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Certification of suitability (CEP) News 27 July 2016 Strasbourg, France
The application forms for the submission of new CEP applications and for requests for revision/renewal have been slightly revised.
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Certification of suitability (CEP) / Procedure of certification (general) News 06 July 2016 Strasbourg, France
The last monthly activity report for the Certification of Substances Division (DCEP) is now available for June 2016.
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European Pharmacopoeia / General News 05 July 2016 Strasbourg, France
Do not miss this opportunity to interact with key representatives from the Chinese and European Pharmacopoeias!

More news

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To date, 29 of the 36 General Chapters and 49 of the 67 excipient monographs on the current work programme have been harmonised. Sign-offs at this meeting include a new monograph on...
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During the last European Pharmacopoeia Commission session held in Strasbourg on 15-16 March 2016, a new chapter was adopted...
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The EDQM has revised the document « Guidance for electronic submissions for Certificates of Suitability (CEPs) applications ».

Agenda

27 September 2016 to 28 September 2016
Tallinn, Estonia
27 September 2016 to 30 September 2016
Skopje
04 October 2016 to 06 October 2016
Fira de Barcelona, Gran Via, Barcelona (Spain)
CPhI Worldwide
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.
  • develops also guidance and standards in the areas of blood transfusion, organ transplantation and consumer health issues.
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.
  • 38 signatory parties (including the EU) and 27 observers (including WHO) as of 09 April 2014.
Official Medicines Control Laboratories (OMCL)
In brief
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  • 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 Certification of Suitability
In brief
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  • 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
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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 public health protection.
  • Cosmetics & Packaging Materials: focusing on the safe use of cosmetics and packaging materials for food and medicines.
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CALL FOR EXPERTS: Join the Ph. Eur. network!
Focus
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The Ph. Eur. Commission has now launched a Call for Experts to participate in the preparation of the 10th Edition Ph. Eur. The participation of experts and stakeholders in the Ph. Eur. public standards-setting process is vital for the development of authoritative and relevant monographs. The experts will be (re)appointed at the 156th Session of the Ph. Eur. Commission (15-16 November 2016).  In addition, this invitation is open to experts from non-European Pharmacopoeia member states and non-observers states. The Ph. Eur. Commission is very much looking forward to working with experts from around the world! 
So join the network!

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How to order

Via the internet at store.edqm.eu in order to benefit from free shipping charges for EDQM publications. 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
  • fax: +33 (0)3 88 41 27 71
  • email: orders@edqm.eu

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