22. Certificate of distribution standard of clinical research materials

The Authority may, on the application of a person who distributes a therapeutic product or CTGT product and on being satisfied, after completion of an assessment of conformity, that the person conforms to an applicable Good Distribution Practice Standard, issue a GDP Certificate to the person subject to any terms and conditions as the Authority thinks fit.

Every GDP 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 GDP 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 —

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

“Good Distribution Practice Standard” means the Authority’s Guidance Notes on Good Distribution Practice and any other good distribution practice standard approved by the Authority.