Article 5
The manufacturer shall ensure that all manufacturing operations subject to an authorization for marketing are carried out in accordance with the information given in the application for marketing authorization as accepted by the competent authorities. The manufacturers shall regularly review their manufacturing methods in the light of scientific and technical progress. When a modification to the marketing authorization dossier is necessary, the application for modification must be submitted to the competent authorities. CHAPTER II PRINCIPLES AND GUIDELINES OF GOOD MANUFACTURING PRACTICE