Electronic Submissions Update – Reminder That the Transition Period for Current Australian Regional Specification Ends 30 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...

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

Source: www.tga.gov.au