The final version of the HMA eSubmission roadmap was 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 six 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

 

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