Articles

Application audits are conducted to verify that devices submitted for inclusion in the ARTG meet the relevant legislative requirements. An application can be audited under two circumstances:
• The application must be selected for auditing under the legislation
• The application is selected for auditing at the discretion of the delegate

Steps in the audit process

  1. The application audit process
  2. Fees associated with audit assessments
  3. Target timeframes for conducting audits
  4. Withdrawing and lapsing your application
  5. Application audit outcome
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Some types of information must be included on all labels, regardless of whether the medicines are prescription medicines, over-the-counter (OTC) medicines or listed medicines. Other information is particular to specific types of medicines.

This guidance is divided into four parts.
• Part 1 describes the structure of the Orders and legal requirements that generally apply to all medicines.
• Part 2 provides guidance to assist you to identify the legal mandatory requirements that apply to certain types of medicines. For each type of medicine, there are references to specific relevant sections of the Orders.
• Part 3 provides guidance on the design of medicine labels and some ‘best practice principles’. This information is not mandatory, but is included to further improve the safe and quality use of medicines.
• Part 4 provides guidance on the tabulated display of Critical Health Information. This includes both mandatory requirements and best practice guidance.

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