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Source: BUS Sachsen-Anhalt (Linie6PLus)

Request information on medicinal products for use in humans authorised or registered in Germany and on immunological medicinal products for use in animals

Description

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

  • the effectiveness,
  • Quality and
  • harmlessness

to review and authorise new medicinal products for use in humans and for immunological veterinary medicinal products.

The PEI is responsible for vaccines and biomedical medicines, namely:

  • immunoglobulins,
  • monoclonal antibodies,
  • blood, bone marrow, tissue preparations,
  • Allergens
  • Testsera,
  • test antigens,
  • gene transfer medicines,
  • somatic cell therapeutics,
  • xenogenic cell therapeutics and
  • genetically engineered blood components.

All other medicinal products for use in humans are the responsibility of the BfArM. The necessary documents for authorisation are submitted by the pharmaceutical company who wishes to place the medicinal product on the market.

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

  • the receipt of an application for authorisation 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 authorisation of a clinical trial to confirm the quality, efficacy and safety of a medicinal product in a group of patients; and
  • the approval or rejection of a clinical trial designed to confirm the quality, efficacy and safety of a medicinal product in a group of patients

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

  • Drug
  • medical devices for use in humans;
    • Examples in the area of responsibility BfArM:
      • Implants
      • bandages,
      • medical software,
      • medical instruments,
      • Dental products
    • Examples in pei's area of responsibility:
      • In vitro diagnostic medical devices for testing for high-risk pathogens such as HIV/AIDS, hepatitis, ZIKA or for the determination of blood groups
      • Reagents and reagent products
  • Medical Classifications
  • Registers in the health sector
  • Supply data
  • Training and access to health professions

If you would like information on the marketing authorisation, testing and safety of a medicinal product for use in humans or immunological veterinary medicinal products, you can obtain information.

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

If you would like to know whether the BfArM has applied for authorisation for a medicinal product, you can view it in a monthly updated list on the BfArM website.
If you need further information, you can submit an online request to the BfArM or the Paul Ehrlich Institute - Federal Institute for Vaccines and Biomedical Drugs (PEI).

BfArM:

  • 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 details.
  • After you have sent your request, you will receive information from the BfArM by e-mail. If you do not have an e-mail address, you can also receive the answer by post.

Pei:

  • You go to the website of the Paul-Ehrlich-Institut on "Contact" at the top right of the homepage
  • Under the tab "Contact form" you can enter your question directly. Alternatively, you can also write an e-mail.
  • After you have sent your request, you will receive information from the PEI by e-mail.

Usually none.
For information that is associated with a very high administrative burden in individual cases: between EUR 15.00 and EUR 500.00.

  • up to 4 weeks
  • for difficult requests, processing may take longer

The text was automatically translated based on the German content.

Federal Ministry of Health (BMG)

No authority found