How to report a problem with an animal medicine online

Summary

How to report an adverse event to animal medicine using the VMD's online reporting service.

What to report

Adverse events are observations that are unfavourable and unintended that happen after giving a medicine to an animal, or after an animal or human are exposed to a medicine.

You should report adverse events:

following use of, or exposure to, authorised veterinary medicines, including where a product has not worked as expected
whether or not they are already listed on the Summary of Product Characteristics (SPCs) for an authorised veterinary product
following off-label use (using聽a medicine in a way that is not specified on the product鈥檚 SPC or label, regardless of whether this was done intentionally such聽as a聽under the聽prescribing cascade, or in error)
involving unauthorised products
involving human medicines administered to animals or where animals have been exposed accidentally to human medicines
in a person following accidental or intentional exposure to a veterinary medicinal product
involving products authorised in a non-UK country, which have been imported for use in the UK and where the event occurred in the UK
where you are unsure if it is related to the product or not
where there are environmental impacts, or
issues relating to the detection of medicinal product residues in foodstuffs of animal origin

What you can鈥檛 report

Do not use this form to report:

adverse events occurring in people following use of human medicines, report these to the聽Medicines and Healthcare products Regulatory Agency (MHRA)
adverse events that have occurred outside the United Kingdom, instead contact聽the government聽organisation聽responsible for veterinary medicines where the adverse event has occurred
adverse events that have occurred following microchip administration, instead contact聽Department for Environment, Food and Rural Affairs (Defra)
complaints or concerns about a veterinary surgeon, these concerns should be addressed to the鈥�
product defects, where there is a problem with a product that may make it unsafe to use or not work properly, unless there has been an adverse event following administration (product defects should be reported to the Marketing聽Authorisation聽Holder responsible for the product)

This form should also not be used to request individual clinical advice. Specific treatment of an animal is best determined by the veterinary professional under whose care they fall. For advice on specific cases, general product advice or when considering off-label use, we advise veterinary professionals to contact the Marketing Authorisation Holder (pharmaceutical company).

General pharmacovigilance-related information can be found here.

Creating an adverse event report using the online form

How to create an online adverse event report for an animal medicine.
Which products to include in an adverse event report

Information on which products to list when completing an adverse event report for an animal medicine or a product which an animal has been exposed to.
After submission of an adverse event report

What happens after you have submitted the online report of an adverse event to an animal medicine.
Reports involving adverse events in an animal

Information required for reporting an adverse event in an animal.
Reports involving adverse events in a person

Information for reporting adverse events in a person following accidental or intentional exposure to an animal medicine.
Reports involving adverse events in the environment

Information on reporting suspected adverse events to animal medicines in the environment.
Adverse event reports involving residues

Information for reporting adverse events involving residues from animal medicine.
Deleting an adverse event report

Information on how to delete a report of an adverse event to an animal medicine.
Further questions on adverse event reports

How to contact the VMD for further support.
Data and privacy

How we use information you give us when you submit an adverse event report.

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