EMA Account Management | Request user access

EMA Account Management allows you to request access on behalf of your organisation for EMA applications such as CTIS, SPOR, IRIS and EudraVigilance. You can check here how to:

Request Access by "Manage My Access" page
Why has my request been automatically rejected?
See the Status of your request by "Track My Request" page
View your current access
Remove your access by "Manage My Access" page

Request Access by "Manage My Access" page
  1. Sign in to EMA Account Management portal
  2. On the home page click on "Manage My Access" tab

  3. In the "Manage My Access" page, in the “Search Access” bar to look for the application you need access to (example: “IRIS”), as this brings up the list of available roles.

  4. Select the roles you need to request by clicking on the "Tick" button to the left of the role (the screenshots below show the role of 'IRIS Industry Manager' as an example).
    The role you selected should now have a green tick.

    Note: If the message "Cannot Add Access Item" appears, you have a pending form to be completed for the same role.

    Your pending forms can be viewed by clicking on the "Latest Form" tab on the portal home page.

    Note: When selecting a user access role, the system will suggest additional roles that could potentially be useful for the user.

  5. Click “Next” and a confirmation page will appear in which you can make additional changes.
    Clicking on cross mark x will remove the role selected and reselection can be made again.

    User administrator: If you are the first person to request a User Administrator role (IRIS User Admin or SPOR Super User) for an organisation, an additional verification step by attaching necessary documentation is required. This does not apply to the IRIS NCA User Admin role.
    Note: For the first user administrator 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. The EMA will refuse requests coming from Gmail, Yahoo and similar private addresses.
    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. Follow steps 1 to 4 above, in the ‘Request Access’ part
    2. Click on the "Attachment" icon.

    3. Upload a completed and signed copy of the “Affiliation Template Letter”, as proof of authority to represent the organisation. This must be on the official company letterhead and signed by someone currently employed by the organisation for which you will assume the User Administrator role. Please note if document is not attached while requesting the User Administrator Role, the request will be denied by the system. After the document has been uploaded, click "Ok".

    4. 3.4. The document attachment icon turns green when a document has been attached and displays the number of attachments. When all details have been provided, click on “Submit”;
  6. Click on Submit
  7. The following screen will appear requesting you to proceed with your request by clicking on “Complete Form” tab the request.
    If you click on "Later" the request form will be available in the "Latest Form" widget on the home page.
  8. In the “Organisation affiliation form” select your organisation...
    and click "Submit Request";
    If the organisation you need to affiliate with is not listed in the drop-down list when you search for it by the organisation name or ‘Organisation ID’ it means that your organisation is not registered in the EMA Organisation Management Service, and therefore, your role request cannot be completed. You can cancel the request or save it for later (the form will be available in the “Latest Forms” page). To request the inclusion of your organisation or update your organisation data in OMS, follow the guidance available in the Organisation Management Service on the EMA's corporate website and SPOR documents on the SPOR portal.
  9. Click “Submit Request” and your request will now go to the approver
Why has my request been automatically rejected?
When a request is rejected automatically by the system you will receive an email explaining the reason for the rejection. The most common reasons are:
  • You are the first User Administrator for your organisation and you did not attach the necessary documentation
  • You submitted a request for an organisation where the User Administrator is not appointed, before requesting the role again make sure a User Administrator has been appointed or, as first thing, request the User Administrator role.
  • For EudraVigilance:
    • You have requested a base role when you already have a base role for your organisation. To request a different base role, please first remove the role you currently have
    • You have requested a supplementary role when you do not have a base role for your organisation
    For the list of Base and Supplementary roles in the EudraVigilance system please refer to the Annex 1 of EudraVigilance Registration Manual for Human and Vet.
See the Status of your request by "Track My Request" page
All user role requests will be shown under "Track My Request".

The status of these requests will by indicated as follows: “Waiting On”, “Waiting”, “Provisioning”, “Complete” and “Denied”. Once the request is approved, the status will switch to complete and will turn green as shown in the table below:

Status Description
Waiting on: The requested item is waiting on an approval.

If the status is showing your Organisation ID the User Administrators of your organisation will need to approve it
Example: Waiting on SPOR Industry Super User (ORG-100000NNN) Approvers
If the request status is showing EMA, the request will be approved by the EMA once the right documentation is submitted. Requests are approved by the EMA only for the first User Administrator of an organisation.
Example: Waiting on SPOR EMA Super User Approvers
Waiting The request is approved and the system is verifying it.
Or the request contains different items, until all items are approved or rejected this Item will remain in a “waiting” state
Provisioning The requested item is approved but not yet assigned/completed
Denied The requested item has been rejected
Complete The requested item has been assigned/completed

View your current access
To view the user access you have:

  1. On the top left menu select "Manage Identity" and "View Identity"

  2. On the left select the "Access" tab where you can find your list of assigned roles.

Remove your access
Every user can request their access to be removed. A User Administrator can remove access for other users of its own organisation. To check how User Administrators can remove access for other users refer to the "Remove access for other users" part of this website.

To remove your own access:
  1. Sign in to EMA Account Management
  2. On the home page click on "Manage My Access"

  3. Click on “Remove Access”

  4. Select the role to be removed by clicking on the "X", the button will turn red;

  5. At the bottom of the page click “Next” a summary page will be displayed;

  6. Click "Submit" at the bottom of the page.

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.