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.
Description
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 reporting the placing on the market of a drug 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 the placing on the market.
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
- a drug is not placed on the market within 3 years of authorization, or
- if a drug is no longer on the market for 3 consecutive years, i.e. has been withdrawn from the market.
Prerequisites
- Approval or registration for medicinal products
- valid approval as pharmaceutical entrepreneur or pharmaceutical entrepreneur
Procedure
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.
Deadlines
- Notification: immediately after the business decision is made, but no earlier than 4 weeks before you place the drug on the market
Deregistration:
- 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.
Remedy
"Sunset Clause is a notice-only process, so there are no appeals.
Links to more information
Status: 23.06.2022
Responsible for editing: Bundesministerium für Gesundheit
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited
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