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

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.

Processing time

  • immediately

Required documents

  • Required document/s

    You do not need to submit any documents.

Online procedures

Fees

  • EUR 100,00 per registration or deregistration

Remedy

"Sunset Clause is a notice-only process, so there are no appeals.

Status:23.06.2022

Responsible for editing:Bundesministerium für Gesundheit

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  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Form, Bavaria-wide
  • Form, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
Information

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