Inclusion of CH-REP in Communication on Vigilance Topics

Swissmedic has now specified that if the reporting is done by a manufacturer domiciled outside of Switzerland and Liechtenstein, the responsible Authorized Representative (“CH-REP”) must be included in the e-mail distribution list.

Read Swissmedic’s full update here. 

Key Points to Note:

Your designated CH-REP must be included in the mailing list for every e-mail correspondence with Swissmedic on vigilance cases (i.e MIRs, FSCA reports and related follow-ups).

If you are a customer of MedEnvoy, please add vigilance@medenvoyglobal.com to your standard distribution list for communication on vigilance topics with Swissmedic.

If you have any questions or require further clarification on Swissmedic’s update on the inclusion of CH-REP in communication on vigilance topics, please contact us. Our team is ready to discuss how you can ensure compliance.