Health Products (Active Ingredients) Regulations 2023 · As enacted · Part 3 · Licences
6. Licence required for manufacture of active ingredients
Feedback & supportSubject to regulation 9, a person must not manufacture any active ingredient unless —
the person holds a valid manufacturer’s licence; and
the manufacture of the active ingredient is carried out in accordance with the conditions of the licence.
A manufacturer of any active ingredient must not use any premises or facility for the manufacture of the active ingredient unless the premises or facility is authorised for such use under the manufacturer’s licence or the provisions of the Act, or by the Authority.
Subregulation 1
Subject to regulation 9, a person must not manufacture any active ingredient unless —
the person holds a valid manufacturer’s licence; and
the manufacture of the active ingredient is carried out in accordance with the conditions of the licence.
Subregulation 2
A manufacturer of any active ingredient must not use any premises or facility for the manufacture of the active ingredient unless the premises or facility is authorised for such use under the manufacturer’s licence or the provisions of the Act, or by the Authority.