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Production of medicinal products without permission

In certain cases, physicians, dentists and non-medical practitioners may manufacture medicinal products without a license, i.e. without having a manufacturing authorization. There are certain regulations for this, and the competent authority must be notified before the activity is commenced.

Anyone who intends to manufacture medicinal products generally requires a manufacturing license in accordance with Section 13 (1) of the German Medicines Act (AMG). For physicians, dentists and non-medical practitioners, the law describes an exception under certain conditions under § 13 para. 2b or § 20d.

Anyone wishing to make use of this exemption must notify the competent authority in accordance with Section 67 (1) and (2) AMG.


You have a license as a (dental) physician or a license as a non-medical practitioner and the production of the medicinal product takes place

  • under your direct professional responsibility and
  • for the purpose of personal use by you on a specific patient.

The notification to the competent authority must be made before the start of the activity.