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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 …

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.

Oxbryta (voxelotor): EMA confirms suspension of sickle cell disease medicine Oxbryta Date: 23. October 2025 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: voxelotor

EMA confirms suspension of sickle cell disease medicine Oxbryta

Information for marketing authorisation holders: Current information on submission for step 3 Date: 23. July 2025 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

Information for marketing authorisation holders: Current information on submission for step 3

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.

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 …

New version of the DMIDS module "Clinical investigations and performance studies" from July 1, 2025 Date: 24. June 2025 Topics: Medical devices Type: News

The BfArM launches a new version of the DMIDS module "Clinical investigations and performance studies" on July 1, 2025.

New radiation protection regulations effective July 1, 2025 Date: 20. June 2025 Type: News

Effective July 1, 2025, new regulations will apply to radiation protection approvals or notifications for clinical trials.

Approval procedure pursuant to Section 31 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025 Date: 20. June 2025 Type: News

The article provides information on the correct procedure for approval procedures in accordance with Section 31 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) in the context of CTR applications and Substantial Modification in CTIS.

Notification procedure pursuant to Section 32 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025 Date: 20. June 2025 Type: News

This article provides information on the correct procedure for reporting a notification procedure in accordance with Section 32 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) as part of CTR submission and for Substantial …

How are the data on antibiotic resistance in section 5.1 of the SmPC to be updated? Date: 10. June 2025 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.

The previously requested EUCAST table (European …

Save the date – next Iris webinar Date: 05. June 2025 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 9th July 2025.

German SAE Report Form PDF, 1MB, File does not meet accessibility standards Date: 28. May 2025 Topics: Medical devices Type: Form

Report form for reporting of serious adverse events (SAE) in clinical trials or performance studies for use by sponsors according to § 3 (5) of the Ordinance on Medical Devices Vigilance

PDF-Form (use of Adobe Acrobat 9.X recommended)

Iris user survey Date: 17. April 2025 Topics: Kodiersysteme Type: News

The Iris user survey is now available!

Is it allowed to register my trial in DRKS if it is already registered in another WHO Primary Registry (e.g. CTIS)? Date: 07. April 2025 Topics: About BfArM Type: FAQ

WHO recommends that clinical trials with one or more recruitment sites in the same country should be registered in only one study registry. For more information, please visit the WHO website.

If you still wish to register in the DRKS (e.g. because …

Save the date – next Iris webinar Date: 31. March 2025 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 15th April 2025.

Reminder: Iris user group meeting – register now Date: 26. March 2025 Topics: Kodiersysteme Type: News

The Iris user group meeting will take place on 15th and 16th May 2025 in Cologne.

How is the reference to the digital package leaflet implemented for centrally authorised medicinal products? Date: 17. February 2025 Topics: Licensing Type: FAQ

The European Medicines Agency (EMA) is the competent authority for centrally authorised medicinal products. The BfArM recommends to contact the EMA in case of questions.

Iris training: Save the date and register Date: 12. February 2025 Topics: Kodiersysteme Type: News

The Iris training will be held as a web-based training from 31st March until 3rd April 2025.