Adverse event reports for centrally authorised veterinary medicinal products should not be sent to the DKMA
03 July 2017
The Danish Medicines Agency no longer requests the direct transfer of serious and unexpected third-country adverse event reports for centrally authorised veterinary medicinal products.
Consequently, the reports should only be sent to EVVET (EudraVigilance Veterinary – the European, veterinary adverse event database administered by the EMA).