NOTE: This method will be available until the 30^th of September 2022. From the 1^st of October only the Request Access for Organisations method will be available.

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 (like IRIS - eAF 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

• 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.

1. On the home page click on the "Manage Access" tab or, on the top left menu, select "Manage Access" and "Manage Access"
   
   
   
2. The page display the list of assigned roles.
   

   Note: If you have one or more user administrator roles assigned the pages displays your own access and the access for the users belonging to the managed organisations.

1. On the home page click on the "Manage Access" tab or, on the top left menu, select "Manage Access" and "Manage Access"
   
   
   
2. Select the role to be removed by clicking on the checkbox of the relevant rows; once selected the “revoke selected roles“ button appears
   
   
3. Click on the "revoke selected roles" button: a confirmation page is displayed;
   
   
4. Roles are not removed immediatly, you will receive a confimation when roles are removed. You can track the status of your removal request with the "Track My Request" tab.