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OTC new medicines registration process

27 August 2020

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Step 4 - Checking guidelines and mandatory requirements

When planning your OTC medicine application you will need to identify and understand the relevant mandatory requirements and guidelines.

Relevant guidelines

Check all of the relevant guidelines for any specific requirements or advice that apply to your application:

Mandatory requirements

The mandatory requirements explain what you need to do for your application to be effective, pass screening and be accepted for evaluation:

Need assistance

If you have read the applicable guidance and need our assistance, you can contact OTC Medicines by email. We will usually respond in writing as meetings are not needed for most OTC medicine applications.

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