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Medicinal products; notification of use, change or termination of a standard marketing authorization

Do you want to use a standard authorization for a medicinal product? You must report this, as well as changes and termination of use.

Online services

Online services

Responsible for you

Bundesinstitut für Arzneimittel und Medizinprodukte

Street address

Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Postal address

Kurt-Georg-Kiesinger-Allee 3

53175 Bonn

Website

www.bfarm.de

Procedure details

The Federal Ministry of Health (BMG) can exempt certain medicinal products from the obligation to obtain individual marketing authorization. This exemption is called standard authorization and is granted by a legal ordinance issued by the BMG. The prerequisite for this is that a risk to humans and animals can be ruled out. To this end, the requirements for quality, efficacy and safety must be proven.
In the case of standard marketing authorizations, the spectrum of medicinally active ingredients ranges from chemical substances such as paracetamol to effective teas.
If you as a pharmaceutical entrepreneur use a standard marketing authorization, you must notify the Federal Institute for Drugs and Medical Devices (BfArM). This obligation to notify also applies if you no longer have a standard marketing authorization or if there are changes requiring notification.
In such a notification, you must provide the following information, among others:

  • Manufacturer
  • name used
  • non-active ingredients used, insofar as they are not specified by law, and
  • the actual composition of the medicinal product, insofar as differences are permitted.

  • You are a pharmaceutical entrepreneur, for example a pharmacist.

  • Required Documents

    Sie müssen für die Anzeige der Nutzung einer Standardzulassung keine weiteren Unterlagen beim BfArM einreichen.

You must submit notifications regarding standard marketing authorizations for medicinal products online.

  • If necessary, register once for the "electronic standard authorization" application on the PharmNet.Bund online platform. You must provide the following information, among others
    • PNR (pharmaceutical company number)
  • Log in to the PharmNet.Bund online portal for the "Electronic standard authorization" application.
  • Follow the menu navigation to make your notification. You can also use the portal to enter change notifications and notifications of termination of use of the standard authorization and send them to the BfArM.
  • You can check the status of your notifications using overview lists.

EUR 100.00 per ad

You must notify us in advance of any change, use or termination.

  • none for initial notifications and notification of termination of use.
  • The authorization number is usually communicated on the next working day.
  • Notifications of variations may have to be reviewed by the BfArM depending on the aspect of the variation. Depending on the complexity, processing at the BfArM usually takes a maximum of 1 week.

The standard approval is an approval exemption. Its use does not constitute an administrative act vis-à-vis the BfArM that can be appealed.

Status: 23.03.2025
Editorially responsible for prodecure description: Bundesministerium für Gesundheit
Source: Federal Portal
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