The new guidance document Drug safety signals VMP describes the necessary steps for submitting signals that are identified by the marketing authorisation holder or foreign authorities. It provides information on the process and the type of application for various variation procedures and gives an overview of the entire procedure for signals for both marketing authorisation holders and Swissmedic.
The Signal notification form VMP form is available for reporting signals via the Safety Portal. The information to be reported can be taken from foreign procedures.
The new guidance document Drug safety signals VMP and the Signal notification form VMP form are applicable with immediate effect.