Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 · As enacted · Part 4 · Ctgt Product Supply — Licensing and Exceptions
12. Class 2 CTGT products transferred by healthcare service licensees
Feedback & supportLast amended by an amending law of 2023.
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:
[Deleted by S 801/2023 wef 18/12/2023]
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 —
[Deleted by S 801/2023 wef 18/12/2023]
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.
For the purposes of paragraph (1), the conditions are —
the unregistered Class 2 CTGT product is —
imported under regulation 7(1)(c) or 9(a)(i) or (ii) for a qualified practitioner to administer it to a patient; or
manufactured for administration to a patient; and
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.
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:
[Deleted by S 801/2023 wef 18/12/2023]
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 —
[Deleted by S 801/2023 wef 18/12/2023]
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.
Subregulation 2
For the purposes of paragraph (1), the conditions are —
the unregistered Class 2 CTGT product is —
imported under regulation 7(1)(c) or 9(a)(i) or (ii) for a qualified practitioner to administer it to a patient; or
manufactured for administration to a patient; and
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.