BfArM - Federal Institute for Drugs and Medical Devices

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CHMP Meeting Highlights April 2023 Date: 05. May 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights April 2023

Working Parties of the European Pharmacopoeia Commission Date: 25. April 2023 Topics: Licensing Type: Article

Working Parties of the European Pharmacopoeia Commission

Groups of Experts of the European Pharmacopoeia Commission Date: 25. April 2023 Topics: Licensing Type: Article

Groups of Experts of the European Pharmacopoeia Commission

Tasks Date: 12. April 2023 Topics: Licensing Type: Article

The BfArM publishes information on supply shortages for human medicinal products

CHMP Meeting Highlights March 2023 Date: 06. April 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights March 2023

In cases where the variation results in changes to the SmPC/PL/labelling - how to submit the final agreed changes to the common texts (English) for type II variations / worksharing procedures (DE=RMS)? Date: 24. March 2023 Topics: Licensing Type: FAQ

According to the CMDh Best Practice Guidances for Variations

the MAH should provide the RMS with the final agreed common texts (english) via e-mail before the "end of procedure".
With "EoP Notification", the RMS circulates the texts to the CMS and …

Processing Statistics of the BfArM 2022 PDF, 205KB, File does not meet accessibility standards Date: 27. February 2023 Topics: Licensing Type: Download

State: December 2022

Coordination of the production of important active substances Date: 23. February 2023 Topics: Licensing Type: Article

The project 'Coordination of the production of important active substances' is a further module for sustained improvement of the security of supply with medicines in Germany.

ICU Taskforce Date: 22. February 2023 Topics: Licensing Type: Article

The Jour Fixe on shortages (transferred to the Advisory Council in July 2020) decided in April 2020 to establish a Task Force to ensure the supply of intensiv care supply with critical medicines during the pandemic. Representatives of the …

Medicines Shortages Single Point of Contact (SPOC) Working Party Date: 22. February 2023 Topics: Licensing Type: Article

The Working Party monitors events and ongoing shortages which could affect the supply of medicines within the European Union. Furthermore, it provides recommendations for the Executive Steering Group on Shortages and Safety of Medicinal Products …

Advisory Council for Delivery and Supply Shortages Date: 22. February 2023 Topics: Licensing Type: Article

According to section 52b subsection 3b of the Medicinal Products Act, the Federal Institute for Drugs and Medical Devices is empowered to set up an Advisory Council to continuously monitor and evaluate the overall supply situation in Germany.

Mitigation measures and additional information on shortages Date: 22. February 2023 Topics: Licensing Type: Article

During ongoing shortages, the BfArM is in constant contact with the marketing authorization holders and the affected medical societies in order to determine mitigation measures.

Demarcation/Borderline questions Date: 17. February 2023 Topics: Licensing Type: Article

Demarcation/Borderline questions

CHMP Meeting Highlights January 2023 Date: 06. February 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights January 2023

CHMP Meeting Highlights February 2023 Date: 06. February 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights February 2023

CHMP Meeting Highlights December 2022 Date: 22. December 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights December 2022

CHMP Meeting Highlights November 2022 Date: 15. November 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights November 2022

CHMP Meeting Highlights October 2022 Date: 20. October 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights October 2022

Interchangeability of Biosimilars Date: 29. September 2022 Topics: Licensing Type: Article

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have emphasised that biosimilars approved in the EU are interchangeable from a scientific viewpoint, meaning that a biosimilar can be used instead of its reference product, …

Licensing of Biosimilars Date: 28. September 2022 Topics: Licensing Type: Article

Licensing of Biosimilars

CHMP Meeting Highlights September 2022 Date: 21. September 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights September 2022

Brexit Date: 15. August 2022 Topics: Licensing Type: Article

The United Kingdom (UK) left the European Union (EU) on 31 January 2020. It became a third country on 1 February 2020. A transitional period lasting until 31 December 2020 was established in the agreement on the UK’s withdrawal. During this period – …

CHMP Meeting Highlights July 2022 Date: 29. July 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights July 2022

CHMP Meeting Highlights June 2022 Date: 30. June 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights June 2022

CHMP Meeting Highlights May 2022 Date: 27. May 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights May 2022

CHMP Meeting Highlights April 2022 Date: 28. April 2022 Topics: Licensing Type: Article

CHMP Meeting Highlights April 2022

Medicinal Products Information System AMIce Date: 21. April 2022 Topics: Licensing Type: Article

AMIce contains the approval data of the German drug regulatory authorities BfArM (Federal Institute for Drugs and Medical Devices), PEI ( Paul-Ehrlich-Institut - Federal Institute for Vaccines and Biomedicines) and BVL (Federal Agency for Consumer …

Uploading of requested or revised documents in the context of validation or assessment. Date: 08. April 2022 Topics: Licensing Type: FAQ

If further, corrected or updated documents as part of the application have been requested as further information (RFI), the sponsor must upload them under the originally submitted document files. Uploading the documents as a direct response to the …

AMIce - Public Part - Module Batch Release Date: 01. April 2022 Topics: Licensing Type: Article

AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the comprehensive medicinal product information system AMIce, managed and updated by the German drug regulatory authorities BfArM, BVL, and PEI.

AMIce - Public Part - Module Medicinal Products Date: 01. April 2022 Topics: Licensing Type: Article

AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the comprehensive medicinal products information system AMIce, managed and updated by the German drug regulatory authorities BfArM, BVL, and PEI.