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Pharmaceutical care / Publications News 15 March 2018 Strasbourg, France
The EDQM has issued its Guidelines on ‘Best Practice for the Automated Dose Dispensing (ADD) Process and Care and Safety of Patients’. ADD is an automated process, which allows one or more medicinal products to be dispensed into a container/pouch for a patient to take at a particular...
Products and Services News 12 March 2018 Strasbourg, France
9 new Ph. Eur. Reference Standards (RS) were released in February 2018
Certification of suitability (CEP) / Procedure of certification (general) News 05 March 2018 Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

More news

The EDQM has revised the document « Guidance for electronic submissions for Certificates of Suitability (CEPs) applications ». The requirements with regards the format of CEP submissions have been updated
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.1 before 31 March 2018.
EDQM has revised the guideline "Content of the dossier for a substance for TSE risk assessment". The revision takes into account all recent regulatory changes in the field and a new paragraph has been added with regard to...


27 March 2018 to 28 March 2018
26 April 2018 to 27 April 2018
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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 29 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.
Ph. Eur.: Republic of Moldova becomes 39th Member

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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