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.
The Federal Ministry of Health (BMG) may exempt certain drugs from the obligation to obtain an individual marketing authorization. This exemption is called standard approval 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 excluded. To this end, the requirements for quality, efficacy and safety must be proven.
In the case of standard approvals, 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 approval, you must notify the Federal Institute for Drugs and Medical Devices (BfArM). This notification obligation also applies if you no longer use a standard marketing authorization or if notifiable changes occur.
In such a notification, you must provide the following information, among other things:
- designation used
- non-active ingredients used, insofar as they are not specified by law, as well as
- actual composition of the drug, insofar as differences are permitted in this respect.
- You are a pharmaceutical entrepreneur, for example a pharmacist.
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.
You must give advance notice of any change, use or termination thereof.
- 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.
The standard approval is an approval exemption. Its use does not constitute an appealable administrative act against the BfArM.
Links to more information
Responsible for editing: Bundesministerium für Gesundheit
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