PART 8 | DUTIES OF MANUFACTURERS, IMPORTERS, ETC., OF HEALTH PRODUCTS |
| 39. 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. |
40.—(1) The Authority may, by written notice, require the manufacturer, importer, supplier or registrant of a health product —| (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. |
| (2) The records mentioned in subsection (1) must be kept in such form and manner and for such period as the Authority may stipulate, and must contain such information in relation to the manufacture, import, supply, use or administration (as the case may be) of the health product as the Authority may require. |
| (3) Any person who fails to comply with any requirement under subsection (1) or (2) 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. |
| (4) Any person who, in compliance or purported compliance with subsection (1)(b), furnishes the Authority or an enforcement officer with any 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. |
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| Furnishing of information or document regarding health product |
41.—(1) The Authority may, by written notice, require the manufacturer, importer, supplier or registrant of a health product to furnish to the Authority, within such time and for such period as may be specified in such notice, any information or document which such person has in the person’s possession or which the person is in a position to obtain regarding such health product.| (2) Any person who fails to comply with a notice given to the person by the Authority under subsection (1) 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. |
| (3) Any person who, in compliance or purported compliance with a notice given to the person by the Authority under 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. |
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| Reporting of defects and adverse effects to Authority |
42.—(1) Where the manufacturer, importer, supplier or registrant of a health product becomes aware of —| (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. |
(2) Where the Authority receives any information under subsection (1) concerning any defect in, or adverse effect of, a health product or becomes aware of any such defect or adverse effect through any other means, it may take any one or more of the following actions:| (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. |
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(3) The Authority may also in any written notice given under subsection (2) require the person to whom the notice has been given to submit to the Authority in such form and manner and within such time and for such period specified by the Authority, a report containing information on —| (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. |
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(4) A statement under subsection (2)(b) must be issued in such form and manner as the Authority may require, including —| (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. |
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(5) Any person who —| (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. |
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(6) For the purposes of this section, a health product has a defect if —| (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. |
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| Verification of quality, safety and efficacy of health product |
43.—(1) Where the Authority has reasonable grounds to believe that a health product may no longer be of adequate quality, safe or efficacious when used for the purpose in respect of which it has been registered under this Act, the Authority may, by written notice, require the manufacturer, importer, supplier or registrant of the health product to take such measures as the Authority may specify to verify the quality, safety or efficacy (as the case may be) of the health product.(2) The measures that the Authority may require under subsection (1) include —| (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. |
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| (3) Any person who fails to comply with a notice given to the person by the Authority under subsection (1) 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. |
| (4) Any person who, in compliance or purported compliance with a notice given to the person by the Authority under 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. |
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| Notification to Authority concerning recall of health product |
44.—(1) Where the manufacturer, importer, supplier or registrant of a health product recalls or intends to recall the health product, such person must, within the prescribed time, notify the Authority of the recall or intended recall and the reasons for it.| (2) On being notified of the recall or intended recall of a health product under subsection (1), the Authority may, 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 recall of the health product and any other matter as the Authority considers necessary. |
(3) Any person who —| (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. |
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| Additional duties under regulations |
| 45. 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. |
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