French Public Health Code
In forceFor the purposes of this section, the following definitions shall apply
1° Adverse reaction: a noxious and unintended response occurring at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or for restoring, correcting or modifying physiological function;
2° Adverse reaction in humans: a noxious and unintended response in a human being following exposure to a veterinary medicinal product;
3° Serious adverse reaction: an adverse reaction which results in death, which is likely to be life-threatening, which causes permanent or prolonged symptoms, which results in a congenital anomaly or malformation, or which causes significant disability or incapacity in the animal treated;
4° Unexpected adverse reaction: an adverse reaction the nature, severity or effect of which is not consistent with the information given in the summary of product characteristics defined in article R. 5141-15 ;
5° Periodic safety update reports: periodic reports containing information recorded in accordance with Article R. 5141-105;
6° Post-marketing surveillance studies: a pharmaco-epidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, with the aim of identifying and studying a risk relating to an authorised veterinary medicinal product;
7° Use outside the terms of the summary of product characteristics defined in article R. 5141-15: the use of a veterinary medicinal product in a way that does not comply with the summary of product characteristics, in particular the misuse or serious abuse of the medicinal product.
