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Certification of suitability (CEP) / Procedure of certification (general) News 20 July 2017 Strasbourg, France
Supplement 9.3 of the Ph. Eur. is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of January 2018, and to follow the instructions given
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European Pharmacopoeia / Ph. Eur. Commission News 17 July 2017 Strasbourg, France
The monograph for Etanercept (2895) – adopted by the Ph. Eur. Commission at its 156th Session, November 2016 – will not be published in Ph. Eur. Supplement 9.3 (publication date July 2017); as a consequence, the implementation date of the monograph will not be 1 January 2018. As...
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Certification of suitability (CEP) News 11 July 2017 Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 29.3 before 30 September 2017.

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The EODD is held again in Switzerland. Swisstransplant marks the occasion with a big celebration on the Bundesplatz in Bern.
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The 2018 subscription of three non-cumulative supplements (9.3, 9.4 and 9.5) to the 9th Edition of European Pharmacopoeia is now available for purchase via the EDQM Store.
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The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

Agenda

09 September 2017
Bern (Switzerland)
19 September 2017 to 20 September 2017
Prague, Czech Republic
26 September 2017 to 27 September 2017
STRASBOURG
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.: Republic of Moldova becomes 39th Member
Focus
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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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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
  • email: orders@edqm.eu

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

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