Directive 1991/412 - Principles and guidelines of good manufacturing practice for veterinary medicinal products - Main contents

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Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products

Official Journal L 228 , 17/08/1991 P. 0070 - 0073

Finnish special edition: Chapter 3 Volume 38 P. 0156

Swedish special edition: Chapter 3 Volume 38 P. 0156

COMMISSION DIRECTIVE of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (91/412/EEC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 81/851/EEC of 28 September 1981 concerning the approximation of the laws of the Member States relating to veterinary medicinal products (1), as last amended by Directive 90/676/EEC (2), and in particular Article 27a,

Having regard to Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products (3),

Whereas all veterinary medicinal products manufactured or imported into the Community, including medicinal products intended for export should be manufactured in accordance with the principles and guidelines of good manufacturing practice;

Whereas, in accordance with national legislation, Member States may require compliance with these principles of good manufacturing practice during the manufacture of products intended for use in clinical trials;

Whereas the detailed guidelines mentioned in Article 27a of Directive 81/851/EEC have been published by the Commission after consultation with the pharmaceutical inspection services of the Member States in the form of a "Guide to good manufacturing practice for medicinal products";

Whereas it is necessary that all manufacturers should operate an effective quality management of their manufacturing operations, and that this requires the implementation of a pharmaceutical quality assurance system;

Whereas officials representing the competent authorities should report on whether the manufacturer complies with good manufacturing practice and that these reports should be communicated upon reasoned request to the competent authorities of another Member State;

Whereas the principles and guidelines of good manufacturing practice should primarily concern personnel, premises and equipment, documentation, production, quality control, contracting out, complaints and product recall, and self inspection;

Whereas the principles and guidelines envisaged by this Directive are in conformity with the opinion of the Committee for Adaptation of Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector created by Article 2b of Directive 81/852/EEC of 28 September 1981 concerning the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (4), as last amended by Directive 87/20/EEC (5),

HAS ADOPTED THIS DIRECTIVE:

CHAPTER I GENERAL PROVISIONS

Article 1

This Directive lays down the principles and guidelines of good manufacturing practice for veterinary medicinal products whose manufacture requires the authorization referred to in Article 24 of Directive 81/851/EEC.

Article 2

For the purposes of this Directive, the definition of medicinal products set out in Article 1 (2) of Council Directive 65/65/EEC (6), and the definition of veterinary medicinal products set out in Article 1 (2) of Directive 81/851/EEC, shall apply.

In addition, - "manufacturer" shall mean any holder of the authorization referred to in Article 24 of Directive 81/851/EEC,

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  "qualified person" shall mean the person referred to in Article 29...

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