Medicinal products; notification of unauthorised manufacture
If the manufacture of medicinal products is intended for which a licence pursuant to Section 13 of the German Medicines Act (AMG) is not required, the medicinal products must be notified with their designation and composition.
A licence pursuant to Section 13(1) of the German Medicines Act (AMG) is not required by a doctor or non-medical practitioner if the medicinal products are manufactured under their direct professional responsibility for the purpose of personal use on 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.
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").
The notification can only be confirmed after all the necessary documents have been submitted, open questions have been clarified and a technical assessment has been carried out. The Medicines Act does not set any deadlines.
Depending on the questions to be clarified, the processing may take some time.
Please select a location in "Localization" so that the address of the responsible authority can be filled in.
Costs for the confirmation of the advertisement: 50 to 5,000 € (according to the list of costs - tariff no. 7.IX.8 / tariff item 220.127.116.11).
They are to be borne by the advertiser.
Links to more information
Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege
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