The final version of the HMA eSubmission roadmap has been updated on 21 June 2019.
The main updates of version 2.2 compared to version 2.1 are the following:
- The timeline for eCTD 4.0 has been removed and will be re-confirmed once the topic is discussed as part of the network strategy
- The CESP dataset module can be used for new MMA by Q2 2020 and will be mandatory by Q1 2021 (further delay)
- For other applications, the CESP dataset module can be used by the end of 2021 and will be mandatory 6 months later
- A date for the preparation of the mandatory use of an EU single submission portal will be decided
- A common telematics service desk will be stepwise implemented by Q1 2021
For more information visit: http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html