Marketing Authorization Holders (MAHs) have a legal obligation, under Directive 2001/83/EC, as amended, to set up and maintain a system for Pharmacovigilance. This involves collection, comparison and evaluation of information about suspected Adverse Drug Reactions (ADRs) to their medicinal products under normal conditions of use in the market place. This requirement must be met by generic pharmaceutical MAHs as well as the holders of the original licenses.
Legal Basis
