Reporting of Adverse Events for Veterinary Medicinal Products
Electronic reporting to EudraVigilanceVeterinary (EudraVigVet) is preferred for all products regardless of procedure used to obtain the MA: National, Mutual Recognition (MRP), Decentralised (DCP) or Centralised Procedure (CP).
Incidences occurring in Norway
Reports on incidences which have taken place in Norway should be submitted directly to EudraVig Vet, and the Norwegian Medicines Agency (NoMA) should be copied as receiver of the report.
Incidences occurring outside Norway
Reports from EU/EAA countries (not including incidences in Norway) and third country reports: When the incidence is reported in the EudraVig Vet NoMA should NOT be copied as a receiver of the message.
Electronic reporting of adverse reaction from NoMA to MAH of veterinary medicinal products
All incidences taking place in Norway and reported directly to NoMA by veterinarians/fish health biologists will be sent to EudraVig Vet and to the relevant MA-holders. Reports on Serious Adverse Drug Reactions are sent, preferably by EudraVig Vet, to the MAH within 15 days after receipt at NoMA. MA-holders without access to EudraVig Vet will receive paper copies of the reports twice yearly