Singapore legislation

Regulation 52

of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021

Regulation 52

Certification of CTGT products intended for export

Amended byS 451/2022 wef 01/07/2022

Subregulation 1

The Authority may, on the application of a person who intends to export a CTGT product, issue to the person a certificate certifying —

(a)

in a case where the CTGT product is registered under the Act, that it is so registered; or

(b)

in a case where the CTGT product is not so registered, that it complies with the standards or requirements specified in the certificate.

Subregulation 2

Amended byS 451/2022 wef 01/07/2022

An application for a certificate under paragraph (1) must —

(a)

be made in the form and manner specified on the Authority’s website; and

(b)

be accompanied by the relevant fee.