South African Health Products Regulatory Authority (SAHPRA)

The objective of an audit of financial statements is to express an opinion on whether the financial statements fairly represent the financial position of the auditee at financial year-end and the results of its operations for the financial year.

The Auditor-General can express one of the following audit opinions:

Clean audit outcome: The financial statements are free from material misstatements (in other words, a financially unqualified audit opinion) and there are no material findings on reporting on performance objectives or non-compliance with legislation.

Financially unqualified with findings: The financial statements contain no material misstatements. Unless the Auditor General expresses a clean audit outcome, findings have been raised on either reporting on predetermined objectives or non-compliance with legislation, or both these aspects.

Qualified audit opinion: The financial statements contain material misstatements in specific amounts, or there is insufficient evidence for the Auditor General to conclude that specific amounts included in the financial statements are not materially misstated.

Adverse audit opinion: The financial statements contain material misstatements that are not confined to specific amounts, or the misstatements represent a substantial portion of the financial statements.

Disclaimer of audit opinion: The auditee provided insufficient evidence in the form of documentation on which to base an audit opinion. The lack of sufficient evidence is not confined to specific amounts, or represents a substantial portion of the information contained in the financial statements.