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

You notify the competent authority of the manufacture of the medicinal products in writing with the self-declaration or online, stating the type of activity and the operating site as well as the name and composition of the medicinal products.

• You have a license to practise as a doctor, dentist or alternative practitioner.
• The medicinal products are prepared under your direct professional responsibility for the purpose of personal use on a specific patient.

• Notification with name and composition of the medicinal products
• Approbation
• Professional license for alternative practitioners

You report the manufacture of medicinal products before you start the activity.

• § 67 Absatz 1 und 2 Arzneimittelgesetz (AMG)
• § 13 Absatz 2b Arzneimittelgesetz (AMG)

• Objection

Further information on how to lodge an objection can be found in your cost assessment notice.

Special information on the manufacture subject to notification:

The quality, efficacy and safety of medicinal products manufactured without a license must be ensured by the doctor or alternative practitioner. As the quality of a medicinal product is determined by the manufacturing process, manufacture must be carried out in accordance with the recognized pharmaceutical rules, in particular the European Pharmacopoeia.

Therefore, appropriate and suitable spatial and hygienic environmental conditions are expected for the manufacturing process so that the quality of the manufactured medicinal product is not impaired. The traceability of the manufacture and, if necessary, testing and the use on the patient must be ensured by the available documentation.

The manufacturing person is ultimately personally responsible for the quality of the medicinal product.

16.01.2025

The text was automatically translated based on the German content.