The Human Medicines Regulations 2012

Requirement for wholesale dealers to deal only with specified persons

44.—(1) The licence holder may not obtain supplies of medicinal products from anyone except—

(a) the holder of a manufacturer’s licence or wholesale dealer’s licence in relation to products of that description; or

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

(2) The licence holder may distribute medicinal products by way of wholesale dealing only to—

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

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

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

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

(3) Where a medicinal product is supplied to a person pursuant to paragraph (2)(c), the licence holder must enclose with the product a document stating—

(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 name and address of the licence holder.

(4) The licence holder must—

(a) keep a record of information supplied in accordance with paragraph (3) for at least five years beginning immediately after the date on which the information is supplied; and

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