Singapore legislation
Regulation 19
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 19
Requirements for wholesaler’s licence for CTGT products
For the purposes of section 24(2)(a)(i) of the Act, an applicant for a wholesaler’s licence for the supply by wholesale of a CTGT product that is not a result of only minimal manipulation of cell or tissue must be able —
to provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities that are necessary for the proper handling, storage and distribution of the CTGT product to prevent the deterioration of the CTGT product while it is in the applicant’s ownership, possession or control; and
to comply with the requirements in the Authority’s Guidance Notes on Good Distribution Practice.