Welcome to EMA Account Management | Self registration & access management

About EMA Account Management
EMA Account Management is the European Medicines Agency’s (EMA) secure online platform where you can request and manage access to EMA applications.

You can use the EMA Account Management portal to:

Create an EMA account (Self-Register): To be able to access EMA applications such as SPOR, IRIS and EudraVigilance you need to have an EMA Account. You can create a new account by completing the Self-service Registration form. In case your email is already in use, retrieve your username here. Wait for the confirmation e-mail before accessing other EMA applications.

Note: it may take some time before your account is active, so if you are not able to access your account immediately try again after 30 minutes.
We advise against using generic (i.e. info@) and private (i.e. Gmail or Yahoo) e-mail addresses due to security reasons. To create an account only personal e-mail address must be used e.g. name.surname@domain.com.
If you have access to any of the following systems, you already have an active EMA account:
SPOR, Eudralink, EudraCT Secure, Service Desk portal, European Union telematics controlled terms (EUTCT), Meeting Management System (MMS), Managing Meeting Document system (MMD), EudraVigilance data analysis system (EVDAS), EudraPortal, European Union Good Manufacturing and Distribution Practices database (EudraGMDP), Paediatrics Records Application (PedRA), Siamed Business Intelligence dashboard (BI DASHBOARD), Corporate GxP database (CorpGXP), European Pharmacovigilance Issues Tracking Tool (EPITT) or Periodic Safety Update Repository (PSUR repository)
If you require an EudraLink account, you can request it via the EMA Service Desk after you have created an EMA account.
Access to SPOR as an unaffiliated user (not linked to an organisation) will be granted automatically on self-registration to EMA Account Management to allow requesting the creation of an organisation in OMS.

Recover your username and password : To recover your username click on the "Forgot Username?" link and you will receive an email with your username.

To reset your password click on the "Forgot Password?" link and follow the instructions.
Note: Check your spam e-mail folder if you have not received the one-time token required to reset your password.
To find out more about how to recover your username and password reference the guidance “Recover your credentials".

Re-activate your account: All EMA accounts are automatically disabled after 6 months of inactivity. Prior to disabling the account, the system sends three reminders to the user (two weeks, one week and one day before the account is disabled).

To re-activate your account you will need to use the "Forgot Password?" process. By re-setting your password your account will be re-activated and a notification sent to your email address. If you are affiliated to an organisation, your 'User Administrator' will also be notified that your account has been re-activated.

Change your contact details: You can change your contact details such as email address and mobile number by logging into the portal and making these changes in the "Edit Identity" area.

To update your name or any other details submit a request via EMA Service Desk.

Request access on behalf of an organisation: Once you have an EMA account you can request access on behalf of your organisation for EMA applications such as SPOR, IRIS and EudraVigilance here.

For more information on how to request access and track the status of your requests, refer to the "Request user access" guide.
To be able to request access on behalf of an organisation you need to ensure that your organisation is registered in EMA's Organisation Management Service (OMS). If your organisation does not appear is the list or organisations when requesting a user role nor in the OMS dictionary after performing a search, you will need to create a change request to register it. For more information on OMS, reference Organisation Management Service on the EMA's corporate website.

Note: it can take from five to ten working days to register a new organisation. Registration in OMS is not required if you are submitting an IRIS application as an individual not affiliated to any organisation.

Manage users of your organisation: 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:
  • IRIS User Admin
  • SPOR Super User
  • EV Human EU QPPV, Trusted Deputy and NCA/CS/NCS Responsible
  • EV VET Responsible and Trusted Deputy
Only the first request for a ‘User Administrator’ role is evaluated and granted by EMA. For the role request to be approved, additional documentation (proof of authority to represent the organisation) must be attached to the request.
EudraVigilance: When requesting access as a Responsible Person or EU QPPV/Additional QPPV/Trusted Deputy please follow the EudraVigilance: how to register (for Human) and/or EudraVigilance Veterinary - Registration.
For more information on the ‘User Administrator’ responsibilities and how the EMA Account Management helps to fulfil them, reference the "User Administrator Guide".


Guidance documentation

EMA Account Management:
Create an EMA Account
Recover your credentials
Request user access
User Administrator Guide
Frequently Asked Questions

System related guidance documentation:
IRIS guide to registration
EudraVigilance Registration Manual for Human
EudraVigilance Registration Manual for Veterinary
SPOR user registration

Support

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

Albert Einstein said:  "Intelligence is not the ability to store information but to know where to find it."   The EMA Account Management platform guides you through accessing EMA applications facilitating interactions between the EMA and their users.