Singapore legislation
Clause 43
Clause 43
Verification of quality, safety and efficacy of health product
(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 notice in writing, 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 —
subjecting the health product to an evaluation in accordance with section 33; and
furnishing the Authority with such evidence of the quality, safety or efficacy of the health product as the Authority may require.
(3)
Any person who fails to comply with a notice given to him 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 him by the Authority under subsection (1), furnishes the Authority with any information or document which he 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.