Extended EudraVigilance medicinal product dictionary (XEVMPD) training

The European Medicines Agency (EMA) offers training on how to submit and retrieve medicinal product data using the extended EudraVigilance medicinal product dictionary (XEVMPD), also known as Article 57 database. This is aimed at ensuring the quality of data in the XEVMPD on authorised or investigational medicinal products. At least one user from each marketing authorisation holder or sponsor of clinical trials should receive training.
HumanClinical trialsData on medicines

Users trained on the submission of data in the XEVMPD and where the organisation's EudraVigilance registration process is completed can start to submit data to the Agency.

If a company has made arrangements with a third-party service provider to submit data on medicines on their behalf, it is sufficient that a staff member of the third-party service provider has successfully completed the training.

XEVMPD training is also available to users from national competent authorities.

The syllabus focuses on product data submission and the use of the XEVMPD user interface (XEVMPDweb):

User manual for the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) user interface (XEVMPDweb)

Reference Number: EMA/389113/2025

English (EN) (16.73 MB - PDF)

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Training

EMA organises training courses which includes theory and hands-on examples using the XEVMPD training environment.

During the training, participants will be able to discuss real-life scenarios with trainers and other participants and seek advice.

Extended EudraVigilance medicinal product dictionary (XEVMPD) training course

Target audience
  • Marketing authorisation holders and sponsors of clinical trials
  • All prospective users of the XEVMPD who pass the knowledge evaluation will be able to register with EudraVigilance and submit medicinal product data to EMA
Duration 1.5 days
Topics covered
  • Legal requirements for marketing authorisation holders to comply with the provisions set out in Article 57(2) of Regulation (EC) 726/2004, as amended by Regulation (EU) 1235/2010 and Regulation (EU) 1027/2012.
  • Requirements for sponsors of clinical trials as outlined in Article 81(3) of Regulation (EU) 536/2014.
  • Extended EudraVigilance product report message (XEVPRM) format used for the electronic submission of information on authorised medicinal products as well as investigational medicinal products.
  • Controlled vocabularies and terminologies.
  • XEVPMD user interface (XEVMPDweb) for the electronic submission and maintenance of different types of medicinal products.
  • Data structure of the extended EudraVigilance medicinal product dictionary (XEVMPD) for data entry and data retrieval.
  • Importance of the XEVMPD to support the pharmacovigilance activities in the EU.
Available training dates

Short training for clinical trial sponsors

EMA organises shorter training courses specifically for clinical trial sponsors. These focus on how to add investigational medicinal product information to the XEVMPD.

EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors

Target audience
  • Commercial and non-commercial sponsors of clinical trials
  • All prospective users of the XEVMPD who pass the knowledge evaluation will be able to register with EudraVigilance and submit medicinal product data to EMA
Duration 1 day (two half days)
Topics covered
  • Requirements for sponsors of clinical trials as outlined in Article 81(3) of Regulation (EU) 536/2014.
  • Extended EudraVigilance product report message (XEVPRM) format used for the electronic submission of information on investigational medicinal products.
  • Controlled vocabularies and terminologies.
  • XEVPMD user interface (XEVMPDweb) for the electronic submission and maintenance of different types of investigational medicinal products.
  • Data structure of the extended EudraVigilance medicinal product dictionary (XEVMPD) for data entry and data retrieval.
  • Importance of the XEVMPD to support the submission of clinical trial information in the Clinical Trials Information System (CTIS).
Available training dates

E-learning

The e-learning course enables self-paced learning focusing on explaining the business requirements, technical aspects and operational procedures for data submission of authorised and unauthorised medicinal products (referred to in the XEVMPD as 'development medicinal products').

The course is available as a series of presentations which you can find on this web page. Users must also review the guidance document(s) related to the submission of authorised or development medicinal product data. Access is free of charge.

XEVMPD e-learning presentations

Presentation - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning - Introduction (version 5.6)

English (EN) (228.32 KB - PDF)

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Presentation - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning - Registration with EudraVigilance (version 5.7)

English (EN) (255.64 KB - PDF)

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Presentation - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning - XEVMPD data submission process (version 1)

English (EN) (522.89 KB - PDF)

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This course does not cover:

Notification of successful completion of e-learning course

After finishing the e-learning course, users can perform an XEVMPD knowledge evaluation. If users perform this knowledge evaluation successfully, the Agency will provide them with a notification of successful completion. At least one user from a company must obtain this since the notification is required from one person during the EudraVigilance registration process of the organisation before data submission can begin.

Companies can register a maximum of five users for the knowledge evaluation. They will not be able to register additional users if the registered users leave the company.

The aim of this service is to support companies in developing their in-house expertise and training courses for new staff and not to train users on an individual basis. EMA advises that companies plan accordingly and ensure internal knowledge transfer.

To register for the knowledge evaluation, submit a request to EMA Service Desk. Please specify if your request concerns knowledge evaluation for authorised medicinal product data or development medicinal product data or both.  

Users who have received notification of successful completion can train other users within their organisation.

Following their registration, participants will receive instructions on how to obtain access to the XEVMPD test environment (XCOMP) for training purposes. Access is limited to eight weeks. The Agency recommends that participants register for the XEVMPD knowledge evaluation after they have reviewed the training material.

The XEVMPD knowledge evaluation consists of two parts:

  • Multiple choice questionnaire: participants have to answer at least 16 out of 20 questions correctly to pass;
  • Product report exam case(s): participants have to enter a mock product report message into the XEVMPD XCOMP environment based on supporting documents and login details received.

Participants have three attempts to pass each section of the knowledge evaluation.

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in February 2026.

11 February 2026

Content on this webpage was updated to reflect the release of the upgraded XEVMPD user interface.

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