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Health products to be registered according to categories in First Schedule
29.—(1) The Authority must register health products under this Act in accordance with the categories specified in the First Schedule. (2) The Authority may —(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.
Registration of health products
30.—(1) An application for the registration of a health product must —(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. (2) Upon receiving an application under subsection (1), the Authority may —(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. (3) The Authority may register a health product under the category and class stated in the application for its registration if the Authority is satisfied, after an evaluation of the health product under section 33, that the health product is suitable to be so registered. (4) If the Authority finds that a health product is not suitable for registration under the category or class stated in the application, it may —(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. (5) If the applicant accepts the recommendation of the Authority under subsection (4)(a), the Authority must, subject to the payment of the appropriate prescribed fee by the applicant, register the health product under the category or class recommended by it. (6) If the applicant does not wish to register the health product under the category or class recommended by the Authority under subsection (4)(a), the applicant may —(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. (7) Upon considering the additional information, documents and samples submitted by the applicant under subsection (6)(a), the Authority may do any of the following:(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. (8) Upon registering a health product under this Act, the Authority must assign a registration number to the health product and must enter in the Register of Health Products the prescribed information pertaining to that health product. (9) Where the Authority refuses to register a health product under subsection (2)(b), (4)(b) or (7)(c), the Authority must, if requested to do so by the applicant, state in writing the reasons for the refusal. (10) Any person who, in making an application for the registration of a 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.
Duration of registration
31. The registration of a health product under this Act remains in force for so long as —(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).
Conditions of registration
32. 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.
Evaluation of health products
33.—(1) In order to ascertain that a health product is suitable for registration under this Act or for registration under any particular category or class, the Authority may —(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. (2) The evaluation of a health product must include such tests and examination of the health product as the Authority thinks necessary to determine the following matters:(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. (3) The requirements that may be prescribed for the purposes of subsection (2)(c) include the following:(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. (4) In determining whether a health product complies with the standards mentioned in subsection (3)(b)(ii), the Authority may consider such evidence as it thinks sufficient from a relevant overseas authority establishing that the manufacture of the health product is of the acceptable standard. (5) The costs of and incidental to the evaluation of a health product must be borne by the applicant for the registration of the health product.
Register of Health Products
34.—(1) The Authority must keep and maintain in such form and manner as it thinks fit a Register of Health Products for the purpose of compiling information in relation to all registered health products. (2) Any person may, during the office hours of the Authority and upon payment of the prescribed fee, inspect such parts of the Register of Health Products as the Authority may determine and obtain extracts from that Register. (3) Any extract from or copy of an entry in the Register of Health Products is prima facie evidence of the information stated in the entry if the extract or copy is certified under the hand of the Chief Executive, or an officer of the Authority duly authorised by the Chief Executive, to be a true extract or copy. (4) The Authority may, from time to time, prepare and publish in such form and manner as it thinks fit a list of all registered health products.
Re‑categorisation or re‑classification of health products on application of registrant
35.—(1) The Authority may, upon the application of the registrant of a registered health product —(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. (2) An application under subsection (1) for the re‑categorisation or re‑classification of a registered health product must —(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. (3) Upon the re‑categorisation or re‑classification of a registered health product under this section, the registrant of the health product must take such steps as may be specified by the Authority to secure the necessary changes to the presentation and advertisement of the health product so as to bring them in conformity with the new category or class of the health product. (4) If the registrant of the health product fails to comply with subsection (3), the registrant 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. (5) Any person who, in making an application under subsection (1) for the re‑categorisation or re‑classification of a registered 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.
Power to re‑categorise or re‑classify health products in absence of application by registrant
36.—(1) Where —(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. (2) Before re‑categorising or re‑classifying a registered health product under subsection (1), the Authority must —(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. (3) If the registrant of the health product —(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. (4) The Authority may also in the notice given under subsection (3) require the registrant of the health product to take such steps as may be specified by the Authority to secure the necessary changes to the presentation and advertisement of the health product so as to bring them in conformity with the new category or class of the health product. (5) The registrant of a health product who fails to comply with any of the requirements attached under subsection (4) to a notice given to the registrant under subsection (3) 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. (6) Where the registrant of a health product does not wish to have the health product re‑categorised or re‑classified as intended by the Authority under this section, the registrant may apply to the Authority to cancel the registration of the health product.
Suspension and cancellation of registration
37.—(1) The Authority may suspend or cancel the registration of a health product if the Authority has reasonable grounds to believe that —(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. (2) The Authority may cancel the registration of a health product if the registrant of the health product fails to pay the prescribed retention fee mentioned in section 31(a) within the prescribed time. (3) The Authority may, upon the application of the registrant of a health product, cancel the registration of the health product. (4) Before suspending or cancelling the registration of any health product under subsection (1) or (2), the Authority must —(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. (5) If the registrant of the health product —(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.
Appeal
38.—(1) Any person who is aggrieved by —(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. (2) Before making a decision under subsection (1), the Minister may refer the matter to an Appeal Advisory Committee and, in making a decision, the Minister must have regard to any report made to the Minister by the Appeal Advisory Committee. (3) Even though an appeal under subsection (1) is pending —(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.
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Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. Read the official text ↗
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