Health Products Act 2007
2020 REVISED EDITION This revised edition incorporates all amendments up to and including 1 December 2021 and comes into operation on 31 December 2021. Prepared and Published by THE LAW REVISION COMMISSION UNDER THE AUTHORITY OF THE REVISED EDITION OF THE LAWS ACT 1983
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. [1 November 2007: Except Part 14]
ARRANGEMENT OF SECTIONS PART 1 PRELIMINARY Section 1. Short title and commencement 2. Interpretation 3. Purposes of Act 4. Act to apply only to health products specified in First Schedule 5. Act not to apply to supply or use of health products and active ingredients for veterinary purposes PART 2 ADMINISTRATION 6. Administration of Act 7. Appointment of enforcement officers 8. Designation of analysts 9. Enforcement officers and analysts deemed to be public officers 10. Advisory Committees 11. Appeal Advisory Committees PART 3 MANUFACTURE AND IMPORT OF HEALTH PRODUCTS 12. Manufacture of health products 13. Import of health products PART 4 SUPPLY OF HEALTH PRODUCTS 14. Wholesaling of health products 15. Prohibition against supply of unregistered health products 16. Prohibition against supply of health products that are adulterated, counterfeits, etc. Section 17. Supply of health products to be carried out in accordance with prescribed requirements 18. Presentation of health products PART 5 ADVERTISEMENT OF HEALTH PRODUCTS 19. Advertisement of health products 20. False or misleading advertisement 21. Further requirements for advertisement of health products 22. Defences 23. Corrective measures in relation to contravening advertisements PART 6 LICENCES 24. Issue and renewal of licences 25. Variation of licence conditions on application by licensee 26. Register of licensees 27. Suspension and revocation of licence and cancellation of approval 28. Appeal PART 7 REGISTRATION OF HEALTH PRODUCTS 29. Health products to be registered according to categories in First Schedule 30. Registration of health products 31. Duration of registration 32. Conditions of registration 33. Evaluation of health products 34. Register of Health Products 35. Re-categorisation or re-classification of health products on application of registrant 36. Power to re-categorise or re-classify health products in absence of application by registrant 37. Suspension and cancellation of registration 38. Appeal PART 8 DUTIES OF MANUFACTURERS, IMPORTERS, ETC., OF HEALTH PRODUCTS Section 39. Application of this Part 40. Keeping of records 41. Furnishing of information or document regarding health product 42. Reporting of defects and adverse effects to Authority 43. Verification of quality, safety and efficacy of health product 44. Notification to Authority concerning recall of health product 45. Additional duties under regulations PART 9 REGULATION OF DEALINGS IN ACTIVE INGREDIENTS 46. Active ingredients to which this Part applies 47. Regulation of manufacture, import, supply, etc., of active ingredients PART 10 ENFORCEMENT 48. Non-compliant health products and active ingredients 49. Powers of enforcement 50. Unlawful alteration, destruction, etc., of documents 51. Obstructing officers in execution of their duties PART 11 PRESUMPTIONS AND OTHER EVIDENTIARY PROVISIONS FOR PURPOSES OF ENFORCEMENT OF ACT 52. Presumption as to liability of importers and manufacturers 53. Presumption as to identity of advertiser 54. Presumption as to purpose for which health product is manufactured, imported or supplied 55. Presumption as to similarity in properties between health products, etc., found and sample taken therefrom 56. Presumption of person’s intention to supply health product found in person’s possession 57. Evidence of analyst PART 12 OFFENCES AND PROSECUTION Section 58. Jurisdiction of court 59. Offences by bodies corporate, etc. 60. Enhanced penalty for corporations 61. Liability for offences by agents or employees 62. Forfeiture 63. Recovery of fees and other expenses incidental to prosecution 64. Non-disclosure of information 65. Composition of offences PART 13 MISCELLANEOUS 66. Protection of confidential information 67. Service of documents 68. Form and authentication of notices, orders and other documents 69. Inaccuracies in documents 70. Exemption 71. Fees 72. Regulations PART 14 REGULATION OF SUPPLY AND USE OF HEALTH PRODUCTS AND ACTIVE INGREDIENTS FOR VETERINARY PURPOSES 73. Supply and use of health products and active ingredients for veterinary purposes 74. Powers of officers enforcing regulations made under section 73 75. Application of Parts 10 to 13 First Schedule — Categories and descriptions of health products to which Act applies Second Schedule — Matters for or in respect of which regulations may be made under section 72
“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 the 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; (h) offer of trials of the health product to members of the public; “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 2001; “Chief Executive” means the person appointed under section 15 of the Health Sciences Authority Act 2001 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 wellbeing, 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; (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 of the licence 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 all or any 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 of the licence to manufacture any health product; “Minister” means, except in Part 14, 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 Revised Edition) as in force before 1 July 1996 and continued by section 3 of the National Parks Board Act 1996; “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 7; “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; (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 1965 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 the person to comply with any requirements made by, or pursuant to, any written law with respect to the medical treatment of individuals 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 individuals, for the purpose of the person’s business or trade; (g) supplying the health product by export to a party outside Singapore; “wholesaler’s licence” means a licence authorising the holder of the licence to supply any health product by wholesale. [10/2019]
(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 any other similar document that 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 in it 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 quality or purity 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 strength, quality or purity 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.
(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 products 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.
Except as provided in Part 14, this Act does not apply in relation to the supply or use by a veterinarian of any health product or active ingredient for veterinary purposes.
The Authority is responsible for the administration and enforcement of this Act (except for Part 14) subject to the general and special directions of the Minister.
(a) any officer of the Authority; or (b) with the approval of the Authority, any other person, to be an enforcement officer for the purposes of this Act.
The Chief Executive may designate any suitably qualified person as an analyst to carry out any test, evaluation or analysis as may be necessary for the purpose of the administration and enforcement of this Act.
Every enforcement officer and analyst is deemed to be a public servant within the meaning of the Penal Code 1871.
The Authority may establish one or more Advisory Committees consisting of any persons that it thinks fit to appoint for the purpose of advising the Authority on such matters arising from the administration and enforcement of this Act as are referred to them by the Authority.
(a) assisting him or her in the determination of any appeal that is brought to him or her under this Act; and (b) advising him or her on any matter arising from any such appeal.
(a) the person holds a valid manufacturer’s licence; and (b) the manufacture of the health product is carried out in accordance with the conditions of the licence.
(a) an adulterated health product; (b) a counterfeit health product; or (c) an unwholesome health product.
(a) in the case of an offence under subsection (1), (3), (4) or (5)(c), to a fine not exceeding $50,000 or to imprisonment for a term not exceeding 2 years or to both; and (b) in the case of an offence under subsection (5)(a) or (b), to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 3 years or to both.
(a) the person holds a valid importer’s licence; and (b) the import of the health product is carried out in accordance with the conditions of the licence.
(a) an adulterated health product; (b) a counterfeit health product; (c) a health product that has been tampered with; or (d) an unwholesome health product.
(a) in the case of an offence under subsection (1), (3), (4) or (5)(d), to a fine not exceeding $50,000 or to imprisonment for a term not exceeding 2 years or to both; and (b) in the case of an offence under subsection (5)(a), (b) or (c), to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 3 years or to both.
(a) the accused — (i) did not know; (ii) had no reason to believe; and (iii) could not, with reasonable diligence, have ascertained, that the health product was in contravention of that subsection; and (b) the accused had taken all such precautions and exercised all such due diligence as could reasonably be expected of the accused in the circumstances to ensure that the health product did not contravene that subsection.
(a) the person holds a valid wholesaler’s licence; and (b) the wholesale supply of the health product is carried out in accordance with the conditions of the licence.
(a) an adulterated health product; (b) a counterfeit health product; (c) a health product that has been tampered with; or (d) an unwholesome health product.
(a) in the case of an offence under subsection (1)(d), to a fine not exceeding $50,000 or to imprisonment for a term not exceeding 2 years or to both; and (b) in the case of an offence under subsection (1)(a), (b) or (c), to a fine not exceeding $100,000 or to imprisonment for a term not exceeding 3 years or to both.
(a) the accused — (i) did not know; (ii) had no reason to believe; and (iii) could not, with reasonable diligence, have ascertained, that the health product was in contravention of that subsection; and (b) the accused had taken all such precautions and exercised all such due diligence as could reasonably be expected of the accused in the circumstances to ensure that the health product did not contravene that subsection.
(a) that the supply of the health product should be carried out only under, and in accordance with the conditions of, a licence issued by the Authority; (b) that the supply of the health product should be carried out only by certain specified persons; (c) that the supply of the health product should be carried out only at certain specified premises; (d) that the supply of the health product should or should not be carried out in any specified manner; (e) that the health product should be supplied only to certain specified persons and for certain specified purposes; (f) that proper records should be kept in relation to any supply made of the health product.
(a) advertise any product or cause any product to be advertised as a health product if that product is not a health product; or (b) advertise any registered health product or cause any registered health product to be advertised in such a way as to represent the registered health product as being usable for any purpose other than that for which it has been registered.
(a) it falsely describes the health product or gives any false information concerning the health product; or (b) it is likely to create an erroneous impression regarding the formulation, composition, design specification, quality, safety, efficacy or uses of the health product.
(a) that the advertisement should include or exclude any specified type of information; (b) that the advertisement should not make certain types of claims about the health product; (c) that the advertisement should be distributed or circulated only to certain classes of persons; (d) that the advertisement should not appear in certain types of publications or media; (e) that the advertisement should be submitted to the Authority for approval before publication.
In any proceedings for an offence under section 19, 20 or 21, it is a defence for the person charged to prove that the person — (a) is a person whose business is to publish or arrange for the publication of advertisements and that the person received the advertisement for publication in the ordinary course of business; (b) has no financial interest in the supply of the health product featured in the advertisement; and (c) did not know and had no reason to suspect that the advertisement would contravene the provisions of section 19, 20 or 21, as the case may be.
(a) to stop the advertisement with immediate effect; (b) to take such measures as may be reasonable and necessary in the circumstances to remove the advertisements that have already been published; (c) to publish a corrective advertisement in such manner and containing such information as may be specified by the Authority.
(a) the person shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both; and (b) the Authority may take such steps as it thinks reasonable and necessary to implement the requirements of the order and recover any costs and expenses reasonably incurred by it in so doing from that person.
(a) such particulars, information, documents and samples as the Authority may require; and (b) if required by the Authority, a statutory declaration by the applicant verifying any information contained in or relating to the application.
(a) issue the licence to the applicant if it is satisfied that — (i) the applicant is a fit and proper person to be issued with a licence or otherwise satisfies such requirements as may be prescribed for the issue of the licence; and (ii) the issue of the licence to the applicant will not be contrary to the public interest; or (b) refuse to issue the licence applied for.
(a) makes any statement or furnishes any document which the person knows to be false or does not believe to be true; or (b) by the intentional suppression of any material fact, furnishes information which is misleading, shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
(a) set out the variation required and the reasons for the variation; and (b) be accompanied by — (i) such particulars, information, documents and samples as the Authority may require; and (ii) if required by the Authority, a statutory declaration by the licensee verifying any information contained in or relating to the application.
(a) makes any statement or furnishes any document which the licensee knows to be false or does not believe to be true; or (b) by the intentional suppression of any material fact, furnishes information which is misleading, shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
(a) the issue of the licence or the grant of the approval has been obtained by fraud or misrepresentation; (b) the licensee or the person to whom the approval has been granted has contravened or is contravening — (i) any provision of this Act; (ii) any condition attached to the licence or approval; or (iii) any other prescribed requirement; (c) the licensee or the person to whom the approval has been granted no longer satisfies any of the prescribed requirements based on which the licence was issued or the approval was granted to the licensee or person; or (d) it is in the public interest to do so.
(a) give to the person to whom the licence has been issued or the approval has been granted (hereafter called the person concerned) written notice of its intention to do so; and (b) in the notice, call upon the person concerned to show cause within the time specified in the notice as to why the licence should not be suspended or revoked or the approval should not be cancelled.
(a) fails to show cause within the period of time given or such extended period of time as the Authority may allow; or (b) fails to show sufficient cause, as to why the licence should not be suspended or revoked or as to why the approval should not be cancelled, the Authority must give written notice to the person concerned of the date from which the suspension or revocation of the licence or the cancellation of the approval is to take effect.
(a) the refusal of the Authority to issue or renew a licence under section 24 or to grant any approval under this Act; (b) any condition attached by the Authority to a licence under section 24; or (c) the decision of the Authority to suspend or revoke a licence or to cancel an approval under section 27, may, within the time specified in the notice informing the person of the refusal, condition, suspension, revocation or cancellation (as the case may be) appeal in writing to the Minister whose decision is final.
(a) any condition attached by the Authority to a licence under section 24; or (b) the decision of the Authority to suspend or revoke a licence or to cancel an approval under section 27, takes effect from the date specified by the Authority, unless the Minister otherwise directs.
(a) subdivide any category of health products into any number of classes as it thinks fit; and (b) when registering any health product under that category, assign that health product into such class within that category as it thinks fit.
(a) be made to the Authority by such person and in such form and manner as the Authority may require; (b) state the category (and, where applicable, the class within that category) under which the applicant is seeking to have the health product registered; and (c) be accompanied by — (i) such particulars, information, documents and samples as the Authority may require; and (ii) if required by the Authority, a statutory declaration by the applicant verifying any information contained in or relating to the application.
(a) register the health product if it is satisfied that — (i) the applicant is a fit and proper person to be granted the registration; (ii) the registration of the health product will not be contrary to the public interest; and (iii) the health product complies with such requirements as may be prescribed; or (b) refuse to register the health product.
(a) recommend to the applicant that the health product be registered under a more suitable category or class as determined by the Authority; or (b) refuse to register the health product.
(a) within such time as the Authority may allow, submit to the Authority such additional information, documents and samples as the Authority may require in support of the application to have the health product registered under the category or class stated in the application; or (b) withdraw the application.
(a) register the health product under the category and class stated in the application if it is satisfied that it is appropriate to do so; (b) subject to the payment of the appropriate prescribed fee by the applicant, register the health product under the category or class recommended by the Authority under subsection (4)(a) if the applicant is agreeable to it; (c) refuse to register the health product.
(a) makes any statement or furnishes any document which the person knows to be false or does not believe to be true; or (b) by the intentional suppression of any material fact, furnishes information which is misleading, shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
(a) the registrant of the health product continues to pay to the Authority within the prescribed time, the prescribed retention fee for the retention of the registration of the health product in the Register of Health Products; and (b) the registration is not otherwise suspended or cancelled by the Authority under section 37(1).
The Authority may attach any conditions to the registration of a health product as it thinks necessary, and may from time to time vary the conditions by giving written notice to the registrant of the health product.
(a) subject samples of the health product to an evaluation by an analyst; (b) require the applicant for the registration of the health product to send samples of the health product for evaluation by an analyst and then submit the evaluation report to the Authority; or (c) consider the evaluation report of any body or organisation, whether in Singapore or elsewhere, that has evaluated the health product.
(a) whether the quality, safety or efficacy of the health product for the purposes for which it is to be used has been satisfactorily established; (b) whether the presentation of the health product is appropriate, given its formulation, composition or design specification and intended purpose; (c) whether the health product complies with such requirements as may have been prescribed in relation to it; (d) any other matters relating to the health product as the Authority thinks relevant.
(a) that the health product should not have in its composition — (i) any prohibited substance; or (ii) any particular substance in excess of the prescribed permitted concentration; (b) that the manufacture of the health product — (i) if carried out in Singapore, should comply with such requirements as may be prescribed; and (ii) if carried out elsewhere, should comply with such standards that are acceptable to the Authority.
(a) transfer the health product from the category or class under which it has been registered to another category or class; and (b) cause such amendments to be made in the Register of Health Products as may be necessitated by the re-categorisation or re-classification of that health product.
(a) be made to the Authority in such form and manner as the Authority may require; and (b) be accompanied by — (i) such particulars, information, documents and samples as the Authority may require; and (ii) if required by the Authority, a statutory declaration by the applicant verifying any information contained in or relating to the application.
(a) makes any statement or furnishes any document which the person knows to be false or does not believe to be true; or (b) by the intentional suppression of any material fact, furnishes information which is misleading, shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
(a) the Authority is satisfied upon information received by it in respect of a registered health product that the health product should be transferred from the category or class under which it has been registered to another category or class; but (b) the registrant of the health product has not made an application under section 35 for the health product to be so re-categorised or re-classified, the Authority may, subject to subsection (2), of its own volition re-categorise or re-classify the health product and cause such amendments to be made in the Register of Health Products as may be necessitated by the re-categorisation or re-classification of that health product.
(a) give to the registrant of the health product written notice of its intention to do so; and (b) in the notice, call upon the registrant, if the registrant wishes, to show cause within the time specified in the notice as to why the health product should not be re-categorised or re-classified as intended by the Authority.
(a) is agreeable to the re-categorisation or re-classification of the health product; or (b) fails to show cause within the period of time given or such extended period of time as the Authority may allow, or fails to show sufficient cause as to why the health product should not be re-categorised or re-classified as intended by the Authority, the Authority must give written notice to the registrant of the health product of the date from which the re-categorisation or re-classification of the health product is to take effect.
(a) the registration has been obtained by fraud or misrepresentation; (b) the registrant of the health product has contravened or is contravening — (i) any provision of this Act; (ii) any condition attached to the registration; or (iii) any other prescribed requirement; (c) the formulation, composition, design specification, quality, safety or presentation of the health product has changed so as to render it unsuitable to continue to be registered; (d) the health product no longer complies with a prescribed requirement; or (e) it is in the public interest to do so.
(a) give to the registrant of the health product written notice of its intention to do so; and (b) in such notice, call upon the registrant of the health product to show cause within the time specified in the notice as to why the registration of the health product should not be suspended or cancelled.
(a) fails to show cause within the period of time given or such extended period of time as the Authority may allow; or (b) fails to show sufficient cause, as to why the registration of the health product should not be suspended or cancelled, the Authority must give written notice to the registrant of the health product of the date from which the suspension or cancellation of the registration of the health product is to take effect.
(a) the refusal of the Authority to register a health product under section 30; (b) any condition attached by the Authority to the registration of a health product under section 32; (c) the decision of the Authority to re-categorise or re-classify a health product under section 36; or (d) the decision of the Authority to suspend or cancel the registration of a health product under section 37, may, within the time specified in the notice informing the person of the refusal, suspension, revocation or cancellation (as the case may be) appeal in writing to the Minister whose decision is final.
(a) any condition attached by the Authority to the registration of a health product under section 32; (b) the decision of the Authority to re-categorise or re-classify a health product under section 36; or (c) the decision of the Authority to suspend or cancel the registration of a health product under section 37, takes effect from the date specified by the Authority, unless the Minister otherwise directs.
The duties imposed by this Part on manufacturers, importers, suppliers and registrants of health products apply in addition to any other duty imposed on them under Part 3, 4 or 7, as the case may be.
(a) to keep such records as the Authority may determine in relation to the manufacture, import, supply, use or administration (as the case may be) of the health product; and (b) to produce such records for inspection by the Authority or an enforcement officer as and when required by the Authority or enforcement officer.
(a) any defect in the health product; or (b) any adverse effect that has arisen or can arise from the use of the health product, it is the duty of such person to inform the Authority within the prescribed time of the defect or adverse effect.
(a) by written notice require the manufacturer, importer, supplier or registrant of the health product to investigate into the defect or adverse effect and make a report of the findings and recommendations to the Authority; (b) by written notice require the manufacturer, importer, supplier or registrant of the health product to issue or cause to be issued to such persons as the Authority may specify or to the general public a statement informing them of the defect or adverse effect and the measures that should be taken for addressing the defect or adverse effect; (c) by written notice require the manufacturer, importer, supplier or registrant of the health product to recall the health product and take such measures as the Authority may specify to secure the immediate stoppage of the manufacture, import, supply, use or administration (as the case may be) of the health product; (d) by written notice prohibit any person from using or administering the health product and require the person to take such measures as the Authority may specify to address any adverse effect that may have arisen from any previous use or administration of the health product; (e) by written notice require the manufacturer, importer, supplier or registrant of the health product to take any other measures as the Authority thinks necessary in the circumstances.
(a) the measures that the person has taken under the notice; (b) the results of the measures so taken; and (c) any other matter as the Authority thinks necessary or relevant in the circumstances.
(a) by publication in any one or more daily newspapers circulating in Singapore; or (b) by dissemination in any alternative medium, within the time and for the period as the Authority may determine.
(a) fails to comply with subsection (1) or a notice given to the person by the Authority under subsection (2) or (3); or (b) in compliance or purported compliance with subsection (1) or a notice given to the person by the Authority under subsection (2) or (3), furnishes the Authority with any information or document which the person knows is false or misleading, shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
(a) it has or has possibly been adulterated or tampered with; (b) it is or is possibly a counterfeit or an unwholesome health product; (c) it is or is possibly of inadequate quality or unsafe or inefficacious for its intended purpose; or (d) it fails or could possibly fail to satisfy such other standards or requirements as may be prescribed.
(a) subjecting the health product to an evaluation in accordance with section 33; and (b) furnishing the Authority with such evidence of the quality, safety or efficacy of the health product as the Authority may require.
(a) fails to comply with subsection (1) or a notice given to the person by the Authority under subsection (2); or (b) in compliance or purported compliance with subsection (1), furnishes the Authority with any information or document which the person knows is false or misleading, shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
The Authority may, with the approval of the Minister, by regulations provide for such additional duties as it thinks fit to be imposed on manufacturers, importers, suppliers and registrants of health products.
This Part applies to such active ingredients as may be prescribed.
(a) prohibit the manufacture, import, supply, transport, possession or storage of any active ingredient except under and in accordance with the conditions of a licence issued by the Authority; and (b) prescribe the requirements to be complied with by any person who manufactures, imports, supplies, transports, possesses or stores any active ingredient.
(a) that the manufacture, import, supply, transport or storage of any active ingredient should be carried out only by certain specified persons; (b) that the manufacture, supply or storage of any active ingredient should be carried out only at certain specified premises; (c) that the manufacture, import, supply, transport or storage of any active ingredient should or should not be carried out in any specified manner; (d) that the packaging of any active ingredient should comply with certain standards or specifications; (e) that the labels on the packaging of any active ingredient should conform to certain specifications and contain certain specified information; (f) that the supply of any active ingredient should only be made to certain specified persons and for certain specified purposes; (g) that proper records should be kept in relation to any supply made of any active ingredient.
(a) a health product is considered as being non-compliant if — (i) it has been manufactured, imported or supplied in contravention of this Act; (ii) it is an adulterated health product, a counterfeit health product, a health product that has been tampered with or an unwholesome health product; or (iii) it does not comply with such requirements as may be prescribed in relation to it; and (b) an active ingredient is considered as being non-compliant if — (i) it has been manufactured, imported or supplied in contravention of this Act; or (ii) it does not comply with such requirements as may be prescribed in relation to it.
(a) at any time and without warrant enter, inspect and search any premises that are being used, or that the enforcement officer has reason to suspect are being used, for or in connection with any purpose that is in contravention of this Act; (b) at any time and without warrant stop, board, inspect and search any conveyance that is being used, or that the enforcement officer has reason to suspect is being used, for or in connection with any purpose that is in contravention of this Act; (c) in accordance with such procedure as may be prescribed and without payment, take for testing, examination or analysis a sample of any health product or active ingredient that is found pursuant to an inspection or a search under paragraph (a) or (b); (d) seize — (i) any health product or active ingredient, wherever found, if the enforcement officer knows or has reason to suspect that the health product or active ingredient is a non-compliant health product or active ingredient; or (ii) any other substance or article which the enforcement officer has reasonable cause to believe to be a substance or an article in relation to which, or by means of which, an offence under this Act is being or has been committed; (e) by written notice require any person to attend at a reasonable time and at a place specified by the enforcement officer to answer any question or to provide a signed statement in writing concerning any suspected contravention of this Act; (f) arrest, without warrant, any person whom the enforcement officer has reason to believe has committed any offence under this Act if — (i) the name and address of that person are unknown; (ii) the person refuses to furnish his or her name or address; (iii) the person furnishes an address out of Singapore; (iv) the enforcement officer has reasonable grounds for believing that the person has furnished a false name or address; or (v) the enforcement officer has reasonable grounds for believing that the person is likely to abscond; (g) require any person — (i) to furnish any information within the person’s knowledge; or (ii) to produce for inspection any document or record within the person’s possession, that the enforcement officer believes on reasonable grounds to be connected with any suspected contravention of this Act or to be otherwise relevant to the administration or enforcement of this Act; (h) retain the original copy of any document or record that the enforcement officer believes on reasonable grounds to be connected with any suspected contravention of this Act or to be otherwise relevant to the administration or enforcement of this Act, or make or cause to be made, without payment, copies of or extracts from such document or record; and (i) by written notice require any person having in the person’s possession any health product or active ingredient that is intended for supply to submit, at the person’s own expense, a sample of such health product or active ingredient to an analyst for analysis.
(a) require the owner or occupier of any premises or conveyance being inspected to provide all reasonable assistance to the enforcement officer for the purpose of the inspection; and (b) if the circumstances so warrant, with such assistance as he or she thinks necessary, break open any door, window, lock, fastener, hold, compartment, box, container, receptacle or any other thing, and any person who fails to comply with any requirement of an enforcement officer under paragraph (a) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.
(a) the Authority knows or has reason to believe that such health product or active ingredient is a non-compliant health product or active ingredient; or (b) a sample of the health product or active ingredient has been taken or obtained under subsection (1)(c) or (i) and sent for analysis and pending the result of the analysis, the Authority is of the opinion that it is necessary to prevent any more of such health product or active ingredient from further being manufactured, imported or supplied.
(a) the enforcement officer who seized the item must immediately give written notice of the seizure to the person from whom the item was seized, if the name and address of that person are known; (b) any person claiming the item seized may within 48 hours after the seizure complain of the seizure to a Magistrate, and the complaint may be heard and determined by the Magistrate who may — (i) confirm the seizure wholly or in part; (ii) disallow the seizure wholly or in part; (iii) order that the item seized be restored to its owner, subject to such condition which the Magistrate may think fit to impose to ensure that the item is preserved for any purpose for which it may subsequently be required; or (iv) order payment to be made to the owner of the item seized of an amount that the Magistrate considers will compensate the owner for any loss or depreciation resulting from the seizure; (c) in the absence of any claim under paragraph (b) or pending the determination of any such claim, the item may be kept or stored in the premises or conveyance where it was seized or may, at the direction of the enforcement officer, be removed to any other place to be kept or stored there; (d) the enforcement officer may — (i) mark, seal or label the item in such manner as he or she thinks fit for the purpose of indicating that the item is under detention; and (ii) lock or seal the premises or conveyance in which the item is being detained; and (e) any person who, without the authority of the enforcement officer — (i) interferes, tampers with, removes, distributes, sells or otherwise disposes of the item; (ii) alters, counterfeits, defaces, destroys, erases or removes any mark, seal or label placed by the enforcement officer on the item under paragraph (d)(i); or (iii) opens, breaks or otherwise tampers with the lock or seal placed by the enforcement officer on any premises or conveyance or part thereof under paragraph (d)(ii), shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
(a) the power of the enforcement officer to require the document or record to be produced for inspection includes the power to require a copy of the document or record to be made available for inspection in legible form (and subsection (1)(h) applies accordingly in relation to any copy so made available); and (b) the power of the enforcement officer to inspect such document or record includes the power to require any person on the premises in question to give the enforcement officer such assistance as the enforcement officer may reasonably require to enable him or her to inspect and make copies of the document or record in legible form or to make records of the information contained in the document or record.
(a) under subsection (1)(e) to answer any question or to provide any signed statement in writing; or (b) under subsection (1)(g) to furnish any information or produce any document or record, in compliance or purported compliance with such requirement, furnishes the enforcement officer with any information, document or record which the person knows is false or misleading, shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
(a) by an enforcement officer under subsection (1)(e) or (i); or (b) by the Authority under subsection (3) or (4), shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.
Any person who alters, suppresses, conceals or destroys any document which the person is or is liable to be required, by or under this Act, to produce to an enforcement officer shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
Any person who obstructs, hinders or impedes any enforcement officer or any other person acting under the direction of the Authority or the Chief Executive in the performance or execution of his or her duty or anything which he or she is authorised, empowered or required to do under this Act shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.
Where any health product or active ingredient is supplied in a package, any person who appears from any statement thereon or attached thereto to have imported or manufactured that health product or active ingredient is presumed, unless the contrary is proved, to have so imported or manufactured the health product or active ingredient.
Where any health product is advertised, the person whose name or particulars appear in the advertisement is presumed, unless the contrary is proved, to be the person who has advertised the health product.
(a) on any premises that are used for the manufacture, storage or supply of health products; (b) in any conveyance that is used for the transportation of health products; or (c) in any automatic vending machine, is presumed, unless the contrary is proved, to be intended for use by humans.
Any quantity of a health product or an active ingredient found in any premises or on any conveyance at the time when a sample of it is taken pursuant to the provisions of this Act is presumed, unless the contrary is proved, to possess the same properties as the sample.
Where any person is found to be keeping or to be in possession of any health product in circumstances in which it would be reasonable to suspect that the person intends to supply the health product, the person is presumed, unless the contrary is proved, to have the health product in the person’s possession for the purpose of supply.
Despite any provision to the contrary in the Criminal Procedure Code 2010, a District Court has jurisdiction to try any offence under this Act and has power to impose the full penalty or punishment in respect of the offence.
(a) to have been committed with the consent or connivance of an officer; or (b) to be attributable to any neglect on an officer’s part, the officer as well as the body corporate shall be guilty of the offence and shall be liable to be proceeded against and punished accordingly.
(a) to have been committed with the consent or connivance of a partner; or (b) to be attributable to any neglect on the part of a partner, the partner as well as the partnership shall be guilty of the offence and shall be liable to be proceeded against and punished accordingly.
(a) to have been committed with the consent or connivance of an officer of the unincorporated association or a member of its governing body; or (b) to be attributable to any neglect on the part of such an officer or member, the officer or member as well as the unincorporated association shall be guilty of the offence and shall be liable to be proceeded against and punished accordingly.
“body corporate” includes a limited liability partnership which has the meaning given by section 2(1) of the Limited Liability Partnerships Act 2005; “officer” — (a) in relation to a body corporate, means any director, partner, member of the committee of management, chief executive, manager, secretary or other similar officer of the body corporate and includes any person purporting to act in any such capacity; or (b) in relation to an unincorporated association (other than a partnership), means the president, the secretary, or any member of the committee of the unincorporated association, or any person holding a position analogous to that of president, secretary or member of a committee and includes any person purporting to act in any such capacity; “partner” includes a person purporting to act as a partner.
Where a body corporate is convicted of an offence under this Act, the penalty that the court may impose shall be a fine not exceeding 2 times the maximum amount that the court could, but for this section, impose as a fine for that offence.
Where an offence under this Act is committed by any person acting as an agent or employee of another person, or being otherwise subject to the supervision or instruction of another person for the purposes of any employment in the course of which the offence was committed, that other person shall, without prejudice to the liability of the firstmentioned person, be liable under this Act in the same manner and to the same extent as if he or she had personally committed the offence if it is proved that the act which constituted the offence was committed with his or her consent or connivance or that it was attributable to any neglect on his or her part.
(a) an offence under this Act has been committed; and (b) the item seized was the subject matter, or was used in the commission, of the offence.
(a) no prosecution is instituted with regard to any item which has been seized under the provisions of this Act; and (b) no claim is made for the item under section 49(5)(b), the item to which the notice relates is deemed to be forfeited.
(a) all expenses incidental to the analysis of any health product or active ingredient in respect of which the conviction is obtained; (b) the cost of the purchase of any sample of the health product or active ingredient for analysis; and (c) any other reasonable expenses incurred by the prosecution.
(a) one half of the amount of the maximum fine that is prescribed for the offence; (b) $5,000.
(a) with the permission of the person from whom the information was obtained; (b) for the purpose of the administration or enforcement of this Act; (c) for the purpose of assisting any public officer or officer of any other statutory board in the investigation or prosecution of any offence under any written law; (d) for any other prescribed purpose; or (e) in compliance with the requirement of any court or the provisions of any written law.
(a) by delivering it to the person or to an adult member or employee of his or her family or household at his or her last known place of residence; (b) by leaving it at the person’s usual or last known place of residence or business in an envelope addressed to the person; (c) by sending it by prepaid registered post addressed to the person at the person’s usual or last known place of residence or business; or (d) in the case of an incorporated company, a partnership or a body of persons — (i) by delivering it to the secretary or other similar officer of the company, partnership or body of persons at its registered office or principal place of business; or (ii) by sending it by prepaid registered post addressed to the company, partnership or body of persons at its registered office or principal place of business.
(a) the signature of the Chief Executive or an enforcement officer; or (b) an official facsimile of such signature, appended to it is sufficient authentication.
(a) any health product (whether or not such health product falls within any of the categories of health products specified in the First Schedule); or (b) any active ingredient.
(a) prohibit the supply or use of any health product or active ingredient for any veterinary purpose, whether absolutely or subject to such exceptions as may be prescribed; (b) require that the supply or use of any health product or active ingredient for veterinary purposes should be made only in accordance with the prescription of a veterinarian; (c) provide for such other restrictions or controls on the supply or use of any health product or active ingredient for veterinary purposes; (d) provide that a contravention thereof shall be an offence punishable with penalties not exceeding a fine of $20,000 or imprisonment for a term of 12 months or both; and (e) provide for the administration and enforcement of such regulations by officers of the Agri-Food and Veterinary Authority.
An officer of the Agri-Food and Veterinary Authority administering and enforcing any regulations made under section 73 has the same powers as are conferred on an enforcement officer by section 49.
(a) any reference in the provisions of those Parts to the Minister is to be read as a reference to the Minister charged with the responsibility for national development; (b) any reference in the provisions of those Parts to the Authority is to be read as a reference to the Agri-Food and Veterinary Authority; (c) any reference in the provisions of those Parts to the Chief Executive is to be read as a reference to the Chief Executive of the Agri-Food and Veterinary Authority; (d) any reference in the provisions of those Parts to an enforcement officer is to be read as a reference to an officer of the Agri-Food and Veterinary Authority who is acting in the administration and enforcement of such regulations; and (e) any reference in the provisions of those Parts to a health product includes any health product that does not fall within any of the categories of health products specified in the First Schedule.
First column Second column Third column Category Description Exceptions and limitations
(a) any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one or more of the specific purposes of — (i) diagnosis, prevention, monitoring, treatment or alleviation of disease; (ii) diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury; (iii) investigation, replacement, modification or support of the anatomy or of a physiological process, mainly for medical purposes; (iv) supporting or sustaining life; (v) control of conception; (vi) disinfection of medical devices; or (vii) providing information by means of in-vitro examination of specimens
derived from the human body, for medical or diagnostic purposes, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means, and which is not a cell, tissue or gene therapy product; and (b) the following articles: (i) any implant for the modification or fixation of any body part; (ii) any injectable dermal filler or mucous membrane filler; (iii) any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means.
(a) cleaning them; (b) perfuming them; (c) changing their appearance; (d) correcting body odours; (e) protecting them; or (f) keeping them in good condition. Sections 12(1),
(a) is intended for use by and in humans for a therapeutic, preventive, palliative or diagnostic purpose, including any of the following purposes: (i) for preventing, diagnosing, monitoring, treating, curing or alleviating any disease, disorder, ailment, injury, handicap or abnormal physical
or mental state, or any symptom thereof; (ii) for investigating, modifying or replacing any physiological process; (iii) for influencing, controlling or preventing conception; (iv) for inducing anaesthesia; (b) has as a constituent any of the following active ingredients: (i) any chemical or botanical element, naturally-occurring chemical or botanical material, or chemical product obtained by chemical change or synthesis; (ii) any metabolite from a micro-organism; (iii) any macromolecule extracted from an organism; (iv) any substance derived from a biological system, including any of the following: (A) a whole cell or micro-organism, such as a whole virus or bacterium used as a vaccine; (B) a part of a micro-organism, such as a sub-unit vaccine; (C) a plasma-derived product; (D) a biotechnology-derived substance, such as a protein or polypeptide, or a recombinant vaccine for a preventive purpose; (c) exerts an inherent effect either pharmacologically, chemically or by
other physiological means, leading to its use for a therapeutic, preventive, palliative or diagnostic purpose; and (d) is not any of the following: (i) a medical device; (ii) a cell, tissue or gene therapy product; (iii) whole blood or any blood component; (iv) any Chinese proprietary medicine; (v) any homoeopathic medicine; (vi) any medicated oil or balm; (vii) any quasi-medicinal product; (viii) any traditional medicine.
“Chinese proprietary medicine” means any medicinal product used in the system of therapeutics according to the traditional Chinese method, that is to say, any medicinal product — (a) which has been manufactured into a finished product; (b) which contains one or more active substances derived wholly from any plant, animal or mineral, or any combination thereof; (c) which is, or all of the active substances of which are, described in the current edition of “A Dictionary of Chinese Pharmacy” «中药大 辞典» or “The Chinese Herbal Medicine Materia Medica” «本草纲目»; (d) which does not contain as an active substance any chemically-defined isolated constituent of any plant,
animal or mineral, or any combination thereof; and (e) which is not intended to be administered by injection into a human body; “current edition”, in relation to any publication which describes a Chinese proprietary medicine, means the latest edition that has taken effect when the Chinese proprietary medicine in question is supplied, and includes that edition as affected by every amendment, addition or deletion to that edition that has taken effect; “homoeopathic medicine” means any substance used in the system of therapeutics in which a disease is treated by the use of minute amounts of one or more substances which, in their undiluted forms, are capable of producing in healthy humans symptoms similar to those of the disease being treated; “medicated oil or balm” means any external medicated embrocation, medicated cream, ointment or inhalant, and which contains one or more of the following active ingredients: (a) any essential oil; (b) any fixed oil derived from plants; (c) methyl salicylate; (d) menthol; (e) camphor; (f) peppermint; “medicinal product” has the meaning given by the Medicines Act 1975; “quasi-medicinal product” means — (a) any anti-dandruff preparation; (b) any medicated cosmetic product for the treatment of
pimples or acne, except any preparation containing etretinate or 13-cis-retinoic acid; (c) any medicated soap; (d) any sweet for relieving coughs or throat irritations; (e) any medicated plaster; (f) any sunscreen or suntan preparation; (g) any medicated beverage; (h) any vitamin or nutritional preparation from any natural source; or (i) any medicated toothpaste; “traditional medicine” means any medicinal product consisting of one or more substances derived from any plant, animal or mineral, or any combination thereof, but does not include the following: (a) any medicinal product to be administered by injection into a human body; (b) any vaccine to be administered to a human; (c) any product derived from human blood; (d) any item specified in the Poisons List in the Schedule to the Poisons Act 1938; (e) any Chinese proprietary medicine.
“Oral dental gum” means any chewing gum, or any similar substance prepared from a gum base of vegetable or synthetic origin, and intended to be chewed for use in promoting dental health or oral hygiene, but does not include any such gum which is manufactured or imported into Singapore solely for research and development purposes by a person who is
registered under the Control of Manufacture Act 1959 in respect of the manufacture of chewing gum.
(a) is intended for use by and in humans for a therapeutic, preventive, palliative or diagnostic purpose, including any of the following purposes: (i) for preventing, diagnosing, treating, curing or alleviating any disease, disorder, injury, ailment, handicap or abnormal physical or mental state, or any symptom thereof; (ii) for replacing, repairing, regenerating or reconstructing any anatomy, or for modifying or replacing any physiological process; (iii) for regulating, repairing, replacing, adding or deleting a genetic sequence or modifying genetic material; (iv) for supporting or sustaining life; (b) has as a constituent any of the following substances or combination of substances: (i) viable or non-viable human cells or tissues; (ii) viable animal cells or tissues; (iii) recombinant nucleic acids, where the effect of the recombinant nucleic acid relates directly to the recombinant nucleic acid sequence that it contains or to the product of the genetic expression of its sequence; (c) achieves its primary intended action by pharmacological, immunological, physiological, metabolic or physical means, leading to its use for a
therapeutic, preventive, palliative or diagnostic purpose; and (d) is not any of the following: (i) a recombinant vaccine for a preventive purpose; (ii) an in-vitro diagnostic product; (iii) bone marrow, peripheral blood or umbilical or placental cord blood from a human that is minimally manipulated and intended for homologous use; (iv) cells and tissues obtained from a patient that are minimally manipulated and re-implanted for homologous use into the same patient during the same surgical procedure; (v) organs and tissues that are minimally manipulated and intended for transplant; (vi) reproductive cells (sperm, eggs) and embryos intended for assisted reproduction; (vii) whole blood and any blood component that is minimally manipulated and intended for treating blood loss or blood disorders.
“homologous use” means the use of a cell, tissue or gene therapy product to repair, reconstruct, replace or supplement the cells or tissue of an individual (called the recipient) if the cell, tissue or gene therapy product performs the same basic function or functions in the recipient as the original cells or tissue in the donor in the same anatomical or histological environment; “minimally manipulated”, in relation to a cell or tissue (but not a gene), means processing the cell or tissue by way of any process so that the biological
characteristics or functions of the cell or the structural properties of the tissue (as the case may be) are not altered, such as by — (a) cutting or sizing; (b) grinding; (c) shaping; (d) centrifugation; (e) soaking in an antibiotic or antimicrobial solution; (f) sterilization or irradiation; (g) cell separation, concentration or purification; (h) filtration; (i) lyophilisation; (j) freezing; (k) cryopreservation; or (l) vitrification. [S 564/2007; S 684/2007; S 438/2010; S 328/2016; S 320/2018; S 103/2021]
(a) for prescribing the requirements in accordance with which the manufacture, import, supply, storage, transport, presentation, advertisement, administration and use of health products are to be carried out; (b) for prohibiting the manufacture, import, supply, possession, storage, transport, advertisement, administration and use of health products that are dangerous to human health;
(c) for prescribing the standards for health products in relation to their composition, quality, efficacy and safety for use; (d) for prescribing the requirements and procedure for obtaining any licence under this Act; (e) for prescribing the requirements in accordance with which the manufacture, import, supply, storage and transport of active ingredients are to be carried out; (f) for prescribing the requirements and procedure for the registration of a health product; (g) for prescribing the duties and obligations of a person to whom any licence or registration is issued or granted under this Act, and the duties and obligation of the person upon the suspension, revocation or cancellation of the licence or registration; (h) for prescribing the requirements for the presentation and advertisement of health products; (i) for regulating the conduct of clinical trials of health products, and prescribing the matters relating to any consent for a subject to participate in such a trial, including — (i) the persons who may so consent; (ii) the considerations which any such person must take into account before so consenting; (iii) the circumstances in which the consent of such person may be relied upon; and (iv) the circumstances in which no consent of any person is required for the subject’s participation in the trial, and whether any matter so prescribed has effect in addition to or despite any other written law or rule of law; (j) for prescribing the procedure for the procurement, testing, examination or analysis of any sample under this Act; (k) for providing for the conduct by the Authority or an enforcement officer of routine inspections of — (i) premises that are being used for the manufacture, supply or storage of health products or active ingredients; or (ii) conveyances that are being used for the transport of health products or active ingredients;
(l) for implementing any international agreement to which Singapore is a party that concerns the regulation of the manufacture, import, supply, possession, storage, transport, presentation, advertisement, administration and use of health products and active ingredients; (m) for providing for the protection of any confidential information that relates to any health product and that is received by the Authority or any enforcement officer in the course of administering and enforcing this Act, and for prescribing the purposes for which such confidential information may be disclosed to any specified person; (n) for prescribing the offences that may be compounded under section 65; and (o) for prescribing any other matter that is necessary to be prescribed for the administration and enforcement of this Act.
(a) restrict the classes of persons by whom and the circumstances under which any health product or active ingredient may be manufactured, imported, supplied, kept in possession, stored, transported or used; (b) restrict the classes of persons to whom and the circumstances under which any health product or active ingredient may be supplied; (c) restrict the places at which, the manner in which and the persons by whom any health product or active ingredient may be stored; (d) require records to be kept or submitted to the Authority in relation to the manufacture, import, supply, possession, storage, transport or use of any health product or active ingredient; (e) make provisions for the regulation of places at which health products are supplied by retail; (f) restrict the classes of persons who may apply for a licence or registration under this Act; (g) prescribe the requirements which must be satisfied by any person before a licence or registration may be granted to the person; (h) prescribe the information, documents and samples that must be submitted by an applicant for any licence or registration; and (i) prescribe the types of assessment and evaluation to be made of any health product before it may be registered. [29/2015]
Bill : 3/2007 First Reading : 22 January 2007 Second and Third Readings : 12 February 2007 Commencement : 1 November 2007 (except Part XIV)
Schedule) Order 2007 Commencement : 1 November 2007
Schedule) (No. 2) Order 2007 Commencement : 1 January 2008
Operation : 31 December 2008
Schedule) Order 2010 Commencement : 10 August 2010
(Amendments made by section 66 of the above Act) Bill : 25/2015 First Reading : 13 July 2015 Second Reading : 17 August 2015 Third Reading : 18 August 2015 Commencement : 1 July 2016 (section 66)
Schedule) Order 2016 Commencement : 1 November 2016 ii
Schedule) Order 2018 Commencement : 1 June 2018
(Amendments made by section 12 of the above Act) Bill : 4/2019 First Reading : 15 January 2019 Second and Third Readings : 12 February 2019 Commencement : 1 April 2019 (sections 12(a) and (b))
Schedule) Order 2021 Commencement : 1 March 2021
C.P. Council Paper G.N. No. S (N.S.) Government Notification Number Singapore (New Series) G.N. No. Government Notification Number G.N. No. S Government Notification Number Singapore G.N. Sp. No. S Government Notification Special Number Singapore L.A. Legislative Assembly L.N. Legal Notification (Federal/Malaysian Subsidiary Legislation) M. Act Malayan Act/Malaysia Act M. Ordinance Malayan Ordinance Parl. Parliament S.S.G.G. (E) No. Straits Settlements Government Gazette (Extraordinary) Number S.S.G.G. No. Straits Settlements Government Gazette Number