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

• Published date: 09 February 1965
• Subject Matter: Industry,Technical barriers,Internal market - Principles,Approximation of laws,Health and safety
• Official Gazette Publication: Journal officiel des Communautés européennes, P 22, 9 février 1965

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31965L0065

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

Official Journal 022 , 09/02/1965 P. 0369 - 0373
Finnish special edition: Chapter 13 Volume 1 P. 0067
Swedish special edition: Chapter 13 Volume 1 P. 0067
Danish special edition: Series I Chapter 1965-1966 P. 0017
English special edition: Series I Chapter 1965-1966 P. 0024
Greek special edition: Chapter 13 Volume 1 P. 0025
Spanish special edition: Chapter 13 Volume 1 P. 0018
Portuguese special edition Chapter 13 Volume 1 P. 0018

COUNCIL DIRECTIVE of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (65/65/EEC)

THE COUNCIL OF THE EUROPEAN ECONOMIC COMMUNITY,

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 primary purpose of any rules concerning the production and distribution of proprietary medicinal products must be to safeguard public health;

Whereas, however, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community;

Whereas trade in proprietary medicinal products within the Community is hindered by disparities between certain national provisions, in particular between provisions relating to medicinal products (excluding substances or combinations of substances which are foods, animal feeding-stuffs or toilet preparations) ; and whereas such disparities directly affect the establishment and functioning of the common market;

Whereas such hindrances must accordingly be removed ; and whereas this entails approximation of the relevant provisions;

Whereas, however, such approximation can only be achieved progressively ; and whereas priority must be given to eliminating the disparities liable to have the greatest effect on the functioning of the common market;

HAS ADOPTED THIS DIRECTIVE:

CHAPTER I Definitions and scope

Article 1

For the purposes of this Directive, the following shall have the meanings hereby assigned to them; 1. Proprietary medicinal product:

Any ready-prepared medicinal product placed on the market under a special name and in a special pack.

2. Medicinal product:

Any substance or combination of substances presented for treating or preventing disease in human beings or animals.

Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.

(1) OJ No 84, 4.6.1963, p. 1571/63. (2) OJ No 158, 16.10.1964, p. 2508/64. 3. Substance:

Any matter irrespective of origin which may be: - human, e.g.

human blood and human blood products;

- animal, e.g.

micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products, etc;

- vegetable, e.g.

micro-organisms, plants, parts of plants, vegetable secretions, extracts, etc;

- chemical, e.g.

elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.

Article 2

The provisions of Chapters II to V shall apply only to proprietary medicinal products for human...