Singapore legislation

Regulation 12

of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021

Regulation 12

Class 2 CTGT products transferred by healthcare service licensees

Amended byS 437/2023 wef 26/06/2023S 801/2023 wef 18/12/2023S 801/2023 wef 18/12/2023

Subregulation 1

For the purposes of section 14(1) of the Act, a wholesaler’s licence is not required for the transfer of an unregistered Class 2 CTGT product under the following circumstances if the conditions in paragraph (2) are satisfied:

(a)

[Deleted by S 801/2023 wef 18/12/2023](b)the transfer of the unregistered Class 2 CTGT product by a healthcare service licensee from any approved permanent premises, temporary premises or approved conveyance of the healthcare service licensee to —

(i)

[Deleted by S 801/2023 wef 18/12/2023](ii)another approved permanent premises, temporary premises or approved conveyance of the healthcare service licensee; or

(iii)

any approved permanent premises, temporary premises or approved conveyance of another healthcare service licensee.

Subregulation 2

Amended byS 437/2023 wef 26/06/2023S 801/2023 wef 18/12/2023

For the purposes of paragraph (1), the conditions are —

(a)

the unregistered Class 2 CTGT product is —

(i)

imported under regulation 7(1)(c) or 9(a)(i) or (ii) for a qualified practitioner to administer it to a patient; or

(ii)

manufactured for administration to a patient; and

(b)

the unregistered Class 2 CTGT product is intended for administration to a patient at the approved permanent premises, temporary premises or approved conveyance to which the unregistered Class 2 CTGT product is transferred.

Read in full context — Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 →