BfArM - Federal Institute for Drugs and Medical Devices

For health and safety

DHPC (Rote-Hand-Brief) on Giapreza 2.5 mg/ml concentrate for preparation of infusion solution

Potentially low fill vials and important information regarding instructions for use

DHPC (Rote-Hand-Brief) on Oncofolic 50 mg/ml solution for infusion/injection, strength 100 mg, 400 mg, 500 mg and 900 mg

Possible risk of visible particles in the solution, use of a filter

DHPC (Rote-Hand-Brief) on Irenate (sodium perchlorate) drops from Austria

Risk of incorrect dosing due to a different dosage (number of drops per millilitre)

European Regulatory Oncology News - ERON

The latest newsletter on innovative medicines for the treatment of cancer is available.

Monthly Iris webinar - May 2024

The next Iris webinar will take place on May 29th, 2024 (1:00pm to 2:30pm CEST).

Classification of reserve antibiotics §35a SGB V

Update of the pathogen list and criteria by RKI and BfArM 2024

BfArM Impulse Report

AI or EU pharmaceutical legislation, the BfArM's annual report provides exciting impulses for the future of medicine.

Services

Reporting risks to the BfArM

Medicinal products

Consumers and healthcare professionals reporting adverse reactions (German)

Medical devices

SNOMED CT

SNOMED CT is currently the most comprehensive health terminology in the world, a constantly growing ontology of preferred terms with their synonyms. The national competence Center for Terminologies at BfArM is responsible for the provision and further development of SNOMED CT in Germany.

Medicinal products

Update of Direct Healthcare Professional Communication (DHPC) on Oncofolic 50 mg/ml solution for infusion/injection, strength 100 mg, 400 mg, 500 mg and 900 mg: Possible risk of visible particles in the solution, use of a filter

2024.05.27

Direct Healthcare Professional Communication (DHPC) on Giapreza 2.5 mg/ml concentrate for preparation of infusion solution: potentially low fill vials and important information regarding instructions for use

2024.05.27

Information letter on Carmubris powder and solvent for solution for infusion: incorrect labeling

2024.05.23

All risk information on medicinal products

Medical devices

Critical vulnerabilities in the real-time operating systems of various venders

Date: 2021.08.19 Topics: Medical devices

All risk information on medical devices

Urgent Field Safety Notice for MINICAP IMMUNOTYPING, CAPILLARYS IMMUNOTYPING, CAPI 3 by SEBIA

Download_VeroeffentlichtAm_EN 2024.05.29 Download_Angaben zum Download PDF, 1MB, File does not meet accessibility standards

All field corrective actions

In focus

DiGA and DiPA

Digital applications are an important element in the digital modernisation of health care and nursing in Germany. They are part of the future eHealth infrastructure and will interact closely with other digital elements such as the electronic health record (ePA).

Digitization

The digitization of the healthcare system holds enormous opportunities for the development of new therapies and efficient healthcare. BfArM acts here as a competent partner with a world-leading digital competence among the institutions responsible for the approval and supervision of medicinal products and medical devices.

Europe and International

The BfArM is the largest drug approval authority in Europe. Experts contribute their knowledge to the scientific committees of the European Medicines Agency (EMA), among others. Throughout the EU and internationally, BfArM makes a significant contribution to the supply of safe and effective medicines.

Research

Research at the BfArM concentrates on important and contemporary research focal points with regard to the marketing authorisation of medicinal products and improving the safety as well as concerning the recording and assessment of risks in connection with medical devices.