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Listed medicine presentation and labels

Formerly included in ARGCM V8.0 Part A
16 September 2020
Download Listed medicine presentation and labels


Provides guidance for sponsors on the regulatory requirements for medicine presentation for listed medicines:

  • Listed medicine presentation
  • Unacceptable presentation of a listed medicine
  • Listed medicine labels
  • TGA assessment of medicine labels
  • Listed medicine label names
  • Labelling requirements for specific ingredients/listed medicines

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