Article 3
By means of the repeated inspections referred to in Article 34 of Directive 81/851/EEC, the Member States shall ensure that manufacturers respect the principles and guidelines of good manufacturing practice laid down by this Directive. For the interpretation of these principles and guidelines of good manufacturing practice, the manufacturers and the agents of the competent authorities refer to the detailed guidelines referred to in Article 27a of Directive 81/851/EEC. These detailed guidelines are published by the Commission in the "Guide to good manufacturing practice for medicinal products" and in its annexes (Office for Official Publications of the European Communities, The Rules Governing Medicinal Products in the European Community, Volume IV).