Article 25 Suspension or revocation of manufacturing authorisation

If an inspection reveals that the holder of an authorisation as referred to in Article 61(1) of Regulation (EU) No 536/2014 fails to comply with good manufacturing practice as set out in Union law, the competent authority may, with regard to this manufacturer, suspend manufacture or imports from third countries of investigational medicinal products for human use, or suspend or revoke the authorisation for a category of preparations or all preparation.