By Dr Agnès Artiges PhD, Director of the European Directorate for the Quality of Medicines, EDQM - European Pharmacopoeia
SubscribeThe standards of the European Pharmacopoeia are designed to meet the needs of licensing authorities, public or private quality control laboratories as well as manufacturers of raw materials and pharmaceutical products.
The published texts enter into force on the same date in all the 30 states, which are Parties to the Convention; this date is chosen on the basis of a proposal by the European Pharmacopoeia Commission and is the subject of a Resolution (AP/CSP) of the Public Health Committee.
The 4th Edition of the European Pharmacopoeia replaced the 3rd Edition on 1 January 2002.
It includes all the texts of the revised 3rd Edition and the new texts adopted since 2000. The 4th Edition includes the following major changes in comparison with the previous edition. The style has been simplified to make it easier to use.
The collection of general monographs covering the various types of medicinal substances and preparations has been expanded. Many monographs have been modernised. Whenever possible certain dangerous reagents have been eliminated. More alternative methods have been added to replace the use of animals for potency testing for biological preparations.
These modifications are the result of extensive collaborative studies involving experts from the national control laboratories, universities and industries at the request of the EDQM, the European Pharmacopoeia Commission, and the licensing authorities (the EMEA in particular).
The 4th Edition is available in printed, CD-ROM or Internet versions, in English and in French.
The 4th Edition printed version, is expanded and updated by non-cumulative supplements published every 4 months to keep pace with accelerating regulatory and technical change. Three non-cumulative supplements are published per year, adding new or revised texts to those of the initial volume and previously published supplements.
The CD-ROM version is cumulative, when a new update is released (three CD-ROMs a year) it supersedes the previous one. It is available in English or French or both, for single users or intranet users. The information is displayed using a Web browser.
The Internet version is also cumulative and automatically updated three times a year. Like the CD-ROM version the information is displayed using a Web browser. A demonstration version is available at www.pheur.org. The internet version is bilingual only.
The entire European Pharmacopoeia can be consulted using a hierarchic table of contents and keyword search. Hyperlinks in the text of a monograph connect to general texts such as general methods, reagents and also to the online database for reference substances.
Official texts implemented at the same date
The implementation date for the texts of the 4th Edition is 1 January 2002. The implementation dates for the supplements are published on the our website www.pheur.org (4.1: 1 April 2002, 4.2: 1 July 2002, 4.3: 1 January 2003 etc.) whatever the version (Printed, CD-ROM or Internet).
How to contact us:
European Directorate for the Quality of Medicines (EDQM)
European Pharmacopoeia
226, avenue de Colmar BP 907
F – 67029 STRASBOURG Cedex 1
France
By telephone:
Publications: +33 (0)3 88 41 20 36
Reference substances: +33 (0)3 88 41 20 35
By Fax: +33 (0)3 88 41 27 71
By E-mail: info@pheur.org