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Certification procedure: revised documents July 2019
Certification of suitability (CEP) / Procedure of certification (general) News 17 July 2019 Strasbourg, France
The EDQM has revised the following documents to reflect current practice and clarify a couple of items: - Terms of reference; - Code of Practice for the Certification procedure.
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The Ph. Eur. revises its general chapter on UV-Vis absorption spectrophotometry
European Pharmacopoeia / General text/chapter News 15 July 2019 Strasbourg, France
At its 162nd session in November 2018, the Ph. Eur. Commission adopted a new version of one of its major general methods. Ultraviolet and visible absorption spectrophotometry (2.2.25) has undergone extensive revision and is published in the 10th Edition (implementation date 1 January...
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Dosage Form Monographs for Public Consultation
European Pharmacopoeia / Public enquiry News 15 July 2019 Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission is undertaking a review of the mandatory dosage form monographs. As part of this process, its Group of experts 12 has revised or elaborated several texts involving preparations which are applied to the skin and one involving...
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As of 1 January 2020 the eCTD is mandatory for ALL CEP applications...
According to the EDQM roadmap for electronic submissions for CEP applications, a major change will be implemented as of 1 January 2020: • eCTD will become mandatory for all CEP applications. • EDQM will stop accepting NeeS...
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Pharmeuropa 31.3 just released
All new texts and texts having undergone technical revisions are published in Pharmeuropa for public consultation. Users and interested parties are welcome to comment on these drafts. It should be noted that: • Although draft...
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Monograph on Rosuvastatin tablets (3008) to be published in Ph. Eur....
The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new monograph on Rosuvastatin tablets (3008) at its 163rd session (March 2019). The monograph will be published in the 1st supplement to the 10th Edition (available in...
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Agenda

10 September 2019 to 11 September 2019
Iselin, New Jersey (USA)
REGISTRATION OPEN! European Pharmacopoeia Workshop on 10-...
08 October 2019 to 09 October 2019
Strasbourg, France
NEW: CombiStats™ Training Course
12 October 2019
London
European Day for Organ Donation and Transplantation

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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 parties (including the EU) and 30 observers (including WHO and TFDA) as of March 2018.
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/news/call-experts-join-ph-eur-network
Call for experts: Join the Ph. Eur. Network!
Focus
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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 control laboratories, licensing authorities and inspectorates), the private sector (pharmaceutical or chemical industries), academia, research organisations and other experts are encouraged to apply. This is an ideal opportunity to take part in the work of the Ph. Eur., to network with professionals with various backgrounds and from all over Europe and beyond, and to help shape Ph. Eur. texts, internationally-recognised quality standards for medicines.

More information on Ph. Eur. Members and observers.

Latest products and services

04 July 2019
15 new reference standards and 22 replacement batches released in...
11 June 2019
18 replacement batches released in May 2019
15 May 2019
2 new Ph. Eur. Reference Standards (RS) and 21 replacement batches...
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