Animal health practitioners
The European Medicines Agency (EMA) collaborates with animal health practitioners, or veterinarians, to ensure the safety and efficacy of veterinary medicines.
VeterinaryMedicines
EMA and animal health practitioners, or veterinarians, work together to improve animal welfare.
Veterinarians are on the front line in preventing and controlling animal and zoonotic diseases, that can spread from animals to people.
They can identify potential risks through surveillance. They can also guide preventive measures to protect animal and public health.
Furthermore, veterinarians work to reduce the risks of antimicrobial resistance.
This partnership is key to upholding a responsible approach in the use of veterinary medicines.
How EMA supports animal health practitioners
EMA makes several resources available to veterinarians to support their daily practice.
These resources include websites that enable searching for trusted information and reporting suspected adverse events.
They also feature quick, easy-to-follow guides on antibiotic prescription.
In addition, EMA hosts events for veterinarians in collaboration with the Federation of Veterinarians of Europe.
For more information on EMA's partners and networks, see:
Veterinary medicines safety day
Reporting suspected adverse eventsin animals is key to ensuring safer medicines and healthy animals. Every report counts.
Ultimately, reporting suspected adverse events will also help public health and the environment.
Animal health practitioners, or veterinarians, are essential in reporting. They are in a unique position to observe adverse events when they occur. That is why animal owners and keepers should not hesitate to report via their veterinarian.
If you have information to report, provide as much as possible, and as quickly as possible. You do not need to determine if there is a problem with the veterinary medicine before submitting your report.
EMA campaign: download and use our reporting resources
EMA's 'Veterinary medicines safety day' campaign aims to raise awareness of the importance of reporting suspected adverse events.
The campaign includes a toolkit for veterinarians on how and when to report.
The toolkit features downloadable resources such as:
- Simple guide on ‘How to report adverse events’
- Presentation on ‘Adverse event reporting in the EU’
- Social media infocards
In 2025, the campaign takes place on 8 April.
Find the campaign resources below.
If you would like to support this campaign, please contact vet-events@ema.europa.eu to get the open source files that you can customise.
How to find information on veterinary medicines
The Veterinary Medicines information website contains up-to-date public information on:
- all authorised veterinary medicines in the European Union (EU) / European Economic Area (EEA);
- registered homeopathic veterinary medicines;
- medicines allowed for use in small pet animals in the EU / EEA.
This website is easily accessible via computer, smartphone, and tablet with access to the internet. It is translated into the 24 EU official languages, plus Icelandic and Norwegian.
Animal health practitioners, or veterinarians, can use the website to:
- search by product name, active substance, species, pharmaceutical form, and authorisation country;
- consult product information and public assessment reports;
- confirm product availability in their (or neighbouring) country;
- find alternative treatments when using the ‘prescription cascade’.
Watch the video below to see how to find information on veterinary medicines approved for use in the EU:
Keeping veterinary medicines safe
The Union Pharmacovigilance Database is a system that supports the recording of:
- suspected adverse event reports;
- signal detection and data analysis;
- and signal management and inspections outcomes.
This database helps keep veterinary medicines safe.
Adverse event reporting in the EU
EMA and national authorities continuously monitor whether animals that have received a vaccine or medication experience any side effects, also called adverse events.
This ensures that the benefits of veterinary medicines continue to outweigh their risks.
Anyone can report an unfavourable and unintended event in an animal, person or the environment following the use of a veterinary medicine.
However, animal health practitioners, or veterinarians, have an essential role to play. They are often the first port of call for animal owners in terms of reporting medicine-related side effects that their animals experience.
How to report adverse events
Select the expandable panels below to read about the steps necessary to report suspected adverse events.
If you want to report adverse events in animals, you need to include the following information:
- The animal species, the age, sex, breed, and identification
- Details of the adverse reaction and the veterinary medicine used
- Any other relevant treatments
You are encouraged to provide as much information as possible in the report.
The appropriate authority can be:
- the national competent authority in your country;
- or the pharmaceutical company listed on the product packaging.
Make sure to use the reporting format that the appropriate authority requires.
For details on where to report suspected adverse events, see:
Supporting documentation can include:
- Photographs or videos of the affected animal, if relevant
- Copies of diagnostic reports or test results
- Copy of the product label or packaging, if available
After you have submitted your report to the appropriate reporting authority, make sure to:
- check if you have received a receipt confirmation;
- provide any additional details, if requested;
- continue monitoring your animal's condition.
What happens after reporting adverse events
Marketing authorisation holders have a legal obligation to continuously monitor adverse event reports.
EudraVigilance Veterinary is the European database that centralises all reports of suspected adverse events in animals.
When marketing authorisation holders identify new risks, competent authorities can take necessary regulatory measures.
These measures include adding new adverse events or warnings to the product information, and publishing information for animal health practitioners.
Very rarely, national competent authorities or the European Commission can suspend veterinary medicines or withdraw them from the market until there are no longer safety concerns.
For more information, see:
Frequently asked questions on adverse event reporting
Select the expandable panels below for frequently asked questions.
An adverse event is an unfavourable and unintended event in an animal, person or the environment that occurs:
following the use of a veterinary medicine, including off-label usage;
or following the use of a human medicine that has been administered to an animal.
It is also known as side-effect, adverse drug reaction or vaccine failure.
All suspected adverse events in animals and humans following the use of veterinary medicines, including off-label use; this also refers to adverse events already stated in the product information.
Any suspicion that a veterinary medicine has not be effective.
Adverse events in people exposed to veterinary medicines or treated animals.
Environmental incidents, high product residues in foods and suspected transmission of infectious agents.
Suspected adverse events in animals after the use of human medicines.
A suspicion of an adverse event - it does not need to be investigated or confirmed.
Report suspected adverse events in all species of animals.
Report any observation of lack of efficacy of a veterinary medicine following its administration to an animal.
This is regardless of whether or not it is in accordance with the summary of product characteristics.
Report any unfavourable and unintended reaction to a veterinary medicine in any animal.
Report any noxious reaction in humans exposed to a veterinary medicine.
Tackling antimicrobial resistance
EMA promotes the prudent and responsible use of antibiotics in both animals and humans. This can lower the risk of bacteria becoming resistant - which is also referred to as antimicrobial resistance.
Animal health practitioners, or veterinarians, can check the categorisation of antibiotics in animals - that EMA's Antimicrobial Advice Ad Hoc Expert Group (AMEG) set up.
An infographic on the AMEG categorisation is available below, in multiple EU languages:
Restrictions in use of antimicrobials
Veterinarians should also be mindful of possible restrictions in the use of antimicrobials for animals.
Please consult EMA's scientific advice for the:
- list of human-reserved antimicrobials and substances designated under Article 37(5) that are not allowed for use in animals - relevant EMA document is available below;
- list of antimicrobials and substances that should not be used under Articles 112, 113 or used under certain conditions - this complements the list of antimicrobials reserved for humans; relevant EMA document and EU legislation link are available below;
For relevant EU legislation, see:
Events and webinars
Select the expandable panel below for a list of events and webinars that EMA and the Federation of Veterinarians of Europe (FVE) co-organised:
- EMA / FVE webinar on veterinary prescription: conditions for using certain antimicrobials under the 'cascade' (16/01/2025)
- EMA / FVE info session on restrictions for the use of certain antimicrobials in animals (23/05/2024)
- European Medicines Agency (EMA) and Federation of Veterinarians of Europe (FVE) info session on the UPD public portal (21/02/2024)
- European Medicines Agency (EMA) and Federation of Veterinarians of Europe (FVE) webinar on the Union Product Database website (27/06/2022)
- European Medicines Agency (EMA) and Federation of Veterinarians of Europe (FVE) webinar on data collection on sales and use of antimicrobials (24/11/2021)