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Flat fees for database search Date: 02. January 2024 Topics: Licensing Type: Article

Hosting of the ABDA database at BfArM was discontinued on January 1st, 2024.

CHMP Meeting Highlights December 2023 Date: 20. December 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights December 2023

Working Parties of the Expert Committees Date: 14. December 2023 Topics: Licensing Type: Article

Working Parties of the Expert Committees

Expert Committees of the German Pharmacopoeia Date: 14. December 2023 Topics: Licensing Type: Article

Expert Committees of the German Pharmacopoeia

CHMP Meeting Highlights November 2023 Date: 15. November 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights November 2023

Clinical Trials Information System – CTIS Date: 02. November 2023 Topics: Licensing Type: Article

Message to sponsors transitioning clinical trials from CTD to CTR/CTIS: Clinical trials (CTs) authorised under the Clinical Trials Directive 2001/20/EC (CTD) likely to be ongoing beyond 30 January 2025 need to be transitioned to the Clinical Trials …

Joint Action on shortages CHESSMEN Date: 31. October 2023 Topics: Licensing Type: Article

The Joint Action on Shortages with its acronym CHESSMEN (Coordination and Harmonisation of the Existing Systems against Shortages of Medicines – European Network) aims to harmonise the existing systems to record and monitor shortage situations within …

Submission of Variations Date: 19. October 2023 Topics: Licensing Type: Article

Commission regulation (EC) 1234/2008 of 24 November 2008applies from 1 January 2010.This new Variation Regulation establishes new rules for the examination of variations to the terms of marketing authorisations for medicinal products for human use …

CHMP Meeting Highlights October 2023 Date: 15. October 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights October 2023