Source: Australian Department of Health
This guidance is to assist sponsors of listed and assessed listed medicines to understand ingredient requirements for market authorisation. This guidance will take you through how to access and use the Therapeutic Goods (Permissible Ingredients) Determination (‘Permissible Ingredients Determination’ or ‘the Determination’) for this purpose.
- About this guidance
- The Permissible Ingredients Determination
- Responsibilities of the sponsor
- Using the Permissible Ingredients Determination
- Ingredients not found in the Permissible Ingredients Determination
- Ingredients Table
- Case study: George and his sting relief product
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