responsibility finder
Schleswig-Holstein

View assessment reports for authorized medicinal products

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6PLus)

Service Description

On the portal for medicinal product information of the federal and state governments, you can view public assessment reports with information on the approval decision for medicinal products as a supplement to the information for healthcare professionals and package leaflets.

In the so-called Public Assessment Reports (PAR), the Federal Institute for Drugs and Medical Devices (BfArM) informs users, for example

  • Doctors,
  • pharmacists and
  • other healthcare professionals.

The PARs contain information on medicinal products and medical devices regarding

  • Quality,
  • efficacy,
  • safety or
  • risks, such as areas of application and possible side effects.

The PARs are intended to contain all essential information for the authorization decision and are a supplement to the already publicly available information for healthcare professionals and package leaflets.

The assessment reports published by the BfArM refer to medicinal products for human use. They are published on the portal for medicinal product information of the federal and state governments (online platform PharmNet.Bund).

You can view these assessment reports there at any time.


Process flow
  • Open the online platform PharmNet.Bund.
  • Click on "Drug Information System" and then on "Search".
  • Once you have accepted the declaration of consent, you can search for medicinal products and also read the assessment reports.
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 for you.

What deadlines do I have to pay attention to?

You do not have to meet any deadlines.

Processing duration

The BfArM publishes the PAR promptly after authorization of the corresponding medicinal products. In the event of major changes to the authorization, for example indication extensions, the BfArM publishes updates promptly. The time required for preparation depends, among other things, on the complexity of the authorized medicinal product.

Legal basis
Appeal

The publication of the public assessment reports does not constitute an appealable decision.

Applications / forms
  • Forms: none
  • Online procedure possible: yes
  • Written form required: no
  • Personal appearance required: no
Author
Forwarding service: Deep link to the original portal

The text was automatically translated based on the German content.

Technically approved by

Federal Ministry of Health

Professionally released on

21.07.2021

Teaser

On the portal for medicinal product information of the federal and state governments, you can view public assessment reports with information on the approval decision for medicinal products as a supplement to the information for healthcare professionals and package leaflets.

Process flow

  • Open the online platform PharmNet.Bund.
  • Click on "Drug Information System" and then on "Search".
  • Once you have accepted the declaration of consent, you can search for medicinal products and also read the assessment reports.

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 for you.

What deadlines do I have to pay attention to?

You do not have to meet any deadlines.

Processing duration

The BfArM publishes the PAR promptly after authorization of the corresponding medicinal products. In the event of major changes to the authorization, for example indication extensions, the BfArM publishes updates promptly. The time required for preparation depends, among other things, on the complexity of the authorized medicinal product.

Legal basis

Appeal

The publication of the public assessment reports does not constitute an appealable decision.

Applications / forms

  • Forms: none
  • Online procedure possible: yes
  • Written form required: no
  • Personal appearance required: no

Author

Forwarding service: Deep link to the original portal

The text was automatically translated based on the German content.

Technically approved by

Federal Ministry of Health

Professionally released on

21.07.2021

Further information and offers