EMA Account Management | User Administrator Guide

A ‘User Administrator’ of an organisation is responsible for approving and revoking access for users of the same organisation. They are also notified when users accounts are reactivated or when the email address of a user has changed. The following roles grant access as ‘User Administrator’ in the EMA Account Management Portal:
  • External Organisation Administrator
  • CTIS High Level Administrator
  • IRIS User Admin
  • SPOR Super User
  • EV Human EU QPPV, Trusted Deputy and NCA/CS/NCS Responsible
  • EV VET Responsible and Trusted Deputy
  • UPD Super User
Only the first request for a ‘User Administrator’ role is evaluated and granted by EMA. For the role request to be approved, additional documentation providing proof of authority to represent the organisation must be attached to the request. Check here for more guidance on how to submit a request for the “User Administrator” role.
Subsequent requests for a ‘User Administrator’ role must be approved by the first ‘User Administrator’.

The External Organisation Administrator is a special role in the EMA Account Management portal. This Administrator, once validated by EMA, can approve or reject requests to become an administrator for other EMA-run systems[1] for their organisation.
EudraVigilance: When requesting access as a Responsible Person or EU QPPV/Additional QPPV/Trusted Deputy please follow the steps described in section 3. of the registration manual for Human and/or for Veterinary.
[1]The Eudravigilance EU QPPV and Responsible are always approved by the EMA.
The following guidance provides more information on the ‘User Administrator’ responsibilities and how the EMA Account Management helps to fulfil them:


External Organisation Administrator
How to approve access
View the list of users for your organisation
How to remove users’ access
Notifications of changes performed by a user

External Organisation Administrator
External Organisation Administrator, once validated by EMA, can approve or reject requests to become an administrator for other EMA-run systems[1] for their organisation.
An External Organisation Administrator can reduce the number of administrators that need to be validated by EMA with a proof of affiliation letter, speeding up the process of administrator approval while ensuring organisations retain control over requests for administrator roles in EMA Account Management. The new process is optional, and organisations can continue using the existing process for administrator registration in EMA Account Management if preferred.



  1. EMA approves the first user of an organisation. A proof of affiliation (attachment) is required otherwise the request is rejected;
  2. External Organisation Administrator approves other External Organisation Administrators and Application Administrators;
  3. Organisation Application Administrator approves other Application Administrators and access to the specific application for the organisation they manage;
  4. Application Users request access:
    • if an Organisation Application Administrator is appointed the request is assigned to Organisation Application Administrator;
    • if no Organisation Application Administrator is appointed the request is escalated to the External Organisation Administrators;
    • if no External Organisation Administrators is appointed the request is automatically rejected;
  5. More information about the approval model can be found in this presentation and a list of specif FAQ is available in the Frequently Asked Questions page.

How to approve access
Once a user submits a request for a role with an affiliation to an organisation in the EMA Account Management Portal, the User Admin for that organisation receives an e-mail stating the name of the user and the type of role/affiliation requested for that organisation.
To process the user access request:
  1. Click on the link you have received in the email;


    Or, alternatively, log into the EMA Acccount Management (https://register.ema.europa.eu). The request will appear in “Your Pending Approvals” and “Approvals” tabs;
  2. Information about the user (user id, name, surname, email) and the request ID are available at the top of the approval;


    Note: The requester’s e-mail should preferably be a work e-mail from the same organisation on behalf of which the user is requesting the user access. However, this does not apply to users requesting affiliation to other organisations.
    Gmail, Yahoo and similar private addresses can be used but are not recommended: the affiliation role is organisation-specific, so if the user leaves the organisation, the Admin User has the responsibility to revoke the access
  3. Select the “Approve” or “Deny” button as appropriate;
  4. Click “Complete”.
    • For approved access – the access is now active, and the requestor is notified by email
    • For rejected access – the access is not granted, and the requestor is notified by email

View the list of users for your organisation
User Administrator can view the list of all users assigned to the organisation they manage the access for, and they can revoke an approved access/affiliation.
To view a list of users in your organisation:
  1. Go to EMA Acccount Management (https://register.ema.europa.eu) ) and “Login” with your credentials;
  2. Click on the ☰ menu on the left, next to the “Home” tab and select “Compliance Activities”. Then select the “Role Admin” for the system you want to see the list of users, for example “EV Role Admin”; The "External Role Admin" allows to select the application that you want to check;


  3. 3. The system will show a form to select an organisation. Select the organisation for which you manage user access;
  4. To list all users for the selected organisation, click on “List Roles” and a list of all users and related roles will be displayed.


How to remove users’ access
User Administrators can view the list of all users assigned to the organisation they manage the user access and they can revoke an approved access/affiliation.
To revoke access from users of your organisation:
  1. Go to EMA Acccount Management (https://register.ema.europa.eu) and “Login” with your credentials;
  2. Click on the ☰ menu on the left next to the “Home” tab and select “Compliance Activities”. Then select the role admin for the application you want to remove access from, for example “EV Role Admin”; The "External Role Admin" allows to select the application that you want to check;


  3. The system will show a form to select an organisation.
    1. Select the organisation you manage the user access for
    2. 2. Select the user you want to remove access from
    3. Click the revoke roles button

  4. The request to revoke role is submitted and you can check its status on the "Track My Request" tab.



Individuals holding a User Administrator role will receive an email notification when any user from their organisation:
• makes changes (adds/removes/updates) to their email address
• are re-activated after a period of inactivity

In the example below, the User Administrator is receiving a notification for a user who changed the email.


EMA Account Management guidance documents
Welcome Page
Create an EMA Account
Recover your credentials
Request user access
User Administrator guide
Frequently Asked Questions

If you cannot find the support you need in the guidance documents, please contact the EMA Service Desk.