EDQM - European Directorate for the Quality of Medicines |

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

Ph. Eur. monograph for Etanercept (2895) – publication postponed

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 Commission at its 156th Session, November 2016 – will not be published in Ph.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...

Pharmeuropa Volume 29 No 3, July 2017

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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Certification Monthly Report of Activities: June 2017

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

Council of Europe Member States set standards to ensure the...

The Committee of Ministers of the Council of Europe has adopted Resolution CM/Res(2017)1 on principles for the selection, evaluation, donation and follow-up of the non-resident living organ donors.

Update on Communicating Chemical Hazards Related to Reference...

Download the document "Update on Communicating Chemical Hazards Related to Reference Standards".

Agenda

09 September 2017

Bern (Switzerland)

European Day for Organ Donation and Transplantation

19 September 2017 to 20 September 2017

Prague, Czech Republic

Conference on the place of the Certification Procedure in...

26 September 2017 to 27 September 2017

STRASBOURG

NEW: CombiStats™ Training Session

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Ph. Eur. 9th Edition presentation

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Certification of Suitability (CEP) News

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https://www.edqm.eu/en/news/all

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.

https://www.edqm.eu/en/news/european-pharmacopoeia

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.
38 signatory parties (including the EU) and 29 observers (including WHO and TFDA) as of November 2016.

https://www.edqm.eu/en/news/omcl-network

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.

https://www.edqm.eu/en/news/certification-of-suitability

The Certification of Suitability

In brief

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.

https://www.edqm.eu/en/news/transfusion-and-transplantation

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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https://www.edqm.eu/en/en/membership-observership

Ph. Eur.: Republic of Moldova becomes 39th Member

Focus

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.

More information on Ph. Eur. Members and observers.

Latest products and services

03 July 2017

Pharmeuropa: Issue 29.3 is complete. Comments before 30 September 2017

23 May 2017

European Pharmacopoeia: supplements 9.1 to 9.5 and new downloadable...

04 May 2017

NEW: The 19th edition of the Blood Guide is now available

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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