RMP Requirement Eliminated – Which Obligations Remain for You?

Since November 1, 2023, medicinal products with known active substances and innovations or biosimilars are no longer required to submit a Risk Management Plan (RMP). As a result, Swissmedic has removed the RMP summaries for these medicinal products from its website as of May 2024.

Despite this change, the obligation to implement additional risk minimization measures (aRMM) remains in place, provided they were specified in the most recently approved RMP. These measures must be continuously adapted to the approved medicinal product information.

If you consider it necessary to adapt or remove these obligations at a later date, you can submit an application of the type “Removal of commitment”.

Existing Obligations Despite Elimination of the RMP Requirement

Your contact