Medicinal products for human use: pharmacovigilance of products

This dossier concerns pharmacovigilance of medicinal products for human use. Amendments revise recitals defining 'medication error' and 'adverse reaction', the marketing authorisation holder's pharmacovigilance system and master file, post-authorisation safety studies, information in the summary of product characteristics and package leaflet, reporting of suspected adverse reactions by Member States and health professionals, safety web-portals, and pharmaceutical residues in water.