Singapore legislation
Regulation 63
Regulation 63
Certificate of distribution standard of therapeutic products
Subregulation 1
The Authority may, on the application of a person who distributes a therapeutic 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.
Subregulation 2
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).
Subregulation 3
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.
Subregulation 4
In this regulation —
Definition
“GDP Certificate” means a certificate issued by the Authority to certify compliance with an applicable Good Distribution Practice Standard;
Definition
“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.