Drugs are, by their own nature, especially risky products, in particular those that just reached the market and were developed in a short time, such as the COVID-19 vaccines. The potential hazards they can involve for patients/ consumers require additional measures of consumer protection, in addition to the general legal framework of manufacturer's liability. This paper focused on one of these additional measures: pharmacovigilance, i.e., the post-commercialization monitoring of pharmaceutical products, from the perspective of European law. The aim of this paper was to demonstrate the role of pharmacovigilance in the prevent ion of harm cause d by defective drugs and consequent consumer protection, highlighting its benefits and flaws. Pharmacovigilance is not a miraculous solution and has its flaws. However, it can be a useful tool for the management of benefit-risk to ensure appropriate drug use after marketing. Liability for defective products only addresses compensation for injuries that already occurred, while pharmacovigilance intervenes ex-ante to prevent the occurrence of some of those damages.
