Regulation 40

Duty of licensed or known importer

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

Subsidiary LegislationIn forceProvision 41 of 61

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

Without affecting any other provision in this Part, a licensed importer or a known importer of a CTGT product —

(a)

must ensure, and maintain objective evidence to establish, that the handling and storage of the CTGT product complies with the following standards:

(i)

in the case of a known importer — the Authority’s Guidance Notes on Good Distribution Practice, Good Distribution Practice Standard for Medical Devices or ISO 13485;

(ii)

in the case of a licensed importer — the Authority’s Guidance Notes on Good Distribution Practice,if the CTGT product —

(iii)

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 the use of a patient of the healthcare service licensee;

(iv)

is authorised for import by the registrant of the CTGT product; or

(v)

is in all respects the same as a registered CTGT product, the registrant of which has not authorised the applicant to import that registered CTGT product;

(b)

must comply with the proper handling and storage requirement in relation to the CTGT product; and

(c)

must not use, for any purpose mentioned in paragraph (b), any premises other than the specified premises, or any other premises that the Authority approves.

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