Service Finder
Registration and deregistration of medicinal products with the Federal Institute for Drugs and Medical Devices
Service 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 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- if a medicinal product is no longer on the market for 3 consecutive years, i.e. has been withdrawn from the market.
Process flow
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.
Requirements
- Authorization or registration for medicinal products
- Valid authorization as a pharmaceutical entrepreneur
Which documents are required?
You do not need to submit any documents.
What are the fees?
EUR 100.00 per registration or deregistration
What deadlines do I have to pay attention to?
- 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.
Processing duration
- immediately
Applications / forms
"Sunset Clause" is a pure notification procedure, so there are no legal remedies.
Appeal
Forms: yes
Online procedure possible: yes
Written form required: no
Personal appearance required: no
Further Information
Author
The text was automatically translated based on the German content.
- Sunset clause: (notification obligation for AM for placing on the market and discontinuation of placing on the market) Receipt
Remark: Display of performance in the source portal
Technically approved by
Federal Ministry of Health
Professionally released on
20.01.2022
Source: Zuständigkeitsfinder Thüringen (Linie6PLus)
Competent Authority
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) - Abteilung Zulassung 1
Address
53175 Bonn, Stadt
