Pharmaceuticals; notice of use, amendment, or termination of a standard marketing authorization.

You want to use a standard authorization for a drug? You must indicate this, as well as changes and termination of use.

Description

Prerequisites

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

Procedure

Notifications regarding drug standard approvals must be made online.

  • If necessary, register once for the "electronic standard marketing authorization" application on the PharmNet.Bund online platform. When doing so, you must provide the following information, among other things:
    • PNR (Pharmaceutical Contractor 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 notifications of changes and notifications of termination of use of the standard marketing authorization and submit them to the BfArM.
  • You can check the status of your notifications using overview lists.

Deadlines

You must give advance notice of any change, use or termination thereof.

Processing time

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

Required documents

  • Required document/s

    You do not need to submit any further documents to the BfArM to notify the use of a standard marketing authorization.

Online procedures

  • PharmNet.Bund - Standardzulassungen

    The use of a standard approval is indicated to the Federal Institute for Drugs and Medical Devices (BfArM) via the "Standard Approvals" application. You can view and individualize the standard approvals online.

Fees

  • EUR 100.00 per ad

Remedy

The standard approval is an approval exemption. Its use does not constitute an appealable administrative act against the BfArM.

Status:23.06.2022

Responsible for editing:Bundesministerium für Gesundheit

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  • 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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