Medicines Act

Coming into Force30 March 1987
Act Number(Original Enactment: Act 52 of 1975)
copyrightNote© Singapore legislation sourced from Singapore Statutes Online. It is subject to copyright of the Singapore Government and is reproduced with the permission of the Attorney-General’s Chambers of Singapore.
Record NumberCap. 176
Published date30 March 1987
Medicines Act
(CHAPTER 176)

(Original Enactment: Act 52 of 1975)

REVISED EDITION 1985
(30th March 1987)
An Act to make provisions with respect to medicinal products and medical advertisements and matters connected therewith; and to make consequential amendments to the Poisons Act (Chapter 234).
[24th June 1977: Parts I and II ;
24th June 1977: Part III (sections 30, 31, 34, 35) ;
24th June 1977: Part V ;
24th June 1977: Part VII, sections 54 to 75 ;
15th November 1977: Part VI ;
16th January 1981: Part IV ;
3rd May 1993: Part III (sections 23-29, 32 and 33) ]
PART I
PRELIMINARY
Short title and commencement
1.—(1) This Act may be cited as the Medicines Act and shall come into operation on such date as the Minister may, by notification in the Gazette, appoint.
(2) The Minister may appoint different dates for the coming into operation of the different Parts or provisions of this Act.
Interpretation
2.—(1) In this Act, unless the context otherwise requires —
“administration” means giving or applying to a human being or an animal, whether orally, by injection or by introduction into the body in any other way, or by external application, whether by direct contact with the body or not; and any reference in this Act to administering a substance or article is a reference to administering 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;
“analysis” includes micro-biological assay and “analyse” has a corresponding meaning;
“analyst” means an analyst appointed by the licensing authority;
[4/2001 wef 01/04/2001]
“animal” includes any bird, fish or reptile;
“assemble”, in relation to a medicinal product, means enclosing the product (with or without other medicinal products of the same description) in a container which is labelled before the product is sold or supplied, or, where the product (with or without other medicinal products of the same description) is already enclosed in the container in which it is to be sold or supplied, labelling the container before the product is sold or supplied in it, and “assembly” has a corresponding meaning;
“Authority” means the Health Sciences Authority established under the Health Sciences Authority Act 2001;
[4/2001 wef 01/04/2001]
“Chief Executive of the Authority” means the person appointed under section 15 of the Health Sciences Authority Act 2001 to be the Chief Executive of the Authority;
[4/2001 wef 01/04/2001]
“clinical trial” means an investigation or series of investigations consisting of the administration of one or more medicinal products of a particular description by, or under the direction of —
(a) a doctor or dentist to one or more of his patients; or
(b) two or more doctors or dentists, each product being administered by or under the direction of one or other of those doctors or dentists to one or more of his patients,
where (in any such case) there is evidence that medicinal products of that description have effects which may be beneficial to the patient or patients in question and the administration of the product or products is for the purpose of ascertaining whether, or to what extent the product has, or the products have, those or any other effects, whether beneficial or harmful;
“composition”, in relation to a medicinal product, means the ingredients of which it consists and the proportions, and the degrees of strength, quality and purity, in which those ingredients are contained in it respectively;
“container”, in relation to a medicinal product, means the bottle, jar, box, packet or other receptacle which contains or is to contain it, not being a capsule, cachet, or other article in which the product is or is to be administered, and where any such receptacle is or is to be contained in another such receptacle, includes the former but does not include the latter receptacle;
“contravention” includes failure to comply and “contravene” has a corresponding meaning;
“dentist” means a person registered under the Dental Registration Act (Cap. 76) whose name appears in the first division of the Register of Dentists;
[22/2007 wef 01/01/2008]
“disease” includes any injury, ailment or adverse condition whether of body or mind;
“doctor” means a person registered under the Medical Registration Act [Cap. 174];
“herbal remedy” means a medicinal product consisting of a substance produced by subjecting a plant or plants to drying, crushing or other process or of a mixture whose ingredients are two or more substances so produced, or of a combination of such mixture with water or such other inert substances as the licensing authority may, by notification in the Gazette, specify;
“hospital” includes any institution for the reception and treatment of the sick and designated as a hospital by the Minister for the purposes of this Act;
“import” means import into Singapore whether by land, sea or air and “export” has a corresponding meaning;
“ingredient”, in relation to the manufacture or preparation of a substance, includes anything which is the sole active ingredient of that substance as manufactured or prepared;
“labelling”, in relation to a container or package of medicinal products, means affixing to or otherwise displaying on it a notice describing or otherwise relating to the contents, and “label” has a corresponding meaning;
“leaflet” includes any written information;
“licensing authority” means the appropriate licensing authority as defined in section 4(1);
[4/2001 wef 01/04/2001]
“manufacture”, in relation to a medicinal product, includes any process carried out in the course of making the product, but does not include dissolving or dispersing the product in, or diluting or mixing it with, some other substance used as a vehicle for the purpose of administering it;
“medicinal test on animals” means an investigation or series of investigations consisting of any of the following:
(a) the administration of a medicinal product of a particular description to one or more animals, where there is evidence that medicinal products of that description have effects which may be beneficial to, or otherwise advantageous in relation to, that animal or those animals, and the product is administered for the purpose of ascertaining whether, or to what extent, it has those or any other effects, whether advantageous or otherwise;
(b) the administration of a medicinal product to one or more animals in circumstances where there is no such evidence as is mentioned in paragraph (a), and the product is administered for the purpose of ascertaining whether, or to what extent, it has any effects relevant to a medicinal purpose;
(c) the administration of any substance or article, other than a medicinal product, to one or more animals for the purpose of ascertaining whether it has any effects relevant to a medicinal purpose or whether there is evidence that it has effects which may be beneficial to, or otherwise advantageous in relation to, that animal or those animals;
“midwife” means a registered midwife within the meaning of the Nurses and Midwives Act 1999;
[46/99 wef 01/05/2000]
“Minister” means —
(a) except as provided in paragraph (b), the Minister for Health; and
(b) for the purpose of performing any function under this Act (whether by the making of any regulations or order or otherwise) where the function is performed exclusively in relation to veterinary medicinal products and animals, the Minister for National Development;
“nurse” means a registered nurse or enrolled nurse within the meaning of the Nurses and Midwives Act 1999;
[46/99 wef 01/05/2000]
“package”, in relation to any medicinal product, means any box, packet or other article in which one or more containers of the products are or are to be enclosed, and, where any such box, packet or other article is or is to be itself enclosed in one or more boxes, packets or other articles, includes each of the boxes, packets or articles in question;
“pharmacist” means a person who is registered as a pharmacist under the Pharmacists Registration Act 2007 and has in force a valid practising certificate issued under that Act;
[48/2007 wef 01/09/2008]
“plant” includes any part of a plant;
“practitioner” means a doctor, dentist or veterinary surgeon;
“product licence”, “manufacturer’s licence” and “wholesale dealer’s licence” have the meanings ascribed to them under sections 5 and 6 and include any such provisional licence;
“registered pharmacy” means premises for the time being entered in the register under section 37;
“retail pharmacy business” means a business (not being a professional practice carried out by a practitioner) which consists of or includes the retail sale of medicinal products other than medicinal products on a general sale list;
“retail sale”, in relation to a medicinal product, shall have the meaning ascribed to it under subsection (2);
“sell” 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 “sale” and “sold” have corresponding meanings;
“substance” means any natural or artificial substance whether in solid or liquid form or in the form of gas or vapour;
“supply” includes having in possession for the purpose of supply;
“treatment”, in relation to disease, includes anything done or provided for alleviating the effects of the disease, whether it is done or provided by way of cure or not;
“veterinary medicinal products” means medicinal products which are manufactured, sold, supplied, imported or exported for the purpose of being administered to animals, but not for the purpose of being administered to human beings;
“veterinary surgeon” means a person who holds a veterinary qualification approved by the Minister and who is licensed to treat, vaccinate or inoculate animals or birds under section 68(1) of the Animals and Birds Act [Cap. 7];
“wholesale dealing”, in relation to a medicinal product, shall have the meaning ascribed
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