{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-35A",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-35A.json",
  "legislation": "uksi/2016/190",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2016",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016",
  "path": "schedule/2/paragraph/35A",
  "kind": "paragraph",
  "number": "35A",
  "heading": "Early Access to Medicines Scheme fees",
  "text": "The fee payable under regulation 12(1)(a) in connection with an application submitted under the Early Access to Medicines Scheme of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table.\nFees for Early Access to Medicines Scheme applications\nColumn 1\nColumn 2\nKind of Application\nFee payable\n1. Promising Innovative Medicine (PIM) designation\n£4,852\n2. EAMS scientific opinion for new medicinal products\n£31,214\n3. Renewal of an EAMS scientific opinion for new chemical or biological medicinal products\n£15,607\n4. EAMS scientific opinion for new indications\n£10,115\n5. Renewal of an EAMS scientific opinion for new indications\n£5,057",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 2 para. 35A inserted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(14)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sum in Sch. 2 para. 35A Table Entry 1 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(13)(a)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sum in Sch. 2 para. 35A Table Entry 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(13)(b)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Sum in Sch. 2 para. 35A Table Entry 3 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(13)(c)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Sum in Sch. 2 para. 35A Table Entry 4 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(13)(d)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Sum in Sch. 2 para. 35A Table Entry 5 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(13)(e)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/35A",
    "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."
}