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General dossier requirements

27 July 2018

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Version history

Version history
Version Description of change Author Effective date
V1.0 Original publication TGA 01 July 2015
V1.1 Minor updates TGA 24 July 2015

Part E deleted section: Paper dossier from NeeS or eCTD format

Added email submission of electronic dossiers

Other minor updates

TGA 21 November 2017
V1.3 Amendments to Part C to update dossier requirements for Registered Complementary and Assessed Listed Medicines TGA March 2018
V1.4 Amendments to Part C to update the reference for dossier requirements for biologicals TGA July 2018

Book pagination