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For your product to be regulated as a biological it must:
- be a therapeutic good (as defined in the Therapeutic Goods Act 1989)
- either meet the definition of a biological or be specified by legislative instrument to be a biological
Your product will not be regulated as a biological if it is:
- an excluded good
- regulated as a therapeutic good, but not as a biological
If your product is regulated as a biological, Pathways for supply of biologicals will explain the levels of regulation applied.