Medicinal products; notification of unauthorised manufacture

A licence pursuant to Section 13(1) of the German Medicines Act (AMG) is not required for persons who are doctors or non-medical practitioners, provided that the medicinal products are manufactured under their direct professional responsibility for the purpose of personal application to a specific patient. However, the manufacture of medicinal products is subject to notification according to Section 67 (2) AMG.The persons concerned must notify the competent authority of their planned activity. The authority checks whether the activity is subject to authorisation, if applicable.

Description of the production activities(if possible, please PDF file)Proof of qualification as a doctor or non-medical practitionerInformation on rooms and facilities


Preconditions
The person making the announcement must be a doctor, dentist or alternative practitioner.
The informal notification is to be sent to the responsible government with the required information and documents (see information sheet under "Further links").

Responsible for the content
Bayerisches Staatsministerium für Gesundheit und Pflege (Bavarian State Ministry of Health and Care)

Last update or date of publication
27.07.2021