Electronic Submissions Update – Reminder that the transition period for current Australian regional specification ends 30 June 2018

6 June 2018

The transition period for the current Australian regional specifications and validation criteria ends on 30 June 2018.

From 1 July 2018 the following specifications and validation criteria must be used to ensure successful validation of each sequence.

eCTD format:

  • eCTD Version 3.1 File downloads and checksums
  • Australian eCTD regional specification and validation criteria version 3.1 excel spreadsheets

For further guidance and information of the specifications refer to eCTD AU module 1 and regional information Specification and guidance for use Version 3.1.

NeeS format:

  • NeeS Version 2.0 File downloads, which includes a new NeeS envelope form
  • Relevant eCTD Version 3.1 file downloads
  • Australian eCTD regional specification and validation criteria version 3.1 excel spreadsheets

For further guidance and information of these specifications refer to AU NeeS specification: Module 1 and regional information Version 2.0.

If you have any queries regarding this transition please contact us: edr@health.gov.au