Control of Goods (Import of Medicinal Substances and Poisons) Regulations (Cap. 421)

SECTIONS 3 AND 6 THE CONTROL OF GOODS (IMPORT OF MEDICINAL SUBSTANCES AND POISONS) REGULATIONS Regulations by the President Federal Government Notices 271 of 1955 225 of 1957 Government Notices 1 of 1964 497 of 1964 Statutory Instrument 384 of 1967 Act No. 13 of 1994 Title 1. These Regulations may be cited as the Control of Goods (Import of Medicinal Substances and Poisons) Regulations. Interpretation 2. In these Regulations, unless the context otherwise requires "advertisement" includes any notice, circular, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light or sound; "appropriate designation", in relation to a substance, constituent or ingredient, means the accepted scientific name or other name descriptive of the true nature of that substance, constituent or ingredient; "appropriate quantitative particulars" means (a) the approximate percentage of each of the active constituents or ingredients contained in any substance or the approximate quantity of each of the active constituents or ingredients contained in any article; or (b) if an article consists of or comprises a number of separate portions of a substance, either the approximate percentage or quantity mentioned in paragraph (a) or the approximate quantity of each of the constituents or ingredients contained in each portion; "container" includes a wrapper; "proprietary designation", in relation to articles consisting of or comprising a substance recommended as a medicine, means a word or words used or proposed to be used in connection with the sale of those articles for the purpose of indicating that they are the goods of a particular person by reason of manufacture, selection or certification or by reason of his offering them for sale or his dealing in or with them; "proprietor", in relation to a proprietary designation, means the person whose goods are indicated or intended to be indicated by that proprietary designation; "substance" includes a preparation; "substance recommended as a medicine", in relation to an article consisting of or comprising a substance so recommended, means a substance which is referred to (a) on the article, or on any wrapper or container in which the article is sold, or on any label affixed to, or in any document enclosed in, the article or such a wrapper or container; or (b) in any placard or other document exhibited at any place in Zambia where the article is sold; or (c) in any advertisement, letter, or other document published by or on behalf of the manufacturer of the article, or any person carrying on business in the course of which the article is sold, or, if the article is sold under a proprietary designation, the proprietor of the designation; in terms which are calculated to lead to the use of the substance for the exertion of some pharmacological effect on the human body, not being terms which give a definite indication that the substance is intended to be used as, or as part of, a food or drink, and not as, or as part of, a medicine. (As amended by G.N. No. 1 of 1964) Particulars to be recorded on containers or labels 3. (1) No person shall import into Zambia any article consisting of or comprising a substance recommended as, or intended to be used as, a medicine unless there is written so as to be clearly legible on the article or a label affixed thereto, or, if the article is imported in a container, on the container or a label affixed thereto, or, if the article is imported in more than one container, on the inner container or a label affixed thereto (a) the appropriate designation of the substance so recommended, or of each of the active constituents thereof, or of each of the ingredients of which it has been compounded; and (b) if the appropriate designation of each of the active constituents or the ingredients is written as aforesaid, the appropriate quantitative particulars of the constituents or ingredients. (2) Notwithstanding the provisions of sub-regulation (1), any article referred to in that sub regulation may be imported into Zambia by (a) a medical practitioner registered or exempted from registration under any written law relating to the registration of medical practitioners; (b) a traveller for his personal use. (As amended by F.G.N. No. 225 of 1957 and G.N. No. 1 of 1964) Prohibition on import of specified poisons except by authorised persons 4. No person shall import into Zambia any poisons specified in the First Schedule or any preparation containing any such poison, whether or not that preparation is a substance recommended as a medicine, unless (a) he is a person who is a member of a class of persons specified in paragraph 1, 2 or 3 of the Second Schedule; or (b) he is authorised to do so in terms of an open general licence issued by the Minister by Gazette notice; or (c) he has obtained a special licence to do so from the Permanent Secretary, Ministry of Health. (As amended by G.N. No. 1 of 1964) Offences and penalties 5. Any person who acts in contravention of or fails to comply with any of the provisions of these Regulations shall be guilty of an offence and shall be liable on conviction to a fine of one thousand five hundred penalty units or to imprisonment for three months, or to both and, in addition to such aforesaid penalty, the court before which a person is so convicted may order any articles in respect of which such offence has been committed to be forfeited. (S.I. No. 384 of 1967 and Act No. 13 of 1994) FIRST SCHEDULE (Regulation 4) SPECIFIED POISONS 1. Barbituric acid or its salts. 2. Derivatives of barbituric acid or their salts. 3. Compounds with any other substance of barbituric acid or compounds with any other substance of its salts or of its derivatives and their salts. 4. Paraldehyde. SECOND SCHEDULE (Regulation 4) AUTHORISED PERSONS 1. Persons authorised to sell poisons in terms of any written law. 2. Pharmacists registered under any written law. 3. Medical practitioners, dental surgeons and veterinary surgeons registered under any written law. (G.N. No. 1 of 1964) Act No. 13 of 1994