Medicinal products; notification of manufacture without authorization
If it is intended to manufacture medicinal products that do not require a license pursuant to Section 13 of the German Medicinal Products Act (AMG), the medicinal products must be notified together with their name and composition.
The notifying party must be a doctor, dentist or alternative practitioner.
The informal notification must 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 and any unanswered questions have been clarified and a professional assessment has been carried out. The Medicinal Products Act does not set any deadlines.
Depending on the questions to be clarified, processing may take some time.
Description of the production activities
(if possible, please PDF file)
Proof of qualification as a doctor or non-medical practitioner
Information on rooms and facilities
Please select a location in "Localization" so that the address of the responsible authority can be filled in.
Prefillable Form, Bavaria-wide:
This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.
Costs for the notification confirmation: 50 to 5,000 € (according to the list of costs - tariff no. 7.IX.8 / tariff item 184.108.40.206)
They are to be borne by the notifying party.
Links to more information
Responsible for editing:Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention
- 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