BfArM - Federal Institute for Drugs and Medical Devices

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Alpha-ID-SE Date: 27. November 2025 Topics: Kodiersysteme Type: Article

The Alpha-ID is a sequential and stable identification number, which is allocated to each entry in the alphabetical index. It permits the encoding of medical and natural language diagnostic terms. Published in 2005 by DIMDI as a prototype, the file …

Marketable medicinal products in the responsibility of the BfArM Date: 24. November 2025 Topics: Licensing Type: Article

On the following page you will find the figures of marketable medicinal products in the responsibility of the BfArM, broken down according to type of authorisation procedure as well as details of the authorisation status. The figures are …

Processing statistics Date: 24. November 2025 Topics: Licensing Type: Article

Here the BfArM publishes the current processing statistics of authorisations and registrations as well as of renewals. The figures are updated on a monthly basis.

Clinical investigations and performance studies Date: 20. November 2025 Type: Article

Pursuant to the Regulations (EU) 2017/745 and (EU) 2017/746 (MDR and IVDR) as well as German national regulations a favourable opinion of the competent ethics committee and an approval of or notification to the competent authority is required in …

Operating the system Date: 20. November 2025 Type: Article

With its barrier-free (according to BITV, German Barrier-free Information Technology Ordinance), graphical user interface the German Medical Devices Information and Database System (Deutsches Medizinprodukte-Informations-und Datenbanksystem, DMIDS) …

Promethazine: New contraindication for children under 6 years of age Date: 20. November 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: promethazine

The BfArM informs that the use of medicines containing promethazine is contraindicated in children under the age of 6 due to age-specific risks.

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

Information Iris Webinar - January 2026

Statistics Date: 20. November 2025 Topics: Licensing Type: Article

The statistics have been updated.

Most common considerations when submitting an initial application or a substantial modification Date: 12. November 2025 Topics: Licensing Type: Article

The following is a list of the most common considerations that occur in the area of validation.