15. Prescribed exceptions

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;

the supply of a CTGT product that —

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

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

the supply of a CTGT product that —

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

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;

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;

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 —

[Deleted by S 801/2023 wef 18/12/2023]

by a healthcare service licensee from any approved permanent premises, temporary premises or approved conveyance of the healthcare service licensee to —

[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

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

the supply of a CTGT product that —

is manufactured by a healthcare service licensee; and

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

[Deleted by S 801/2023 wef 18/12/2023]

the supply by a healthcare service licensee of a CTGT product that is manufactured by the healthcare service licensee, to —

[Deleted by S 801/2023 wef 18/12/2023]

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

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

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a known manufacturer who has given a notice to manufacture under regulation 4 that has not been refused, cancelled or withdrawn;

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

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;

the supply of a CTGT product for —

the purpose of scientific education or research and development; or

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

the supply by wholesale of a CTGT product that is —

manufactured solely for export; or

imported solely for re‑export.

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.

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;

the supply of a CTGT product that —

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

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

the supply of a CTGT product that —

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

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;

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;

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 —

[Deleted by S 801/2023 wef 18/12/2023]

by a healthcare service licensee from any approved permanent premises, temporary premises or approved conveyance of the healthcare service licensee to —

[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

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

the supply of a CTGT product that —

is manufactured by a healthcare service licensee; and

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

[Deleted by S 801/2023 wef 18/12/2023]

the supply by a healthcare service licensee of a CTGT product that is manufactured by the healthcare service licensee, to —

[Deleted by S 801/2023 wef 18/12/2023]

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

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

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;

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

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;

the supply of a CTGT product for —

the purpose of scientific education or research and development; or

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

the supply by wholesale of a CTGT product that is —

manufactured solely for export; or

imported solely for re‑export.

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.