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Bund 99003091019000 Typ 1

Inhalt

Leistungsschlüssel

99003091019000

Leistungsbezeichnung

Notification Participation in BtM traffic for pharmacies without a license requirement Registration

Leistungsbezeichnung II

Notify the pharmacy or veterinary in-house pharmacy to participate in the narcotics trade

Leistungstypisierung

Typ 1

Begriffe im Kontext

nicht vorhanden

Leistungstyp

Leistungsobjekt mit Verrichtung

Leistungsgruppierung

-

Verrichtungskennung

Registrierung (19)

SDG Informationsbereiche

  • nicht SDG-relevant

Lagen Portalverbund

  • Anmeldepflichten (2010100)
  • Prüfung und Nachweise für Sachkunde und Sicherheit (2120300)

Einheitlicher Ansprechpartner

Nein

Fachlich freigegeben am

09.04.2025

Fachlich freigegeben durch

Federal Ministry of Health (BMG)

Handlungsgrundlage

Teaser

If you run a pharmacy, you must register your participation in the narcotics trade with the Federal Institute for Drugs and Medical Devices (BfArM).

Volltext

If you run a pharmacy, you need a narcotics number. You can apply for this at the Federal Institute for Drugs and Medical Devices (BfArM). This allows you to participate in the narcotics trade. The same applies if you are a veterinarian and run your own veterinary in-house pharmacy.

The following facilities must report their participation in the narcotics trade:

  • Individual pharmacies
  • network pharmacies
  • Hospital pharmacies
  • Veterinary in-house pharmacies

After registration, you will be assigned a narcotics number:

  • When setting up a new pharmacy, you will always receive a new narcotics number.
  • Successors to an existing pharmacy generally receive the narcotics number of the predecessor.
  • As the operator of a network pharmacy, you will receive narcotics numbers for your main and branch pharmacies.
  • Veterinarians generally receive their own narcotics numbers. This also applies if you take over an existing veterinary in-house pharmacy.

If you already have a narcotics number, you must notify the BfArM of any changes. You must report the following changes:

  • New establishment
  • Change of the operator
  • Change of legal form
  • Change in the name of the pharmacy or the operator
  • Change of address of the pharmacy or the operator
  • Closure
  • Waiver of participation in the narcotics trade

If you operate several pharmacies, you must also report the following changes

  • the conversion from main pharmacy to branch pharmacy
  • the conversion of a branch pharmacy into a main pharmacy

If you manage a hospital pharmacy, you must also report the following:

  • the change of name or address of the pharmacy manager
  • the change of a pharmacy manager

Erforderliche Unterlagen

If you wish to register individual, group and hospital pharmacies, waive participation in narcotics traffic or report changes:

  • Copy of the new operating license or
  • written confirmation from the competent state authority that the previous operating license is still valid
  • if available: already assigned narcotics number
  • if the name of the person operating the pharmacy or the person in charge of the hospital pharmacy changes: copy of the name change or marriage certificate, if applicable

If you wish to register veterinary in-house pharmacies, notify us that you no longer wish to participate in the narcotics trade or notify us of changes:

  • Copy of the new veterinary practice dispensary certificate or
  • written confirmation from the competent state authority that the previous veterinary in-house dispensary certificate is still valid
  • if available: already assigned narcotics number
  • if the name of the person operating the veterinary practice dispensary changes: copy of the name change or marriage certificate, if applicable

Voraussetzungen

For pharmacists:

  • You run or manage a pharmacy.

For veterinarians:

  • You own a veterinary in-house pharmacy.
  • You have a valid operating license.
  • You have a valid veterinary in-house pharmacy certificate.

Kosten

Gebühr: 110€ - 250€

Verfahrensablauf

You can notify the Federal Institute for Drugs and Medical Devices (BfArM) online or in writing of your participation in the narcotics trade, changes or withdrawal.

Report participation, changes or withdrawal online:

  • Go to the website of the federal portal and call up the online application.
    • If you are submitting the application as a private individual, you will need an electronic ID document (e.g. the online function of your ID card) and a BundID account.
  • The online application will guide you step by step through the required information.
  • Upload the required documents as a file and send the application. The file must not be larger than 10 megabytes. The following file formats are accepted:
    • PDF
    • PNG
    • JPEG
  • The BfArM will check your information and documents.
    • If documents are incomplete, you will be asked to submit missing documents by e-mail. Incomplete procedures cannot be processed.
  • If all documents have been submitted, the BfArM will send you your narcotics number or a confirmation of your change by post.
  • You will also receive a notification of costs by post.
  • You pay the fees.

Report participation and changes in writing:

  • Go to the BfArM website and fill out the form "Notification for individual pharmacies, compounding pharmacies, hospital pharmacies, veterinary in-house pharmacies".
    • To report a closure and a waiver of participation in narcotics traffic, use the form "Waiver of participation in narcotics traffic".
  • Print out the form or save it.
  • Sign the form and send it to the BfArM by post or e-mail.
  • The BfArM will check your details.
    • If any documents are incomplete, you will be asked by e-mail to submit all missing documents. Incomplete applications cannot be processed.
  • Once all documents have been submitted, the BfArM will send you your narcotics number or a confirmation of your change by post.
  • You will also receive a notification of costs by post.
  • You pay the fees.

Bearbeitungsdauer

1 Woche(n)

Frist

You can submit the (new) operating license or the (new) veterinary in-house pharmacy certificate or a written confirmation from the competent state authority that they are still valid without delay. You must submit any changes immediately.

Weiterführende Informationen

Hinweise

You can take legal action or lodge an objection against charges and fees incurred. The deadline for paying these fees is not postponed.

Rechtsbehelf

  • Contradiction
    • Detailed information on how to lodge an objection can be found in the notification.

Kurztext

  • Pharmacies and veterinarians must report their participation in the narcotics trade and receive a narcotics number
  • Pharmacies and veterinarians are obliged to report changes, e.g. address or change of business

Ansprechpunkt

nicht vorhanden

Zuständige Stelle

nicht vorhanden

Formulare

nicht vorhanden