Certification of suitability to the Monographs of the European Pharmacopoeia GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS
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.
These categories are based on those (IA-IAIN/IB/II) of the European Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and also Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC and Commission Implementing and Regulation (EU) 2021/17 establishing a list of variations not requiring assessment. Classification of changes may differ occasionally due to specific CEP needs and leading sometimes to a different approach.
In addition, this guideline describes the requirements for the renewal of CEPs and for a transfer of holdership.
CEP holders are encouraged to submit all annual notifications together once a year, but which may also be submitted accompanied by other types of changes.
Where a group of changes consists of different types of revisions, the group must be submitted and handled according to the “highest” revision type included in the group.
CEP holders are reminded that in case of submission of only notifications, but which includes changes not classifiable as a notification, will be rejected and the changes will then need to be resubmitted using the correct classification (with associated documentation and fee).
The possibility to change format of the CEP is also specifically addressed, following implementation of the CEP 2.0.
This guideline should be read in conjunction with PA/PH/CEP (24) 51 “Stepwise process to get a CEP/having a change approved”.