responsibility finder
Schleswig-Holstein

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

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6PLus)

Service Description

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

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

  • 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 medicinal products, namely

  • immunoglobulins,
  • monoclonal antibodies,
  • blood, bone marrow and 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 are the responsibility of the BfArM. The necessary documents for authorization are submitted by the pharmaceutical company wishing 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 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 medicinal product in a patient group, and
  • the approval or rejection of a clinical trial intended to confirm the quality, efficacy and safety of a medicinal product in a patient group

Note:
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 the 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
  • Registers in the health care system
  • Health care data
  • Training and access to healthcare professions

Process flow

If you are looking for information on already approved or previously approved medicinal products, 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 an application has been made to the BfArM for the authorization of a medicinal product, you can view this in a monthly updated list on the BfArM website.
If you require further information, you can submit an online request to the BfArM or the Paul Ehrlich Institute - Federal Institute for Vaccines and Biomedicines (PEI).

BfArM:

  • Go to the BfArM website and call up the electronic contact form under the "Contact" tab.
  • 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 a reply by post.

PEI:

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

none

Which documents are required?

none

What are the fees?

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

What deadlines do I have to pay attention to?

none

Processing duration
  • up to 4 weeks
  • processing may take longer for difficult requests
Legal basis
Applications / forms
Author
Forwarding service: Deep link to the original portal

The text was automatically translated based on the German content.

Technically approved by

Federal Ministry of Health (BMG)

Professionally released on

24.09.2020

Teaser

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

Process flow

If you are looking for information on already approved or previously approved medicinal products, 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 an application has been made to the BfArM for the authorization of a medicinal product, you can view this in a monthly updated list on the BfArM website.
If you require further information, you can submit an online request to the BfArM or the Paul Ehrlich Institute - Federal Institute for Vaccines and Biomedicines (PEI).

BfArM:

  • Go to the BfArM website and call up the electronic contact form under the "Contact" tab.
  • 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 a reply by post.

PEI:

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

Requirements

none

Which documents are required?

none

What are the fees?

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

What deadlines do I have to pay attention to?

none

Processing duration

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

Legal basis

Applications / forms

Author

Forwarding service: Deep link to the original portal

The text was automatically translated based on the German content.

Technically approved by

Federal Ministry of Health (BMG)

Professionally released on

24.09.2020

Further information and offers