Centralised, decentralised, mutual recognition and national marketing authorisation procedures


Our goal is to present to the authorities well prepared documents which will ensure the smooth assessment of the registration procedure in Europe. If you have not already chosen the type of application procedure for your particular product, EuDRAcon can help you by laying out the pros and cons of the European marketing authorisation procedures, as well as the circumstances for approving or revoking authorisation.

Our list of services covers:

  • Compilation and submission of all data and documentation for the following marketing authorisation procedures:
  • Centralised authorisation procedure (CP)
  • Decentralised authorisation procedure (DCP)
  • Mutual recognition procedure (MRP)
  • National authorisation procedure (NP)
  • Selection of Reference Member States (RMS) and Concerned Member States (CMS) where necessary
  • Preparing, evaluating and updating of the dossier
  • Submission of documentation to RMS and CMS
  • Maintaining correspondence with Health Agencies all over the European Union
  • Monitoring deadlines
  • Providing certified translation required for the application
  • Writing SPC, package leaflets/labelling.