Compliance with clinical trial authorisation
Article 4
1. The manufacturer shall ensure that all manufacturing operations for investigational medicinal products are carried out in accordance with the documentation and information provided by the sponsor pursuant to Article 25 of Regulation (EU) No 536/2014 and as authorised in accordance with the procedure laid down in Chapter II, or if documentation and information was subsequently amended, in Chapter III of abovementioned Regulation (EU) No 536/2014. 2. The manufacturer shall regularly review his manufacturing methods in the light of scientific and technical progress and experience gained by the sponsor during the development of the investigational medicinal product. The manufacturer shall inform the sponsor of his reviews of the manufacturing methods. Where, following a review, an amendment to the clinical trial authorisation is necessary, the application for the amendment shall be submitted in accordance with Article 16 of Regulation (EU) No 536/2014 where the change to the clinical trial is a substantial modification or the amendment shall be carried out in accordance with Article 81(9) of that Regulation where the change to the clinical trial is not a substantial modification.