Drug safety signals regarding human medicinal products – introduction of a new form
A new Signal Notification Form is now to be used for initial and follow-up signals which are reportable to Swissmedic in accordance with guidance document MU101_20_001e_WL Guidance document Drug Safety Signals HMV4. A Cover Letter is no longer required.
The new form should make the structure of the reporting of signals more standardised and easier.
The form is available for use with immediate effect. Use of the Signal Notification Form will be mandatory for reporting safety signals as of 1 January 2020 at the latest. Additional documentation relating to the signal report, such as assessment reports, detailed statements, references, etc. should be appended to the notification form.
The notification form should not be used for information on signal reports that already have a Swissmedic Signal ID. For these reports, a Cover Letter stating the Signal ID in the subject line should be attached as hitherto.
Chapter 10 of the guidance document MU101_20_001e_WL Guidance document Drug Safety Signals HMV4 (“Formal requirements for signal reporting”) has been adapted accordingly.