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:
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)
If you don't have an EMA Account, follow these steps to self-register:

  1. Go to EMA Acccount Management (https://register.ema.europa.eu)
  2. Click on "Create a new EMA account" which will open an “EMA - Self-service registration form”;

  3. Complete the “EMA – Self-service Registration Form” and click on “Register”;
    Tick the “IRIS access as Individual Use” checkbox if you need access to IRIS as an Individual User and not on behalf of an organisation to submit, for example, Innovation Task Force (ITF) meeting requests, orphan or scientific advice applications.

    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
  4. Tick the "User Agreement" checkbox and then click on the "I agree" button;

  5. Set up “Security Questions”, answer the captcha question and click the “Next” button.
    You can select the security question by clicking on the dropdown icon
  6. 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;

    Note: Check your spam e-mail folder if you have not received one-time token. The email subject is "EMA Registration - One-time Token".
  7. 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: If you requested access to IRIS as an individual user, it may take up to 30 minutes until the access is granted.

  8. 8. 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

EMA Account Management guidance documents
Welcome Page
Create an EMA Account
Recover your credentials
Request user access
User Administrator guide
Frequently Asked Questions

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