Swissmedic Revised Risk Management Guidance for Human Medicines
Freyr Global Regulatory Affairs
![Freyr Global Regulatory Affairs]()
Freyr Global Regulatory Affairs
Regulatory Assessment, Market Authorizations, Post-Approval Changes, HA Query Management.
Swissmedic revised the ‘Risk Management’ guidance to indicate its application for the use of human medicines. The document is effective from March 01, 2022, and it clarifies various obligations to submit a Risk Management Plan (RMP) for authorization application mentioned in section 6. The title has been revised from HMV4 to HMP to clearly state that it doesn’t include veterinary medicinal product information.
?A new section on the “Switzerland-specific Annex” (SSA) substantiates and presents any discrepancies concerning the safety or pharmacovigilance activities.
For compliance best practices, reach out to a proven Regulatory expert like Freyr.