The Quality and Safety of Organs Intended for Transplantation Regulations 2012

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

6.—(1) The provisions of the 2004 Act referred to in paragraph (2) shall apply, subject to the modifications specified in [F1 paragraphs (4) and (5)], in relation to a licence under Schedule 1 to these Regulations as they apply to licences under paragraph 1 of Schedule 3, (licences for the purposes of section 16) to that Act.

(2) The provisions are—

(a) section 19(1), (2), (5) and (7) (right to reconsideration of licensing decisions);

(b) sections 20 to 24 (which relate to appeals and powers to give directions);

(c) section 37(1) to (5) (directions); and

(d) paragraphs 2(4)(c) to (f) and (5), 5, 7 to 11, and 13 of Schedule 3 (licences for the purposes of section 16).

(3) In their application by virtue of this regulation, those provisions extend to Scotland (as well as to the rest of the United Kingdom).

(4) In their application by virtue of this regulation—

(a) section 19 (right to reconsideration of licensing decisions) shall apply as if in subsection (2) the words “, or designated individual,” were omitted F2 ...;

(b) section 23 (conduct of licensed activities) shall apply as if subsection (1) were limited to directions that the Authority considers necessary to ensure compliance with [F3 these Regulations, as they apply in relation to Great Britain, and with the Directive and the Implementing Directive, as they apply in relation to Northern Ireland];

(c) section 24 (changes of licence circumstance) shall apply as if subsection (1) were limited to directions that the Authority considers necessary to ensure compliance with [F3 these Regulations, as they apply in relation to Great Britain, and with the Directive and the Implementing Directive, as they apply in relation to Northern Ireland] and as if for subsections (2)(b) and (3)(b) there were substituted—

“(b) on any other person who has authority to act under the licence;”;

(d) section 37 (directions) shall apply—

(i) as if the reference in subsection (1) to “this Part” were to these Regulations; and

(ii) as if any reference in subsection (5) to a licence were to a licence under Schedule 1 to these Regulations;

(e) paragraph 2(4)(c) to (f) and 5 (characteristics of licence) of Schedule 3 shall apply as if it were limited to directions that the Authority considers necessary to ensure compliance with [F3 these Regulations, as they apply in relation to Great Britain, and with the Directive and the Implementing Directive, as they apply in relation to Northern Ireland];

(f) paragraph 7 (power to revoke licence) of that Schedule shall apply as if sub-paragraphs (1)(b) and (2)(b), (e) and (f) were omitted and as if for sub-paragraph (2)(b) there were substituted —

“(b) if it is satisfied that the licence holder has failed to discharge, or is unable because ofincapacity to discharge, any of its duties,”;

(g) paragraph 8 (power to vary licence) of that Schedule shall apply as if sub-paragraphs (1), (2)(b), (3) and (4) were omitted;

(h) paragraph 9 (power to suspend licence) of that Schedule shall apply as if for sub-paragraph (3) there were substituted the following sub-paragraph—

“(3) Notice under sub-paragraph (1) shall be given to the licence holder or to any otherperson who has authority to act under the licence.”;

(i) paragraph 10 (procedure in relation to licensing decisions) of that Schedule shall apply as if sub-paragraph (2)(b) were omitted; and

(j) paragraph 11 (notification of licensing decisions) of that Schedule shall apply as if sub-paragraphs (1)(b) and (3)(b) were omitted and as if for sub-paragraphs (2)(b) and 4(b) there were substituted—

“(b) any other person who has authority to act under the licence.”;

(5) In its application by virtue of this regulation, section 22 (appeal on a point of law) of the 2004 Act is to have effect in Scotland as if the reference to the High Court were a reference to the Court of Session.

Textual Amendments

F1 Words in reg. 6(1) substituted (14.7.2014) by The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 (S.I. 2014/1459), regs. 1(1), 4(a)

F2 Words in reg. 6(4)(a) omitted (14.7.2014) by virtue of The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 (S.I. 2014/1459), regs. 1(1), 4(b)

F3 Words in reg. 6 substituted (31.12.2020) by The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/483), regs. 1, 3(5) (as substituted by S.I. 2020/1305, regs. 1, 6); 2020 c. 1, Sch. 5 para. 1(1)