Singapore legislation

Regulation 15

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

Regulation 15

Prescribed exceptions

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

Subregulation 1

For the purposes of section 15(1) of the Act, the prescribed exceptions to the prohibition against the supply of an unregistered CTGT product are the following: (a)the supply of a CTGT product by a qualified practitioner to a patient of the qualified practitioner;

(b)

the supply of a CTGT product that —

(i)

is imported in accordance with regulation 9(a)(i) by a licensed importer; and

(ii)

is supplied by the licensed importer to a healthcare service licensee;

(c)

the supply of a CTGT product that —

(i)

is imported in accordance with regulation 7(1)(c) by a known importer that is also a healthcare service licensee; and

(ii)

is pursuant to the written instructions of a qualified practitioner who is a personnel of the healthcare service licensee, and is for administration to a patient of the healthcare service licensee;

(d)

the supply by a healthcare service licensee of a CTGT product that is imported in accordance with regulation 7(1)(c) or 9(a)(ii), to a patient of the healthcare service licensee;

(e)

the supply of a CTGT product that is imported in accordance with regulation 7(1)(c) or 9(a)(i) or (ii), and is supplied —

(i)

[Deleted by S 801/2023 wef 18/12/2023](ii)by a healthcare service licensee from any approved permanent premises, temporary premises or approved conveyance of the healthcare service licensee to —

(A)

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

(C)

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

(ea)the supply of a CTGT product that —

(i)

is manufactured by a healthcare service licensee; and

(ii)

is for the administration to a patient of the healthcare service licensee, or another healthcare service licensee;

(eb)[Deleted by S 801/2023 wef 18/12/2023](ec)the supply by a healthcare service licensee of a CTGT product that is manufactured by the healthcare service licensee, to —

(i)

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

(f)

the supply in accordance with regulation 16 of a Class 1 CTGT product that is —

(i)

manufactured by a licensed manufacturer, or a known manufacturer who has given a notice to manufacture under regulation 4 that has not been refused, cancelled or withdrawn;

(ii)

imported by a licensed importer, or a known importer who has given a notice to import under regulation 7 that has not been refused, cancelled or withdrawn; or

(iii)

supplied by a licensed wholesaler, or a known wholesaler who has given notice to the Authority under regulation 10 to supply the CTGT product by wholesale and the notice has not been refused, cancelled or withdrawn;

(g)

the supply of a CTGT product for —

(i)

the purpose of scientific education or research and development; or

(ii)

a non‑clinical purpose,but only if there is no supply of the CTGT product to the public;

(h)

the supply by wholesale of a CTGT product that is —

(i)

manufactured solely for export; or

(ii)

imported solely for re‑export.

Subregulation 2

For the purposes of paragraph (1)(f), a CTGT product is treated as a Class 1 CTGT product if it would have been so assigned had the CTGT product been registered.

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