EudraVigilance Veterinary - Reporting for Marketing Authorisation Holders (MAHs)

Adverse events occurring in the EEA

A veterinarian or other health care professional, an owner or any other person may wish to report a suspected adverse event observed in an animal or human following the use of a veterinary medicinal product.  This primary source will either inform the Marketing Authorisation Holder (MAH) of the product concerned or to the national competent authority (NCA).  A valid report will at least include the following information; an identifiable reporter, details on the animal(s) or human concerned, details on the product(s) concerned and details on the observed event. On receipt of a valid report, the MAH should provide the full information immediately and in no case later than 15 calendar days, for any suspected serious adverse reactions and human reactions, to the NCA on whose territory the adverse event occurred. And where possible, it is strongly recommended that non-serious adverse events are sent directly to the EVVet database and to the NCAs of occurrence (for UK, IE, IS, NT and EE only to EVVet).

The NCA will check and acknowledge the report and forward the full information to the central EVVet database. The NCA may also consider informing the other MAH(s) of the report for the other products that may have been involved.

When the primary source sends the information directly to the NCA, the authority will forward the full information within 15 days to the central EVVet database and to the MAH(s) of the suspect veterinary medicinal products.

Adverse events occurring outside the EEA

The MAH should report all suspected serious and unexpected adverse reactions related to its veterinary medicinal products, human adverse reactions and any suspected transmission via a medicinal product of any infectious agent, occurring in the territory of a third country brought to its attention. These should be reported immediately and in no case later than 15 calendar days following receipt, to the central EVVet database.

Any personal data from the primary source and all other persons being named in the original report should only be kept by the MAH or the NCA that has first received the information from the primary source and should not be included in the reports sent by the MAH to the NCA or sent by the NCA to the central EVVet database.

Electronic reporting is obligatory and 3 different routes have been set-up to allow for the electronic distribution of safety information by the MAH. Additional guidance for MAHs on the various registration options, reporting, transmission options, and access to data is here. The reporting route depends largely on the number of safety reports that a MAH or CA has to deal with.

The Gateway - REQUIRES REGISTRATION (and is typically for Stakeholders with a large number of reports, and an existing company database).