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Regulation 23 Audited information

(1)

Any information required to be audited by these Regulations, including an audited sales report, must be prepared and approved by the manufacturer or supplier and audited by a qualified independent auditor and must be accompanied by—

(a)

a statement from the qualified independent auditor that the audited sales report or audited information has been audited in accordance with applicable auditing standards;

(b)

details of the specific applicable auditing standards relied on by the qualified independent auditor;

(c)

a report by the qualified independent auditor and signed by the qualified independent auditor which provides a reasonable assurance (as provided for in the applicable auditing standards) that the information in the audited sales report or audited information has not been materially misstated; and

(d)

the final audit plan prepared in accordance with the applicable auditing standards.

F1(1A)

Where a manufacturer or supplier has provided information under regulation 21 or 22, the Secretary of State may, for the purposes of verifying the information provided, request the manufacturer or supplier to provide that information in an audited form.

(1B)

A request made under paragraph (1A)—

(a)

must be made within 12 months of receipt of the information provided in accordance with the relevant report; and

(b)

must require the audited report to be provided within a period of not less than 3 months and not more than 12 months from the date on which the Secretary of State makes the request.

F2(1C)

A manufacturer or supplier who provides a presentation report to the Secretary of State in accordance with Schedule 1 or Schedule 3 must, at the same time as providing an audited sales report, provide the Secretary of State with—

(a)

a statement from the manufacturer or supplier that the most recently submitted presentation report has been subject to procedures agreed between the manufacturer or supplier and a qualified independent auditor in accordance with an applicable related services standard; and

(b)

the relevant report of the qualified independent auditor produced in accordance with the applicable related services standard.

(2)

In this regulation—

  • “applicable auditing standards” means any relevant International Standard on Auditing and related Statements or Standards produced by the Financial Reporting Council Limited M1; F3...

  • F4“applicable related services standard” means any relevant International Standard on Related Services recognised by, or equivalent standard produced by, the Financial Reporting Council Limited; and

  • “qualified independent auditor” means the auditor of the manufacturer's or supplier's statutory audited accounts, or with the agreement of the Secretary of State, another suitably qualified auditor.

Annotations

Textual amendments

F1

Reg. 23(1A)(1B) inserted (1.1.2025) by The Branded Health Service Medicines (Costs) (Amendment) Regulations 2024 (S.I. 2024/1277), regs. 1(1), 12

F2

Reg. 23(1C) inserted (1.7.2025) by The Branded Health Service Medicines (Costs) (Amendment) Regulations 2025 (S.I. 2025/667), regs. 1(1), 5(a)

F3

Words in reg. 23(2) omitted (1.7.2025) by virtue of The Branded Health Service Medicines (Costs) (Amendment) Regulations 2025 (S.I. 2025/667), regs. 1(1), 5(b)

F4

Words in reg. 23(2) inserted (1.7.2025) by The Branded Health Service Medicines (Costs) (Amendment) Regulations 2025 (S.I. 2025/667), regs. 1(1), 5(b)

Marginal citations

M1

Registered Number 02486368. Copies of the relevant statements and standards can be obtained from the Financial Reporting Council Limited, 8th Floor, 125 London Wall, London, EC2Y 5AS or at https://www.frc.org.uk/auditors/audit-assurance/standards-and-guidance.