Abstract: The European Parliament and the Council of the European Union have
recently adopted Regulation (EU) No 1235/2010^1 and
Directive 2010/84/EU^2 concerning the pharmacovigilance of
medicinal products for human use. These and other European institutions have
been laying down rules on the subject for decades, but this is the first time
they have enacted legislation specifically and (almost) exclusively regulating
pharmacovigilance. This paper analyzes the context, causes, objectives, key
points and challenges of the new legislation.