The Risk Management Plan (RMP) is a mandatory part of the marketing authorization documents of a medicinal product and is updated throughout the entire life cycle of a medicinal product.

The published RMP Summary is part of the RMP and describes the safety profile of a medicinal product and lists the measures planned for further investigation and monitoring of the risks and for their prevention or minimization.

By publishing the RMP summaries, the Federal Institute for Drugs and Medical Devices (BfArM) informs you as a user, for example as a

• patients
• nursing staff
• Doctors and physicians,
• pharmacist or as a representative of the
• representative of the healthcare system.

The RMP summaries are published in German and English on the portal for drug information of the federal and state governments (online platform PharmNet.Bund). The BfArM publishes a monthly updated list of preparations for which an RMP summary has already been posted on PharmNet.Bund on its website.

The RMP summaries supplement the summaries of the Public Assessment Reports (PAR) on medicinal products as well as the package leaflets and information for healthcare professionals, which are also publicly available on PharmNet.Bund.