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Update on the review of CEP applications for sartans and the availability of test methods for nitrosamines
European network of OMCLs News 17 October 2018 Strasbourg, France
Following the detection of the impurity NDMA (N-nitrosodimethylamine) in valsartan at the end of June, the EDQM has conducted a complete review of the manufacturing information submitted in all Certificate of suitability (CEP) applications for valsartan and other structurally related...
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New OMCL method for simultaneous determination of NDMA and NDEA in sartans
European network of OMCLs News 11 October 2018 Strasbourg, France
Today the first method for simultaneous determination of NDMA and NDEA in Sartan tablets, developed and validated for Valsartan tablets has been released by the German OMCL in Karlsruhe.
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Ph. Eur. Supplement 9.7: CEP holders are invited to update their applications
Certification of suitability (CEP) / Procedure of certification (general) News 09 October 2018 Strasbourg, France
Supplement 9.7 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 April 2019, and to follow the instructions given in the document.
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Revised Guideline on requirements for revision/renewal of CEPs
The revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ (PA/PH/CEP (04) 2 7R) will enter into force in January 2019. Notable changes include the...
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Certification Monthly Report of Activities: September 2018
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
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New Council of Europe’s EDQM publication on the donation of oocytes
This publication aims at providing clear, accurate and balanced information to women about the donation of oocytes (also known as egg cells).
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Agenda

23 October 2018 to 24 October 2018
Strasbourg, France
Training Course on Statistical Process Control (SPC) for ...
29 November 2018
Strasbourg, France
FREE Webinar - ‘How to read a CEP’
12 December 2018 to 14 December 2018
New Delhi, India
CPhI India & CEP One-to-One Sessions

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See Reference standards Catalogue
See Reference standards Catalogue
Ph. Eur. 9th Edition presentation
Ph. Eur. 9th Edition presentation
Reference Standards & publication store
Reference Standards & publication store
Free Publications and Databases
Free Publications and Databases
Certification of Suitability (CEP) News
Certification of Suitability (CEP) News
Have a question? FAQ & HelpDesk
https://www.edqm.eu/en/news/all
The Vision of the EDQM
In brief
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  • A Directorate of the Council of Europe created in 1964.
  • A leading organisation that protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use.
  • Also develops guidance and standards in the areas of blood transfusion, organ transplantation and consumer health issues.
https://www.edqm.eu/en/news/european-pharmacopoeia
The European Pharmacopoeia
In brief
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  • Main objective is to provide common quality standards to control the quality of medicines and of substances used in the manufacture of medicines (human and veterinary use).
  • Legally binding in European member states.
  • 39 signatory countries (including the EU) and 30 observers (including WHO and TFDA) as of December 2017.
https://www.edqm.eu/en/news/omcl-network
Official Medicines Control Laboratories (OMCL)
In brief
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  • A network of independent public laboratories appointed by the national authorities.
  • Around 70 laboratories provide human and technical resources to implement testing programmes.
  • 36 European countries and 5 countries outside Europe participate in the various activities and programmes.
https://www.edqm.eu/en/news/certification-of-suitability
The Certification of Suitability
In brief
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  • Established in 1994.
  • Over 4,900 certificates covering more than 1,100 substances have been granted in more than 60 countries.
  • Assessment is jointly performed by a network of around 100 assessors from the national competent authorities and EDQM assessors.
  • Organises an inspection programme involving a network of around 30 inspectors from 20 different national competent authorities and the EDQM.

 

https://www.edqm.eu/en/news/transfusion-and-transplantation
HealthCare Activities
In brief
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  • Blood Transfusion & Organ Transplantation: elaborating ethical, legal and safety standards.
  • Pharmaceutical Care : developing and promoting best practices
  • Anti-counterfeiting activities: supporting the protection of public health.
  • Cosmetics & Packaging Materials: focusing on the safe use of cosmetics and packaging materials for food and medicines.
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https://www.edqm.eu/en/membership-observership
Ph. Eur. Commission: Uzbekistan became the 30th Observer
Focus
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During its March 2018 session, the Ph.Eur. Commission unanimously decided to grant Uzbekistan observer status. This brings to 30 the number of observers, from 6 continents. As observer, Uzbekistan can participate in the scientific work of the Commission and its expert meetings, attend Commission sessions and become involved in other EDQM activities. Observer status also facilitates development of a mutually-beneficial relationship and sharing of expertise on issues pertinent to the quality of medicines and healthcare.

More information on Ph. Eur. Members and observers.

Latest products and services

27 September 2018
Ph. Eur. Supplement 9.7 available now
07 September 2018
9 new Ph. Eur. Reference Standards released in August 2018
17 July 2018
4 elemental impurity chemical reference standards (CRS) available in...
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Via our web store at store.edqm.eu in order to benefit from free handling charges (on publications only). Alternatively, you can send your order to the EDQM Sales section by :

  • post: EDQM – Council of Europe, 7 allée Kastner, CS 30026, 67081 Strasbourg, France
  • email: orders@edqm.eu

Invoices can be paid by credit card via internet or by bank transfer.

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https://www.edqm.eu/en/../en/presentation-edqm
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