Pharmacovigilance

What is Pharmacovigilance?

Pharmacovigilance is a means of continuing to monitor the safety and efficacy of products once they are approved and in the marketplace. Veterinary Pharmacovigilance concerns the safety and efficacy of veterinary medicines used for the treatment, prevention or diagnosis of disease in animals.

What is an adverse event?

An adverse event is a report of a harmful and unintended outcome which is due to exposure to a veterinary medicine administered to an animal. In other words it is any harmful or unexpected side effect to a veterinary medicine. Adverse reactions can occur in animals treated with veterinary medicines, or people who are exposed to veterinary medicines or treated animals. Adverse events also include instances where a veterinary medicine does not work as intended (lack of efficacy), adverse environmental effects and problems with residues of veterinary medicines in human food (milk and meat).

What happens to reports when they are received?

Following receipt of the report, a Norbrook representative will be in touch to discuss the case. Every adverse event report received by Norbrook is recorded and investigated, before being reported to the government agency of the country in which the event occurred.

How can I report an adverse event?

If you consider that you or your animal(s) have reacted badly to a veterinary medicine and you need veterinary or medical advice, you should contact your veterinary surgeon or doctor who will be able to discuss the reaction with you, initiate any treatment required (if possible take the medicine container, or label for a large pack, or package leaflet with you).

You should also report the event to Norbrook using the form below.

You can report a suspected adverse reaction to, or lack of efficacy of, a veterinary medicine by clicking on the link below. When you fill in the report you will need to provide basic information about:

• The name of the product which you think caused the adverse reaction or lack of efficacy.

• The animal(s) or person(s) in which the adverse reaction or lack of efficacy occurred.

• The signs observed of the adverse reaction or lack of efficacy that is suspected.

• Your contact details as the reporter of the adverse reaction or lack of efficacy. You can record this information in the four sections of the form. Your report can be submitted without any additional information, but if you are able to provide further details, these can be added in the final section of the report.

If you have any questions or would prefer to make the report over the telephone, then please call your local Norbrook representative via the Contact section or the Pharmacovigilance team in Newry on +4428 3026 0200 (9am-5.30pm GMT) or for North America enquiries please call +1 913 599 5777