You are here
Therapeutic Goods (Biologicals—Specified Things) Instrument 2021
This Instrument specifies whether certain things are or are not biologicals for the purposes of the Therapeutic Goods Act 1989.
Recently published
This page was published on [date_placeholder].
Recently updated
This page was updated on [date_placeholder]. See page history for details.
Official version of legislation
The Federal Register of Legislation is the authorised Australian Government website for Commonwealth legislation. It contains the full text and details of the life cycle of individual laws.
Guidance referring to this legislation
-
GuidanceGuidance to help sponsors figure out if their therapeutic goods are medicines, biologicals, or medical devices.
-
GuidanceAustralian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.
-
GuidanceGuidance to help you understand which therapeutic goods will be regulated as a biological.