AU eCTD specification: Module 1 and regional information

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Version 3.0

14 April 2015

Please note: This version (V3.0) of the specification is acceptable until 30 June 2018. Version V3.1 becomes effective on 1 January 2018.

This guidance:

  • applies to all regulatory activities[1] provided to us in eCTD[2] format
  • needs to be used with the ICH eCTD Specification to prepare a valid eCTD submission[3].

In this guidance


Footnotes

  1. A subgroup of an Application which can be a group of related sequences for one approval or notification process. Usually defined for the lifecycle of the specific approval process.
  2. electronic Common Technical Document
  3. generic term that refers to an application, a regulatory activity type and/or a sequence. Often used when not referring specifically to a particular hierarchical level of the application

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