EMA: Guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Requirements for transmission of information on non-interventional post-authorisation safety studies (Rev. 2)

This addendum specifies requirements for the transmission of study protocols, updated protocols following substantial amendments, final study reports and progress reports if requested on post-authorisation safety studies initiated, managed or financed by marketing authorisation holders voluntarily or pursuant to an obligation. Where the full statistical analytical plan is not included in the protocol, it should be reported following the same requirements as for the study protocol.