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.
On this page
- Electronic data interchange partners
- Required action before starting registration
- Registering for safety and product reporting
- Training and testing requirements
- Starting the electronic registration process
- Submitting registration documents
- Delegating the registration process
- Change of QPPV/RP and provision of regulatory contact point
- Change of registered users
- Legal framework
Electronic data interchange partners
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:
- 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 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.
Required action before starting registration
|Marketing authorisation holders and applicants||Commercial sponsors||Non-commercial sponsors|
Obtain EudraCT number from the EudraCT database
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:
- providing a notification of successful completion of the XEVMPD knowledge evaluation for at least one user;
- submitting the required registration documents.
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 firstname.lastname@example.org 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.
- Electronic registration process – EudraVigilance registration phases I, II and III
- Eudravigilance – registration user management
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 solution||Organisations registering for safety reporting||Organisations registering for product reporting|
|EVWEB||Provide notification of successful completion of the EudraVigilance training on electronic reporting of ICSRs for at least one user||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 and perform mandatory testing with the European Medicines Agency||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 the European Medicines Agency||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)|
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)
In the user registration request cover letter, they should clearly state that EVDAS access is required. This is currently only available to registered users from national competent authorities.
From 2017, EVDAS will also become available to marketing authorisation holders in the EEA. For more information see: EudraVigilance change management.
Submitting registration documents
After electronic registration, organisations are required to submit a set of signed and scanned registration documents by email to email@example.com.
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.
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 firstname.lastname@example.org. 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:
From 13 June 2016, 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’.
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 email@example.com.
- 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 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’).
- 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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- EudraVigilance registration system: Introduction of new functionalities (2016-06-17)
- Introduction of a 'regulatory contact point' for marketing authorisation holders (2016-06-17)
- Eudravigilance registration user management (2016-06-17)
- Electronic registration process – EudraVigilance registration phases I, II and III (2016-06-17)
- EudraVigilance registration documents (2016-06-17)
- Delegating the EudraVigilance registration process (2016-06-17)
- Change of qualified person for pharmacovigilance and responsible person for EudraVigilance (2016-06-17)
- EudraVigilance Form A (2016-06-17)
- EudraVigilance Form B (2016-06-17)
- EudraVigilance user declaration (2016-06-17)
- EudraVigilance delegation declaration - registration process delegation form (2016-06-17)