BfArM - Federal Institute for Drugs and Medical Devices

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Information Iris Webinar - January 2026 PDF, 129KB, File is accessible Date: 20. November 2025 Type: Download

Information Iris Webinar - January 2026

Official Launch of Iris Version 6 Date: 20. November 2025 Topics: Kodiersysteme Type: News

Please save the date for the launch webinar on January 28, 2026, at either 10:00 CET or 17:00 CET.

How can an acceleration or prioritisation of the assessment of a variation procedure be requested from BfArM, and what information is required? Date: 05. November 2025 Topics: Licensing Type: FAQ

Generally, applications are processed in the order in which they are received. Exceptions to this rule may be made in justified cases if this leads to an improvement in an existing critical supply situation or if it can avert a critical supply …

Structure of the BfArM in text form PDF, 172KB, File is accessible Date: 05. November 2025 Topics: About BfArM Type: Download

Structure

Structure of the BfArM PDF, 135KB, File does not meet accessibility standards Date: 05. November 2025 Topics: About BfArM Type: Download

Structure

Iris version 6 is available for ICD-11 mortality coding Date: 04. November 2025 Topics: Kodiersysteme Type: News

The Iris software has been used for ICD-10 mortality coding for more than 20 years. Now, Iris is also available for ICD-11 mortality coding.

Iris User Manual V6.1.0.9S1 - track changes PDF, 5,42 MB, File does not meet accessibility standards Date: 31. October 2025 Topics: Kodiersysteme Type: Download

Iris User Manual V6.1.0.9S1 - track changes

Iris User Manual V6.1.0.9S1 PDF, 4,41 MB, File does not meet accessibility standards Date: 31. October 2025 Topics: Kodiersysteme Type: Download

Iris User Manual V6.1.0.9S1

User Interface English V6.1.0-Y2025S1 ZIP, 14 kB, File does not meet accessibility standards Date: 31. October 2025 Topics: Kodiersysteme Type: Download

User Interface English V6.1.0-Y2025S1

Downloads Iris Institute - Terms and conditions for downloading (PDF, 244 kB) PDF, 244KB, File is accessible Date: 17. October 2025 Topics: Kodiersysteme Type: Download

Downloads Iris Institute - Terms and conditions for downloading

Comments concerning texts published in Issue 12.2 PDF, 329KB, File does not meet accessibility standards Date: 01. October 2025 Topics: Licensing Type: Download

Comments concerning texts published in Issue 12.2

Causes of death coding in Iris with ICD-11 testing results PDF, 207KB, File is accessible Date: 22. September 2025 Type: Download

Causes of death coding in Iris with ICD-11 testing results

Non-exhaustive list of multidrug-resistant bacteria and criteria for classification of an antibiotic as a reserve antibiotic according to § 35a para. 1 SGB V (as of 4 August 2025) PDF, 316KB, File does not meet accessibility standards Date: 04. August 2025 Type: Download

Reserve antibiotics: Exemption from the benefit assessment by standardized criteria according to §35A social code book (SGB) V

Guidance for Applicants Scientific Advice PDF, 311KB, File is accessible Date: 15. July 2025 Topics: About BfArM Type: Download

Guidance for Applicants Scientific Advice

Radiation applications in combined clinical trials (clinical trials submitted to both CTIS and DMIDS) Date: 14. July 2025 Type: News

For studies with submission in CTIS and DMIDS, only one radiation protection submission is required - depending on the study focus CTIS or DMIDS.

Presenation Iris Webinar July 2025 PDF, 411KB, File does not meet accessibility standards Date: 09. July 2025 Topics: Kodiersysteme Type: Download

Presenation Iris Webinar July 2025

Are variations to purely national licences that contain only one single change but several marketing authorisations regarded as a grouping? Date: 03. July 2025 Topics: Licensing Type: FAQ

Yes. These variations are categorised as “horizontal groupings” according to Article 13.d.2) of Regulation 712/2012/EC. However, when submitting such variations to the BfArM they should not be submitted as a grouping but as a collective notification …