Download - Veterinary Medicines Directorate - Defra

VMGN No. 11
QUICK START GUIDE
This Veterinary Medicines Guidance Note (VMGN) is aimed primarily at Marketing
Authorisation Holders (MAH) and is intended to provide guidance on pharmacovigilance
and the reporting of adverse events.
The quick start guide is a summary of the provisions of the Veterinary Medicines
Regulations (VMR); detailed information is found in the body of the guidance note.
MAHs have a legal obligation to record any information which they receive about adverse
events involving their veterinary medicinal products. Adverse events associated with
veterinary medicines include adverse reactions in animals which occur after use in
accordance with the advice on the label or following off-label use, and suspected lack of
expected efficacy after use in accordance with the label, and adverse reactions in humans
following exposure to a veterinary medicine or a treated animal.
MAHs must report any animal adverse events involving death, permanent disability, lifethreatening
illness or congenital abnormality, and all human reactions, to the relevant
competent authority within 15 days of their receipt of the information. For adverse events
which occur in the UK, the VMD is the relevant competent authority.
The scope of pharmacovigilance includes incidents arising from exposure to a veterinary
medicine present in the environment, and issues concerning the validity of withdrawal
periods.
MAHs must include reports of all adverse events and other pharmacovigilance issues
involving a veterinary medicine in the Periodic Safety Update Report (PSUR) for the
product. A scientific evaluation of the risk-benefit balance of the veterinary medicine is an
important aspect of a PSUR, which should also include an estimation of exposure to the
veterinary medicine and the incidence of adverse events associated with it.
The VMD should be informed immediately about any concerns relating to the safety of a
veterinary medicine arising from pharmacovigilance or resulting from quality issues.
FURTHER INFORMATION
For more information on pharmacovigilance please contact the VMD‟s pharmacovigilance
team on 01932 338427 or alternatively contact VMD reception on 01932 336911 and
quote “pharmacovigilance”.
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