Verordnung der Bundesministerin für Gesundheit und Frauen betreffend Pharmakovigilanzanforderungen und Pharmakovigilanzmeldungen (Pharmakovigilanz-Verordnung 2006 – PhVO 2006)

This regulation sets out the requirements for pharmacovigilance, which is the monitoring of the safety of medicines after they have been authorised for use. It details the procedures for reporting adverse drug reactions and other safety concerns. This affects pharmaceutical companies, healthcare professionals, and patients by ensuring that medicines are continuously monitored for safety and that any emerging risks are identified and managed promptly.