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Regulation 23A Regulations relating to the quality and safety of blood and blood componentsF1

(1)

An appropriate authority in Great Britain may by regulations make provision in relation to—

(a)

standards and requirements relating to a quality system for blood establishments and hospital blood banks, including provision amending regulations 7(1)(b), 9(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 regulations 7(3)(b), 9(1)(h) 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 regulations 8, 9(1)(e) 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)

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

(e)

in relation to the whole of Great Britain, the Secretary of State acting with the consent of the Welsh Ministers and the Scottish Ministers

Annotations

Textual amendments

F1

Regs. 23A-23E inserted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 13 (as amended by S.I. 2020/1304, regs. 1, 13); 2020 c. 1, Sch. 5 para. 1(1)