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European Pharmacopoeia
SUMMARY OF:
WHAT IS THE AIM OF THE CONVENTION AND THE DECISION?
The aim of the convention, drawn up by the Council of Europe in 1964, was to provide a legal basis for harmonising specifications for medicinal substances of general interest to Europe’s population and to encourage the drawing up of specifications for the growing number of new medicinal substances appearing on the market.
The decision accepts, on behalf of the European Community (now the European Union (EU)), the Convention on the Elaboration of a European Pharmacopoeia.
KEY POINTS
The purpose of the European Pharmacopoeia is to ensure the quality of medicines and the substances that they contain. It comprises monographs that become official standards applicable in the territories of the countries that are contracting parties to the convention.
On , a protocol to the convention was signed in order to enable the European Community to accede to it. It entered into force on .
Over time, the membership of the European Pharmacopoeia has grown to cover most European countries, along with the EU. Member countries’ delegations participate in the European Pharmacopoeia Commission (see below) and have the right to vote on all technical matters. The EU votes on behalf of the EU Member States in regard to all non-technical matters.
In addition, many non-European countries participate in the commission as observers. They can therefore be involved in the commission’s scientific work, benefit from this experience and access work on the quality control of medicines and the analytical methods used.
The elaboration of the European Pharmacopoeia is undertaken by two bodies.
- The European Pharmacopoeia Commission 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 European Committee on Pharmaceuticals and Pharmaceutical Care of the Council of Europe is an intergovernmental steering committee whose core task is to support the competent authorities of parties to the European Pharmacopoeia Convention, with the aim of making the medication process safer, more responsible and accessible. It exercises general oversight over the European Pharmacopoeia Commission’s activities and sets the date of application of the monographs, along with supporting the commission in the development of the European Paediatric Formulary. It does not, however, interfere with the technical content of the monographs.
EU law makes specific reference to the mandatory character of the European Pharmacopoeia’s monographs in Directive 2001/83/EC on medicines for humans (see summary) and Regulation (EU) 2019/6 on medicines for veterinary use (see summary).
DATE OF ENTRY INTO FORCE
The convention entered into force in the EU on .
BACKGROUND
On , Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Switzerland and the United Kingdom signed a convention, drawn up under the aegis of the Council of Europe, on the elaboration of a European Pharmacopoeia.
For further information, see:
- The European Pharmacopoeia – Membership & observership (Council of Europe).
MAIN DOCUMENTS
Convention on the elaboration of a European Pharmacopoeia (OJ L 158, , pp. 19–21).
Successive amendments to the Convention have been incorporated into the original document. This consolidated version is of documentary value only.
Council Decision 94/358/EC of accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia (OJ L 158, , pp. 17–18).
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