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Certification of suitability (CEP) News 20 January 2017 Strasbourg, France
The application forms for the submission of new Certificate of Suitability applications and for requests for revision or renewal have been slightly revised in order to remove the reference to the EDQM Dropbox and submission of CD-ROM/DVD.
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European Pharmacopoeia News 16 January 2017 Strasbourg, France
With the implementation of the ICH Q3D guideline on elemental impurities, the control of elemental impurities is undergoing a shift in paradigm, moving away from pure substance-based testing towards a holistic control strategy in the finished product.
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Products and Services News 12 January 2017 Strasbourg, France
The EDQM is pleased to announce that the 2016 issue of Pharmeuropa Bio & Scientific Notes is available online

More news

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Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment.
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The EDQM has revised the document "Guidance for electronic submissions for Certificates of Suitability (CEPs) applications".
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The 6th edition of the new Guide is now published. It contains the most updated information and guidance for all professionals involved in the donations and transplantation of human organs.

Agenda

07 February 2017 to 08 February 2017
Strasbourg, France
17 June 2017 to 21 June 2017
Copenhagen
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.
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.
  • 38 signatory parties (including the EU) and 29 observers (including WHO and TFDA) as of November 2016.
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.
The Certification of Suitability
In brief
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  • 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
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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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Ph. Eur. Commission: Japan became the 30th Observer
Focus
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Recently the Ph.Eur. Commission unanimously decided to grant Japan observer status. This brings to 30 the number of observers, from 6 continents. As observers, Japan can participate in the scientific work of the Commission and its expert meetings, attend Commission sessions and become involved in the other EDQM activities. Observer status also facilitates development of a mutually-beneficial relationship and sharing of expertise on issues pertinent to the pharmaceutical and healthcare sector.

• More information on Ph. Eur. Members and observers.

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How to order

Via the internet at store.edqm.eu in order to benefit from free shipping charges for EDQM publications. 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
  • fax: +33 (0)3 88 41 27 71
  • email: orders@edqm.eu

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

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