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Certification of suitability (CEP) / Procedure of certification (general) | News | 13 January 2020 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Products and Services | News | 07 January 2020 | Strasbourg, France
The 10.2 supplement of the European Pharmacopoeia is now available and will be applicable in 38 European countries as of 1 July 2020.
EDQM / All activities | News | 21 November 2019 | Strasbourg, France
As part of its efforts to improve customer service, the EDQM has developed a streamlined version of its HelpDesk and FAQs platform. The new HelpDesk was redesigned on the basis of feedback received from users and now benefits from a more intuitive interface, which is expected to enhance customer support and improve user experience.
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...
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.