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Anzeige einer Arzneimittelvermittlung

Hessen 99005110169000, 99005110169000 Typ 3

Inhalt

Leistungsschlüssel

99005110169000, 99005110169000

Leistungsbezeichnung

Notification of a pharmaceutical brokerage

Leistungsbezeichnung II

nicht vorhanden

Leistungstypisierung

Typ 3

Begriffe im Kontext

nicht vorhanden

Leistungstyp

Leistungsobjekt mit Verrichtung

Leistungsgruppierung

Arzneimittel (005)

Verrichtungskennung

Anzeige (169)

SDG Informationsbereiche

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

Lagen Portalverbund

nicht vorhanden

Einheitlicher Ansprechpartner

Nein

Fachlich freigegeben am

15.12.2022

Fachlich freigegeben durch

Hessian Ministry for Social Affairs and Integration

Teaser

Do you want to report a brokerage of medicinal products?

Volltext

If you wish to act as an intermediary for medicinal products in accordance with Section 52c AMG, you must notify us in advance.

Erforderliche Unterlagen

- Business registration (for self-employment)

Voraussetzungen

- If you work as a self-employed intermediary, you must have registered a business

- You may only act as a medicinal product broker pursuant to Section 52c (1) if you have your registered office in the area of application of this Act, in another member state of the European Union or in another state party to the Agreement on the European Economic Area.

Kosten

Gebühr: 25€ - 250€

Verfahrensablauf

- You submit your notification to the competent authority using the online form and upload the required document if necessary,
- the confirmation will be issued if the competent authority determines that the legal requirements have been met.

Bearbeitungsdauer

2 - 4 Woche(n)

Frist

The notification must be made before the start of the activity

Weiterführende Informationen

nicht vorhanden

Hinweise

In addition to a risk-based inspection of companies, monitoring also includes the taking and testing of medicinal product samples. In order for the authorities to fulfill their monitoring obligations, there is a notification obligation (Section 67 of the German Medicinal Products Act (AMG)) for "companies and facilities that develop, manufacture, clinically test or subject to residue testing, test, store, package, place on the market or otherwise trade in medicinal products".

Rechtsbehelf

Administrative court action

Kurztext

- Notification of a pharmaceutical brokerage
- The activity of brokering medicinal products must be notified.
- Responsible: Darmstadt Regional Council

Ansprechpunkt

Please contact the Hessian State Office for Health and Care.

Zuständige Stelle

Hessian State Office for Health and Care.

Formulare

Forms/online services available: Yes
Written form required: No
Informal application possible: No
Personal appearance necessary: No