Sunset-Clause: (Anzeigepflicht für AM für das Inverkehrbringen und die Einstellung des Inverkehrbringens) Entgegennahme

If you want to offer a medicinal product or if you withdraw it from 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).

• 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• if a medicinal product is no longer on the market for 3 consecutive years, i.e. has been withdrawn from the market.

You do not need to submit any documents.

• Authorization or registration for medicinal products
• Valid authorization as a pharmaceutical entrepreneur

EUR 100.00 per registration or deregistration

Registration and deregistration with the Federal Institute for Drugs and Medical Devices is done online.

• If necessary, register on the online platform PharmNet.Bund. Authentication takes place centrally via the registration and user administration (RuBen).
• Select the "Sunset Clause" display procedure.
• Follow the menu navigation to register or deregister for medicinal products. The procedure allows both individual and collective notifications.
• You can check the status of your notifications using an overview list.

• immediately

• Notification: immediately after the business decision has been made, but not earlier than 4 weeks before you place the medicinal product 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.

"Sunset Clause" is a pure notification procedure, so there are no legal remedies.

• Placing on the market and discontinuation of placing on the market (sunset clause) Notification, receipt
• Registration and deregistration with the Federal Institute for Drugs and Medical Devices (BfArM) required if medicinal product
  • a product is to be made available for sale or use (placing on the market) or
  • are withdrawn from the market (discontinuation of placing on the market)
• Registration and deregistration via online platform
• Costs: EUR 100.00 per notification
• Responsible: Federal Institute for Drugs and Medical Devices (BfArM)

Federal Institute for Drugs and Medical Devices (BfArM) - Marketing Authorization Division 1

Address Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, City

Telephone +49 228 99307-4310

E-Maile-sunset-clause@bfarm.de

Federal Institute for Drugs and Medical Devices (BfArM) - Marketing Authorization Division 1

Address Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, City

Telephone +49 228 99307-4310

E-mailsunset-clause@bfarm.de

Forms: yes

Online procedure possible: yes

Written form required: no

Personal appearance required: no