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European Pharmacopoeia / Announcements | News | 20 November 2019 | Strasbourg, France
Come visit the EDQM stand from 26 to 28 November at the India Expo Centre (1A.N03). At our stand, you can meet the team and find out more about the 10th Edition of the European Pharmacopoeia (Ph. Eur.), the Ph. Eur. Reference Standards and Certificates of Suitability (CEPs).
Certification of suitability (CEP) / Procedure of certification (general) | News | 12 November 2019 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
EDQM / All activities | News | 04 November 2019 | Strasbourg, France
A phishing campaign has been launched from the internet by impersonating an EDQM user in e-mails aimed at infecting the recipients’ computers. These e-mails have been sent from outside the EDQM’s infrastructure, which is why the EDQM has no control over them.
Certification of suitability (CEP) / Procedure of certification (general) | News | 29 October 2019 | Strasbourg, France
EMA and CMDh have published documents on their websites, (EMA/189634/2019 and CMDh/404/2019: “Information on nitrosamines for marketing authorisation holders”), which request marketing authorisation holders (MAH) to follow an investigation process described for synthesised APIs (other than sartans with a tetrazole ring). Although EDQM does not expect this issue to impact many substances, it is...
EDQM / Contact the EDQM | News | 29 October 2019 | Strasbourg, France
Come visit the EDQM stand from 5 to 7 November at the Messe Frankfurt (Hall 8, 80A90). Book a one-to-one session with our colleagues from the Certification Department. They will be happy to answer your questions and discuss issues such as the CEP procedure, CEP applications or inspections.
Certification of suitability (CEP) | News | 09 October 2019 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 31.4 before 31 December 2019.
Certification of suitability (CEP) / Procedure of certification (general) | News | 09 October 2019 | Strasbourg, France
CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of April 2020 in the supplement 10.1 of Ph.Eur, and to follow the instructions given in the document.
Certification of suitability (CEP) | Notes | 30 September 2019 | Strasbourg, France
The EDQM is currently having some difficulty in achieving the assessment times for revisions and renewals of CEP applications - both initial requests and assessment of responses to requests for information. The delay is currently around 5 weeks (i.e. the outcome of the assessment is being communicated 5 weeks after the expected date). EDQM does assure applicants that the outcome will be...
Certification of suitability (CEP) | News | 16 September 2019 | Strasbourg, France
The EDQM is aware of a quality defect in ranitidine medicines used to treat heartburn and stomach ulcers.
Certification of suitability (CEP) / Procedure of certification (general) | News | 17 July 2019 | Strasbourg, France
The EDQM has revised the following documents to reflect current practice and clarify a couple of items: - Terms of reference; - Code of Practice for the Certification procedure.
Certification of suitability (CEP) / Procedure of certification (general) | News | 15 July 2019 | Strasbourg, France
According to the EDQM roadmap for electronic submissions for CEP applications, a major change will be implemented as of 1 January 2020: • eCTD will become mandatory for all CEP applications. • EDQM will stop accepting NeeS submissions for notifications, revisions and renewal applications. Therefore, all such submissions need to be in eCTD format.
EDQM / All activities | News | 09 July 2019 | Strasbourg, France
The international conference “EDQM & European Pharmacopoeia: State-of-the-Art Science for Tomorrow’s Medicines” took place on 19 to 20 June 2019 in Strasbourg to mark the publication of the 10th Edition of the European Pharmacopoeia (Ph. Eur.) and the 25th Anniversary of the European OMCL Network and of the Certification of Suitability Procedure.
Certification of suitability (CEP) / Procedure of certification (general) | News | 18 June 2019 | Strasbourg, France
The EDQM has now finalised the review and update of the vast majority of CEP dossiers for sartans containing a tetrazole ring structure. The CEP dossiers have been assessed following a risk- and science-based approach. When sufficient data was given to demonstrate that there were no risks of presence of nitrosamines and a limit in the specification of the active substance was not necessary (based...
European Pharmacopoeia / Monograph | News | 13 June 2019 | Strasbourg, France
The European Commission has issued its final legally binding decision on medicines containing valsartan, candesartan, irbesartan, losartan and olmesartan on 2 April 2019. This decision was based on the scientific assessment of angiotensin-II-receptor antagonists (sartans) containing a tetrazole group performed by the Committee for Medicinal Products for Human Use (CHMP), the conclusions of which...
EDQM / All activities | News | 06 June 2019 | Strasbourg, France
The latest EDQM Annual Report provides an overview of its accomplishments. In 2018 much was accomplished in the field of setting quality standards for the manufacture and control of medicines in Europe and beyond.