The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Please note: This version (V1.0) of the specification is acceptable until 30 June 2017. Version 2.0 becomes effective on 1 January 2018.
All dossiers must be structured in accordance with the Common Technical Document (CTD) format, a format Australia initially adopted in 2004.
For electronic dossiers using the NeeS format:
- Use the CTD folder structure as detailed in the Annex to the ICH guideline Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use (pdf, 286kb) - external site.
- Make sure the breakdown of the electronic submission conforms with the ICH Granularity Document (the Annex to the Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use).
- Follow the ICH and AU eCTD file naming conventions.