The Health Service Products (Provision and Disclosure of Information) Regulations 2018

• “statutory audited accounts”—in relation to a producer whose individual accounts are required to be audited in accordance with Part 16 of the Companies Act 2006, means the producer's individual accounts audited in accordance with that Part;in relation to a producer whose individual accounts are exempt under section 477 of the Companies Act 2006 from audit under Part 16 of that Act, means the producer's individual accounts;in relation to a producer whose accounts individual accounts are exempt under section 479A of the Companies Act 2006 from audit under Part 16 of that Act, means the consolidated accounts of the parent undertaking on the same group as the producer (see section 479A(2)(a) of that Act).Column 1 – financial thresholdColumn 2 – daily penalty: first 14 daysColumn 3 – daily penalty: fifteenth and subsequent daysmore than £5,000,000 but less than £20,000,000£500£1,000£20,000,000 or more but less than £50,000,000£1,000£2,000£50,000,000 or more but less than £100,000,000£2,500£5,000£100,000,000 or more£5,000£10,000

SCHEDULE 4 — Disclosure of information under section 246B of the 2006 Act: prescribed bodies and prescribed purposes

1

• (1) The bodies specified in column 1 of Table 1, being bodies appearing to the Secretary of State to represent UK producers, are prescribed for the purposes of section 264B(1)(k) of the 2006 Act.

• (2) The purpose for which a body specified in column 1 of Table 1 may use confidential or commercially sensitive information disclosed to it under section 264B(1) of the 2006 Act is the purpose prescribed in the corresponding entry in column 2 of that Table.

Column 1 – Bodies	Column 2 – The purpose for which information disclosed under section 264B(1) of the 2006 Act may be used
Association of British Healthcare Industries;Association of Pharmaceutical Specials Manufacturers;British Association of European Pharmaceutical Distributors;British Generic Manufacturers Association;British Healthcare Trades Association;British In Vitro Diagnostics Association;Healthcare Distribution Association;NHS Pharmacy Production Committee;NHS Pharmaceutical Quality Assurance;Proprietary Association of Great Britain;Surgical Dressings Manufacturers Association Committee;Urology Trade Association.	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(a) to (l).
Association of Independent Multiple Pharmacies;Company Chemists' Association;National Pharmacy Association.	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(a) to (k).
BioIndustry Association;Ethical Medicines Industry Group.	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(c), (e), (g), (i), (l) and (m).
Association of the British Pharmaceutical Industry	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(c), (e), (g), (i) and (k) to (m).
British Medical Association;Dispensing Doctor's Association.	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(a), (c), (d), (f), (g) and (i) to (k).
Pharmaceutical Services Negotiating Committee	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(b) and (c).

2

• (1) The bodies specified in column 1 of Table 2 are prescribed for the purposes of section 264B(1)(l) of the 2006 Act.

• (2) The purpose for which a body specified in column 1 of Table 2 may use confidential or commercially sensitive information disclosed to it under section 264B(1) of the 2006 Act is the purpose prescribed in the corresponding entry in column 2 of that Table.

Column 1 – Bodies	Column 2 – Purpose for which information disclosed under section 264B(1) of the 2006 Act may be used
Any NHS foundation trust;Any NHS trust established under the 2006 Act;Any integrated care board.	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(c).
Any NHS trust established under the 2006 Wales Act;Any Local Health Board.	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(f).
Any Health Board constituted under section 2 of the 1978 Act	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(i).
The Regional Health and Social Care Board established under section 7 of the Health and Social Care (Reform) Act Northern Ireland 2009	The purpose is that of exercising functions connected with any of the matters specified in section 264A(3)(k).

SCHEDULE 5 — Information about supply of unbranded generic health service medicines or special health service medicines: transitional provisions

General

1

This Schedule makes transitional provision in relation to—

• (a) the recording, keeping and provision of information about the supply of unbranded generic health service medicines by members of Scheme M and Scheme W (see paragraphs 2 and 3), and

• (b) the recording, keeping and provision of information about the supply of special health service medicines by members of the Specials MoU (see paragraphs 4 and 5).

Transitional provision: information about supply of unbranded generic health service medicines

2

• (1) A Scheme member is not required to comply—

• (a) with regulation 7 or 8 in any month which falls within a transitional quarter, or

• (b) with regulation 9 in respect of any transitional quarter.

• (2) But this paragraph is subject to paragraph 3.

• (3) In this paragraph and paragraph 3—

• “Scheme end date” means—in the case of a member of Scheme M, the day on which Scheme M ceases to operate following notice of termination being given by the Secretary of State in accordance with that Scheme;in the case of a member of Scheme W, the day on which Scheme W ceases to operate following notice of termination being given by the Secretary of State in accordance with that Scheme;

• “Scheme member” means a UK producer who, immediately before 1st July 2018, is a member of Scheme M or Scheme W;

• “transitional quarter” means a quarterly period (as determined in accordance with regulation 9(2)) which—begins on or after 1st July 2018, butbefore the Scheme end date.

• (4) For the purposes of this paragraph, it does not matter whether the Secretary of State gives notice of termination in accordance with Scheme M or Scheme W before, on or after 1st July 2018.

Circumstances in which transitional provision in paragraph 2 ceases to apply

3

• (1) This paragraph applies to a Scheme member—

• (a) who does not provide the Scheme information to the Secretary of State for a Scheme quarter within the submission period, or

• (b) who, before the Scheme end date, ceases to be a member of the Scheme.

Such a member is referred to in this paragraph as an “exiting member”.

• (2) An exiting member must comply with regulation 7 or 8 (or both, as the case may be) on and after the exit date.

• (3) An exiting member must also comply with regulation 9 in respect of each transitional quarter which begins on or after the exit date.

• (4) In addition, where the exit date falls during a transitional quarter, the exiting member must comply with regulation 9 in respect of the remaining part of that quarter.

• (5) In this regulation—

• “exit date”—in relation to an exiting member to whom sub-paragraph (1)(a) applies, means the day after the day on which the submission period ends;in relation to an exiting member to whom sub-paragraph (1)(b) applies, means the day on which the member ceases to be a member of the Scheme;

• “Scheme information” means—in the case of a member of Scheme M, the information which the member is required under Scheme M to provide to the Secretary of State for each Scheme quarter;in the case of a member of Scheme W, the information which the member is required under Scheme W to provide to the Secretary of State for each Scheme quarter;

• “Scheme quarter”—in the case of a member of Scheme M, means a quarterly period—which is specified in that Scheme as a period for which Scheme information is to be provided, andfor which the submission period ends after 1st July 2018;in the case of a member of Scheme W, means a quarterly period—which is specified in that Scheme as a period for which Scheme information is to be provided, andfor which the submission period ends after 1st July 2018;

• “submission period” means the period within which Scheme information must be submitted following the end of a Scheme quarter.

Transitional provision: information about supply of special health service medicines

4

• (1) A Specials MoU member is not required to comply—

• (a) with regulation 11, 12 or 13 in any month which falls within a transitional quarter, or

• (b) with regulation 14 in respect of any transitional quarter.

• (2) But this paragraph is subject to paragraph 5.

• (3) In this paragraph and paragraph 5—

• “Specials MoU end date” means the day on which the Specials MoU ceases to operate following notice of termination being given by the Secretary of State in accordance with the MoU;

• “Specials MoU member” means a UK producer who, immediately before 1st August 2018, is a participating manufacturer for the purposes of the Specials MoU;

• “transitional quarter” means a quarterly period (determined in accordance with regulation 14(2)) which begins—on or after 1st August 2018, butbefore the day on which the Specials MoU end date.

• (4) For the purposes of this paragraph, it does not matter whether the Secretary of State gives notice of termination in accordance with the Specials MoU before, on or after 1st August 2018.

Circumstances in which transitional provision in paragraph 4 ceases to apply

5

• (1) This regulation applies to a Specials MoU member—

• (a) who does not provide the specials information to the Secretary of State for an MoU quarter within the submission period; or

• (b) who, before the Specials MoU end date, ceases to be a Specials MoU member.

Such a member is referred to in this paragraph as an “exiting member”.

• (2) An exiting member must comply with regulations 11, 12 and 13 on and after the exit date.

• (3) An exiting member must comply with regulation 14 in respect of each transitional quarter which begins on or after the exit date.

• (4) In addition, where the exit date falls during a transitional quarter, the exiting member must comply with regulation 14 in respect of the remaining part of that quarter.

• (5) In this regulation—

• “exit date”—in relation to an exiting member to whom sub-paragraph (1)(a) applies, means the day after the day on which the submission period ends;in relation to an exiting member to whom sub-paragraph (1)(b) applies, means the day on which the member ceases to be a member;

• “MoU quarter” means a quarterly period—which is specified in the Specials MoU as a period for which specials information is to be provided, andfor which the submission period ends after 1st August 2018;

• “specials information” means the information which a Specials MoU member is required under the Specials MoU to provide to the Secretary of State in respect of each MoU quarter;

• “submission period” means the period within which the specials information must be provided to the Secretary of State following the end of the relevant MoU quarter.

Signed

Signed by the authority of the Secretary of State for Health and Social Care.

O'Shaughnessy — Parliamentary Under-Secretary of State, — 2018-06-05

Explanatory note

(This note is not part of the Regulations)

Part 1 of the RegulationsPart 1 of the Regulations deals with citation and commencement of the Regulations (regulation 1), their application (regulation 3), exceptions (regulation 4) and presumptions which will apply if information is provided to the Secretary of State via an online gateway.

Part 2 of the RegulationsPart 2 of the Regulations deals with routine provision of information about the supply of unbranded generic health service medicines. “Unbranded generic health service medicine” is defined in regulation 6.

Part 3 of the RegulationsPart 3 of the Regulations deals with routine provision of information about the supply of made and imported special health service medicines. “Made special health service medicine” and “imported special health service medicine” are defined in regulation 10.

Part 4 of the RegulationsPart 4 of the Regulations deals with the provision on request of general information about the supply of UK health service products. The key terms used in this Part are defined in regulation 15.

Part 5 of the RegulationsPart 5 of the Regulations deals with the provision of information about costs incurred by UK producers in connection with the manufacturing, distribution or supply of UK health service products.

Part 6 of the RegulationsPart 6 of the Regulations deals with the provision of information about the price and availability of health service medicines.

Part 7 of the RegulationsInformation that UK producers are required to provide under the Regulations may, in certain cases, be provided in the form of a reasonable estimate, rather than an actual amount. Where a producer provides information on the basis of such an estimate, regulation 30 allows the Secretary of State to require the producer to explain why an estimate has been used and also the method used to calculate that estimate.

Part 8 of the RegulationsPart 8 of the Regulations deals with enforcement and appeals.

Part 9 of the RegulationsRegulation 34 and Schedule 4 prescribe bodies for the purposes of section 264B(1)(k) and (l) of the 2006 Act. Those provisions also prescribe, in accordance with section 264B(3)(g) of the 2006 Act, the purpose for which those bodies may use any confidential or commercially sensitive information disclosed to them under section 264B of the 2006 Act.

Part 10 of the RegulationsRegulation 35 and Schedule 5 make transitional provision.

Footnotes

[^f00001]: 2006 c. 41; sections 264A and 264B were inserted by the Health Services Medical Supplies (Costs) Act 2017 (c. 23) (“the 2017 Act”), section 8. Section 265(5) was amended by the 2017 Act, section 10(9). Section 265(5A) was inserted by the 2017 Act, section 10(10). See section 275(1) of the National Health Service Act 2006 for the definition of “prescribed” and “regulations”.

[^f00002]: Section 264C was inserted by the Health Services Medical Supplies (Costs) Act 2017, section 8. Section 265(9) was substituted by the Health Services Medical Supplies (Costs) Act 2017, section 10(13).

[^f00003]: See the definition of “Welsh health service products” in section 264A(15) of the National Health Service Act 2006.

[^f00004]: See the definition of “Scottish health service products” in section 264A(13) of the National Health Service Act 2006.

[^f00005]: See the definition of “Northern Ireland health service products” in section 264A(12) of the National Health Service Act 2006.

[^f00006]: See the definition of “UK producer” in section 264A(1) of the National Health Service Act 2006.

[^f00007]: See the definition of “UK health service products” in section 264A(14) of the National Health Service Act 2006.

[^f00008]: See section 266(6) of the National Health Service Act 2006 for the definition of “health service medicine”.

[^f00009]: Copies of the list can be obtained from: https://www.pharmacopoeia.com/what-is-the-ban-book or The Stationery Office, PO Box 29, Norwich, NR3 1GN.

[^f00010]: The Drug Tariff (England) is available at https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff or from NHS Business Services Authority, Stella House, Goldcrest Way, Newburn Riverside, Newcastle upon Tyne, NEI5 8NY.

[^f00011]: The Drug Tariff (Wales) is available at https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff or from NHS Business Services Authority, Stella House, Goldcrest Way, Newburn Riverside, Newcastle upon Tyne, NEI5 8NY.

[^f00012]: The Drug Tariff (Scotland) is available at http://www.isdscotland.org/Health-Topics/Prescribing-and-Medicines/Scottish-Drug-Tariff/ or from Information Services Division, NHS National Services Scotland, Gyle Square, 1 South Gyle Crescent, Edinburgh EH12 9EB.

[^f00013]: The Drug Tariff (Northern Ireland) is available at http://www.hscbusiness.hscni.net/services/2034.htm or from Business Services Organisation Headquarters, 2 Franklin Street Belfast, BT2 8DQ.

[^f00014]: See section 266(6) of the National Health Service Act 2006 (c. 41) for the definition of “manufacturer”.

[^f00015]: Regulation 167 of the 2012 Regulations was amended by S.I. 2017/715.

[^f00016]: See the definition of “information notice” in section 264A(6) of the National Health Service Act 2006.

[^f00017]: See Article 57(1)(o) of Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ NO L 136, 30.04.2004, p1), as last amended by Regulation 1072/2012 of the European Parliament and of the Council of 25 October 2012 (OJ No L 316, 14.11.2012, p38).

[^f00018]: 2005 asp 13.

[^f00019]: Scheme M is available from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU or online at: http://webarchive.nationalarchives.gov.uk/20130123201658/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_115260 .

[^f00020]: Scheme W is available from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU or online at: http://webarchive.nationalarchives.gov.uk/20130123204650/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4114370

[^f00021]: 1978 c.29.

[^f00022]: 2006 c. 41.

[^f00023]: 2006 c. 42.

[^f00024]: S.I. 1972/1265 (N.I. 14).

[^f00025]: S.I. 2000/124, amended by S.I. 2000/870, 2006/860, 2007/1898 and 2018/384.

[^f00026]: S.I. 2012/1916, amended by S.I. 2013/1855, 2016/186 and 2017/715; there are other amending instruments but none is relevant.

[^f00027]: S.I. 2013/349, to which there are amendments not relevant to these Regulations.

[^f00028]: S.R. 1997 No.381.

[^f00029]: S.I. 2013/898 (W. 102), to which there are amendments not relevant to these Regulations.

[^f00030]: 2006 c. 46.

[^f00031]: The Health and Social Care Information Centre was established by section 252 of the Health and Social Care Act 2012 (c. 7).

[^f00032]: 2000 c. 36.

[^f00033]: 2002 asp 13.

[^f00034]: 1971 c. 80.

[^f00035]: S.I. 2006/5; the Regulations were revoked, subject to transitional provisions, by the Public Contracts Regulations 2015 (S.I. 2015/102), regulation 116.

[^f00036]: S.S.I. 2012/88; the Regulations were revoked, subject to transitional provisions, by the Public Contracts (Scotland) Regulations 2015 (S.S.I/446), regulation 97.

[^f00037]: S.I. 2015/102, to which there are amendments not relevant to these Regulations.

[^f00038]: S.S.I. 2015/446, to which there are amendments not relevant to these Regulations.

[^f00039]: 2009 c. 1 (N.I.)

Editorial notes

[^c23006581]: 2006 c. 41; sections 264A and 264B were inserted by the Health Services Medical Supplies (Costs) Act 2017 (c. 23) (“the 2017 Act”), section 8. Section 265(5) was amended by the 2017 Act, section 10(9). Section 265(5A) was inserted by the 2017 Act, section 10(10). See section 275(1) of the National Health Service Act 2006 for the definition of “prescribed” and “regulations”.

[^c23006591]: Section 264C was inserted by the Health Services Medical Supplies (Costs) Act 2017, section 8. Section 265(9) was substituted by the Health Services Medical Supplies (Costs) Act 2017, section 10(13).

[^c23006601]: See the definition of “Welsh health service products” in section 264A(15) of the National Health Service Act 2006.

[^c23006611]: See the definition of “Scottish health service products” in section 264A(13) of the National Health Service Act 2006.

[^c23006621]: See the definition of “Northern Ireland health service products” in section 264A(12) of the National Health Service Act 2006.

[^c23006631]: See the definition of “UK producer” in section 264A(1) of the National Health Service Act 2006.

[^c23006641]: See the definition of “UK health service products” in section 264A(14) of the National Health Service Act 2006.

[^c23006651]: See section 266(6) of the National Health Service Act 2006 for the definition of “health service medicine”.

[^c23006661]: Copies of the list can be obtained from: https://www.pharmacopoeia.com/what-is-the-ban-book or The Stationery Office, PO Box 29, Norwich, NR3 1GN.

[^c23006671]: The Drug Tariff (England) is available at https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff or from NHS Business Services Authority, Stella House, Goldcrest Way, Newburn Riverside, Newcastle upon Tyne, NEI5 8NY.

[^c23006681]: The Drug Tariff (Wales) is available at https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/drug-tariff or from NHS Business Services Authority, Stella House, Goldcrest Way, Newburn Riverside, Newcastle upon Tyne, NEI5 8NY.

[^c23006691]: The Drug Tariff (Scotland) is available at http://www.isdscotland.org/Health-Topics/Prescribing-and-Medicines/Scottish-Drug-Tariff/ or from Information Services Division, NHS National Services Scotland, Gyle Square, 1 South Gyle Crescent, Edinburgh EH12 9EB.

[^c23006701]: The Drug Tariff (Northern Ireland) is available at http://www.hscbusiness.hscni.net/services/2034.htm or from Business Services Organisation Headquarters, 2 Franklin Street Belfast, BT2 8DQ.

[^c23006711]: See section 266(6) of the National Health Service Act 2006 (c. 41) for the definition of “manufacturer”.

[^c23006721]: Regulation 167 of the 2012 Regulations was amended by S.I. 2017/715.

[^c23006731]: See the definition of “information notice” in section 264A(6) of the National Health Service Act 2006.

[^c23006751]: 2005 asp 13.

[^c23006761]: Scheme M is available from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU or online at: http://webarchive.nationalarchives.gov.uk/20130123201658/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_115260 .

[^c23006771]: Scheme W is available from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU or online at: http://webarchive.nationalarchives.gov.uk/20130123204650/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4114370

[^c23006781]: 1978 c.29.

[^c23006791]: 2006 c. 41.

[^c23006801]: 2006 c. 42.

[^c23006811]: S.I. 1972/1265 (N.I. 14).

[^c23006821]: S.I. 2000/124, amended by S.I. 2000/870, 2006/860, 2007/1898 and 2018/384.

[^c23006831]: S.I. 2012/1916, amended by S.I. 2013/1855, 2016/186 and 2017/715; there are other amending instruments but none is relevant.

[^c23006841]: S.I. 2013/349, to which there are amendments not relevant to these Regulations.

[^c23006851]: S.R. 1997 No.381.

[^c23006861]: S.I. 2013/898 (W. 102), to which there are amendments not relevant to these Regulations.

[^c23006871]: 2006 c. 46.

[^c23006891]: 2000 c. 36.

[^c23006901]: 2002 asp 13.

[^c23006911]: 1971 c. 80.

[^c23006921]: S.I. 2006/5; the Regulations were revoked, subject to transitional provisions, by the Public Contracts Regulations 2015 (S.I. 2015/102), regulation 116.

[^c23006931]: S.S.I. 2012/88; the Regulations were revoked, subject to transitional provisions, by the Public Contracts (Scotland) Regulations 2015 (S.S.I/446), regulation 97.

[^c23006941]: S.I. 2015/102, to which there are amendments not relevant to these Regulations.

[^c23006951]: S.S.I. 2015/446, to which there are amendments not relevant to these Regulations.

[^c23006961]: 2009 c. 1 (N.I.)

[^key-daef14b64633148fbea14d2b27b77d31]: Word in reg. 29(4) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 15(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

[^key-8a00330d72dd25b0655c2599b6d8b12e]: Words in reg. 29(4) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 15(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

[^key-606d268fdc17488a4b5a7516f03f62be]: Word in reg. 29(4) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 15(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-c694c30a1d4ed38a2ca7bcd9e872b128]: Word in reg. 29(4) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 15(c); 2020 c. 1, Sch. 5 para. 1(1)

[^key-84fa6521ea59fb470c998b366a449e16]: Words in Regulations substituted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), reg. 1(2), Sch. para. 1(1)(3) (with Sch. para. 1(2))

[^key-f4243b9cacaa907d21e78a927334dbd6]: Words in reg. 5 substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 58(2) (with reg. 3)

[^key-75913eaee8c4a011826d66211da1aa34]: Words in reg. 9(3)(b) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 58(3) (with reg. 3)

[^key-06766562f95a7814a96440f5e2c9c74e]: Words in reg. 14(3)(b) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 58(4) (with reg. 3)

[^key-a21938884562295f5aacf7f9d7e881d5]: Words in reg. 23(4)(b) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 58(5) (with reg. 3)

[^key-6bd8fa8686da5c7bb314061d9d1cc46b]: Words in reg. 26(5)(b) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 58(6) (with reg. 3)

[^key-9cb387f577c2f3b49af9f0123d4fc610]: Words in Sch. 1 para. 1(1) inserted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 58(7)(a) (with reg. 3)

[^key-f25e2b9593ed762971506455356273aa]: Words in Sch. 1 para. 1(1) omitted (1.2.2023) by virtue of The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 58(7)(b) (with reg. 3)

[^key-8604630113d96bc9b64074e4f2a48b6e]: Sch. 1 para. 5(za)(zb) inserted (24.2.2025) by The Procurement Act 2023 (Consequential and Other Amendments) Regulations 2025 (S.I. 2025/163), regs. 1(2), 24(2)(a)

[^key-9f4ba11a917608960619db42b945f43d]: Words in Sch. 1 para. 5(2) substituted (24.2.2025) by The Procurement Act 2023 (Consequential and Other Amendments) Regulations 2025 (S.I. 2025/163), regs. 1(2), 24(2)(b)