EDQM: Updated Guideline on CEP Revisions and Renewals
The European Directorate for the Quality of Medicines & HealthCare has published a revised version of its guideline on the revision and renewal of Certificates of Suitability (CEPs) (PA/PH/CEP (04) 02), aligning it with recent EU legislation on variation procedures.
The update clarifies situations where revision of an existing CEP is not possible and a new application is required. It also provides guidance on CEP 2.0 and expectations for risk assessments.
A two-month transition period applies following publication. The revised guideline will become fully applicable from 1 July 2026.
Source:
EDQM: Newsroom
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