Information - Services - Formalities by subjects - Equipment, goods and materials - Consumer protection - Drugs; Application for information about admission - Dienstleistungsportal Bayern

Description

The Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI), Federal Institute for Vaccines and Biomedical Products, 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, tissue preparations,
• allergens,
• test sera,
• test antigens,
• gene transfer drugs,
• somatic cell therapeutics,
• xenogenic cellular therapeutics, and
• genetically engineered blood components.

All other medicinal products for human use fall under the responsibility of the BfArM. The necessary documents for marketing authorisation are submitted by the pharmaceutical entrepreneur 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 marketing 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 approval 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 intended to confirm the quality, efficacy and safety of a medicinal product in a group of patients.

Notice:
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 area of responsibility PEI:
    • 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 registries
• Healthcare data
• Training and access to health care professions

Prerequisites

none

Procedure

If you are looking for information on medicinal products that have already been authorised or were previously 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 a marketing authorisation for a medicinal product has been applied for at the BfArM, you can view this in a monthly updated list on the BfArM website.
If you need further information, you can submit an inquiry online to the BfArM or to the Paul Ehrlich Institute - Federal Institute for Vaccines and Biomedical Products (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 email address, you can also receive the answer by mail.

PEI:

• You go to the website of the Paul Ehrlich Institute on "Contact" on 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 query, you will receive information from the PEI by e-mail.

Deadlines

none

Processing time

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

Required documents

• Erforderliche Unterlage/n

  none

Forms

• Form, Bavaria-wide: Kontaktformular des Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) auf der Internetseite des BfArM

  Please note

  This form requires no signature. You can sent it electronically (e.g. by secure email or De-Mail) or as hardcopy to the responsible authority.

• Form, Bavaria-wide: Kontaktformular des Paul-Ehrlich-Instituts (PEI) auf der Internetseite des PEI

  Please note

  This form requires no signature. You can sent it electronically (e.g. by secure email or De-Mail) or as hardcopy to the responsible authority.

Fees

• As a rule, none.
  In the case of information that involves a very high administrative burden in individual cases: between EUR 15.00 and EUR 500.00.

Legal bases

• § 34 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)

Links to more information

• Öffentliche Arzneimitteldatenbank auf der Internetseite von PharmNet.Bund
• Informationen zur Zulassung von Arzneimitteln auf der Internetseite des PEI
• Informationen zu offenen Zulassungsanträgen auf der Internetseite des BfArM
• Informationen zur Zulassung von Arzneimitteln auf der Internetseite des BfArM