Abstract
A major revision of the pharmacovigilance legislation came into force in the European Union (EU) in 2010 and applies from July 2012. A technical implementing regulation and detailed guidance have been issued in 2012 to facilitate this enhancement of EudraVigilance. Major emphasis has been put on further strengthening the role of EudraVigilance as regards simplifying adverse reaction reporting, collecting adverse reactions, detecting new risks, monitoring known or potential risks and providing stakeholders with adequate access to adverse reaction data.
The legislation has created the Pharmacovigilance Risk Assessment Committee that is responsible for assessing all aspects of the risk management of medicines for human use. The Risk management system are a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products. The requirements in the Directive and Regulation include provisions for post-authorisation efficacy studies, in addition to post-authorisation safety studies.
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