Regulated as a biological

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.