Here you will find more detailed instructions for reporting suspected quality defects (including counterfeits) in veterinary medicinal products (VMP), veterinary products (VP) or veterinary technical devices (VTD).
What is a quality defect?
A defect in the quality of a product can generally be defined as a non-compliance of the product with the required qualitative and quantitative parameters. This is mainly due to non-compliance with the specifications set out in the registration dossier (for VMP) or the approval decision (for VP). This inconsistency may manifest itself as any unusual characteristic that does not correspond to the description of the product in the package leaflet or in the summary of product characteristics, as appropriate. This may include the appearance of the packaging (e.g. language version, size or shape, leakage, discrepancy in the labeling of the inner and outer packaging or package leaflet, damage, contamination), the appearance of the product (e.g. different color, shape, presence of foreign particles, non-standard turbidity, missing content), missing application aids, changes in other properties of the product (e.g. non-standard odor, taste, consistency, solubility, friability of tablets). A number of these defects can also be a sign that it is a counterfeit.
Information on quality defects (including counterfeits) USKVBL obtains:
- through participation in the international Rapid Alert System (RAS),
- from the inspection activities of the Inspection Department of the USKVBL and testing samples of products taken under the Market Surveillance Programme by the Department of the Official Laboratory for the Control of Veterinary Medicines of the USKVBL,
- from reports from breeders, operators, veterinarians, manufacturers, marketing authorisation holders of VMP or approval of VP, distributors and other entities.
How to report
Report suspected quality defects using the form
Contact (USKVBL)
Completed forms or questions:
by email:
to the Czech data box of the USKVBL; by letter to USKVBL
Telephone consultations, inquiries (continuous telephone connection): Tel. +420 720 940 693
Reporting suspected quality defects and counterfeits is important
Defects in quality cannot be ruled out despite thorough examination and testing of the products. Cases of counterfeiting products are also increasing. In order to protect animal health, public health and the environment, it is necessary to take effective measures in a timely manner to minimise possible adverse effects of products with quality defects. The competent authorities (including USKVBL) or the European Commission may suspend or prohibit the placing on the market or order the withdrawal from the market of a product or specific batches thereof affected by a quality defect. Thank you for taking the time to report suspected quality defects and counterfeits and contribute to ensuring the safety of animals, humans and the environment.
Instruction No 02/2004 Reporting of suspected or detected quality defects is intended for operators and marketing authorisation holders and provides details on how to proceed in cases of suspected or confirmed quality defects.
Documents are available only in Czech - at this link.