{
  "url": "https://openlegislation.uk/medicines-veterinary-medicinal-products-applications-for-product-licences-regulations-1993/regulation-2",
  "json_url": "https://openlegislation.uk/medicines-veterinary-medicinal-products-applications-for-product-licences-regulations-1993/regulation-2.json",
  "legislation": "uksi/1993/2398",
  "legislation_title": "The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993",
  "legislation_url": "https://openlegislation.uk/medicines-veterinary-medicinal-products-applications-for-product-licences-regulations-1993",
  "path": "regulation/2",
  "kind": "regulation",
  "number": "2",
  "heading": "Interpretation",
  "text": "(1) In these Regulations—\n“the Act” means the Medicines Act 1968;\n“application” means a request for the grant of a product licence and shall comprise all the documents submitted in support of it, and “applicant” shall be construed accordingly;\n“Directive 81/851” means Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products amended by Council Directive 90/676/EEC;\n“Directive 81/852” means Council Directive 81/852/EEC 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 amended by Council Directive 87/20/EEC and Commission Directive 92/18/EEC;\n“Directive 90/677” means Council Directive 90/677/EEC extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products;\n“immunological product” means a veterinary medicinal product used in order to produce active or passive immunity or to diagnose the state of immunity, to which Directives 81/851 and 90/677 apply;\n“product licence” means a product licence in relation to a veterinary medicinal product to which Directive 81/851 applies;\n“standard provisions for licences” means the relevant standard provisions prescribed by regulations under section 47(1) of the Act; and\n“veterinary medicinal product” has the meaning assigned to that expression in Directive 81/851 and for the purposes of these Regulations shall be treated as a medicinal product within the meaning of section 130 of the Act.\n(2) In these Regulations any reference to a numbered regulation or Schedule shall be construed as a reference to the regulation or Schedule so numbered in these Regulations.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L317, 6.11.81, p.1."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ No. L373, 31.12.90, p.15."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ No. L317, 6.11.81, p.16."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "OJ No. L15, 17.1.87, p.34."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "OJ No. L97, 10.4.92, p.1."
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "OJ No. L373, 31.12.90, p.26."
    },
    {
      "type": "footnote",
      "label": "f7",
      "text": "The current Regulations are S.I. 1971/972 amended by S.I. 1972/1226, 1974/1523, 1977/675, 1039, 1053, 1983/1730."
    }
  ],
  "outstanding_effects": [
    {
      "type": "substituted",
      "affecting": "uksi/1994/2157",
      "affecting_title": "The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) (Amendment) Regulations 1994"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1993/2398/regulation/2",
    "retrieved_at": "2026-10-29T13:50:12.688736+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."
}