Certification of Suitability News
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Certification Monthly Report of Activities
(14/05/13) The Certification of Substances Division (DCEP) will publish on a monthly basis, a report containing some relevant figures relating to its main activities. April 2013 Certification Monthly Report
CEPs for Herbal drug preparations
The EDQM guideline “Content of the dossier for herbal drugs and herbal drugs preparation quality evaluation” has been revised
(12/04/13) The EDQM has revised the document “Content of the dossier for herbal drugs and herbal drugs preparation quality evaluation”. The documentation to be submitted has been updated to reflect the current regulatory requirements.
Definition section of Ph. Eur. monographs and CEPs
(04/02/13) The EDQM would like to inform applicants that new applications for a Certificate of Suitability, for which the substance is not in line with the requirements of the Definition Section of the related monograph, are no longer accepted.
CEPs for Herbal drug preparations
Clarification on Drug extract ratio (DER)
(28/01/13) For better use of CEPs for Herbal Drug preparations by applicants and national licensing Authorities, the EDQM clarifies the following points:
- The drug extract ratio (DER) is systematically mentioned as a sub-title on CEPs for extracts. Those CEPs granted before May 2012 will be progressively updated as they are being revised.
- The DER mentioned on CEPs corresponds to the DER calculated on the genuine extract (extract without excipients).
- The DER is displayed in the public Certification database.
Renewal of EDQM ISO 9001 :2008 Certification
and extension of its scope to pharmacopoeial activities
(11/01/13) The certification was awarded by Afnor Certification (AFAQ) in December 2012. To register as ISO 9001:2008 compliant, the EDQM underwent a stringent evaluation process that included its quality management system, a full documentation review and staff training and competence management.
Event
8th Edition European Pharmacopoeia Training Session (Chemicals)
Strasbourg, France
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Actions on CEPs
- Read the updates on the latest CEP suspensions, CEP withdrawals and CEP restorations.
- EDQM Policy ‘Suspension or Cancellation of a Certificate of Suitability' PA/PH/CEP (08) 17, R3
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Additional information
EDQM Council of Europe
7 allée Kastner, CS 30026,
F67081 Strasbourg, France
Tel. +33 (0)3 88 41 30 30
Fax +33 (0)3 88 41 27 71
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