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Certification of suitability (CEP) / Procedure of certification (general) | News | 09 April 2018 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
European Pharmacopoeia / General | News | 16 February 2018 | Mumbai, Inde
The Indian Pharmacopoeia Commission (IPC) and EDQM are pleased to announce their joint symposium on ‘Drug Standards and Regulatory Updates’ on 26 to 27 April in Mumbai, India.
Certification of suitability (CEP) / Certification content of dossier | News | 29 January 2018 | Strasbourg, France
The EDQM has revised the document « Guidance for electronic submissions for Certificates of Suitability (CEPs) applications ». The requirements with regards the format of CEP submissions have been updated
Certification of suitability (CEP) / Procedure of certification (general) | News | 19 January 2018 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.1 before 31 March 2018.
Certification of suitability (CEP) / Procedure of certification (general) | News | 19 January 2018 | Strasbourg, France
Supplement 9.5 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 1 July 2018, and to follow the instructions given in the document.
Certification of suitability (CEP) / Products with risk of TSE | News | 10 January 2018 | Strasbourg, France
EDQM has revised the guideline "Content of the dossier for a substance for TSE risk assessment". The revision takes into account all recent regulatory changes in the field and a new paragraph has been added with regard to the requirements for raw materials used for medical devices.
Certification of suitability (CEP) | News | 11 October 2017 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, have signed a Memorandum of Understanding which lays the foundation for ANVISA to consider the use of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) for their evaluation of marketing authorisation applications (MAAs) for medicinal...
Certification of suitability (CEP) / CEP new application | News | 10 October 2017 | Strasbourg, France
As of 1 January 2018: eCTD mandatory for new CEP applications and NeeS or eCTD for revision or renewal applications
Certification of suitability (CEP) / Procedure of certification (general) | News | 27 September 2017 | Prague, Czech Republic
The EDQM held a 2-day conference in Prague to exchange with the worldwide pharmaceutical sector and to keep authorities and manufacturers alike informed of recent developments and of the future of its Certification of suitability to the monographs of the European Pharmacopoeia in the global regulatory environment.
Certification of suitability (CEP) | News | 22 September 2017 | Strasbourg, France
Following a recent administrative reform in India, new districts and mandals have been created on the State of Telangana. This reorganisation has an impact for CEPs and applications for CEPs (new and revision).
Certification of suitability (CEP) / CEP new application | News | 22 September 2017 | Strasbourg, France
The company details (name, address, postal code, plot numbers…) mentioned in the application form for a CEP application (holders, manufacturing sites etc.) are reported on the CEPs. This information must therefore be accurately declared.