{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012.json",
  "id": "nisr/2012/134",
  "title": "The Medicines (Products for Human Use) (Fees) Regulations 2012",
  "short_title": "Medicines (Products for Human Use) (Fees) 2012",
  "long_title": "These Regulations revoke and re-enact in consolidated form, with some amendments, the Medicines (Products for Human Use) (Fees) Regulations 2010 (“the 2010 Regulations”). They make amendments to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Regulations”) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Clinical Trials Regulations”).",
  "citation": "S.R. 2012/134",
  "type": "nisr",
  "year": "2012",
  "number": "134",
  "version": "current",
  "date": "2012-02-23",
  "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-2012/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-2012/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-2012/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-2012/regulation-3",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/4",
      "kind": "regulation",
      "number": "4",
      "heading": "Fee for scientific advice: application for, or variation to, EU marketing authorization",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-4",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/5",
      "kind": "regulation",
      "number": "5",
      "heading": "Fee for scientific advice: classification of a medicinal product",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-5",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/6",
      "kind": "regulation",
      "number": "6",
      "heading": "Fee for advertising advice",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-6",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/7",
      "kind": "regulation",
      "number": "7",
      "heading": "Fee for pharmacovigilance advice",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-7",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/8",
      "kind": "regulation",
      "number": "8",
      "heading": "Fee for advice on labelling or leaflets",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-8",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/9",
      "kind": "regulation",
      "number": "9",
      "heading": "Fee for regulatory advice",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-9",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/10",
      "kind": "regulation",
      "number": "10",
      "heading": "Fee for advice for other purposes",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-10",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/11",
      "kind": "regulation",
      "number": "11",
      "heading": "Time for payment of fees under regulations 4 to 10",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-11",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "part/3",
      "kind": "part",
      "number": "3",
      "heading": "Capital Fees for Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/12",
      "kind": "regulation",
      "number": "12",
      "heading": "Fees for applications for authorizations, licences or certificates etc.",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-12",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/13",
      "kind": "regulation",
      "number": "13",
      "heading": "Fee for applications for copy certificates of good manufacturing practice",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-13",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/14",
      "kind": "regulation",
      "number": "14",
      "heading": "Fees for applications for certificates and copy certificates by exporters of medicinal products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-14",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "part/4",
      "kind": "part",
      "number": "4",
      "heading": "Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/15",
      "kind": "regulation",
      "number": "15",
      "heading": "Meaning of “set of applications”",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-15",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/16",
      "kind": "regulation",
      "number": "16",
      "heading": "Fees for applications for regulatory assistance under the mutual recognition procedure",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-16",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/17",
      "kind": "regulation",
      "number": "17",
      "heading": "Time for payment of fees under regulation 16",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-17",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "part/5",
      "kind": "part",
      "number": "5",
      "heading": "Capital Fees for Applications for Variations of Authorizations, Registrations, Licences and Authorisations and for Associated Inspections",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/18",
      "kind": "regulation",
      "number": "18",
      "heading": "Fees for variations of authorizations, registrations, licences and authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-18",
      "extent": null,
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    },
    {
      "path": "regulation/19",
      "kind": "regulation",
      "number": "19",
      "heading": "Fees for amendments to clinical trial authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-19",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/20",
      "kind": "regulation",
      "number": "20",
      "heading": "Applications for multiple variations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-20",
      "extent": null,
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      "parent": "part/5"
    },
    {
      "path": "part/6",
      "kind": "part",
      "number": "6",
      "heading": "Capital Fees for Assessment of Labels and Leaflets",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/21",
      "kind": "regulation",
      "number": "21",
      "heading": "Meaning of “set of proposed changes”",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-21",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/22",
      "kind": "regulation",
      "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-2012/regulation-22",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "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-2012/regulation-23",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "part/7",
      "kind": "part",
      "number": "7",
      "heading": "Capital Fees for Applications for Renewals of Certain Licences, Authorizations and Registrations and for Associated Inspections",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/24",
      "kind": "regulation",
      "number": "24",
      "heading": "Fees for renewals of certain manufacturer’s licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-24",
      "extent": null,
      "status": null,
      "parent": "part/7"
    },
    {
      "path": "regulation/25",
      "kind": "regulation",
      "number": "25",
      "heading": "Fees for renewals in terms which are not identical to the existing authorization, licence or registration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-25",
      "extent": null,
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    },
    {
      "path": "part/8",
      "kind": "part",
      "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",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/26",
      "kind": "regulation",
      "number": "26",
      "heading": "Fees for regulatory assistance for certain marketing authorizations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-26",
      "extent": null,
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      "parent": "part/8"
    },
    {
      "path": "part/9",
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      "number": "9",
      "heading": "Capital Fees for Inspections",
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    },
    {
      "path": "regulation/27",
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      "heading": "Fees for inspections",
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      "extent": null,
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    {
      "path": "regulation/28",
      "kind": "regulation",
      "number": "28",
      "heading": "Payer of inspection fee (contract laboratories and API manufacturing sites)",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-28",
      "extent": null,
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    },
    {
      "path": "regulation/29",
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      "heading": "Inspections in connection with multiple applications",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-29",
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    {
      "path": "regulation/30",
      "kind": "regulation",
      "number": "30",
      "heading": "Fees for inspections relating to good clinical practice in clinical trials",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-30",
      "extent": null,
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    },
    {
      "path": "regulation/31",
      "kind": "regulation",
      "number": "31",
      "heading": "Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer’s licence",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-31",
      "extent": null,
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    {
      "path": "regulation/32",
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      "heading": "Adjustment and refund of inspection fees in respect of a wholesale dealer’s licence",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-32",
      "extent": null,
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      "parent": "part/9"
    },
    {
      "path": "part/10",
      "kind": "part",
      "number": "10",
      "heading": "Periodic Fees for Authorizations, Registrations, Licences and Authorisations",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/33",
      "kind": "regulation",
      "number": "33",
      "heading": "Periodic fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-33",
      "extent": null,
      "status": null,
      "parent": "part/10"
    },
    {
      "path": "regulation/34",
      "kind": "regulation",
      "number": "34",
      "heading": "Periodic fees for clinical trial authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-34",
      "extent": null,
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      "parent": "part/10"
    },
    {
      "path": "part/11",
      "kind": "part",
      "number": "11",
      "heading": "Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership",
      "url": null,
      "extent": null,
      "status": null,
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    },
    {
      "path": "regulation/35",
      "kind": "regulation",
      "number": "35",
      "heading": "Meaning of “good clinical practice accreditation scheme”",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-35",
      "extent": null,
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      "parent": "part/11"
    },
    {
      "path": "regulation/36",
      "kind": "regulation",
      "number": "36",
      "heading": "Fees for applications for membership and certificates",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-36",
      "extent": null,
      "status": null,
      "parent": "part/11"
    },
    {
      "path": "part/12",
      "kind": "part",
      "number": "12",
      "heading": "Capital Fee for a Person Appointed Hearing",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/37",
      "kind": "regulation",
      "number": "37",
      "heading": "Fee for a person appointed hearing",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-37",
      "extent": null,
      "status": null,
      "parent": "part/12"
    },
    {
      "path": "regulation/38",
      "kind": "regulation",
      "number": "38",
      "heading": "Time for payment under regulation 37",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-38",
      "extent": null,
      "status": null,
      "parent": "part/12"
    },
    {
      "path": "part/13",
      "kind": "part",
      "number": "13",
      "heading": "Fees in relation to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/39",
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    },
    {
      "path": "regulation/40",
      "kind": "regulation",
      "number": "40",
      "heading": "Fees for applications made at the invitation of the licensing authority",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-40",
      "extent": null,
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    },
    {
      "path": "regulation/41",
      "kind": "regulation",
      "number": "41",
      "heading": "Fees for applications for certificates",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-41",
      "extent": null,
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    },
    {
      "path": "regulation/42",
      "kind": "regulation",
      "number": "42",
      "heading": "Fees for variations of certificates",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-42",
      "extent": null,
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    },
    {
      "path": "regulation/43",
      "kind": "regulation",
      "number": "43",
      "heading": "Time for payment of fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-43",
      "extent": null,
      "status": null,
      "parent": "part/13"
    },
    {
      "path": "part/14",
      "kind": "part",
      "number": "14",
      "heading": "Administration",
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      "extent": null,
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    },
    {
      "path": "regulation/44",
      "kind": "regulation",
      "number": "44",
      "heading": "Payment of fees to Ministers",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-44",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/45",
      "kind": "regulation",
      "number": "45",
      "heading": "Time for payment of capital fees in connection with applications or inspections",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-45",
      "extent": null,
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      "parent": "part/14"
    },
    {
      "path": "regulation/46",
      "kind": "regulation",
      "number": "46",
      "heading": "Time for payment of capital fees – applications made by small companies",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-46",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/47",
      "kind": "regulation",
      "number": "47",
      "heading": "Payment of fees in respect of a traditional herbal registration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-47",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/48",
      "kind": "regulation",
      "number": "48",
      "heading": "Time for payment of periodic fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-48",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/49",
      "kind": "regulation",
      "number": "49",
      "heading": "Penalty fees for late payment of periodic fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-49",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/50",
      "kind": "regulation",
      "number": "50",
      "heading": "Daily penalty fees for late payment of periodic fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-50",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/51",
      "kind": "regulation",
      "number": "51",
      "heading": "Refund or waiver of fees under regulation 49 or 50",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-51",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/52",
      "kind": "regulation",
      "number": "52",
      "heading": "Adjustment, waiver, reduction or refund of fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-52",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/53",
      "kind": "regulation",
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    {
      "path": "schedule/2/part/5",
      "kind": "part",
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      "heading": "Capital Fees for Assessment of Labels and Leaflets",
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    {
      "path": "schedule/2/paragraph/49",
      "kind": "paragraph",
      "number": "49",
      "heading": "A set of changes",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-49",
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      "path": "schedule/2/paragraph/50",
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      "heading": "More than one set of changes proposed",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-50",
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      "path": "schedule/2/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",
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      "heading": "Regulatory assistance",
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      "path": "schedule/2/paragraph/52",
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      "heading": "Regulatory assistance – same manufacturer",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-52",
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      "path": "schedule/3",
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      "path": "schedule/3/paragraph/1",
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      "heading": "General provisions relating to fees for inspections",
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      "heading": "Fees: general",
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      "path": "schedule/3/paragraph/3",
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      "heading": "Traditional herbal medicinal products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-3/paragraph-3",
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      "path": "schedule/3/paragraph/4",
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    {
      "path": "schedule/3/paragraph/5",
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      "heading": "Wholesale dealer’s licence: general",
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      "path": "schedule/3/paragraph/6",
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      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-3/paragraph-6",
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      "path": "schedule/3/paragraph/7",
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      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-3/paragraph-7",
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      "path": "schedule/4",
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      "heading": "PERIODIC FEES FOR LICENCES",
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    {
      "path": "schedule/4/part/1",
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      "path": "schedule/4/paragraph/1",
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      "path": "schedule/4/part/2",
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      "path": "schedule/4/paragraph/2",
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      "heading": "Determining the total value of the product",
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      "path": "schedule/4/paragraph/3",
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      "heading": "Manufacturer’s prices",
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      "path": "schedule/4/paragraph/4",
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      "path": "schedule/4/part/3",
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      "heading": "Marketing authorizations",
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      "path": "schedule/4/paragraph/6",
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      "heading": "Marketing authorization: where Part 2 of the Act applies",
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      "path": "schedule/4/paragraph/7",
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      "heading": "Marketing authorization: derivatives",
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      "path": "schedule/4/paragraph/8",
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      "heading": "Number of fee periods",
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      "path": "schedule/4/paragraph/9",
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      "heading": "Authorisation for two or more kinds of medicinal product",
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      "path": "schedule/6/paragraph/6",
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      "path": "schedule/6/paragraph/7",
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      "heading": "Traditional herbal registration: complex variation",
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      "path": "schedule/6/paragraph/8",
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    {
      "path": "schedule/7/paragraph/1",
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      "heading": "Interruptions of manufacture, assembly, sale or supply",
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      "heading": "Scientific advice: paediatric indications",
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      "path": "schedule/8/paragraph/1",
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