{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-amendment-regulations-2023/regulation-24",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-amendment-regulations-2023/regulation-24.json",
  "legislation": "uksi/2023/314",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-amendment-regulations-2023",
  "path": "regulation/24",
  "kind": "regulation",
  "number": "24",
  "heading": "Amendment of Schedule 2",
  "text": "(1) Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates) is amended as follows.\n(2) In paragraph 1 (interpretation)—\n(a) after the definition of “active ingredient from a new source”, insert—\n““EAMS scientific opinion” has the meaning given in regulation 8(1) of the Human Medicines Regulations;”, and\n(b) after the definition of “Phase IV trial”, insert—\n““Promising Innovative Medicines designation” means a designation issued by the licensing authority under the Early Access to Medicines Scheme in accordance with regulation 167C(2)(a) of the Human Medicines Regulations;”.\n(3) In paragraph 24(5) (marketing authorisations), in the second column (fee payable) of the table (fees for marketing authorisation applications)—\n(a) in item 1 (major application)—\n(i) in entry (a), for “£29,732” substitute “£32,705”,\n(ii) in entries (b) to (d), for “£62,421” substitute “£68,663”,\n(iii) in entry (e), for “£18,437” substitute “£20,281”,\n(iv) in entry (f), for “£62,421” substitute “£68,663”,\n(v) in entry (g), for “£18,437” substitute “£20,281”,\n(vi) in entry (h), for “£92,753” substitute “£102,028”,\n(b) in item 2 (complex application)—\n(i) in entries (a) to (c), for “£17,330” substitute “£19,063”,\n(ii) in entry (d), for “£10,443” substitute “£11,487”,\n(iii) in entry (e), for “£17,330” substitute “£19,063”,\n(iv) in entry (f), for “£10,443” substitute “£11,487”,\n(v) in entry (g), for “£25,643” substitute “£28,207”,\n(c) in item 3 (standard application)—\n(i) in entries (a) to (c), for “£6,350” substitute “£6,985”,\n(ii) in entry (d), for “£5,783” substitute “£6,361”,\n(iii) in entry (e), for “£6,350” substitute “£6,985”,\n(iv) in entry (f), for “£5,783” substitute “£6,361”,\n(v) in entry (g), for “£9,402” substitute “£10,342”,\n(d) in item 4 (simple application), in entries (a) to (f), for “£2,564” substitute “£2,820”,\n(e) in item 5 (parallel import licence applications)—\n(i) in entry (a), for “£1,792” substitute “£1,971”,\n(ii) in entry (b), for “£6,663” substitute “£8,722”,\n(iii) in entry (c), for “£18,180” substitute “£19,998”, and\n(f) in item 6 (change of ownership application), for “£442” substitute “£486”.\n(4) In paragraph 25(1) (fees where application includes reclassification)—\n(a) in sub-paragraph (a), for “£11,992” substitute “£33,003”, and\n(b) in sub-paragraph (b), for “£8,162” substitute “£8,978”.\n(5) In paragraph 27 (joint development)—\n(a) in sub-paragraph (2)—\n(i) in paragraph (a)(i), for “£17,330” substitute “£19,063”,\n(ii) in paragraph (b)(i), for “£6,350” substitute “£6,985”,\n(iii) in paragraph (c)(i), for “£17,330” substitute “£19,063”,\n(iv) in paragraph (d)(i), for “£6,350” substitute “£6,985”, and\n(b) in sub-paragraph (3)(a)(i), for “£6,350” substitute “£6,985”.\n(6) In paragraph 28 (application for multiple authorisations)—\n(a) in sub-paragraph (2)—\n(i) in paragraph (a)(i), for “£17,330” substitute “£19,063”,\n(ii) in paragraphs (b)(i) and (c)(i), for “£6,350” substitute “£6,985”,\n(b) in sub-paragraph (3), in paragraphs (b)(i) and (c)(i), for “£6,350” substitute “£6,985”, and\n(c) in sub-paragraph (4)(b), for “£734” substitute “£1,308”.\n(7) In paragraph 28A (application by pre-assessment of modules)—\n(a) in sub-paragraphs (1)(a) to (c), for each “£23,188.25” substitute “£25,507”, and\n(b) in sub-paragraphs (2)(a) to (c), for each “£4,332.50” substitute “£4,766”.\n(8) In paragraph 30(1) (manufacturer’s licences and authorisations)—\n(a) in paragraph (a), for “£183” substitute “£201”,\n(b) in paragraph (b), for “£344” substitute “£378”, and\n(c) in paragraph (c), for “£3,143” substitute “£3,457”.\n(9) In paragraph 31 (wholesale dealer’s licences)—\n(a) in sub-paragraph (1), for “£1,803” substitute “£1,983”,\n(b) in sub-paragraph (2), for “£902” substitute “£992”, and\n(c) in sub-paragraph (5), for “£399” substitute “£439”.\n(10) In paragraph 32 (broker’s registrations)—\n(a) in sub-paragraph (1), for “£1,803” substitute “£1,983”, and\n(b) in sub-paragraph (2), for “£399” substitute “£439”.\n(11) In paragraph 33 (active substance registrations)—\n(a) in sub-paragraph (1)—\n(i) in paragraph (a), for “£3,143” substitute “£3,457”,\n(ii) in paragraph (b), for “£1,803” substitute “£1,983”, and\n(b) in sub-paragraph (2), for “£399” substitute “£439”.\n(12) In paragraph 34 (clinical trial authorisations)—\n(a) in sub-paragraph (a), for “£3,060” substitute “£3,366”, and\n(b) in sub-paragraph (b), for “£225” substitute “£248”.\n(13) In paragraph 35(1) (traditional herbal registrations), in the second column (fee payable) of the table (fee for application for traditional herbal registration), in entry 5 (change of ownership application), for “£442” substitute “£486”.\n(14) After paragraph 35, insert—\n“Early Access to Medicines Scheme fees\n35A. 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£3,986\n2. EAMS scientific opinion for new medicinal products\n£25,643\n3. Renewal of an EAMS scientific opinion for new chemical or biological medicinal products\n£12,821\n4. EAMS scientific opinion for new indications\n£8,309\n5. Renewal of an EAMS scientific opinion for new indications\n£4,154\n”\n(15) In paragraph 38 (marketing authorisations)—\n(a) in the second column (fee payable) of Table 1 (fees for applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008)—\n(i) in entries 1(a) and 1(b), for “£277” substitute “£344”,\n(ii) in entry 1(c), for “£2,493” substitute “£2,742”,\n(iii) in entry 1(d), for “£7,693” substitute “£8,462,\n(iv) in entry 2(a), for “£277” substitute “£344”,\n(v) in entry 2(b), for “£496” substitute “£1,255”,\n(vi) in entry 2(c), for “£2,703” substitute “£2,973”,\n(vii) in entry 2(d), for “£7,883” substitute “£8,671”,\n(b) in the second column (fee payable) in Table 2 (fees for applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008 and of marketing authorisations in force in Great Britain)—\n(i) in entry 1, for “£277” substitute “£344”,\n(ii) in entry 2, for “£734” substitute “£1,308”,\n(iii) in entry 3, for “£8,309” substitute “£9,140”,\n(iv) in entry 4, for “£25,643” substitute “£33,003”,\n(v) in entry 5, for “£622” substitute “£684”,\n(vi) in entry 6, for “£1,652” substitute “£1,817”,\n(vii) in entry 7, for “£9,010” substitute “£9,911”,\n(viii) in entry 8, for “£26,276” substitute “£28,904”, and\n(c) in the second column (fee payable) in Table 3 (fees for reclassification variation applications)—\n(i) in entry (a), for “£11,992” substitute “£33,003”,\n(ii) in entry (b), for “£8,162” substitute “£8,978”.\n(16) In paragraph 40(1) (reclassification of marketing authorisations), for “£734” substitute “£1,308”.\n(17) In paragraph 42(1) (variation of parallel import licence)—\n(a) in paragraph (a), for “£11,992” substitute “£33,003”,\n(b) in paragraph (b), for “£8,162” substitute “£8,978”, and\n(c) in paragraph (c), for “£357” substitute “£393”.\n(18) In paragraph 43 (manufacturer’s authorisations and licences)—\n(a) in sub-paragraph (a), for “£257” substitute “£283”, and\n(b) in sub-paragraph (b), for “£514” substitute “£565”.\n(19) In paragraph 44 (variation of manufacturer’s authorisations and licences), for “£257” substitute “£283”.\n(20) In paragraph 45 (wholesale dealer’s licences), for “£486” substitute “£535”.\n(21) In paragraph 46 (variation of wholesale dealer’s licence), for “£257” substitute “£283”.\n(22) In paragraph 47 (variation of a broker’s registration), for “£257” substitute “£283”.\n(23) In paragraph 48 (variation of an active substance registration), for “£257” substitute “£283”.\n(24) In paragraph 49(1) (clinical trial authorisations) for “£225” substitute “£248”.\n(25) In paragraph 53(a)(ii) (multiple reclassification variation applications), for “£734” substitute “£1,308”.\n(26) In paragraph 54 (a set of changes)—\n(a) in sub-paragraph (1)—\n(i) in paragraph (a), for “£518” substitute “£570”,\n(ii) in paragraph (b), for “£328” substitute “£361”, and\n(b) in sub-paragraph (2), for “£186” substitute “£205”.\n(27) In paragraph 56 (renewal of a marketing authorisation)—\n(a) in sub-paragraphs (a) and (b), for “£747” substitute “£822”, and\n(b) in sub-paragraph (c), for “£9,682” substitute “£10,650”.\n(28) In paragraph 57(2) (renewal of multiple marketing authorisations)—\n(a) in sub-paragraphs (a)(i) and (a)(ii), for “£747” substitute “£822”,\n(b) in sub-paragraph (b)(i), for “£9,682” substitute “£10,650”, and\n(c) in sub-paragraph (b)(ii), for “£747” substitute “£822”.\n(29) In paragraph 57A (capital fee for conducting a major safety review)—\n(a) in sub-paragraph (a), for “£51,286” substitute “£56,415”,\n(b) in sub-paragraph (b), for “£59,595” substitute “£65,555”,\n(c) in sub-paragraph (c), for “£67,904” substitute “£74,694”, and\n(d) in sub-paragraph (d), for “£76,213” substitute “£83,834”.\n(30) In paragraph 57B(4)—\n(a) in the second column (fee payable where the licensing authority carries out a full assessment) of the table (fees for testing of samples)—\n(i) in entry 1(a), for “£180” substitute “£198”,\n(ii) in entry 1(b), for “£215” substitute “£237”,\n(iii) in entry 1(c), for “£230” substitute “£253”,\n(iv) in entry 2, for “£1,660” substitute “£1,826”,\n(v) in entry 3, for “£1,910” substitute “£2,101”,\n(vi) in entry 4, for “£2,340” substitute “£2,574”,\n(vii) in entry 5, for “£3,690” substitute “£4,059”,\n(viii) in entry 6, for “£6,410” substitute “£7,051”,\n(ix) in entry 7, for “£10,350” substitute “£11,385”, and\n(b) in the third column (fee payable where the licensing authority carries out a paper-based assessment) of the table—\n(i) in entries 1(a), (b) and (c), for “£90” substitute “£99”,\n(ii) in entries 2 and 3, for “£305” substitute “£367”,\n(iii) in entry 4, for “£305” substitute “£992”,\n(iv) in entry 5, for “£677” substitute “£992”,\n(v) in entries 6 and 7, for “£677” substitute “£1,849”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Paragraph 1 of Schedule 2 was amended but the amendment is not relevant to these Regulations."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Table inserted by S.I. 2019/775 and amended by S.I. 2020/1488."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "Amended by S.I. 2019/775(as amended by S.I. 2020/1488)."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "Amended by S.I. 2019/775(as amended by S.I. 2020/1488)."
    },
    {
      "type": "footnote",
      "label": "f5",
      "text": "Inserted by S.I. 2019/775 (as amended by S.I. 2020/1488)."
    },
    {
      "type": "footnote",
      "label": "f6",
      "text": "Table substituted by S.I. 2019/775(as amended by S.I. 2020/1488)."
    },
    {
      "type": "footnote",
      "label": "f7",
      "text": "Amended by S.I. 2019/775."
    },
    {
      "type": "footnote",
      "label": "f8",
      "text": "Amended by S.I. 2019/775(as amended by S.I. 2020/1488)."
    },
    {
      "type": "footnote",
      "label": "f9",
      "text": "Inserted by S.I. 2019/775 (as amended by S.I. 2020/1488)."
    },
    {
      "type": "footnote",
      "label": "f10",
      "text": "Amended by S.I. 2019/775 (as amended by S.I. 2020/1488)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2023/314/regulation/24",
    "retrieved_at": "2026-10-28T21:47:53.846751+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."
}