What happens to the reports?
- Published: January 19, 2021
- Last updated: August 17, 2022
The Swedish Medical Products Agency registers and processes all reports received regarding suspected adverse events in the national pharmacovigilance database. An acknowledgment of receipt is sent to the reporter.
According to the EU Regulation on Veterinary Medicinal Products (EU) 2019/6, all reports of suspected adverse events, regardless of severity, must be registered in the EudraVigilance Veterinary Database (EVV) within 30 days. (EudraVigilance is the data-processing network and database for managing and analysing information on suspected adverse events to medicines which have been authorised in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
In the new EU Regulation, a new signal management process has been implemented to monitor suspected adverse events. As a result, there is no longer a requirement for marketing authorization holders or national competent authorities to assess the potential causal association on each individual report and register this assessment in the EVV. Instead, EVV will now be used by marketing authorization holders or national competent authorities to detect any previously unknown risks, so-called signals. As EVV contains a large amount of data, the possibility of finding such information increases.
The marketing authorization holder should carry out continuous analysis of all available data to identify signals related to use of veterinary medicinal products in animals. When necessary, and at least once a year, marketing authorization holders should record all results of their signal management, including a conclusion of the benefit / risk balance, in the EudraVigilance Veterinary Database (EVV).
The Swedish Medical Products Agency collaborates with the European Medicines Agency, EMA, together with other national competent authorities to perform signal management and evaluate the results of signal management registered in EVV by marketing authorization holders.
Adverse events and other potential new risks, so-called signals, are regularly discussed in a specific EU working group at EMA, so called Veterinary Pharmacovigilance Working Party. This working group comprises of representatives from all EU member states. The EMA publishes annually summaries of the suspected adverse events in animals reported following the use of medicines approved in all EU countries.