Within the framework of the authorisation procedure, Swissmedic assesses the quality, safety and effectiveness of the medicinal product in question on the basis of the comprehensive scientific documentation that is submitted.
If the criteria for authorisation are fulfilled, Swissmedic grants the marketing authorisation, specifies the method of sale (on prescription only/dispensing point) and approves the information for healthcare professionals and the patient information.
The Guidance document Drug Safety Signals HMP has been comprehensively revised, its structure has been modified and its content has been clarified; in parallel, the Signal Notification Form has been revised and adapted to the new requirements
