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Hessen 99005112169000, 99005112169000 Typ 3

Inhalt

Leistungsschlüssel

99005112169000, 99005112169000

Leistungsbezeichnung

Notification of other activities involving medicinal products, active substances, other substances and tissues intended for the manufacture of medicinal products

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

Ja

Fachlich freigegeben am

05.02.2024

Fachlich freigegeben durch

Hessian Ministry of Labor, Integration, Youth and Social Affairs and Hessian Ministry for Family Affairs, Senior Citizens, Sport, Health and Care

Teaser

Do you want to report any other activity in connection with medicinal products, active substances, other substances and tissues intended for the manufacture of medicinal products?

Volltext

If you

  • a retail business with over-the-counter medicines,
  • the storage of medicinal products and their documents,
  • the brokerage of medicinal products,
  • the license-free manufacture of medicinal products for doctors, dentists and other persons authorized to practice medicine on humans, or
  • the license-free manufacture of medicinal products for hospitals or rescue service organizations

you must notify the Hessian State Office for Health and Care.

The Hessian State Office for Health and Care is also your point of contact for changes to the notified activities.

Erforderliche Unterlagen

Notification of retail trade in over-the-counter medicines:

  • see form on the page on the distribution of medicinal products

Notification of a warehouse or document storage facility:

  • Name and address of the company
  • Precise description of the activities (for whom is what stored?)

Notification of a pharmaceutical brokerage:

  • See form on the page on the distribution of medicinal products

Notification of licence-free manufacture of medicinal products for doctors, dentists and other persons authorized to practice medicine on humans and notification of licence-free manufacture of medicinal products for hospitals and emergency services:

  • see form on the page on the obligation to notify

Notification of a medicinal product collection:

  • see information sheet on the page on the distribution of medicinal products

Voraussetzungen

The respective requirements must be met for the advertisement.

Prerequisites include

Notification of a retail trade in over-the-counter medicines:

  • Appointment of a responsible person with the required expertise
  • Name and address of the retailer

Notification of a warehouse or document storage facility:

  • Name and address of the company
  • Precise description of the activities (for whom is what stored?)

Notification of a pharmaceutical brokerage:

  • Specific description of the activity
  • Name and address of the companies you wish to work for

Notification of licence-free manufacture of medicinal products for doctors, dentists and other persons authorized to practise medicine on humans and notification of licence-free manufacture of medicinal products for hospitals and rescue service organizations:

  • Personal details, name and address of the practice or rescue organization or hospital
  • Details of the exact activities
  • Designation of the responsible person with the required expertise

Notification of a collection of medicinal products:

  • see information sheet on the homepage:

Kosten

Verwaltungsgebühr: 33€ - 275€ Mehr erfahren

Verfahrensablauf

  • Please complete the relevant form, preferably on your PC, sign it and send it as a scan attached to an e-mail to the following address: Anzeige67@hlfgp.hessen.de.
  • Further information is available at the following link:

Bearbeitungsdauer

2 - 4 Woche(n)

Frist

Notification must be made before the start of the activity

Weiterführende Informationen

The Hessian State Office for Health and Care monitors the movement of medicinal products for human use at all pharmaceutical companies as well as wholesalers and retailers in Hesse.

Hinweise

nicht vorhanden

Rechtsbehelf

Administrative court action

Kurztext

  • Notification of other activities involving medicinal products, active substances, other substances and tissues intended for the manufacture of medicinal products
  • Other activities in connection with medicinal products, active substances, other substances and tissues intended for the manufacture of medicinal products must be notified
  • Responsible: Hessian State Office for Health and Care

Ansprechpunkt

nicht vorhanden

Zuständige Stelle

The Hessian State Office for Health and Care is responsible.

Formulare

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