62. Certificate of manufacturing standard of therapeutic products

The Authority may, on the application of a person who manufactures a therapeutic product (called the manufacturer) and on being satisfied, after completion of 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 the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products and any other good manufacturing practice standard approved by the Authority.