Adverse events related to veterinary medicinal products

Veterinarians are required to report suspected adverse events, but anyone can submit a report, including wholesalers, authorised retailers, animal owners, farmers and pet owners.

If you are an animal owner, you can ask your veterinarian to submit the report on your behalf, as they have access to the medical records and can provide more detailed and accurate information.

You can report a suspected adverse event in one of the following ways:

1. To the Croatian Veterinary Institute:
   • using the online form for reporting suspected adverse events e-Form
   • using the form for reporting suspected adverse events . Once completed, the form must be sent by e-mail to farmakovigilancija@veinst.hr or by post to the address given in the form.
2. To the marketing authorisation holder, using the contact details in the package leaflet of the veterinary medicinal product.

Using one of these methods is sufficient.

Note:
Personal information required to report a suspected adverse event is used in accordance with the General Data Protection Regulation and solely for the purpose of establishing the safety of use of the veterinary medicinal product.

Any suspected adverse event should be reported, whether mild or serious. A suspected adverse event should be reported even if you are not sure that the veterinary medicinal product was the cause. The adverse event does not need to be investigated or confirmed before it is reported.

You should report:

• adverse events in animals
• lack of the expected efficacy of a veterinary medicinal product
• reactions in humans after contact with a veterinary medicinal product
• residues of the product in food above the permitted limits
• adverse effects on the environment

If several veterinary medicinal products were administered to one animal and you are not sure which one caused the adverse event, one report is sufficient. However, separate reports are required in the following cases:

• when the adverse event occurs in more than one animal species (a separate report is required for each species)
• when the adverse event occurs in more than one person (a separate report is required for each person)
• when the adverse event occurs in both an animal and a human (separate reports are required for the animal and for the human)
• when several species are affected in an environmental incident (separate reports are submitted for each species)

You will receive an e-mail confirming that your report has been received.

After reviewing your report, we may contact you, if necessary, to obtain additional information about the reported adverse event.

Some of the data from the report are sent to the European pharmacovigilance database. Personal data of the reporter or the animal owner (e.g. name, address) are neither transferred to nor stored in the database. The database is managed by the European Medicines Agency on behalf of the regulatory authorities of the European Union. For transparency and the safe use of veterinary medicinal products, the database is publicly available for viewing reported suspected adverse events for a specific veterinary medicinal product or active substance.

Every report of a suspected adverse event contributes to a better understanding of how veterinary medicinal products are used in practice.

All reports are used for the continuous monitoring of the benefit-risk balance of veterinary medicinal products.

By reporting, you contribute to the safe and effective use of veterinary medicinal products and to protecting the health of animals, humans and the environment.