Medicinal products; registration and deregistration of placing on the market
If you want to offer a drug or if you take it off the market, you must report this.
- Approval or registration for medicinal products
- valid approval as pharmaceutical entrepreneur or pharmaceutical entrepreneur
Registration and deregistration with the Federal Institute for Drugs and Medical Devices is done online.
- If necessary, register on the PharmNet.Bund online platform. Authentication runs centrally via the registration and user administration (RuBen).
- Select the "Sunset Clause" display procedure.
- Follow the menu navigation to register or deregister for drugs. The procedure allows both individual and collective notifications.
- You can check the status of your messages using an overview list.
- Notification: immediately after the business decision is made, but no earlier than 4 weeks before you place the drug on the market
- 2 months before the end of placing on the market.
- The expiration date of the last batch placed on the market must not be more than 10 years in the future.
"Sunset Clause is a notice-only process, so there are no appeals.
Links to more information
Responsible for editing:Bundesministerium für Gesundheit
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