Source: BUS Sachsen-Anhalt (Linie6Plus)

View summaries of risk management plans (RMPs) for authorized medicinal products

Description

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). On its website, the BfArM publishes 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 package leaflets and information for healthcare professionals.

Prerequisites

There are no prerequisites.

Required documents

You do not need to submit any documents.

Fees (costs)

There are no costs.

Deadlines

There is no deadline.

Processing time

The BfArM publishes the RMP summaries promptly after authorization of the corresponding medicinal products. Priority for publication is given to new authorizations of original preparations. Thereafter, RMP summaries for generics (copycat products) are also considered for publication.

Legal remedy

The publication of the RMPs is not an appealable decision.

Applications / Forms

Forms available: No

Written form required: No

Informal application possible: No

Personal appearance necessary: No

Online services available: Yes

Procedure

Open the online platform PharmNet.Bund.
Click on "Drug information system" and then on "Search".
Accept the declaration of consent.
After entering the active substance or trade name you are looking for, you will be taken to the documents of the RMP summary (German and English) under "Additional documents".