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 …