Directive 1983/570 - Amendment of Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products - Main contents

official title

 

Legal instrument	Directive
Number legal act	Directive 1983/570
Original proposal	COM(1980)789
CELEX number i	31983L0570

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Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products

Official Journal L 332 , 28/11/1983 P. 0001 - 0010

Finnish special edition: Chapter 13 Volume 13 P. 0163

Spanish special edition: Chapter 13 Volume 14 P. 0205

Swedish special edition: Chapter 13 Volume 13 P. 0163

Portuguese special edition Chapter 13 Volume 14 P. 0205

COUNCIL DIRECTIVE of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (83/570/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 Directives on the approximation of the laws relating to proprietary medicinal products must be adapted to scientific progress and take account of the experience obtained since their adoption;

Whereas Article 15 (2) of 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 (3) provides that the Commission shall submit to the Council a proposal containing appropriate measures leading towards the abolition of any remaining barriers to the free movement of proprietary medicinal products, not later than four years after the entry into force of the abovementioned Directive;

Whereas it is necessary from the point of view of public health and the free movement of medicinal products for the competent authorities to have at their disposal all useful information on authorized proprietary products, based in particular on summaries, adopted in the other Member States, of the characteristics of products;

Whereas it is necessary to specify certain provisions relating to physicochemical, biological or microbiological tests on proprietary medicinal products and to introduce the principle of bio-availability and mutagenesis tests in order to safeguard public health; (1) OJ No C 287, 9.11.1981, p. 127. (2) OJ No C 189, 30.7.1981, p. 39. (3) OJ No L 147, 9.6.1975, p. 13.

Whereas the approximation of laws brought about in this connection must enable a proprietary product, manufactured and marketed in one Member State on the basis of harmonized provisions, to be allowed into another Member State, taking into due consideration the initial authorization, save in exceptional cases submitted for an opinion to the Committee for Proprietary Medicinal Products set up by Directive 75/319/EEC,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (1) is hereby amended as follows: 1. The second paragraph of Article 4 is amended as follows: (a) in point 6, "if less than three years" is deleted;

(b) in point 8 (a) of the English version, "a List of published references" is replaced by "a bibliography";

(c) point 9 is replaced by the following:

"9. A summary, in accordance with Article 4a, of the product characteristics, one or more specimens or mock-ups of the sales presentation of the proprietary product, together with a package leaflet where one is to be enclosed."

• 2. 

  The following Article 4a is inserted:

"Article 4a

The summary of the product characteristics referred to in point 9 of the second paragraph of Article 4 shall contain the following information: 1. Name of the proprietary...

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