Newsroom Certification of suitability
Information for CEP applicants - EDQM-DCEP non-working days in 2025
In order to facilitate the calculation of the timelines as described in the policy document “Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure” (PA-PH-CEP (13) 110,...
CEP Procedure: 30 years of scientific excellence
This year marks the 30th anniversary of the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) Procedure, established by the European Directorate for the Quality of Medicines & HealthCare (EDQM). Since 1994, the CEP procedure has significantly contributed to the...
Certification monthly report of activities: End of November 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of November 2024 Certification Monthly Report For more information, access the Certification Database.
Increasing the EDQM’s global impact: Brazilian health authority to rely on CEP evaluation procedure
In a decision advancing international convergence in pharmaceuticals worldwide, the Brazilian health regulatory authority, Agência Nacional de Vigilância Sanitária (ANVISA), has decided to consider evaluation reports from international regulatory bodies in their decision-making process . This...
CEPs for sterile substances – Guideline for preparing your dossier now available
The European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes to provide further guidance to applicants for the preparation of their dossiers to obtain a Certificate of Suitability (CEP) for a sterile substance. This document clarifies the conditions for acceptability of this...
Certification monthly report of activities: End of October 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of October 2024 Certification Monthly Report For more information, access the Certification Database.
Removal of expiry notifications from the EDQM DCEP Sharing Tool
The EDQM DCEP Sharing Tool is used to share EDQM documents securely between the Certification of Substances Department (DCEP) and CEP holders or applicants. Users receive an e mail with a link when a document is shared with them. Links expire after 60 days, after which time the documents cannot...
Implementation of the European Pharmacopoeia Supplement 11.7 – Notification for CEP holders
Supplement 11.7 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2025, and to follow the...
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.4
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 36.4. The table below lists the substances...
Certification monthly report of activities: End of September 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of September 2024 Certification Monthly Report For more information, access the Certification Database.
Save the date: Webinar Everything you've always wanted to know about the certification (CEP) procedure.
The EDQM invites CEP holders and users to participate in a webinar to facilitate the understanding of the Certification Procedure on 21 November 2024. Programme overview: The EDQM invites CEP holders and users to participate in a webinar to ask any kind of questions on the Certification Procedure...
Certification monthly report of activities: End of August 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of August 2024 Certification Monthly Report For more information, access the Certification Database.
Certification monthly report of activities: End of July 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of July 2024 Certification Monthly Report For more information, access the Certification Database.
Making a significant difference – 2023 EDQM annual report published in new engaging digital format
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published its 2023 annual report. For the first time, the report is completely digital, with a new, intuitive design and interactive features, facilitating your discovery journey and making it...
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.3
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 36.3. The table below lists the substances...
Certification monthly report of activities: End of June 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of June 2024 Certification Monthly Report For more information, access the Certification Database.
Implementation of the European Pharmacopoeia Supplement 11.6 – Notification for CEP holders
Supplement 11.6 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 January 2025, and to follow the...
Certification monthly report of activities: End of May 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May 2024 Certification Monthly Report For more information, access the Certification Database.
Certification monthly report of activities: End of April 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2024 Certification Monthly Report For more information, access the Certification Database.
How to identify the manufacturing sites linked to CEP application (revised document)?
Please consult the revised policy document which has been updated to complete the identification of the manufacturing sites by the SPOR OMS coordinates. The use of these coordinates is mandatory, and companies should ensure that their organisation name and location address(es) given to the EDQM...