Abstract
In February this year, the EuropeanMedicines Agency (EMA) placed on the Internet the first seven Good Pharmacovigilance Practice (GVP) modules, out of a full set of 16, for public consultation; the remainder will be available over the next few months. The consultation time is over, and I did not make any comments directly for reasons that are clear: the size and complexity of the documents; the cross referencing needed for consistency in the details; and that there is less than half of the full GVP available now. The GVP is coincident with new, important EU Directives (Directive 2010/84/EU) and Regulations (Regulation [EU] No 1235/2010) amending existing legislation that were adopted in the EU in December 2010. These are comprehensive developments in pharmacovigilance (PV) and need serious, critical reflection.
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