Singapore legislation
Regulation 57
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 57
Non-compliant CTGT products
For the purposes of section 48(a)(iii) of the Act, a CTGT product is considered as being non‑compliant if it fails to comply with the product quality characteristics, specifications and labelling approved by the Authority —
(a)
at the time of the registration of the CTGT product; or
(b)
under regulation 48.