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Certification Monthly Report of Activities: January 2019
Certification of suitability (CEP) / Procedure of certification (general) News 12 February 2019 Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
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Elemental impurities reference standards: leaflets now include expanded uncertainty
Reference Standard / Chemical reference standard (CRS) News 12 February 2019 Strasbourg, France
The EDQM has updated the leaflets of its reference standards for elemental impurities (lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS) with further information to facilitate their use and make traceability transparent. The mass fractions of the...
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Montenegro ratifies convention against trafficking in human organs
Transplantation / Legal Framework News 11 February 2019 Strasbourg, France
Montenegro ratified the Council of Europe Convention against Trafficking in Human Organs on 5 February 2019. The Convention will commence having legal effect in the country as of 1 June 2019. The Convention identifies various activities constituting human organ trafficking which...
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The chapter on water: micro determination (2.5.32.) has been revised...
The chapter on water: micro determination (2.5.32.) has been revised in the Ph. Eur. Supplement 9.8. The revised part is reproduced here after: The instrument qualification is carried out according to established quality system...
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Call for experts: Join the Ph. Eur. Network!
The EDQM is renewing its call for expressions of interest to join the European Pharmacopoeia (Ph. Eur.) as an independent scientific expert. Professionals from national authorities (e.g. pharmacopoeial authorities, official medicines...
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Update on the EDQM review of CEP applications for sartan substances (...
Following new information received recently about the presence of nitrosamine impurities in a drug substance covered by a certificate of suitability (CEP), the EDQM has taken immediate action and suspended CEP R1-CEP 2009-247-Rev 02/...
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Agenda

13 March 2019 to 14 March 2019
Strasbourg, France
JOINT EDQM-USP ‘13th International Symposium on Pharmace...
18 June 2019 to 20 June 2019
Shanghai, China
CPhI China & CEP One-to-One Sessions
19 June 2019 to 20 June 2019
Strasbourg, France
International Conference on the ‘EDQM & European Pharmaco...

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https://www.edqm.eu/en/news/all
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.
  • Also develops guidance and standards in the areas of blood transfusion, organ transplantation and consumer health issues.
https://www.edqm.eu/en/news/european-pharmacopoeia
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.
  • 39 signatory countries (including the EU) and 30 observers (including WHO and TFDA) as of December 2017.
https://www.edqm.eu/en/news/omcl-network
Official Medicines Control Laboratories (OMCL)
In brief
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  • 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.
https://www.edqm.eu/en/news/certification-of-suitability
The Certification of Suitability
In brief
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  • 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.

 

https://www.edqm.eu/en/news/transfusion-and-transplantation
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 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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https://www.edqm.eu/en/membership-observership
Ph. Eur. Commission: Uzbekistan became the 30th Observer
Focus
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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.

Latest products and services

07 February 2019
29 new Ph. Eur. Reference Substances (RS) and 18 replacement batches...
24 January 2019
Ph.Eur. Supplement 9.8 available now
24 October 2018
Recently released: 2 new Ph. Eur. Reference standards Zoledronic...
See all Products and Services news

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.

@Edqm_news on Twitter

Videos

https://www.edqm.eu/en/../en/presentation-edqm
https://www.edqm.eu/en/../en/9th-edition-european-pharmacopoeia-maintaining-high...
https://www.edqm.eu/en/../en/inside-the-council-of-europe
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