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The Vision of the EDQM
- 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.
- Develops also 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.
- 37 signatory parties (including the EU) and 25 observers (including WHO) in 2012.
Official Medicines Control
Laboratories (OMCL) in Brief
- A network of official laboratories appointed by the national authorities.
- 80 laboratories pool human and technical resources to implement testing programmes.
- 30 European countries participate in the various activities and programmes.
The Procedure for Certification
of Suitability (CEP) in Brief
- Established in 1994.
- Over 3500 certificates covering 850 substances have been granted in more than 50 countries.
- Assessment is jointly performed by assessors from the national competent authorities and EDQM assessors
- Organises an inspection programme to check compliance with both GMP and the CEP with a network of national inspectors.
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 public health protection.
- Cosmetics & Packaging Materials: focusing on the safe use of cosmetics and packaging materials for food and medicines.
The Vision of the EDQM
- 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.
- Develops also guidance and standards in the areas of blood transfusion, organ transplantation and consumer health issues.
Latest News
21 May 2013
EDQM participates in the 23rd Regional Congress of the ISBT
This event is especially significant as the EDQM will present its new edition of the Guide to the Preparation, Use and Quality Assurance of Blood Components (17th Edition 2012).
06 May 2013
The eTACT service continues its progress
The eTACT project has taken further steps towards achieving a secure, patient-friendly and cost-effective traceability service for medicines.
06 May 2013
The EDQM Store gets a facelift!
The EDQM begins to roll out its completely redesigned EDQM Store. Read all about the changes in the new Store
Focus
Focus
The EDQM, Council of Europe is a proud supporter of World Blood Donor Day and its objectives of:
• thanking blood donors for their life-saving donations;
• promoting voluntary unpaid blood donation; and
• promoting self-sufficiency in safe blood and blood products based on voluntary unpaid blood donation.
The host country for World Blood Donor Day 2013 is France, through its national blood service, the Etablissement Français du Sang (EFS).
The Medicrime Convention
Latest update: Morocco
The Medicrime Convention, drawn up by the Council of Europe, is the first international treaty against counterfeit medical products and similar crimes involving threats to public health. The Convention has been signed by 22 countries, member and non-member states of the CoE, and ratified by 1 country. The latest signatures include Morocco (13/12/12), Guinea (10/10/12), Spain (08/10/12), Armenia (20/09/12) and Moldova (20/09/12).
Impact on European Pharmacopoeia texts of Directive 2010/63/EU
on protection of animals used for scientific purposes
Chairs of Ph. Eur. Groups of Experts met EU representatives and stakeholders to evaluate the impact of the Directive on Ph. Eur. texts. In a continued endeavour to disseminate the use of the 3R principles, Experts evaluated optimal measures to encourage and support the implementation of the 3R’s, in accordance with the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes and in line with the new EU directive.
The Council of Europe reinforces the need for strong ethical, safety and quality measures.
Transplant medicine and transplantation have progressed during recent decades. An organ or tissue donation can significantly improve a person’s quality of life and even save their life. In addition to the ethical issues, all transplanted material of human origin, human cells and tissues carry risks of disease transmission, which must be controlled by the application of stringent donor selection criteria and comprehensive quality systems. > More on Human Tissues and Cells
The EDQM, Council of Europe is a proud supporter of World Blood Donor Day and its objectives of:
• thanking blood donors for their life-saving donations;
• promoting voluntary unpaid blood donation; and
• promoting self-sufficiency in safe blood and blood products based on voluntary unpaid blood donation.
The host country for World Blood Donor Day 2013 is France, through its national blood service, the Etablissement Français du Sang (EFS).
Upcoming Events
2-5 June 2013
23rd Regional Congress of the ISBT
Amsterdam, The Netherlands
14 June 2013
World Blood Donor Day
Paris, France
25-27 June 2013
CPhI China
Shanghai, China
Products & Services
Products and Services
A New design for the EDQM Store
The EDQM begins to roll out its completely redesigned EDQM Store. Clients will still be able to order or request quotations for publications, and make payments. However, the new redesigned website will also allow clients to check the status of their order and track shipments. The site will be fully operational by mid-May. The address of the new Store remains unchanged: www.edqm.eu/store.
Pharmeuropa – Issue 25.2 now complete
Deadline for comments: 30 June 2013
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.
EDQM Releases New Edition of ‘Organ, Tissue and Cells Guide’ Publication
The EDQM has just released the 2nd edition of its ‘Organ, Tissue and Cells’ Guide. This publication compiles all of the existing recommendations and resolutions, as well as some additional reports from the Council of Europe. The publication is FREE to download.
7th Edition Packages
The EDQM proposes three different packages for customers that wish to purchase several formats at the same time. The electronic versions (USB Key & Online) are completely cumulative and have some unique features such as fully searchable; hyperlinks in the text of a monograph give access to information on general methods as well as links to the EDQM’s Knowledge and Reference Standards databases.
Safe Cosmetics for Young Children - 1st Edition
This Guide emphasizes the importance of safety evaluation of cosmetic products for infants and provides guidance and support for manufacturers and safety assessors. It is available in print version in English. An online version will soon be available for all purchasers of the print version.
EDQM Reference Standards
New batches and products available daily
The EDQM supplies over 2400 reference standards. Information on the standards is freely available via its online database which gets updated daily. This database also provides a link to the entire catalogue and a list of the newly adopted batches and new products.
A New design for the EDQM Store
The EDQM begins to roll out its completely redesigned EDQM Store. Clients will still be able to order or request quotations for publications, and make payments. However, the new redesigned website will also allow clients to check the status of their order and track shipments. The site will be fully operational by mid-May. The address of the new Store remains unchanged: www.edqm.eu/store.
EDQM Council of Europe
7 allée Kastner, CS 30026,
F67081 Strasbourg, France
Tel. +33 (0)3 88 41 30 30
Fax +33 (0)3 88 41 27 71
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