Service Finder
View summaries of risk management plans (RMPs) for authorized medicinal products
Service 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). 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.
Process flow
- 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".
Requirements
There are no prerequisites.
Which documents are required?
You do not need to submit any documents.
What are the fees?
There are no costs.
What deadlines do I have to pay attention to?
There is no deadline.
Processing duration
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.
Applications / forms
The publication of the RMPs is not an appealable decision.
Appeal
Forms available: No
Written form required: No
Informal application possible: No
Personal appearance necessary: No
Online services available: Yes
What else should I know?
There are no indications or special features.
Further Information
Author
Federal Institute for Drugs and Medical Devices (BfArM)
Forwarding service: Deep link to the source portal
The text was automatically translated based on the German content.
Technically approved by
Federal Ministry of Health (BMG)
Professionally released on
06.05.2022
Source: Zuständigkeitsfinder Thüringen (Linie6Plus)
Start your request directly online:
Competent Authority
Paul-Ehrlich-Institut (PEI), Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel
Address
63225 Langen (Hessen)
Telephone
+49 6103 77-0Telephone
+49 6103 77-1771Remark: Hotline for inquiries from the public and medical professionals
Fax
+49 6103 77-1234Opening times
- Monday to Friday: 9:00 - 17:00
Further Authorities
Address
53175 Bonn, Stadt
Remark: Bonn office
Link to the directions:
https://www.bfarm.de/DE/Das-BfArM/Anfahrt/_artikel.html