European Pharmacopoeia

The European Union supports the European Pharmacopoeia, which was drawn up by the Council of Europe. The objective of this institution is to harmonise national laws on the manufacture, circulation and distribution of medicines in Europe.

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.

SUMMARY

On 22 July 1964, Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Switzerland and the United Kingdom (1) signed a Convention, drawn up under the aegis of the Council of Europe, on the elaboration of a European Pharmacopoeia.

The objectives are to harmonise specifications for medicinal substances of general interest to the population 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 met by creating a European Pharmacopoeia comprising monographs which become official standards applicable in the territories of the countries which are Contracting Parties to the Convention.

On 16 November 1989 a Protocol to this Convention was signed in order to enable the European Community to accede to it. It entered into force on 1 November 1992.

The European Pharmacopoeia currently has 38 European members, including the European Union (EU). The 37 member countries are:

• the EU-15, namely Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom (1);
• three of the European Free Trade Association (EFTA) countries, namely Iceland, Norway and Switzerland;
• the thirteen most recent Member States of the EU, namely Croatia, Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, the Slovak Republic, Slovenia, Bulgaria and Romania;
• the four EU candidate countries, namely the former Yugoslav Republic of Macedonia (FYROM), Montenegro, Serbia and Turkey;
• Bosnia and Herzegovina, and Ukraine.

The European Pharmacopoeia also has 26 observers, including the World Health Organisation (WHO). The 25 observer countries are:

• six European countries, namely Albania, Republic of Belarus, Georgia, Kazakhstan, Moldova and the Russian Federation;
• nineteen non-European countries, namely Algeria, Argentina, Australia, Azerbaijan, Brazil, Canada, China, Israel, Madagascar, Malaysia, Morocco, Republic of Guinea, Senegal, Singapore, South Africa, Syria, the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare, Tunisia and the United States.

The elaboration of the European Pharmacopoeia is undertaken by two bodies:

• the European Pharmacopoeia Commission, which prepares and adopts the technical decisions relating to monographs. It comprises eminent scientists appointed by each Contracting Party and chosen for their competence in certain fields;
• the Public Health Committee of the Council of Europe, which exercises administrative authority over the Commission's activities and sets the date of application of the monographs but cannot interfere with their technical content.

RELATED ACTS

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (l21230) [Official Journal L 311 of 28.11.2001].

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (l21231) [Official Journal L 311 of 28.11.2001].

Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products [OJ L 174 of 1.7.2011].

last update 06.04.2014

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(1) The United Kingdom withdraws from the European Union and becomes a third country (non-EU country) as of 1 February 2020.