Regulation 52
Certification of CTGT products intended for export
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Subsidiary LegislationIn forceProvision 53 of 61
Regulation 52
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.