The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

Requirement that wholesale dealers deal only with specified persons

9.—(1) The holder of a wholesale dealer’s licence shall obtain supplies of relevant medicinal products only from either—

(a) a manufacturer’s licence holder or wholesale dealer’s licence holder in respect of such products; or

(b) a person who holds an authorisation granted by another EEA State authorizing the manufacture of such products or their distribution by way of wholesale dealing.

(2) The holder of a wholesale dealer’s licence shall distribute relevant medicinal products by way of wholesale dealing only to—

(a) a holder of a wholesale dealer’s licence relating to those products;

(b) a holder of an authorization granted by the competent authority of another EEA State authorising the supply of those products by way of wholesale dealing;

(c) any person who may lawfully sell those products by retail or who may lawfully supply them in circumstances corresponding to retail sale; or

(d) any person who may lawfully administer those products.

(3) Where any relevant medicinal product is supplied to any person pursuant to paragraph (2)(c), the licence holder shall enclose with the product a document which makes it possible to ascertain—

(a) the date on which the supply took place;

(b) the name and pharmaceutical form of the product supplied;

(c) the quantity of product supplied; and

(d) the names and addresses of the person or persons from whom the products were supplied to the licence holder.

(4) The licence holder shall—

(a) keep a record of the information supplied pursuant to paragraph (3) for a minimum period of five years after the date on which it is supplied; and

(b) ensure, during that period, that that record is available to the licensing authority for inspection.