{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-amendment-regulations-2025/regulation-29",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-amendment-regulations-2025/regulation-29.json",
  "legislation": "uksi/2025/317",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-amendment-regulations-2025",
  "path": "regulation/29",
  "kind": "regulation",
  "number": "29",
  "heading": "Amendment of Schedule 4",
  "text": "(1) Schedule 4 (Periodic fees for licences) is amended as follows.\n(2) In paragraph 5 (marketing authorisations), in column 2 (fee payable) of the table (periodic fees for holding a marketing authorisation)—\n(a) in entry 1, for “£10,681” substitute “£11,627”;\n(b) in entry 2, for “£338” substitute “£368”;\n(c) in entry 3(a), for “£10,681” substitute “£11,627”;\n(d) in entry 3(b)(i), for “£2,671” substitute “£2,908”;\n(e) in entry 3(b)(ii), for “£1,332” substitute “£1,450”;\n(f) in entries 3(b)(iii), (c) and (d), for “£338”, in each place it occurs, substitute “£368”;\n(g) in entries 3(e) to (h), for “£84”, in each place it occurs, substitute “£92”.\n(3) In paragraph 6 (marketing authorisation: where Part 2 of the Act applies), for “£338” substitute “£368”.\n(4) In paragraph 7 (marketing authorisation: derivatives)—\n(a) in sub-paragraph (a), for “£10,681” substitute “£11,627”;\n(b) in sub-paragraph (b), for “£7,209” substitute “£7,847”.\n(5) In paragraph 11(1) and (2) (manufacturer’s licences or manufacturing authorisations), for “£515”, in both places it occurs, substitute “£561”.\n(6) In paragraph 12 (wholesale dealer’s licences)—\n(a) in sub-paragraph (1), for “£317” substitute “£346”;\n(b) in sub-paragraph (2), for “£189” substitute “£206”.\n(7) In paragraph 15(1)(b) (additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to special medicinal products)—\n(a) for Table 1 (additional periodic fee in connection with notices for imported special medicinal products) substitute—\n“\nTable 1\nAdditional periodic fee in connection with notices for imported special medicinal products\nColumn 1\nColumn 2\nNumber of special import notices\nAdditional amount\n1 to 20\n£86\n21 to 100\n£427\n101 to 500\n£2,131\n501 to 1,000\n£4,261\n1,001 to 2,000\n£8,521\n2,001 to 5,000\n£17,042\n5,001 to 10,000\n£34,083\n10,001 to 15,000\n£51,125\n15,001 to 20,000\n£68,166\n20,001 to 25,000\n£85,208\n25,001 to 30,000\n£102,249\n30,001 to 35,000\n£119,291\n35,001 to 40,000\n£136,333\n40,001 to 45,000\n£153,375\n45,001 to 50,000\n£170,417\nEach additional 5,000 above 50,000\n£170,417 plus £17,042 for each additional 5,000 special import notices\n”;\n(b) in the second column (additional amount) of Table 2 (Additional periodic fee in connection with the number of different special medicinal products notified for import)—\n(i) in the entry “1 to 5”, for “£100” substitute “£122”;\n(ii) in the entry “6 to 10”, for “200” substitute “£244”;\n(iii) in the entry “11 to 20”, for “£400” substitute “£487”;\n(iv) in the entry “21 to 50”, for “£1,000” substitute “£1,218”;\n(v) in the entry “51 to 100, for “£2,000” substitute “£2,435”;\n(vi) in the entry “101 to 200”, for “£4,000” substitute “£,4,869”;\n(vii) in the entry “For each additional 100 special medicinal products notified for import above 200”, for “£2,000” substitute “£4,869 plus £2,435 for each additional 100 special medicinal products notified for import”.\n(8) In paragraph 16 (traditional herbal registrations), for “£84” substitute “£92”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Amended by S.I. 2023/314."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Amended by S.I. 2023/314."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "Amended by S.I. 2023/314."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "Amended by S.I. 2023/314."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "Amended by S.I. 2023/314."
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "Amended by S.I. 2023/314."
    },
    {
      "type": "footnote",
      "label": "f7",
      "text": "Amended by S.I. 2023/314."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2025/317/regulation/29",
    "retrieved_at": "2026-10-28T21:18:55.696056+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."
}