At the time of market approval of a medicinal product knowledge about its safety is based on nonclinical experiments and clinical studies, carried out with calculated numbers of selected volunteers and patients. Thus, safety information of a just launched medicinal product requires further input which remains so in varying degrees even years after approval and continued administration to increasing numbers of patients. In most cases the knowledge gap concerning safety is getting smaller during the course of the application of a medicinal product due to reports from physicians, pharmacists and other health care professionals, as well as reports from patients. Of special interest are reports about adverse drug reactions that rarely occur, occur in specific patient groups (e.g. in children, elderly, etc.) or might be related to long-term use. Moreover, it is also very important to learn more about the medicinal product’s interactions with other medications.
Thus, in order to get comprehensive information about the safety of a medicinal product it is obligatory for Marketing Authorization Holders to systematically collect and update suspected adverse drug reactions, process and forward it to the local authorities.
Such information is then provided by most local authorities on their home page in local language. For those concerned it is advised to visit the respective homepage as required.
How can you report adverse drug reactions?
In order to report adverse drug reactions please download and fill in the form as indicated below: