Singapore legislation
Regulation 9
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
Regulation 9
Requirements for importer’s licence for CTGT products
For the purposes of section 24(2)(a)(i) of the Act, the applicant for an importer’s licence for the import of a CTGT product that is not a result of only minimal manipulation of cell or tissue must be able —
to ensure that —
in the case of an unregistered CTGT product, the product is imported on behalf of a healthcare service licensee pursuant to a valid prescription given by a qualified practitioner (who is a personnel of the healthcare service licensee) for administration to a patient of the healthcare service licensee;
in the case of an unregistered CTGT product, the product is imported —
by a healthcare service licensee on the written instructions of a qualified practitioner (who is a personnel of the healthcare service licensee) for administration to a patient of the healthcare service licensee; or
by the holder of a pharmacy licence that is for administration to a patient of a qualified practitioner pursuant to a valid prescription given by the qualified practitioner;
the CTGT product is intended to be supplied solely for the purpose of scientific education or research and development, or for a non‑clinical purpose;
the CTGT product is imported solely for the purpose of export;
the CTGT product is authorised for import by the registrant of the CTGT product; or
the CTGT product is in all respects the same as a registered CTGT product, the registrant of which has not authorised the applicant to import that CTGT product;
to comply with the proper handling and storage requirement, if the CTGT product is imported in accordance with paragraph (a)(i), (iii), (iv), (v) or (vi); and
to comply with the requirements in the Authority’s Guidance Notes on Good Distribution Practice, if the CTGT product is imported in accordance with paragraph (a)(i), (v) or (vi).