Singapore legislation

Regulation 65

of Health Products (Therapeutic Products) Regulations 2016

Regulation 65

Product quality surveillances

Subregulation 1

The Authority may at any time conduct a product quality surveillance for the purposes of ensuring that a therapeutic product is not a non-compliant health product within the meaning of section 48(a) of the Act.

Subregulation 2

The Authority may require a manufacturer, supplier, licensee or registrant of a therapeutic product to furnish, without charge, any number of samples of the therapeutic product for evaluation by the Authority in the product quality surveillance.

Subregulation 3

A person who fails to comply with a requirement of the Authority under paragraph (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.