Display the manufacture of medicinal products by persons authorized to practice medicine without a license

    As a doctor, dentist or person authorized to practice medicine on humans, would you like to manufacture medicinal products (e.g. infusion solutions) without a license? Then you must notify us.

    Description

    If you wish to manufacture medicinal products without a license, you must report this.

    Competent office

    Hessian State Office for Health and Care

    Contact person

    Hessisches Landesamt für Gesundheit und Pflege - Abteilung V Pharmazie

    Address

    postal address

    (Zentrale Postanschrift)

    Post office box 11 03 52

    64218 Darmstadt

    address

    (Zentrale Hausanschrift)

    Heinrich-Hertz-Str. 5

    64295 Darmstadt

    Save contact

    Contact

    telephone: +49 611 3259-1000

    fax: +49 611 3279-1028

    e-mail: pharmazie@hlfgp.hessen.de

    Internet

    Version

    Technisch geändert on 20.10.2025

    Language version

    de

    Sprache: de

    Required documents

    List of the medicinal products to be manufactured with their name and composition.

    Forms

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

    Administrative court action

    Procedure

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

    Deadlines

    The notification must be made before the start of the activity.

    Costs

    Fee from 25,00 EUR to 250,00 EUR

    Further Information

    • Information on the obligation to notify according to § 67 AMG
      Since the 15th AMG amendment in 2009, all manufacturing has been subject to the German Medicinal Products Act, including that carried out by doctors, dentists or other persons authorized to practice medicine on humans in medical practices or healthcare facilities. These activities are now subject to notification in accordance with Section 67 AMG and are also subject to monitoring by the competent authority, which in Hesse is represented by the Darmstadt Regional Council, Pharmaceutical Monitoring.

    Area of validity

    Hesse

    Official approval

    Officially approved by Hessian Ministry for Social Affairs and Integration on 15.12.2022

    Version

    Technisch erstellt on 16.01.2024

    Technisch geändert on 29.09.2025

    Keywords

    erlaubnisfreie, Arzneimittel, Herstellung

    Language version

    Deutsch

    Sprache: de

    Technisch erstellt on 07.06.2017

    Technisch geändert on 14.05.2025

    Englisch

    Sprache: en

    Sprachbezeichnung nativ:

    English

    Technisch erstellt on 07.07.2021

    Technisch geändert on 26.11.2019