13. After regulation 23 insert—
23A.—(1) The appropriate authority may by regulations make provision in relation to—
(a)standards and requirements relating to a quality system for blood establishments, including provision amending regulations 7(1)(b) and 13(a) in so far as those provisions relate to those standards and requirements;
(b)information to be provided to donors of blood and blood components, including provision amending regulation 7(2)(a) and Part A of Part 2 of the Schedule;
(c)information to be obtained from donors of blood and blood components, including provision amending regulation 7(2)(b) and Part B of Part 2 of the Schedule;
(d)eligibility criteria for donors of blood and blood components, including provision amending regulation 7(2)(d) and Part 3 of the Schedule;
(e)storage, transport and distribution requirements, including provision amending regulation 7(3)(b) and paragraphs 1 and 2 of Part 4 of the Schedule;
(f)quality and safety requirements for blood and blood components, including provision amending regulation 7(3)(c) and Part 5 of the Schedule;
(g)traceability requirements, including provision amending regulation 8 and Part 6 of the Schedule;
(h)deferral criteria for donors of blood and blood components, including provision amending paragraphs 2.1 to 2.4 of Part 3 of the Schedule;
(i)the requirements applicable to autologous transfusions, including provision amending paragraph 3 of Part 4 of the Schedule; and
(j)the procedure for notifying serious adverse reactions and events and notification format, including provision amending regulation 12B and Parts 7 and 8 of the Schedule.
(2) The provision that may be made in regulations under paragraph (1) includes provision to modify, or further modify, the Annex to Commission Directive 2005/62/EC as it applies by virtue of these Regulations.
(3) In paragraph (1), “appropriate authority” means—
(a)in relation to England, the Secretary of State;
(b)in relation to Wales—
(i)the Welsh Ministers; or
(ii)the Secretary of State acting with the consent of the Welsh Ministers;
(c)in relation to Scotland—
(i)the Scottish Ministers; or
(ii)the Secretary of State acting with the consent of the Scottish Ministers;
(d)in relation to Northern Ireland—
(i)the Department of Health in Northern Ireland;
(ii)the Secretary of State acting with the consent of that Department;
(e)in relation to the whole of the United Kingdom, the Secretary of State acting with the consent of the Welsh Ministers, the Scottish Ministers and the Department of Health in Northern Ireland.
23B.—(1) Regulations made by the Secretary of State or the Welsh Ministers under regulation 23A are to be made by statutory instrument.
(2) For regulations made under regulation 23A by the Scottish Ministers, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010(1) (Scottish statutory instruments).
(3) Any power of the Department of Health in Northern Ireland to make regulations under regulation 23A is exercisable by statutory rule for the purposes of the Statutory Rules (Northern Ireland) Order 1979(2).
(4) Any power in regulation 23A to make regulations includes power to make—
(a)different provision for different purposes;
(b)consequential, supplementary, incidental, transitional, transitory or saving provision.
23C.—(1) Except as specified in paragraph (2), a statutory instrument containing regulations made by the Secretary of State under regulation 23A is subject to annulment in pursuance of a resolution of either House of Parliament.
(2) A statutory instrument containing regulations made under regulation 23A(1)(h) may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, each House of Parliament.
23D.—(1) Except as specified in paragraph (2), a statutory instrument containing regulations made by the Welsh Ministers under regulation 23A is subject to annulment in pursuance of a resolution of National Assembly for Wales.
(2) A statutory instrument containing regulations made under regulation 23A(1)(h) may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, the National Assembly for Wales.
23E.—(1) Except as specified in paragraph (2), regulations made by the Scottish Ministers under regulation 23A are subject to the negative procedure (see section 28 of the Interpretation and Legislative Reform (Scotland) Act 2010 (“the 2010 Act”) (instruments subject to the negative procedure)).
(2) Regulations made by the Scottish Ministers under regulation 23A(1)(h) are subject to the affirmative procedure (see section 29 of the 2010 Act (instruments subject to the affirmative procedure)).
23F.—(1) Except as specified in paragraph (2), regulations made by the Department of Health in Northern Ireland under regulation 23A are subject to negative resolution within the meaning of section 41(6) of the Interpretation Act (Northern Ireland) 1954(3) (definitions for parliamentary purposes) as if they were a statutory instrument within the meaning of that Act.
(2) Regulations may not be made by that Department under regulation 23A(1)(h) unless a draft of the regulations has been laid before and approved by a resolution of the Northern Ireland Assembly.”.