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mixins.searchInfo_searchTermRegistration and deregistration of medicinal products with the Federal Institute for Drugs and Medical Devices

Registration and deregistration of medicinal products with the Federal Institute for Drugs and Medical Devices

Source: BUS Rheinland-Pfalz

As a pharmaceutical entrepreneur, you are obliged to register and deregister medicinal products with the Federal Institute for Drugs and Medical Devices (BfArM).

  • Registration means the notification of the placing on the market of a medicinal product for which you have a marketing authorization. Placing on the market means making a product available for sale or use.
  • Deregistration means the notification of the end of placing on the market.

The procedure is also known as the "sunset clause".
Even if you no longer produce a medicinal product, you must report this.
The marketing authorization loses its validity if

  • a medicinal product is not placed on the market within 3 years of authorization or
  • if a medicinal product is no longer on the market for 3 consecutive years, i.e. has been withdrawn from the market.

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