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:


To be able to access EMA applications such as CTIS, SPOR, IRIS, EudraVigilance and UPD 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.

To find out more about how to Create an EMA Account reference the guidance "Create an EMA Account".



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".



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.

If you want to terminate your EMA account, you can use the "Terminate Account" functionality, this removes all your roles and disable your EMA Account.

To find out more about how to Re-activate your account reference the guidance "Recover your credentials - Re-activate your account - Forgot Password?".



You can change your mobile number by logging into the portal and making these changes in the "Edit Identity" area.

To update your name, e-mail or any other details submit a request via EMA Service Desk.
How can you change your e-mail address?
Due to improvements to EMA security and for more accurate interaction with EMA internal systems, users are no longer able to change/update their e-mail address via EMA Account Management Portal. The following actions should be taken if you need to change/update your e-mail address:
  • If you change organisation, you need to create a new account with new e-mail address via EMA Account Management Portal. Request to disable old account and remove access should be requested via EMA Service Desk.
  • If your organisation changed the domain the ticket should be created via EMA Service Desk and the bulk change would be performed for all users of that domain. These changes are not applicable to Eudralink accounts and need to be requested separately via EMA Service Desk.
  • If your surname has changed and therefore your e-mail address has been changed as well, you can create new account with the new name and e-mail address and request to have your previous access re-assigned to your new account, or you can request update of the surname and e-mail address via EMA Service Desk. By requesting Service Desk updating your details your user name will not change. These changes are not applicable to Eudralink accounts and need to be requested separately via EMA Service Desk.


Once you have an EMA account you can request access on behalf of your organisation for EMA applications such as CTIS*, SPOR, IRIS, EudraVigilance and UPD using the new access request process, 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.
*Note for CTIS:
  • Only CTIS Member State, European Commision and Sponsor High Level Administrator can be requested in EMA Account Management.
  • All other CTIS roles can be assigned/requested directly in the CTIS portal.
For further documentation about CTIS roles you can have a look here.
 To find out more about how to Request access on behalf of an organisation reference the guidance "Request user access".



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:
  • External Organisation Administrator
  • CTIS High Level Administrator
  • IRIS - eAF User Admin
  • SPOR Super User
  • EV Human EU QPPV, Trusted Deputy and NCA/CS/NCS Responsible
  • EV VET Responsible and Trusted Deputy
  • UPD Super User
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.

The External Organisation Administrator is a special role in the EMA Account Management portal. This Administrator, once validated by EMA, can approve or reject requests to become an administrator for other EMA-run systems[1] for their organisation.
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.
[1]The Eudravigilance EU QPPV and Responsible are always approved by the EMA.
For more information on the 'User Administrator' responsibilities and how the EMA Account Management helps to fulfil them, reference the "User Administrator Guide".



All EMA users accessing and processing data from EMA systems are responsible for:
  • protecting confidentiality of sensitive data and the rights of the data subjects, in accordance with the applicable laws on the protection of individuals with regard to the processing of personal data;
  • providing transparent information in their privacy statements on theier activities regarding the flow of data to EMA Systems;
  • implementing appropriate technical and organisational measures to protect information and personal data against unauthorised or unlawful access, disclosure, dissemination, alteration, destruction or accidental loss;
  • notifying the Agency immediately of any security incidents including personal data breaches leading to the above in relation to personal data transmitted to, stored in or otherwise generated from EMA Systems
Parties and users should also safeguard electronic data from tampering or unauthorised disclosure in accordance with the appropriate data protection legislation. This protection must extend beyond transactions to any files or databases that contain information conveyed via electronic data interchange.

Parties should also promote 'security awareness' within the organisation against the risk of social engineering and 'spear phishing', by educating and instructing users on recognising malicious emails and sites that are not filtered by organisational technical controls.

Parties must also maintain the confidentiality of passwords and other codes used for accessing this information. If an intermediary performs any services in respect of such confidential information, these should be subject to equivalent security measures.

For more information on security and confidentiality principles that stakeholders using EMA systems need to comply with, reference the "EMA security principles and responsibilities".

For more information on how to sign in into EMA applications, reference the "How to log into EMA Systems".



Guidance documentation

EMA Account Management:
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
Privacy Statement

System related guidance documentation:
CTIS training environement [Module 03: User Access Management]
IRIS guide to registration
EudraVigilance Registration Manual for Human
EudraVigilance Registration Manual for Veterinary
SPOR user registration
UPD user registration | UPD release notes

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 servicenow@ema.europa.eu indicating your name, surname and your unique username and we will help you with your access request.

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.