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Certification of suitability (CEP) / CEP new application | News | 26 November 2021 | Strasbourg, France
On 1 October 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) commenced the use of a new IT tool to manage CEP applications. The implementation of this tool requires that timelines for evaluation of all CEP applications and their revisions/renewal be specified in working days instead of calendar days, which will also provide greater clarity on deadlines for...
EDQM / Quality Management system | News | 15 November 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) Laboratory successfully obtained the renewal of its accreditation according to the ISO/IEC 17025:2017 standard in October 2021 from the Belgian accreditation organisation BELAC, confirming the validity of the results generated for its European Pharmacopoeia reference standards. The accreditation scope covers 21...
Certification of suitability (CEP) | News | 27 October 2021 | Strasbourg, France
Would you like to build a career in regulatory affairs? Do you have excellent chemical synthesis or analytical chemistry skills? Do you have the scientific expertise required to check the acceptability of applications for Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) on receipt, to critically review data according to ICH, EU and EDQM guidelines, to prepare...
Certification of suitability (CEP) | News | 20 October 2021 | Strasbourg, France
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 33.4. The table below lists the substances affected by these revisions and for which a CEP has been granted.
Certification of suitability (CEP) | News | 19 October 2021 | Strasbourg, France
Supplement 10.7 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 2022, and to follow the instructions given below.
News | 08 October 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
European Pharmacopoeia / Public enquiry | News | 05 October 2021 | Strasbourg, France
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.4 is 31 December 2021.
Certification of suitability (CEP) / Chemical purity | News | 29 September 2021 | Strasbourg, France
In April 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) reported that it had received information about the possible presence of potentially mutagenic azido impurities in certain sartan active substances. Investigations requested by the EDQM indicated that only a few sources were impacted. A number of measures were taken to ensure that any active substance...
Certification of suitability (CEP) / Procedure of certification (general) | News | 27 September 2021 | Strasbourg, France
A revised version of the terms of reference and rules of procedure for the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure has been adopted by the Certification Steering Committee and is available on the website of the European Directorate for the Quality of Medicines & HealthCare (EDQM): Terms of Reference and Rules of Procedure (PA/PH/CEP (01) 1...
Certification of suitability (CEP) / Procedure of certification (general) | News | 24 September 2021 | Strasbourg, France
From the beginning of October 2021, the CEP Department (DCEP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) will use a new IT application for the management of its activities. The implementation of this tool will entail certain changes in the way the EDQM communicates with applicants for Certificates of Suitability to the European Pharmacopoeia monographs (CEPs...
Certification of suitability (CEP) | News | 14 September 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Certification of suitability (CEP) | News | 01 September 2021 | Strasbourg, France
As the eCTD format is mandatory for the submission of all applications for Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs), except for applications for the risk of transmissible spongiform encephalopathy (TSE) (PDF format) and for substances for veterinary use (eCTD or VNeeS format), the European Directorate for the Quality of Medicines & HealthCare (EDQM)...
Certification of suitability (CEP) | News | 09 August 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
EDQM / Job opportunities | News | 22 July 2021 | Strasbourg, France
Do you have experience in chemical hazard classification and Safety Data Sheet (SDS) requirements? Are you detail-oriented and able to work under pressure and meet deadlines? Do you have the excellent written and oral communication skills required to gather and provide technical information to users? Would you like to contribute to the activities of an International Organisation working for human...
EDQM / Job opportunities | News | 22 July 2021 | Strasbourg, France
Do you have professional media or communications experience, including drafting press releases, social media news and responding to journalist requests, gained in a medical/scientific setting? Alternatively, do you have a scientific background with professional media or communications experience?  Would you be able to lead a team in implementing the EDQM’s communications strategy promoting the...