Skip to content

Part 6 · Duties and Obligations of Manufacturers, Importers, Etc., of Therapeutic Products

38. Duty of licensed wholesaler

Feedback & support

Without prejudice to any other provision in this Part, a holder of a wholesaler’s licence for a therapeutic product —

(a)

must ensure, and maintain objective evidence to establish, that the handling, storage and distribution of the therapeutic product complies with any standard set out by the Authority on the Authority’s website for the therapeutic product;

(b)

may only supply the therapeutic product by wholesale to a person who may lawfully supply such therapeutic products in accordance with the Act;

(c)

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

(d)

must not use, for any purpose mentioned in paragraph (c), any premises other than the premises specified in the holder’s licence, or such other premises as may be approved from time to time by the Authority.

Report

Part 7

Exceptions — Manufacture, Import and Wholesale of Therapeutic Products Without Licence

Part 8

Exceptions — Supply of Therapeutic Products Without Registration

Part 8A

Exception — Emergency Therapeutic Products

Part 9

Miscellaneous

Schedules