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  • Changing a competent authority for registered actors

Changing a competent authority for registered actors

[Specific to EO]

The change of responsible Competent Authority (CA) can be necessary in some specific cases. EUDAMED will only allow to select a new responsible CA for those specific cases and among the possible CAs that the system will present.

The change can be triggered by either:

  • For an EU economic operator, a move of location inside the same country;

  • For a non-EU manufacturer, a change of Authorised Representative or a change of responsible Competent Authority for their Authorised Representative;

  • For a non-EU SPP producer, a change in the market distribution of their SPPs;

For the non-EU manufacturers, their responsible CA must be at any moment one of the responsible CA(s) of the AR(s) with which they have an active mandate.

  1. To do so, on the homepage of EUDAMED, click on Manage your actor data:

    EUDAMED manage your actor data link in the dashboard

  2. In the new page, click on Action and then choose Change competent authority:

    EUDAMED actions button
    EUDAMED change competent authority link under actions button when changing a competent authority

    Note

    If a request for Change competent authority has already been submitted, no further editing of the actor data is allowed till the change is either accepted or rejected.

    If a draft has already been created, the competent authority cannot be changed.

    Note

    You will notice the change request in your actor data. The section Competent Authority, will display two parts, Current competent authority and New competent authority:

  3. In the new window, you will notice an almost exact copy of your actor data form, with one exception. At the bottom of the page, the section Select a new Competent Authority displays. Choose your new competent authority from the dropdown list:

    EUDAMED competent authority change request fields when changing a competent authority
    5.png

    Note

    For non-EU manufacturers, the results in the dropdown list are determined by the responsible Competent Authorities of the Authorised Representative(s) they have an active mandate with.

  4. Once you have selected a new competent authority, enter the reason for the change of CA in the free text box below:

    EUDAMED select a new competent authority and reason for change CA fields when changing a competent authority

  5. Click on Submit request:

    EUDAMED submit request button

  6. A pop-up message will appear, click on Confirm to continue with your current action or Cancel to go back:

    EUDAMED competent authority change request confirmation message and button when changing a competent authority

  7. A success message will appear, non-EU manufacturers need to wait for the concerned Authorised Representative to assess the CA change request:

    EUDAMED competent authority change request successfully submitted message when changing a competent authority

To see your pending/rejected competent authority change requests:

  1. On the homepage of EUDAMED, click on Manage your actor data:

  2. If you have any pending/rejected requests, they will be accessible via the link found in the notice message.

    Pending request message:

    EUDAMED pending request message when changing a competent authority

    Rejected request message:

    EUDAMED rejected request message when changing a competent authority

  3. Once you have clicked on the link, you will arrive to an overview of your change request:

    Note

    Only active mandates will be displayed in the Authorised representative(s) mandates section:

    11.png

    Reason for rejection and other details:

    EUDAMED competent authority change assessment outcome