CEP (Certificate of Suitability)
An EDQM-issued certificate confirming an API meets European Pharmacopoeia quality standards.
Definition
A Certificate of Suitability, issued by the European Directorate for the Quality of Medicines (EDQM), confirms that an API's specifications comply with the relevant European Pharmacopoeia monograph. It is the EU equivalent of a US DMF for API market access.
Why It Matters
Buyers formulating for the EU market will typically ask whether an API is CEP-backed before proceeding.