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Validating change of Competent Authority requests

The change of responsible Competent Authority (CA) can be necessary in some specific cases as:

  • An EU economic operator that moves inside the same country;

  • A non-EU manufacturer that changes of Authorised Representative or changes of responsible Competent Authority for their Authorised Representative;

  • A non-EU SPP producer that change the market distribution of their SPPs;

The new CA will be able to assess the request and accept or not to be the new CA.

  1. Select Validate change requests from the Actor Management section:

    EUDAMED validate change requests link in the actor management page
  2. You will find the pending requests at the bottom of the page:

    EUDAMED pending requests in change request management page when validating change of Competent Authority requests
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  3. Click on it to open the change request, the new window will display all the details concerning the change request:

    EUDAMED change request details when validating change of Competent Authority requests
  4. At the bottom of the page, you will have the Assessment outcome section, here you will decide whether you approve the change of competent authority request or whether you reject it:

    EUDAMED assessment outcome toggle button
  5. If you click on Approve, the button will turn green:

    EUDAMED approve change of competent authority request and complete assessment button
  6. If you click on Not Approved, the button will turn red and a mandatory free-text box will appear asking you to justify your decision for not approving the request:

    EUDAMED not approved change of competent authority request and justification fields
  7. To finish, you can click on Complete assessment:

    EUDAMED complete assessment button
  8. A success message will appear:

    EUDAMED success message for change of competent authority request
  9. If the request was accepted, the new CA will get a notification of the changes made, as well as the concerned Economic Operator and the old CA.

  10. If the request was not approved, the concerned Economic Operator will get a notification with the reason for rejection.