The Blood Safety and Quality Regulations 2005

[^key-866f967f960f116f76a4be0adbc65bb6]: Reg. 2(1) substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), reg. 5(b) (as substituted by S.I. 2020/1304, regs. 1, 5); 2020 c. 1, Sch. 5 para. 1(1)

[^key-c01978b6f4d7d94a2077ccc3b10f039e]: Words in reg. 6(2)(b) substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), reg. 6 (as amended by S.I. 2020/1304, regs. 1, 6); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0add98dbc6b8d636a4c1ee3ae73b1c75]: Reg. 7(1A) inserted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 7(b) (as amended by S.I. 2020/1304, regs. 1, 7(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3f6adbcdc08872ff275cd281eb7ab945]: Reg. 7(1)(b) substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 7(a) (as substituted by S.I. 2020/1304, regs. 1, 7(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-2f12a046fc730eac704dd93996874b17]: Words in reg. 7(3)(a) substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 7(c); 2020 c. 1, Sch. 5 para. 1(1)

[^key-b17c88067e5043273ecddad618fd82aa]: Words in reg. 8(2) substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 8(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-dbf8ca35a6a324ea6f7fcf4a360a0b73]: Words in reg. 8(1) substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 8(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3829f3c0656a4eb69f5fd95cc9f20df0]: Reg. 9(1A) inserted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 9(b) (as amended by S.I. 2020/1304, regs. 1, 8(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-5dd0fd34e0839c8b3fc5ebfa6187cca4]: Reg. 9(1)(b) substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 9(a) (as substituted by S.I. 2020/1304, regs. 1, 8(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-72cd2117990e2b9b2ee6ee49bdba0cf8]: Words in reg. 13(a) inserted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 10(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

[^key-b2bad7e4544087552301397e5fae59b4]: Words in reg. 13 heading substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 10(a) (as substituted by S.I. 2020/1304, regs. 1, 9); 2020 c. 1, Sch. 5 para. 1(1)

[^key-76cf2a4ea24e955854ebefbcf25aa39a]: Words in reg. 13 substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 10(aa) (as substituted by S.I. 2020/1304, regs. 1, 9); 2020 c. 1, Sch. 5 para. 1(1)

[^key-740ce76ceae83b1c13eb5268910ceb96]: Reg. 13A inserted by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 10A (as inserted by S.I. 2020/1304, regs. 1, 10); 2020 c. 1, Sch. 5 para. 1(1)

[^key-6a34b55d1b14e489baf99b7766e8d8e1]: Reg. 16A substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 11 (as substituted by S.I. 2020/1304, regs. 1, 11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-064004c0bbdbe0dea6f2bc88cd6e0e3b]: Words in reg. 23 heading inserted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 12(1)(a) (as substituted by S.I. 2020/1304, regs. 1, 12); 2020 c. 1, Sch. 5 para. 1(1)

[^key-dc90832ea1ee5bb16fa8a31149959ee0]: Words in reg. 23(1) substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 12(1)(b) (as substituted by S.I. 2020/1304, regs. 1, 12); 2020 c. 1, Sch. 5 para. 1(1)

[^key-430d1850177b6082285601ad1430ee1b]: Words in Sch. 1 Pt. 3 para. 1 substituted (31.12.2020) by The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), reg. 14 (as substituted by S.I. 2020/1304, regs. 1, 14); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_f2e835da-ea16-446c-d130-5a10b9a8c3ce]: Word in reg. 13(a) omitted (31.12.2020) by virtue of The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/4), regs. 1, 10(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fbdc4103d206cbd90ec50639e06f4d8c]: Sum in reg. 22(2)(a) substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 17(2)(a)

[^key-b5b6bcd0cd900f3e6976cef05c4f0e1d]: Reg. 2(3) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 20

[^key-e1140ebb60d020dd72052e907ad0d6ca]: Sum in reg. 22(2)(b) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(2)(a)

[^key-a8a404fed62ce98bb60f32efd30c42fe]: Sum in reg. 22(2)(c) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(2)(b)

[^key-982e9c5a4e6532ec833f85c80fac6326]: Sum in reg. 22(2A)(b) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(3)

[^key-d49665cc74097e64557f3f10ca15608c]: Sum in reg. 22(3)(a) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(4)(a)

[^key-7b1f241ef49d0402af7dcc1107741d81]: Sum in reg. 22(3)(b) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(4)(b)

[^key-609bc18a397913fa14e824ef355886a0]: Sum in reg. 22(3A) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(5)

[^key-f1af2b5b6d128494b4f7ad35e4a802d0]: Sum in reg. 22(3C)(c) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(6)

[^key-a493c890a2046876dbe2e89ad1e93578]: Sum in reg. 22(5)(a) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(7)(a)

[^key-c660a98307b5e9bd216205d781d5059d]: Sum in reg. 22(5)(b) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(7)(b)

[^key-c6e9ee63ea863b410376fadc9ce3728b]: Sum in reg. 22(5B)(a) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(8)(a)

[^key-d0b4d1d4aa11871f278dc2b67dbeb004]: Sum in reg. 22(5B)(b) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(8)(b)

[^key-45c689dd82db5b4995ab1ff60692dd11]: Sum in reg. 22(5C)(a) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(9)(a)

[^key-4f5e4e408a9053c7d49d3ed487b76a7b]: Sum in reg. 22(5C)(b) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(9)(b)

[^key-5e442efc316c37ffd153eff0ab74a1c0]: Sum in reg. 22(5E) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 13(10)

Requirement that facilities retain certain data

12A

• (1) A person responsible for management of a facility shall ensure that the facility—

• (a) retains the data set out in Section B of Part 6 of the Schedule, in an appropriate and readable storage medium, for a period of at least 30 years; and

• (b) has in place a system in place to record each unit of blood or blood component received, whether or not locally used, and the final destination of that received unit whether transfused, used in the manufacture of medicinal products, discarded or returned to the blood establishment or hospital blood bank.

Requirement to report serious adverse reactions and events

12B

• (1) A person responsible for management of a reporting establishment shall ensure that the reporting establishment—

• (a) has in place procedures to retain the record of transfusions for a period of at least 30 years;

• (b) notifies blood establishments without delay of any serious adverse reactions observed in recipients during or after transfusion which may be attributable to the quality or safety of blood or blood components; and

• (c) notifies the Secretary of State as soon as is known all relevant information about suspected serious adverse reactions using the notification formats set out in Section A and Section C of Part 7 of the Schedule.

• (2) A person responsible for management of a reporting establishment shall ensure that the reporting establishment—

• (a) notifies the Secretary of State of all relevant information about serious adverse reactions of imputability level 2 and 3 as referred to in Section B of Part 7 of the Schedule, which may be attributable to the quality and safety of blood or blood components;

• (b) notifies the Secretary of State, as soon as is known, of any case of transmission of infectious agents by blood or blood components;

• (c) as part of the notification referred to in paragraph (a), describes the actions taken with respect to other implicated blood or blood components that have been distributed for transfusion or for plasma fractionation;

• (d) as soon as is reasonably practicable after each suspected serious adverse reaction, evaluates that reaction according to the imputability levels set out in Section B of Part 7 of the Schedule;

• (e) completes the serious adverse reaction notification, upon conclusion of the investigation, using the format set out in Section C of Part 7 to the Schedule; and

• (f) submits a complete report to the Secretary of State on serious adverse reactions in any calendar year by no later than 1st April in the following calendar year, using the format set out in Section D of Part 7 to the Schedule.

• (3) A person responsible for management of a reporting establishment shall ensure that the reporting establishment notifies the Secretary of State as soon as is known, using the notification formats set out in Section A of Part 8 of the Schedule, of all relevant information about serious adverse events which may put in danger donors or recipients other than those directly involved in the event concerned.

• (4) A person responsible for management of a reporting establishment shall ensure that the reporting establishment—

• (a) as soon as is reasonably practicable after each serious adverse event, evaluates that serious adverse event to identify preventable causes within the process;

• (b) upon completion of the investigation, completes the serious adverse event notification, using the format set out in Section B of Part 8 of the Schedule; and

• (c) submits a complete report to the Secretary of State on serious adverse events in any calendar year by no later than 1st April in the following calendar year, using the format set out in Section C of Part 8 of the Schedule.

• (5) Provided that either the condition set out in paragraph (6)(a), or the conditions set out in paragraph (6)(b) and (c) are satisfied, a facility may make arrangements with a hospital blood bank for the hospital blood bank to submit to the Secretary of State or the blood establishment the reports required by paragraphs (1)(b) and (c), (2)(a),(b),(e) and (f) and (4)(b) and (c) on the facility’s behalf.

• (6) The conditions referred to in paragraph (5) are that—

• (a) the person responsible for management of the hospital blood bank is the same person as the person responsible for management of the facility with which the arrangement is made; or

• (b) the arrangements referred to in paragraph (5) must be—

• (i) evidenced by a written agreement, and

• (ii) made with the person responsible for management of the hospital blood bank who supplied the blood or blood components to the facility for transfusion; and

• (c) the facility must supply the information necessary to enable the hospital blood bank to make the reports within the timescale specified by this regulation in relation to that report .

Import of blood and blood components into the United Kingdom

Disclosure of information by blood establishments and hospital blood banks

Inspections, etc.

Records to be kept by the Secretary of State

Requirement that the Secretary of State communicate certain information to other competent authorities

16A

The Secretary of State must, in respect of Northern Ireland, communicate to the competent authorities of member States such information as is appropriate with regard to serious adverse reactions and events in order to guarantee that blood or blood components known or suspected to be defective are withdrawn from use and discarded.

Powers of entry, etc.

Criminal offences

Penalties

Defence of due diligence

Offences by bodies corporate and Scottish partnerships

Fees

Specific epidemiological situations

Transitional provisions

Consequential amendments

PART6 — RECORD OF DATA ON TRACEABILITY

A. BY BLOOD ESTABLISHMENTS

1

Blood establishment identification

2

Blood donor identification

3

Blood unit identification

B. BY FACILITIES

1

Blood component supplier identification

2

Issued blood component identification

3

Transfused recipient identification

4

For blood units not transfused, confirmation of subsequent disposition

5

Date of transfusion or disposition (year/month/day)

6

Lot number of the component, if relevant.

PART 7 — NOTIFICATION OF SERIOUS ADVERSE REACTIONS

SECTION A — Rapid notification format for suspected serious adverse reactions

SECTION B — Serious adverse reactions – imputability levels

SECTION C — Confirmation format for serious adverse reactions

SECTION D — Annual notification format for serious adverse reactions

PART 8 — NOTIFICATION OF SERIOUS ADVERSE EVENTS

SECTION A — Rapid Notification Format for Serious Adverse Events

SECTION B — Confirmation Format for Serious Adverse Events

SECTION C — Annual Notification Format for Serious Adverse Events

Modification of provisions of the Annex to Commission Directive 2005/62/EC

1A

• (1) For the purposes of these Regulations as they apply in relation to Great Britain, the Annex to Commission Directive 2005/62/EC is to be read with the modifications specified in the following paragraphs.

• (2) Paragraph 2.5 is to be read as if the reference to compliance with the Directives mentioned in that paragraph was a reference to compliance with the requirements which those Directives would require to be imposed if those Directives formed part of domestic law.

• (3) Paragraph 4.3 is to be read as if the reference to—

• (a) the requirements of Council Directive 93/42/EEC and Directive 98/79/EC were a reference to the requirements of the Medical Devices Regulations 2002;

• (b) third countries were a reference to countries other than the United Kingdom.

• (4) Paragraph 6.1.1 is to be read as if the reference to the requirements set out in Annexes II and III to Directive 2004/33/EC were a reference to the requirements set out in Parts 2 and 3 of the Schedule.

• (5) Paragraph 6.2.2 is to be read as if the reference to third countries were a reference to countries other than the United Kingdom.

• (6) Paragraph 6.3.2 is to be read as if the reference to the requirements set out in Annex IV to Directive 2002/98/EC were a reference to the requirements set out in regulation 7(7).

• (7) Paragraph 6.3.3 is to be read as if the reference to a test mentioned in Annex IV to Directive 2002/98/EC were a reference to a test for the infections mentioned in regulation 7(7)(c).

• (8) Paragraph 6.5.2 is to be read as if—

• (a) the reference to requirements in Article 14 of Directive 2002/98/EC and Commission Directive 2005/61/EC were a reference to the requirements set out in regulation 8;

• (b) the words “The label for a final blood component shall comply with the requirements of Annex III to Directive 2002/98/EC.” were omitted.

• (9) Paragraph 6.5.3 is to be read as if the reference to compliance with Article 7 of Directive 2004/33/EC were a reference to compliance with regulation 7(3) (in relation to labelling), regulation 8 and paragraph 3.2 of Part 4 of the Schedule.

• (10) Paragraph 6.6.1 is to be read as if the reference to mandatory requirements set out in the Directive were a reference to the requirements set out in these Regulations.

• (10A) Paragraph 7.1 is to be read as if the reference to “Directive 2003/94/EC” were to “the Good Manufacturing Practice Directive, within the meaning of paragraph (a) of the definition of that term in regulation 8(1) of the Human Medicines Regulations 2012.

• (11) Paragraph 9.1 is to be read as if the reference to the standards set out in Annex V of Directive 2004/33/EC were a reference to the standards set out in Part 5 of the Schedule.

• (12) Paragraph 9.2 is to be read as if the reference to regulatory requirements were a reference to the requirements in regulation 12B.

• (13) Paragraph 10.1 is to be read as if for “according to approved procedures” there were substituted “ and in accordance with the procedures required by the quality system established and maintained by the blood establishment ”.

References to the requirements set out in the Annex to Commission Directive 2005/62/EC

1B

References in regulations 7, 9 and 13, as they apply in relation to Great Britain, to the requirements set out in the Annex to Commission Directive 2005/62/EC are to be read as a reference to the requirements which that Annex would require to be imposed if that Annex formed part of domestic law.

Designation of the competent authority for Northern Ireland and scope of the Regulations

Requirement for authorisation

Authorisation of a blood establishment

Suspension or revocation of authorisation

The responsible person for a blood establishment

Blood establishment requirements

Labelling of blood and blood components and traceability

Hospital blood bank requirements

Requirement for hospital blood banks to provide information to the Secretary of State

Service of notices relating to hospital blood banks

Objections to suspensions, revocations etc

Requirement that facilities retain certain data

Requirement to report serious adverse reactions and events

Import of blood and blood components into Great Britain

Import of blood and blood components into Northern Ireland

13A

Any person who imports blood or blood components into Northern Ireland from a third country must ensure that each unit which they import—

• (a) has been prepared in accordance with standards equivalent to the standards and requirements set out in the Annex to Commission Directive 2005/62/EC; and

• (b) meets standards of quality and safety equivalent to those laid down in Part 5 of the Schedule.

Disclosure of information by blood establishments and hospital blood banks

Inspections, etc.

Records to be kept by the Secretary of State

Requirement that the Secretary of State communicate certain information in respect of Northern Ireland to other competent authorities

Powers of entry, etc.

Criminal offences

Penalties

Defence of due diligence

Offences by bodies corporate and Scottish partnerships

Fees

Specific epidemiological situations in relation to Great Britain

Specific epidemiological situations in relation to Northern Ireland

23ZA

• (1) Where the Secretary of State is aware of a specific epidemiological situation, such as an outbreak of a disease, which may affect the safety of blood donations, and as a result of which the Secretary of State considers that specific deferral criteria for the collection of blood donations should be adopted, the Secretary of State must in relation to Northern Ireland—

• (a) notify blood establishments that those criteria must be adopted; and

• (b) notify the Commission of—

• (i) the epidemiological situation; and

• (ii) the additional deferral criteria which blood establishments are required to adopt in relation to it pursuant to sub-paragraph (a).

• (2) A blood establishment shall adopt and comply with any criteria for additional tests notified to them by the Secretary of State pursuant to paragraph (1).

Regulations relating to the quality and safety of blood and blood components

23A

• (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

Scope and nature of powers

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 (Scottish statutory instruments).

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (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.

Scrutiny of regulations made by the Secretary of State

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.

Scrutiny of regulations made by the Welsh Ministers

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.

Scrutiny of regulations made by the Scottish Ministers

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)).

Transitional provisions

Consequential amendments