Directive 1975/319 - Approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products - Main contents

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Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products

Official Journal L 147 , 09/06/1975 P. 0013 - 0022

Finnish special edition: Chapter 13 Volume 4 P. 0098

Greek special edition: Chapter 13 Volume 3 P. 0066

Swedish special edition: Chapter 13 Volume 4 P. 0098

Spanish special edition: Chapter 13 Volume 4 P. 0092

Portuguese special edition Chapter 13 Volume 4 P. 0092

SECOND COUNCIL DIRECTIVE of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (75/319/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;

Having regard to the proposal from the Commission;

Having regard to the Opinion of the European Parliament (1);

Having regard to the Opinion of the Economic and Social Committee (2);

Whereas the approximation begun by Council Directive 65/65/EEC (3) of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products should be continued and the implementation of the principles laid down in that Directive should be ensured;

Whereas in order to reduce the disparities which remain, rules should be laid down on the control of proprietary medicinal products and the duties incumbent upon the Member States' competent authorities should be specified with a view to ensuring compliance with legal requirements;

Whereas, in order to progress towards free movement of proprietary medicinal products, the issue of authorizations to place one and the same proprietary medicinal product on the market in two or more Member States should be facilitated;

Whereas, for this purpose, a Committee for Proprietary Medicinal Products should be set up, consisting of representatives of the Member States and of the Commission, responsible for giving an opinion as to whether a particular proprietary medicinal product complies with the requirements set out in Directive 65/65/EEC;

Whereas this Directive represents merely one step towards achievement of the objective of the free movement of proprietary medicinal products ; whereas, therefore, further measures with a view to abolishing any remaining barriers to the free movement of proprietary medicinal products will be necessary in the light of experience gained, particularly in the abovementioned Committee;

Whereas in order to facilitate the movement of proprietary medicinal products and to prevent the controls carried out in one Member State from being repeated in another, minimum requirements should be laid down for manufacture and imports coming from third countries and for the grant of the authorization relating thereto;

Whereas it should be ensured that, in the Member States, the supervision and control of the manufacture of proprietary medicinal products is carried out by a person who fulfils minimum conditions of qualification;

Whereas, moreover, the provisions of this Directive and of that of Directive 65/65/EEC which relate to proprietary medicinal products, although appropriate, are inadequate for vaccines, toxins and serums, proprietary medicinal products based on human blood or blood constituents, proprietary medicinal products based on radio-active isotopes and homeopathic proprietary medicinal products ; whereas the application thereof should consequently not be imposed at the present time in respect of such proprietary medicinal products;

Whereas certain rules in this Directive entail amendments to various provisions of Directive 65/65/EEC,

HAS ADOPTED THIS DIRECTIVE:

CHAPTER I Application for authorization to place proprietary medicinal products on the market

Article 1

Member States shall take all appropriate...

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