Regulation 9
Requirements for importer’s licence for CTGT products
of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021
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).