{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008.json",
  "id": "uksi/2008/552",
  "title": "The Medicines (Products for Human Use-Fees) Regulations 2008",
  "short_title": "Medicines (Products for Human Use-Fees) 2008",
  "long_title": "These Regulations revoke and re-enact in consolidated form, with some amendments, The Medicines (Products for Human Use-Fees) Regulations 1995 (“the 1995 Regulations”) and make amendments to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Products Regulations”).",
  "citation": "S.I. 2008/552",
  "type": "uksi",
  "year": "2008",
  "number": "552",
  "version": "current",
  "date": "2008-02-28",
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/introduction",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "part/1",
      "kind": "part",
      "number": "1",
      "heading": "General",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/1",
      "kind": "regulation",
      "number": "1",
      "heading": "Citation and commencement",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-1",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "regulation/2",
      "kind": "regulation",
      "number": "2",
      "heading": "Interpretation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-2",
      "extent": null,
      "status": null,
      "parent": "part/1"
    },
    {
      "path": "part/2",
      "kind": "part",
      "number": "2",
      "heading": "Capital Fees for Pre-Application Meetings",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/3",
      "kind": "regulation",
      "number": "3",
      "heading": "Interpretation of Part 2",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-3",
      "extent": null,
      "status": null,
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    },
    {
      "path": "regulation/4",
      "kind": "regulation",
      "number": "4",
      "heading": "Fee for scientific advice: application for or variation to EC marketing authorization",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-4",
      "extent": null,
      "status": null,
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    {
      "path": "regulation/5",
      "kind": "regulation",
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      "heading": "Fee for scientific advice: classification of a medicinal product",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-5",
      "extent": null,
      "status": null,
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    },
    {
      "path": "regulation/6",
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      "heading": "Fee for advertising advice",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-6",
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      "path": "regulation/7",
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      "heading": "Fee for pharmacovigilance advice",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-7",
      "extent": null,
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    {
      "path": "regulation/8",
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      "heading": "Fee for advice on labelling or leaflets",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-8",
      "extent": null,
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      "path": "regulation/9",
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    {
      "path": "regulation/10",
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      "heading": "Fee for advice for other purposes",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-10",
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      "path": "regulation/11",
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      "heading": "Time for payment of fees under regulations 4 to 10",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-11",
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    {
      "path": "part/3",
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      "number": "3",
      "heading": "Capital Fees for Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections",
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    },
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      "path": "regulation/12",
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      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-12",
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    {
      "path": "regulation/13",
      "kind": "regulation",
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      "heading": "Fee for applications for copy certificates of good manufacturing practice",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-13",
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      "path": "regulation/14",
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      "heading": "Fees for applications for certificates and copy certificates by exporters of medicinal products",
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      "path": "part/4",
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      "number": "4",
      "heading": "Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States",
      "url": null,
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    },
    {
      "path": "regulation/15",
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      "heading": "Meaning of “set of applications”",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-15",
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    {
      "path": "regulation/16",
      "kind": "regulation",
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      "heading": "Fees for applications for regulatory assistance under the mutual recognition procedure",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-16",
      "extent": null,
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      "path": "regulation/17",
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      "heading": "Time for payment of fees under regulation 16",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-17",
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      "path": "part/5",
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    },
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      "path": "regulation/18",
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      "heading": "Fees for variations of authorizations, registrations, licences and authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-18",
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    {
      "path": "regulation/19",
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      "heading": "Fees for amendments to clinical trial authorisations",
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    {
      "path": "regulation/20",
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      "heading": "Applications for multiple variations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-20",
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    {
      "path": "part/6",
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      "heading": "Capital Fees for Assessment of Labels and Leaflets",
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    },
    {
      "path": "regulation/21",
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      "number": "21",
      "heading": "Meaning of “set of proposed changes”",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-21",
      "extent": null,
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    {
      "path": "regulation/22",
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      "number": "22",
      "heading": "Fees for assessment of a set of proposed changes to labels and leaflets",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-22",
      "extent": null,
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    {
      "path": "regulation/23",
      "kind": "regulation",
      "number": "23",
      "heading": "Time for payment of fees under regulation 22",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-23",
      "extent": null,
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    },
    {
      "path": "part/7",
      "kind": "part",
      "number": "7",
      "heading": "Capital Fees for Applications for Renewals of Certain Manufacturer’s Licences and for Associated Inspections",
      "url": null,
      "extent": null,
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    },
    {
      "path": "regulation/24",
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    {
      "path": "regulation/25",
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      "heading": "Fees for renewals in terms which are not identical to the existing authorization, licence or certificate",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-25",
      "extent": null,
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    },
    {
      "path": "part/8",
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      "number": "8",
      "heading": "Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorizations",
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      "path": "regulation/26",
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      "path": "part/9",
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      "path": "regulation/28",
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      "heading": "Payer of inspection fee (contract laboratories and API manufacturing sites)",
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      "path": "regulation/30",
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      "heading": "Fees for inspections relating to good clinical practice in clinical trials",
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    {
      "path": "part/10",
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      "heading": "Periodic Fees for Marketing Authorizations and Licences",
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    },
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      "path": "regulation/31",
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    {
      "path": "part/11",
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      "number": "11",
      "heading": "Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership",
      "url": null,
      "extent": null,
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    },
    {
      "path": "regulation/33",
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      "path": "regulation/34",
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    {
      "path": "part/12",
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      "path": "regulation/36",
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      "heading": "Time for payment under regulation 35",
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      "extent": null,
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      "path": "part/13",
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    },
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      "path": "regulation/37",
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      "heading": "Payment of fees to Ministers",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-37",
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      "path": "regulation/38",
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      "heading": "Time for payment of capital fees in connection with applications or inspections",
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      "path": "regulation/39",
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      "heading": "Time for payment of capital fees – applications made by small companies",
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      "path": "regulation/40",
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    {
      "path": "regulation/41",
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      "heading": "Penalty fees for late payment of periodic fees",
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    {
      "path": "regulation/42",
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      "heading": "Daily penalty fees for late payment of periodic fees",
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      "extent": null,
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      "path": "regulation/43",
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      "heading": "Refund or waiver of fees under regulation 41 or 42",
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    {
      "path": "regulation/44",
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      "number": "44",
      "heading": "Adjustment, waiver, reduction or refund of fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-44",
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    },
    {
      "path": "regulation/45",
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      "number": "45",
      "heading": "Suspension of licences and certificates",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-45",
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    },
    {
      "path": "regulation/46",
      "kind": "regulation",
      "number": "46",
      "heading": "Civil proceedings to recover unpaid fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-46",
      "extent": null,
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      "parent": "part/13"
    },
    {
      "path": "part/14",
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    },
    {
      "path": "regulation/47",
      "kind": "regulation",
      "number": "47",
      "heading": "Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-47",
      "extent": null,
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      "parent": "part/14"
    },
    {
      "path": "part/15",
      "kind": "part",
      "number": "15",
      "heading": "Revocationand Savings",
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      "extent": null,
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    },
    {
      "path": "regulation/48",
      "kind": "regulation",
      "number": "48",
      "heading": "Revocation and savings",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/regulation-48",
      "extent": null,
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      "parent": "part/15"
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/signature",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/1",
      "kind": "schedule",
      "number": "1",
      "heading": "CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES AND CERTIFICATES",
      "url": null,
      "extent": null,
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    },
    {
      "path": "schedule/1/part/1",
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      "heading": "Interpretation",
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    },
    {
      "path": "schedule/1/paragraph/1",
      "kind": "paragraph",
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      "heading": null,
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-1",
      "extent": null,
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      "parent": "schedule/1/part/1"
    },
    {
      "path": "schedule/1/part/2",
      "kind": "part",
      "number": "2",
      "heading": "Capital Fees for Applications for Authorizations, Licences and Certificates",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": "Marketing authorizations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-2",
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    {
      "path": "schedule/1/paragraph/3",
      "kind": "paragraph",
      "number": "3",
      "heading": "Fees where application includes reclassification",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-3",
      "extent": null,
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    {
      "path": "schedule/1/paragraph/4",
      "kind": "paragraph",
      "number": "4",
      "heading": "Fees where person holds clinical trial certificate",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-4",
      "extent": null,
      "status": null,
      "parent": "schedule/1/part/2"
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    {
      "path": "schedule/1/paragraph/5",
      "kind": "paragraph",
      "number": "5",
      "heading": "Joint development",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-5",
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    {
      "path": "schedule/1/paragraph/6",
      "kind": "paragraph",
      "number": "6",
      "heading": "Applications for multiple authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-6",
      "extent": null,
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      "parent": "schedule/1/part/2"
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      "path": "schedule/1/paragraph/7",
      "kind": "paragraph",
      "number": "7",
      "heading": "Authorisation for a national homoeopathic product",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-7",
      "extent": null,
      "status": null,
      "parent": "schedule/1/part/2"
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    {
      "path": "schedule/1/paragraph/8",
      "kind": "paragraph",
      "number": "8",
      "heading": "Manufacturer’s licences and authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-8",
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      "status": null,
      "parent": "schedule/1/part/2"
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      "path": "schedule/1/paragraph/9",
      "kind": "paragraph",
      "number": "9",
      "heading": "Wholesale dealer’s licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-9",
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      "path": "schedule/1/paragraph/10",
      "kind": "paragraph",
      "number": "10",
      "heading": "Clinical trial authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-10",
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      "parent": "schedule/1/part/2"
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    {
      "path": "schedule/1/paragraph/11",
      "kind": "paragraph",
      "number": "11",
      "heading": "Traditional herbal registrations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-11",
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      "parent": "schedule/1/part/2"
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    {
      "path": "schedule/1/part/3",
      "kind": "part",
      "number": "3",
      "heading": "Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States",
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    {
      "path": "schedule/1/paragraph/12",
      "kind": "paragraph",
      "number": "12",
      "heading": "Interpretation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-12",
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    {
      "path": "schedule/1/paragraph/13",
      "kind": "paragraph",
      "number": "13",
      "heading": "Outgoing mutual recognition applications",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-13",
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      "status": null,
      "parent": "schedule/1/part/3"
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    {
      "path": "schedule/1/part/4",
      "kind": "part",
      "number": "4",
      "heading": "Capital Fees for Applications for Variations of Authorizations, Licences and Registrations",
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      "extent": null,
      "status": null,
      "parent": "schedule/1"
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    {
      "path": "schedule/1/paragraph/14",
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      "heading": "Interpretation",
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    {
      "path": "schedule/1/paragraph/15",
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      "number": "15",
      "heading": "Marketing authorizations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-15",
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    {
      "path": "schedule/1/paragraph/16",
      "kind": "paragraph",
      "number": "16",
      "heading": "Variation of marketing authorizations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-16",
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      "path": "schedule/1/paragraph/17",
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      "heading": "Reclassification of marketing authorizations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-17",
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    },
    {
      "path": "schedule/1/paragraph/18",
      "kind": "paragraph",
      "number": "18",
      "heading": "Variation of marketing authorization: natural homoeopathic products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-18",
      "extent": null,
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    {
      "path": "schedule/1/paragraph/19",
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      "heading": "Variation of parallel import licence",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-19",
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      "parent": "schedule/1/part/4"
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    {
      "path": "schedule/1/paragraph/20",
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      "heading": "Manufacturer’s authorisations and licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-20",
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    {
      "path": "schedule/1/paragraph/21",
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      "heading": "Variation of manufacturer’s authorisations and licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-21",
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    {
      "path": "schedule/1/paragraph/22",
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      "heading": "Wholesale dealer’s licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-22",
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      "path": "schedule/1/paragraph/23",
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      "heading": "Variation of wholesale dealer’s licence",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-23",
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      "path": "schedule/1/paragraph/24",
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      "heading": "Clinical trial authorisations",
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      "path": "schedule/1/paragraph/25",
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      "heading": "Traditional herbal registrations",
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      "path": "schedule/1/paragraph/26",
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      "heading": "Identical variations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-26",
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      "heading": "Complex Variation Applications",
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      "heading": "Multiple reclassification variation applications",
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      "path": "schedule/1/part/5",
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      "number": "5",
      "heading": "Capital Fees for Assessment of Labels and Leaflets",
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      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/29",
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      "heading": "Interpretation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-29",
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    },
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      "path": "schedule/1/paragraph/30",
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      "number": "30",
      "heading": "Single set of changes",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-30",
      "extent": null,
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      "parent": "schedule/1/part/5"
    },
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      "path": "schedule/1/paragraph/31",
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      "heading": "More than one set of charges purposed",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-31",
      "extent": null,
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      "parent": "schedule/1/part/5"
    },
    {
      "path": "schedule/1/part/6",
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      "number": "6",
      "heading": "Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorizations",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/32",
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      "heading": "Regulatory assistance",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-32",
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    },
    {
      "path": "schedule/1/paragraph/33",
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      "number": "33",
      "heading": "Regulatory assistance – same manufacturer",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-33",
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    },
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      "path": "schedule/2",
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      "heading": "FEES FOR INSPECTIONS",
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    },
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      "path": "schedule/2/paragraph/1",
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    },
    {
      "path": "schedule/2/paragraph/3",
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      "heading": "Third country traditional herbal medicinal products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-2/paragraph-3",
      "extent": null,
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    },
    {
      "path": "schedule/2/paragraph/4",
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      "heading": "Sites concerned with starting materials for traditional herbal medicinal products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-2/paragraph-4",
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    },
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      "path": "schedule/2/paragraph/5",
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    {
      "path": "schedule/2/paragraph/6",
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      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-2/paragraph-6",
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    },
    {
      "path": "schedule/2/paragraph/7",
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      "heading": "Wholesale dealer’s licences: inspection of short duration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-2/paragraph-7",
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      "path": "schedule/3",
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      "heading": "PERIODIC FEES FOR LICENCES",
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    },
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      "path": "schedule/3/part/1",
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    {
      "path": "schedule/3/part/2",
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      "heading": "Calculation of Turnover",
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    {
      "path": "schedule/3/paragraph/3",
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      "heading": "Manufacturer’s prices",
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      "path": "schedule/3/part/3",
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    },
    {
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      "heading": "Marketing authorizations",
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    {
      "path": "schedule/3/paragraph/6",
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      "heading": "Marketing authorization: where Part 2 of Act applies",
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    },
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      "path": "schedule/3/paragraph/7",
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      "heading": "Marketing authorization: derivatives",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-3/paragraph-7",
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    },
    {
      "path": "schedule/3/paragraph/8",
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      "heading": "Number of fee periods",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-3/paragraph-8",
      "extent": null,
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    },
    {
      "path": "schedule/3/paragraph/9",
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      "heading": "Authorisation for two or more kinds of medicinal product",
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    },
    {
      "path": "schedule/3/paragraph/10",
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      "heading": "Reduced fees",
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    },
    {
      "path": "schedule/3/paragraph/11",
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      "heading": "Manufacturer’s licences or manufacturing authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-3/paragraph-11",
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    },
    {
      "path": "schedule/3/paragraph/12",
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      "heading": "Wholesale dealer’s licences",
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    },
    {
      "path": "schedule/3/paragraph/13",
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      "heading": "Wholesale dealer’s licences: evidence",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-3/paragraph-13",
      "extent": null,
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    },
    {
      "path": "schedule/3/paragraph/14",
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      "heading": "Wholesale dealer licences: exempt imported products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-3/paragraph-14",
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    },
    {
      "path": "schedule/3/paragraph/15",
      "kind": "paragraph",
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      "heading": "Additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to exempt imported products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-3/paragraph-15",
      "extent": null,
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      "parent": "schedule/3/part/3"
    },
    {
      "path": "schedule/3/paragraph/16",
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      "heading": "Clinical trial authorisations",
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      "parent": "schedule/3/part/3"
    },
    {
      "path": "schedule/3/paragraph/17",
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