Dies ist die interne Entwicklungsumgebung des FIM Portals. Bitte nutzen Sie die produktive Umgebung.

Versand von apothekenpflichtigen Arzneimitteln Erlaubnis

Baustein Leistungen 99005002005000 Typ 2/3

Steckbrief

Katalog: unbestimmter Freigabestatus

Leistungsschlüssel

99005002005000

Leistungsbezeichnung

Dispatch of pharmacy-only medicines Permission

Leistungsbezeichnung II

Apply for permission to ship pharmacy-only medicines

Leistungstypisierung

Typ 2/3

Begriffe im Kontext

nicht vorhanden

Leistungstyp

Leistungsobjekt mit Verrichtung

Leistungsgruppierung

Drugs (individuell, 005)

Verrichtungskennung

Erlaubnis (005)

SDG Informationsbereiche

  • Erlangung von Lizenzen, Genehmigungen oder Zulassungen im Hinblick auf die Gründung und Führung eines Unternehmens

Lagen Portalverbund

  • Erlaubnisse und Genehmigungen (2010400)

Einheitlicher Ansprechpartner

Ja

Fachlich freigegeben am

06.05.2025

Fachlich freigegeben durch

Federal Ministry of Health (BMG)

Handlungsgrundlage

Stammtext

Bibliothek: fachlich freigegeben (gold)

Teaser

If you want to send pharmacy-only medicines as a pharmacy, you need a permit to do so. You can find out more here.

Volltext

The mail order of pharmacy-only medicines is subject to authorization. For each public pharmacy through which you, as the pharmacy owner, wish to send pharmacy-only medicines, you need your own mail-order permit.

In order to obtain the permit, your mail-order pharmacy must meet certain quality requirements.

For example:

  • Your mail-order business is carried out from a public pharmacy in addition to the usual pharmacy operations
  • a quality assurance system is in place, which means, among other things
    • the medicine is packaged, transported and delivered in such a way that quality and efficacy are maintained
    • delivery is made to the person named in the order; this may be a named person or a named group of persons
    • the advice provided by the pharmaceutical staff is given in German
  • You generally send the available medicine within 2 working days of receiving the order
  • You use a shipment tracking system
  • the second delivery is free of charge
  • You have taken out transport insurance for the shipment

Erforderliche Unterlagen

  • Proof of the operating license for the pharmacy
  • Assurance from the applicant that they meet the requirements for quality management and the mail-order process and that they will provide mail-order services in addition to the usual pharmacy operations

If you wish to use premises outside the approved pharmacy premises for the mail-order business, you must provide the following information and proof of the additional premises:

  • Size
  • Nature
  • Furnishings
  • Function
  • Floor plans to scale
  • rental agreement

Voraussetzungen

  • Dispatches may only be made from a public pharmacy in addition to the usual pharmacy operations.
  • Your public pharmacy has an operating license.
  • A quality assurance system for the dispatch process is in place.
  • If the medicinal products are distributed via e-commerce, i.e. via the Internet, appropriate facilities and equipment must be available.

Kosten

nicht vorhanden

Verfahrensablauf

nicht vorhanden

Bearbeitungsdauer

nicht vorhanden

Frist

Mail-order sales of pharmacy-only medicines may only commence after a license has been granted.

Weiterführende Informationen

nicht vorhanden

Hinweise

If the competent authority grants the mail-order authorization, it forwards this information to the Federal Institute for Drugs and Medical Devices (BfArM). The BfArM publishes information on authorized mail-order pharmacies in a national register. As a mail-order pharmacy, you are obliged to display the specified EU safety logo on your website. A click on the logo leads to the details of the webshop operator in the register. This serves to inform consumers about authorized mail-order pharmacies in the European Union (EU).

Rechtsbehelf

nicht vorhanden

Kurztext

  • Dispatch of pharmacy-only medicines is subject to authorization
  • a public pharmacy requires a license for every mail-order sale of medicines
  • Permit possible if certain quality requirements are met, for example
    • mail order business is carried out from a public pharmacy in addition to the usual pharmacy business
    • a quality assurance system is in place, which means, among other things
      • Medicines are packaged, transported and delivered in such a way that quality and efficacy are maintained
      • Delivery is made to the person specified in the order; this may be a named person or a named group of persons
      • Advice is provided by the pharmaceutical staff in German
    • Dispatch of available medicines generally within 2 working days of receipt of the order
    • System for shipment tracking available
    • Second delivery is free of charge
    • Transport insurance taken out

Ansprechpunkt

nicht vorhanden

Zuständige Stelle

nicht vorhanden

Formulare

nicht vorhanden

Ursprungsportal

nicht vorhanden