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Accept or reject a pre-existing application/notification

If a Sponsor submits a pre-existing application/notification, the Competent Authority can Accept or Reject it.

  1. Click Accept or Reject at the top right corner of the page:

    EUDAMED accept and reject buttons

    • If you Accept, a pop-up window will appear for you to provide comments and attach any relevant document.

    • If you Reject, a pop-up window will appear for you to provide comments and attach any relevant document to the rejection.

  2. Click Complete action.

    EUDAMED comments and documents for rejection fields and complete and close buttons

  3. Once accepted the pre-existing application/notification is set to the status that corresponds to the value selected by the Sponsor in the field What is the status of the CI/PS application or PMCF/PMPF notification?

    If rejected, the Sponsor can click Register normal update to create a new version of the pre-existing application/notification in draft state and re-submit it.