3/1/2024 0 Comments Ema vet![]() ![]() How do I report an adverse reaction? Animal owner/VeterinarianĪnimal 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. If you still have questions about reporting an adverse reaction, contact the Veterinary Medicinal Products Unit. 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. Undesirable effects occurring after off-label use are also considered to be adverse reactions or suspected adverse reactions. any unfavourable and unintended reaction in an animal to a medicinal product for human use.any suspected transmission of an infectious agent via 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 noxious reaction in humans exposed to a veterinary medicinal product.any observation of a lack of efficacy of a veterinary medicinal product.any unfavourable and unintended reaction in any animal to a veterinary medicinal product.You can find a list of the different types of suspected adverse reactions/undesirable effects in Article 73 of Regulation 2019/6. What suspected undesirable effects (adverse reactions) can be reported? ![]() It is therefore very important that suspected adverse reactions following the use of a veterinary medicinal product are reported as often as possible. If not many adverse reactions are reported, this number will be an underestimate of the actual number of animals affected. Based on reports, it can be calculated how often a specific unidentified adverse reaction will occur in a group of treated animals. 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. These adverse reactions are listed in the package leaflet of the veterinary medicinal product.Īfter 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. Potential adverse reactions emerge during these studies, before the veterinary medicinal product is authorised. This is done before it becomes available for use in animals. The more information that is reported, the more accurate our understanding of adverse reactions from veterinary medicinal products.īefore 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. The reporting of suspected undesirable effects/adverse reactions is a very important part of monitoring veterinary medicines.
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