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If you are developing a biological product, you need to consider the classification of your product to understand the level of supporting data required to support your application for inclusion on the ARTG.
Before classifying your biological, check that your product:
- meets our definition of a biological
- is regulated as a biological
- is not excluded from regulation
- is not exempt from certain regulatory requirements.
Classification of biologicals is based on either of the following:
- mention in Schedule 16 (Class 1 and 4 biologicals)
OR
- Method of preparation and intended use (Class 2 and 3 biologicals)
Additional criteria are used to determine exemptions.