{
  "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977",
  "json_url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977.json",
  "id": "uksi/1977/1038",
  "title": "The Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977",
  "short_title": "Medicines (Manufacturer's Undertakings for Imported Products) 1977",
  "long_title": "These Regulations made under section 19(3)(b) of the Medicines Act 1968 prescribe the conditions which are to be incorporated in undertakings given by or on behalf of overseas manufacturers of imported medicinal products where applicants are required by the licensing authority to produce the undertakings in connection with applications for product licences. The regulations relate to such matters as the provision of staff, premises and plant for the manufacture, handling and storage of medicinal products, record keeping and the supply of information to holders of product licences.",
  "citation": "S.I. 1977/1038",
  "type": "uksi",
  "year": "1977",
  "number": "1038",
  "version": "current",
  "date": "1977-06-16",
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 8,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/introduction",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/1",
      "kind": "regulation",
      "number": "1",
      "heading": "Citation and commencement",
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/regulation-1",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/2",
      "kind": "regulation",
      "number": "2",
      "heading": "Interpretation",
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/regulation-2",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/3",
      "kind": "regulation",
      "number": "3",
      "heading": "Prescribed conditions for manufacturer's undertakings",
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/regulation-3",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/signature",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule",
      "kind": "schedule",
      "number": null,
      "heading": "PRESCRIBED CONDITIONS FOR MANUFACTURER'S UNDERTAKINGS",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/paragraph/1",
      "kind": "paragraph",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/schedule/paragraph-1",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/schedule/paragraph-2",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/3",
      "kind": "paragraph",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/schedule/paragraph-3",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/4",
      "kind": "paragraph",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/schedule/paragraph-4",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/5",
      "kind": "paragraph",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/schedule/paragraph-5",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/6",
      "kind": "paragraph",
      "number": "6",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/schedule/paragraph-6",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/7",
      "kind": "paragraph",
      "number": "7",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/schedule/paragraph-7",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "schedule/paragraph/8",
      "kind": "paragraph",
      "number": "8",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/schedule/paragraph-8",
      "extent": null,
      "status": null,
      "parent": "schedule"
    },
    {
      "path": "note",
      "kind": "note",
      "number": null,
      "heading": "Explanatory note",
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/note",
      "extent": null,
      "status": null,
      "parent": null
    }
  ],
  "has_text": true,
  "pdfs": [
    {
      "title": "Printed copy",
      "main": true,
      "language": null,
      "date": "1977-07-06",
      "size": null,
      "url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/pdf/uksi_19771038_en.pdf",
      "source_url": "https://www.legislation.gov.uk/uksi/1977/1038/pdfs/uksi_19771038_en.pdf"
    }
  ],
  "outstanding_effects": [
    {
      "type": "added",
      "affected_provisions": "reg.2(1A)",
      "affecting": "uksi/1992/2845",
      "affecting_title": "The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992",
      "affecting_provisions": "reg.3"
    },
    {
      "type": "amended",
      "affected_provisions": "reg.3",
      "affecting": "uksi/1992/2845",
      "affecting_title": "The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992",
      "affecting_provisions": "reg.4"
    },
    {
      "type": "added",
      "affected_provisions": "reg.4",
      "affecting": "uksi/1992/2845",
      "affecting_title": "The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992",
      "affecting_provisions": "reg.5"
    },
    {
      "type": "added",
      "affected_provisions": "Sch, paras 2A, 3A",
      "affecting": "uksi/1992/2845",
      "affecting_title": "The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992",
      "affecting_provisions": "reg.6(2)(3)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch, para 7(a)(b)",
      "affecting": "uksi/1992/2845",
      "affecting_title": "The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992",
      "affecting_provisions": "reg.6(4)"
    },
    {
      "type": "added",
      "affected_provisions": "Sch, paras 7A, 7B",
      "affecting": "uksi/1992/2845",
      "affecting_title": "The Medicines (Manufacturer’s Undertakings for Imported Products) Amendment Regulations 1992",
      "affecting_provisions": "reg.6(5)"
    },
    {
      "type": "substituted",
      "affected_provisions": "reg. 2(1)",
      "affecting": "uksi/1994/3144",
      "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994",
      "affecting_provisions": "Sch. 7 para. 4"
    },
    {
      "type": "inserted",
      "affected_provisions": "reg. 1A",
      "affecting": "uksi/2005/2745",
      "affecting_title": "The Veterinary Medicines Regulations 2005",
      "affecting_provisions": "Sch. 8 Pt. 3 para 11"
    }
  ],
  "made_under": [],
  "changes_made_to": 8,
  "changes_made_to_url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/changes.json",
  "changes_made_by": 0,
  "changes_made_by_url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/changes/by-it.json",
  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/medicines-manufacturers-undertakings-for-imported-products-regulations-1977/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1977/1038",
    "retrieved_at": "2026-10-29T19:57:12.107747+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."
}