Listed medicine presentation and labels

Formerly included in ARGCM V8.0 Part A

Last updated

16 September 2020

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

Supporting documents

Listed medicine presentation and labels [PDF, 248.28 KB]

Listed medicine presentation and labels [Word, 149.73 KB]

Topics