BfArM - Federal Institute for Drugs and Medical Devices

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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