The Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Amendment Regulations 1993

Explanatory Note

(This note is not part of the Regulations)

These Regulations further amend the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971 (“the 1971 Regulations”) so 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 which are marketed within the European Community.

The Regulations insert a new requirement into the 1971 Regulations requiring applicants for wholesale dealer’s licences which relate to products to which Chapters II to V of the 1965 Directive apply (a definition of which is inserted by regulation 2) to give the name and address of a responsible person who is to oversee wholesaling operations. (regulation 3, article 5(b) of the Directive).

Such applicants are also required by the amendments made by these Regulations to submit details of an emergency plan to be instituted where products are recalled (article 6(d) of the Directive) and of arrangements for keeping records relating to products received or dispatched (article 6(e) of the Directive).