The Risk Management Plan (RMP) is a mandatory part of the marketing authorization documents of a medicinal product and is updated throughout the life cycle of a medicinal product.
The published summary of the RMP (RMP Summa-ry ) is a part of the RMP and describes the safety profile of a drug and lists the measures intended to further investigate and monitor the risks and to prevent or minimize them.
By publishing the summaries of RMPs, the Federal Institute for Drugs and Medical Devices (BfArM) informs you as a user, for example as a
- Physician and doctor,
- pharmacist or as a representative of the
- Representative of the health care system.
The RMP summaries are published on the portal for drug information of the federal and state governments (online platform PharmNet.Bund) in German and English. The BfArM publishes on its website a monthly updated list of preparations for which an RMP summary has already been posted on PharmNet.Bund.
The RMP summaries supplement the summaries of the public assessment reports (PAR) on medicinal products, which are also publicly available on PharmNet.Bund, as well as the directions for use and expert information.