Guideline on good pharmacovigilance practices (GVP) Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev 3):
VIII.Addendum.I.1. Introduction:
This Addendum provides additional information on legal requirements (identifiable by the modal verb “shall”) and recommendations (identifiable by the modal verb “should”) for the submission of study protocols, progress reports and final study reports of non-interventional post-authorisation safety studies (PASS) to national competent authorities and the Agency. It also provides additional information as regards the registration of non-interventional PASS in the EU PAS Register. It does not provide recommendations for the transmission of information to ethics committees, national review boards or other bodies in place according to national legislation.
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EMA GVP Module 8, Addendum I:
