{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-38",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-38.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/38",
  "kind": "paragraph",
  "number": "38",
  "heading": "Marketing authorisations",
  "text": "(1) Unless sub-paragraph (2) or any of paragraphs 39 to 42 and 51 to 53 applies, the fee payable under regulation 19(1) in connection with an application for a variation to the terms of a marketing authorisation of a kind described in column 1 of the appropriate table is the fee specified in the corresponding entry in column 2 of the appropriate table.\n(2) This paragraph applies—\n(a) to an application for a variation to the terms of a marketing authorisation of a kind described in item 1(c) or 2(c) in Table 1 or item 3 in Table 2; and\n(b) where the application only concerns a new source or supply of a substance listed in Part 7 of this Schedule.\n(3) If paragraph (2) applies, the appropriate fee for an application of the kind described—\n(a) in item 1(c) of column 1 to Table 1, is the amount specified for an application of that type in item 1(b) of column 2;\n(b) in item 2(c) of column 1 to Table 1, is the amount specified for an application of that type in item 2(b) of column 2;\n(c) in item 3 of column 1 of Table 2, is the amount specified for item 2 in column 2 of Table 2.\n(4) In sub-paragraph (1), the appropriate table is—\n(a) in respect of an application for a variation of a marketing authorisation which is within the scope of Chapter II (variations to marketing authorisations granted in accordance with Directive 87/22/EEC, Chapter 4 of Directive 2001/82/EC or Chapter 4 of Directive 2001/83/EC) of Commission Regulation (EC) No 1234/2008, Table 1;\n(b) in respect of an application for a variation of a marketing authorisation which is within the scope of Chapter IIa (variations to purely national marketing authorisations) of Commission Regulation (EC) 1234/2008 and of marketing authorisations in force in Great Britain, Table 2;\n(c) in respect of a reclassification variation application, Table 3.\n(5) In Table 1, “reference authority” has the meaning given in Article 20(2)(b) of Commission Regulation (EC) No 1234/2008.\n(6) In Table 2 “UK national application” means an application for a variation to the terms of a UK national marketing authorisation within the meaning of Article 2(9) of Commission Regulation (EC) 1234/2008.\nTable 1\nFees for applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008\nColumn 1Kind of variation\nColumn 2Fee payable\n1. Application for a single kind variation\n(a)\nType IB Application\n£419\n(b)\nType II Application\n£419\n(c)\nType II Complex Variation Application\n£3,338\n(d)\nExtended Type II Complex Variation Application\n£10,301\n2. Applications for a Group\n(a)\nMinor Variation (Type IB) Group Application\n£419\n(b)\nMajor Variation (Type II) Group Application\n£1,528\n(c)\nMajor Variation (Type II) Complex Group Application\n£3,619\n(d)\nMajor Variation (Type II) Extended Complex Group Application\n£10,555\nTable 2\nFees for applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008and of marketing authorisations in force in Great Britain\nColumn 1Kind of national variation\nColumn 2Fee payable\n1. National Type 1B Application\n£419\n2. National Type II Application\n£1,593\n3. National Type II Complex Variation Application\n£11,126\n4. National Type II Extended Complex Variation Application\n£40,173\n5. National Type IB Minor Variation Group Application\n£833\n6. National Type II Major Variation Group Application\n£2,212\n7. National Type II Major Variation Complex Group Application\n£12,065\n8. National Type II Major Variation Extended Complex Group Application\n£35,184\n9 Variation of a UKMA(GB) which was granted following an application made under the unfettered access route, provided a corresponding variation has been approved to the related UKMA(NI) for the same product\n£nil\n10 Variation of a UKMA(GB) which was granted following an application made under the unfettered access route, provided a corresponding variation has been approved to the related European Union marketing authorisation for the same product\nApply fees and fee categories in Table 1\n11 Variation of a UKMA(UK) or a UKMA(GB) which was granted following an application other than an application made under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by a competent authority of an EEA State under Article 28 of the 2001 Directive, provided a corresponding variation has been approved to the related marketing authorisation or UKMA(NI) for the same product\nApply fees and fee categories in Table 1\n12 Variation of a UKMA(GB) which was granted following an application where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), provided a corresponding variation has been approved to the related European Union marketing authorisation or UKMA(NI) for the same product\nApply fees and fee categories in table 1\nTable 3\nFees for reclassification variation applications\nColumn 1Kind of reclassification variation\nColumn 2Fee payable\nApplication falling within the category described in—\n(a)\nparagraph 15(a)\n£40,173\n(b)\nparagraph 15(b)\n£10,929",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 2 para. 38(4)(b) inserted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(9)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(vii))"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sch. 2 para. 38(6) Table 1 substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(9)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(vii))"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sum in Sch. 2 para. 38(6) Table 1 Item 1(a)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(i)(aa)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Sum in Sch. 2 para. 38(6) Table 1 Item 1(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(i)(bb)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Sum in Sch. 2 para. 38(6) Table 1 Item 1(d) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(i)(cc)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Sum in Sch. 2 para. 38(6) Table 1 Item 2(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(ii)(aa)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Sum in Sch. 2 para. 38(6) Table 1 Item 2(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(ii)(bb)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Sum in Sch. 2 para. 38(6) Table 1 Item 2(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(ii)(cc)"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Sum in Sch. 2 para. 38(6) Table 1 Item 2(d) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(ii)(dd)"
    },
    {
      "type": "F",
      "label": "F10",
      "text": "Words in Sch. 2 para. 38(6) Table 2 heading inserted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(9)(b)(ii)(aa) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(vii))"
    },
    {
      "type": "F",
      "label": "F11",
      "text": "Sum in Sch. 2 para. 38(6) Table 2 Item 1 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(i)"
    },
    {
      "type": "F",
      "label": "F12",
      "text": "Sum in Sch. 2 para. 38(6) Table 2 Item 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(ii)"
    },
    {
      "type": "F",
      "label": "F13",
      "text": "Sum in Sch. 2 para. 38(6) Table 2 Item 3 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(iii)"
    },
    {
      "type": "F",
      "label": "F14",
      "text": "Sum in Sch. 2 para. 38(6) Table 2 Item 4 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(iv)"
    },
    {
      "type": "F",
      "label": "F15",
      "text": "Sum in Sch. 2 para. 38(6) Table 2 Item 5 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(v)"
    },
    {
      "type": "F",
      "label": "F16",
      "text": "Sum in Sch. 2 para. 38(6) Table 2 Item 6 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(vi)"
    },
    {
      "type": "F",
      "label": "F17",
      "text": "Sum in Sch. 2 para. 38(6) Table 2 Item 7 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(vii)"
    },
    {
      "type": "F",
      "label": "F18",
      "text": "Sum in Sch. 2 para. 38(6) Table 2 Item 8 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(viii)"
    },
    {
      "type": "F",
      "label": "F19",
      "text": "Words in Sch. 2 para. 38(6) Table 2 inserted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(9)(b)(ii)(bb) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(vii))"
    },
    {
      "type": "F",
      "label": "F20",
      "text": "Sum in Sch. 2 para. 38(6) Table 3 Entry (a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(c)(i)"
    },
    {
      "type": "F",
      "label": "F21",
      "text": "Sum in Sch. 2 para. 38(6) Table 3 Entry (b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(c)(ii)"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "Chapter IIa of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/38",
    "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."
}