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eCTD AU module 1 and regional information
Specification and guidance for use, V3.1
Please note: V3.0 of the specification is acceptable until 30 June 2018. This version (V3.1) becomes effective on 1 January 2018.
|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|