{
  "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-5/paragraph-2",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-5/paragraph-2.json",
  "legislation": "uksi/1994/3144",
  "legislation_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994",
  "path": "schedule/5/paragraph/2",
  "kind": "paragraph",
  "number": "2",
  "heading": "Introductory",
  "text": "The requirements of this Schedule supplement those of Council Directive 92/27/EEC relating to:\n(a) special warnings necessary for particular medicinal products;\n(b) the legal status for supply to the patient, in accordance with Council Directive 92/26/EEC;\n(c) identification and authenticity.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "am",
      "affecting": "uksi/2003/1618",
      "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003"
    },
    {
      "type": "added",
      "affecting": "uksi/1998/3105",
      "affecting_title": "The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998"
    },
    {
      "type": "amended",
      "affecting": "uksi/1998/3105",
      "affecting_title": "The Medicines for Human Use (Marketing Authorisation Etc.) Amendment Regulations 1998"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2009/1164",
      "affecting_title": "The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009"
    },
    {
      "type": "amended",
      "affecting": "uksi/2000/292",
      "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "am",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1994/3144/schedule/5/paragraph/2",
    "retrieved_at": "2026-10-29T13:21:07.489272+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."
}