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Process to change a registered OTC medicine

27 August 2020

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Step 3 - Checking relevant guidelines and requirements

Your application to change an ARTG entry for a registered OTC medicine needs to clearly describe each proposed change and include information to support the change so that it will pass screening and be accepted for evaluation. Notification applications do not undergo a screening process.

To determine the information necessary to support the change, you need to identify and understand the relevant requirements and guidelines:

Need assistance

If you have read the applicable guidance and need our assistance email OTC medicines with your enquiry.

We will usually provide written advice. Meetings are not needed for most OTC medicine applications.

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