Directive 1991/356 - Principles and guidelines of good manufacturing practice for medicinal products for human use - Main contents

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Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use

Official Journal L 193 , 17/07/1991 P. 0030 - 0033

Finnish special edition: Chapter 13 Volume 20 P. 0206

Swedish special edition: Chapter 13 Volume 20 P. 0206

COMMISSION DIRECTIVE of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (91/356/EEC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to 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 (1), as last amended by Directive 89/381/EEC (2), and in particular Article 19a thereof,

Whereas all medicinal products for human use 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 19a of Directive 75/319/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 accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Proprietary Medicinal Products Sector set up by Article 2b of Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (3), as last amended by Directive 89/341/EEC (4),

HAS ADOPTED THIS DIRECTIVE: CHAPTER I GENERAL PROVISIONS

Article 1

This Directive lays down the principles and guidelines of good manufacturing practice for medicinal products for human use whose manufacture requires the authorization referred to in Article 16 of Directive 75/319/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 (5), shall apply.

In addition,

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  'manufacturer' shall mean any holder of the authorization referred to in Article 16 of Directive 75/319/EEC,

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  'qualified person' shall mean the person referred to in Article 21 of Directive 75/319/EEC,

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  'pharmaceutical quality assurance' shall mean the sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use,

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  'good manufacturing practice' shall mean the part of quality assurance which ensures...

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