Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 · As enacted · Part 4 · Ctgt Product Supply — Licensing and Exceptions
14. Wholesale supply of self‑manufactured CTGT products
Feedback & supportFor the purposes of section 14(1) of the Act, a wholesaler’s licence is not required for the supply by wholesale of a CTGT product by a licensed manufacturer or known manufacturer of that CTGT product, if that manufacturer complies with the requirements in paragraph (2).
A manufacturer mentioned in paragraph (1) must provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities for the proper handling, storage and distribution of the CTGT product that are necessary to prevent the deterioration of the CTGT product while it is in that manufacturer’s ownership, possession or control.
Subregulation 1
For the purposes of section 14(1) of the Act, a wholesaler’s licence is not required for the supply by wholesale of a CTGT product by a licensed manufacturer or known manufacturer of that CTGT product, if that manufacturer complies with the requirements in paragraph (2).
Subregulation 2
A manufacturer mentioned in paragraph (1) must provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities for the proper handling, storage and distribution of the CTGT product that are necessary to prevent the deterioration of the CTGT product while it is in that manufacturer’s ownership, possession or control.