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  • Validate Competent Authority change requests

Validate Competent Authority change requests

An EO who is already registered and validated as an actor may under certain circumstances need to change the CA who is responsible for their validation and supervision. Such requests are made by the actor and sent to the new proposed CA for validation. The change of responsible CA can be necessary in some specific cases, such as:

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

  • A non-EU manufacturer that changes its Authorised Representative or has its Authorised Representative change the responsible Competent Authority;

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

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. 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. Check the information and switch the toggle to either Approved or Not approved:

    EUDAMED assessment outcome toggle button

  5. Click on Approve and then on Complete assessment:

    EUDAMED approve change of competent authority request and complete assessment button

  6. If you click on Not Approved, enter the reason in the Justification field and click on Complete assessment:

    EUDAMED not approved change of competent authority request and justification fields

  7. A success message will appear:

    EUDAMED success message for change of competent authority request

  8. 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.

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

    Note

    When an Authorised Representative changes their responsible CA, every non-EU manufacturer who is linked to that Authorised Representative will be notified (both via Notifications and email). The notification will be triggered once the new CA has approved the request from the Authorised Representative to change the responsible CA.

    notifications1.png