The Medicines (Products for Human Use) (Fees) Regulations 2016

[^c23108441]: OJ No L 311, 28.11.2001, p67; relevant amending instruments are Directive 2002/98/EC of the European Parliament and of the Council (OJ No L 33, 8.2.2003, p30), Commission Directive 2003/63/EC (OJ No L 159, 27.6.2003, p46), Directive 2004/24/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p85), Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34), Regulation (EC) No 1901/2006 of the European Parliament and of the Council (OJ No L 378, 27.12.2006, p1), Regulation (EC) No 1394/2007 of the European Parliament and of the Council (OJ No L 324, 10.12.2007, p121), Directive 2008/29/EC of the European Parliament and of the Council (OJ No L 81, 20.3.2008, p51), Directive 2009/53/EC of the European Parliament and of the Council (OJ No L 168, 30.6.2009, p33), Commission Directive 2009/120/EC (OJ No L 242, 15.9.2009, p3), Directive 2010/84/EU of the European Parliament and of the Council (OJ No L 348, 31.12.2010, p74), Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74) and Directive 2012/26/EU of the European Parliament and of the Council (OJ No L 299, 27.10.2012, p1).

[^c23108451]: 1968 c.67.

[^c23108461]: S.I. 2004/1031; relevant amending instruments are S.I. 2004/3224, 2005/2754 and 2759, 2006/562, 1928 and 2984, 2007/289 and 3101, 2008/941, 2009/1164, 2010/1882 and 2012/1916.

[^c23108471]: OJ No L 334, 12.12.2008, p7. This regulation has been amended by Commission Regulation (EC) No 712/2012 (OJ No L 209, 4.8.2012, p4).

[^c23108481]: S.I. 1971/972; relevant amending instruments are S.I. 1992/2846, 1994/2852, 2004/1031 and 2005/2789.

[^c23108491]: OJ No L 262, 14.10.2003, p22.

[^c23108501]: OJ No L 147, 9.6.1975, p13. This Directive has been codified and assembled with others into Directive 2001/83/EC.

[^c23108511]: OJ No L 214, 24.8.1993, p1. This Regulation has been amended by Commission Regulation (EC) No 649/98 (OJ No L 88, 24.3.1998, p7), Council Regulation (EC) No 807/2003 (OJ No L 122, 16.5.2003, p36) and Council Regulation (EC) No 1647/2003 (OJ No L 245, 29.9.2003, p19).

[^c23108521]: S.I. 2012/1916.

[^c23108531]: Regulation 256A was inserted by S.I. 2013/1855.

[^c23108541]: Section 104 has been amended by S.I. 2004/1031, 2006/2407, 2012/1916.

[^c23108551]: Relevant amending instrument is S.I. 2012/1916.

[^c23108571]: OJ No L 136, 30.4.2004, p1; relevant amending instruments are Regulation (EC) No 1901/2006 of the European Parliament and of the Council (OJ No L 378, 27.12.2006, p1), Regulation (EC) No 1394/2007 of the European Parliament and of the Council (OJ No L 324, 10.12.2007, p121), Regulation (EC) No 219/2009 of the European Parliament and of the Council (OJ No L 87, 31.3.2009, p109), Regulation (EC) No. 470/2009 of the European Parliament and of the Council (OJ No L 152, 16.6.2009, p11), Regulation (EU) No 1235/2010 of the European Parliament and of the Council (OJ No L 348, 31.12.2010, p1) and Corrigendum (OJ L 201, 27.7.2012, p.138).

[^c23108581]: Revocations and amendments to regulation 31 have been made by S.I. 2005/2754 and 2006/1928.

[^c23108591]: Regulation 256C was inserted by S.I. 2013/1855.

[^c23108601]: 2006 c.46.

[^c23108611]: Chapter IIa of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4)

[^c23108631]: Copies of the documents can be downloaded from the licensing authority's website at www.mhra.gov.uk or obtained by writing to the licensing authority at 151 Buckingham Palace Road, London, SW1W 9SZ or by sending an email to info@mhra.gsi.gov.uk.

[^c23108641]: S.I. 1971/1267: Part 2 of the Act is applied by article 3 of the Order which has been amended by S.I. 1994/3119, 2004/1031 and 2006/2407.

[^c23108651]: Article 11 has been amended by Directive 2004/27/EC of the European Parliament and of the Council (OJ No L 136, 30.4.2004, p34) and Directive 2010/84/EU of the European Parliament and of the Council (OJ No L 348, 31.12.2010, p74).

[^c23108661]: OJ No L 152, 16.6.2009, p1.

[^key-00a2750d02cead5d568eccd6bc33f650]: Sum in Sch. 3 para. 8(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(6)(a)(i)

[^key-0100d808ba39a6ad1574f95de8cc9e21]: Sum in Sch. 2 para. 24(5) Table Item 3(g) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(c)(v)

[^key-026c014bee3d91c59c34a913bdd39e0e]: 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)

[^key-02a3660d884fc52b438307b71f9f04b6]: Sum in reg. 15(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 14(b)

[^key-03bd7de41ae4a640c1da342c9f11f90d]: Sum in Sch. 4 para. 5 Table Entry 3(b)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(d)

[^key-04c19fa6723a95fb2b425ee3f857bbeb]: Sum in Sch. 5 Table Item 5 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(b)(iv)

[^key-05bbd29f36c98c3b1b9cc7dc49ede206]: Sum in Sch. 2 para. 41(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(16)(c)

[^key-05bf3931d4954d34b08cbf2191047691]: Sum in Sch. 3 para. 6(2)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(4)(a)

[^key-0661b3c556bd6f416bbc01eccde6a591]: Sum in reg. 27(1) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 22

[^key-06738e8de67d4bd6a1bd908813ed3039]: Sum in Sch. 2 para. 28(2)(a)(i) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(6)(a)(i)

[^key-069c771f2e84c37adc6a552f10de10bd]: 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)

[^key-06bdb2baa538d7a1e9d28ec996454b96]: Sum in Sch. 4 para. 7(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(4)(a)

[^key-06e80d68550e6c2a2dd394fd491b2a02]: Sum in Sch. 2 para. 25(1)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(4)(a)

[^key-07047e8b31ccb8ba77af4a9215958aca]: Sum in Sch. 2 para. 54(2) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(26)(b)

[^key-07aced0332fce9239a4f2fdb1736a4c0]: Sch. 2 para. 39A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(11) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-07cc2a87a5d095727cc7704aa48d7127]: Sum in Sch. 2 para. 29(4) 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(7)(a)(ii)(cc)

[^key-0947c693af59f70419d0a73985f9806c]: 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)

[^key-0966d6e5fc7ca5f3099180d35e05f02d]: Sch. 2 para. 24(5) Table Item 4(e) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(d)(iii)

[^key-0aec4894d61e7d059b09a5089a05b00f]: Sum in Sch. 2 para. 35(5) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(d)

[^key-0c8d23aeeec7a76190c4b96b189483f8]: Sum in Sch. 2 para. 31(1) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(9)(a)

[^key-0de13464bdb80e0bc9900e22e2b0c4fd]: Reg. 4 omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 4

[^key-10592a925f5c16aa7417952fe275bc7d]: Sum in Sch. 4 para. 11(2) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(5)

[^key-1093dfdcdc7417d45216909dc8b9c5c5]: Sum in Sch. 2 para. 24(5) Table Item 1(e) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(a)(iii)

[^key-11e1b6f9ae08b835a5c69f4a0a5eb523]: Sum in Sch. 2 para. 29(4) 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(7)(a)(i)(bb)

[^key-122cf035ff6532a9ca3ef4d7ad5cdc2f]: Sum in Sch. 2 para. 48 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(23)

[^key-1243f1b7fc018a61e7865229ae936e65]: Sum in Sch. 2 para. 35(3)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(b)(ii)

[^key-12c7ab5deee98ebab6d218ef5f3337fa]: Sum in Sch. 2 para. 25(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(4)(b)

[^key-14114ef37019d4cb109faaf33b65eb87]: Sum in Sch. 3 para. 8(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(6)(a)(ii)

[^key-14489d2eb723c5e95bcd51ede77002a3]: Sum in Sch. 2 para. 42(1)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(17)(a)

[^key-1455eda6e838dc52a7115856090e417e]: Sum in Sch. 3 para. 9(3)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(c)(ii)

[^key-15621d0e8de1f002bca5c00934ff3ab2]: Sch. 2 para. 40A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(12) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(viii)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-157be47a9d11ee1581a9baf3959b260b]: Words in Sch. 1 para. 1 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 6(a)(iii) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-15cede2eb8f4cdabcbb44878a57d8781]: Sum in reg. 47(1)(a)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(a)(i)

[^key-15ead23fd553d9b178e38d9f5b01746a]: Sum in reg. 19C substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 17

[^key-18abdfb12085e383173cbbc3fceb9ffa]: Sum in Sch. 2 para. 24(5) Table 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(3)(b)(ii)

[^key-18cd7b7e74719ba10c346c9b231b8a9f]: Sum in reg. 47(2)(a)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(c)(i)

[^key-1a5eed2679f36e58dde20075f3ac49f7]: Sum in reg. 27(3) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 20(b)

[^key-1cbbd7377f9df6a5ded461a2e299009a]: Words in Sch. 1 para. 1 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 6(a)(i) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-1e522610efe3418d9b8371c9eabb5f4e]: Sum in Sch. 3 para. 9(1)(b)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(b)(ii)

[^key-1f8483456e76cf6a694c25b1efbcd23c]: Sch. 2 para. 27(3)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(7)(b) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-200799a501779e6dc972936e258bdf8d]: Sum in Sch. 4 para. 5 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), 29(2)(a)

[^key-2240a22a5af6664ff98e42434a3316c5]: 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)

[^key-24864bc20803ce648435fc63e247a62a]: Sum in Sch. 2 para. 28(3)(c)(i) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(6)(b)

[^key-24f94659da182662a9ba802c32847024]: Sum in Sch. 3 para. 7(3) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(5)

[^key-255946a43f1d2ee11ae6cca4b932a9de]: Sch. 2 para. 28A inserted by S.I. 2019/775, Sch. 1 para. 7(8A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(vi))

[^key-2664b142a4f37489d1d98aa5c03861ab]: Reg. 19EA inserted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 17

[^key-27e977717aa4af63a292d5b985274f8a]: Words in Sch. 2 para. 39(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(10)(b) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-291986cb9f35cf43b61b1622a0cc4571]: Sum in Sch. 2 para. 29(4) 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(7)(a)(ii)(aa)

[^key-29ab430ddfc1e0e94523c9022e2c1f19]: Sum in Sch. 2 para. 57A(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(29)(a)

[^key-2a6d5200194edc2359ae0afa52b89901]: 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)

[^key-2b80667d2898cc1c909bd410ef67a30e]: Sum in Sch. 4 para. 12(2) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(6)(b)

[^key-2cad091961e543b44dc9b62735221b7e]: Sum in Sch. 3 para. 9(1)(b)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(b)(i)

[^key-2dd6344845c4c8a2ca85ed9333686354]: Sum in Sch. 2 para. 50(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(25)(a)

[^key-2e217e4c59a1053a0aed6359326a3a1a]: Words in Sch. 2 para. 39(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(10)(a) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-2e54cb4c44e51a60c80574fa5f7ce072]: Sum in Sch. 5 Table Item 7 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(b)(v)

[^key-2fd23b420ffb4132d4bd88164ba543b4]: 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)

[^key-3122471a014cfee58de542bd06a30682]: Sum in Sch. 4 para. 7(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(4)(b)

[^key-313132f41b760e14b01dfe40a7af8327]: Words in reg. 12(1) inserted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 10

[^key-31ce995f119e871334c2705460214437]: Sum in Sch. 2 para. 32(2) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(10)(b)

[^key-32f379dda0a6dab57f6060018afc62d7]: Sch. 2 para. 24(5) Table Item 3(f) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(c)(iv)

[^key-332af3ca3a33d38febab6abe0d68fe47]: Words in Sch. 2 para. 1 inserted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(2)(a)

[^key-336ec2b62aac073b44bae229fa1696a6]: Sch. 2 Pts. 6-6B, substituted for Sch. 2 Pt. 6 (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(13) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ix)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3571eb499749f54fdcb1510496748283]: Sum in Sch. 2 para. 56(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(27)(b)

[^key-35b4b1eed790bc7fe4c07be97d46b491]: Sum in Sch. 3 para. 10(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(8)(b)

[^key-36bb5dc7dfecfc5b36addaa18c6ac92a]: Sum in Sch. 2 para. 33(1)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(10)(a)

[^key-3787f6e2239287c196451423b32a4b3e]: Sum in Sch. 2 para. 24(5) Table Item 5(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(e)(ii)

[^key-389ce625b83cd29316444397614f13f3]: Sum in reg. 5(1)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 5(a)

[^key-38cb2b5e3a5687a783d9aa6b33ff0687]: Sch. 1 para. 5 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 6(b) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-397f2d12d768866b132bc442405485f1]: Sum in reg. 19A(1) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 15(a)

[^key-39c2234d0827014dbfadaa27ceca41ab]: 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)

[^key-39c8c875f7010bfe14f8f0c84e50edc2]: Sum in reg. 47(2)(a)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(c)(ii)

[^key-39f0c3f94594ee71512bd4b69e8ac77f]: Sum in Sch. 2 para. 46 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(21)

[^key-3ba8582ad59c4d994f534aaa432b590f]: 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)

[^key-3bb3d5c87c77ee6b4d9ed87cbc22e1eb]: Reg. 19(1)(a)(ii) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 1(a) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3c89f0fef83ff5d63c01a2baef356b01]: Sum in Sch. 4 para. 16 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(8)

[^key-3cda82e33017c8dba948fa9fcd4d7695]: Sum in Sch. 2 para. 29(6) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(7)(b)

[^key-407e3344a00ee603e6097de77073b58b]: Regs. 19A-19G inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 2 (with Sch. 1 para. 11) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 188(c)(i)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-410b0991149d609fd8754607f20ef197]: 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)

[^key-411ac9a09f2bcc8af1634cf989ba3c59]: Sum in Sch. 2 para. 43(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(18)(a)

[^key-4133048ccd61ba6557e088f984167f97]: Reg. 7 omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 7

[^key-414553119eed51ba00017e2395a07ec8]: Sum in reg. 19C(3)(a) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 15(b)(i)

[^key-419912be5c6a477d6ac63fb7d16731f9]: Reg. 10A inserted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 1ZA (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(a))

[^key-4218df2740326134cb4ca05352ee277d]: 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)

[^key-42e2a738ad91c695a24a82ba898920bc]: Sum in Sch. 2 para. 29(4) 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(7)(a)(i)(aa)

[^key-43f7bc42b311441234f342b4b6201664]: Sch. 2 para. 27(2)(a)-(d) substituted for Sch. 2 para. 27(2)(a)-(c) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(7)(a) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-44e6b478293d0fdd0a372e921ff9650b]: Sum in Sch. 3 para. 10(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(8)(a)

[^key-4951c062fd04efa3c62f6dc0f5eb820d]: Words in Sch. 4 para. 1 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 8 (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-4aaaf06551c5525cde4d48b4f20bfc10]: Sum in Sch. 3 para. 5(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(3)(a)

[^key-4b5f78865f4815985ff2712ccaee7fb4]: Sum in Sch. 2 para. 35(1) Table Entry 3(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(a)(iii)(aa)

[^key-4bf0702ca5f0f9db3f778102c21541a4]: Sch. 2 para. 28(3)(b)(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(8)(b) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-5063fca7308c556226875b0bd3337b92]: Sum in Sch. 2 para. 50(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(25)(b)

[^key-50db38dbf14e2f4251cff7b949a674af]: Sum in Sch. 2 para. 31(5) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(9)(b)

[^key-5285d27f34e110bab375527383addb44]: Sum in Sch. 2 para. 42(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(17)(c)

[^key-532ed67cca9ea2aab486938605e3b6d5]: Sum in reg. 42(1) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 24

[^key-53f0058fe7f90d0283d580d1633bce7b]: Reg. 10 omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 10

[^key-5450846932f3b3684b46d78382368445]: Word in Sch. 2 para. 21(o) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(2)(a)

[^key-55d903dfff9ae7b4c8eb4b8fe6de91c1]: Sch. 2 para. 24(5) Table Item 2(f) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(b)(iv)

[^key-5665a0ff2ba8dd205d4f5567de61fef1]: Sum in reg. 15(3) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 12(c)

[^key-58ba960e23306afdda39f04bb06e02a5]: Words in Sch. 2 para. 23(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(4)(b) (with Sch. 1 para. 11) (as amended byThe Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(iii)(bb)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-5a0138babde4ca3de74bb9339b82c78a]: Sum in Sch. 2 para. 30(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(8)(b)

[^key-5a29ab374334cf5088186dc9e75bdb7b]: Sum in Sch. 2 para. 24(5) Table Item 1(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(a)(i)

[^key-5a6519a576b7e0c3fde5b62a85e8db9e]: Sum in Sch. 2 para. 35(1) Table Entry 1(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(a)(i)(bb)

[^key-5a7c0e890d7ef13c57035ee19ec23470]: Sum in Sch. 5 Table Item 3 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(a)(iii)

[^key-5b53e2101cce433c42836bc8b7c879c9]: 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)

[^key-5b70557cd9865f72e4dd9fdf49c385a0]: Sum in Sch. 3 para. 9(3)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(c)(i)

[^key-5b7f134c210485bc2a700190731e62dc]: Sum in Sch. 2 para. 24(5) Table Item 3(a)-(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(c)(i)

[^key-5c02df0ae93b645d6f4cfd15e43f6eed]: Sum in Sch. 2 para. 31(2) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(9)(b)

[^key-5dddb746c023200ca363f7cbe31914cb]: Sum in Sch. 4 para. 6 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(3)

[^key-5e6b1dcbed101eb8ecb2666aae642d6f]: Sum in Sch. 5 Table Item 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(b)(ii)

[^key-5e82b2bf899eb9375c1927f2d47f6662]: Word in Sch. 8 heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 10(2) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-5f390b5c712e80cbfda209a360fd7200]: Sum in reg. 47(1)(a)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(a)(ii)

[^key-5f5319c71cef9001be53af6e59f33e01]: Sch. 2 para. 24(5) Table Item 1(f) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(a)(iv)

[^key-5fbe2c11e176be10bcdda51f121ca8a5]: Sum in Sch. 3 para. 9(1)(b)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(b)(i)

[^key-618018a7439926938facaed317b63ae0]: Sum in reg. 19C(2)(c) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 15(a)(iii)

[^key-61cd0c080398730bce9b6ee441943bf6]: Sum in reg. 19EA substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 19

[^key-621fd239e39527c7b7d190e414f3174a]: Sum in Sch. 4 para. 5 Table Entry 3(b)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(e)

[^key-62537078fb303b291821fd6d851a9864]: Sum in reg. 5(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 5(b)

[^key-629a46b654038902b171c98b10cef70a]: Sum in Sch. 2 para. 50(d) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(25)(d)

[^key-63c3e04331ca79669c870ac929dd4bb6]: Words in Sch. 1 para. 1 inserted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 23

[^key-6400f2cfe64e0fb572327f40d841bae4]: Sum in Sch. 2 para. 44 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(19)

[^key-6466b9b93e267c3fa8d8daef36a72de9]: Words in reg. 23(7) substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 3(4)(c)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(d))

[^key-65c4969f31319dd3db6160096324a964]: 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)

[^key-665346f53592731adefa17e2d929e55c]: 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)

[^key-66be60aa4de0dca8a5d0165f434f7bce]: Sum in Sch. 2 para. 28A(1)(a)-(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(6)(a)

[^key-67595afbcc42fe6249fad94a9144ccad]: Sum in Sch. 2 para. 57(2)(a)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(28)(a)

[^key-676369249fb2daf0bef153690ae0ea5d]: Sum in Sch. 2 para. 24(5) Table Item 2(a)-(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(b)(i)

[^key-6830ba683a1a5616ef4c2abbb86dd50e]: Words in Sch. 2 para. 1 inserted (11.4.2018) by The Secretaries of State for Health and Social Care and for Housing, Communities and Local Government and Transfer of Functions (Commonhold Land) Order 2018 (S.I. 2018/378), art. 1(2), Sch. para. 20(ff) (with art. 14)

[^key-6855f540eafcbb455e7952d0f9a3de91]: Words in reg. 23(7) substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 3(4)(e)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(d))

[^key-6b0fb5d47181c047074dc2387a4d892d]: Sum in reg. 19E(2)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 18(a)

[^key-6b34ccaccd7544760cfe838f4464dc2f]: Words in Sch. 2 para. 21(p) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(2)(b)

[^key-6bef36270463cf58447756af44675a5b]: Sum in reg. 8 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 8

[^key-6d4eb00e0b370be833774623bf8cb284]: Sum in reg. 41(1) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 23(a)

[^key-6d96e0aa551934ca4053307566fd73ee]: Sum in Sch. 2 para. 41(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(16)(b)

[^key-6de6b26b7262731e43a9002e561f99bd]: 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))

[^key-6eab6c98fa3ed1a899f80c703b0470c2]: Sum in reg. 47(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(b)

[^key-70bc6233396644e1e177e968f45c8182]: Sch. 2 para. 24(5) Table Item 4(d) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(d)(ii)

[^key-727174780e20deac181f62b5872bc69b]: Reg. 19(1)(e) inserted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 1(aa) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(b))

[^key-72778cbf27b6f1688772990ba79ba25d]: Sum in Sch. 3 para. 9(1)(a)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(a)(ii)

[^key-72bbad8d17785a021e610f7b4c73d0e7]: Sum in Sch. 4 para. 11(1) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(5)

[^key-75a6a69b1f225d13583b0c7516aead07]: Sum in Sch. 5 Table Item 7 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(a)(v)

[^key-75cff3bde27871c66ca01c231af4e990]: Sum in Sch. 4 para. 5 Table Entry 3(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(f)

[^key-75fae320e41d90f5bcb6a043a70591a6]: Sum in Sch. 3 para. 9(1)(a)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(7)(a)(i)

[^key-770cd890db59f5913a0a05182b6c2a0f]: 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)

[^key-7859acd52b27b5a5b33c058f5ed8d414]: Sum in Sch. 2 para. 57(2)(b)(ii) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(28)(c)

[^key-797c7777baefd9dbf2441ac3bd763312]: 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)

[^key-7ab0d9cd004e0881d5da2959ab9070d1]: Sum in Sch. 5 Table Item 1 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 30(2)(a)(i)

[^key-7bc3be72bff23b8dd0f0649f6458724a]: Sch. 2 para. 57B substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(30)

[^key-7fb38990ef6dc21fded580934d73c0c0]: Sch. 2 para. 22(1)(a)(b) substituted for words in Sch. 2 para. 22(1) (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(3)(a) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ii)(aa))

[^key-7fb99618cbe144262b178dca2de71dd3]: Sum in reg. 47(2)(a)(iii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(c)(iii)

[^key-809eb2b760c4157152de2aedd4499bbb]: Sum in Sch. 3 para. 6(2)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 28(4)(b)

[^key-8105a5c9cba9fdc3afa73bdd3cbfd014]: 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)

[^key-81bc77427824bd8754505553921dd410]: Sum in reg. 19A(2)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 15(c)

[^key-8201ddc02ea6877305cbca4192260d82]: Words in Sch. 1 para. 1 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 6(a)(iv) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(f)(ii)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-8208bf5c322de08710966de932c97396]: Sum in Sch. 2 para. 35(1) Table Entry 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(12)(a)(ii)(aa)

[^key-82673e317affe7cc84a8f8c85191c2aa]: Sum in reg. 47(2)(a)(iv) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 26(c)(iv)

[^key-82cf6d906fc081951fdcef30abba6a2a]: Sum in Sch. 2 para. 41(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(16)(a)

[^key-83fa0a0fa85455eae9e23a08f265ae59]: 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)

[^key-85b8f3be14adf618e9a203da0dde3fb9]: Sum in Sch. 2 para. 45 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(20)

[^key-862cafa92f2ea47d68cc21ec64c03889]: 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))