The FAMHP reminds marketing authorisation holders of the obligation to add recommendations on the use of contraception to the package leaflet of genotoxic medicines.
In February 2020, the European Medicines Agency published an advice, based on a request from the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), on the use of contraception in male and female patients after discontinuation of treatment with a genotoxic medicine. This recommendation applies both to clinical trials and marketing authorisation applications.
The CMDh noted that the relevant information from the published recommendation has not yet been included in most of the package leaflets of the medicines concerned and calls on marketing authorisation holders to add this information as soon as possible.
To change patient information leaflets, marketing authorisation holders should submit a Type IB variation under the C.I.z classification and use the worksharing variation procedure when possible. If new additional data are required, they should submit a type II variation under classification C.I.4.