Therapeutic goods determinations

5 December 2017

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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).

Permissible ingredients

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.

Manufacturing principles

These instruments determine principles to be observed in the manufacture of therapeutic goods for use in humans. See:

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.