Reporting an adverse event

Before a veterinary medicinal product is given a marketing authorisation, the Veterinary Medicinal Products Unit assesses whether it works effectively and is safe, based on studies carried out by the marketing authorisation holder. This is done before it becomes available for use in animals. Potential adverse reactions emerge during these studies, before the veterinary medicinal product is authorised. These adverse reactions are listed in the package leaflet of the veterinary medicinal product.

After the veterinary medicinal product is authorised and placed on the market, it is possible that unknown adverse reactions (or suspected adverse reactions) may be seen. These are more likely to be noticed by animal owners and veterinarians, because they use the veterinary medicinal product to treat much larger groups of animals. Based on reports, it can be calculated how often a specific unidentified adverse reaction will occur in a group of treated animals. If not many adverse reactions are reported, this number will be an underestimate of the actual number of animals affected. It is therefore very important that suspected adverse reactions following the use of a veterinary medicinal product are reported as often as possible.

What suspected undesirable effects (adverse reactions) can be reported?

You can find a list of the different types of suspected adverse reactions/undesirable effects in Article 73 of Regulation 2019/6.

They are:

• any unfavourable and unintended reaction in any animal to a veterinary medicinal product;
• any observation of a lack of efficacy of a veterinary medicinal product;
• any environment incident;
• any noxious reaction in humans exposed to a veterinary medicinal product;
• any finding that the maximum levels of residues have been exceeded in an animal product after the set withdrawal period has been respected;
• any suspected transmission of an infectious agent via a veterinary medicinal product;
• any unfavourable and unintended reaction in an animal to a medicinal product for human use.

Undesirable effects occurring after off-label use are also considered to be adverse reactions or suspected adverse reactions. For example, if veterinary medicinal products are used for animal species other than those specified in the product information provided to obtain a marketing authorisation, or if a different dosage is used.

More information

If you still have questions about reporting an adverse reaction, contact the Veterinary Medicinal Products Unit.

How do I report an adverse reaction?

Animal owner/Veterinarian

Animal owners and veterinarians can report suspected adverse reactions following the use of veterinary medicinal products to the marketing authorisation holder (supplier) concerned or to the Veterinary Medicinal Products Unit.

Reports by animal owners

As an animal owner, you can report any adverse reactions or suspected adverse reactions you think you may have observed after administering a veterinary medicinal product to your animal(s).

You can report adverse reactions:

• To a veterinarian. This is the simplest option. The veterinarian is then required to report the adverse reaction or suspected adverse reaction in a person or animal to the marketing authorisation holder or the Veterinary Medicinal Products Unit.
• To the supplier (marketing authorisation holder) of the veterinary medicinal product. To do this, contact directly the supplier named on the label and/or package leaflet of the veterinary medicinal product. The supplier is required to accept your report, save it to a database, investigate it and pass it on to the EMA’s veterinary pharmacovigilance database (EudraVigilance database). If it relates to a suspected adverse reaction in an animal of a medicinal product for human use, the report must be sent to the Veterinary Medicinal Products Unit.
• To the Veterinary Medicinal Products Unit. You can send your report directly to the Veterinary Medicinal Products Unit using the form for reporting an adverse reaction or suspected adverse reaction to a veterinary medicinal product.

Reports by veterinarians

• As a veterinarian, you have an important gatekeepers’ role in relation to the use of veterinary medicinal products. You are required to report suspected adverse reactions/undesirable effects in animals and humans to the marketing authorisation holder/supplier or the Veterinary Medicinal Products Unit within 15 days (see Veterinary Medicines Regulation 2022, Article 5.1). If you suspect an adverse reaction following the use of a veterinary medicinal product from a third country or a medicinal product for human use (cascade), you can report this to the Veterinary Medicinal Products Unit.
• It’s obviously not possible for a veterinarian to say for certain, based on a single animal or case, that an undesirable effect is related to treatment with a veterinary medicinal product. That is why we always talk about a ‘suspected’ adverse reaction or ‘suspected’ undesirable effect.
• To make a report to the Veterinary Medicinal Products Unit, use the form for reporting an adverse reaction or suspected adverse reaction to a veterinary medicinal product.
• You can find more information about adverse reactions on the website of the European Medicines Agency (EMA) and on the IRIS platform (see below).

What happens to my report?

Marketing authorisation holders (and the authorities) are required to pass on reports of suspected undesirable effects/adverse reactions to the European pharmacovigilance database (EudraVigilance), which is hosted by the EMA. This database contains every report made anywhere in the world about a veterinary medicinal product registered in the European Union.

Based on all of the reports in EudraVigilance, the marketing authorisation holder and the authorities carry out a process called ‘signal detection’ for each veterinary medicinal product and active ingredient. This involves applying an algorithm to the database. It’s a kind of mathematical analysis of all reported clinical symptoms (such as diarrhoea) from the veterinary medicinal product concerned, which are then compared with the ratio of all reported clinical symptoms from all other veterinary medicinal products (relative odds ratio). Next, of course, a further analysis is required to check whether it is clear that the veterinary medicinal product concerned was actually involved. For example, reports often state that another veterinary medicinal product was administered at the same time, and the reported symptoms might match that other product better. Or the time between the administration of the veterinary medicinal product and the appearance of the symptoms may be implausibly long.

To ensure that this process runs smoothly, it is therefore very important that reports contain as much information as possible, and that this information is of good quality.

If there is a strong suspicion that a certain undesirable effect was caused by the veterinary medicinal product, the marketing authorisation holder sends a ‘signal’ to IRIS (an EMA program) for monitoring or amendment of the package leaflet. This signal is analysed by the authorities. If it is clear that the veterinary medicinal product causes a certain undesirable effect (adverse reaction), the marketing authorisation holder or the authorities will include that fact in the package leaflet. At this stage, it is no longer a ‘suspected’ undesirable effect, it is simply an undesirable effect (adverse reaction).

You can find information about signals that have been sent, including ones where the link with the veterinary medicinal product has not yet been fully established, on the IRIS platform. A search function lets you search for a particular veterinary medicinal product.

Information for marketing authorisation holders

Reporting

As a marketing authorisation holder you must make individual reports of suspected adverse reactions electronically, within 30 days, to the EMA’s EudraVigilance database. This also applies to reports arising from studies and new data in the literature.

It also applies to reports relating to veterinary medicinal products for which a marketing authorisation has only been issued at the national level, as well as reports of suspected adverse reactions in humans or animals that occur outside of the European Union after use of a veterinary medicinal product registered in the EU. Reports must be submitted in VICH format.

A full list of the reporting obligations of marketing authorisation holders can be found in:

• The EMA Guideline “Collection and recording of suspected adverse events”;
• Section 5 of the Veterinary Medicinal Products Regulation (Articles 73 to 81);
• Implementing Regulation (EU) 2021/1281 or the Implementing Act on Good Pharmacovigilance Practices.

EudraVigilance database

(Union Pharmacovigilance Database)

EudraVigilance is the database used to manage all of the reports and analyse information about suspected adverse reactions to veterinary medicinal products approved within the European Economic Area (EEA). The European Medicines Agency (EMA) manages the system on behalf of the regulatory network for medicines in the European Union (EU).

The pharmacovigilance functions mentioned in the Regulation are implemented as follows:

• Recording of reports of suspected adverse reactions (AERs): EVWeb
• Signal detection and data analysis: EVVet DWH (data warehouse)
• Signal management and inspection results: IRIS.

More information

You can find more information about EudraVigilance Veterinary on the EMA website. If you still have questions about the EudraVigilance database, contact the EMA Service Desk.

Legal basis

Section 5 of the Veterinary Medicinal Products Regulation (Articles 73 to 81) describes the rules relating to monitoring of veterinary medicines. Implementing Regulation (EU) 2021/1281 and the Implementing Act on Good Pharmacovigilance Practices provide more details.

Note: This Regulation has completely changed the rules relating to the monitoring of veterinary medicines. It is expected that the procedures will be clarified further over the next few years, and guidance documents will be supplemented or amended. As soon as this happens, we will amend the text on this website. You can always find the latest information about the new pharmacovigilance rules on the EMA Pharmacovigilance website.