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Joint Commission of Experts on the Classification of Substances Date: 06. October 2023 Topics: Licensing Type: Article

The Federal Office of Consumer Protection and Food Safety (BVL) and the Federal Institute for Drugs and Medical Devices (BfArM) established an independent Joint Expert Commission - Commission on the Classification of Borderline Substances, which are …

CHMP Meeting Highlights September 2023 Date: 21. September 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights September 2023

Priority list for paediatric medicines for fall-winter 2023/2024 (available in German only)
Last updated: 2023.08.16 - pdf
PDF, 101KB, File does not meet accessibility standards
Date: 16. August 2023 Topics: Licensing Type: Download

Priority list for paediatric medicines for fall-winter 2023/2024 - Last updated: 2023.08.16 - pdf

How are the data on antibiotic resistance in section 5.1 of the SmPC to be updated? Date: 08. August 2023 Topics: Licensing Type: FAQ

Data on the resistance situation of systemically available antibiotics in Germany is regularly reassessed in the Z.A.R.S. project and is considered in the resistance table for Section 5.1 of the SmPC. In addition, the annually updated data from EUCAST

Whom do I need to contact in order to apply for a PNR (pharmaceutical company number)? Which documents must be provided? Date: 07. August 2023 Topics: Licensing Type: FAQ

For the allocation of a PNR, please contact the e-mail account Partnerinformationen@bfarm.de stating "Application for a new PNR" in the subject line.

In order to create a PNR in the pharmaceutical companies database "Partnerinformationen", the …

Contact persons for licensing of medicinal products Date: 01. August 2023 Topics: Licensing Type: Article

Contact persons for licensing of medicinal products

CHMP Meeting Highlights July 2023 Date: 28. July 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights July 2023

List of essential paediatric medicines pursuant to Section 35 subsection 5a German Social Code Book V (SGB V) (available in German only)
Last updated: 2023.07.27 - pdf
PDF, 482KB, File does not meet accessibility standards
Date: 27. July 2023 Topics: Licensing Type: Download

List of essential paediatric medicines pursuant to Section 35 subsection 5a German Social Code Book V (SGB V) - Last updated: 2023.07.27 - pdf

According to section B.11 of annex I of Regulation (EU) No 536/2014, the cover letter shall indicate where to find the reference safety information (RSI) in the application dossier. Should reference be made to a specific version of the investigator’s brochure (IB) or summary of product characteristics (SmPC) or to the version valid at the time of SUSAR reporting? Date: 07. July 2023 Topics: Licensing Type: FAQ

Reference should not be made to a specific version of the IB or SmPC, but to the most recently approved version at the time of SUSAR reporting, so the information remains valid even in case of subsequent amendments to the IB or SmPC. If, in contrast, …

How long shall adverse events be recorded, documented and reported to the sponsor? Date: 07. July 2023 Topics: Licensing Type: FAQ

According to article 41(2) of Regulation (EU) No 536/2014, investigators shall record and document all adverse events and report all serious adverse events to the sponsor, unless the protocol provides differently. The start and end time for …