To request access on behalf of an organisation:



Note: All organisation names are stored in EMA Organisation Management Service (OMS) in English, if you wish to look for an organisation name in a different language you have to change the language to the related ISO code. Please note not all organisations have a local translation of their name in the local language.
If the organisation you need to affiliate with is not listed in the results, it means that your organisation is not registered in the EMA Organisation Management Service, and therefore, your role request cannot be completed. 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.

If you select a role for an organisation where a user administrator is missing the system will show the following message: There is no user administrator assigned to ORG-100000XXX. Your organisation must have one or more users who have been granted user admin role to approve such requests. Make sure to select a User Administrator role first. A detailed explanation of the approval model can be found here.
To select the role of User Administrator (like IRIS User Admin or SPOR Super User) for your organisation, that organisation must first have at least one User Administrator allocated and validated by the EMA. This is done by completing the affiliation template and signed by an approved signatory (this person should be different from the person submitting the request) from your organisation, then the document can be downloaded or drag and dropped into the allocated box (see below).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 (this person should be different from the person submitting the request). Please note if document attached for requesting the User Administrator Role is not compliant to above requirements, the request will be denied by the EMA administrators. In case a password is required the new password should have at least 8 characters(s) comprising: 4 valid character types (lowercase, uppercase letters, digits and special characters); at least 1 uppercase letter; 1 digit and 1 special character.
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.
NOTE: This method will be available until the 30th of September 2022. From the 1st of October only the Request Access for Organisations method will be available.


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.
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Note: When selecting a user access role, the system will suggest additional roles that could potentially be useful for the user.
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 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.
- Follow steps 1 to 4 above, in the ‘Request Access’ part
- Click on the "Attachment" icon.
- 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".
- 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”;
If you click on "Later" the request form will be available in the "Latest Form" widget on the home page.
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.
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.
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) ApproversIf 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 |



