Explanatory Note
(This Note is not part of the Regulations)
These Regulations amend the Medicines Act 1968 (“the Act”) to implement 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 EC”).
In particular, the Regulations amend the Act so as to provide (by new subsections (3A), (7) and (8) inserted in section 8 of the Act by regulation 2) that the distribution by way of wholesale dealing of a product to which Chapters II to V of the 1965 Directive apply requires a wholesale dealer’s licence (article 3.1 of the Directive). “The 1965 Directive”is a term which, by virtue of regulation 3 of the Medicines Act 1968 (Amendment) (No. 2) Regulations 1992 (S.I. 1992/3271), is now defined in section 132(1) of the At. The new subsections (3B) and (3C) of section 8 inserted by regulation 2(4) provide that distribution by way of wholsale dealing of products to which Chapters II to V of the 1965 Directive apply is authorised by a wholesale dealer’s licence only where it occurs in the course of a business carried on at a place specified in the licence (article 3.1 of the Directive), and that the holder of a manufacturer’s licence for such a product does not require a wholesale dealer’s licence for the wholesale distribution of that product (article 3.3 of the Directive).
Regulation 4 amends section 14 of the Act to require a wholesale dealer’s licence for exportation to a member State of imported products to which Chapters II to V of the 1965 Directive apply (articles 1.2 and 3.1 of the Directive).
Regulation 6 inserts a new section 49A of the Act which applies the requirement for a wholesale dealer’s licence to the export to member States of the EC of products to which Chapters II to V of the 1965 Directive apply (articles 1.2 and 3.1 of the Directive).
Regulations 3 and 7 make minor amendments to the Act consequential on the changes to section 8 of the Act.