CEP Procedure

Certification of Suitability of the Monographs of the European Pharmacopoeia (CEP)

The purpose of the certification procedure is to provide proof that the quality of the substances used in human and veterinary medicines are suitably controlled by the relevant monographs of the European Pharmacopoeia.

The procedure applies to substances for which a monograph (general monograph and/or specific monograph) has been adopted by the European Pharmacopoeia Commission.

The procedure applies to manufacturers (or their authorized representatives) of substances obtained by synthesis, extraction or fermentation, and substances involving TSE risk. Accordingly, both ‘Chemical certificates’ and/or `TSE certificates`or `Herbal drug certificates`are issued.

Applications should be submitted to the EDQM certification division at the address below.

A constantly updated list of certificates granted is published on the EDQM website.

For information about CEP procedure, please contact:

EDQM Certification Division, (European Pharmacopoeia), 7 allée Kastner, CS 30026, F-67081 Strasbourg, France;

Internet: www.edqm.eu

Inquires concerning CEP applications should be addressed to: Certification Division, certification@edqm.eu