In order to facilitate certain procedures between marketing authorisation holders (MAH) and the Federal Agency for Medicines and Health Products (FAMHP), the FAMHP has drawn up a number of guidelines on electronic reporting by marketing authorisation holders/clinical trial sponsors, based on the procedure of the European Medicines Agency (EMA).
EudraVigilance E2B/R3
Since 22 November 2017, the European Medicines Agency (EMA) has been using an updated EudraVigilance application compliant with the E2B\R3 standard, replacing EudraVigilance E2B\R2.
The EudraVigilance system enables the exchange of individual adverse reaction reports (Individual Case Safety Reports, ICSRs) in E2B\XML format between the organisations concerned and the EMA. These reports are validated in accordance with predefined guidelines (business rules).
The European database of reports on suspected adverse reactions to medicines is available online via www.adrreports.eu.
More information
- The revised EudraVigilance stakeholder change management plan
- European Medicines Agency (EMA)
- Frequently asked questions about EudraVigilance Registration