Regulation 57
Non-compliant CTGT products
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Subsidiary LegislationIn forceProvision 58 of 61
Regulation 57
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.