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Certification of suitability (CEP) | News | 12 October 2017 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 29.4 before 31st December 2017.
Certification of suitability (CEP) | News | 12 October 2017 | Strasbourg, France
Supplement 9.4 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 April 2018, and to follow the instructions given in the document
Certification of suitability (CEP) / Procedure of certification (general) | News | 10 October 2017 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
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 | 23 September 2017 | Strasbourg, France
Register today for a free webinar on ‘How to get acceptance of CEP Revisions quickly’. This webinar will outline the process for applying for revisions of CEP application files and give advice on how to obtain their fast acceptance. Learn about the revisions process, the correct classification of changes, and how to prepare and organise the documentation.
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.
Certification of suitability (CEP) | News | 06 September 2017 | Strasbourg, France
In October, the EDQM will be present at CPhI Worldwide in Frankfurt (Germany). At this yearly gathering of the pharmaceutical industry, the EDQM is looking forward to meeting as many of its clients as possible.
European Pharmacopoeia / International harmonisation | News | 04 September 2017 | Brasília, Brazil
The European Directorate for the Quality of Medicines and HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, today announced the signing of a Memorandum of Understanding (MOU) on their intention to strengthen relations and promote further co-operation in the field of medicines’ quality and science-based pharmacopoeial standards.
EDQM | News | 27 June 2017 | Strasbourg, France
The EDQM has just published its 2016 Annual Report. The report is an opportunity to review the different activities of the past year and reflect on what the EDQM accomplished and developed.