Schemas for the Guidance on the electronic data interchange

of safety data for veterinary medicinal products in the EU

This document provides a schematic representation of the reporting procedures and actions allowing an efficient and quick electronic distribution of safety information in accordance with the relevant legislative requirements. These schemas focus on the requirements with regard to distribution of expedited event reports (situation I, II, III) while excluding the follow-up with regard to analysis (scientific and regulatory).

Situation I: The primary source (veterinarian or health care professional, owner, breeder) reports directly to the national competent authority (NCA)

For adverse events having occurred in the EU and are directly reported from e.g. veterinarians to the NCA, the NCA will input the data into the EVVet database and will send the adverse event reports to all MAHs whose products have been included in the adverse event reports.

Situation II: The primary source (veterinarian or health care professional, owner, breeder) reports directly to the MAH

For adverse events having occurred in the EU and communicated first by e.g. a veterinarian to a MAH, the MAH to sends the case, within 15 days to the MemberState on whose territory the adverse event occurred. The MemberState on whose territory the adverse event occurred is responsible for forwarding the adverse event report to the EVVet central database.

Situation III: Third country reporting

The MAH should send adverse events reporting for third country reports directly to the EudraVigilance Veterinary database.

ACTION / PERFORMED BY
1. The national competent authority sends the message within 15 days to
- Eudravigilance veterinary (EVVet DB) (a)
- the MAH(s) of the suspect drug (s) (b) / NCA
2. The MAH (s) checks the reports and sends an acknowledgment to the competent authority (c) / MAH
3. The NCA checks the acknowledgements received from EV vet DB and MAH(s) and stores them locally (d) / NCA
Any follow-up reports from the MAH(s) will follow the situation II

ACTION

/ PERFORMED BY
1. The MAH (A) reports within 15 days (a) to the NCA on whose territory the adverse event report occurred / MAH
2. The NCA checks the report, adds the NCA's assessment and sends the report within 15 days (b) to EV Vet DB where it becomes available for all NCAs including the Reference Member State (RMS), when relevant. / NCA
3. The NCA sends an Ack to the reporting MAH (c) / NCA
4. The MAH (A) checks and stores the Ack / MAH
5. The NCA checks and stores the Ack received from EV Vet DB (d) / NCA
6. If a further VMP(s) is used as concomitant medication, and is suspected of having interacted with any of the other VMP(s) administered concurrently, or it is suspected of having caused the adverse event:
The NCA transmits the adverse event report to the MAH(s) of the VMP(s) given concurrently (e). Hereby the NCA also informs the MAH of the other VMP(s) that the case has been entered into EVVetDB where it automatically becomes available to all NCAs including the RMS for the other VMP(s), when relevant / NCA
7. The MAH(s) for the other VMP(s) send an Ack to the NCA. (f) / MAH (s)
for other products
8. The NCA stores the Ack received from MAH for the other VMP(s). / NCA
ACTION / PERFORMED BY
1. The MAH reports within 15 days of becoming aware of the report to the EudraVigilance Veterinary DB (a). / MAH
2. The report(s) become available(c)to the Agency and all competent authorities of the Member States.
3. The MAH (A) checks and stores the received Ack from the EVVet DB (b) / MAH

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Version 1.02 - 12 February 2009