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The Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Amendment Regulations 1983

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EXPLANATORY NOTE

These Regulations further amend the Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Regulations 1971 which prescribed the form and manner in which an application for the grant of a manufacturer's licence or a wholesale dealer's licence is to be made and the information that is to be furnished with each application.

The 1971 Regulations, as amended, prescribed particulars which are to be contained in, or accompany, every application, for the grant of a wholesale dealer's licence relating to an imported proprietary medicinal product. A proprietary medicinal product was defined for the purposes of the 1971 Regulations as having the same meaning as in sections 7(7) and 8(4) of the Medicines Act 1968, which sections were inserted in that Act by S.I. 1977/1050 and S.R. (N.I.) 1977 No. 170.

These Regulations amend the 1971 Regulations so that such particulars are to be contained in, or accompany, every application for the grant of a wholesale dealer's licence relating to a proprietary medicinal product, as defined in sections 7(7) and 8(4) of the Medicines Act 1968 as those sections were amended by S.I. 1983/1724, and to a ready-made veterinary drug, as similarly defined, and which, in each case, is imported other than from a member State of the European Communities (Regulation 2).

The Regulations implement in part Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products.

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