeutic preparations containing not more than 0.01% of phenyl mercuric salts as a preservative, antiseptic dressings on toothbrushes; in textiles containing not more than 0.01% of phenyl mercuric salts as a bacteriostat and fungicide.


Phenylpropanolamine; its salts substances containing less than 1%.


Phosphoric acid; Substances containing phosphoric acid, not being decaling preparations containing more than 50%; weight in weight of ortho-phosphoric acid.


Phosphorus compounds, the following:


Chlorfenvinphos; Granular preparations.

Dichlorvos; Preparations in aerosol dispensers containing not more than one per cent; weight in weight of dichlorvos; material impregnated with dichlorvos for slow release.


Disulfoton
Fonofos
}

Granular preparations

Oxydemeton-methyl; aerosol dispensers containing not more than 0.25%, weight in weight of oxydemeton-methyl.

Parathion
Phorate
Thionazin
}

Granular preparations

Picric acid; Substances containing less 5% cent picric acid.


Podophyllum resin;


Preparations containing not more than 1-5 per cent weight in weight of podophyllum resin.


Potassium hydroxide; Substances containing the equivalent of less than 17% of total caustic alkalinity expressed as potassium hydroxide; accumulators; batteries.


Procaine; Feeding stuffs containing this substance.


Quinine; its salts; preparations containing not more than 1% of quinine or its salts; soft drinks, wines or tonic wines; preparations containing not more than 15 wines or confectionery.


Sodium 4-(dimenthylamino) benzene diazosulphonate; Granular preparations.


Sodium ethyl mercurithiosalicylate; Therapeutic substances containing less than 0.1 % of sodium ethyl mercurithi mercurithiosalicylate as a preservative.


Sodium fluoride; substances containing less than 3% of sodium as a preservative; dentifrices containing not more than 0.3% of sodium fluoride; mouth wash tablets containing not more than 0.2% of sodium fluoride and liquid mouth washes containing not more than 0.05% thereof; tablets containing not more than 0.016% weight in weight of sodium fluoride and intended when chewed to prevent tooth decay.


Sodium hydroxide; substances containing the equivalent of less than 12% of total caustic alkalinity expressed as sodium hydroxide.


Sodium nitrite; substances other than preparations containing more than 0.1% of sodium nitrite of for the destruction of rats and mice.


Sodium silicofluoride; substances containing less than 3% of sodium silicofluoride as a preservative.


Sulphuric acid; substances containing less than 9%; weight in weight of sulphuric acid (H2SO4); accumulators; batteries and sealed containers in which sulphuric acid is packed together with car batteries for use in those batteries; fire extinguishers.


In Group 11 in this Schedule the expression "Granular preparation" in relation to a poison means a preparation:-


(a) which consists of absorbent mineral or synthetic solid particles impregnated with the poison, the size of the particles being such that not more than 4% weight in weight of the preparation is capable than 1% a sieve with a mesh of 150 microns;


(b) which has an apparent density of not less than 0.4 grammes per millilitre if compacted without pressure; and


(c) not more than 12% of which, weight in weight consists of the poison.


______


FOURTH SCHEDULE
(Regulation 11)
(Substituted by Legal Notice 154 of 1977.)


SUBSTANCES REQUIRED BY REGULATION 11 TO BE SOLD ONLY ON A PRESCRIPTION GIVEN BY A REGISTERED MEDICAL PRACTITIONER REGISTERED DENTIST OR REGISTERED VETERINARY SURGEON
______


LIST "D"


Acetanilide; alkyl acetanilides.
Acetihexamide.
Acetylcarbromal.
Amidopyrine; its salts; amidopyrine sulphonates; their salts.
p-Aminobenzenesulphonamide; its salts; derivatives of p-aminobenzensulphonamide having any of the hydrogen atoms of the p-amino group or of the sulphonamide group substituted by another radical; their salts; except when contained in ointments or surgical dressings or in preparations for the prevention and treatment of diseases in poultry.
Alcuronium chloride. Allylisopropylacetylurea.
Aminorex; its salts.
Amitriptyline; its salts.
Androgenic, oestrogenic and progestational substances, the following: (except anovulatory compounds used as oral contraceptives)

Derivatives of stilbene, dibenzyl or napthalene with oestrogenic activity; their esters.

Steroid compounds with androgenic or oestrogenic or progestational activity; their esters.
Azacyclonol; its salts.
Acepromazine; its salts.
Aceprometazine.
Acetophenazine; its salts
Acetcarbromal.
Acetophenazine; its salts.
Acetylpromazine; its salts.
Adrenaline; its salts except in preparations for external use only, or in inhalants that are not in aerosol dispensers, or rectal preparations, or in eye preparations.
Aletamine hydrochloride.
Alimemazine.
Allnortoxiferin chloride.
Alpadolene acetate.
Alpazalone.
Alprenolol hydrochloride.
Alseroxylon.
Amantadine hydrochloride.
Ambutonium bromide.
Amfecloral; its salts.
Amidofebrin.
Aminazin.
Aminocaproic acid.
Aminomercaptopurine.
Aminophenazone.
Aminopyrine.
Aminorex; its salts.
Amitriptyline; its salts.
Amoxycillin.
Amphetamine and its salts.
Amphomycin and its salts, its esters and salts of such esters or any substance, the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Amphotericin; their salts and preparations or any substance, the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than living organisms.
Ampicillin, its salts derivatives and preparations.
Azathioprine; its salts.


Bacitracin; its salts; its esters; their salts or any substance, the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Barbituric acid; its salts; derivatives of barbituric acid; their salts; compounds of barbituric acid; its salts; its derivatives, their salts, with any other substance.
Benapryzine; its salts.
Benapryzine hydrochloride.
Bencurine iodide.
Bendrofluazide.
Bendroflumethiazide.
Benbromarene.
Benzhexol; its salts.
Benzoctamine; its salts.
Benztropine and its homologues; their salts.
Benzphetamine and its salts.
Benzthiazide.
Benzydroflumethiaside.
Benzyl, phenethyl or phenoxyethyl hydrazines, their alpha-methyl derivatives; acyl derivatives of any of the foregoing salts of any compounds comprised in this heading.
Beta-chloralose.
Betahistine dihydrochloride.
Beta-hypophamine.
Bistropamide.
Bleomycin sulphate.
Brethylium tosylate.
Bromisovalorylurea.
Bromisovalum.
Bromvaletone.
4-Bromo 2, 5 Dimethoxy-x-methyl Phenethylamine (Bromo-stp).
Bumetanide.
Busulphan; its salts.
Butaperazine; its salts.
Buthalital sodium.
Buthalitone sodium.


Calcium novobiocin.
Calcitonin.
Candicidin; its salts; its esters; their salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Capreomycin and its salts; its salts and its esters if such esters or any substance the chemical and biological properties of which are identical with or similar to this anti-microbial substances, but which is produced by means other than by living organisms.
Capreomycin and its salts, its esters and salts if such esters or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Captodiame; its salts.
Caramiphen; its salts except tablets containing not more than the equivalent of 7.5 mg of caramiphen base, and liquid preparations containing not more than the equivalent of 0.1% of caramiphen base.
Carbromal.
Carbamazepine.
Carbenicillin and preparations.
Carfenazine and its salts.
Carisoprodol.
Carphenazine and its salts.
Cavalose.
Centrophenozine hydrochloride.
Cephaloridine; its salts; its esters and salts in such esters or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Cephalosporins, that is to any antimicrobial substances containing in their chemical structure a fussed dihydrothiazine B-Lactam nucleus; their salts; their esters and their salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substances but which is produced by means other than by living organisms.
Chloral: its addition and its condensation products, their molecular compounds except when contained in the form of chloral hydrate in preparations intended for external application only: and when contained in the form of alphachloralose.
Chlordiazepoxide; its salts.
Chioralurethane.
Chlormethiazole; its salts.
Chloramphenicol and antimicrobial substances derived there from including homologues, substitution products and esterified compounds and preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substances, but which is produced by means other than by living organisms.
Chlorethazine hydrochloride.
Chlorglypropamide; its salts.
Chlormethiazole; its salts.
Chlorhexadol.
Chlormethine; its salts.
Chlormethylencycline and preparations.
Chlorothiazide and other derivatives of benzo-1:2:4-thiadiazine 7-sulphonamide 1:1-dioxide, whether hydrogenated or not.
Chlorphenoxamine; its salts.
Chlorphentermine and its salts.
Chlorproethazine; its salts.
Chiorpropamide; its salts.
Chlorprothixan.
Chlorprothixene and other derivatives of 9-methylenethiaxanthen; their salts.
Chlortetracycline and preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Chlorthalidone and other derivatives of o-chlorobenzene sulphonanide.
Cinchophen.
Clofazimine.
Clomiphene; its salts.
Clomipramine hydrochloride.
Clomecycline and preparations.
Clonidine hydrochloride.
Clopamide.
Clopenthixol.
Cloperphenthixan.
Clophanoxate hydrochloride.
Clorexolone.
Clorprenaline; its salts when contained in aerosol dispensers.
Clotixamide.
Clotrimazole except where the medicinal product is in the form of a cream.
Cloxacillin and preparations.
Colchaminc; its salts.
Colchicine; its salts.
Colchicum; alkaloids of; their salts.
Colistin; its salts and preparations.
Cortexolone; its salts; its esters; their salts; any acetal derivatives and its salts.
Cortiscosteroids, that is to say any substance which contains the chemical structure of pregn-4-ene-3, 20-dione, or of pregna-1, 4-diene-3, 20-dione and has the 11-carbon atom directly linked to oxygen, with the exception of flugestone; their esters and their salts, any acetal derivatives of a corticesteriod and its salts.
Corticotrophins, natural and preparations.
Corticotrophins synthetic and preparations.
Corticotropin and preparations.
Co-trimoxazole.
Crotethamide.
Cyclarbamate.
Cyclofenil.
Cyclopenthiazide.
Cycloserine; its salts and preparations.
d-Cycloserine.
Cyclothiazide.
Cycrimine; its salts.
Cypenamine; its salts.
Cytarabine.


Daunomycin hydrochloride.
Daunorubicin hydrochloride.
Deanol 4-chlorophenoxyacetate hydrochloride.
Debrisoquine.
Decamethonium iodide.
Dehydropbenzperidol.
1:2 Dehydrocortisone; its esters and preparations.
Demecarium Bromide.
Demecolcine; its salts.
Demeclocycline; its salts and preparations.
Demethoxyreserpine; its salts.
Demethylchlortetracycline; its salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Deserpidine; its salts.
Desipramine; its salts.
Desmethylimipramine.
Dexamphetamine and its salts.
Diallylmalonylurea.
Diallynortoxiferine dichloride.
Diallytoxferine dichloride.
Diazepam and other compounds containing the chemical structure of dihydro-1: 4-Benzodiazepine substituted to any degree their salts.
Diazoxide.
Dibenzepin; its salts.
Dibenzyl derivatives with oestrogenic activity; their esters (and when contained in sterile aqueous solutions sterile oily solutions and sterile suspensions).
Dichoralphemazone.
Di-(2-chloroethyl) amine, N-substituted derivatives of.
Dichlorphenamide.
Dicloxacillin sodium.
Diethanolamine fusidate.
Diethazine; its salts.
Diethazine hydrochloride.
Diguanil.
Dihydro-1: 4-benzodiazepine compounds substituted to any degree; their salts.
Dihydrostreptomycin; its salts and preparations.
Dihydrotheclin; its esters.
3-(3, 4-Dihydroxyphenyl) alanine; its salts.
Diiodotyrosine.
Dimepropion.
2,5-Dimethox-4, x-dimethyphenethylamine and its salts.
Dimethylaminoantipyrine; its salts.
Dimethylaminophenazone; its salts.
Dinitrocresols (DNOC); their compounds with a metal or a base, except preparations for use in agriculture or horticulture.
Dinitronaphthols, dinitrophenols, Dinitrothymols.
Diphenylhydantoin sodium.
Diphenoxylate and its salts in preparations containing, per dosage unit, not more than 2-5 milligrammes of diphenoxylate calculated as base and not less than twenty-five microgrammes of atropine sulphate.
Disopyramide.
Distigmine bromide.
Disulfiram.
Dithienylaliy lamines; dithienylalkylallylamines; their salts; except diethylthiambutene, dimethylthiambutene and othylmethylthiambutene.
Dixyrazine; its salts.
Dopea; its salts.
Dothiopin; its salts.
Doxapram; its salts.
Doxorubicin.
Doxycycline; its salts and preparations.
Droperidol.


Eazamine hydropcj; prode.
Ectylcarbomide.
Ectylurea.
Epinephrine; its salts except in preparations for external use only or in inhalants or rectal preparation or in eye preparation.
Emylcamate.
Ephedrine; its optical isomers; their salts; when contained in aerosol dispeners.
Epithiazide.
Ergomonamine; its salts.
Ergonovine; its salts.
Ergot, alkaloids of whether hydrogenated or not; their homologues; any salt of any substance falling within this item.
Erythromycin; its salts; its esters; their salts and preparations containing any of them or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Estrogenic substances conjugated.
Etacrynic acid; its salts.
Ethacrynic acid; its salts.
Ethaminal sodium.
Ethamycin.
Ethchlorvynol.
Ethinamate.
Ethionamide.
Ethoheptazine; its salts.
Ethopropazine; its salts.
Ethybenztropine; its salts.
Ethylnoradranaline; its salts when contained in aerosol dispensers.
Etophylate.
Euphcramin.


Fencamfamin; its salts.
Fenethylline; its salts.
Fenfluramine; its salts.
Fenmetramide; its salts.
Fenoprofen calcium salt.
Fenpipramide; its salts.
Fentanyl and its salts.
Flamazine.
Flavomycin. its salts; its esters and their salts.
Flavomate; its salts.
Flucloxacillin and preparations.
Flufenamic acid; its salts; its esters; their salts.
Flumethiazide.
Fluopromazine; its salts.
Fluorouracil.
Flupenthixol; its salts.
Fluphenazine; its salts.
Flurazepam.
Framomycin or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Framycetin and its salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance but which is produced by means other than by living organisms.
Furaltadone; its esters; its salts and their salts.
Furazolidone; its salts; its esters and their salts.
Fusidic acid; its salts; its esters and salts of such esters.


Galenomycin.
Gentamicin; its salts; its ester and salts of such esters or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance but which is produced by means other than by living organisms.
Glibenclamide.
Glucophage.
Glutethimide; its salts.
Glybutamide.
Glycodiazine.
Glykresin.
Glymidine.
Griseofulvin.
Guamecycline; its salts and preparations.
Guanethidine.


Hachimycin; its salts; its esters; their salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other then by living organisms.
Haloperiodol and other 4-substituted derivatives of N-(3-p-fluor-ebensylpropyl) piperidine.
Heparin calcium.
Hexamethone salts.
Hexamethonium salts.
Hexamine phenylcinchoninate.
Hexenium salts.
Hexapropymate.
Hydrazines benzyl, phenethyl and phenoxyethyl; their x-methyl derivatives; acyl derivatives of any of the foregoing substances comprised in this item; salts of any compounds comprised in this item.
Hydroxy-N, N-dimethyltryptamines; their esters or ethers; any salts of any substance falling within this item.
Hydrochlorothiazide.
Hydrocortamate hydrochloride.
Hydroxyurea.
Hydroxyzine; its salts.


Ibenzmethyzine.
Ibuprofen.
Imipramine; its salts.
Indomethacin; its salts.
Iprindole; its salts.
Ipoveratril; its salts.
Isoaminile; its salts.
Isoethari.ne; its salts, when contained in aerosol dispensers.
Isopropyl meprobamate.
N-Isopropylethylnoradrenaline; its salts.
Isoprenaline; its salts when contained in aerosol dispensers.
Isopropylnoradrenaline; its salts.
Isoproterenol.


Kanamycin and its salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Ketamine hydrochloride.
Ketroprofin.


L-Dopa; its salts.
Levisoprenaline; its salts.
Levodopa; its salts.
Liothyronine.
Liothyronine sodium.
Loperamide hydrochloride.
Lorazepam.
Lymecycline.
Lysergamide and its salts.
Lysergide and other N-alkyl derivatives of lysergamide; their salts.


Mazindol.
Mebanazine.
Mebutamate.
Meclofrenoxate; its salts.
Medazepam.
Mefanamic acid; its salts esters, their salts.
Mephenesin; its esters.
Meprobamate.
Metazalone.
Metformin; its salts.
Methaqualone; its salts.
Melphalan.
Mepazine hydrochloride.
Mephenetoin; its salts.
Mephenytoin; its salts.
Mercaptopurine; its salts, derivative of mercaptopurine their salts.
Mesoridazine; its salts.
Mesuridazine; its salts.
Metacortandracin.
Methacycline; its salts and preparations.
Methampurene.
Methilazine.
Methicillin sodium.
Methixene; its salts.
Methoserpidine; its salts.
Methotrimeprazine; its salts.
Methoxophenadein; its salts.
Methoxalen.
10-Methoxydeserpidine; its salts.
Methoxyphenamine; its salts.
Methyclothazide.
Methylacetanilide.
Methylamoncheptane.
Methylamphetamine and its salts.
Methylbenzyihydrazine.
N-Methyl-2-(Methylbenzhydryloxy)-ethylamine; its salts.
Methyl Dopa.
9-Methylenethiazanthen derivatives; their salts.
Methylpentynol; its esters and other derivatives.
Methylpenidate; its salts.
Methysulphonal.
Methysergide; its salts.
a-Methylphenethylamine, B-methylphenethylamine and a-ethylphenethylamine; any synthetic compounds structurally derived from any of those substances by substitution in the aliphatic part or by ring closure therein (or by both such substitution and such closure) or by substitution in the aromatic ring (with or without substitution at the nitrogen atom), except ephedrine, its opticalisom-ers and N-substituted derivatives, fenfluramine, hydroxyamphetamine, methoxyphenamine, phenylpropanolamine, pholedrine and prenylamine, any salt of any substance falling within this item.
Methyprylone.
Metiguanide.
Metoclopramide; its salts.
Metolozone.
Metopimazine; its salts.
Mithramycin.
Mitoclomine; its salts.
Molindone hydrochloride.
Morazone.
Myelobromol.


Nafcillin; its salts and preparations.
Nafidrofuryl oxalate.
Nalidixic acid; its salts and esters.
Naloxone hydrochloride.
Natamycin.
Neomycin; its salts and preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Nialamide.
Niridazole.
Nitrazepam; its salts.
Nitrofurazone; its salts; its esters and their salts.
Nitrofurantoin; its salts; its esters and their salts.
Nitromin.
p-Nitrosulphathiazole.
Noradrenaline; its salts.
Noramidopyrine methanesulphonate sodium.
Nortriptyline; its salts.
Novobiocin; its salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.
Nystatin; its salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance, but which is produced by means other than by living organisms.


Oestrogenic substances, conjugated.
Oleandomycin; its salts; its esters and salts of such esters and their preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance but which is produced by means other than by living organisms.
Oripramol hydrochloride.
Orciprenaline; its salts; when contained in aerosol dispensers.
Orphenadrine; its salts.
Oxaminiquine.
Oxazepam; its salts.
Oxethazaine.
Oxolinic acid.
Oxprenolol hydrochloride.
Oxytetracycline; its salts and preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance but which is produced by means other than by living organisms.
Oxyphenbutazone.
Oxytocins natural and synthetic.


Pancuronium Bromide.
Parcetaldehyde.
Paraldehyde.
Paramethadione.
Paramethasone.
Pargyline; its salts.
Pecazine; its salts.
Pemoline; its salts.
Penethamate hydriodide.
Penicillin and Derivatives.
Penicillamine; its salts.
Pentamethonium salts.
Pentazocin; its salts.
Pentresamide.
Perhexiline hydrogen maleate.
Pericyazine.
Perphenazine.
Phenacaine hydrochloride.
Phenacemide.
Phenaglycodol.
Phenatine; its salts.
Phenbutrazate.
Phencyclidine; its salts.
Phendimetrazine; its salts.
Phenetidylphenacetin.
Phenformin; its salts.
Phenothiazine, derivatives of; their salts; except dimethoxanate, its salts and promethazine, its salts and molecular compounds.
Phenoxypropazine; its salts.
Phentermine; its salts.
Phenylacetamide.
Phenylacetylearbamide.
Phenylacetamide.
Phenylacetylurea.
Phenylbutazone; its salts.
5-Phenylhydantoin; its alkyl and aryl derivatives; their salts.
2-Phenylcinchoninic acid; 2-salicylcinchoninie acid; their salts; their esters.
Phenylpropylmethylamine; its salts.
Pimafucin.
Pimozide; its salts.
Pipamazine.
Pituitary gland, the active principles of other than corticotrophins, oxytocins and vasopressins; except when contained in inhalants or in preparations intended for external application only.
Pivhydrazine; its salts.
Pizotyline.
Polymethylenebistrimethyl ammonium salts.
Polymyxins; their salts and preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance but which is produced by means other than by living organisms.
Polythiazide.
Practolol.
Pramindole; its salts.
Praxilene.
Prazitone; its salts.
Prozosin hydrochloride.
Procainamide; its salts.
Procaine benzylpenicillin.
Procarbazine; its salts.
Prochlorperazine; its salts.
Procyclidine; its salts.
Profenamine.
Prolintane; its salts.
Promoxolan.
Propionazine and its preparations.
Propylhexedrine; its salts except when contained in inhalers (PI only).
Propynylcyclohexanol carbamate.
Proquamezine; its salts.
Proseptasine.
Prothionamide.
Prothipendyl; its salts.
Prothixene; its salts.
Protriptylin; its salts.
Pseudoephedrine; its salts; its quanternary compounds; their salts simple or complex.
Pyrathiazine.
L-Pyroglutamyl-L-histidyl-L-proline amide.


Quinethazone.
Quinine; its salts except in preparations containing less than 10% of quinine or its salts.


Rauwolfia.
Rescinnamine.
Reserpine.
Rifamycins, that is to say, a group of related antimicrobial macrolactams, either produced by the growth of streptomyces mediaterranei or by modification of such products, and containing the chemical structure of 11-acetoxy-7, 9, 15-trihydroxy-lithe methoxy-2, 6, 8, 10, 12-pentamethylpentadeca-2, 4, 14-tionoc acid amide attached by the nitrogen atom and by the oxygen atom in the 15-position respectively to the 7-and 2-positions of a 5, 6, 9-trioxygenated, 2, 4-dimethyl-l-oxenaphto (2, 1-b) furan; any salt or ester of a substance comprised in this entry and any salt or such ester or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance but which is produced by means other than by living organisms.
Ristocetins and their salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance but which is produced by means other than by living organisms.
Rimiterol hydrobromide.
Rolitetracycline; its salts and preparations.


Salazopyrin.
Salazosulphadimidine except when contained in ointments or surgical dressings or in preparations for the prevention and treatment of diseases in poultry.
Salbutamol; its salts.
2-Salicylcinchoninic acid; its salts and esters.
Sensibamine; its salts.
Silver sulphadiazine.
Sodium cromoglycate.
Sodium fusidate and preparations.
Sodium glymidine.
Sodium noramidopyrine methanesulphonate.
Sodium valproate.
Sotalol hydrochloride or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance but which is produced by means other than by living organisms.
Spectinomycin; its salts; its esters; their salts.
Spiramycin; its salts and preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance but which is produced by means other than by living organisms.
Streptomycin; its salts derivatives and salts of such derivatives and their preparations or substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance but which is produced by means other than by living organisms.
Styramate.
Sulphaquinoxalline.
Sulphinpyrazone.
Sulphaomyxin sodium.
Suprarenal gland meulla, the active principles of; their salts; except when contained in preparation intended for external application only or in inhalants (other than inhalants in aerosol dispensers containing adrenaline or its salts) rectal preparations or preparations intended for use in the eye.
Suxamethonium; its salts.
Syrosingopine.


Tamoxifen citrate.
Teclothiazide.
Terbutaline; its salts when contained in aerosol dispensers.
Tetrabenazine; its salts.
Tetracosactrin.
Tetraethylthiuram disulphide.
Thalidomide; its salts.
Thiazinamium methyl sulphate.
Thiethylperazine; its salts.
Thiocarlide; its salts.
Thioguanine, its salts.
Thioproperazine; its salts.
Thioridazine; its salts.
Thyrocalcitonin.
Thyroglobulin.
Thyroid gland, the active principles of; their salts.
Timolol maleate.
Tiocarlide; its salts.
Tobramycin sulphate.
Tofenacin; its salts.
Tolbutamide.
Tranexamic acid.
Tranylcypromine; its salts.
Tretamine; its salts.
Triacetyloleanodomycin and preparations.
Triamtereine.
Triaziquone.
Tribromoethanol.
Tribromethyl alcohol.
Trichomycin.
Triclofos; its salts.
2,2,2-Trichloroethyl alcohol, esters of; their salts.
Triethanomelamine; its salts.
Trifluoperazine; its salts.
Trimethadione.
Trimipramine; its salts.
Trinuride.
Tropicamide.
Trermired.
Tropicamide.
Tropine diphenylmethyl ether.
Troxidone.
Tybamate.
Tylosin; its salts; its esters and their salts.


Vancomycin; its salts or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance but which is produced by means other than by living organisms.
Vasopressins, natural and synthetic.
Verapamil; its salts.
Viomycin; its salts and preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance but which is produced by means other than by living organisms.
Viocin sulphate.
Virginiamycin and preparations or any substance the chemical and biological properties of which are identical with or similar to this antimicrobial substance but which is produced by means other than by living organisms.


Xylylanthranilic acid; its salts, its esters their salts.


______


FIFTH SCHEDULE
(Regulation 13)
(Substituted by Legal Notice 154 of 1971.)


FORM TO WHICH THE SUBSTANCES SPECIFIED ARE RESTRICTED WHEN SOLD BY LICENSED SELLERS OF PART II POISONS
______


LIST "E"


PART A


Aldicarb; preparations for use in agriculture or horticulture.
Alpha-chloralose; preparations intended for indoor use in the destruction of rats or mice and containing not more than four per cent, weight in weight, of alphachloralose.
Arsenical substances;

Arsenious oxide; sheep dips, sheep washes.

Arsenic sulphides; sheep dips, sheep washes.

Calcium arsenites; agricultural and horticultural insecticides or fungicides.

Copper acetoarsenite; agricultural and horticultural insecticides or fungicides.

Copper arsenates; agricultural and horticultural insecticides or fungicides.

Copper arsenites; agricultural and horticultural insecticides or fungicides.

Lead arsenites; agricultural and horticultural insecticides or fungicides.

Sodium arsenates; sheep dips, sheep washes.

Sodium thioarsenates; sheep dips, sheep washes.


Barium carbonate; preparations for the destruction of rats or mice.
B-(2, -3, 5-Dimethyl-2-oxocyclohexyl"-2-hydroxyethyl) Glutarimide preparations for use in forestry.
Dinitrocresols (DNOC); their compounds with a metal or a base, preparations for use in agriculture or horticulture.
Dinosam; its compounds with a metal or a base; preparations for use in agriculture or horticulture.
Dinoseb; its compounds with a metal or a base; preparations for use in agriculture or horticulture.
Drazoxolon; its salts; preparations for use in agriculture or horticulture.
Endosulfan; preparations for use in agriculture or horticulture.
Endothal; its salts; preparations for use in agriculture or horticulture.
Endrin; preparations for use in agriculture or horticulture.
Fenazaflor; preparations for use in agriculture or horticulture.
Formetanate; preparations for use in agriculture or horticulture.
Mercurial substances:

Mercuric chloride; agricultural and horticultural fungicides, seed and bulb dressings, insecticides.

Mercuric iodide; agricultural and horticultural fungicides; seed and bulb dressings.

Organic compounds of mercury; agricultural and horticultural fungicides, seed and bulb dressings, solutions containing not more than 5%., weight in volume, of phenyl mercuric acetate for use in swimming baths.
Metallic oxalates other than potassium quadroxalate; Photographic solutions or material.
Methidathion preparations for use in agricultural or horticultural.
Methomyl; preparations for use in agriculture or horticulture.
Nitrobenzene; Agricultural and horticultural insecticides; substances for the treatment of bee disease; ointments for the treatment of animals.
Organo-tin compounds, the following:

Compounds of fentin; preparations for use in agriculture or horticulture.
Phosphorus compounds, the following; Preparations for use in agriculture or horticulture.

Amiton.

Azinphos-ethyl.

Azinphos-methyl.

Chlorfenvinphos.

Demephion.

Demeton-methyl.

Demeton-O.

Demeton-S.

Demeton-O-methyl.

Demeton-S-methyl.

Demeton-S-methyl sulphone.

Dichlorvos.

Diethyl 4-methyl-7-coumarinyl phosphorothionate.

Diethyl p-nitrophenyl phosphate.

Dimefox.

Dioxathion.

Disulfoton.

Ethion.

Ethyl p-nitrophenyl phenylphosphorothionate.

Fonofos.

Mazidox.

Mecarbam.

Mevinphos.

Mipafox.

Omethoate.

Oxydemeton-methyl.

Parathion.

Phenkapton.

Phorate.

Phosphamidon.

Schradan.

Sulfotep.

TEPP (HETP).

Thiometon.

Thionazin.

Triphosphoric pentadimethylamide.

Vamidothion.

Sodium 4-(dimethylamino) benzenediazosulphonate; preparation for use in agriculture or horticulture.

Zinc phosphide; preparations for the destruction of rats and mice.


______


PART B


POISONS WHICH MAY BE SOLD BY A LICENSED SELLER OF PART II POISONS ONLY TO PERSONS ENGAGED IN THE TRADE OR BUSINESS OF AGRICULTURE OR HORTICULTURE AND FOR THE PURPOSES OF THAT TRADE OR BUSINESS


Aldicarb.
Arsenical poisons other than lead arsenates and copper acetoarsenite.
Dinitro resols (DNOC); their compounds with a metal or a base; except winter washes containing not more than the equivalent of 5% of dinitrocresols.
Dinosam; its compounds with a metal or a base.
Dinoseb; its compounds with a metal or a base.
Drazoxolon; its salts.
Fenazaflor.
Formetanate.
Mercuric chlorides; mercuric iodides; organic compounds of mercury; except solutions containing not more than 5%, weight in volume, of phenyl mercuric acetate for use in swimming baths.
Methomyl.
Niclofolan.
Organo-tin compounds, the following:

Compounds of fentin.
Phosphorus compounds, the following:

Amiton.

Azinphos-ethyl.

Azinphos-methyl.

Chlorfenvinphos.

Demephion.

Demeton-methyl.

Demeton-O.

Demeton-S.

Demeton-O-methyl.

Demeton-S-methyl.

Demeton-S-methyl sulphone.

Dichlorvos

Diethyl 4-methyl-7-coumarinyl phosphorothionate.

Diethyl p-nitrophenyl phosphate.

Dimefox.

Dioxathion.

Disulfoton.

Ethion.

Ethyl p-nitrophenyl phenylphosphorothionate.

Fonofos.

Mazidox.

Mecarbam.

Mevinphos.

Mipafox, except in for form of a cap on a stick or wire.

Omethoate.

Oxydemeton-methyl.

Parathion.

Phenkapton.

Phorate.

Phosphamidon.

Schradan.

Sulfotep.

Thiometon.

Thionazin.

Triphosphoric pentadimethylamide.

Vamidothion.

Sodium 4-(dimethylamino) benzenediazosulphonate.


______


PART C


SUBSTANCES WHICH MAY NOT BE SOLD FOR USE IN AGRICULTURE OR HORTICULTURE UNLESS HAVING A DISTINCTIVE COLOUR OR HAVING AN ADDITIVE WHICH RENDERS THE SUBSTANCE A DISTINCTIVE COLOUR
______


Arsenical poisons.
Drazoxolon; its salts.
Fluoroacetamide; fluoroacetanilide.
Monofluoroacetic acid; its salts.
Organo-tin compounds, the following:

Compounds of fentin.
Phosphorus compounds, the following:

Azinphos-ethyl.

Azinphos-methyl.

Chlorfenvinphos.

Demeton-methyl.

Demeton-S-methyl sulphone.

Dichlorvos.

Dioxathion.

Disulfoton in solution.

Ethion.

Mecarbam.

Mevinphos.

Omethoate.

Oxydemeton-methyl.

Phenkapton.

Phorate in solution.

Phosphamidon.

Thiometon.

Thionazin.

Vamidothion.


______


SIXTH SCHEDULE
(Regulation 16)
______


STATEMENT OF PARTICULARS AS TO PROPORTION OF THE POISON IN CERTAIN CASES PERMITTED BY REGULATION 16 (2)


Poisons
Particulars
Alkoids -

Aconite, alkoids of:
The proportion of any one alkoid of aconite that the preparation would be calculated to contain on the assumption that all the alkoids of aconite in the preparation were that alkoid.
Belladona, alkoids of.

Calabar Bean, alkoid of.

Ephedra, alkoids of.

Ergot, alkoids of.

Gelsemium, alkoids of.

The same as the above, with the substitution for the reference to aconite of a reference to belladonna, calabar bean or such other of the said posons as the case may require
Jaborandi, alkoids of.
Lobelia, alkoids of
Pomegranate, alkoids of.
Quebracho, alkoids of, other than the alkoids
of red quebracho.
Sabadilla, alkoids of.
Solanaceous alkoids not otherwise included
in the Poisons List.
Stavesacre, alkoids of
Vetatrum, alkoids of

Yohimba, alkoids of.

Antimonial poisons.
The proportions of antimony trioxide (Sb2O3) or antimony trioxide (Sb2O5), that the preparation would be calculated to contain on the assumption that the antimony (Sb) in the poision had been wholly converted to antimony trioxide or antimony pentoxide as the case may be.
Arsenical poisons
The proportion of arsenic trioxide (As2O3) or arsenic pentoxide (As2O5) that the preparation would be calculated to contain on the assumption that the arsenic (As) in the poison had been wholly converted to arsenic trioxide or arsenic pentoxide as the case may be.
Barium, salts of.
The proportion of one particular barium salt which the preparation would be calculated to contain on the assumption that the barium (Ba) in the poison had been wholly converted to that salt.
Digitalis, glycosides of, other active
principles of digitalis.
The number of units of activity as defined in the British Pharmacopoeia contained in a specified quantity of the preparation.
Hydrocyanic acid, cyanides, double cyanides
of mercury and zinc
The proportion of hydrocynic acid (HCN) that the preparation would be calculated to contain on the assumption that the cyanides in the poison had been wholly converted into hydrocyanic acid.
Insulin
The number of activity as defined in the British Pharmacopoeai contained in a specified quantity of the preparation.


Lead, compounds of, with acids from fixed
oils.
The proportion of lead oxide (PbO) that the preparation would be calculated to contain on the assumption that the lead in the poison had been wholly converted into lead oxide.
Mercury, organic compounds of.
The proportion of organically combined mercury (Hg) contained in the preparation.


Nux Vomica.
The proportion of strychnine contained in the preparation.
Opium.
The proportion of morphine contained in the preparation.
Phenols.
The proportion of phenols (added together) contained in the preparations.
Compounds of phenol with a metal.
The proportion of phenols (added together) that the preparation would be calculated to contain on the assumption that the compounds of phenols with a metal had been wholly converted into the corresponding phenols.
Pituitary gland the active principles of.
Either-

(a) the number of units of activity as defined in the British Pharmacopoeia contained in a specified quantity of the preparation; or

(b) the amount of pituitary gland, or of anterior or posterior lobe of the gland, as the case may be, from which a specified quantity of the preparation was obtained, together with an indication whether the amount related to fresh or dried gland substance.
Potassium hydroxide.
The proportion of potassium monoxide (K2O) which the preparation would be calculated to contain on the assumption that the potassium hydroxide in the preparation had been wholly converted into potassium monoxide.
Sodium hydroxide.
The proportion of sodium monoxide (Na2O) which the preparation would be calculated to contain on the assumption that the sodium hydroxide in the preparation has been wholly converted into sodium monoxide.
Srophanthus, glycosides of.
The amount of Standard Tincture of Strophanthus as defined in the British Pharmacopoeia which possesses the same activity as a specified quantity of the preparation when assayed by the method described in the said Pharmacopoeia.
Suprarenal gland medulla, the active principles of; their salts.
Either -

(a) the proportion of suprarenal gland or of the medulla of the gland. as the case may be, contained in the preparation; or

(b) the amount of suprarenal gland, or of the medulla of the gland, as the case may be, from which a specified quantity of the preparation was obtained together with an indication whether the amount relates to fresh or dried gland substance.
Thyroid gland; the active principles of, their salts.
Either-

(a) the proportion of thyroid gland contained in the preparation; or

(h) the amount of thyroid gland from which a specified quantity of the preparation was obtained together with an indication whether the amount relates to fresh or dried gland substance.

______


SEVENTH SCHEDULE
(Regulation 17)
(Substituted by Legal Notice 154 of 1977.)
______


INDICATION OF CHARACTER PRESCRIBED BY REGULATION 17(1) FOR THE PURPOSE OF SECTION 66 (1) (c) (iii) OF THE ACT
______


LIST `F


(1) To be labelled with the words "Caution. It is dangerous to take this preparation except under medical supervision.":-


Medicines made up ready for the internal treatment of human ailments and containing insulin.


(2) To be labelled with the words "Caution. It is dangerous to exceed the stated dose.":-


Medicines (other than medicines containing insulin and medicines mentioned in paragraph (9) made up ready for the internal treatment of human ailments except in the case of a substance included in the First Schedule.


(3) To be labelled with the words "Poison. For animal treatment only.":-


Medicines made up ready for the treatment of animals.


(4) To be labelled with the words "Caution. This preparation may cause serious inflammation of the skin in certain persons and should be used only in accordance with expert advice.":-


Preparations for the dyeing of hair containing phenylene diamines, tolylene diamines or other alkylated-benzene diamines or their salts.


(5) To be labelled with the words "Caution. This substance is caustic.":-


Potassium hydroxide, sodium hydroxide, and articles containing either of those substances.


(6) To be labelled with the words "Caution. This substance is poisonous. The inhalation of its vapour mist, spray or dust may have harmful consequences. It may also be dangerous to let it come into contact with the skin or clothing.":-


Dinitrocresols (DNOC); their compounds with a metal or a base; except preparations for the treatment of human ailments and except winter washes containing not more than the equivalent of 5% of dinitrocresols.


Dinosam; its compounds with a metal or a base.

Dinoseb; its compounds with a metal or a base.

Drazoxolon; its salts.

Endosulfan.

Endothal; its salts.

Endrin.

Fenazaflor.

Fluoroacetamide; fluoroacetanilide.

Organic compounds of mercury in aerosols.

Organo-tin compounds, the following:-

Compounds of fentin.

Phosphorus compounds, the following:-

Amiton.

Azinphos-ethyl.

Azinphos-methyl.

Chlorfenvinphos.

Demephion.

Demeton-methyl.

Demeton-O.

Demeton-S.

Demeton-O-methyl.

Demeton-S-methyl.

Demeton-S-methyl sulphone.

Dichlorvos.

Diethyl 4-methyl-7-coumarinyl phosphorothionate.

Diethyl p-nitrophenyl phosphate.

Dimefox.

Dioxathion.

Disulfoton.

Ethion.

Ethyl p-nitrophenyl phenylphosphorothionate.

Fonofos.

Mazidox.

Mecarbam.

Mevinphos.

Mipafox.

Omethoate.

Oxydemeton-methyl.

Parathion.

Phenkapton.

Phorate.

Phosphamidon.

Schradan.

Sulfotep.

TEPP (HETP).

Thiometon.

Thionazin.

Triphosphoric pentadimethylamide.

Vamidothion.

Sodium 4-(dimethylamino) benzenediazosulphonate.


(7) To be labelled with the words "Caution. This preparation should be administered only under medical supervision. The vapour is dangerous.":-


Medicines made up ready for the internal or external treatment of human ailments and containing dyflos.


(8) To be labelled with the words "Caution. This substance is poisonous. Inhalation of the powder is dangerous. It is also dangerous to let the substance come into contact with the skin or clothing.":-


Monofluoracoetic acid; its salts.


(9) To be labelled with the words "Caution. This may cause drowsiness. If affected, do not drive or operate machinery.":-


Anti-histamine substances, the following, their salts; their molecular compounds.

Antazolin.

Bromodiphenhydramine.

Buclizine.

Carbinoxamine.

Chlorcyclizine.

Chlorpheniramine.

Cinnarizine.

Clemizole.

Cyclizine.

Cyproheptadine.

3-Di-n-butylaminomethyl-4, 5, 6-trihydroxyphthalide.

Diphenhydramine.

Diphenylpyraline.

Doxylamine.

Isothipendyl.

Mebhydrolin.

Meclozine.

Phenindamine.

Pheniramine.

Phenyltoloxamine.

Promethazine.

Pyrrobutamine.

Thenalidine.

Tolpropamine.

Triprolidine.

Substances being tetra-N-substituted derivatives of ethyienadiamine or propylenediamine.


(10) To be labelled with the words "Caution. Ingestion can be harmful. If this preparation is used on the hands, they should be thoroughly washed before handling food.":-


Preparations for topical application containing methanthelinium bromide or propantheline bromide.


(11) To be labelled with the words "Caution. Do not inhale vapour or allow contact with skin, eyes or clothing.":-


Bromomethane.


______


EIGHTH SCHEDULE
(Regulation 23)
(Substituted by Legal Notice 154 of 1977.)
______


POISONS TO WHICH REGULATION 23 (TRANSPORT) APPLIES
______


LIST ‘G’


Aldicarb.
Arsenical poisons.
Barium, salts of.
Bromomethane.
Dinitrocresols (DNOC), their compounds with a metal or a base, when contained in preparations for use in agriculture or horticulture, except winter washes containing not more than the equivalent of 5% of dinotrocresols.
Dinosam, its compounds with a metal or a base, when contained in preparations for use in agriculture or horticulture.
Dinoseb, its compounds with a metal or a base, when contained in preparations for use in agriculture or horticulture.
Drazoxolon; its salts.
Endosulfan.
Endothal; its salts.
Endrin.
Fenazaflor.
Fluoroacetamide; fluoroacetanilide.
Formetanate.
Hydrocyanic acid; cyanides, other than ferrocyanides and ferricyanides, except preparations containing less than the equivalent of 0.1%, weight in weight of hydrocyanic acid (HCN).
Methomyl.
Monofluoroacetic acid; its salts.
Monofluoracetic acid; its salts.
Nicotine, except in solid preparations containing less than 4% of nicotine.
Organo-tin compounds, the following:-

Compounds of fentin.
Phosphorus compounds, the following:-

Amiton.

Azinphos-ethyl.

Azinphos-methyl.

Chlorfenvinphos.

Demephion.

Demeton-methyl.

Demeton-O.

Demeton-S.

Demeton-O-methyl.

Demeton-S-methyl.

Demeton-S-methyl sulphone.

Dichlorvos.

Diethyl 4-methyl-7-coumarinyl phosphorothionate.

Diethyl p-nitrophenyl phosphate.

Dimefox.

Dioxathion.

Ethion.

Ethyl p-nitrophenyl phenylphosphorothionate.

Fonofos.

Mazidox.

Mecarbam.

Mevinphos.

Mipafox.

Omethoate.

Oxydemeton-methyl.

Parathion.

Phenkapton.

Phorate.

Phosphamidon.

Schradan.

Sulfotep.

TEPP (HETP).

Thiometon.

Thionazin.

Triphosphoric pentadimethylamide.

Vamidothion.

Sodium 4-(dimethylamino) benzenediazosulphonate.

Strychnine.

Thallium, salts of.

________


NINTH SCHEDULE
(Regulation 25)
_________


FORM OF APPLICATION TO BE FILLED BY A LICENSED STOREKEEPER FOR A LICENCE TO SELL PART II POISONS (SECTION 64 OF THE ACT)


PHARMACY AND POISONS ACT


APPLICATION FOR A LICENCE TO SELL PART 11 POISONS


I, ........................... being a licensed storekeeper carrying on business at .................... hereby apply for a licence to sell such Part 11 poisons as may be permitted by the Pharmacy and Poisons Act, Part V1, and the Poisons Regulations.


The application refers only to the premises situated at the above address.


I hereby nominate ........................... to act as my deputy (deputies) for the sale of poisons in accordance with regulation 13 (1) of the Poisons Regulations.


Date: ...................................... Signature: ............................


I hereby certify that to the best of my knowledge and belief the applicant ........................ of .........................................., is of good character and is a fit and proper person to be a Licensed Seller of Part II Poisons.

Police Officer


Rank:

Police Station:

Date:

______


TENTH SCHEDULE
(Regulation 26)
______


FORM OF LICENCE TO BE ISSUED TO A LICENSED STOREKEEPER LICENSING HINT TO SELL CERTAIN PART II POISONS


PHARMACY AND POISONS ACT


LICENCE


This Licence cannot be transferred and is available for one place of business only. To [name] of [address]


You are hereby licensed to sell such Part II Poisons as are enumerated at the foot hereof.


Your particular attention is drawn to the Poisons Regulations, especially those portions dealing with the sale, supply, storage, labelling and transport of poisons.


By order of the Pharmacy and Poisons Board.


Secretary

_____


ELEVENTH SCHEDULE
(Regulation 27)
______


SCALE OF FEES IN RESPECT OF LICENCES, REGISTRATIONS, ETC.



$
Registration of premises ..................................
10.00 per annum.
Licence to sell Part II poisons ............................
10.00 per annum.
Licence to sell medicines ..................................
10.00 per annum.
Registration of pharmacist ................................
10.00
Application for manufacturer's licence ..................
20.00
Manufacturer's licence ....................................
200.00 per annum.
Application for wholesale licence ........................
20.00
Wholesale licence ..........................................
200.00 per annum.

______


TWELFTH SCHEDULE
(Regulation 28)
______


FORM OF CERTIFICATES OF REGISTRATION AS PHARMACIST


PHARMACY AND POISONS ACT


This is to certify that ........................ of ........................., who has duly passed the Qualifying Examination for Pharmacists' of .........................................., has been registered as a Pharmacist and is an authorised seller of Poisons under the Pharmacy and Poisons Act.


This certificate expires on the 31st December, 19...


Date:


Registrar, Pharmacy and Poisons Board


______


THIRTEENTH SCHEDULE
(Regulation 29)
______


FORM OF REGISTER OF PHARMACISTS


REGISTER OF PHARMACISTS

Year:

Name
Address
Date qualified
Where qualified
Date registered
Signature of Registrar







______


FOURTEENTH SCHEDULE
(Regulation 30)
______


FORM OF REGISTER OF PREMISES


REGISTER OF PERSONS ENTITLED TO SELL DRUGS, MEDICINES AND POISONS


Licence
No.
Name
Address
of
premises
Class
of
business
Name of Deputy
or Deputies permitted to sell






______


FIFTEENTH SCHEDULE
(Regulation 31)
______


PHARMACY AND POISONS ACT


FORM OF APPLICATION FOR LICENCE TO SELL MEDICINES


To the Chairman,

Pharmacy and Poisons Board,

Suva.


I, ................................. of ..........................., hereby apply for a licence to sell medicines. My place of business is situated ............................... miles from the nearest registered pharmacist at .......................................


Date:


Signature of Applicant


I hereby certify that to the best of my knowledge and belief the applicant's place of business is situated the stated distance from the nearest pharmacist's business at ........................... and that the applicant is a fit and proper person to sell medicines.


Police Officer


Rank:

Police Station:

Date:

______


SIXTEENTH SCHEDULE
(Regulation 32)
______


PHARMACY AND POISONS ACT


FORM OF LICENCE TO SELL MEDICINES


To [name] [address]


You are hereby licensed to sell such patent and other medicines as are enumerated at the foot hereof.


This licence cannot be transferred and is available for one place of business only.
This licence is for a period of six months only and expires on the ...............,19...


By order of the Pharmacy and Poisons Board.


Secretary


______


SEVENTEENTH SCHEDULE
(Regulation 35)
______


PHARMACY AND POISONS ACT


CERTIFICATE FOR THE PURCHASE OF A POISON


For the purposes of sub-paragraph (i) of paragraph (a) of sub-section (2) of section 66 of the Pharmacy and Poisons Act, I, the undersigned, a householder of [full postal address] from my knowledge of [full name of intending purchaser] of [full postal address] certify that he is a person to whom [name of poison] may properly be supplied.


I hereby certify that [intending purchaser to sign his name here] is the signature of the said [full name of intending purchaser].


[Endorsement required when the householder giving the certificate is not known to the seller of the poison as a responsible person of good character.]


I hereby certify that in so far as is known to the police of the district in which .................. resides he is a responsible person of good character.


Police Officer

Rank:

Police Station:

Date:

______


EIGHTEENTH SCHEDULE
(Regulation 36)
______


FORM OF ENTRY TO BE MADE UNDER REGULATION 36 IN THE BOOK TO BE KEPT BY SELLERS OF POISONS IN ACCORDANCE WITH SECTION 66 (2) (b) OF THE ACT



Date of Sale

Name of poison
Quantity supplied

Purchaser's
Purpose for which stated to be required
Date of Certificate (if any)
Name of person giving certificate (if any)
Signature of purchaser of where signed order is permitted by the Poisons Regulations date of such order
Name
Address
Occupation











______


NINETEENTH SCHEDULE
(Regulation 13)
(Inserted by Regulations 29 January 1964.)
______


PHARMACY AND POISONS ACT


FORM OF LICENCE TO PURCHASE ARSENICAL POISON

No. .................

This is to certify that permission has been granted to .................................................................
........................................................... of .....................................................................................
to purchase....................................................................................................................................
for the purpose of ........................................................................................................................
This licence expires on ................................................................................................................
Dated at Suva this...................day of .............., 19...


Secretary, Pharmacy and Poisons Board.


This licence may not be transferred and must be produced at the time of each purchase.

______


TWENTIETH SCHEDULE
(Regulation 33)
(Inserted by Regulations 3 April 1970.)
______


PHARMACY AND POISONS ACT

FORM OF APPLICATION FOR LICENCE TO SELL ANIMAL MEDICINE


Date.............................


To

The Chairman,

Pharmacy and Poisons Board, Suva.


I, .............................................. of ................................................ being the holder of a licence to sell poisons, hereby apply for a licence to sell animal medicine.


I nominate the following employee(s) to be my deputy/deputies in the sale of such animal medicine:-

.......................................................
.......................................................
........................................................


...........................
Signature of Applicant

______


TWENTY-FIRST SCHEDULE
******************
(Superseded by Legal Notice No. 122 of 1982.)


Controlled by Ministry of Health


* See Legal Notice No. 50 of 1984.


** See Pharmacy and Poisons (Animal Medicine Licences) Regulations (ante page 1.)



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