Singapore legislation
Regulation 18
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 18
Supply of CTGT products manufactured under agreement with licensed or known manufacturer
Subregulation 1
Without limiting any other provision in these Regulations, the prohibition in section 15(1) of the Act against the supply of a health product unless the health product is registered, does not apply to a CTGT product that is manufactured in accordance with paragraph (2) or (3) and is supplied in any of the following cases:
[Deleted by S 801/2023 wef 18/12/2023](b)by a licensed manufacturer or known manufacturer to a healthcare service licensee for the use of the CTGT product by a patient of the healthcare service licensee;
[Deleted by S 801/2023 wef 18/12/2023](d)by a healthcare service licensee for the use of the CTGT product on a patient of the healthcare service licensee.
Subregulation 2
For the purposes of paragraph (1), if the CTGT product is a result of only minimal manipulation of cell or tissue, the CTGT product must be manufactured under an agreement between a known manufacturer and the healthcare service licensee mentioned in paragraph (1)(b) or (d).
Subregulation 3
For the purposes of paragraph (1), if the CTGT product is not a result of only minimal manipulation of cell or tissue, the CTGT product must be manufactured —
under an agreement between a licensed manufacturer and the healthcare service licensee mentioned in paragraph (1)(b) or (d);
in accordance with its formulation and specifications, and the written instructions of a qualified practitioner, who is a personnel of the healthcare service licensee mentioned in paragraph (1)(b) or (d), and for the use solely by or in connection with the patient mentioned in that paragraph;
in specified premises or any other premises that the Authority approves; and
in accordance with the terms and conditions specified in the manufacturer’s licence held by the licensed manufacturer.
Subregulation 4
Paragraph (3)(b) does not apply to prohibit the supply of an unregistered CTGT product to any patient of the healthcare service licensee mentioned in paragraph (1)(b) or (d), if the requirements in paragraph (3)(a), (c) and (d) are satisfied and the manufacture consists only of changing the outer package or other packaging in which the container is further enclosed for the purpose of dispensing the CTGT product.