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Certification of suitability (CEP) | News | 12 August 2020 | Strasbourg, France
The EDQM has concluded its investigation following reports that paracetamol manufactured by a specific company holding a certificate of suitability could be contaminated with the impurity 4-chloroaniline (PCA).
Certification of suitability (CEP) / Procedure of certification (general) | News | 10 August 2020 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Certification of suitability (CEP) / Procedure of certification (general) | News | 23 July 2020 | Strasbourg, France
Supplement 10.3 of the Ph. Eur is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of January 2021, and to follow the instructions given in the document.
Certification of suitability (CEP) / CEP revision | News | 21 July 2020 | Strasbourg, France
Following experience gained since the introduction of the revised EDQM Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 7R corr) in January 2019, this announcement is intended to clarify a couple of items.
Certification of suitability (CEP) / Procedure of certification (general) | Certificate of suitability (CEP) | 16 July 2020 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 32.3 before 30 September 2020.
Certification of suitability (CEP) / API | News | 10 July 2020 | Strasbourg, France
Following the publication of an article in the Dutch newspaper Nieuwe Rotterdamsche Courant Handelsblad (NRC) concerning an impurity (4-chloroaniline) in the active substance paracetamol manufactured by a specific company which holds a certificate of suitability, the EDQM is actively working with the company and other stakeholders to better understand the potential impact of this impurity and the...
EDQM / All activities | News | 30 June 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare’s 2019 annual report is now available, providing a comprehensive overview of our activities in 2019 and information on our achievements and events.
Certification of suitability (CEP) | News | 23 June 2020 | 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...
EDQM / All activities | News | 11 June 2020 | Strasbourg, France
The EDQM’s core activities include the provision of documentary and physical (reference) standards to ensure the quality of medicines and their ingredients. Availability of and access for patients to quality medicines is more important than ever in the context of the current COVID-19 pandemic.
EDQM / All activities | News | 24 April 2020 | Strasbourg, France
Free training resources: online sessions for home learning – Sign up today! Online training is the ideal way to improve your skills during quarantine. Why not make the most of your time at home to pick up new skills and gain valuable knowledge by attending an online training session? The good news is that all the EDQM training sessions and webinars are available free online, covering a wide...
Certification of suitability (CEP) / CEP new application | News | 14 April 2020 | Strasbourg, France
In the context of having switched to working remotely during the COVID-19 pandemic, the EDQM has prioritised certain activities linked with CEPs over others and it is important to share this with our stakeholders.
Certification of suitability (CEP) / Procedure of certification (general) | Notification | 07 April 2020 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 32.2 before 30 June 2020. More information in document PA/PH/CEP (20) 17.
Certification of suitability (CEP) / Nitrosamines | News | 27 March 2020 | Strasbourg, France
The EDQM recognises that due to the impact of the global outbreak of COVID-19, many CEP holders are encountering significant challenges in completing the work within the timelines previously announced in the EDQM request to CEP holders to perform a risk evaluation of their chemically synthesised APIs with regards nitrosamine formation, published on the EDQM Website (EDQM request October 2019).
EDQM / All activities | News | 19 March 2020 | Strasbourg, France
Due to the measures implemented by the French government in its fight against the COVID-19 pandemic, the EDQM will, until further notice, only be able to answer queries through its Online HelpDesk. We will continue to do our utmost to provide you with the best possible service, but please note that there may still be delays in processing requests.
Certification of suitability (CEP) | News | 13 March 2020 | Strasbourg, France
The EDQM would like to inform CEP holders of the impact of the COVID-19 outbreak on activities related to the CEP procedure. With regards to sending CEPs, due to issues experienced in shipping/delivering CEPs in some zones considered at risk, the EDQM is contacting the relevant CEP holders in advance to confirm that delivery is possible or to propose alternatives when companies are closed.