|
29.10.2025
|
Urgent Field Safety Notice for 9180 Electrolyte Analyzer by Roche Diagnostics GmbH
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 49951/25
|
|
27.08.2025
|
Urgent Field Safety Notice for 8-402 Atemtraining-Set by Flexicare Medical Limited
Product group Physical therapy -
insufflation technique
Reference 21354/25
|
|
08.07.2025
|
Urgent Field Safety Notice for 3mensio Workstation by Pie Medical Imaging B.V.
Product group Medical data processing (software) -
software for computer-based treatment
Reference 28334/25
|
|
15.12.2025
|
Updated information Iris Webinar - January 2026
Updated information Iris Webinar - January 2026
|
|
06.08.2025
|
Thalidomide, lenalidomide and pomalidomide: Requirements for the prescription in Germany
Active substance: thalidomide, lenalidomide, pomalidomide
The Federal Institute for Drugs and Medical Devices (BfArM) once again draws attention to the applicable safety regulations and the requirements for the proper prescription of thalidomide, lenalidomide and pomalidomide.
|
|
29.10.2025
|
Successful Regional Training on Bioequivalence Study Assessment Held in Nairobi
Successful Regional Training on Bioequivalence Study Assessment Held in Nairobi
|
|
04.07.2025
|
Submission of Variations
Aerosol dispensers containing fluorinated greenhouse gases, including medicinal metered dose inhalers, may only be placed on the market, supplied or made available to third parties in the EU from 1 January 2025 if they are labelled in accordance with Article 12(3) of Regulation (EU) 2024/573 on fluorinated greenhouse gases (F-Gas Regulation).
|
|
08.12.2025
|
Structure of the BfArM in text form
Structure of the BfArM (date 08.12.2025)
|
|
08.12.2025
|
Structure of the BfArM
Structure of the BfArM (date 08.12.2025)
|
|
04.06.2025
|
Statistics "Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)"
The following table gives an overview of the herbal, homeopathic and anthroposophic medicinal products with completed marketing authorisation or registration procedure which are available on the German market.
|
|
31.10.2025
|
spec-ICD11-V2025S10 PDF
spec-ICD11-V2025S10 PDF
|
|
31.10.2025
|
spec-ICD11-V2025S10
spec-ICD11-V2025S10
|
|
23.06.2025
|
Sodium oxybate: Review of use in alcohol dependence
Active substance: sodium oxybate
The European Medicines Agency (EMA) is starting to review medicines containing sodium oxybate.
|
|
05.06.2025
|
Save the date – next Iris webinar
The next Iris webinar will be held on 9th July 2025.
|
|
31.10.2025
|
Role Identification of Causes of Death Algorithm (RICoDA version 2_1)
Role Identification of Causes of Death Algorithm (RICoDA version 2_1)
|
|
30.06.2025
|
Request for super-grouping
Request for super-grouping
|
|
24.07.2025
|
Reporting Recalls
Reporting Recalls
|
|
31.10.2025
|
Release notes Iris MUSE V6.1.0.9
Release notes Iris MUSE V6.1.0.9
|
|
25.07.2025
|
Radiation Protection Act
Below you will find all important information about the changes in the radiation protection act applicable since 01.07.2025.
|
|
14.07.2025
|
Radiation applications in combined clinical trials (clinical trials submitted to both CTIS and DMIDS)
For studies with submission in CTIS and DMIDS, only one radiation protection submission is required - depending on the study focus CTIS or DMIDS.
|