Health Products Act

• Jurisdiction: Singapore
• Coming into Force: 31 December 2008
• Act Number: (Original Enactment: Act 15 of 2007)
• Record Number: Cap. 122D
• Published date: 31 December 2008

Health Products Act

(CHAPTER 122D)

(Original Enactment: Act 15 of 2007)

REVISED EDITION 2008

(31st December 2008)

An Act to regulate the manufacture, import, supply, presentation and advertisement of health products and of active ingredients used in the manufacture of health products and provide for matters connected therewith.

[1st November 2007: Except Part XIV]

PART I PRELIMINARY 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. Interpretation 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; [Deleted by Act 10 of 2019 wef 01/04/2019] “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; “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; “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; “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; “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; “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; “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; “National Parks Board” means the National Parks Board established by the repealed National Parks Act (Cap. 198A, 1991 Ed.) as in force before 1 July 1996 and continued by section 3 of the National Parks Board Act (Cap. 198A); [Act 10 of 2019 wef 01/04/2019] “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; “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); “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 ...