This Module contains guidance on the planning, conduct, reporting and follow-up of pharmacovigilance inspections in the EU and outlines the role of the different parties involved. General guidance is provided under III.B., while III.C. covers the overall operation of pharmacovigilance inspections in the EU.
In this GVP Module, all applicable legal requirements are referenced as explained in the GVP Introductory Cover Note and are usually identifiable by the modal verb “shall”. Guidance for the mplementation of legal requirements is provided using the modal verb “should”.
Directive 2001/83/EC as amended is referenced as ‘DIR’, Regulation (EC) No 726/2004 as amended as ‘REG’ and the Commission Implementing Regulation (EU) No 520/2012 as amended as “IR”.