Regulation 5

the applicant is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling and storage of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the applicant’s ownership, possession or control;

the therapeutic product —

is imported on behalf of a specified healthcare service licensee pursuant to a valid prescription given by a qualified practitioner (who is a personnel of the specified healthcare service licensee) for the use of the qualified practitioner’s patient;

is intended to be supplied solely for the purpose of scientific education or research and development, or for a non-clinical purpose;

is imported solely for the purpose of export;

is intended to be supplied for use on a ship, and the therapeutic product is one that is required to be carried on board the ship under the Merchant Shipping (Medical Stores) Regulations (Rg 3), the Merchant Shipping (Maritime Labour Convention) (Medicines and Medical Equipment) Regulations 2014 (G.N. No. S 181/2014) or any other written law, for the treatment of persons on board that ship;

is intended to be supplied for use on an aircraft, and the therapeutic product forms part of the medical supplies required under the Air Navigation Order (O 2) or any other written law, for the treatment of persons on board the aircraft;

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

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

the applicant is able to comply with the requirements in the Authority’s Guidance Notes on Good Distribution Practice for importers set out on the Authority’s website if the therapeutic product is imported in accordance with sub‑paragraph (b)(i), (vi) and (vii).