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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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 the 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 that 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 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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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 submitting 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 (except if 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 login credentials have been sent to the qualified person for pharmacovigilance (QPPV), testing can be initiated.

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
EVWEBProvide notification of successful completion of the EudraVigilance training on electronic reporting of ICSRs for at least one userProvide 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 and perform mandatory testing with the European Medicines AgencyProvide 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 the European Medicines AgencyProvide 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 currently only compatible with Internet Explorer version 8. They may be compatible with later versions if 'compatibility view' is activated. 

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

 

Access to the EudraVigilance data analysis system (EVDAS) (updated)

EMA has published detailed steps for national competent authorities and marketing authorisation holders to follow to request access to the EudraVigilance data analysis system (EVDAS):

EVDAS will become available to marketing authorisation holders in the EEA from November 2017

Marketing authorisation holders should register from 1 June 2017 at allocated time slots to allow the Agency to process the high volume of new registrations:

Please note that the Agency will queue registrations received past the allocated time slot and process them as time permits. This may delay access to EVDAS.

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

National competent authorities do not need to follow a time schedule for their EVDAS user registration requests.

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 revised EudraVigilance access policy;
  • make e-RMRs and line listings available to signal management teams within their company. 

Signal management experts, who do not have an EVDAS account, can access individual cases using their EVWEB account.

The Agency will communicate the exact date it will activate marketing authorisation holders' user accounts in the third quarter of 2017. 

After activation, users will be able to access EVDAS at https://bi.ema.europa.eu.

For more information see: EudraVigilance change management.

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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, the European Medicines Agency has implemented a new feature within the EudraVigilance registration database:

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’.

 

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Change of registered users

The registered QPPV/RP and trusted deputy users must notify the EudraVigilance registration team about any changes affecting their access rights (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.

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Legal framework 

Safety reporting

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