L 26222 Official Journal of the European Union 14.10.2003 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, 7y  All manufacturers should operate an effective quality Having regard to the Treaty establishing the European Community, Having regard to Directive 2001/83/EC of the European Parlia- ment and of the Council of 6 November 2001 on the Commu- nity code relating to medicinal products for human use (), as last amended by Commission Directive 2003/63/EC (), 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 Commis- sion 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)  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 administra- tive 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 (%) requires that detailed guidance be drawn up, in accor- dance with the guidelines on good manufacturing prac- tice, 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 provi- sions of Directive 91/356/EEC to cover good manufac- turing 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. () OJ L 311, 28.11.2001, p. 67. () OJ L 159, 27.6.2003, p. 46. () OJ L 193,17.7.1991, p. 30. (% OJL121,1.5.2001, p. 34. 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. (99 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 label- ling of those products are necessary. (10)  The measures provided for in this Directive are in accor- dance 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 authorisation referred to in Article 13 of Directive 2001/20/EC. Atticle 2 Definitions For the purposes of this Directive, the following definitions shall apply: 1. ‘medicinal product’ means any product as defined in Article 1(2) of Directive 2001/83/EC; 2. ‘investigational medicinal product’ means any product as defined in Article 2(d) of Directive 2001/20/EC; 3. ‘manufacturer’ means any person engaged in activities for which the authorisation referred to in Article 40(1) and (3) of Directive 2001/83/EC or the authorisation referred to in Article 13(1) of Directive 2001/20/EC is required;