1. What is actually an intermittent Cover Posting Report (PSUR)?
Periodic security enhance reports are pharmacovigilance data files designed to give a protection change leading to an evaluation of your effect of one’s records to the exposure-benefit balance out-of a healing tool. They will be submitted from the revenue authorisation owners within defined date facts during the blog post-authorisation stage.
After that info and you will guidance towards submitting from PSURs on the Eu, for instance the a number of Connection recommendations times and you may regularity from submission are offered during the Module VII “Occasional shelter upgrade statement” of the rule into good pharmacovigilance practices (GVP) and also in the next concerns and you may responses.