Regulation 41

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

in the case of a known wholesaler — 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 wholesaler — the Authority’s Guidance Notes on Good Distribution Practice;

may only supply the CTGT product by wholesale to a person who may lawfully supply that CTGT product in accordance with the Act;

must provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities for the handling, storage and distribution of the CTGT product that are necessary to prevent the deterioration of the CTGT product while it is in the wholesaler’s ownership, possession or control; and

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