Authority for Justice and Consumer Protection
Manufacture of medicinal products without a permit

As a doctor, dentist or alternative practitioner, you may manufacture medicinal products without a licence under certain conditions.

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Detailed description

If you intend to manufacture medicinal products, you usually need a manufacturing licence.

Doctors, dentists and alternative practitioners do not need this under certain conditions. They can manufacture medicinal products without a permit according to Section 13 Paragraph 2b AMG.

If you meet the requirements and wish to make use of this exemption, you must notify the competent authority before starting work.

Information

Important notes

Prerequisites

You have a license as a (dental) doctor or a permit as a naturopath and the manufacture of the medicinal product takes place
- under your direct professional responsibility and
- for the purpose of your personal use in a specific patient.

Documents required

Name and address of the doctor or alternative practitioner
Name and address of the facility where the medicinal product is manufactured
name of the medicinal product
Contact details, home address, profession (specialization) of the doctor or alternative practitioner

Please note

The person making the report must provide all information correctly and completely.

Indication of the medicinal product to be manufactured, specification if necessary.

The medicinal products manufactured may not be used in the context of a clinical trial.

Deadlines

You must submit the notification to the competent authority before starting your activity.

Procedure & Fees

Procedure

Fill out the online form.
You have the option of submitting your application using the online form or in writing.
If you submit the application using the online form, you automatically submit the data of the online application to the responsible authority online.
Report your activities in writing using the form and send the notification by post or, if necessary, by email to the responsible authority.
The ad is checked for accuracy and confirmed.
You will receive the confirmation letter and the fee notice by post.
The responsible authority will be informed of the report.
The responsible authority will examine the notification and contact you with further questions if there are any ambiguities or discrepancies.
The responsible authority does not confirm receipt of the notification.

Processing time

Processing takes 2-3 weeks. The processing time and the extent of the inquiries depend on the quality of the information submitted and may require on-site monitoring.

Fees

The administration fee is based on the Hamburg fee schedule.

Legal notes

Legal remedies

An appeal against this decision may be filed with the administrative court (depending on the registered office of the authorisation holder or applicant) within one month of notification.

Legal basis

§ 13 para. 2b of the German Medicines Act (AMG)

§ 20d of the German Medicines Act (AMG)

Section 67 Paragraph 1 and 2 of the German Medicines Act (AMG)

Address and contact information