An adverse drug reaction (ADR) to a (veterinary) medicinal product means any unexpected, often harmful reaction occurring after it is administered. (Veterinary) medicines used for the prophylaxis, diagnosis, or treatment of physiological functions or to influence the said functions can cause such reactions. Clinical trials carried out before a veterinary medicine is authorised are restricted both in terms of the number of animals and the duration of the treatment. Rare risks can thus only be identified after the product is placed on the market, in the framework of wider application and everyday use. Acquiring information thanks to spontaneous reports remains the best tool for identifying this kind of problem as early as possible.
In principle, ADRs can be reported by any person who observes one, i.e. veterinarians, physicians, pharmacists and other medical professionals. Animal owners, however, can and should report an ADR that comes to their attention.
For those using or dispensing medicinal products as part of their professional activities, it is mandatory to report ADRs to the Agency as prescribed by Article 59 of the Law on Therapeutic Products of 15 December 2000 (HMG) and in articles 35-39 of the Ordinance on Medicinal Products of 17 October 2001 (VAM).