{
  "url": "https://openlegislation.uk/eu-decision-1994-358/introduction",
  "json_url": "https://openlegislation.uk/eu-decision-1994-358/introduction.json",
  "legislation": "eudn/1994/358",
  "legislation_title": "Council Decision of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia (94/358/EC)",
  "legislation_url": "https://openlegislation.uk/eu-decision-1994-358",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Council Decision\nof 16 June 1994\naccepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia\n(94/358/EC)\nTHE COUNCIL OF THE EUROPEAN UNION,\nHaving 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),\nHaving regard to the proposal from the Commission,\nHaving regard to the opinion of the European Parliament,\nWhereas 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;\nWhereas, 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 and 81/852/EEC, the compulsory nature of the European Pharmacopoeia monographs for all medicinal products covered by Community legislation;\nWhereas 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;\nWhereas the Community constitutes the principal world exporting zone for medicinal products;\nWhereas most medicinal products which circulate between the Community and third countries are the subject of monographs drawn up by the European Pharmacopoeia;\nWhereas these monographs should therefore serve as the basis for free circulation of these products between the Community and third countries;\nWhereas the Community should therefore accede to the Convention in order to facilitate trade with the other Contracting Parties,\nHAS DECIDED AS FOLLOWS:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No C 128, 9. 5. 1994."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (OJ No L 147, 9. 6. 1975, p. 1). Directive as last amended by Directive 93/39/EEC (OJ No L 214, 24. 8. 1993, p. 22)."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ No L 317, 6. 11. 1981, p. 16). Directive as last amended by Directive 93/40/EEC (OJ No L 214, 24. 8. 1993, p. 31)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/1994/358/introduction",
    "retrieved_at": "2026-11-01T15:19:34.471946+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}