EMA Account Management is the European Medicines Agency’s (EMA) secure online platform where you can request and manage access to EMA applications.
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.
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. email@example.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.
To find out more about how to Create an EMA Account reference the guidance "Create an EMA 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.
To find out more about how to Re-activate your account reference the guidance "Recover your credentials - Re-activate your account - Forgot Password?
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.
To find out more about how to Request access on behalf of an organisation reference the guidance “Request user access