Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2 7R corr, September 2018)

The holder of a certificate of suitability (CEP) shall inform the EDQM of any change to information in the CEP application by sending an appropriate request for revision demonstrating that the conditions laid down in the present guideline are met.