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Certification of suitability (CEP) / Procedure of certification (general) News 20 July 2018 Strasbourg, France
Supplement 9.6 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 January 2019, and to follow the instructions given in the document.
Certification of suitability (CEP) / Procedure of certification (general) Guideline 17 July 2018 Strasbourg, France
The EDQM document “Implementation of ICH Q3D in the Certification Procedure” has been revised based on experience gained by EDQM since the initial implementation of the policy. Its implementation date is the 1st September 2018.
European Pharmacopoeia / Monograph News 17 July 2018 Strasbourg, France
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment. If you would like to receive e-mail alerts when an issue is complete, please register for Pharmeuropa online. Pharmeuropa issue 30.3 is now complete. Deadline for...

More news

This project will favour better interaction between the analytical and enforcement actors involved in the fight against falsified medicines and medical devices.
The new monograph on Sulfobutylbetadex sodium (2804) was published in Supplement 9.6 of the European Pharmacopoeia.
The monograph for Water, highly purified (HPW) will be suppressed on 1 April 2019 from the Ph. Eur.

Agenda

09 October 2018 to 11 October 2018
Madrid, Spain
The Vision of the EDQM
In brief
  • 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.
The European Pharmacopoeia
In brief
  • 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.
Official Medicines Control Laboratories (OMCL)
In brief
  • 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.
The Certification of Suitability
In brief

 

  • 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.

 

HealthCare Activities
In brief
  • 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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Ph. Eur. Commission: Uzbekistan became the 30th Observer
Focus

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.

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

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