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International Risk Information

[Australia] Therapeutic goods determinations (2016-08-02)
  • Registration Date 2016-08-04
  • Hit 625

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).
-Therapeutic Goods (Foreign Countries) Determination 2016(link is external)

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.
-Therapeutic Goods (Permissible Ingredients) Determination No.2 of 2016(link is external)

Manufacturing principles

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(link is external)

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.
-Therapeutic Goods (Things that are not Biologicals) Determination No. 1 of 2011

http://www.tga.gov.au/therapeutic-goods-determinations

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