On 26 July 2018, the European Medicines Agency (EMA) integrated the services of EudraVigilance (human) with EMA's Account Management portal and Organisations Management Service (OMS).
All users, including organisations, need an active EMA account created through the EMA Account Management portal.
EMA has published a registration manual and frequently asked questions on EudraVigilance, and has updated this page with information for companies and users wishing to register with, access or manage their account for EudraVigilance (human) production environment. A quick interactive guide to the revised registration process is also available:
For more information, see:
Users should follow the instructions below:
Marketing authorisation holders (MAH) and applicants | Commercial sponsors | Non-commercial sponsors |
| Obtain EUCT number from CTIS | Obtain EUCT number from CTIS | |
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An organisation can use two different types of electronic transmission mode for reporting:
Gateway users need to activate transmission as follows:
XCOMP mirrors the EudraVigilance production environment and allows organisations to test the submission of individual case safety reports (ICSRs) and extended EudraVigilance product report messages (XEVPRMs).
The testing process is mandatory for organisations submitting safety reports using a gateway solution or the EV Post function, and these organisations therefore require an XCOMP profile which they will use to perform quality assurance testing. Organisations are not required to test the submission of product reports.
Organisations using a local gateway for safety reporting cannot be added to the extended EudraVigilance medicinal product dictionary (XEVMPD) community, unless their gateway solution supports submission of both safety and product reports.
Organisations are advised to register a virtual affiliate if they intend to use a different electronic exchange solution for the submission of product reports. For more information, see the registration manual and frequently asked questions featured on this page.
All users, including organisations, need an active EMA account created through the EMA Account Management portal.
Users with access to EMA-hosted websites or online applications already have an EMA account and they should use the same login credentials. These include the European clinical trials database (EudraCT)/Clinical Trials Information System (EUCT), EMA Service Desk, EudraVigilance data analysis system (EVDAS), European Union good manufacturing and distribution practices database (EudraGMDP), Substances, Products, Organisations and Referentials (SPOR) portal and the IRIS portal for orphan designation.
Each organisation registering with EudraVigilance needs to be represented by a designated individual from this organisation.
Organisations need to register electronically via the Organisation Management System (OMS) in the SPOR portal. To register a headquarters, affiliate or virtual affiliate of an organisation in EudraVigilance, please refer to the EudraVigilance registration manual.
They also need to upload a set of signed and scanned registration documents.
National competent authorities should register directly in the production environment (unless they are gateway users). This is required to grant scientific users immediate online access to all pharmacovigilance data stored in EudraVigilance.
Clinical research organisations (CROs), IT vendors and third-party service providers that do not qualify as sponsors, MAHs or applicants cannot register with the EudraVigilance production environment. However, these entities may be registered by a MAH, applicant, commercial or non-commercial sponsor as a third party service provider acting on behalf of these organisations by providing services related to EudraVigilance.
Users already registered with EudraVigilance can access the production environment by clicking on the link below:
To sign into the XCOMP environment, MAHs, NCAs and sponsors should use the same single sign-on credentials as for the EMA Account Management portal and other EMA applications. These are the same login details used to access the production environment. Registration of an organisation in the production environment automatically creates an XCOMP profile. This enables MAHs, NCAs and sponsors to use the same self-service process to manage access and maintain accurate data on their organisation. For more information, see EudraVigilance XCOMP stakeholder communication – 18 March 2020 For guidance on how to register and manage a user account, and to access XCOMP, users should consult section 7 of the EudraVigilance registration manual IT vendors and third-party service providers should follow the instructions under IT vendors and third party service providers. Users can access the XCOMP environment by clicking on the link below:
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Users need an active EMA account. If a user does not have an active EMA account, they can create one on EMA's Account Management portal.
For EudraVigilance access, users should log into the EMA Account Management portal and request a 'EudraVigilance role'. For more details, see the EudraVigilance registration manual.
MAHs are legally required to have a qualified person for pharmacovigilance (QPPV) based in the European Union (EU) in place at all times, in line with Directive 2001/83/EC Article 104(3)(a). The QPPV must be registered in Eudravigilance.
MAHs are also required to provide the name, phone number and email address of a regulatory contact point. This can be a staff member or a department. For more information, see:
The QPPV can add the regulatory contact point details by accessing their EudraVigilance Human restricted area and selecting 'Manage my profile'.
Commercial and non-commercial sponsors and national competent authorities should nominate a responsible person (RP) for EudraVigilance and register them in Eudravigilance.
If the QPPV or RP changes within an organisation, the organisation must nominate a new QPPV or RP within 10 calendar days. The existing QPPV/RP cannot be removed from EudraVigilance until their replacement is registered, and registration documents for the newly appointed QPPV/RP need to be included.
For detailed instructions on how to change the QPPV and RP for EudraVigilance, see:
Delegating the registration process
The QPPV or RP can delegate the functions related to registration of new users and affiliates with EudraVigilance to a trusted deputy within the same organisation.
Trusted deputies should request this role and await approval by the MAH QPPV or the RP in the case of commercial, non-commercial sponsors and NCAs.
They should use the 'Add HQ user' facility in the 'Manage your profile' section and complete the online user registration form with details of the trusted deputy.
For a quick interactive guide to the revised EudraVigilance registration process, see below:
IT vendors and third-party service providers should register with the EudraVigilance XCOMP environment via the EMA Account Management system. IT vendors and third-party service providers who offer software solutions and services related to electronic reporting can register as gateway organisations with the EudraVigilance XCOMP environment for testing purposes. Registration allows users to submit test files to the XCOMP environment via a gateway connection only; no access to the EVWEB application will be possible. For detailed instructions on how to register with XCOMP as a vendor, see: |
Users should request this role via the 'Manage Access' tab in their EMA account management profile and await approval by their organisation's QPPV or RP.
Level 2B access is an additional and specific access right that can be assigned by the QPPV or trusted deputy to registered EVWEB or EVDAS users. It includes access to case narratives in accordance with the EudraVigilance Access Policy and can be assigned to users in support of signal management or where the review of ICSR data is warranted in the context of a pharmacovigilance assessment procedure by the MAH.
Users should request this role via the 'Manage Access' tab in their EMA account management profile and await approval by their organisation's QPPV or trusted deputy.
Organisations should refer to the section 'Who needs to report what' on EudraVigilance: electronic reporting to find out whether to register for safety reporting, product reporting or both.
| Type of electronic exchange solution | Organisations registering for safety reporting | Organisations registering for product reporting |
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| EVWEB | Provide notification of successful completion of the EudraVigilance training on electronic reporting of ICSRs for at least one user. This applies to face to face training or online competency assessment. | Provide notification of successful completion of the XEVMPD knowledge evaluation for at least one user. |
| EV Post | Provide notification of successful completion of the EudraVigilance training on electronic reporting of ICSRs for at least one user (applies to face to face training or online competency assessment) and perform mandatory testing with EMA. | Provide notification of successful completion of the XEVMPD knowledge evaluation for at least one user (transmission testing and loading of XEVPRMs using XCOMP is optional). |
| Gateway | Perform mandatory testing with EMA. | Provide notification of successful completion of the XEVMPD knowledge evaluation for at least one user (transmission testing and loading of XEVPRMs using XCOMP is optional). |
Safety reporting
The electronic reporting of suspected adverse reactions is mandatory in accordance with Article 107(3) and 107a(4) of Directive 2001/83/EC and with the provisions of Annex III of the Regulation No 536/2014 (Clinical Trials Regulation).
The electronic reporting of suspected unexpected serious adverse reactions (SUSARs) originating from clinical trials is further detailed on EMA’s webpage Reporting safety information on clinical trials.
Product reporting
The electronic submission of information on medicines by marketing authorisation holders is regulated in accordance with Article 57(2), second subparagraph of Regulation (EC) 726/2004.
Three types of stakeholder can register with EudraVigilance to meet their legal obligations set out in the pharmacovigilance legislation and clinical trials legislation;
National competent authorities in the EEA need to register with EudraVigilance, including regional pharmacovigilance centres, where applicable.
Three types of industry users need to register with EudraVigilance:
Non-commercial sponsors frequently rely on funding which comes partly or entirely from public funds or charities. Non-commercial clinical trials are conducted by researchers without the participation of the pharmaceutical industry.
A non-commercial trial is conducted by a non-commercial organisation with no industry sponsor, and is not part of the development programme for a marketing authorisation of a medicinal product or, if potentially leading to a marketing application, where the holder of the intellectual property/patent is a not-for profit organisation.
A trial may qualify as non-commercial if funding is provided in the form of an educational, unrestricted grant for administrative support and does not exceed 10% of the cost of the trial, or where the medicine is provided free by a company.
Clinical research organisations (CROs) who do not qualify as sponsors, marketing authorisation holders or applicants cannot register with EudraVigilance. The same applies to IT vendors. However, CROs and IT vendors may be registered by a marketing authorisation holder, applicant, commercial or non-commercial sponsor as a third party service provider acting on behalf of these organisations by providing services related to EudraVigilance.