40. Duty of licensed or known importer

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

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

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;

in the case of a licensed importer — the Authority’s Guidance Notes on Good Distribution Practice,if the CTGT 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 the use of a patient of the healthcare service licensee;

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

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;

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

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.