The Human Tissue (Quality and Safety for Human Application) Regulations 2007

[^key-9bbdb4e8be84df69db859daf22846915]: Word in reg. 7(2) substituted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 3(1)(b)

[^key-d5b6bc1313785faac8a82a0e52c0c632]: Word in reg. 7(3) omitted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 3(1)(c)(i)

[^key-6f03ce7cf5f04a03aeef921da067bbf9]: Words in reg. 7(3) inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 3(1)(c)(ii)

[^key-5f2dc3a3a35fabb75ea059ab8913ed53]: Reg. 7(5) substituted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 3(1)(e)

[^key-29e4834a91955c48d9b4f15007239e1e]: Reg. 7(6) omitted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 3(1)(f)

[^key-44ee71e02f0df84275fd489a7cbb3167]: Words in reg. 10(3) substituted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 3(3)(c)

[^key-bfa4d603f4245f2cc2ce54573996f90f]: Words in reg. 28(1)(a) substituted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 6(4)

[^key-bb55fc60e32c115e9690c199e754f8f8]: Sch. 1 para. 5A inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 7(2) (with reg. 10)

[^key-31664e983e81641cb74dc08d874e08f9]: Sch. 2 heading substituted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 8(1)(a)

[^key-2edbf9d40fd357209e7c5faa2a8a5978]: Sch. 2 para. 1A inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 8(1)(c) (with reg. 10)

[^key-591490d2d9fc149e7d0e87613cef5ff6]: Sch. 2 para. 4A inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 8(1)(f)

[^key-de611e96ac6bf27839e30e7346888667]: Sch. 2 paras. 15, 16 inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 8(1)(g)

[^key-a643aec79d9ef5b185d27ccff4229576]: Regs. 4A-4E inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(4) (as amended by S.I. 2020/1306, regs. 1, 6); 2020 c. 1, Sch. 5 para. 1(1)

[^key-8602ae7d9372d9c03c58bfd8b5c6984e]: Regs. 34ZA-34ZC inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(19) (as amended by S.I. 2020/1306, regs. 1, 23); 2020 c. 1, Sch. 5 para. 1(1)

[^key-a771ab6ffcc97050ab945998c74bf9e2]: Sch. 2 restricted (temp.) (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 4 (as amended by S.I. 2020/1306, regs. 1, 26(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3bdc4336bc5789dba63afb0266ed0445]: Words in reg. 2(3) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(1A) (as inserted by S.I. 2020/1306, regs. 1, 3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-193c47b9ad07c524807b4481942f451f]: Words in reg. 3 inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(2) (as substituted by S.I. 2020/1306, regs. 1, 4); 2020 c. 1, Sch. 5 para. 1(1)

[^key-887aa2e4375366211e1ffb9dd0d9917e]: Words in reg. 4 substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(3) (as substituted by S.I. 2020/1306, regs. 1, 5); 2020 c. 1, Sch. 5 para. 1(1)

[^key-9a34cce0e50a5740fe6244676084d6c2]: Words in reg. 5(1) inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(5)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

[^key-e60cef5beafdebf0ffbd634641ae90d1]: Words in reg. 5(1) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(5)(a)(ia) (as inserted by S.I. 2020/1306, regs. 1, 7(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-b981cc2d5df88fc3d3db92973f50fa17]: Words in reg. 5(1) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(5)(a)(ib) (as inserted by S.I. 2020/1306, regs. 1, 7(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-7eac3797b77a26c10947eacfec8adbe3]: Words in reg. 5(1) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(5)(a)(ii) (as amended by S.I. 2020/1306, regs. 1, 7(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-1d7a1dceecda711b280134d196649aae]: Words in reg. 5(1) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(5)(a)(iia) (as inserted by S.I. 2020/1306, regs. 1, 7(c)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-2d653c62bb6f443343ec314268ee8d40]: Words in reg. 5(1) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(5)(a)(iib) (as inserted by S.I. 2020/1306, regs. 1, 7(c)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d2745b8e70d3cf5bb669898f2e5693bb]: Words in reg. 5(1) inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(5)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

[^key-9657023648b7d5386bc1d36f6ca6ebac]: Reg. 5(4)(b) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(5)(b) (as substituted by S.I. 2020/1306, regs. 1, 7(d)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-2a74042bfd324b962713077f16ad2ddb]: Words in reg. 6(1)(a) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(5A) (as inserted by S.I. 2020/1306, regs. 1, 8); 2020 c. 1, Sch. 5 para. 1(1)

[^key-5918f6d5d8c0ea118651daf0cd8b6519]: Words in reg. 7(1A) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(6)(a) (as substituted by S.I. 2020/1306, regs. 1, 9); 2020 c. 1, Sch. 5 para. 1(1)

[^key-98944dcd13118c3c0d739b99dd0958b6]: Reg. 7(4) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(6)(b) (as substituted by S.I. 2020/1306, regs. 1, 9); 2020 c. 1, Sch. 5 para. 1(1)

[^key-1fd9e01334f5ffece6521bb08386ac57]: Words in reg. 7(5) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(6)(c) (as substituted by S.I. 2020/1306, regs. 1, 9); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d573b2283b324676f43ecd12172f34d6]: Reg. 7A heading substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(7)(a) (as substituted by S.I. 2020/1306, regs. 1, 10); 2020 c. 1, Sch. 5 para. 1(1)

[^key-eabe40f9b7c12f529accff167b9e1e76]: Words in reg. 7A(1) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(7)(b)(i) (as substituted by S.I. 2020/1306, regs. 1, 10); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0480ef988729787e34dc12d6042636c8]: Words in reg. 7A(1) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(7)(b)(ii) (as substituted by S.I. 2020/1306, regs. 1, 10); 2020 c. 1, Sch. 5 para. 1(1)

[^key-a813f7ae81bddcb4820a1bbd3b04157a]: Words in reg. 7A(1)(a) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(7)(c) (as substituted by S.I. 2020/1306, regs. 1, 10); 2020 c. 1, Sch. 5 para. 1(1)

[^key-4c1add00cc54ad4727cfab963c54e325]: Words in reg. 7A(1)(b)(i) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(7)(d) (as substituted by S.I. 2020/1306, regs. 1, 10); 2020 c. 1, Sch. 5 para. 1(1)

[^key-7cfebb334f0e95b5940b44233be41db4]: Words in reg. 7A(1)(b)(ii) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(7)(e) (as substituted by S.I. 2020/1306, regs. 1, 10); 2020 c. 1, Sch. 5 para. 1(1)

[^key-e02c1eaee67b0f7a38b3707902e46d6b]: Reg. 11(4B)(c)(d) substituted by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(9)(a) (as substituted by S.I. 2020/1306, regs. 1, 12); 2020 c. 1, Sch. 5 para. 1(1)

[^key-49dccf8fdbd4ac260887aac4afc009ce]: Words in reg. 11(4C)(b) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(9)(b) (as substituted by S.I. 2020/1306, regs. 1, 12); 2020 c. 1, Sch. 5 para. 1(1)

[^key-5aa124f0119cb490a663eca5de7363c9]: Reg. 11(4A)-(4C) restricted (temp.) (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 4 (as amended by S.I. 2020/1306, regs. 1, 26); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d21ad486e55d4c4e6dd1cbd80aad4119]: Reg. 16 heading substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(10)(a) (as substituted by S.I. 2020/1306, regs. 1, 13(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-101614df6eb9963543e70491cfbda38a]: Words in reg. 16(1) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(10)(b) (as amended by S.I. 2020/1306, regs. 1, 13(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-cdb794f9e05a389fb3a21f482ea957bb]: Words in reg. 16(2) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(10)(b) (as amended by S.I. 2020/1306, regs. 1, 13(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-5d801559a6562bcc6e1e55e3b4681254]: Reg. 16(3) inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(10)(c); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_93ed6e56-37b8-43d1-df26-61651a9f055d]: Reg. 16A inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(10A) (as inserted by S.I. 2020/1306, regs. 1, 14); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3b0c75e1f481287c7585c2f0e0d2361e]: Reg. 20(1)(a) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(11)(a)(i) (as substituted by S.I. 2020/1306, regs. 1, 15(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-a5109ca594edbcb54ab065921e79c7bf]: Reg. 20(1)(c)(d) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(11)(a)(ii) (as substituted by S.I. 2020/1306, regs. 1, 15(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-5840c8ac214c96623f467065b2086113]: Reg. 20(3) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(11)(b) (as substituted by S.I. 2020/1306, regs. 1, 15(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-714ffa89b4f7c737886a567c8bb9c7b2]: Words in reg. 20A heading inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(12)(a) (as substituted by S.I. 2020/1306, regs. 1, 16); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d775d01873e14ad35c6769ff4b8be880]: Words in reg. 20A(1) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(12)(b) (as substituted by S.I. 2020/1306, regs. 1, 16); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0cdba72e6671d92d1cdb17b53c4a4def]: Reg. 20A(3) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(12)(c) (as substituted by S.I. 2020/1306, regs. 1, 16); 2020 c. 1, Sch. 5 para. 1(1)

[^key-4862d8b5ce4692017a117f616e2aa4f2]: Reg. 20A(4) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(12)(d) (as substituted by S.I. 2020/1306, regs. 1, 16); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d1ad3e4dc3a647d5de3cc427a83e716b]: Reg. 20A(5) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(12)(e) (as substituted by S.I. 2020/1306, regs. 1, 16); 2020 c. 1, Sch. 5 para. 1(1)

[^key-ba9b1f6ace8bc6d35ac2122e1596052c]: Words in reg. 20A(7) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(12)(f) (as substituted by S.I. 2020/1306, regs. 1, 16); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3935780db461a859fc5163f713210233]: Words in reg. 20A(11) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(12)(g) (as substituted by S.I. 2020/1306, regs. 1, 16); 2020 c. 1, Sch. 5 para. 1(1)

[^key-054fdf08a8cfe2ee2e8f2544281d63d9]: Words in reg. 20B heading inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(13)(a) (as substituted by S.I. 2020/1306, regs. 1, 17); 2020 c. 1, Sch. 5 para. 1(1)

[^key-ddf3e11639859fff23f852826ec72faa]: Words in reg. 20B(1)(a) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(13)(b) (as substituted by S.I. 2020/1306, regs. 1, 17); 2020 c. 1, Sch. 5 para. 1(1)

[^key-89d9cd6c975fa316f66bd91b1c825b8d]: Words in reg. 20B(1)(b) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(13)(c) (as substituted by S.I. 2020/1306, regs. 1, 17); 2020 c. 1, Sch. 5 para. 1(1)

[^key-84394d63c73b9f8b63d74b4d19e3da24]: Words in reg. 20B(1)(c) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(13)(d) (as substituted by S.I. 2020/1306, regs. 1, 17); 2020 c. 1, Sch. 5 para. 1(1)

[^key-25e01e6fa011d9f48dc8575d88d8a425]: Words in reg. 20B(4) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(13)(e) (as substituted by S.I. 2020/1306, regs. 1, 17); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d655c22931f16e06b331f587b7c41c96]: Words in reg. 20C heading inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(14)(a) (as substituted by S.I. 2020/1306, regs. 1, 18); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f1abc9065bfad85a3849ac544e09c585]: Words in reg. 20C(1) inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(14)(b)(i) (as substituted by S.I. 2020/1306, regs. 1, 18); 2020 c. 1, Sch. 5 para. 1(1)

[^key-71442f988f74d1a78b94cfafac734fca]: Words in reg. 20C(1) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(14)(b)(ii) (as substituted by S.I. 2020/1306, regs. 1, 18); 2020 c. 1, Sch. 5 para. 1(1)

[^key-236f3b79e0249ea8e9c4423f7ed8da32]: Words in reg. 21A heading inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(15)(a) (as substituted by S.I. 2020/1306, regs. 1, 19); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0c324ad7a87927d8c2c82dc1227c7e8b]: Words in reg. 21A(1)(a) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(15)(b) (as substituted by S.I. 2020/1306, regs. 1, 19); 2020 c. 1, Sch. 5 para. 1(1)

[^key-ae32cc8dfd4be8925c3ffc070045094c]: Words in reg. 21A(1)(b) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(15)(c) (as substituted by S.I. 2020/1306, regs. 1, 19); 2020 c. 1, Sch. 5 para. 1(1)

[^key-28d0afb12cede45529bb01626bb35817]: Words in reg. 21A(1)(c) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(15)(d) (as substituted by S.I. 2020/1306, regs. 1, 19); 2020 c. 1, Sch. 5 para. 1(1)

[^key-cf00e8029216ffc884fada13cc2a555e]: Words in reg. 22A heading inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(16)(a) (as substituted by S.I. 2020/1306, regs. 1, 20); 2020 c. 1, Sch. 5 para. 1(1)

[^key-7b6af1acf29aef4ebde353bc7e77e8a1]: Words in reg. 22A(1)(a) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(16)(b) (as substituted by S.I. 2020/1306, regs. 1, 20); 2020 c. 1, Sch. 5 para. 1(1)

[^key-385d97864ac3bb076cdff72ef949e587]: Words in reg. 22A(1)(b) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(16)(c) (as substituted by S.I. 2020/1306, regs. 1, 20); 2020 c. 1, Sch. 5 para. 1(1)

[^key-dfd2414fa80f7f373e7af17408ed96d1]: Words in reg. 22A(1)(c) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(16)(d) (as substituted by S.I. 2020/1306, regs. 1, 20); 2020 c. 1, Sch. 5 para. 1(1)

[^key-da0ee4fed3e8d74ac4a1efebad9a28c9]: Words in reg. 27(4) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(17) (as substituted by S.I. 2020/1306, regs. 1, 21); 2020 c. 1, Sch. 5 para. 1(1)

[^key-71c971e14741c9f437f48b56f6019d05]: Words in Sch. 1 para. 5A substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(20) (as substituted by S.I. 2020/1306, regs. 1, 24); 2020 c. 1, Sch. 5 para. 1(1)

[^key-83e0fd1a3e776e7bae79360ee4eb487f]: Sch. 2 para. 1 substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(a) (as amended by S.I. 2020/1306, regs. 1, 25(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-b92e8c96a5241ea85f1c3177721ae242]: Words in Sch. 2 para. 1A substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(b) (as substituted by S.I. 2020/1306, regs. 1, 25(c)); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_49fa4b47-880e-46e7-e1c6-477c310df503]: Sch. 2 para. 1ZA inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(aa) (as inserted by S.I. 2020/1306, regs. 1, 25(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_7cdb173e-3686-4941-da73-f66d56d1375c]: Sch. 2 para. 4ZA inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(ca) (as inserted by S.I. 2020/1306, regs. 1, 25(e)); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_9b3b9ec1-ca9f-4d99-9b32-f6ae8effb334]: Sch. 2 para. 7A inserted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(e) (as inserted by S.I. 2020/1306, regs. 1, 25(g)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-20706f13ae960b429a6715076778fcdc]: Words in Sch. 2 para. 4 substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(c)(i) (as substituted by S.I. 2020/1306, regs. 1, 25(d)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-7fdce75a4999767082394f3a0da27221]: Words in Sch. 2 para. 4 substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(c)(ii) (as substituted by S.I. 2020/1306, regs. 1, 25(d)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-5ef89a0321c357b04203543e1552f4aa]: Words in Sch. 2 para. 7 substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(d)(i) (as substituted by S.I. 2020/1306, regs. 1, 25(f)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d23bae11593f61305d2668e4ec7b5437]: Words in Sch. 2 para. 7(b) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(d)(ii) (as substituted by S.I. 2020/1306, regs. 1, 25(f)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-b17511fd7da0756edd7dfd220de462b3]: Words in Sch. 2 para. 15(5) omitted (31.12.2020) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(21)(f) (as inserted by S.I. 2020/1306, regs. 1, 25(g)); 2020 c. 1, Sch. 5 para. 1(1); 2020 c. 1, Sch. 5 para. 1(1)

[^key-ea59d3e15cb6760ab7080194bd86802d]: Word in reg. 2(3)(c) omitted (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 39(a)

[^key-61d285413cbb188c98f6db00ca365652]: Reg. 2(3)(e) and word inserted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 39(b)

[^key-0542eedd9c09555f7447c55ec5c67468]: Reg. 2(3)(f) and word inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 21(b)

[^key-582b3932f6575e7bcf55d9f666c3ef64]: Word in reg. 2(3)(d) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 21(a)

Import from the EEA and Gibraltar

7A

• (1) No person may import tissues or cells intended for human application into Northern Ireland from an EEA state ..., unless—

• (a) the import is from a tissue establishment which is accredited, designated, authorised or licensed under the laws or other measures adopted in an EEA state... for the purpose of implementing the first, second and third Directives; or

• (b) the import—

• (i) is from a person who is approved to procure tissues or cells intended for human application under the laws or other measures adopted in an EEA state ... for the purpose of implementing the first, second or third Directives; and

• (ii) follows the procurement of those tissues or cells in conditions accredited, designated, authorised or licensed under the laws or other measures adopted in an EEA state... for the purpose of implementing the first, second or third Directives.

Application of the 2004 Act in relation to licences under Schedule 1

Extension of other provisions of the 2004 Act to Scotland

Breach of requirement to hold a licence or to act under a third party agreement

Preconditions to grant of licence

Duty of designated individual

Information and confidentiality

Breach of confidentiality requirement

Duties of the Authority in relation to application of the Single European Code in relation to Northern Ireland

20A

• (1) In relation to Northern Ireland, the Authority must allocate to each licence holder one or more unique numbers to be the tissue establishment number or numbers in relation to that licence holder in accordance with Annex VII and paragraph 2(a) of Article 10b of the third Directive.

• (2) Any number allocated under paragraph (1) must be in the format specified in Annex VII to the third Directive.

• (3) In relation to Northern Ireland, the Authority must take steps to enable the information specified in Annex VIII to be recorded in the EU Tissue Establishment Compendium in relation to each licence holder.

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5) The Authority must take the steps mentioned in paragraph (3) to enable the information mentioned in that paragraph to be recorded before the end of the period of 10 working days beginning with the day on which the person becomes a licence holder.

• (6) Paragraph (7) applies if the Authority becomes aware that any information recorded under paragraph (3) was incorrectly recorded or requires updating.

• (7) Where this paragraph applies, the Authority must take steps to enable the information to be corrected or updated—

• (a) in the case of a correction or update that the Authority considers to be a significant change to the information recorded under paragraph (3), before the end of the period of 10 working days beginning with the day on which the Authority became aware that the information was incorrectly recorded or required updating;

• (b) in any other case, as soon as is reasonably practicable.

• (8) Paragraph (9) applies if the Authority becomes aware that—

• (a) any information recorded in the EU Tissue Establishment Compendium in respect of a tissue establishment in a relevant state was incorrectly recorded or requires updating; or

• (b) a tissue establishment in a relevant state has not complied with the requirements of the laws or other measures adopted in that state for the purpose of implementing paragraph 1 of Article 10b of the third Directive and the non-compliance is significant.

• (9) Where this paragraph applies, the Authority must inform the competent authority in the relevant state in question of the information to be corrected or updated or the non-compliance in question.

• (10) If the Authority becomes aware that the information recorded in the EU Tissue and Cell Product Compendium requires updating, it must inform the European Commission and the competent authority in the relevant state.

• (11) In this regulation—

• “relevant state” means an EEA state;

• “working day” means any day other than—a Saturday or Sunday;Christmas Day or Good Friday; ora day which is a bank holiday under the Banking and Financial Dealings Act 1971 in any part of the United Kingdom.

Inspection of third country premises etc , Northern Ireland

20B

• (1) Paragraph (2) applies where—

• (a) qualifying tissues or cells are imported into Northern Ireland from a third country by an importing licence holder;

• (b) the tissues or cells are distributed in an EEA state...; and

• (c) the competent authority in that state ... (“the requesting authority”) requests the Authority to carry out any of the following activities—

• (i) to arrange for an inspection of any third country premises to be carried out on behalf of the Authority;

• (ii) to arrange for an inspection of any relevant documents held by a third country supplier to be carried out on behalf of the Authority;

• (iii) to exercise the Authority’s power under paragraph 7(2) of Schedule 3 to the 2004 Act to revoke a licence held by an importing licence holder;

• (iv) to exercise the Authority’s powers under paragraph 8(3) of Schedule 3 to the 2004 Act to vary a licence held by an importing licence holder; or

• (v) other appropriate control measures.

• (2) The Authority must carry out the activity in question specified in paragraph (1)(c), unless it considers that it would be inappropriate to do so in the particular circumstances of the case.

• (3) Before an inspection of any premises is carried out pursuant to paragraph (2), the Authority must—

• (a) make arrangements with the competent authority which made the request under paragraph (1) for that competent authority to participate in the inspection; or

• (b) notify the competent authority which made the request under paragraph (1) that the Authority has decided that it is not appropriate for that competent authority to participate in the inspection and give reasons for that decision.

• (4) For the purposes of ascertaining whether qualifying tissues or cells imported into Northern Ireland from a third country meet standards of quality and safety equivalent to those laid down in these Regulations, the Authority may arrange for either or both of the following to be carried out on its behalf—

• (a) an inspection of any third country premises; or

• (b) an inspection of any relevant document held by a third country supplier.

• (5) The Authority may arrange for a report to be made on any inspection carried out in pursuance of paragraph (2) or (4).

• (6) Any inspection carried out in pursuance of paragraphs (2) and (4) must be carried out by a person authorised by the Authority for the purposes of this regulation.

• (7) An inspection of any premises made under this regulation must include, in particular—

• (a) the inspection of any equipment found on the premises;

• (b) the inspection and copying of any relevant documents or records found on the premises; and