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Reference Standard / General News 16 November 2018 Strasbourg, France
The expertise of the EDQM laboratory has recently been confirmed by an ISO 17025 accreditation for Nuclear Magnetic Resonance spectroscopy (NMR) and quantitative Nuclear Magnetic Resonance spectroscopy (qNMR). These modern and state of the art techniques further expand the technical...
Transplantation / Legal Framework News 08 November 2018 Strasbourg, France
The Council of Europe Convention against Trafficking in Human Organs was ratified by Portugal on 8 November 2018 and will commence having legal effect in the country as of 1 March 2019. The Convention identifies various activities constituting human organ trafficking which ratifying...
Transplantation / Organ News 06 November 2018 Strasbourg, France
The Organ Guide now in its 7th Edition supports professionals on a practical level to improve the rate of successful and safe organ transplantation. The Organ Guide collates updated information to provide professionals with the most recent advances in the field, as well as technical...

More news

Following new information recently received by EDQM about the detection of low levels of N-nitrosodiethylamine (NDEA) in Valsartan manufactured by MYLAN LABORATORIES Ltd , the EDQM has immediately suspended the certificate of...
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
The revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ (PA/PH/CEP (04) 2 7R) will enter into force in January 2019. Notable changes include the...

Agenda

29 November 2018
Strasbourg, France
12 December 2018 to 14 December 2018
New Delhi, India
29 January 2019 to 30 January 2019
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.
  • 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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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
  • e-mail: orders@edqm.eu

Invoices can be paid by credit card via internet or by bank transfer.

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