The Human Medicines Regulations 2012

Type Statutory-Instrument
Publication 2012-07-19
Last updated 2026-03-31
State In force
Department King's Printer of Acts of Parliament
PDF Download
articles 4
Reform history JSON API

[^key-0fe5f26e4123b340e1a527eee0dbf1c8]: Words in reg. 42(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 31(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 21(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-98b1e82509ae044441c0589d46374a93]: Reg. 45E(3)(b)(i) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 40(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 29(a))

[^key-c1cc7c5cc58a36220f36327b182772db]: Words in reg. 44(2)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 35(2)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 25(a)(i)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-8666aa39dff2c84dd669522b5096fc11]: Reg. 44(2)(c) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 35(2)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(a)(ii))

[^key-80bd6d172e7605f507601c40cdc6e2cb]: Reg. 44(5)(b) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 35(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(b))

[^key-28247d3d3aab6b311438854c2c975e1b]: Reg. 44(5)(e) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 35(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(c))

[^key-b596f2dcc25f88cd7e8c21cf29fc09d4]: Word in reg. 44(6)(c) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 35(5)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3fa08fa2eb71113105ca85d22ec743f5]: Reg. 44(8)-(10) inserted (31.12.2020) by S.I. 2019/775, regs. 1, 35(6) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 25(e))

[^key-81df6de44634c22534871673d42b99e3]: Reg. 45(1A) inserted (31.12.2022) The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 36(2) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 26(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-7a23d4c8f5b42126886414d0185c1d1a]: Reg. 45(2)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 36(3) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 26(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0ce1b1236693786866cee68e4af3460f]: Reg. 45A(1)(1A) substituted for reg. 45A(1) (31.12.2020) by S.I. 2019/775, regs. 1, 38(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 28(a))

[^key-3c1056e776a546c5cbb3a9379cd469d6]: Words in reg. 45A(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 38(3)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-4f50fffa785c2e18f5d8138ff5e59629]: Words in reg. 45A(2)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 38(3)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-54868c2d29c333d27b7d40252d35612d]: Words in reg. 45A(2)(c) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 38(3)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-b53377de11b193df7d8ccd2604b67995]: Reg. 45A(3) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 38(4); 2020 c. 1, Sch. 5 para. 1(1)

[^key-aad7b12647f099770443cf2ab3c25e0e]: Reg. 45D(1)(b)(ii) and word omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 39; 2020 c. 1, Sch. 5 para. 1(1)

[^key-9b3795bcaf7ceec52e6c7818b86fbf0c]: Reg. 45M(2)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 42(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 31); 2020 c. 1, Sch. 5 para. 1(1)

[^key-57ca45641779860617dc011a47633fea]: Words in reg. 45M(3) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 42(3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-a5a7d0ca304ef63ea4052ab2505cbf10]: Reg. 45O(1)(1A) substituted for reg. 45O(1) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0e05e5c86ced8780bc1dd42b34718d5d]: Reg. 45O(2)(2A) substituted for reg. 45O(2) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-20b91604b5354ef7119acf48f458c654]: Words in reg. 45O(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-9cdf2bc8545c7b26d3ea23c20323b8fe]: Words in reg. 45O(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-18027a7cae4a8e9fd6f5477792dc9aba]: Words in reg. 45O(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4)(c) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-841d3ff4c8bf5f980a8c7b9dae572aa9]: Words in reg. 45O(3)(c)(ii) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4)(d) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-8c3acb5b1fb32f614abb895f65d54cc7]: Reg. 45O(3A) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 32(d))

[^key-d69d8d426b3d66dd9abaca6e2ce33b27]: Words in reg. 45O(4) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(5)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(e)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d7ac35898c1ea8686a1c66358ecc0cdc]: Words in reg. 45O(4)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(5)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(e)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-8e56b9d741c7eded5205fd4011fa13e6]: Words in reg. 45O(4)(b)(i) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(5)(c) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(e)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-e4aa96fb825b70ce2039741255bb31f4]: Reg. 45O(6)-(9) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(6) (as amended by S.I. 2020/1488, Sch. 2 para. 32(f)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-95fc57cf7903fa1fa0fc76777d500a51]: Word in reg. 46(2)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-afa673c8559f2a2f5539b65f7178487a]: Words in reg. 46(3) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-9b4316465241712c2581b3701da5c093]: Words in reg. 46(6) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(4)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 33(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-5624b38bb351d8b174855cb53fa3c56d]: Word in reg. 46(6)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(4)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 33(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f4cf3b9eadfa8e2bc727485df4fca027]: Words in reg. 46(9) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(6); 2020 c. 1, Sch. 5 para. 1(1)

[^key-2c949b2dc5e6b936d455f2eed0e63140]: Words in reg. 46(11)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 45(7); 2020 c. 1, Sch. 5 para. 1(1)

[^key-af0d580e4d446eee2ce125e6e30b43f3]: Words in reg. 47(3) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 46(2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d3cf2d0913badbe9dc4f2a0f9b62a226]: Words in reg. 47(4) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 46(2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-76b831ba6a8122acb2b0ba22e9740c01]: Words in reg. 48(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(2)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 35(a)(i)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-1e8dcadd6a115dcbc19d8aab326a7beb]: Words in reg. 48(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(2)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 35(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-9d89b32ec1ebc7593b61264fbed1a078]: Words in reg. 48(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(2)(c); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f3ffa0d7fa08379e4131b24788ef4493]: Words in reg. 48(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(2)(d) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 35(c)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-08ec062ff4eec29fa827951d58878b8e]: Reg. 48(3)-(9) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 47(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 35(d)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-71838eba29af0096fd9620eb88c7ed32]: Words in reg. 49(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 48(2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-82f042c888d9fcd24bf99f840e4c2deb]: Reg. 49(1A)-(1C) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 48(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 36(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-14306f09cd6015c8073af9a6395d2c18]: Reg. 49(3) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 48(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 36(b))

[^key-f0363a4275c3d896e2732a958bfb9ade]: Reg. 49(3A) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 48(5); 2020 c. 1, Sch. 5 para. 1(1)

[^key-825f31ef8dbed8c4c4ca4a0bd4097c24]: Reg. 49(9)(10) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 48(6) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 36(c)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-6855384ecded35fa6bfe2a080b4c692f]: Reg. 50(3A) inserted (31.12.2020) by S.I. 2019/775, regs. 1, 49(1B) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 37(a))

[^key-471a5113488c336cad95e3aab14fa94a]: Reg. 50(4) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 49(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 37(b))

[^key-01dfcd2266594f114cf6b8cc9a637389]: Reg. 50(5A)-(5C) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 49(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 37(c)(i)(ii)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-194cbacf15db258c70b14bd9874cdeeb]: Reg. 50(6)(za)-(zg) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 49(4); 2020 c. 1, Sch. 5 para. 1(1)

[^key-2deacf65de5a5f5622c52a36917d153b]: Reg. 50(6)(a)-(ab) substituted for reg. 50(6)(a) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 49(4A) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 37(d)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-af93692555898a42e29107248a1d21d6]: Reg. 50(6)(b)-(bb) substituted for reg. 50(6)(b) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 49(4A) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 37(d)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-452cb6886979d5f97688a8a83d3ce44f]: Reg. 50(6)(c)-(cb) substituted for reg. 50(6)(c) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 49(4A) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 37(d)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-18e7a6b32fdd761e1d1606037ec2e9d7]: Reg. 50(7)(8) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 49(5); 2020 c. 1, Sch. 5 para. 1(1)

[^key-bca4a5cbde0241d1b6c197e9310e84ac]: Reg. 50(1A) inserted after subparagraph (1) (31.12.2020) by virtue of S.I. 2019/775, regs. 1, 49(1A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 37(a))

[^key-f8725858620be2185c2493bba2987d80]: Regs. 58(4A)-(4C) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 62(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 45(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d81c4c9cf9da7a6f38fd2bed88623a74]: Reg. 58(8)(9) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 62(4) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 45(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-18f8f163de08a86779f02d1114033321]: Words in reg. 54(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 59(2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-b7443a59e17ce9e14ec6290a53c4f519]: Reg. 54(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 59(3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f7e285d175f707a877fe686483099b29]: Reg. 55 substituted (31.12.2020) by S.I. 2019/775, reg. 60 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 44)

[^key-1c4ead76c24f5a27175d1d8e23c7518b]: Words in reg. 56(2) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 61; 2020 c. 1, Sch. 5 para. 1(1)

[^key-6831a8337190aa439bdca90c21f98084]: Words in reg. 59(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 65(1A) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 48(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-21308f1af9eb9f86ff49b79caae5a418]: Reg. 59(3A)-(3C) inserted (31.12.2020) by S.I. 2019/775, reg. 65(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 48(c))

[^key-3cf3212632210b7f827a5e021e825e73]: Word in reg. 59(4) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 65(4); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f40410c3f7446b116c44380ee423438c]: Reg. 59(4A)-(4E) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 65(5); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f32619d01353d82dc65847a3e0c2cb15]: Words in reg. 59(5) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 65(6) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 48(d)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-94ced616e91a919fa4ac034e562c9894]: Words in reg. 60 inserted (31.12.2020) by S.I. 2019/775, reg. 66(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 49)

[^key-24304376b0b0ba3255806956db739588]: Words in reg. 60 inserted (31.12.2020) by S.I. 2019/775, reg. 66(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 49)

[^key-f212e4ceaea44a472cb5926852a087a2]: Words in reg. 60(3) inserted (31.12.2020) by S.I. 2019/775, reg. 66(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 49)

[^key-99a12f3dc4779e7a25250cb4feabb41b]: Reg. 60(9) substituted (31.12.2020) by S.I. 2019/775, reg. 66(d) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 49)

[^key-7fa99410e85ab2f37d2d2549cf7eba3b]: Words in reg. 60(10) inserted (31.12.2020) by S.I. 2019/775, reg. 66(e) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 49)

[^key-98cc14d69a170c4c2975c0adee9b8dc0]: Reg. 61(4) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 68(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 51(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-6eaffd331d2dcd1f7653534b1051faef]: Words in reg. 61(6) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 68(2A) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 51(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-95f74656307c93ea4b31671d78f64744]: Reg. 61(6A) inserted (31.12.2020) by S.I. 2019/775, reg. 68(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 51(c))

[^key-d9b07da39a2d9542a66b3ca9c4013442]: Reg. 61(7A)-(7C) inserted (31.12.2020) by S.I. 2019/775, reg. 68(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 51(e))

[^key-19fead2cf1b78cb83de3c9ae213e3268]: Words in reg. 61(13) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775) (S.I. 2019/775), reg. 68(5) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 51(f)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-efeeedef7de36cbfec0d7aaa6f7608aa]: Reg. 64(4)(d) substituted (31.12.2020) by S.I. 2019/775, reg. 69 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 52)

[^key-43412826f2b3547556318d3d21b24a2b]: Reg. 65(5)(za) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 71; 2020 c. 1, Sch. 5 para. 1(1)

[^key-470a1c58dca0ed3a8c0d106524c03a64]: Reg. 66(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 74 (as amended by (S.I. 2020/1488), reg. 1, Sch. 2 para. 55); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0b8f04c7d8c93e7cb092444732386d31]: Words in reg. 66A(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 75; 2020 c. 1, Sch. 5 para. 1(1)

[^key-d49f4684534611e0cd2c3eb186740399]: Words in reg. 68(5) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-cce5bf28d3bc8d8328760d40decdd441]: Words in reg. 68(7) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-1a9096b9a4eb550e7dab055456b51c1f]: Reg. 68(7)(a)(b) and words substituted for words (31.12.2020) by S.I. 2019/775, reg. 77(3)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 57(a))

[^key-0f4ee21fe9693b7055686a077f3e8186]: Words in reg. 68(8)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(4); 2020 c. 1, Sch. 5 para. 1(1)

[^key-e9ef2ba15e05f827f80c80442624474e]: Words in reg. 68(9)(a) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 77(5) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 57(b))

[^key-262bdd483fb3cbfbf958c6978e6d2b3d]: Words in reg. 68(10)(a) substituted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(6)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f7edf66cdda312a83b8d4bab4c523e7c]: Reg. 68(10)(b) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(6)(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-c344acc92ec9a9b6cf7897fb1cabc363]: Words in reg. 68(11)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(7); 2020 c. 1, Sch. 5 para. 1(1)

[^key-6ef859bb35ecd057e9e8f66d99a18c70]: Reg. 68(11B)-(11G) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(8) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 57(c)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-1d4beed2627e05ceceec58f8102a2a0c]: Words in reg. 68(12) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(9)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-ba7edf02fd162baec931094d94df7192]: Words in reg. 68(12) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(9)(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-c5fe713561dd59f9dea9a99d221819c3]: Reg. 68(13) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 77(10); 2020 c. 1, Sch. 5 para. 1(1)

[^key-31b26f89af94cf154ee38bd3945dd066]: Reg. 69(10) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 78; 2020 c. 1, Sch. 5 para. 1(1)

[^key-94f99cc0f118bf4b697c0650916a44c0]: Reg. 70 omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 79; 2020 c. 1, Sch. 5 para. 1(1)

[^key-db1ed311026ad5fb0f90ee2282629f23]: Reg. 71(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 80(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-83527964031ccfbf2322247dec7534a9]: Words in reg. 73(5C) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 82(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 60)

[^key-5343431fcd66e1eab18e93753280f332]: Words in reg. 73(5A)(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 82(2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-255b5af1640a7f06b83c3bd90bfe0e95]: Reg. 75(5)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 83(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-6eb1912d0fb4da29ebee4e1dd662de9f]: Word in reg. 75(5)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 83(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-e6cbd4e749cec207bbc233049a8795b7]: Reg. 76(2) substituted (31.12.2020) by S.I. 2019/775, reg. 84 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 61)

[^key-9b5073afff300750b9cdac813136c73c]: Words in reg. 79(1) substituted (31.12.2020) by S.I. 2019/775, reg. 88(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 65)

[^key-7e6da9e8041a4c9df9637191af3bd402]: Words in reg. 79(2) substituted (31.12.2020) by S.I. 2019/775, reg. 88(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 65)

[^key-cdd823776e4c55015e0616f393b5e5cb]: Word in reg. 80 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 89(2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d06c9d1bad1aee8b29dcf71a4180e3c3]: Reg. 80(a) substituted (31.12.2020) by S.I. 2019/775, reg. 89(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(a))

[^key-856472fde56ade59b789f99c3bb8b749]: Reg. 80(b) substituted (31.12.2020) by S.I. 2019/775, reg. 89(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(b))

[^key-2b17a0836b33e6113ef219f3560ed1e5]: Words in reg. 80(c) inserted (31.12.2020) by S.I. 2019/775, reg. 89(4A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(c))

[^key-d18306a680860ad6542e295424b09ba0]: Reg. 80(d) inserted (31.12.2020) by S.I. 2019/775, reg. 89(5) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(d)(ii)(iii)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-6663cdf4137cb8ad4fd7e1199effba8b]: Words in reg. 89(1)(b) substituted (31.12.2020) by S.I. 2019/775, reg. 90A (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 67)

[^key-2b9c95eeb41cfb7d554e8c5e98dce412]: Reg. 91 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 90B (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 67)

[^key-940a69cf5c48e0d49d6e5e9b49a174cb]: Words in reg. 97(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 94(3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3670186a828d10faaef98683a220556f]: Reg. 102(7)(8) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 98 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 75); 2020 c. 1, Sch. 5 para. 1(1)

[^key-e8849394549528f933c734a9e45811b0]: Reg. 103(1A)(1B) inserted (31.12.2020) by S.I. 2019/775, reg. 99(1A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 76(a))

[^key-47c5e8376477a82018f901626003f894]: Reg. 103(4)(a)-(c) substituted for words in reg. 103(4) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 99(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 76(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-49c06398518bc2fb329c1ce7907b1d93]: Reg. 103(5A)(5B) inserted (31.12.2020) by S.I. 2019/775, reg. 99(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 76(c))

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