Medicinal products; notification of manufacture without a license
If the manufacture of medicinal products is intended, for which a license according to Section 13 of the German Medicines Act (AMG) is not required, the medicinal products must be notified with their designation and composition.
Description
A license according to Section 13 (1) of the German Medicines Act (AMG) is not required for physicians or non-medical practitioners 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 under Section 67 (2) of the AMG.
The persons concerned must notify the competent authority of their planned activity. The authority checks whether the activity is subject to authorization, if applicable.
Prerequisites
The person making the announcement must be a physician, dentist or alternative practitioner.
Procedure
The informal notification is to be sent to the responsible government with the required information and documents (see information sheet under "Further links").
Deadlines
The notification can only be confirmed after all the necessary documents have been submitted and any open questions have been clarified and a professional assessment has been carried out. The German Medicines Act does not set any deadlines.
Processing time
Depending on issues to be resolved, processing may take time.
Required documents
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Description of the production activities
(if possible, please PDF file)
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Proof of qualification as a doctor or non-medical practitioner
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Information on rooms and facilities
Forms
Please select a location in "Localization" so that the address of the responsible authority can be filled in.
Fees
Costs for the confirmation of the advertisement: 50 to 5,000 € (according to the list of costs - tariff no. 7.IX.8 / tariff item 1.1.4.3).
They are to be borne by the advertiser.
Links to more information
Status:27.10.2023
Responsible for editing:Bayerisches Staatsministerium für Gesundheit und Pflege
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Form, Bavaria-wide
- Form, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited
If you select a location under "Localization" the contact details of the responsible authority and, if applicable, locally valid information will be displayed.