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Source: BUS Sachsen-Anhalt (Linie6PLus)

Request information on medicinal products for human use that are approved or registered in Germany and on immunological medicinal products for animal use


The Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI), Federal Institute for Vaccines and Biomedical Products, are responsible at national and European level for,

  • the efficacy,
  • quality and
  • safety

of new medicinal products for use in humans and for immunological veterinary medicinal products and to approve them.

The PEI is responsible for vaccines and biomedical drugs, namely.

  • Immunoglobulins,
  • monoclonal antibodies,
  • blood, bone marrow, tissue preparations,
  • allergens,
  • test sera,
  • test antigens,
  • gene transfer drugs,
  • somatic cell therapeutics,
  • xenogeneic cell therapeutics, and
  • genetically engineered blood components.

All other medicinal products for human use fall under the responsibility of the BfArM. The necessary documents for approval are submitted by the pharmaceutical entrepreneur who wishes to place the drug on the market.

The BfArM or PEI can therefore provide you with the following information:

  • the receipt of an application for marketing authorization of a medicinal product (The overview, which is updated once a month, can be found on the BfArM homepage),
  • the receipt of an application for approval of a clinical trial to confirm the quality, efficacy and safety of a drug in a group of patients, and
  • the approval or rejection of a clinical trial intended to confirm the quality, efficacy and safety of a medicinal product in a group of patients.

The BfArM or the PEI can also provide you with further information on the following topics:

  • Drug Safety
  • Medical devices for use in humans;
    • Examples in the area of responsibility of BfArM:
      • Implants,
      • dressing materials,
      • medical software,
      • medical instruments,
      • dental products
    • Examples in the PEI area of responsibility:
      • In vitro diagnostics for testing for high-risk pathogens such as HIV/AIDS, hepatitis, ZIKA or for determining blood groups.
      • Reagents and reagent products
  • Medical classifications
  • Health care registers
  • Healthcare data
  • Education and access to health care professions

As a rule, none.
For information that involves a very high administrative effort in individual cases: between EUR 15.00 and EUR 500.00.

  • up to 4 weeks
  • Processing may take longer for difficult requests

Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedical Drugs

Address Paul-Ehrlich-Straße 51-59
63225 Langen (Hesse), city
  • +49 6103 77-0
  • Hotline for inquiries from the public and medical professionals
    +49 6103 77-1771
Fax +49 6103 77-1234
Opening hours
  • Monday to Friday: 9:00 am - 5:00 pm

If you are looking for information about medicines that have already been approved or were previously approved, you can search for them in the free public database of the Federal Institute for Drugs and Medical Devices (BfArM).

If you would like to know whether a marketing authorization for a drug has been applied for at the BfArM, you can view this in a monthly updated list on the BfArM website.
If you need more information, you can submit an inquiry online to the BfArM or to the Paul Ehrlich Institute - Federal Institute for Vaccines and Biomedical Products (PEI).


  • You go to the BfArM website and call up the electronic contact form under the "Contact" tab.
  • You select your target group and follow the next steps of the contact form by selecting your request and entering your contact information.
  • After you have sent your request, you will receive information from the BfArM by e-mail. If you do not have an email address, you can also receive the answer by mail.


  • Go to the website of the Paul Ehrlich Institute and click on "Contact" at the top right of the entry page.
  • Under the tab "Contact form" you can enter your question directly. Alternatively, you can also write an e-mail.
  • After you have sent your inquiry, you will receive information from the PEI by e-mail.

Federal Ministry of Health (BMG)

The text was automatically translated based on the German content.

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