Duration of contraception following the end of treatment with medicinal products with genotoxic potential

01.09.2025

Swissmedic requests marketing authorisation holders to review their medicinal products with genotoxic potential and, if necessary, to submit an application to update the medicinal product information.

According to the guidance document Product information for human medicinal products, the current applicable recommendations issued by EMA (SWP/NcWP recommendations on the duration of contraception following the end of treatment with a genotoxic drug [EMA/CHMP/SWP/74077/2020]) should be consulted as regards duration of contraception after treatment with medicinal products with genotoxic potential (e.g. oncologicals) has ended. These recommendations were updated and clarified in 2023 as part of revision 1.

Swissmedic asks marketing authorisation holders to review their medicinal products with genotoxic potential and, in the event of discrepancies with the revised EMA recommendations, to accordingly modify the information in the medicinal product information concerning duration of contraception following the end of treatment.

The modification should be made with the next regular type II variation to the medicinal product information, but no later than 30 September 2026. If the modification is submitted as a separate application, a variation C.I.z type IB should be used.

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