Introductory text

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 113 and 100a thereof, in conjunction with the first sentence of Article 228 (2) and the first subparagraph of Article 228 (3),

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament^f1,

Whereas the Convention on the elaboration of a European Pharmacopoeia, which was drawn up within the Council of Europe, aims to harmonize specifications for medicinal substances and pharmaceutical preparations to enable them to circulate in Europe; whereas the monographs of the European Pharmacopoeia become official technical rules applicable within the territories of the countries which are Contracting Parties to the Convention;

Whereas, furthermore, in order to facilitate the free circulation of medicinal products inside its territory, the Community has already unilaterally recognized, by Directives 75/318/EEC^f2 and 81/852/EEC^f3, the compulsory nature of the European Pharmacopoeia monographs for all medicinal products covered by Community legislation;

Whereas the Member States are Contracting Parties to the Convention; whereas it might be reasonably expected that a growing number of countries, particularly those of eastern Europe, will accede to the Convention;

Whereas the Community constitutes the principal world exporting zone for medicinal products;

Whereas most medicinal products which circulate between the Community and third countries are the subject of monographs drawn up by the European Pharmacopoeia;

Whereas these monographs should therefore serve as the basis for free circulation of these products between the Community and third countries;

Whereas the Community should therefore accede to the Convention in order to facilitate trade with the other Contracting Parties,

HAS DECIDED AS FOLLOWS: