Enhanced pharmacovigilance (enhanced PV) is the targeted, structured collection of data on specific safety issues associated with a medicinal product following market authorisation. It comes into effect when the data situation indicates that further information needs to be collected.
Usually this involves obtaining follow-up information on specific spontaneous cases from the reporting source using customised questionnaires containing specific relevant questions. For example, all case reports of encephalopathy associated with a particular medicinal product could be followed up as a way of generating additional data on their outcome.
Last updated on:17.02.2016