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The Branded Health Service Medicines (Costs) Regulations 2018

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23.—(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.

(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(1); 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.

(1)

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.

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