European Pharmacopoeia

1) OBJECTIVE

To harmonize national laws on the manufacture, movement and distribution of medicinal products in Europe by creating a European Pharmacopoeia.

2) ACT

Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia [Official Journal L 158 of 25.06.1994].

3) SUMMARY

On 22 July 1964, Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Switzerland and the United Kingdom signed a Convention, under the auspices of the Council of Europe, on the elaboration of a European Pharmacopoeia.

The objectives are to harmonize specifications for medicinal substances which are of general interest to the peoples of Europe and to hasten the drawing-up of specifications for the growing number of new medicinal substances appearing on the market.

These objectives are attained by creating a European Pharmacopoeia made up of monographs which become official standards applicable in the territories of the Contracting States.

On 16 November 1989 a Protocol to the Convention was signed which enabled the European Community to accede to the Convention. The Protocol entered into force on 1 November 1992.

A total of 32 European countries are now party to the Convention:

the 15 Member States of the European Union and the European Community itself;
three EFTA countries (Island, Norway & Switzerland);
seven of the ten acceding states (Cyprus, Czech Republic, Estonia, Hungary, Latvia, Slovakia & Slovenia);
two of the three candidate countries (Romania & Turkey);
finally, Bosnia and Herzegovina, Croatia, Serbia and Montenegro and the Former Yugoslav Republic of Macedonia.

The European Pharmacopoeia is drawn up by two bodies:

the European Pharmacopoeia Commission is responsible for preparing and adopting technical decisions on the monographs. It consists of eminent scientists appointed by each of the Contracting Parties for their competence;
the Public Health Committee of the Council of Europe administratively oversees the Commission's activities and, in particular, lays down the date for implementation of the monographs, although it may not alter any of their technical content.

4) IMPLEMENTING MEASURES

5) FOLLOW-UP WORK

For further information: European Pharmacopoeia

Last updated: 28.6.2006