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If you want to offer a drug or if you take it off the market, you must report this.
As a pharmaceutical entrepreneur, you are obliged to register and deregister medicinal products with the Federal Institute for Drugs and Medical Devices (BfArM).
The procedure is also known as the "Sunset Clause."
You must also notify us if you no longer produce a drug.
The marketing authorization becomes invalid if
You do not need to submit any documents.
Registration and deregistration with the Federal Institute for Drugs and Medical Devices is done online.
EUR 100,00 per registration or deregistration
Deregistration:
"Sunset Clause is a notice-only process, so there are no appeals.
Do you want to use a standard authorization for a medicinal product? You must report this, as well as changes and termination of use.