Health Products (Active Ingredients) Regulations 2023 · As enacted · Part 5 · Certificates
33. Certificate of manufacturing standard of active ingredients
Feedback & supportThe Authority may —
on the application of a person who manufactures an active ingredient; and
on being satisfied, after completion of an assessment of conformity, that the manufacture of the active ingredient conforms to the Good Manufacturing Practice standard,issue to the person a certificate stating that the person has complied with the Good Manufacturing Practice standard in the manufacture of the active ingredient (called in this regulation a GMP certificate), subject to any terms and conditions that 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 accompanied by the relevant fee specified in the Health Products (Fees) Regulations 2022.
Subregulation 1
The Authority may —
on the application of a person who manufactures an active ingredient; and
on being satisfied, after completion of an assessment of conformity, that the manufacture of the active ingredient conforms to the Good Manufacturing Practice standard,issue to the person a certificate stating that the person has complied with the Good Manufacturing Practice standard in the manufacture of the active ingredient (called in this regulation a GMP certificate), subject to any terms and conditions that the Authority thinks fit.
Subregulation 2
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).
Subregulation 3
An application for a GMP certificate must be accompanied by the relevant fee specified in the Health Products (Fees) Regulations 2022.