Singapore legislation
Regulation 54
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 54
Certificate of distribution standard of CTGT products
Subregulation 1
The Authority may, on the application of a person who distributes —
a CTGT product; or
a starting material used in the manufacture of a CTGT product,(called in this paragraph the distributor) and on being satisfied, after completion of an assessment of conformity, that the distributor conforms to an applicable Good Distribution Practice Standard, issue a GDP Certificate to the distributor subject to any terms and conditions that 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.