{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016.json",
  "id": "uksi/2016/190",
  "title": "The Medicines (Products for Human Use) (Fees) Regulations 2016",
  "short_title": "Medicines (Products for Human Use) (Fees) 2016",
  "long_title": "These Regulations revoke and re-enact, with some amendments, the Medicines (Products for Human Use) (Fees) Regulations 2013 (“the 2013 Regulations”). They make amendments to the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the 1995 Regulations”).",
  "citation": "S.I. 2016/190",
  "type": "uksi",
  "year": "2016",
  "number": "190",
  "version": "current",
  "date": "2016-02-11",
  "revised": true,
  "valid_from": "2026-04-28",
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/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-2016/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-2016/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-2016/regulation-3",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/3A",
      "kind": "regulation",
      "number": "3A",
      "heading": "Fee for scientific or other advice",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-3A",
      "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 authorisation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-4",
      "extent": null,
      "status": "repealed",
      "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-2016/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-2016/regulation-6",
      "extent": null,
      "status": "repealed",
      "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-2016/regulation-7",
      "extent": null,
      "status": "repealed",
      "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-2016/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-2016/regulation-9",
      "extent": null,
      "status": "repealed",
      "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-2016/regulation-10",
      "extent": null,
      "status": "repealed",
      "parent": "part/2"
    },
    {
      "path": "regulation/10A",
      "kind": "regulation",
      "number": "10A",
      "heading": "Waiver for advice given to small and medium companies",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-10A",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "regulation/11",
      "kind": "regulation",
      "number": "11",
      "heading": "Time for payment of fees under regulations 3A to 8",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-11",
      "extent": null,
      "status": null,
      "parent": "part/2"
    },
    {
      "path": "part/3",
      "kind": "part",
      "number": "3",
      "heading": "Capital Fees for Applications for Authorisations, Registrations, Licences or Certificates and for Associated Inspections",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/12",
      "kind": "regulation",
      "number": "12",
      "heading": "Fees for applications for authorisations, registrations, licences or certificates etc.",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-12",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/13",
      "kind": "regulation",
      "number": "13",
      "heading": "Fee for application to be included on the list of online sellers of medicines",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-13",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/14",
      "kind": "regulation",
      "number": "14",
      "heading": "Fee for applications for additional copy certificates",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-14",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "regulation/15",
      "kind": "regulation",
      "number": "15",
      "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-2016/regulation-15",
      "extent": null,
      "status": null,
      "parent": "part/3"
    },
    {
      "path": "part/4",
      "kind": "part",
      "number": "4",
      "heading": "Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/16",
      "kind": "regulation",
      "number": "16",
      "heading": "Meaning of “set of applications”",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-16",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/17",
      "kind": "regulation",
      "number": "17",
      "heading": "Fees for applications for regulatory assistance under the mutual recognition procedure",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-17",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "regulation/18",
      "kind": "regulation",
      "number": "18",
      "heading": "Time for payment of fees under regulation 17",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-18",
      "extent": null,
      "status": null,
      "parent": "part/4"
    },
    {
      "path": "part/5",
      "kind": "part",
      "number": "5",
      "heading": "Capital Fees for Applications for Variations of Authorisations, Registrations and Licences and for Associated Compliance Activities",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/19",
      "kind": "regulation",
      "number": "19",
      "heading": "Fees for variations of authorisations, registrations and licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/19A",
      "kind": "regulation",
      "number": "19A",
      "heading": "Fees for certification of plasma master files",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19A",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/19B",
      "kind": "regulation",
      "number": "19B",
      "heading": "Fee for certification of vaccine antigen master files",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19B",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/19C",
      "kind": "regulation",
      "number": "19C",
      "heading": "Fees for assessment of post-authorisation safety studies",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19C",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/19D",
      "kind": "regulation",
      "number": "19D",
      "heading": "Fee for carrying out a major safety review",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19D",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/19E",
      "kind": "regulation",
      "number": "19E",
      "heading": "Fee for assessment of periodic safety update reports",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19E",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/19EA",
      "kind": "regulation",
      "number": "19EA",
      "heading": "Fee for assessment of clinical trial annual safety reports",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19EA",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/19F",
      "kind": "regulation",
      "number": "19F",
      "heading": "Fee for testing of samples by the appropriate authority",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19F",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/19G",
      "kind": "regulation",
      "number": "19G",
      "heading": "Time for payment of fees under regulations 19A to 19F",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19G",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/20",
      "kind": "regulation",
      "number": "20",
      "heading": "Fees for modifications to clinical trial authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-20",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/21",
      "kind": "regulation",
      "number": "21",
      "heading": "Fees for notification of changes and reports for broker's registrations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-21",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/22",
      "kind": "regulation",
      "number": "22",
      "heading": "Fees for notification of changes and compliance Reports for active substance registrations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-22",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "regulation/23",
      "kind": "regulation",
      "number": "23",
      "heading": "Applications for multiple variations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-23",
      "extent": null,
      "status": null,
      "parent": "part/5"
    },
    {
      "path": "part/6",
      "kind": "part",
      "number": "6",
      "heading": "Capital Fees for Assessment of Labels and Leaflets",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/24",
      "kind": "regulation",
      "number": "24",
      "heading": "Meaning of “set of proposed changes”",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-24",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/25",
      "kind": "regulation",
      "number": "25",
      "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-2016/regulation-25",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "regulation/26",
      "kind": "regulation",
      "number": "26",
      "heading": "Time for payment of fees under regulation 25",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-26",
      "extent": null,
      "status": null,
      "parent": "part/6"
    },
    {
      "path": "part/7",
      "kind": "part",
      "number": "7",
      "heading": "Capital Fees for Applications for Renewals of Certain Licences, Authorisations and Registrations and for Associated Inspections",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/27",
      "kind": "regulation",
      "number": "27",
      "heading": "Fees for renewals of certain manufacturer's licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-27",
      "extent": null,
      "status": null,
      "parent": "part/7"
    },
    {
      "path": "regulation/27A",
      "kind": "regulation",
      "number": "27A",
      "heading": "Fee for renewals of a marketing authorisation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-27A",
      "extent": null,
      "status": null,
      "parent": "part/7"
    },
    {
      "path": "regulation/28",
      "kind": "regulation",
      "number": "28",
      "heading": "Fees for renewals in terms which are not identical to the existing authorisation, licence or registration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-28",
      "extent": null,
      "status": null,
      "parent": "part/7"
    },
    {
      "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 Authorisations",
      "url": null,
      "extent": null,
      "status": "repealed",
      "parent": null
    },
    {
      "path": "regulation/29",
      "kind": "regulation",
      "number": "29",
      "heading": "Fees for regulatory assistance for certain marketing authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-29",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "part/8"
    },
    {
      "path": "part/9",
      "kind": "part",
      "number": "9",
      "heading": "Capital Fees for Inspections",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/30",
      "kind": "regulation",
      "number": "30",
      "heading": "Fees for inspections",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-30",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "regulation/31",
      "kind": "regulation",
      "number": "31",
      "heading": "Fees for inspections of pharmacovigilance service providers",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-31",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "regulation/32",
      "kind": "regulation",
      "number": "32",
      "heading": "Payer of inspection fee (contract laboratories and API manufacturing sites)",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-32",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "regulation/33",
      "kind": "regulation",
      "number": "33",
      "heading": "Inspections in connection with multiple applications",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-33",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "regulation/34",
      "kind": "regulation",
      "number": "34",
      "heading": "Fees for inspections relating to good clinical practice in clinical trials",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-34",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "regulation/35",
      "kind": "regulation",
      "number": "35",
      "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-2016/regulation-35",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "regulation/36",
      "kind": "regulation",
      "number": "36",
      "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-2016/regulation-36",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "regulation/37",
      "kind": "regulation",
      "number": "37",
      "heading": "Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-37",
      "extent": null,
      "status": null,
      "parent": "part/9"
    },
    {
      "path": "part/10",
      "kind": "part",
      "number": "10",
      "heading": "Periodic Fees for Authorisations, Registrations and Licences",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/38",
      "kind": "regulation",
      "number": "38",
      "heading": "Periodic fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-38",
      "extent": null,
      "status": null,
      "parent": "part/10"
    },
    {
      "path": "regulation/39",
      "kind": "regulation",
      "number": "39",
      "heading": "Periodic fee for persons included on the list of online sellers of medicines",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-39",
      "extent": null,
      "status": null,
      "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,
      "parent": null
    },
    {
      "path": "regulation/40",
      "kind": "regulation",
      "number": "40",
      "heading": "Meaning of “good clinical practice accreditation scheme”",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-40",
      "extent": null,
      "status": null,
      "parent": "part/11"
    },
    {
      "path": "regulation/41",
      "kind": "regulation",
      "number": "41",
      "heading": "Fees for applications for membership and certificates",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-41",
      "extent": null,
      "status": null,
      "parent": "part/11"
    },
    {
      "path": "part/12",
      "kind": "part",
      "number": "12",
      "heading": "Capital Fee for a Review Upon Oral Representations or a Person Appointed Hearing",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/42",
      "kind": "regulation",
      "number": "42",
      "heading": "Fee for a review upon oral representations or a person appointed hearing",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-42",
      "extent": null,
      "status": null,
      "parent": "part/12"
    },
    {
      "path": "regulation/43",
      "kind": "regulation",
      "number": "43",
      "heading": "Time for payment under regulation 42",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-43",
      "extent": null,
      "status": null,
      "parent": "part/12"
    },
    {
      "path": "part/13",
      "kind": "part",
      "number": "13",
      "heading": "Fees in relation to the Part 6 of the Human Medicines Regulations (certification of homoeopathic medicinal products)",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/44",
      "kind": "regulation",
      "number": "44",
      "heading": "Interpretation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-44",
      "extent": null,
      "status": null,
      "parent": "part/13"
    },
    {
      "path": "regulation/45",
      "kind": "regulation",
      "number": "45",
      "heading": "Fees for applications made at the invitation of the licensing authority",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-45",
      "extent": null,
      "status": null,
      "parent": "part/13"
    },
    {
      "path": "regulation/46",
      "kind": "regulation",
      "number": "46",
      "heading": "Fees for applications for certificates",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-46",
      "extent": null,
      "status": null,
      "parent": "part/13"
    },
    {
      "path": "regulation/47",
      "kind": "regulation",
      "number": "47",
      "heading": "Fees for variations of certificates",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-47",
      "extent": null,
      "status": null,
      "parent": "part/13"
    },
    {
      "path": "regulation/48",
      "kind": "regulation",
      "number": "48",
      "heading": "Time for payment of fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-48",
      "extent": null,
      "status": null,
      "parent": "part/13"
    },
    {
      "path": "part/14",
      "kind": "part",
      "number": "14",
      "heading": "Administration",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/49",
      "kind": "regulation",
      "number": "49",
      "heading": "Payment of fees to Ministers",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-49",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/50",
      "kind": "regulation",
      "number": "50",
      "heading": "Time for payment of capital fees in connection with applications or inspections",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-50",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/51",
      "kind": "regulation",
      "number": "51",
      "heading": "Time for payment of capital fees – applications made by small companies",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-51",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/52",
      "kind": "regulation",
      "number": "52",
      "heading": "Payment of fees in respect of a traditional herbal registration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-52",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/53",
      "kind": "regulation",
      "number": "53",
      "heading": "Time for payment of periodic fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-53",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/54",
      "kind": "regulation",
      "number": "54",
      "heading": "Penalty fees for late payment of periodic fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-54",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/55",
      "kind": "regulation",
      "number": "55",
      "heading": "Daily penalty fees for late payment of periodic fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-55",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/56",
      "kind": "regulation",
      "number": "56",
      "heading": "Refund or waiver of fees under regulation 54 or 55",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-56",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/57",
      "kind": "regulation",
      "number": "57",
      "heading": "Adjustment, waiver, reduction or refund of fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-57",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/58",
      "kind": "regulation",
      "number": "58",
      "heading": "Suspension of licences and authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-58",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "regulation/59",
      "kind": "regulation",
      "number": "59",
      "heading": "Civil proceedings to recover unpaid fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-59",
      "extent": null,
      "status": null,
      "parent": "part/14"
    },
    {
      "path": "part/15",
      "kind": "part",
      "number": "15",
      "heading": "Amendments to Other Legislation",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/60",
      "kind": "regulation",
      "number": "60",
      "heading": "Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-60",
      "extent": null,
      "status": null,
      "parent": "part/15"
    },
    {
      "path": "regulation/61",
      "kind": "regulation",
      "number": "61",
      "heading": "Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-61",
      "extent": null,
      "status": null,
      "parent": "part/15"
    },
    {
      "path": "regulation/62",
      "kind": "regulation",
      "number": "62",
      "heading": "Amendment of the Human Medicines Regulations 2012",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-62",
      "extent": null,
      "status": null,
      "parent": "part/15"
    },
    {
      "path": "part/16",
      "kind": "part",
      "number": "16",
      "heading": "Revocations and Savings",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/63",
      "kind": "regulation",
      "number": "63",
      "heading": "The Medicines (Products for Human Use) (Fees) Regulations 2013",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-63",
      "extent": null,
      "status": null,
      "parent": "part/16"
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/signature",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/1",
      "kind": "schedule",
      "number": "1",
      "heading": "General interpretation provisions",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/1/paragraph/1",
      "kind": "paragraph",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-1/paragraph-1",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-1/paragraph-2",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/3",
      "kind": "paragraph",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-1/paragraph-3",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/4",
      "kind": "paragraph",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-1/paragraph-4",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/1/paragraph/5",
      "kind": "paragraph",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-1/paragraph-5",
      "extent": null,
      "status": null,
      "parent": "schedule/1"
    },
    {
      "path": "schedule/2",
      "kind": "schedule",
      "number": "2",
      "heading": "Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/2/part/1",
      "kind": "part",
      "number": "1",
      "heading": "General: interpretation and categories of applications and variations",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/2"
    },
    {
      "path": "schedule/2/paragraph/1",
      "kind": "paragraph",
      "number": "1",
      "heading": "Interpretation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": "General: categories of Applications and Variations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-2",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/3",
      "kind": "paragraph",
      "number": "3",
      "heading": "Administrative variation application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-3",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/4",
      "kind": "paragraph",
      "number": "4",
      "heading": "Extension application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-4",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/5",
      "kind": "paragraph",
      "number": "5",
      "heading": "Complex application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-5",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/6",
      "kind": "paragraph",
      "number": "6",
      "heading": "Complex registration application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-6",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/7",
      "kind": "paragraph",
      "number": "7",
      "heading": "Complex variation application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-7",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/8",
      "kind": "paragraph",
      "number": "8",
      "heading": "Decentralised procedure application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-8",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/9",
      "kind": "paragraph",
      "number": "9",
      "heading": "Extended Type II Complex Variation Application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-9",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/10",
      "kind": "paragraph",
      "number": "10",
      "heading": "Major application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-10",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/11",
      "kind": "paragraph",
      "number": "11",
      "heading": "Mutual recognition procedure incoming application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-11",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/12",
      "kind": "paragraph",
      "number": "12",
      "heading": "New excipient variation application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-12",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/13",
      "kind": "paragraph",
      "number": "13",
      "heading": "New indication variation application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-13",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/14",
      "kind": "paragraph",
      "number": "14",
      "heading": "Parallel Import Licence application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-14",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/15",
      "kind": "paragraph",
      "number": "15",
      "heading": "Reclassification variation application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-15",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/16",
      "kind": "paragraph",
      "number": "16",
      "heading": "Reduced registration application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-16",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/17",
      "kind": "paragraph",
      "number": "17",
      "heading": "Simple application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-17",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/18",
      "kind": "paragraph",
      "number": "18",
      "heading": "Standard application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-18",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/19",
      "kind": "paragraph",
      "number": "19",
      "heading": "Standard registration application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-19",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/20",
      "kind": "paragraph",
      "number": "20",
      "heading": "Standard variation application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-20",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/21",
      "kind": "paragraph",
      "number": "21",
      "heading": "Standard variation application for a homoeopathic medicinal product",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-21",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/22",
      "kind": "paragraph",
      "number": "22",
      "heading": "Type IB and Type II Applications",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-22",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/paragraph/23",
      "kind": "paragraph",
      "number": "23",
      "heading": "Type II Complex Variation Application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-23",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/1"
    },
    {
      "path": "schedule/2/part/2",
      "kind": "part",
      "number": "2",
      "heading": "Capital Fees for Applications for Authorisations, Licences, Registrations and Certificates",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/2"
    },
    {
      "path": "schedule/2/paragraph/24",
      "kind": "paragraph",
      "number": "24",
      "heading": "Marketing authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-24",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/24A",
      "kind": "paragraph",
      "number": "24A",
      "heading": "Fees where an application for a European Union marketing authorisation had been made before IP completion day",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-24A",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/25",
      "kind": "paragraph",
      "number": "25",
      "heading": "Fees where application includes reclassification",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-25",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/26",
      "kind": "paragraph",
      "number": "26",
      "heading": "Fees where person holds clinical trial certificate",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-26",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/27",
      "kind": "paragraph",
      "number": "27",
      "heading": "Joint development",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-27",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/28",
      "kind": "paragraph",
      "number": "28",
      "heading": "Application for multiple authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-28",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/28A",
      "kind": "paragraph",
      "number": "28A",
      "heading": "Application by pre-assessment of modules",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-28A",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/29",
      "kind": "paragraph",
      "number": "29",
      "heading": "Authorisation for a national homoeopathic product",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-29",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/30",
      "kind": "paragraph",
      "number": "30",
      "heading": "Manufacturer's licences and authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-30",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/31",
      "kind": "paragraph",
      "number": "31",
      "heading": "Wholesale dealer's licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-31",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/32",
      "kind": "paragraph",
      "number": "32",
      "heading": "Broker's registrations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-32",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/33",
      "kind": "paragraph",
      "number": "33",
      "heading": "Active substance registrations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-33",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/34",
      "kind": "paragraph",
      "number": "34",
      "heading": "Clinical trial authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-34",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/35",
      "kind": "paragraph",
      "number": "35",
      "heading": "Traditional herbal registrations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-35",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/35A",
      "kind": "paragraph",
      "number": "35A",
      "heading": "Early Access to Medicines Scheme fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-35A",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/paragraph/36",
      "kind": "paragraph",
      "number": "36",
      "heading": "Online sellers of medicines",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-36",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/2"
    },
    {
      "path": "schedule/2/part/3",
      "kind": "part",
      "number": "3",
      "heading": "Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/2"
    },
    {
      "path": "schedule/2/paragraph/37",
      "kind": "paragraph",
      "number": "37",
      "heading": "Outgoing mutual recognition applications",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-37",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/3"
    },
    {
      "path": "schedule/2/part/4",
      "kind": "part",
      "number": "4",
      "heading": "Capital Fees for Applications for Variations of Authorisations, Licences and Registrations",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/2"
    },
    {
      "path": "schedule/2/paragraph/38",
      "kind": "paragraph",
      "number": "38",
      "heading": "Marketing authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-38",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/39",
      "kind": "paragraph",
      "number": "39",
      "heading": "Variation of marketing authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-39",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/39A",
      "kind": "paragraph",
      "number": "39A",
      "heading": "Variation of orphan marketing authorisations: small and medium companies",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-39A",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/40",
      "kind": "paragraph",
      "number": "40",
      "heading": "Reclassification of marketing authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-40",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/40A",
      "kind": "paragraph",
      "number": "40A",
      "heading": "Fees where an application for a variation or an extension of a European Union marketing authorisation had been made before IP completion day",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-40A",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/41",
      "kind": "paragraph",
      "number": "41",
      "heading": "Variation of marketing authorisation: national homoeopathic products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-41",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/42",
      "kind": "paragraph",
      "number": "42",
      "heading": "Variation of parallel import licence",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-42",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/43",
      "kind": "paragraph",
      "number": "43",
      "heading": "Manufacturer's authorisations and licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-43",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/44",
      "kind": "paragraph",
      "number": "44",
      "heading": "Variation of manufacturer's authorisations and licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-44",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/45",
      "kind": "paragraph",
      "number": "45",
      "heading": "Wholesale dealer's licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-45",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/46",
      "kind": "paragraph",
      "number": "46",
      "heading": "Variation of wholesale dealer's licence",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-46",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/47",
      "kind": "paragraph",
      "number": "47",
      "heading": "Variation of a broker's registration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-47",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/48",
      "kind": "paragraph",
      "number": "48",
      "heading": "Variation of an active substance registration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-48",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/49",
      "kind": "paragraph",
      "number": "49",
      "heading": "Clinical trial authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-49",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/50",
      "kind": "paragraph",
      "number": "50",
      "heading": "Traditional herbal registrations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-50",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/51",
      "kind": "paragraph",
      "number": "51",
      "heading": "Identical variations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-51",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/52",
      "kind": "paragraph",
      "number": "52",
      "heading": "Complex Variation Applications",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-52",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/paragraph/53",
      "kind": "paragraph",
      "number": "53",
      "heading": "Multiple reclassification variation applications",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-53",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/4"
    },
    {
      "path": "schedule/2/part/5",
      "kind": "part",
      "number": "5",
      "heading": "Capital Fees for Assessment of Labels and Leaflets",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/2"
    },
    {
      "path": "schedule/2/paragraph/54",
      "kind": "paragraph",
      "number": "54",
      "heading": "A set of changes",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-54",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/5"
    },
    {
      "path": "schedule/2/paragraph/55",
      "kind": "paragraph",
      "number": "55",
      "heading": "More than one set of changes proposed",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-55",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/5"
    },
    {
      "path": "schedule/2/part/6",
      "kind": "part",
      "number": "6",
      "heading": "Capital Fee for the Renewal of a Marketing Authorisation",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/2"
    },
    {
      "path": "schedule/2/paragraph/56",
      "kind": "paragraph",
      "number": "56",
      "heading": "Renewal of a marketing authorisation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-56",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/6"
    },
    {
      "path": "schedule/2/paragraph/57",
      "kind": "paragraph",
      "number": "57",
      "heading": "Renewal of multiple marketing authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-57",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/6"
    },
    {
      "path": "schedule/2/part/6A",
      "kind": "part",
      "number": "6A",
      "heading": "Capital Fee for Conducting a Major Safety Review",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/2"
    },
    {
      "path": "schedule/2/paragraph/57A",
      "kind": "paragraph",
      "number": "57A",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-57A",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/6A"
    },
    {
      "path": "schedule/2/part/6B",
      "kind": "part",
      "number": "6B",
      "heading": "Capital Fee for Testing of Samples by the Appropriate Authority",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/2"
    },
    {
      "path": "schedule/2/paragraph/57B",
      "kind": "paragraph",
      "number": "57B",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-57B",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/6B"
    },
    {
      "path": "schedule/2/part/7",
      "kind": "part",
      "number": "7",
      "heading": "Relevant Substances",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/2"
    },
    {
      "path": "schedule/2/paragraph/58",
      "kind": "paragraph",
      "number": "58",
      "heading": "Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 38(2)(b)",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-58",
      "extent": null,
      "status": null,
      "parent": "schedule/2/part/7"
    },
    {
      "path": "schedule/3",
      "kind": "schedule",
      "number": "3",
      "heading": "Fees for inspections",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/3/paragraph/1",
      "kind": "paragraph",
      "number": "1",
      "heading": "General provisions relating to fees for inspections",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-3/paragraph-1",
      "extent": null,
      "status": null,
      "parent": "schedule/3"
    },
    {
      "path": "schedule/3/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": "Fees: general",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-3/paragraph-2",
      "extent": null,
      "status": null,
      "parent": "schedule/3"
    },
    {
      "path": "schedule/3/paragraph/3",
      "kind": "paragraph",
      "number": "3",
      "heading": "Traditional herbal medicinal products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-3/paragraph-3",
      "extent": null,
      "status": null,
      "parent": "schedule/3"
    },
    {
      "path": "schedule/3/paragraph/4",
      "kind": "paragraph",
      "number": "4",
      "heading": "Sites concerned with starting materials for traditional herbal medicinal products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-3/paragraph-4",
      "extent": null,
      "status": null,
      "parent": "schedule/3"
    },
    {
      "path": "schedule/3/paragraph/5",
      "kind": "paragraph",
      "number": "5",
      "heading": "Wholesale dealer's licence: general",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-3/paragraph-5",
      "extent": null,
      "status": null,
      "parent": "schedule/3"
    },
    {
      "path": "schedule/3/paragraph/6",
      "kind": "paragraph",
      "number": "6",
      "heading": "Wholesale dealer's licence: traditional herbal medicinal products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-3/paragraph-6",
      "extent": null,
      "status": null,
      "parent": "schedule/3"
    },
    {
      "path": "schedule/3/paragraph/7",
      "kind": "paragraph",
      "number": "7",
      "heading": "Wholesale dealer's licences: inspection of short duration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-3/paragraph-7",
      "extent": null,
      "status": null,
      "parent": "schedule/3"
    },
    {
      "path": "schedule/3/paragraph/8",
      "kind": "paragraph",
      "number": "8",
      "heading": "Broker's registrations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-3/paragraph-8",
      "extent": null,
      "status": null,
      "parent": "schedule/3"
    },
    {
      "path": "schedule/3/paragraph/9",
      "kind": "paragraph",
      "number": "9",
      "heading": "Active substance registrations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-3/paragraph-9",
      "extent": null,
      "status": null,
      "parent": "schedule/3"
    },
    {
      "path": "schedule/3/paragraph/10",
      "kind": "paragraph",
      "number": "10",
      "heading": "Office-based inspections",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-3/paragraph-10",
      "extent": null,
      "status": null,
      "parent": "schedule/3"
    },
    {
      "path": "schedule/4",
      "kind": "schedule",
      "number": "4",
      "heading": "Periodic fees for licences",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/4/part/1",
      "kind": "part",
      "number": "1",
      "heading": "Interpretation",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/4"
    },
    {
      "path": "schedule/4/paragraph/1",
      "kind": "paragraph",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-1",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/1"
    },
    {
      "path": "schedule/4/part/2",
      "kind": "part",
      "number": "2",
      "heading": "Value of the Product Sold or Supplied",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/4"
    },
    {
      "path": "schedule/4/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": "Determining the total value of the product",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-2",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/2"
    },
    {
      "path": "schedule/4/paragraph/3",
      "kind": "paragraph",
      "number": "3",
      "heading": "Manufacturer's prices",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-3",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/2"
    },
    {
      "path": "schedule/4/paragraph/4",
      "kind": "paragraph",
      "number": "4",
      "heading": "Information requirements",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-4",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/2"
    },
    {
      "path": "schedule/4/part/3",
      "kind": "part",
      "number": "3",
      "heading": "Periodic Fees for Marketing Authorisations and Licences",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/4"
    },
    {
      "path": "schedule/4/paragraph/5",
      "kind": "paragraph",
      "number": "5",
      "heading": "Marketing authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-5",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/3"
    },
    {
      "path": "schedule/4/paragraph/6",
      "kind": "paragraph",
      "number": "6",
      "heading": "Marketing authorisation: where Part 2 of the Act applies",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-6",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/3"
    },
    {
      "path": "schedule/4/paragraph/7",
      "kind": "paragraph",
      "number": "7",
      "heading": "Marketing authorisation: derivatives",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-7",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/3"
    },
    {
      "path": "schedule/4/paragraph/8",
      "kind": "paragraph",
      "number": "8",
      "heading": "Number of fee periods",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-8",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/3"
    },
    {
      "path": "schedule/4/paragraph/9",
      "kind": "paragraph",
      "number": "9",
      "heading": "Authorisation for two or more kinds of medicinal product",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-9",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/3"
    },
    {
      "path": "schedule/4/paragraph/10",
      "kind": "paragraph",
      "number": "10",
      "heading": "Reduced fees",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-10",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/3"
    },
    {
      "path": "schedule/4/paragraph/11",
      "kind": "paragraph",
      "number": "11",
      "heading": "Manufacturer's licences or manufacturing authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-11",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/3"
    },
    {
      "path": "schedule/4/paragraph/12",
      "kind": "paragraph",
      "number": "12",
      "heading": "Wholesale dealer's licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-12",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/3"
    },
    {
      "path": "schedule/4/paragraph/13",
      "kind": "paragraph",
      "number": "13",
      "heading": "Wholesale dealer's licences: evidence",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-13",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/3"
    },
    {
      "path": "schedule/4/paragraph/14",
      "kind": "paragraph",
      "number": "14",
      "heading": "Wholesale dealer's licences: special medicinal products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-14",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/3"
    },
    {
      "path": "schedule/4/paragraph/15",
      "kind": "paragraph",
      "number": "15",
      "heading": "Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-15",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/3"
    },
    {
      "path": "schedule/4/paragraph/16",
      "kind": "paragraph",
      "number": "16",
      "heading": "Traditional herbal registrations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-16",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/3"
    },
    {
      "path": "schedule/4/paragraph/17",
      "kind": "paragraph",
      "number": "17",
      "heading": "Online sellers of medicines",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-17",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/3"
    },
    {
      "path": "schedule/4/part/4",
      "kind": "part",
      "number": "4",
      "heading": "Types of Marketing Authorisation for which only One Periodic Fee is Payable",
      "url": null,
      "extent": null,
      "status": null,
      "parent": "schedule/4"
    },
    {
      "path": "schedule/4/paragraph/18",
      "kind": "paragraph",
      "number": "18",
      "heading": "Parallel import licences",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-18",
      "extent": null,
      "status": null,
      "parent": "schedule/4/part/4"
    },
    {
      "path": "schedule/5",
      "kind": "schedule",
      "number": "5",
      "heading": "Fees for certificates of registration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-5",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/6",
      "kind": "schedule",
      "number": "6",
      "heading": "Time for payment of capital fees: small companies",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/6/paragraph/1",
      "kind": "paragraph",
      "number": "1",
      "heading": "Interpretation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-6/paragraph-1",
      "extent": null,
      "status": null,
      "parent": "schedule/6"
    },
    {
      "path": "schedule/6/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": "Major application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-6/paragraph-2",
      "extent": null,
      "status": null,
      "parent": "schedule/6"
    },
    {
      "path": "schedule/6/paragraph/3",
      "kind": "paragraph",
      "number": "3",
      "heading": "Complex application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-6/paragraph-3",
      "extent": null,
      "status": null,
      "parent": "schedule/6"
    },
    {
      "path": "schedule/6/paragraph/4",
      "kind": "paragraph",
      "number": "4",
      "heading": "Multiple application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-6/paragraph-4",
      "extent": null,
      "status": null,
      "parent": "schedule/6"
    },
    {
      "path": "schedule/6/paragraph/5",
      "kind": "paragraph",
      "number": "5",
      "heading": "Outgoing mutual recognition application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-6/paragraph-5",
      "extent": null,
      "status": null,
      "parent": "schedule/6"
    },
    {
      "path": "schedule/6/paragraph/6",
      "kind": "paragraph",
      "number": "6",
      "heading": "Application for traditional herbal registration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-6/paragraph-6",
      "extent": null,
      "status": null,
      "parent": "schedule/6"
    },
    {
      "path": "schedule/6/paragraph/7",
      "kind": "paragraph",
      "number": "7",
      "heading": "Traditional herbal registration: complex variation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-6/paragraph-7",
      "extent": null,
      "status": null,
      "parent": "schedule/6"
    },
    {
      "path": "schedule/6/paragraph/8",
      "kind": "paragraph",
      "number": "8",
      "heading": "Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-6/paragraph-8",
      "extent": null,
      "status": null,
      "parent": "schedule/6"
    },
    {
      "path": "schedule/6/paragraph/9",
      "kind": "paragraph",
      "number": "9",
      "heading": "Inspection fees in connection with applications",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-6/paragraph-9",
      "extent": null,
      "status": null,
      "parent": "schedule/6"
    },
    {
      "path": "schedule/7",
      "kind": "schedule",
      "number": "7",
      "heading": "Waiver, reduction or refund of capital fees",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/7/paragraph/1",
      "kind": "paragraph",
      "number": "1",
      "heading": "Interruptions of manufacture, assembly, sale or supply",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-1",
      "extent": null,
      "status": null,
      "parent": "schedule/7"
    },
    {
      "path": "schedule/7/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": "Reclassification",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-2",
      "extent": null,
      "status": null,
      "parent": "schedule/7"
    },
    {
      "path": "schedule/7/paragraph/3",
      "kind": "paragraph",
      "number": "3",
      "heading": "Variation of a traditional herbal registration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-3",
      "extent": null,
      "status": null,
      "parent": "schedule/7"
    },
    {
      "path": "schedule/7/paragraph/4",
      "kind": "paragraph",
      "number": "4",
      "heading": "Withdrawal of application in relation to marketing authorisation, traditional herbal registration or clinical trial authorisation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-4",
      "extent": null,
      "status": null,
      "parent": "schedule/7"
    },
    {
      "path": "schedule/7/paragraph/5",
      "kind": "paragraph",
      "number": "5",
      "heading": "Withdrawal of application in relation to a certificate of registration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-5",
      "extent": null,
      "status": null,
      "parent": "schedule/7"
    },
    {
      "path": "schedule/7/paragraph/6",
      "kind": "paragraph",
      "number": "6",
      "heading": "Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence, manufacturer's licence, broker's registration or active substance registration",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-6",
      "extent": null,
      "status": null,
      "parent": "schedule/7"
    },
    {
      "path": "schedule/7/paragraph/7",
      "kind": "paragraph",
      "number": "7",
      "heading": "Refusal of application for grant of marketing authorisation, traditional herbal registration or clinical trial authorisation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-7",
      "extent": null,
      "status": null,
      "parent": "schedule/7"
    },
    {
      "path": "schedule/7/paragraph/7A",
      "kind": "paragraph",
      "number": "7A",
      "heading": "Orphan marketing authorisation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-7A",
      "extent": null,
      "status": null,
      "parent": "schedule/7"
    },
    {
      "path": "schedule/7/paragraph/8",
      "kind": "paragraph",
      "number": "8",
      "heading": "Parallel import licence",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-8",
      "extent": null,
      "status": null,
      "parent": "schedule/7"
    },
    {
      "path": "schedule/7/paragraph/9",
      "kind": "paragraph",
      "number": "9",
      "heading": "Surrender of marketing authorisation at same time as a variation application",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-9",
      "extent": null,
      "status": null,
      "parent": "schedule/7"
    },
    {
      "path": "schedule/7/paragraph/10",
      "kind": "paragraph",
      "number": "10",
      "heading": "Clinical trial authorisation",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-10",
      "extent": null,
      "status": null,
      "parent": "schedule/7"
    },
    {
      "path": "schedule/7/paragraph/11",
      "kind": "paragraph",
      "number": "11",
      "heading": "Scientific advice: paediatric indications",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-11",
      "extent": null,
      "status": null,
      "parent": "schedule/7"
    },
    {
      "path": "schedule/7/paragraph/12",
      "kind": "paragraph",
      "number": "12",
      "heading": "Refunds: treated as having been paid on account",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-12",
      "extent": null,
      "status": null,
      "parent": "schedule/7"
    },
    {
      "path": "schedule/8",
      "kind": "schedule",
      "number": "8",
      "heading": "Adjustment , waiver reduction or refund of periodic fees",
      "url": null,
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "schedule/8/paragraph/1",
      "kind": "paragraph",
      "number": "1",
      "heading": "Refund on surrender or revocation of authorisation, registration or licence",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-8/paragraph-1",
      "extent": null,
      "status": null,
      "parent": "schedule/8"
    },
    {
      "path": "schedule/8/paragraph/2",
      "kind": "paragraph",
      "number": "2",
      "heading": "Adjustment and refund: licences relating to imported special medicinal products",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-8/paragraph-2",
      "extent": null,
      "status": null,
      "parent": "schedule/8"
    },
    {
      "path": "schedule/8/paragraph/2A",
      "kind": "paragraph",
      "number": "2A",
      "heading": "Waiver or refund: converted EU marketing authorisations",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-8/paragraph-2A",
      "extent": null,
      "status": null,
      "parent": "schedule/8"
    },
    {
      "path": "schedule/8/paragraph/3",
      "kind": "paragraph",
      "number": "3",
      "heading": "Refunds: treated as having been paid on account",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-8/paragraph-3",
      "extent": null,
      "status": null,
      "parent": "schedule/8"
    },
    {
      "path": "note",
      "kind": "note",
      "number": null,
      "heading": "Explanatory note",
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/note",
      "extent": null,
      "status": null,
      "parent": null
    }
  ],
  "has_text": true,
  "pdfs": [
    {
      "title": "Printed copy",
      "main": true,
      "language": null,
      "date": "2016-02-24",
      "size": 433167,
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/pdf/uksi_20160190_en.pdf",
      "source_url": "https://www.legislation.gov.uk/uksi/2016/190/pdfs/uksi_20160190_en.pdf"
    },
    {
      "title": "UK Explanatory Memorandum",
      "main": false,
      "language": null,
      "date": "2016-02-24",
      "size": 50564,
      "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/pdf/uksiem_20160190_en.pdf",
      "source_url": "https://www.legislation.gov.uk/uksi/2016/190/pdfs/uksiem_20160190_en.pdf"
    }
  ],
  "outstanding_effects": [],
  "made_under": [],
  "changes_made_to": 505,
  "changes_made_to_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/changes.json",
  "changes_made_by": 20,
  "changes_made_by_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/changes/by-it.json",
  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190",
    "retrieved_at": "2026-10-28T23:27:13.215121+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."
}