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Regulation 7A Import into Northern Ireland from the EEAF1F7

United Kingdom

(1)

No person may import tissues or cells intended for human application into F2Northern Ireland from an EEA state F3..., 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 stateF4... 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 F5... 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 stateF6... for the purpose of implementing the first, second or third Directives.

Annotations

Textual amendments

F1

Reg. 7A 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(2)

F2

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)

F3

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)

F4

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)

F5

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)

F6

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)

F7

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)