This document is the sixteenth annual report of the Pharmacovigilance Inspectors Working Group (PhV IWG). The PhV IWG was established by the European Medicines Agency (hereinafter “the Agency”) within the scope of Article 57(1)(i) of Regulation (EC) No 726/2004.
Following a report on its first year of operation, the PhV IWG mandate was endorsed by the Heads of Medicines Agencies on 18-19 May 2009 and by the Agency’s Management Board on 1 October 2009, thereby formally establishing the PhV IWG.
The PhV IWG focuses on the harmonisation and coordination of pharmacovigilance-related activities at EU (hereinafter the “Union”) level. The group’s role and activities are described in more detail in its work plan. The group supports the coordination of the provision of pharmacovigilance inspectionrelated advice and provides a link to other groups such as the Committee for Medicinal Products for Human Use (CHMP), the Committee for Veterinary Medicinal Products (CVMP), the Pharmacovigilance Risk Assessment Committee (Human Medicinal Products) (PRAC), and the Pharmacovigilance Working Party (Veterinary Medicinal Products) (PhVWP-V).