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TIGes Harmonised eCTD Guidance
- The TIGes Harmonised eCTD guidance version 2.0 can be found here and Release notes
here
- The Technical validation of eCTD submissions for new MAAs in DCP - ( pilot phase) can be found here
- The BPG for the use of eCTD in MRP/DCP version 3.0 can be found here
- eCTD validation criteria v4.1 CURRENT (Valid until 31 August 2013)
- eCTD validation criteria v5.0 NEW (Mandatory from 1 September 2013) and Release notes here
TIGes Harmonised NeeS Guidance
EMA eSubmission Guidance for the Centralised Procedure
Implementation of the new versions of eCTD and NeeS Validation Criteria:
The Implementation guide for the EU Module 1 Specification, version 2.0, EU e CTD Validation Criteria, version 5.0 and EU NeeS Validation Criteria, version 4.0 can be found here.
During a transition period from 1 July to 1 September 2013, the new validation criteria should only be used for validation of eCTD/NeeS submissions built in accordance with the EU M1 specification v2.0. After 1 September 2013, only submissions compliant with the new validation criteria are accepted (v.5.0 for eCTD and v.4.0 for NeeS). Please refer to the Implementation Guide on the TIGes webpage for the EU module 1, when published.
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