European Pharmacopoeia
The European Pharmacopoeia (www.edqm.eu) is published by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe in Strasbourg. The publication contains standardised specifications defining the quality of pharmaceutical preparations, their constituents and containers.
The Finnish Medicines Agency (FIMEA) is the Finnish national authority in pharmacopoeia matters.
The European Pharmacopoeia, its supplements, as well as, the Internet and the CD-ROM version can be ordered from:
- EDQM Online Store https://www.edqm.eu/store
- EDQM Publications, (European Pharmacopoeia), 7 allée Kastner, CS 30026, F-67081 Strasbourg, France; fax +33 3 88 41 27 71; e-mail: orders@edqm.eu.
- bookshops.
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 unit 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 Unit, (European Pharmacopoeia), 7 allée Kastner, CS 30026, F-67081 Strasbourg, France; Internet: www.edqm.eu.
Inquires concerning CEP applications should be addressed to:
Certification unit: certification@edqm.eu
Updated 1.1.2010