How does the new EU regulation affect reporting in Sweden?

The new EU regulation on veterinary medicinal products (EU) 2019/6 applies from 28 January 2022.

Some of the important changes are summarized below:

• Both serious and non-serious reports of suspected adverse events are to be submitted within 30 days to the EudraVigilance Veterinary (EVV) database operated by the European Medicines Agency (EMA).
• All medicines mentioned in an adverse event report are considered suspected (a causal relationship does not have to be stated).
• Marketing authorisation holders should submit reports of suspected adverse events directly to EudraVigilance Veterinary (EVV) database operated by the European Medicines Agency (EMA).
• Periodic safety update reports (PSURs) are no longer a requirement and are replaced by continuous analysis and evaluation of reported suspected adverse events, so-called signal management.
• All reports of suspected adverse events in the EudraVigilance Veterinary (EVV) database must be analysed and evaluated continuously by both the relevant authorities and pharmaceutical companies in each Member State.
• Signal management must be documented in the EudraVigilance Veterinary (EVV) database.
• A Union Product Database for approved / registered veterinary medicinal products has been launched and information from this database will be linked to the EudraVigilance Veterinary (EVV) database.
• Member States have a more comprehensive overview of suspected adverse events in order to detected new risks and previously unknown adverse events more quickly.