Health Products (Therapeutic Products) Regulations 2016 · As enacted · Part 7 · Exceptions — Manufacture, Import and Wholesale of Therapeutic Products Without Licence
57. Therapeutic products for research or non‑clinical purposes
Feedback & supportA manufacturer’s licence is not required for the manufacture of a therapeutic product, if the manufacture —
is solely for —
the purpose of scientific education or research and development; or
a non-clinical purpose; and
is not for any supply to the public.
A manufacturer of a therapeutic product for any of the purposes mentioned in paragraph (1)(a)(i) or (ii) is not required to maintain records of manufacture in compliance with regulation 31.
A person may supply a therapeutic product for any of the purposes mentioned in paragraph (1)(a)(i) or (ii) without holding a wholesaler’s licence if there is no supply of the therapeutic product to the public.
Subregulation 1
A manufacturer’s licence is not required for the manufacture of a therapeutic product, if the manufacture —
is solely for —
the purpose of scientific education or research and development; or
a non-clinical purpose; and
is not for any supply to the public.
Subregulation 2
A manufacturer of a therapeutic product for any of the purposes mentioned in paragraph (1)(a)(i) or (ii) is not required to maintain records of manufacture in compliance with regulation 31.
Subregulation 3
A person may supply a therapeutic product for any of the purposes mentioned in paragraph (1)(a)(i) or (ii) without holding a wholesaler’s licence if there is no supply of the therapeutic product to the public.