Compliance with marketing authorisation
Article 5
1. The Member States shall ensure that all manufacturing or import operations for medicinal products subject to a marketing authorisation are carried out by manufacturers in accordance with the information provided in the application for that marketing authorisation. 2. The Member States shall oblige the manufacturer to regularly review his manufacturing methods in light of scientific and technical progress. If a variation to the marketing authorisation dossier is necessary, the variation shall take place by the arrangements established in accordance with Article 23b of Directive 2001/83/EC.