Singapore legislation
Regulation 56
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 56
Product quality surveillances
Subregulation 1
The Authority may at any time conduct a product quality surveillance for the purposes of ensuring that a CTGT 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, an importer, a wholesaler, a supplier or a registrant of a CTGT product to provide, without charge, any number of samples of the CTGT 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.