The Human Medicines Regulations 2012

[^key-067e66b7f173428c0cfa664180642162]: Words in Sch. 12A para. 22(1)(d) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 140(d) (with reg. 1(2))

[^key-f5667e9b9d0b3f3f0456fa8107472ff9]: Words in Sch. 12A para. 30(g) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 140(e)

[^key-d9e58e0c101a5a230bac9cac355b7cef]: Words in Sch. 24 para. 7(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(a)

[^key-807cc23f677eccc91e9ce86f07780c35]: Words in Sch. 24 para. 15 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(b)

[^key-9c396ed6c78311b34bddf3f578a85a39]: Words in Sch. 24 para. 16 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(c)

[^key-e44f0d2baee47e5b1bc874c10a742c14]: Sch. 24 para. 18A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(d)

[^key-7bad1f08b821b9af24192d4197ac439f]: Words in Sch. 24 para. 23 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 142(f)

[^key-f1813c5ad7922113c0206c256abf9c5f]: Words in Sch. 27 para. 8(c)(ii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 143(a)

[^key-719f37e5de967cbdca66d3fbe42cc1d9]: Words in Sch. 27 para. 11(f) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 143(b)

[^key-811cb7f8d5e1aace5b0161569b287999]: Words in Sch. 30 para. 1 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 144(a)

[^key-5896f2383478f260fede6d7b9f51b07a]: Words in Sch. 30 para. 2 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 144(b)

[^key-84801b9095b557d35201960ae671a652]: Words in Sch. 30 para. 6 omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 144(c)

[^key-b77a6ac130d073386c531a10e89d034b]: Sch. 33A para. 29A omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 145

[^M_F_f8c232e6-1046-4810-e660-a5c9b8b686e1]: Words in reg. 259(2) substituted (31.12.2020) by S.I. 2019/775, reg. 202 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 156)

[^M_F_2c1ae496-b503-47d9-dfbc-47bc20a30d0a]: Words in reg. 346(2)(d)(iva) omitted (2.12.2024) by virtue of The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 9(b)

[^M_F_891d4cbe-be19-4b24-ff9f-e0c41c373c34]: Words in reg. 346(2)(d)(iva) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 7 and words in reg. 346(2)(d)(iva) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 7

[^M_F_1a9c3d77-f81c-4c1d-b953-dfe23b852dae]: Words in reg. 346(2)(d)(iva) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 11(2)(b)(i) and words in reg. 346(2)(d)(iva) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 11(2)(b)(i)

[^key-601d39ce14efee8f9c450bb275e21ed2]: Regs. 17A, 17B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 6

[^key-89d027c5e0b2502e038a2b766c5d5d39]: Reg. 27A inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 10

[^key-540d5b8a2360eb0eec8e05aa27ae7ef6]: Regs. 29A, 29B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 12

[^key-364df8aaab31854056cb402b4a5f88fb]: Regs. 37A, 37B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 14

[^key-04d0655e38de6740bc1d7a30cdcedb6a]: Reg. 50K inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 17

[^key-716a599c2b163bb584bdb1aebf862226]: Regs. 74A, 74B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 18

[^key-fb9c75fd92f08337a0ba5704286abe02]: Regs. 170A, 170B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 23

[^key-7c014024b65fbd8e25dd65f46cf47e14]: Reg. 257CA inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 31

[^key-08d7d29a017197702e25396ceecd8c83]: Sch. 3 paras. 1A, 1B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 34(4)

[^key-0739633a5c097981ec1a8664685ad68c]: Sch. 4 Pts. 1A, 1B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 35

[^key-70df672744023e67aa2df45f63ced90b]: Sch. 7 para. 12B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 36

[^key-878a53dbcb1b90f6cb6aa6403f3dde9c]: Words in reg. 17(1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 5(2)

[^key-dc1308b83234b44c8d4c90de64e9899d]: Reg. 17(1A) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 5(3)

[^key-6d17c396d1f48336fbe817c702756895]: Reg. 17(10)(11) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 5(4)

[^key-d7d6e2a55a5a67c69661f4cb0b86a4d8]: Sch. 24 Pts. 6, 7 inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 38

[^key-9fd9f1f4416a9c1fd930ecf55649da45]: Words in reg. 20(2) substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 7

[^key-d65dba98bcfb7c602dad61f8b948d44c]: Reg. 22(1A)(1B) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 8

[^key-b558ad8fe2d75c49462a955a54323d44]: Reg. 26(2)(d)(e) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 9(b)

[^key-44a3af98b8cc0e70bd46a29e9d073be3]: Word in reg. 26(2)(b) omitted (23.7.2025) by virtue of The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 9(a)

[^key-94d50d05063d6f2847bf48583da018e9]: Reg. 29(2A)-(2F) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 11

[^key-4dcdf3dd1991a6dfd86ee9be336b3b6d]: Word in reg. 37(6)(aa) omitted (23.7.2025) by virtue of The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 13(2)(a)

[^key-dd0b04f1c210038ad043c08e2ec31766]: Reg. 37(6)(ab)(ac) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 13(2)(b)

[^key-d20ee87cfc664ff86dc6f434b7c4c136]: Words in reg. 37(8) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 13(3)

[^key-0cad15182751c457dfdf64143cf5536a]: Reg. 39(5A)-(5E) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 15(3)

[^key-afec8381d55c81c62723d7e905a91174]: Words in reg. 39(4) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 15(2)

[^key-8c8e91ed38fad68afd111aeee87109a6]: Words in reg. 39(5) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 15(2)

[^key-96fca090ba099dc7fdf9939c638bd0d0]: Words in reg. 50(5) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 16(2)

[^key-9e55e8e88a9ceb39c30065d964a863ee]: Reg. 50(5AA)(5AB) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 16(3)

[^key-9346671b2cc98f16c5679ff0e3ecb047]: Reg. 167(6A)(6B) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 19(3)

[^key-22bf171f95d71f8da7718ac0722e423c]: Words in reg. 167(7) omitted (23.7.2025) by virtue of The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 19(4)

[^key-5621758a33f9e7b224c48ab19ec99ae7]: Words in reg. 167(6) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 19(2)

[^key-2cc7bb00eb23238079516433042eebed]: Words in reg. 167G(1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 20(2)(a)

[^key-5128fb7547b6f7035de01c9b551e228c]: Words in reg. 167G(1)(c) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 20(2)(b)

[^key-803713206d7d4c149bbb086adeda48cd]: Reg. 167G(1A)(1B) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 20(3)

[^key-548c3ec163a361b250ba103859f366f6]: Reg. 169(A1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 21

[^key-73e3a9b84f0c2b2ff2611f98c49224ed]: Reg. 170(A1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 22

[^key-086d38c3153b5ea130f4fc742ba7dceb]: Reg. 171(A1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 24

[^key-5545abbc7bf5f2f607803093836129da]: Words in reg. 178(e) substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 26

[^key-37f950b4452d43f983fe6702b11f57f8]: Reg. 188(1B)(1C) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 27(4)

[^key-fd10401edfb2477c2aa43fd67e84382d]: Words in reg. 188(1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 27(2)(a)

[^key-bf170808d57ee1344f85f27cce06791e]: Reg. 188(1)(ca) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 27(2)(b)

[^key-ad8855b863ebb674f1157404b8086df2]: Words in reg. 188(1A) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 27(3)(a)

[^key-9e5036934be3a1b99ee37a2fabd85175]: Reg. 188(1A)(ba) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 27(3)(b)

[^key-37d8324fc11a23af3202716e69352add]: Reg. 202A(2)(d)(e) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 28

[^key-79c82291e07480263b7d669b3f912265]: Reg. 257(10) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 29

[^key-bd53d2dc14075857db4e625040d5e121]: Reg. 258(9) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 32

[^key-845442067ac07eba009ac72d00645a4e]: Words in reg. 8(1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 4

[^key-65ba2478396a30f6fe9bf1a6793d1ea9]: Reg. 346(2)(c)(ai)(bi) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(a)

[^key-beec3e3900a3061bc4d3d9b077e8231e]: Reg. 257C(5) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 30

[^key-ee910be191fbfaf75c14b2a999c19ee7]: Reg. 346(2)(c)(iiza)-(iizc) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(b)

[^key-2dd111431b040a62f80f1b403f8d692a]: Reg. 346(2)(c)(iiiza)(iiizb) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(c)

[^key-39936e7f1e19b6e853d5a5ff7467035f]: Reg. 346(2)(c)(va) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(d)

[^key-9f863d70d662ad86456ef0a56d95ac16]: Reg. 346(2)(c)(xivb)(xivc) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(e)

[^key-0a0949b9a2ac48c6c5e838c4864d4c88]: Reg. 346(2)(c)(xxviiiazb)(xxviiiazc) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(f)

[^key-695add89d71f5c9dd739a9bc86cceeb6]: Reg. 346(2)(c)(xxviiik) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(g)

[^key-7ea8a865c5e6504e3dc4f82abee07c5b]: Words in Sch. 8 para. 9A inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 37(2)

[^key-c986b7eade6b8c5751c8e07cadc83994]: Sch. 8 para. 16 substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 37(3)

[^key-deb821a300f9c1312ba80935a11285e0]: Words in Sch. 3 para. 1(2)(c) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 34(2)(a)

[^key-a82d36ed4a663088ea317739c5b4ce95]: Sch. 3 para. 1(2)(ca)(cb) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 34(2)(b)

[^key-a2938b26c8e95a9b8be75f181d6db570]: Words in Sch. 3 para. 1(2)(d) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 34(2)(c)

[^key-d664e5e91ea0694a838abafb9de9a939]: Words in reg. 175(3)(a) substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 25(2)(a)

[^key-12117344f607327084331c378e46acd1]: Words in reg. 175(3)(b) substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 25(2)(b)

[^key-8c31a330bf68d1db2f4e6b155e4ff12d]: Words in reg. 175(3)(c) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 25(2)(c)

[^key-c402eb95b2c9f6a24b585c6c494533b9]: Sch. 3 para. 1(3)(ba) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 34(3)

[^key-f2ea0d2f96ff7130a21215337c5d82ea]: Regs. 222A, 222B inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 9

[^key-2e98c0b317eeec9edeed7e010180d102]: Sch. 25 para. 6A inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 11

[^key-792ea46493b047dd9ab741dbc8434980]: Sch. 26 para. 4A inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 12(2)

[^key-0381ffec22e831cdbfda57ea25558287]: Sch. 26 para. 10A inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 12(3)

[^key-fa1cc353e36fd8f3c2a8d8702b3dbb87]: Reg. 3(5A) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 4(3)

[^key-48e3d41ea9318f004df638d4ea51cdcf]: Reg. 3(11A) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 4(5)

[^key-d5343a340070d4470e5b8973a9cdf605]: Word in reg. 3(2) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 4(2)

[^key-0f665dae8e1a8bced873f560d5b2c34a]: Word in reg. 3(10) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 4(4)

[^key-d5d2a5a4387419a935330460440042d8]: Words in reg. 3(12)(b) substituted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 4(6)

[^key-8af1e42ae3b22642445a9ab0fd96d721]: Words in reg. 8(1) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 5(2)(a)

[^key-582b8f84ec8226d6fd37dd899fbd2f94]: Words in reg. 8(1) substituted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 5(2)(b)

[^key-8e7563b6f2ab96f992f094f6e8aee9d7]: Reg. 8(3) substituted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 5(3)

[^key-cd75074eed61e3fa8fcd4574bd539537]: Reg. 18(5A) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 6(3)

[^key-3a8569ca7e7b755a6cb83c56d3313b7d]: Words in reg. 18(4) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 6(2)

[^key-83fa8174276ad9c991fd049ab58cb3ad]: Words in reg. 221(1) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 8(2)

[^key-8f532135278c8cffafd22ae97feda06d]: Words in reg. 221(2) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 8(3)

[^key-71ad2fb86f9df782b4fc3a1924411ec8]: Words in reg. 221(3)(a) inserted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 8(4)

[^key-a5d35e1fdfb218dbbd51755d3f359a6f]: Words in reg. 274(2)(b) substituted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 10

[^key-ef603b23ffc361c177596c20196b7cc6]: Words in reg. 220(2)(b) substituted (1.10.2025) by The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (S.I. 2025/758), regs. 1(2), 7

[^key-590f4ed31ea5a22c73805e3c0442c0ab]: Reg. 220B inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(a), 7(4)

[^key-db5f645abff57e0c39555db74a5178e0]: Words in reg. 62(5) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(3) (with reg. 12(19)(a))

[^key-a7142ae0c667e9e6256ca94fc9b98032]: Words in reg. 106(2) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(4) (with reg. 12(19)(a))

[^key-186e9a1d49b013748c314c48053139ad]: Words in reg. 131(2) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(5) (with reg. 12(19)(a))

[^key-bf5d36d822957821a68ed5bb848b01fa]: Reg. 217B(2)(b) substituted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(7) (with reg. 12(19)(b))

[^key-b92c75e3869c4035a4d7d50cf99fd313]: Words in reg. 217BA(2)(b) substituted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(8)

[^key-78f9497a43047111521ae624e7d9d2a0]: Reg. 217C(2)(a) substituted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(9)(a) (with reg. 12(19)(c))

[^key-dcd611b3247ae01e438dcffd8e5fc2a3]: Words in reg. 217C(2)(b) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(9)(b)

[^key-319948b229a7f1e9f5aafe628b1662fc]: Words in reg. 217CA(2)(a) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(10)

[^key-32bd4e40b7ceffc62db1b463cc9ed372]: Reg. 220(2)(c) substituted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(a), 7(2) (with art. 7(5))

[^key-459891e086f8b751ae67eb7589f4378b]: Words in reg. 248(2)(b) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(12) (with reg. 12(19)(a))

[^key-ec6d23a78e9ea672642e9ad386279831]: Words in reg. 250(3) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(13) (with reg. 12(19)(a))

[^key-01bca82fbafbeaf1cd502bd14e4d09b8]: Words in reg. 255(1)(c) omitted (7.1.2026) by virtue of The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(14)

[^key-5b73d1614655f5055bcc8d0d615351d7]: Reg. 346(2)(c)(xxviiiezb) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(16)(b)

[^key-074d32acb82cfb85a10a327e2a16752e]: Reg. 235A inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 9

[^key-5b65c0fe4695464534f720df3f8c93eb]: Words in Sch. 16 heading inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 13(a)

[^key-29447245d909a0520ef56abbceaeeb0c]: Words in Sch. 16 Pt. 1 heading inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 13(b)

[^key-1aefc5b579cdc8ecc93135e951cac0aa]: Word in Sch. 17 Pt. 2 Table substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 14(2)(a)

[^key-0771813ee8d0173286658944c0bb44d8]: Words in Sch. 17 Pt. 2 Table omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 14(2)(b)

[^key-0270916c4784e9401d227f4c89ad899c]: Word in Sch. 17 Pt. 3 Table substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 14(3)(a)

[^key-9a4d061aa51c7aac700332c32f815466]: Words in Sch. 17 Pt. 3 Table omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 14(3)(b)

[^key-40a1a676985175dd173c5ffe2d5078e8]: Word in Sch. 17 Pt. 5 Table substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 14(4)(a)

[^key-701a25e6e640b9d54e08cf55b9a76656]: Words in Sch. 17 Pt. 5 Table omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 14(4)(b)

[^key-56d090a5c0698f0073e803cb92bbd1cc]: Words in Sch. 26 Pt. 1 heading substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 15

[^key-6e696237832ecdef63a4b102715f49ce]: Reg. 3(5B) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 3(3)

[^key-745cf229ef545e742f0c37def0d014f8]: Words in reg. 3(2) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 3(2)

[^key-bea4054999fbae53061032130b5a8514]: Word in reg. 3(11) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 3(4)

[^key-3f4a8c0aace5b9424cfc65e440138cd5]: Words in reg. 3(12)(b) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 3(5)

[^key-bcc5c0874742a5e71819d38c650709a7]: Words in reg. 3A heading substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(2)

[^key-01da335395ad8f834036b97bb60207f7]: Reg. 3A(6) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(7)

[^key-545055632a43e545a6c6a271282c801a]: Reg. 3A(1) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(3)

[^key-337649ca8a62924c55ed43015c0d9537]: Reg. 3A(2) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(3)

[^key-95bd2472786b53b6e5c32aa9cc59535b]: Words in reg. 3A(3) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(4)

[^key-e4cc9182894bb0f93a13a278565a1df8]: Reg. 3A(4)(a) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(5)

[^key-fa6a170455d931c4d98f40efe5695e49]: Words in reg. 3A(5) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 4(6)

[^key-20c6774184a37436a5c0814f2b3c8ee9]: Words in reg. 8(1) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 5

[^key-cee19b3280bbd92baf38f294c9e6d1b0]: Reg. 19(4E)(4F) substituted for reg. 19(4D) (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(4)

[^key-b0ca7bf98f9f4b0f89fb7551cce6a01e]: Words in reg. 19(4A) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(2)(a)(i)

[^key-8208f521edb6c25d368907454415983e]: Words in reg. 19(4A) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(2)(a)(ii)

[^key-fc61fee07531ae697eed6430c0246087]: Reg. 19(4A)(d) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(2)(d)

[^key-2c1cdc9acbaf46ceed0997b7bd601cda]: Words in reg. 19(4A)(b) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(2)(b)(i)

[^key-016d75722e4bb5b6fdd0873b1f5e79d1]: Word in reg. 19(4A)(b) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(2)(b)(ii)

[^key-450bba3a79b175741f1f14d056a8cbb3]: Word in reg. 19(4A)(c) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(2)(c)

[^key-2d085183ff68f61ca003af7228228199]: Reg. 19(4B) omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 6(3)

[^key-a5ad161229ccff3ddb6428a64ca9dac4]: Words in reg. 213(1) inserted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 7

[^key-00fbe0e78144fcb1063b40becabc068f]: Words in reg. 233(8) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 8

[^key-6f6178ca213faa4b1b09f48a861114f0]: Reg. 247A omitted (31.3.2026) by virtue of The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 10

[^key-b3664d2fc625aca8d0c1e76ed1f4e50f]: Words in reg. 250(4A) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 11(a)

[^key-5856159c9bdc2207d1757b21fca4122d]: Words in reg. 250(4A) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 11(b)

[^key-e5106c3e8a9ba43fc9ddb034b7b98233]: Words in reg. 346(2)(c)(xxviiiga) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 12

A person who supplies medicinal products pursuant to an arrangement made with—

• (a) the Common Services Agency;

• (b) a health authority;

• (c) a special health authority;

• (d) an NHS trust;

• (da) an integrated care board;

• (db) NHS England;

• (dc) a local authority; ...

• (dd) the United Kingdom Health Security Agency;

• (de) Public Health Agency; or

• (e) an NHS foundation trust; ...

• (f) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

A local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006).

PART12A — Sale of medicines to the public at a distance

Interpretation

256A

• (1) In this Part—

• “common logo” means the common logo that is required to be clearly displayed on websites offering medicinal products for sale at a distance to the public in accordance with the requirements laid down in the implementing acts adopted by the Commission under Article 85c(3) of the 2001 Directive;

• “information society services” means information society services as defined in Article 1(2) of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services;

• “the list” means the list of persons who are entitled to supply medicinal products by information society services that is maintained on the website of the licensing authority;

• ...

• “website of the EMA” means the website of the EMA that—gives explicit information to the viewer on the website of the licensing authority containing information on persons authorised or entitled to supply medicinal products at a distance in Northern Ireland;provides information on the purpose of the common logo;provides background information about the risks related to medicinal products supplied illegally to the public by means of information society services;provides information on Community legislation applicable to falsified medicinal products;contains a hyperlink to the website of the licensing authority.

• “website of the licensing authority” means a website of the licensing authority providing information on—the national legislation applicable to the offering of medicinal products for sale at a distance to the public by information society services;the differences between Northern Ireland and EEA States regarding classification of medicinal products and the conditions for their supply;the purpose of the common logo;the list of persons offering medicinal products for sale at a distance by means of information society services as well as their website addresses;background information about the risks related to medicinal products supplied illegally to the public by means of information society services;a hyperlink to the website of the EMA;

• (2) In this Part, references to selling a medicinal product at a distance to the public by means of information society services, however expressed, include supplying and offering to sell or supply a medicinal product at a distance to the public by means of information society services (and related expressions are to be interpreted accordingly).

Person who may sell medicinal products by information society services

256B

• (A1) This regulation applies to a person who is an established service provider (as defined in regulation 2(1) of the Electronic Commerce (EC Directive) Regulations 2002) in Northern Ireland.

• (1) A person may not sell a medicinal product at a distance to the public by means of information society services unless that person satisfies the following conditions.

• (2) Condition A is that the person is included on the list ....

• (3) Condition B is that the product to be sold by information society services is covered by a UK marketing authorisation or an authorisation granted—

• (a) under Regulation (EC) No 726/2004; or

• (b) by a competent authority of the member State in which that product is destined to be sold.

• (3A) Condition B does not apply to—

• (a) a special medicinal product;

• (b) a medicinal product where the product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of any provision of section 10 of the Medicines Act 1968; or

• (c) a medicinal product where—

• (i) the product is a result of a process of assembly of a medicinal product that is an authorised medicinal product within the meaning of regulation 3(15);

• (ii) regulation 17(1) does not apply to the process of assembly by virtue of any provision of section 10 of the Medicines Act 1968;

• (iii) the process of assembly results in a change in the presentation of the authorised medicinal product; and

• (iv) by reason of the change in paragraph (iii) the product does not comply with condition B.

• (4) Condition C is that the person selling the medicinal product is authorised or entitled to sell to the public, including by information society services, medicinal products of that type or classification ....

• (5) Condition D is that where the sale is to a member of the public in the United Kingdom, it is in accordance with regulations 214 (sale or supply of prescription only medicines), 220 (sale or supply of medicinal products not subject to general sale) and 221 (sale or supply of medicinal products subject to general sale).

• (6) Condition E is that the person selling the medicinal product has given a valid notification to the licensing authority.

• (7) Condition F is that the person selling medicinal products at a distance complies with the relevant provisions of the Electronic Commerce (EC Directive) Regulations 2002.

• (8) A person has not given a valid notification for the purposes of paragraph (6) if—

• (a) that person is not included on the list;

• (b) that person’s entry on the list is suspended by the licensing authority; or

• (c) the licensing authority has been notified under regulation 256E(b) to remove that person from the list.

Notification requirements for sellers of medicinal products at a distance

256C

• (1) The licensing authority may not enter a person’s details on the list unless it has been notified in accordance with paragraphs to (5).

• (2) The notification must include—

• (a) the name or corporate name of the person to be listed;

• (b) information about—

• (i) that person’s permanent address from which the activity of selling medicinal products by information society services is to be carried out,

• (ii) the commencement date of the activity of selling medicinal products by information society services,

• (iii) the address of the website used for the purposes of selling medicinal products by information society services,

• (iv) all relevant information necessary to identify the website, and

• (v) information about the classification of all the medicinal products offered for sale at a distance.

• (3) The notification shall—

• (a) be in English; and

• (b) unless paragraph (4) applies, in relation to the person whose details are to be entered on the list—

• (i) be signed by that person, and

• (ii) contain that person’s telephone number and e-mail address if this is available.

• (4) Where the notification is made by another person (“A”) on behalf of the person whose details are to be entered on the list, the notification shall—

• (a) contain the name and address of A;

• (b) be signed by A; and

• (c) contain the telephone number and e-mail address for A if this is available.

• (5) The notification shall contain contact details for the site from which the activity of selling medicinal products by information society services is to be carried out including the—

• (a) site address;

• (b) name of person who may be contacted; and

• (c) the telephone number and e-mail address of the person who may be contacted.

Procedure for listing persons who may supply medicinal products at a distance

256D

• (1) If the licensing authority receives a notification under regulation 256C it must accept or refuse to include that person on the list within the period of 90 days beginning immediately after the day on which the notification is received by the authority.

• (2) Paragraph (1) applies only if the requirements of regulation 256C(2) have been met.

• (3) Before determining if a person can be included on the list, the licensing authority may require the person giving the notification to provide such information as the licensing authority thinks necessary, within the period specified by the licensing authority.

• (4) If a notice under paragraph (3) requires the person giving the notification to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (1).

• (5) In paragraph (4), the “information period” means the period—

• (a) beginning with the day on which the notice is given, and

• (b) ending with the day on which—

• (i) the licensing authority receives the information; or

• (ii) the person from whom the information is requested shows to the satisfaction of the licensing authority that the information cannot be provided.

• (6) The licensing authority must give the person giving the notification a notice stating reasons for its decision in any case where—

• (a) the licensing authority refuses to include the person giving the notification on the list; or

• (b) if the licensing authority lists the person giving the notification otherwise that in accordance with the information supplied in the notification.

Removal of a person’s entry from the list