Service Portal Niedersachsen Startseite
Please enter a search term.
Please note:You can only obtain complete information if you indicate the place of residence, the place of business or the building project, depending on the procedure.

View summaries of risk management plans (RMPs) for authorised medicines

The risk management plan (RMP) is a mandatory part of the marketing authorisation documents of a medicinal product and is updated throughout the entire life cycle of a medicinal product.

The published summary of the RMP (RMP Summa-ry) is part of the RMP and describes the safety profile of a drug and lists the measures that are planned for further investigation and monitoring of the risks as well as for their prevention or minimization.

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

  • Patientin und Patient
  • Nurse
  • Doctor,
  • Pharmacist or as a
  • Representative of the health care system.

The RMP summaries are published in German and English on the portal for drug information of the Federal Government and the Länder (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 in PharmNet.Bund.

The RMP summaries supplement the summaries of public assessment reports (PAR) on medicinal products as well as the package leaflets and product information, which are also publicly available in PharmNet.Bund.
 

Process flow

  • Open the online platform PharmNet.Bund.
  • Click on "Drug Information System" and then on "Research".
  • Accept the declaration of consent.
  • After entering the active ingredient or trade name you are looking for, you get 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 have 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 authorisation of the corresponding medicinal products. Here, the priority of publication is on new approvals of original preparations. Thereafter, RMP summaries on generics (copycat preparations) are also taken into account for publication.

Legal basis

Section 34 (1a) No. 3 of the Act on the Marketing of Medicinal Products (Arzneimittelgesetz - AMG) in conjunction with (1d)

Applications / forms

Forms available: No

Written form required: No

Informal application possible: No

Personal appearance required: No

Online services available: Yes

Appeal

The publication of the RMPs is not an appealable decision.

What else should I know?

There are no clues or peculiarities.

Technically approved by

Federal Ministry of Health (BMG)

Author

The text was automatically translated based on the German content.

Source: Serviceportal Niedersachsen (Portalverbund des Bundes und der Länder)

Further Links

Single points of contact of the state of Lower Saxony, Single points of contact of the countries of Europe, advice and assistance for EU citizens and their families.
Access information on the single point of contact for the state of Lower Saxonyvisit Website Internal Market, Industry, Entrepreneurship and SMEsVisit advice and assistance for EU citizens and their families