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Section 19A: Guidance for industry

Supplying substitute medicines when registered medicines are unavailable or in short supply

4 January 2018

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Making an appeal

The TGA internal review guidelines apply to the following 'initial decisions' made regarding an application or approval to import and supply medicines under section 19A of the Therapeutic Goods Act:

  • approval, including conditions of approval
  • refusal to approve
  • lapsing.

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