European Pharmacopoeia

The European Pharmacopoeia of the Council of Europe is a listing of a wide range of active substances and excipients used to prepare pharmaceutical products in Europe. The 2005 edition includes 1800 specific and general monographs, including various chemical substances, antibiotics, biological substances; Vaccines for human or veterinary use; Immunosera; Radiopharmaceutical preparations; Herbal drugs; Homoeopathic preparations and homoeopathic stocks. It also contains Dosage forms, General monographs, Materials and Containers, Sutures; 268 General methods with figures or chromatograms and 2210 reagents are described.The monographs give quality standards for all the main medicines used in Europe. All medicines sold in the 36 Member States of the European Pharmacopoeia must comply with these quality standards so that consumers have a guarantee for products obtained from pharmacies and other legal suppliers.

The European Pharmacopoeia is developed by the European Directorate for the Quality of Medicines ("EDQM") and is a part of the Council of Europe, Strasbourg, France. It has been created by the "Convention on the elaboration of a European Pharmacopoeia" from 1964. [http://conventions.coe.int/Treaty/Commun/QueVoulezVous.asp?NT=050&CL=ENG] . Although the Pharmacopoeia is often listed as one of Council of Europe partial agreements, it is not, strictly speaking, a partial agreement. It has a different legal basis from the others, being established as the result of a treaty. The others were established by a "statutory resolution" adopted by the Committee of Ministers.

* 1st edition - published 1967
* 2nd edition - published 1980
* 3rd edition - published 1997
* 4th edition - published 2001, valid from 1.1.2002
* 5th edition - published 15.6.2004, valid from 1.1.2005
* 6th edition - published 16 July 2007, valid from 1.1.2008

It is published by EDQM in English and French, official national translations are available in German and Spanish (Spanish version only online).

Currently there are 37 members of the "European Pharmacopoeia Commission":
* Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republik, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Republic of Macedonia, Turkey, United Kingdom and European Union. In these countries and the European Union the "Ph. Eur." is the official pharmacopoeia. Additional local pharmacopoeias may exist (e. g. in United Kingdom and Germany). Not all of these countries are member states of the European Union.

Observers from 20 member and non-member states of the Council of Europe and international organisations take part on sessions of the "European Pharmacopoeial Commission":
*Albania, Algeria, Australia, Belarus, Brazil, Canada, China, Georgia, Israel, Madagascar, Malaysia, Morocco, Kazakhstan, Russian Federation, Senegal, Syria, Tunisia, Ukraine, United States of America, WHO

The convention is open for signature by all European countries. Other countries can get observer status.

Since 5th edition the pharmacopoeia is published in 2 volumes. Volume 1 contains general chapters and monographs (e .g on dosage forms, methods of analysis, reagents), volume 2 contains all substance monographs. During runtime of current edition several supplements are published. Electronic versions are also available (CD-ROM and online version).

The European Pharmacopoeia is often abbreviated "Ph. Eur.", especially when it is referenced in a drug's ingredients.

References

ee also

*Pharmacopoeia
*The International Pharmacopoeia

External links

* [http://www.edqm.eu Official web site of the EDQM]

Further reading

30 ans de Pharmacopée européenne. - In : Moniteur les pharmacies et laboratoires, n° 2096 (5 nov. 1994), pp.26-27

ARTIGES, Agnes : 1994! : the European Pharmacopoeia celebrates its 30th anniversary. - In : Regulatory affairs journal (Jan. 1994), p.1

ARTIGES, Agnes : L'apport juridique dans l'institution de la Pharmacopée européenne, unpublished thesis, Université de Paris II, 1979

ARTIGES, Agnes : Elaboration and revision of texts of the European Pharmacopoeia. - In : Pharmeuropa, vol. 7, no. 4 (Dec. 1995), pp.445-450

ARTIGES, Agnes and SPIESER, Jean-Marc : The role and future of the European Pharmacopoeia. - In : Regulatory affairs journal (May-June 1994), pp.349-351, 437-440