Anzeige einer Arzneimittelvermittlung
Inhalt
Begriffe im Kontext
- Erlangung von Lizenzen, Genehmigungen oder Zulassungen im Hinblick auf die Gründung und Führung eines Unternehmens
Fachlich freigegeben am
Fachlich freigegeben durch
If you wish to act as an intermediary for medicinal products in accordance with Section 52c AMG, you must notify us in advance.
- 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.
- 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.
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".
- Notification of a pharmaceutical brokerage
- The activity of brokering medicinal products must be notified.
- Responsible: Darmstadt Regional Council
Forms/online services available: Yes
Written form required: No
Informal application possible: No
Personal appearance necessary: No