Regulation 7 Licensing requirement

United Kingdom

(1)

No person shall store tissue or cells intended for human application otherwise than under the authority of a licence under Schedule 1.

F1(1A)

Subject to paragraphs (4) and (5), no person may import F2... from a third country tissues or cells that are intended for human application otherwise than under the authority of a licence under Schedule 1.

(2)

Subject to paragraphs (4) and F3(5), no person shall do an activity to which this paragraph applies otherwise than—

(a)

under the authority of a licence under Schedule 1, or

(b)

in pursuance of a third party agreement.

(3)

Paragraph (2) applies to the procurement, testing, processing, distributionF4... or export F5from the United Kingdom to a third country of tissue and cells intended for human application.

F6(4)

The Authority may authorise any person to distribute, import from a third country or export to a third country tissues or cells directly from where the procurement takes place to an organisation responsible for human application for immediate human application where that authorisation relates to tissues or cells specified by the Authority.

F7(5)

Where the Authority is satisfied that there is a case of emergency, it may authorise any person to distribute, import F8... from a third country or export from the United Kingdom to a third country tissues or cells.

F9(6)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7)

Schedule 1 shall apply in relation to licences for the purposes of this regulation.

Annotations

Textual amendments

F1: Reg. 7(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), 3(1)(a)
F2: 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)
F3: 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)
F4: 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)
F5: 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)
F6: 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)
F7: 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)
F8: 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)
F9: 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)