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The term "pharmacovigilance" is defined as the ongoing and systematic monitoring of the safety of medicinal products.

The findings on the safety of a medicinal product are not complete at the time of first licensing. This is mainly due to the fact that the clinical testing of a medicinal product is performed in a relatively small number of patients. Additionally, these patients have been selected specifically for the clinical trial under consideration of various aspects and do not generally represent the average patient in a doctor's office. As a rule, rare or very rare undesired effects, interactions, or other dangers in connection with the use of a medicinal product can therefore not necessarily be recognised in clinical trials. Serious rare undesired effects are of particular importance for the overall evaluation of a new medicinal product. New information on the safety of a medicinal product can become known long after it has been licensed and is dependent upon new developments in medical science.

The BfArM collects and evaluates reports of adverse drug reactions and takes the necessary measures for patient protection.