PART I | Short title and commencement |
1.—(1) This Act may be cited as the Health Products Act.| (2) Part XIV shall come into operation on such date as the Minister charged with the responsibility for national development may, by notification in the Gazette, appoint. |
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2.—(1) In this Act, unless the context otherwise requires —| “active ingredient” means any substance or compound that is usable in the manufacture of a health product as a pharmacologically active constituent; |
| “adverse effect”, in relation to a health product, means any debilitating, harmful, toxic or detrimental effect that the health product has been found to have or to be likely to have on the body or health of humans when such health product is used by or administered to humans; |
“advertisement”, in relation to a health product, means the publication, dissemination or conveyance of any information for the purpose of promoting, whether directly or indirectly, the sale or use of that health product by any means or in any form, including the following:| (a) | publication in a newspaper, magazine, journal or other periodical; | | (b) | display of posters or notices; | | (c) | circulars, handbills, brochures, pamphlets, books or other documents; | | (d) | letters addressed to individuals or bodies corporate or unincorporate; | | (e) | photographs or cinematograph films; | | (f) | sound broadcasting, television, the Internet or other media; | | (g) | public demonstration of the use of the health product; and | | (h) | offer of trials of the health product to members of the public; |
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| “Agri-Food and Veterinary Authority” means the Agri-Food and Veterinary Authority established under section 3 of the Agri-Food and Veterinary Authority Act (Cap. 5); |
| “analyst” means any person who is designated as an analyst by the Chief Executive under section 8; |
| “Appeal Advisory Committee” means an Appeal Advisory Committee established by the Minister under section 11; |
| “Authority” means the Health Sciences Authority established under section 3 of the Health Sciences Authority Act (Cap. 122C); |
| “Chief Executive” means the person appointed under section 15 of the Health Sciences Authority Act to be the Chief Executive of the Authority; |
“clinical trial” means an investigation in respect of a health product that involves human subjects and that is intended to —| (a) | discover or verify its clinical, pharmacological or pharmacodynamic effects; | | (b) | identify any adverse effect that may arise from its use; | | (c) | study its absorption, distribution, metabolism and excretion; or | | (d) | ascertain its safety or efficacy; |
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| “efficacy”, in relation to a health product that is a device, includes the ability of the device to properly carry out its intended purpose; |
“enforcement officer” means —| (a) | the Chief Executive; or | | (b) | any officer of the Authority or any other person who is appointed by the Chief Executive under section 7 to be an enforcement officer; |
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“health product” means any substance, preparation or device —| (a) | that —| (i) | is represented for use by humans; | | (ii) | whether because of its presentation or otherwise, is likely to be taken for use by humans; or | | (iii) | is included in a class of substances, preparations or devices which are or are ordinarily intended for use by humans, |
| solely or principally for a health-related purpose; and |
| | (b) | that falls within any of the categories of health products specified in the First Schedule; |
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“health-related purpose” means a therapeutic, preventive, palliative, diagnostic or cosmetic purpose, or any other purpose for the promotion or preservation of human health and well-being, and includes the following:| (a) | preventing, diagnosing, monitoring, treating, curing or alleviating any disease, disorder, ailment, injury, handicap or abnormal physical or mental state, or the symptoms thereof, in humans; | | (b) | compensating for any injury or handicap in humans; | | (c) | investigating, modifying or replacing any part of the human anatomy or any physiological process in humans; | | (d) | testing the susceptibility of humans to any disease, disorder or ailment; | | (e) | influencing, controlling or preventing conception in humans; | | (f) | testing for pregnancy in humans; | | (g) | inducing anaesthesia in humans; | | (h) | destroying or inhibiting micro-organisms that may be harmful to humans; and | | (i) | cleansing, fragrancing, deodorising, beautifying, preserving, improving, altering or restoring the complexion, skin, hair, nails or teeth of humans; |
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| “importer’s licence” means a licence authorising the holder thereof to import any health product; |
“intended purpose”, in relation to a health product, means the use for which the health product is intended according to the specifications of its manufacturer as stated on any or all of the following:| (a) | the label of the health product; | | (b) | the instructions for use of the health product; | | (c) | the promotional materials in relation to the health product; |
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| “label”, in relation to a health product or an active ingredient, means any written, printed or graphic representation that appears on or is attached to the health product or active ingredient or any part of its packaging, and includes any informational sheet or leaflet that accompanies the health product or active ingredient when it is being supplied; |
| “licence” means any licence issued by the Authority under this Act; |
“manufacture”, in relation to a health product, means to make, fabricate, produce or process the health product and includes —| (a) | any process carried out in the course of so making, fabricating, producing or processing the health product; and | | (b) | the packaging and labelling of the health product before it is supplied; |
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| “manufacturer’s licence” means a licence authorising the holder thereof to manufacture any health product; |
| “Minister” means, except in Part XIV, the Minister charged with the responsibility for health; |
| “packaging”, in relation to a health product or an active ingredient, means the container and other packaging material in which the health product or active ingredient is supplied; |
| “presentation”, in relation to a health product, means the way in which the health product is presented for supply, and includes matters relating to the name of the health product, the packaging and labelling of the health product and any other informational material associated with the health product; |
| “prohibited substance” means a substance that is prescribed as a substance that is not to be contained at all in any health product or in any particular category of health products; |
“recall”, in relation to a health product, means any action taken by its manufacturer, importer, supplier or registrant to remove the health product from the market or to retrieve the health product from any person to whom it has been supplied, because the health product —| (a) | may be hazardous to health; | | (b) | may fail to conform to any claim made by its manufacturer or importer relating to its quality, safety or efficacy; or | | (c) | may not meet the requirements of this Act; |
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| “Register of Health Products” means the Register of Health Products kept and maintained by the Authority under section 34; |
| “registered health product” means a health product currently registered under Part VII; |
| “registrant”, in relation to a registered health product, means the person who applied for and obtained the registration of the health product under this Act; |
| “regulations” means regulations made under section 72; |
| “sample”, in relation to a health product or an active ingredient, includes a sample of the packaging of the health product or active ingredient; |
“supply”, in relation to a health product, means to transfer possession of the health product by any means whether or not for reward, and includes the following:| (a) | to sell the health product, whether by retail, wholesale or auction; | | (b) | to expose or display the health product as an invitation to treat; | | (c) | to transfer possession of the health product by exchange, gift, lease, loan, hire or hire-purchase; | | (d) | to supply the health product in connection with —| (i) | a contract for the provision of any goods or the performance of any service; or | | (ii) | any advertising, sponsorship or promotional activity; |
| | (e) | to supply the health product by way of administration to or application in any person in the course of any diagnosis, treatment or test; | | (f) | to offer, agree or attempt to supply the health product in any of the ways described in paragraphs (a) to (e) or to cause or permit the health product to be so supplied; and | | (g) | to keep or possess the health product for the purpose of supplying it in any of the ways described in paragraphs (a) to (f); |
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| “veterinarian” means a person who is licensed under section 53 of the Animals and Birds Act (Cap. 7) to treat, vaccinate or inoculate any animal or bird; |
“wholesale”, in relation to a health product, means any one or more of the following:| (a) | supplying the health product to a person who obtains the health product for the purposes of supplying it again to some other person; | | (b) | supplying the health product to a person as a commercial sample in the normal course of a lawful trade; | | (c) | supplying the health product to a Government department or statutory body which requires the health product for the purposes of the public service or use in connection with the exercise of any statutory power; | | (d) | supplying the health product to a person or an institution concerned with scientific education or research which requires the health product for the purpose of education or research; | | (e) | supplying the health product to a person who requires the health product for the purpose of enabling him to comply with any requirements made by, or in pursuance of, any written law with respect to the medical treatment of persons employed by that person in any business or trade carried out by that person; | | (f) | supplying the health product to a person who requires to use the health product, other than by way of administration to one or more persons, for the purpose of his business or trade; | | (g) | supplying the health product by export to a party outside Singapore; |
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| “wholesaler’s licence” means a licence authorising the holder thereof to supply any health product by wholesale. |
(2) For the purposes of this Act —| (a) | a health product is adulterated if it contains or has been mixed with any substance or ingredient that is not stated on its label as being one of its constituent substances or ingredients, except where the substance is an inactive ingredient —| (i) | which is permitted as a food additive or flavouring agent according to the Codex Alimentarius or such other similar document as may be prescribed; or | | (ii) | which is approved by the Authority; |
| | (b) | a health product is counterfeit if —| (i) | it is presented in such a manner as to resemble or pass off as a registered health product when in fact it is not; or | | (ii) | it is presented with any false information as to its manufacturer or origin; |
| | (c) | a health product is tampered with if it has been modified or interfered with in any way, including through the introduction or incorporation therein of any substance or component that is not referred to in the specifications of its manufacturer; and | | (d) | a health product is unwholesome if —| (i) | it is not in conformity as regards strength, quality or purity with the specifications of its manufacturer; | | (ii) | it has a strength which differs from, or a standard of purity or quality which falls below, that which is represented on its label; | | (iii) | any of its constituent substances or ingredients, as stated on its label, has been extracted or omitted from it; | | (iv) | it contains any prohibited substance or any substance in excess of the prescribed permitted concentration; | | (v) | it consists in whole or in part of any filthy, putrid or decomposed substance; | | (vi) | it has been manufactured or stored under unsanitary conditions; | | (vii) | it has been kept in a package which is composed in whole or in part of any substance which may render the contents injurious to health; | | (viii) | it has been packed with any substance so as to reduce the purity, quality, strength or beneficial properties that it would have had if it had not been so packed; or | | (ix) | it has passed its expected useful life or its expiry date as assigned by its manufacturer. |
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| (3) For the purposes of this Act, a licence or registration is not in force during the period of its suspension. |
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3. The purposes of this Act are —| (a) | to provide for the categorisation of health products in accordance with their different characteristics and uses; | | (b) | to provide the framework for a uniform approach for —| (i) | the registration of health products; and | | (ii) | the regulation of the manufacture, import, supply, storage, presentation and advertisement of health products; |
| | (c) | to allow for each category of health product to be registered and regulated by reference to its formulation, composition, design specification, quality, safety and efficacy and within the framework provided by this Act; and | | (d) | to prescribe the standards for health products in relation to their formulation, composition, design specification, quality, safety, efficacy and presentation. |
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| Act to apply only to health products specified in First Schedule |
4.—(1) Except for and as provided in Part XIV, this Act shall apply only in relation to the categories of health products that are specified and described in the first and second columns of the First Schedule to the extent prescribed in the third column thereof.| (2) The Minister may, after consultation with the Authority, by order published in the Gazette add to, amend or vary the categories and descriptions of health products in the First Schedule and the extent to which the provisions of this Act shall apply thereto. |
| (3) In prescribing the extent to which this Act shall apply to any category of health products, the Minister may, in the third column of the First Schedule, specify the provisions or any part of any provision of this Act that shall or shall not apply in relation to such category of health products. |
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| Act not to apply to supply or use of health products and active ingredients for veterinary purposes |
| 5. Except as provided in Part XIV, this Act shall not apply in relation to the supply or use by a veterinarian of any health product or active ingredient for veterinary purposes. |
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