EudraVigilance: how to register | European Medicines Agency (2024)

On 26 July 2018, the European Medicines Agency (EMA) integrated the services of EudraVigilance (human)with EMA's Account Management portal andOrganisations Management Service (OMS).

Obtaining MedDRA licence and EUCT (CTIS) number

Users should follow the instructions below:

Transmission mode for reporting

An organisation can use two different types of electronic transmission mode for reporting:

• 'Gateway' or 'EV Post' function: new organisations need to register separately to use the external compliance testing environment (XCOMP) and the production environment;
• 'EVWEB' users (also known as 'Webtraders') will be registered in the production environment only, unless they also request to use the XCOMP environment.

Gateway users need to activate transmission as follows:

• when registering a new organisation, they should completeform below. The EMA Gateway team will then send the organisation the connectivity details.

• if they wish to change from Webtrader to Gateway, they must raise a Service Desk request to make the change and add the corresponding documents.

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 profilewhich 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.

Access EMA account management

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.

Access SPOR Portal

They also need to upload a set of signed and scanned registration documents.

• EudraVigilance 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 productionenvironment by clicking on the link below:

Access EudraVigilance Production

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.

Qualified person for pharmacovigilance, regulatory contact point and responsible person for Eudravigilance

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:

• Introduction of a 'regulatory contact point' for marketing authorisation holders

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:

• New Organization First User QPPV/RP or Change of EU QPPV/RP

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.

Other users

• General users should request the appropriate role in the EMA Account Management Portal and await approval by the organisation's QPPV or RP.
• CRO users should request a 'contributor' role for each of the organisations they are providing EudraVigilance-related services.

For a quick interactive guide to the revised EudraVigilance registration process, see below:

• Quick interactive guide to EudraVigilance registration process

Access to the EudraVigilance data analysis system (EVDAS)

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 accessfor marketing authorisation holders (MAH)

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.

Safety reporting

The electronic reporting of suspected adverse reactions is mandatory in accordance with Article 107(3) and 107a(4) of Directive 2001/83/ECand 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 isfurther 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 (NCAs):
  • electronic reporting of ICSRs to EudraVigilance (EVWEB 8);
  • re-routing of ICSRs from EudraVigilance to NCAs (EVWEB 8);
  • managing signals and performing data analysis (EVDAS);
• Marketing authorisation holders (MAHs):
  • electronic reporting of ICSRs to EudraVigilance (EVWEB 8);
  • obtaining access to ICSRs reported by NCAs to EudraVigilance (EVWEB 8);
  • managing signals (EVDAS);
  • electronic submissions of XEVMPD product report messages (EVWEB 7);
• Commercial and non-commercial sponsors:
  • electronic reporting of ICSRs resulting from clinical trials (EVWEB 8).

Regulators

National competent authorities in the EEA need to register with EudraVigilance, including regional pharmacovigilance centres, where applicable.

Pharmaceutical industry

Three types of industry users need to register with EudraVigilance:

• Marketing authorisation holder (MAH): a pharmaceutical company holding one or more valid marketing authorisations for medicinal products in the EEA, regardless of the authorisation route of the particular medicinal product they are reporting on;
• Applicant: a pharmaceutical company applying for a marketing authorisation in the EEA;
• Commercial sponsor: an individual, company, institution or organisation responsible for the initiation, management and financial framework of a clinical trial.

Non-commercial sponsors

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.

Third party service providers

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.