Pharmaceuticals; inspection of published assessment reports.
On the portal for drug information of the federal government and the states, you can view public assessment reports with information on the approval decision of drugs, as a supplement to the expert information and directions for use.
Description
In the so-called public assessment reports (PAR), the Federal Institute for Drugs and Medical Devices (BfArM) informs users, for example
- Physicians,
- pharmacists and
- other health care professionals.
The PARs contain information on medicinal products and medical devices concerning
- 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 approval decision and are a supplement to the already publicly available expert information and information for use.
The assessment reports published by the BfArM relate to medicinal products for use in humans. They are published on the portal for drug information of the federal and state governments (online platform PharmNet.Bund).
You can view these assessment reports there at any time.
Prerequisites
There are no prerequisites.
Procedure
- Open the PharmNet.Bund online platform.
- Click on "Drug information system" and then on "Search".
- After you have accepted the declaration of consent, you can search for drugs and also read the assessment reports.
Deadlines
You do not have to meet any deadlines.
Processing time
The BfArM publishes the PAR promptly after approval of the corresponding drugs. In the event of major changes to the marketing authorization, for example indication extensions, the BfArM publishes updates in a timely manner. The time period for preparation depends, among other things, on the complexity of the approved drug.
Online procedures
-
PharmNet.Bund - Arzneimittel-Informationssystem
In the PharmNet.Bund drug information system, in addition to administrative data relating to the approval of drugs, further information such as technical information and directions for use can also be searched free of charge.
Remedy
The publication of public assessment reports is not an appealable decision.
Links to more information
Status:25.02.2023
Responsible for editing:Bundesministerium für Gesundheit
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Form, Bavaria-wide
- Form, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited
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