null Revised Guideline on requirements for revision/renewal of CEPs: corrected version available

EDQM Strasbourg, France 20/11/2018

N.B. A corrected version of the guidelines is available where under change 4.II.1.1 c) & e) specific documentation 2 has been deleted and under 4.II.1.2. condition 4 has been deleted since superfluous.

The revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ (PA/PH/CEP (04) 2 7R) will enter into force in January 2019. Notable changes include the classification of changes related to the introduction of a new manufacturer of a starting material (see page 7), explicit reference to recent changes in the regulatory environment e.g. ICH M7 or, in the context of the implementation of ICH Q3D in the Certification procedure, the possibility to introduce/change a Risk management summary (RMS).The document also lists an expanded number of situations where revision of an existing CEP will no longer be possible and a new separate CEP application is required.

Examples include the introduction of a new substantially different route of synthesis (even when the impurity profile of the final substance is equivalent), unless it replaces the current process, or the addition of a new manufacturing site of the final substance which does not belong to the same group, even when specifications are unchanged (see page 3 for a complete list of these situations).
The EDQM will publish in the near future clarification and the procedures on how to handle separate applications when needed.