Updated Version of the HMA eSubmission Roadmap (v2.2) Available

The final version of the HMA eSubmission roadmap has been updated on 21 June 2019.

 

 

 

 

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