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eCTD AU module 1 and regional information

Specification and guidance for use, V3.1

18 October 2017

Book pagination

Version history

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

Version history
Version Description of change Author Effective date
V0.90 Original draft publication for pilot implementation and industry review Group Support Unit
Market Authorisation Group

AU eCTD specification for official use.

Version 3.0 aligns the numbering for CTD specifications (previously 2.2) and NeeS specifications (previously 1.0) to bring all formats under one version number

Regulatory Operations Unit
Market Authorisation Division

Updates to provide greater clarity and align with version 3.1 of the AU eCTD specifications and validation criteria.

Updates to Envelope

Updates to Headers and associated XML elements

Additions to Sequence Types and Sequence Descriptions to cater for MMDR recommendations.

Split of the Regulatory Activity Lead value 'Prescription' into 'Prescription-chemical' and 'Prescription-biological'

Contingent changes to cater for possibility of Work Grouping and Work Sharing

Updates to Bookmark/TOC/Hyperlink guidance

Consideration for Automation processes and planned portal

Updates to Product Information Headings

Updates to specific Lifecycle Operations Guidance

Prescription Medicines Authorisation Branch 01/01/2018

Book pagination