Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 · As enacted · Part 9 · Certification
52. Certification of CTGT products intended for export
Feedback & supportLast amended by an amending law of 2022.
The Authority may, on the application of a person who intends to export a CTGT product, issue to the person a certificate certifying —
in a case where the CTGT product is registered under the Act, that it is so registered; or
in a case where the CTGT product is not so registered, that it complies with the standards or requirements specified in the certificate.
An application for a certificate under paragraph (1) must —
be made in the form and manner specified on the Authority’s website; and
be accompanied by the relevant fee.
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 —
in a case where the CTGT product is registered under the Act, that it is so registered; or
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
An application for a certificate under paragraph (1) must —
be made in the form and manner specified on the Authority’s website; and
be accompanied by the relevant fee.