Singapore legislation
Regulation 57
Regulation 57
Therapeutic products for research or non‑clinical purposes
Subregulation 1
A manufacturer’s licence is not required for the manufacture of a therapeutic product, if the manufacture —
(a)
is solely for —
(i)
the purpose of scientific education or research and development; or
(ii)
a non-clinical purpose; and
(b)
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.