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In force2020 Revised Edition

Part 8 · Duties of Manufacturers, Importers, Etc., of Health Products

43. Verification of quality, safety and efficacy of health product

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(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.

(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.

Report

Part 9

Regulation of Dealings in Active Ingredients

Part 10

Enforcement

Part 11

Presumptions and Other Evidentiary Provisions for Purposes of Enforcement of Act

Part 12

Offences and Prosecution

Part 13

Miscellaneous

Part 14

Regulation of Supply and Use of Health Products and Active Ingredients for Veterinary Purposes

Schedules