Therapeutic goods determinations
If you intend to rely on any legislation referred to on this website, you should access copies of the official versions. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
Specified foreign countries under section 19A(3)
This determination specifies the foreign countries in which registration or approval for general marketing of specified therapeutic goods in at least one of those countries is a prerequisite for the purposes of subparagraph 19A(1)(b)(i) of the Therapeutic Goods Act 1989 (Act).
This determination specifies the ingredients that are permitted for use in a medicine listed in the Australian Register of Therapeutic Goods under subsection 26BB of the Therapeutic Goods Act and any requirements associated with their use in such medicines.
This instrument determines principles to be observed in the manufacture of therapeutic goods for use in humans.
- Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013
- Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No.1)
Things that are not Biologicals
This determination sets out therapeutic goods that are not biologicals for the purposes of Part 3-2A of the Act.
Things that are Biologicals
This instrument specifies things that comprise or contain live animal cells, tissue or organs are regulated as biologicals.