e-Submission guideline: new version (2.9)

Better Regulation strategyis based on three key action lines:

  • promoting the design andapplication of better regulation tools at the EU level, notably simplification, reduction of administrative burdens and impact assessment.
  • working more closely with Member States to ensure that better regulationprinciples are applied consistently throughout the EU by all regulators.
  • reinforcing the constructive dialoguebetween stakeholders and all regulators at the EU and national levels.

In this context, the "eSubmission guideline" concerning the electronic submission of dossiers for variation of marketing authorisation for medicines for human use has been updated.
The version 2.9 is now available.
The "guideline" will apply to any electronic dossier introduced from 1 June 2010.

Last updated on 25/01/2013