EMA Account Management | How to create a new EMA Account
In order to obtain appropriate user access roles to access EMA applications like IRIS, SPOR and EudraVigilance, you need to have an EMA user account.
If you have access to any of the following systems, you already have an active EMA account:
If you don't have an EMA Account, follow these steps to self-register:
Clinical Trials Information System (CTIS), 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)
EMA Account Management guidance documents
Create an EMA Account
Recover your credentials
Request user access
User Administrator guide
Frequently Asked Questions
EMA security principles and responsibilities
How to log into EMA Systems
- Go to EMA Acccount Management (https://register.ema.europa.eu)
- Click on "Create a new EMA account" which will open an “EMA - Self-service registration form”;
- Complete the “EMA – Self-service Registration Form” and click on “Register”;
Note: Access to IRIS as an Individual User is now granted by default. This can be used to submit, for example, Innovation Task Force (ITF) meeting requests, orphan or scientific advice applications as an individual and not on behalf of an organisation.
If the message "The email you have chosen is already in use. Please retrieve your login details linked to this account by clicking on Forgot your username." is displayed, it is possible to retrieve the username linked to the email with the Forgot Username? link on the login page.
Note: all passwords must be at least 8 characters long and contain 4 different character types. Example passwords that meet the requirements; P4$$w0rd, Americ@52, M3d!cines
By checking the "User Agreement", you acknowledge that you have read and understood the Privacy Statement
- Enter the value of the “One-time token” you received by email and complete the submission of your request by clicking on the “Confirm” button.
The token is valid for half and hour and the expiration can be checked in the Token Expiration box.
Note: Check your spam e-mail folder if you have not received one-time token. The email subject is "EMA Registration - One-time Token".
- Once the self-registration request has been completed, an automatic notification will be sent to the email address that you provided to confirm your account registration.
Note: To access IRIS as an individual user, it may take up to 30 minutes until the access is granted.
- You can now request user access to EMA Applications such as IRIS, SPOR and also submit online queries to the EMA Service Desk for support
If you cannot find the support you need in the guidance documents, please contact the EMA Service Desk
Alternatively, if you are unable to access the EMA Service Desk, please send an email directly to firstname.lastname@example.org
indicating your name, surname and your unique username and we will help you with your access request.