Guidance

Pharmacovigilance: veterinary adverse event reporting (VMGN 11)

For Marketing Authorisation Holders (MAHs) concerning pharmacovigilance and the reporting of adverse events to veterinary medicines.

From:
Veterinary Medicines Directorate
Published
30 June 2014

This publication was withdrawn on

Guidance replaced by Veterinary Pharmacovigilance: your responsibilities

Documents

Pharmacovigilance: Guidance on Adverse Events

Ref: VMGN No. 11

PDF, 280 KB, 18 pages

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Details

Marketing Authorisation Holders (MAHs) have a legal obligation to record any information which they receive about adverse events involving their veterinary medicinal products.

These can occur after use in accordance with the advice on the label, following off-label use or if there is suspected lack of efficacy (the product has not worked) when used in accordance with the label. Reporting also relates to humans following exposure to a veterinary medicine or a treated animal.

MAHs must report any animal adverse events involving death, permanent disability, life threatening illness or congenital abnormality, and all human reactions, to the relevant competent authority. In the UK this is the Veterinary Medicines Directorate.

The scope of reporting includes incidents arising from exposure to a veterinary medicine present in the environment, and issues concerning the validity of withdrawal periods.

A scientific evaluation of the risk-benefit balance of the veterinary medicine is an important aspect of reporting.

Published 30 June 2014