Explanatory note

These Regulations further amend the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 (“the 1971 Regulations”) by implementing in part Council Directive 92/25/EEC (OJ No. L113, 30.4.92, p. 1) (“the Directive”) which concerns the wholesale distribution of medicinal products for human use.

The Regulations insert new requirements into the 1971 Regulations for holders of wholesale dealer’s licences which relate to products to which the Chapters II to V of the 1965 Directive apply (a definition of which is inserted in regulation 2). In particular, such persons are required to—

• institute an emergency plan to ensure the effectiveness of any recall of such products (regulation 3(2), article 6(d) of the Directive);

• keep specified records of products received or dispatched (regulation 3(2), articles 6(e) and 8 of the Directive) which must be kept for five years (article 6(f) of the Directive);

• specify the persons from whom such products may be obtained and to whom such products may be supplied (regulation 3(3), article 6(b) and (c) of the Directive); and

• specify that the licence shall name a person as responsible for ensuring that the conditions of the licence are being adhered to (regulation 3(3), article 5(b) of the Directive).