Regulation 1993/2309 - Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products - Main contents

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Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products

Official Journal L 214 , 24/08/1993 P. 0001 - 0021

Finnish special edition: Chapter 13 Volume 24 P. 0158

Swedish special edition: Chapter 13 Volume 24 P. 0158

COUNCIL REGULATION (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 235 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products particularly those derived from biotechnology (4) has established a Community mechanism for concertation, prior to any national decision relating to a high-technology medicinal product, with a view to arriving at uniform decisions throughout the Community; whereas this route should be followed, particularly in order to ensure the smooth functioning of the internal market in the pharmaceutical sector;

Whereas the experience acquired as a result of Directive 87/22/EEC has shown that it is necessary to establish a centralized Community authorization procedure for technologically advanced medicinal products, in particular those derived from biotechnology; whereas this procedure should also be available to persons responsible for placing on the market medicinal products containing new active substances which are intended for use in human beings or in food-producing animals;

Whereas in the interest of public health it is necessary that decisions on the authorization of such medicinal products should be based on the objective scientific criteria of the quality, the safety and the efficacy of the medicinal product concerned to the exclusion of economic or other considerations; whereas, however, Member States should exceptionally be able to prohibit the use on their territory of medicinal products for human use which infringe objectively defined concepts of public order or public morality; whereas, moreover, a veterinary medicinal product may not be authorized by the Community if its use would contravene the legal measures laid down by the Community within the framework of the common agricultural policy;

Whereas, in the case of medicinal products for human use, the criteria of quality, safety and efficacy have been extensively harmonized by Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (5), and the Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation and administrative action relating to proprietary medicinal products (6), and by Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products (6);

Whereas in the case of veterinary medicinal products, the same results have been achieved by Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (7) and by Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical,...

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