Medicinal products; notification of manufacture without authorization

If the manufacture of medicinal products for which a license is not required in accordance with Section 13 of the German Medicinal Products Act (AMG) is intended, the medicinal products must be notified together with their name and composition.

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This form can be submitted electronically (e.g. via a secure contact form using your user account with login via the electronic ID function or the ELSTER certificate) or handwritten and signed in paper form to the responsible authority.

For contact details of the responsible authoritiy and local valid information select under "Select location" a location.

A license pursuant to Section 13 (1) of the German Medicinal Products Act (AMG) is not required for physicians or alternative 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 must be notified in accordance with Section 67 Para. 2 AMG.

The persons concerned must notify the competent authority of their planned activity. The authority will check whether the activity may require a license.

The notifying party must be a doctor, dentist or alternative practitioner.

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

The informal notification must be sent to the responsible government with the required information and documents (see information sheet under "Further links").

Costs for the notification confirmation: 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 notifying party.

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.