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

[F1 Importing licence holders: requests for inspections [F2 , Northern Ireland] U.K.

22A.— (1) This regulation applies where—

(a) any licensed activity in relation to qualifying tissues or cells imported into [F3 Northern Ireland] from a third country is carried out on any premises—

(i) to which a licence held by an importing licence holder relates; or

(ii) which are relevant third party premises in relation to an importing licence holder;

(b) the tissues or cells are distributed in an EEA stateF4 ...; and

(c) the competent authority in that state F5 ... requests the Authority to arrange for an inspection of the premises to be carried out.

(2) The Authority must arrange for an inspection of the premises in question to be carried out under regulation 22(1) by a duly authorised person, unless the Authority considers that it would be inappropriate to do so in the particular circumstances of the case.

(3) Before an inspection is carried out under paragraph (2), the Authority must make arrangements with the requesting authority for it to participate in the inspection, unless the Authority considers that the participation of the requesting authority is not appropriate in the circumstances.

(4) Where the Authority considers that the participation of the requesting authority in the inspection would not be appropriate in the circumstances, the Authority must notify the requesting authority of its decision and give reasons for that decision.

(5) In this regulation—

“duly authorised person” in the context of any provision, means a person authorised by the Authority to act for the purposes of that provision;

“qualifying tissues or cells” means tissues or cells intended for human application;

“requesting authority” means the competent authority which made the request under paragraph (1) for the Authority to arrange for the inspection to be carried out.]

Textual Amendments

F1 Reg. 22A 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), 6(2)

F2 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)

F3 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)

F4 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)

F5 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)