21. Certificate of manufacturing standard of clinical research materials

The Authority may, on the application of —

a manufacturer of any clinical research material; or

a manufacturer of a starting material used in the manufacture of clinical research material that is a CTGT product,and on being satisfied, after completing an assessment of conformity, that the manufacturer conforms to an applicable Good Manufacturing Practice Standard, issue a GMP Certificate to the manufacturer subject to any terms and conditions as the Authority thinks fit.

Every GMP Certificate issued is valid for a period specified in the certificate, being not longer than 3 years starting on the date of commencement of the assessment mentioned in paragraph (1).

An application for a GMP Certificate must —

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

be accompanied by the relevant fee.

In this regulation —

“GMP Certificate” means a certificate issued by the Authority to certify compliance with an applicable Good Manufacturing Practice Standard;

“Good Manufacturing Practice Standard” means any of the following as shown on the Authority’s website:

for therapeutic products —

the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products; or

any other good manufacturing practice standard approved by the Authority;

for CTGT products —

the Good Manufacturing Practice Standard for CTGT products issued by the Authority; or

any other good manufacturing practice standard that is approved by the Authority.