Medicinal products for human use: pharmacovigilance of products

This dossier concerns pharmacovigilance of medicinal products for human use. Amendments address the Eudravigilance database as a single point of receipt, a medicines safety web-portal, creation of a Pharmacovigilance Risk Assessment Committee, post-authorisation safety studies, reporting of suspected adverse reactions by health professionals and patients, traceability of biological medicinal products, funding, and monitoring environmental effects of pharmaceutical residues.