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Do you want to use a standard authorization for a medicinal product? You must report this, as well as changes and termination of use.
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:
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.
EUR 100.00 per ad
You must notify us in advance of any change, use or termination.
The standard approval is an approval exemption. Its use does not constitute an administrative act vis-à-vis the BfArM that can be appealed.
If you want to offer a drug or if you take it off the market, you must report this.