Veterinarians and breeders:
The following paragraphs deal mainly with the reporting of suspected adverse reactions to veterinary medicinal products (VMP) (they have a marketing authorisation number and a packaging code). These fall within the scope of Regulation (EU) 2019/6 on veterinary medicinal products and Act No 378/2007 on pharmaceuticals, as amended.
How to report
Report suspected adverse reactions using the form. Please send the completed form directly to the MAH of the VMP or the USKVBL.
Contact (USKVBL)
Completed forms or questions:
by email:
to the Czech data box of the USKVBL; by letter to USKVBL
Telephone consultations, questions:
tel. +420 541 518 206, +420 541 518 272, or +420 720 940 693
However, Act No 166/1999 on veterinary care, as amended, and the related Decree No 159/2021 on veterinary products and veterinary technical devices also address the reporting of suspected adverse reactions for veterinary products (VP) and veterinary technical devices (VTD), for which separate forms are prepared.
If you are not sure which form to choose, contact USKVBL.
Reporting suspected adverse reactions is important
Adverse reactions of medicinal products cannot be excluded despite thorough clinical investigations in the approval process. It often appears only with a wide practical application. Systematic collection and evaluation of individual cases is therefore often the only basis for identifying links between observed adverse reactions and the use of specific drugs.
What to report
1. Animal reaction to VMP that is unfavorable and unintended
2. Insufficient efficacy of VMP after administration to the animal, regardless of compliance with product information
3. Environmental emergencies recorded after administration of VLP to an animal
4. Adverse reaction in human exposed to VMP
5. Detection of residues above the maximum levels in compliance with the withdrawal period
6. Suspected transmission of infectious agents via VMP
7. Animal reaction to a medicinal product for human use which is unfavourable and unintended
Minimum data for reporting
1. Data on identifiable animals, persons or environment
2. Names of veterinary or human medicinal products
3. Data on adverse reactions
4. Identifiable Reporter or Source (Your reports are subject to data protection and are anonymised. The whistleblower's personal data will only be used for further enquiries.)
Who reports
• The operator shall report via the veterinarian who administered the medicinal product to the animal. The report shall be submitted either by the USKVBL or by the marketing authorisation holder of the medicinal product.
• An animal keeper who uses authorised medicinal products intended for animals which, on the basis of a marketing authorisation, may be sold without a prescription and outside pharmacies. The report shall be submitted either by the USKVBL or by the marketing authorisation holder of the medicinal product.
• The keeper of animals from which products intended for human consumption are obtained shall be required to report suspected adverse reactions to a veterinarian.
In this case, the USKVBL is fully available to the breeders for consultation and assistance with reporting.
Other (marketing authorisation holders, manufacturers, distributors, retailers, pharmacies, etc.):
Other entities and operators are subject to additional obligations under the current pharmacovigilance legislation, including the reporting of suspected adverse reactions.
When receiving information from breeders or veterinarians on possible adverse effects of a veterinary medicinal product, we recommend that they refer to the information in the ‘Veterinaries and breeders’ section or directly encourage them to contact the USKVBL.
What happens after reporting suspected adverse reactions
Each report shall be recorded in the European database on adverse reactions to veterinary medicinal products and analysed. The likely relationship between the product and the reaction is assessed, compared with other similar cases and trends monitored. The report enables a better understanding of the safety profile of products and a timely response to potential risks.
You do not have to be 100% sure that the cause of the problem was the drug. Suspicion is enough. The expert assessment shall be carried out by the staff of the pharmacovigilance system.
The Package Leaflet and the Summary of Product Characteristics (SPC) for VLP always contain an up-to-date list of adverse reactions detected and their frequency. You can find this information for individual VLPs here, on the USKVBL website.
More detailed information on the adverse reactions identified at European and global level can be found in the European Database for Reporting Suspected Adverse Reactionsof Medicinal Products here.
Adverse reactions are evaluated as signals of potential risks. Based on the analysis of these signals, measures may be taken such as updating the package leaflet, changing the conditions of use of the product, issuing a warning or, as a last resort, withdrawing the product from the market.
Thank you for taking the time to report suspected adverse reactions and contribute to ensuring the safety of animals, humans and the environment.
Main legislation:
Regulation (EU) 2019/6 on veterinary medicinal products, including Commission Implementing Regulation (EU) 2021/1281 laying down rules for the application of Regulation (EU) 2019/6 as regards good pharmacovigilance practice and the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products
Act No 378/2007 on pharmaceuticals, as amended
Act No 166/1999 on veterinary care, as amended
Decree 159/2021 Coll., on veterinary products and veterinary technical devices