MEDICINES (ADVERTISEMENT AND SALE) ACT 1956

LAWS OF MALAYSIA ONLINE VERSION OF UPDATED TEXT OF REPRINT Act 290 MEDICINES (ADVERTISEMENT AND SALE) ACT 1956 As at 1 May 2013 2 MEDICINES (ADVERTISEMENT AND SALE) ACT 1956 First enacted … … … … … 1956 (F.M. Ordinance No. 10 of 1956) Revised … … … … … 1983 (Act 290 w.e.f. 18 August 1983 PREVIOUS REPRINTS First Reprint ... ... ... ... ... 2001 Second Reprint ... ... ... ... ... 2006 3 LAWS OF MALAYSIA Act 290 MEDICINES (ADVERTISEMENT AND SALE) ACT 1956 ARRANGEMENT OF SECTIONS Section 1. Short title 2. Interpretation 3. Prohibition of advertisements relating to certain diseases 4. Prohibition of advertisements relating to abortion 4A. Prohibition of advertisements relating to skill or service 4B. Advertisements of medicines to be approved 5. Provisions as to offences under sections 3, 4, 4 A and 4B 6. Disclosure of composition of medicines 6A. Authorized officers 6B. Power of investigation 6 C. Examination of witnesses 6 D. Power to enter premises 6E. Penalty for obstructing or impeding an authorized officer 6F. Sanction to prosecute and conduct of prosecutions 7. Regulations SCHEDULE 5 LAWS OF MALAYSIA Act 290 MEDICINES (ADVERTISEMENT AND SALE) ACT 1956 An Act to prohibit certain advertisements relating to medical matters and to regulate the sale of substances recommended as a medicine. [Peninsular Malaysia—1 October 1956, LN. 172/1956; Sabah and Sarawak—1 January 1976, P.U. (A) 400/1975] Short title 1. This Act may be cited as the Medicines (Advertisement and Sale) Act 1956. Interpretation 2. In this Act, unless the context otherwise requires— “advertisement” includes any notice, circular, report, commentary, pamphlet, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light or sound; “authorized officer” means a pharmacist in the public service who is authorized in writing by the Minister under section 6A to exercise the powers of an authorized officer under this Act; “Poisons List” means the Poisons List in the First Schedule to the Poisons Act 1952 [Act 366], or the corresponding provision of law in force in Sabah or Sarawak, as the case may be; 6 Laws of Malaysia ACT 290 “private hospital” means a hospital registered under the Private Hospitals Act 1971 [Act 43]; “proprietary designation”, in relation to the sale of an article 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 articles consisting of or comprising the substance 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; and the expression “proprietor”, in relation to such a designation, means the person whose goods are indicated or intended to be indicated as aforesaid by the designation; “public hospital” includes any public clinic, public dispensary or other public institution for the reception of the sick whether as in-patients or out-patients; “registered” used with reference to a person practicing a profesion means registered under the provisions of the law for the time being applicable to the registration of persons practising such profession; “substance” includes a preparation; “substance recommended as a medicine”, in relation to the sale of an article consisting 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 the place where the article is sold; or (c) in any advertisement published after the passing of this Act by or on behalf of the manufacturer of the article, or the person carrying on the business in the course of which the article was sold, or, in a case where the article Medicines (Advertisement and Sale) 7 was under a proprietary designation, the proprietor of the designation, in terms which are calculated to lead to the use of the substance for the prevention or treatment of any ailment, infirmity or injury affecting 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; “word” includes a letter and a numeral. Prohibition of advertisements relating to certain diseases 3. (1) Subject to this Act, no person shall take any part in the publication of any advertisement referring to any article, or articles of any description, in terms which are calculated to lead to the use of that article or articles of that description as a medicine, an appliance or a remedy for the purpose of— (a) prevention or treatment of the diseases and conditions of human beings as specified in the Schedule; (b) practising contraception among human beings; (c) improving the condition or functioning of the human kidney or heart, or improving the sexual function or sexual performance of human beings; (d) diagnosis of a disease as specified in the Schedule: Provided that this subsection shall not apply to any advertisement published by the Federal Government or any State Government or any local or public authority, or by the governing body of a public hospital or by any person authorized to publish such advertisement by the Minister. (1A) The Minister may add to, delete from or amend the Schedule from time to time by order. 8 Laws of Malaysia ACT 290 (2) In any proceedings for a contravention of the foregoing provisions of this section, it shall be a defence for the person charged to prove that the advertisement to which the proceedings relate was published only so far as was reasonably necessary to bring it to the notice of persons of the following classes or of one or some of them, that is to say— (a) members of a local or public authority; (b) members of the governing body of a public hospital; (c) registered medical practitioners; (d) registered dentists; (e) registered nurses and midwives; (f) registered pharmacists, chemists and wholesalers and retailers of poisons licensed under the Poisons Act 1952, or the corresponding law in force in Sabah or Sarawak, as the case may be, to sell poisons listed in Part I of the Poisons List; (g) persons undergoing training with a view to becoming registered medical practitioners, registered dentists, registered nurses or registered pharmacists or chemists. Prohibition of advertisements relating to abortion 4. Subject to this Act, no person shall take any part in the publication of any advertisement referring to any article, or articles of any description, in terms which calculated to lead to the use of that article or articles of that description for procuring the miscarriage of women. Medicines (Advertisement and Sale) 9 Prohibition of advertisement relating to skill or service 4A. Subject to this Act, no person shall take part in the publication of any advertisment— (a) which refers to any skill or service relating to the treatment, prevention or diagnosis of any ailment, disease, injury, infirmity or condition affecting the human body; and (b) which is capable of including, or which contains an invitation, whether express or implied, to, any person to seek advice of the advertiser or any person referred to in the advertisement in connection with such skill or service: Provided that this section shall not apply to any advertisement published— (aa) with the approval of the Minister, by any professional body related to the medical profession or to any other allied profession which is established by or registered under any written law; or (bb) with the approval of the Medicine Advertisements Board established by the Minister, by any private hospital or by any— (i) private clinic; (ii) private radiological clinic; (iii) private medical laboratory, operated by a registered medical practitioner having a valid annual practising certificate under the Medical Act 1971 [Act 50]. 10 Laws of Malaysia ACT 290 Advertisements of medicines to be approved 4B. (1) No person shall take any part in the publication of any advertisement referring to any article, or articles of any description, in terms which are calculated to lead to the use of that article of that description as a medicine, an appliance or a remedy for the purpose of treatment or prevention of diseases or conditions of human beings other than the diseases and conditions specified in subsection 3(1), unless such advertisement has been approved by the Medicine Advertisements Board. (2) Any advertisement proposed to be published may be submitted to the Medicine Advertisements Board for approval in the manner provided for by regulations made under section 7. Provisions as to offences under sections 3, 4, 4A and 4B 5. (1) If any person contravenes any of the provisions of sections 3, 4, 4A and 4B, he shall, subject to the provisions of this Act, be liable on summary conviction— (a) in the case of a first conviction, to a fine not exceeding three thousand ringgit or to imprisonment for any term not exceeding one year or to both; and (b) in the case of a subsequent conviction, to a fine not exceeding five thousand ringgit, or to imprisonment for a term not exceeding two years, or to both. (2) Where, in any proceedings for a contravention of any of the provisions of sections 3, 4 and 4B it is proved— (a) that an advertisement was published referring to any article, or articles of any description, in terms calculated to lead to the use of that article of that description— (i) in the case of a contravention of section 3, for the treatment of human beings for such diseases as is mentioned in subsection (1) of that section; Medicines (Advertisement and Sale) 11 (ii) in the case of a contravention of section 4, for procuring the miscarriage of women; or (iii) in the case of contravention of section 4B, for treatment or prevention of diseases or conditions of human beings other than the diseases and conditions specified in subsection 3(1); (b) that the advertisement also referred to the article in terms calculated to indicate that it or they were manufactured, produced, imported, sold or offered for sale by the person charged, then, unless the contrary is proved, it shall be presumed for the purpose of those proceedings that that person took part in the publication of the advertisement, but without prejudice to the liability of any other person. (2A) Where in any proceedings for a contravention of section 4A, it is proved that an advertisment was published referring to any skill or service in terms calculated to indicate that such skill or service was provided by the person charged, then, unless the contrary is proved, it shall be presumed for the purpose of these proceedings that the person charged took part in the publication of the advertisement, but without prejudice to the liability of any other person. (3) In any proceedings for a contravention of any the provision of sections 3, 4 and 4B, it shall be a defence for the person charged to prove— (a) that the advertisement to which the proceedings relate was published in such circumstances that he did not know and had no reason to believe that he was taking part in the publication thereof; or (b) that the said advertisement was published only in a publication of a technical character intended for circulation mainly amongst persons of the following classes, or one or some of them, that is to say— 12 Laws of Malaysia ACT 290 (i) registered medical practitioners; (ii) registered dentists; (iii) registered nurses and midwives; (iv) registered pharmacists, chemists and wholesalers and retailers of poisons licensed under the Poisons Act 1952, or the corresponding law in force in Sabah or Sarawak, as the case may be, to sell poisons listed in Part I of th