{
  "url": "https://openlegislation.uk/eu-directive-2001-83/article-54",
  "json_url": "https://openlegislation.uk/eu-directive-2001-83/article-54.json",
  "legislation": "eudr/2001/83",
  "legislation_title": "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",
  "legislation_url": "https://openlegislation.uk/eu-directive-2001-83",
  "path": "article/54",
  "kind": "article",
  "number": "54",
  "heading": null,
  "text": "The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:\n(a) the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the product contains up to three active substances, the international non-proprietary name (INN) shall be included, or, if one does not exist, the common name;\n(b) a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;\n(c) the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;\n(d) a list of those excipients known to have a recognized action or effect and included in the detailed guidance published pursuant to Article 65. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated;\n(e) the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;\n(f) a special warning that the medicinal product must be stored out of the reach and sight of children;\n(g) a special warning, if this is necessary for the medicinal product;\n(h) the expiry date in clear terms (month/year);\n(i) special storage precautions, if any;\n(j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place;\n(k) the name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him;\n(l) the number of the authorization for placing the medicinal product on the market;\n(m) the manufacturer's batch number;\n(n) in the case of non-prescription medicinal products, instructions for use;\n(o) for medicinal products other than radiopharmaceuticals referred to in Article 54a(1), safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to:\nverify the authenticity of the medicinal product, and\nidentify individual packs,\nas well as a device allowing verification of whether the outer packaging has been tampered with.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Inserted by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 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 (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2001/83/article/54",
    "retrieved_at": "2026-11-01T15:22:59.083752+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."
}