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
Contact
Internet
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
Basis for legal action
Legal remedy
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 AMGSince 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
Keywords
erlaubnisfreie, Arzneimittel, Herstellung