{ "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-15", "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-15.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/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", "text": "(1) The additional amount referred to in paragraphs 11(3) and 14 in relation to any fee period is—\n(a) the fee specified in the entry in column 2 of Table 1 (additional periodic fee in connection with notices for imported special medicinal products) corresponding to the estimated number of special import notices for that fee period specified in column 1, and\n(b) the fee specified in the entry in column 2 of Table 2 (additional periodic fee in connection with the number of different special medicinal products imported) corresponding to the estimated number of different special medicinal products imported for that fee period specified in column 1.\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\nTable 2\nAdditional periodic fee in connection with the number of different special medicinal products notified for import\nColumn 1\nColumn 2\nNumber of different special medicinal products notified for import\nAdditional amount\n1 to 5\n£122\n6 to 10\n£244\n11 to 20\n£487\n21 to 50\n£1,218\n51 to 100\n£2,435\n101 to 200\n£,4,869\nFor each additional 100 special medicinal products notified for import above 200\n£4,869 plus £2,435 for each additional 100 special medicinal products notified for import\n(2) For the purposes of this paragraph, the estimated number of special import notices for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.\n(3) For the purposes of this paragraph, the estimated number of different special medicinal products notified for import for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.", "extent": null, "status": null, "version": "current", "annotations": [ { "type": "F", "label": "F1", "text": "Sch. 4 para. 15(1) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 26(7)" }, { "type": "F", "label": "F2", "text": "Sch. 4 para. 15(1)(b) Table 1 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(a)" }, { "type": "F", "label": "F3", "text": "Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(i)" }, { "type": "F", "label": "F4", "text": "Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(ii)" }, { "type": "F", "label": "F5", "text": "Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(iii)" }, { "type": "F", "label": "F6", "text": "Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(iv)" }, { "type": "F", "label": "F7", "text": "Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(v)" }, { "type": "F", "label": "F8", "text": "Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(vi)" }, { "type": "F", "label": "F9", "text": "Words in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(vii)" }, { "type": "F", "label": "F10", "text": "Sch. 4 para. 15(3) inserted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 26(8)" } ], "outstanding_effects": [], "provenance": { "source": "legislation.gov.uk", "source_url": "https://www.legislation.gov.uk/uksi/2016/190/schedule/4/paragraph/15", "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." }