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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 fields to accept 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.