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General guidance for listed medicines

Formerly ARGCM V 8.0 Part B
20 May 2020
Download General guidance for listed medicines

Description

Guidance for sponsors on the regulatory framework for ‘lower risk’ listed medicines:

  • Overview listed medicines and listed assessed medicines pathways
  • Legislative requirements for listing medicines in the ARTG
  • Application process to list a medicine in the ARTG
  • Conditions of listing
  • How to make a change to a listed medicine’s ARTG entry

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