Newsroom Certification of suitability
CEP 2.0: new requirements for the content of the chemical purity and herbal drugs/herbal drug preparation dossiers
The European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes to provide further clarification regarding the presentation and content of the “Specification” section (3.2.S.4.1) to all applicants preparing an application in CEP 2.0 format. When completing section 3.2.S.4.1,...
Certification monthly report of activities: End of September 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of September 2023 Certification Monthly Report For more information, access the Certification Database.
CEP holders invited to comment on draft monographs published in Pharmeuropa 35.4
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 35.4. The table below lists the substances...
Implementation of the European Pharmacopoeia Supplement 11.4 – Notification for CEP holders
Supplement 11.4 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 2024, and to follow the...
CEP 2.0 – Certificates of suitability: electronic signature features
On 1 September 2023, the European Directorate for the Quality of Medicines & HealthCare (EDQM) implemented electronic signatures for CEPs and some other documents as part of the CEP 2.0 project. A document explaining the features of electronic signatures is now available on our website:...
Changes to the acceptability of CEP applications for sterile grade materials
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is updating its policy concerning the acceptability of CEP applications for sterile active substances. Until now, acceptability requirements have applied to the manufacturing processes only when the manufacturer of the...
CEP 2.0: Changes from September 2023 to information published in Certification Online and Knowledge databases
The launch of CEP 2.0 will bring changes, beginning in September, to the information on CEPs published on the Certification Online and Knowledge databases. The tabulated data will now include additional columns showing SPOR ORG and LOC-ID information for the holder where this is available,* as...
Certification monthly report of activities: End of August 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of August 2023 Certification Monthly Report For more information, access the Certification Database.
Certification monthly report of activities: End of July 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of July Certification Monthly Report For more information, access the Certification Database.
CEP 2.0: The CEP letter of access is ready for use!
The replacement of the declaration of access box on the CEP document by a separate letter of access is one of the changes introduced with the implementation of the CEP 2.0. The template for this letter is now finalised taking into account comments received during the public consultation. The CEP...
Important update on N-nitrosamine impurities in substances covered by CEPs
On 7 July 2023, the EMA published a revised version of the “Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products”. This update includes new...
CEP 2.0: implementation date
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is pleased to announce that the CEP 2.0 will be implemented on 1 September 2023. From that date onwards, new dossier applications and renewal applications will receive a CEP 2.0, whereas revision applications will receive a...
Implementation of the European Pharmacopoeia Supplement 11.3 – Notification for CEP holders
Supplement 11.3 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 2024, and to follow the...
CEP holders invited to comment on draft monographs published in Pharmeuropa 35.3
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 35.3. The table below lists the substances...
Certification monthly report of activities: End of June 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of June 2023 Certification Monthly Report For more information, access the Certification Database.
2022 Highlights – EDQM annual report now available
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its 2022 annual report, providing a comprehensive overview of its activities and achievements, and putting select data on the present state of EDQM/Council of Europe public health initiatives at your...
CEP 2.0: List of authorities and organisations which have access to assessment and/or inspection reports.
In line with previous communication on CEP 2.0 related to the Authorities database and the updated Holder’s Commitment, the EDQM has now published the list of authorities and organisations with which the EDQM has a Memorandum of Understanding and/or Confidentiality Agreement in place allowing...
Revised Policy document PA/PH/CEP (04) 1, 7R on Content of the CEP dossier released for public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is revising the policy document PA/PH/CEP (04) 1, 6R ‘Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use’. The draft document for public...
Certification monthly report of activities: End of May 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May 2023 Certification Monthly Report For more information, access the Certification Database.
Certification monthly report of activities: End of April 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2023 Certification Monthly Report For more information, access the Certification Database.