Cookies facilitate the provision of our services. By using our services, you agree to our use of necessary cookies. You can refuse the use of optional cookies or only allow certain cookies. You can find further information in our privacy policy.

responsibility finder
Schleswig-Holstein

We only need 2 pieces of information from you.

Where?

Specify your location to receive regionalized information.

What?

You searched in services/administrative services.

Selected service: Display the manufacture of medicinal products by persons authorized to practice medicine without a license
Information about "Display the manufacture of medicinal products by persons authorized to practice medicine without a license" was found.

Enter words here that describe what you are looking for (e.g. felling a tree) or a matter for citizens and companies (e.g. house construction, marriage).
Enter here names or the name of a body, office or authority you are looking for (e.g. Finanzamt Kiel, Polizei Lübeck).

Display the manufacture of medicinal products by persons authorized to practice medicine without a license

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6Plus)

Service Description

If you, as a person authorized to practice medicine, wish to manufacture medicinal products under your direct professional responsibility for the purpose of personal use on a specific patient, you must register this activity with the competent authority.

Every doctor and every dentist is personally obliged to report the manufacture of medicinal products for individual patients. This applies to every person who is authorized to practice medicine on humans, including alternative practitioners.


Process flow

You notify the competent authority of the manufacture of the medicinal products in writing with the self-declaration or online, stating the type of activity and the operating site as well as the name and composition of the medicinal products.

Requirements
  • You have a license to practise as a doctor, dentist or alternative practitioner.
  • The medicinal products are prepared under your direct professional responsibility for the purpose of personal use on a specific patient.
Which documents are required?
  • Notification with name and composition of the medicinal products
  • Approbation
  • Professional license for alternative practitioners
What are the fees?

Levy: 50,00 EUR
Payment in advance: no

What deadlines do I have to pay attention to?

You report the manufacture of medicinal products before you start the activity.

Processing duration

Processing time: 4 - 6 Weeks

Legal basis
Appeal
  • Objection

Further information on how to lodge an objection can be found in your cost assessment notice.

Applications / forms
What else should I know?

Special information on the manufacture subject to notification:

The quality, efficacy and safety of medicinal products manufactured without a license must be ensured by the doctor or alternative practitioner. As the quality of a medicinal product is determined by the manufacturing process, manufacture must be carried out in accordance with the recognized pharmaceutical rules, in particular the European Pharmacopoeia.

Therefore, appropriate and suitable spatial and hygienic environmental conditions are expected for the manufacturing process so that the quality of the manufactured medicinal product is not impaired. The traceability of the manufacture and, if necessary, testing and the use on the patient must be ensured by the available documentation.

The manufacturing person is ultimately personally responsible for the quality of the medicinal product.

Weiterführende Informationen

Teaser

If you, as a person authorized to practice medicine, wish to manufacture medicinal products under your direct professional responsibility for the purpose of personal use on a specific patient, you must register this activity with the competent authority.

Process flow

You notify the competent authority of the manufacture of the medicinal products in writing with the self-declaration or online, stating the type of activity and the operating site as well as the name and composition of the medicinal products.

Requirements

  • You have a license to practise as a doctor, dentist or alternative practitioner.
  • The medicinal products are prepared under your direct professional responsibility for the purpose of personal use on a specific patient.

Which documents are required?

  • Notification with name and composition of the medicinal products
  • Approbation
  • Professional license for alternative practitioners

What are the fees?

Levy: 50,00 EUR
Payment in advance: no

What deadlines do I have to pay attention to?

You report the manufacture of medicinal products before you start the activity.

Processing duration

Processing time: 4 - 6 Weeks

Legal basis

Appeal

  • Objection

Further information on how to lodge an objection can be found in your cost assessment notice.

Applications / forms

What else should I know?

Special information on the manufacture subject to notification:

The quality, efficacy and safety of medicinal products manufactured without a license must be ensured by the doctor or alternative practitioner. As the quality of a medicinal product is determined by the manufacturing process, manufacture must be carried out in accordance with the recognized pharmaceutical rules, in particular the European Pharmacopoeia.

Therefore, appropriate and suitable spatial and hygienic environmental conditions are expected for the manufacturing process so that the quality of the manufactured medicinal product is not impaired. The traceability of the manufacture and, if necessary, testing and the use on the patient must be ensured by the available documentation.

The manufacturing person is ultimately personally responsible for the quality of the medicinal product.

Weiterführende Informationen

Further information and offers