EudraVigilance: how to register

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Pharmaceutical companies holding or applying for a marketing authorisation in the European Economic Area (EEA), sponsors of clinical trials and national competent authorities in the EEA need to register with EudraVigilance for the electronic data interchange of pharmacovigilance information. The registration process is a prerequisite for electronic reporting.

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Stakeholders and obligations

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);
    • electronic submissions of XEVMPD product report messages (EVWEB 7).

 

Electronic data interchange partners

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: 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) which do not qualify as a sponsor, marketing authorisation holder or applicant 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.

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IT vendors and third party service providers

Registration with EudraVigilance XCOMP (test) environment

IT Vendors and third party service providers which 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 as a vendor, see: 

Registration with EudraVigilance production environment

Clinical research organisations (CROs), IT vendors and third party service providers that do not qualify as a sponsor, MAH or applicant 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.

 

Required action before starting registration

Marketing authorisation holders and applicantsCommercial sponsorsNon-commercial sponsors
 
Obtain EudraCT number from the EudraCT database
  • Obtain MedDRA licence number 
  • Micro and small-sized enterprises qualified by the SME office are eligible for a low revenue EudraVigilance MedDRA fee waiver

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Registering for safety and product reporting

Each organisation registering with EudraVigilance needs to be represented by a designated individual of this organisation.

There are different types of electronic exchange solution that an organisation can opt to use:

  • ‘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 WEB traders) will be registered in the production environment only, unless they also request to use the XCOMP environment.

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).

Organisations are not required to test the submission of product reports. However, the testing process is mandatory for organisations submitting safety reports using a gateway solution or the EV Post function.

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.

Registering new organisations with EudraVigilance and the XEVMPD community

New organisations requesting registration with EudraVigilance will be added to the XEVMPD community in the production environment after:

If a new organisation requests to be registered in XCOMP, it will automatically be added to the XEVMPD gateway community in XCOMP.

Once the EudraVigilance registration in XCOMP is completed and the qualified person for pharmacovigilance (QPPV) has received login credentials, testing can start.

Adding organisations already registered with EudraVigilance to XEVMPD

Organisations that are already registered with EudraVigilance and use EVWEB and the EV Post function for safety reporting should send a request to be added to the XEVMPD gateway community to eudravigilanceregistration@ema.europa.eu stating the organisation’s name and ID in production (and optionally in the XCOMP environment).

The organisation needs to provide a notification that at least one user has successfully completed the XEVMPD knowledge evaluation.

Once the organisation has been added to XEVMPD, users can access the community using their existing EudraVigilance login details.

Organisations using a local gateway for safety reporting cannot be added to the XEVMPD community unless their gateway solution supports submission of both safety and product reports.

If a different electronic exchange solution is intended for submission of product reports, organisations are advised to register a virtual affiliate for that purpose.

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Training and testing requirements

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 solutionOrganisations registering for safety reportingOrganisations registering for product reporting
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 PostProvide 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).
GatewayPerform mandatory testing with EMAProvide notification of successful completion of the XEVMPD knowledge evaluation for at least one user (transmission testing and loading of XEVPRMs using XCOMP is optional).

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Starting the electronic registration process

Organisations are required to register electronically using the EudraVigilance online test environment registration form  and/or the EudraVigilance online production environment registration form as applicable.

The forms are compatible with Internet Explorer version 8 and above, Chrome and Firefox web browsers.

To register a headquarters, affiliate or individual users to an organisation in EudraVigilance, please refer to: 

 

Access to the EudraVigilance data analysis system (EVDAS)

EMA has published detailed steps for NCAs and MAHs to request access to the EudraVigilance data analysis system (EVDAS):

EVDAS is available to MAHs in the EEA from 22 November 2017

The qualified person for pharmacovigilance (QPPV) of an MAH can appoint up to five EVDAS users at headquarter level. A trusted deputy of the QPPV can also register these users on their behalf. 

There are two EVDAS profiles: 'EVDAS scientific' and 'EVDAS administrative'.

Registered users will be able to:

  • access EVDAS and related reports, including electronic reaction monitoring reports (e-RMRs), active substance groupings, line listings and individual cases (via individual case safety report forms) in accordance with the EudraVigilance access policy (EVDAS scientific profile);
  • make e-RMRs and line listings available to signal management teams within their organisation (EVDAS Administrative profile). 

Signal management experts of a MAH who do not have an EVDAS account can access individual cases related to line listings using their EVWEB account.

Registered MAH users have active user accounts and access to EVDAS from 22 November 2017.

 

Level 2B access for 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 of the MAH. 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.

The QPPV or trusted deputy can grant level 2B access to already registered users as part of the secure area of EudraVigilance.

Level 2B access is not automatically granted to EVDAS scientific user profiles. This access needs to be assigned in addition, if required.

Level 2B access is available as of 22 November 2017.

 

Submitting registration documents

After electronic registration, organisations are required to submit a set of signed and scanned registration documents by email to eudravigilanceregistration@ema.europa.eu.

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Delegating the registration process

The qualified person for pharmacovigilance (QPPV) or responsible person for EudraVigilance (RP) can delegate the functions related to registration of new users and affiliates with EudraVigilance to a trusted deputy within the same organisation.

QPPV/RPs should register the trusted deputy with EudraVigilance as a user in the first instance. The delegation and the registration of the deputy can be performed simultaneously. QPPV/RPs can do this by entering the EudraVigilance restricted area using their username and password. 

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.

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Change of QPPV/RP and provision of regulatory contact point

If the qualified person for pharmacovigilance (QPPV) or responsible person for EudraVigilance (RP) changes within an organisation, the organisation must notify the EudraVigilance registration team immediately by email to eudravigilanceregistration@ema.europa.eu. Registration documents for the newly appointed QPPV/RP need to be included:

Marketing authorisation holders are legally required to have a QPPV based in the European Union (EU) in place at all times: Directive 2001/83/EC, Article 104(3)(a).

To help meet these obligations, EMA has implemented a new feature within the EudraVigilance registration system:

  • Marketing authorisation holders are required to provide the name, phone number and email address of a regulatory contact point. This can be a staff member or a department.
  • The EudraVigilance registration team communicates with regulatory contact points in case the registered EU QPPV of a marketing authorisation holder leaves and a new EU QPPV has not been registered.
  • To provide this information, the registered EU QPPV or trusted deputy user should log in to the secure area of EudraVigilance and complete the relevant fields under the option ‘Edit organisation’.

For more information see:

 

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Change of registered users

The registered QPPV/RP and trusted deputy must notify the EudraVigilance registration team immediately about any changes affecting the access rights of their nominated users (e.g. end of employment with the registered organisation, change of department within the registered organisation). They need to send an email to eudravigilanceregistration@ema.europa.eu.

For more information, see EudraVigilance: security principles and responsibilities

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Legal framework 

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.

The electronic reporting of suspected unexpected serious adverse reactions (SUSARs) originating from clinical trials is set out in the Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’) and is based on the principles set out in Directive 2001/20/EC.

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.

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Contact point:

Technical registration queries:
Tel. +44 (0) 20 3660 7523
EMA Service Desk 

General registration queries:
Tel. +44 (0) 20 3660 7523
Email: eudravigilance
registration@ema.europa.eu