Directive 2003/94 - Principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use - Main contents

official title

Avis juridique important

|

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Text with EEA relevance)

Official Journal L 262 , 14/10/2003 P. 0022 - 0026

Commission Directive 2003/94/EC

of 8 October 2003

laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(1), as last amended by Commission Directive 2003/63/EC(2), and in particular Article 47 thereof,

Whereas:

• (1) 

  All medicinal products for human use manufactured or imported into the Community, including medicinal products intended for export, are to be manufactured in accordance with the principles and guidelines of good manufacturing practice.

• (2) 

  Those principles and guidelines are set out in 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(3).

• (3) 

  Article 13(3) of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(4) requires that detailed guidance be drawn up, in accordance with the guidelines on good manufacturing practice, on the elements to be taken into account when evaluating investigational medicinal products for human use with the object of releasing batches within the Community.

• (4) 

  It is therefore necessary to extend and adapt the provisions of Directive 91/356/EEC to cover good manufacturing practice of investigational medicinal products.

• (5) 

  Since most of the provisions of Directive 91/356/EEC need to be adjusted, for the sake of clarity that Directive should be replaced.

• (6) 

  In order to ensure conformity with the principles and guidelines of good manufacturing practice, it is necessary to lay down detailed provisions on inspections by the competent authorities and on certain obligations of the manufacturer.

• (7) 

  All manufacturers should operate an effective quality management system of their manufacturing operations, which requires the implementation of a pharmaceutical quality assurance system.

• (8) 

  Principles and guidelines of good manufacturing practice should be set out in relation to quality management, personnel, premises and equipment, documentation, production, quality control, contracting out, complaints and product recall, and self-inspection.

• (9) 

  In order to protect the human beings involved in clinical trials and to ensure that investigational medicinal products can be traced, specific provisions on the labelling of those products are necessary.

• (10) 

  The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use, set up under Article 121 of Directive 2001/83/EC,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Scope

This Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use whose manufacture requires the authorisation referred to in Article 40 of Directive 2001/83/EC and in respect of investigational medicinal products for human use whose manufacture requires the...

This text has been adopted from EUR-Lex.

This page is also available in a full version containing the summary of legislation, the legal context, de Europese rechtsgrond, other dossiers related to the dossier at hand and finally the related cases of the European Court of Justice.