Notification of a pharmaceutical brokerage

    Do you want to report a brokerage of medicinal products?

    Description

    If you wish to act as an intermediary for medicinal products, you must notify us in advance.

    Online service

    Anzeige von Tätigkeiten mit Arzneimitteln nach § 67 AMG

    ID: L100001_385517436

    Description

    Mit diesem Onlineantrag können gem. § 67 Arzneimittelgesetz (AMG) Betriebe, Einrichtungen, Personen und Personenvereinigungen die Ausübung von Tätigkeiten im Zusammenhang mit Arzneimitteln, Wirkstoffen, anderen zur Arzneimittelherstellung bestimmte Stoffe und Gewebe vor der Aufnahme der Tätigkeiten der zuständigen Behörde anzeigen.

    Use this service online

    Trust level

    You need an account with password to use this online service (trust level: low).

    further information on the level of trust for online services

    Version

    Technisch erstellt on 03.02.2023

    Technisch geändert on 20.10.2025

    Language

    Deutsch

    Sprache: de

    Technisch erstellt on 07.06.2017

    Technisch geändert on 14.05.2025

    Competent office

    The competent authority is the Hessian State Office for Health and Care (HLfGP).

    Contact point

    Please contact the Hessian State Office for Health and Care (HLfGP).

    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

    • Business registration (for self-employment)

    Forms

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

    Prerequisites

    • If you work as a self-employed intermediary, you must have registered a business
    • You may only act as a medicinal product broker if you have your registered office in the area of application of this law, in another member state of the European Union or in another state party to the Agreement on the European Economic Area.

    Administrative court action

    Procedure

    • 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.

    Deadlines

    The notification must be made before the start of the activity

    Processing time

    2 to 4 weeks

    Costs

    Fee from 33,00 EUR to 275,00 EUR

    Notes (specifics)

    In addition to a risk-based inspection of establishments, the monitoring also provides for the taking and testing of medicinal product samples. In order for the authorities to fulfill their monitoring obligations, there is an obligation to notify "companies and facilities that develop, manufacture, clinically test or subject medicinal products to residue testing, test, store, package, place on the market or otherwise trade in them".

    Area of validity

    Hesse

    Official approval

    Officially approved by Hessian Ministry for Family Affairs, Senior Citizens, Sport, Health and Care on 10.10.2025

    Version

    Technisch erstellt on 16.12.2022

    Technisch geändert on 17.10.2025

    Keywords

    Arzneimittel, Vermittler, Vermittlung, Arzneimittelvermittlung, Arzneimittelvermittler

    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