S.L. 458.42 ст. 6Compliance with marketing authorisation.

(1) It shall be the duty of the manufacturer to ensure that all manufacturing operations for medicinal products subject to a marketing authorisation are carried out in accordance with the information provided in the application for marketing authorisation as accepted by the Licensing Authority.

(2) It shall be the duty of the manufacturer to review regularly his manufacturing methods in the light of scientific and technical progress.

(3) If a variation to the marketing authorisation dossier is necessary, the application for modification shall be submitted to the Authority.