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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...
Patient & Consumer Protection / Anti-counterfeiting activities News 22 September 2017 Strasbourg, France
On 21 September 2017, Turkey became the eleventh state to ratify the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (CETS No. 211), also known as the MEDICRIME Convention
Products and Services News 20 September 2017 Strasbourg, France
The 9.4 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 April 2018.

More news

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...
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).
With a view to improving the correspondence between liquid chromatography column brand names and the reagents used to describe the stationary phases used with these columns, an overall review of all the monographs concerned has been...

Agenda

26 September 2017 to 27 September 2017
STRASBOURG
10 October 2017 to 11 October 2017
Strasbourg, France
17 October 2017 to 19 October 2017
Strasbourg, France
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.
  • 38 signatory parties (including the EU) and 29 observers (including WHO and TFDA) as of November 2016.
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 4,200 certificates covering more than 1,000 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 involving a network of around 100 assessors and 30 inspectors from 24 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.: Republic of Moldova becomes 39th Member
Focus

On 24 January 2017, the Permanent Representation of the Republic of Moldova to the Council of Europe handed to Mr Thorbjørn Jagland, Secretary General of the Council of Europe, the instrument of accession to the Convention on the Elaboration of a European Pharmacopoeia [European Treaty Series n° 050], as amended by the Protocol of 16 November 1989.
The Convention has entered into force in the Republic of Moldova on 25 April 2017, making the country the 39th Member State of the European Pharmacopoeia.

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How to order

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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