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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

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 …

How to report SUSARs in case of a failure of the EudraVigilance database or other technical issues? Date: 07. July 2023 Topics: Licensing Type: FAQ

Generally, in case of a system failure or other technical issues, SUSARs can be reported via the joint portal for reporting adverse reactions by healthcare professionals of the BfArM and the PEI after prior consultation with the BfArM. However, the …

How to report SUSARs from clinical trials not falling within the scope of Regulation (EU) No 536/2014 but within the scope of the German Medicinal Products Act (Arzneimittelgesetz) in the version in force on 26 January 2022 (corresponding to Directive 2001/20/EC)? Date: 07. July 2023 Topics: Licensing Type: FAQ

As communicated in the sponsor handbook on the Clinical Trials Information System (EMA/923413/2022 – v. 3.01, 20 December 2022, section 9.1), SUSARs should be reported to the EudraVigilance database only, even if they occurred in clinical trials …

Which scale should be used to determine a causal relationship between an event and an investigational medicinal product? Date: 07. July 2023 Topics: Licensing Type: FAQ

We recommend the use of a binary scale that only distinguishes between “related” and “not related”. See also: Council for International Organisation of Medical Sciences (CIOMS): Management of Safety Information from Clinical Trials: Report of CIOMS

How to report SUSARs from compassionate use programmes? Date: 07. July 2023 Topics: Licensing Type: FAQ

In contrast to SUSARs from clinical trials, SUSARs from compassionate use programmes must be reported to the competent higher federal authority according to section 6(6)(1) of the German Ordinance on Medicinal Products for Compassionate Use …

What to do in case of missing acknowledgment (ACK) for a SUSAR report? Date: 07. July 2023 Topics: Licensing Type: FAQ

The EMA is responsible for ACK transmission and this can take up to 48 hours. Before inquiring the status of ACK, please wait at least three working days. The sender should also check whether a “Message Disposition Notification” (MDN) is available, …

Opinion No. 01/2023 of the Joint Expert Commission on Classification of Substances PDF, 1MB, File does not meet accessibility standards Date: 03. July 2023 Topics: Licensing Type: Download

Classification of products containing zinc

CHMP Meeting Highlights June 2023 Date: 30. June 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights June 2023

Are there shortened deadlines for phase I studies? Date: 14. June 2023 Topics: Licensing Type: FAQ

Mononational phase I studies are assessed within 26 days after successful validation. Should the application be free of defects, a decision can be made by day 31. This also applies to other mononational studies of other phases.

Should it be a …

CHMP Meeting Highlights May 2023 Date: 01. June 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights May 2023

"Compassionate Use" Programmes Date: 09. May 2023 Topics: Licensing Type: Article

"Compassionate Use" was introduced into the German legislation with the 14th amendment of the German Medicinal Product Act (AMG) and modified by the amendment of the German Medicinal Product Act in July 2009.