Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 · As enacted · Part 2 · Ctgt Product Manufacture — Licensing and Exceptions
5. Manufacturing other CTGT products for research or non‑clinical purposes
Feedback & supportFor the purposes of section 12(1) of the Act, a manufacturer’s licence is not required for the manufacture of a CTGT product that is not a result of only minimal manipulation of cell or tissue if that product —
is not manufactured for any supply to the public; and
is manufactured solely for —
the purpose of scientific education or research and development; or
a non‑clinical purpose.
A manufacturer of a CTGT product that is mentioned in paragraph (1)(a) or (b) is not required to maintain records of manufacture in compliance with regulation 32.
Subregulation 1
For the purposes of section 12(1) of the Act, a manufacturer’s licence is not required for the manufacture of a CTGT product that is not a result of only minimal manipulation of cell or tissue if that product —
is not manufactured for any supply to the public; and
is manufactured solely for —
the purpose of scientific education or research and development; or
a non‑clinical purpose.
Subregulation 2
A manufacturer of a CTGT product that is mentioned in paragraph (1)(a) or (b) is not required to maintain records of manufacture in compliance with regulation 32.