Pharmacovigilance: change in procedure for requesting follow-up information for individual case safety reports

23.04.2020

Healthcare professionals are under extreme pressure due to the coronavirus epidemic. Swissmedic is therefore changing its procedure for requesting follow-up information for individual case safety reports with immediate effect as follows: For all case safety reports sent to Swissmedic, at least one request (previously at least two requests) for follow-up information should be made if relevant details for assessing the case are missing.

This change applies to all authorisation holders and is initially for a limited period up to 30 June 2020.