BfArM - Federal Institute for Drugs and Medical Devices

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Joint Advice through the BfArM and the Federal Joint Committee (G-BA) Date: 02. February 2024 Topics: About BfArM Arzneimittelsicherheit Licensing Type: Article

As part of the exemption of reserve antibiotics from the benefit assessment according to section 35a SGB V, the list of criteria and pathogens for classification as a reserve antibiotic was updated.

Expert Advisory Committee for Prescription-Only Issues Date: 30. June 2023 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Meetings of the Expert Advisory Committee for Prescription-Only Issues (in accordance with section 53 German Medicines Act) take place twice yearly (January/June).

Instructions for submission of an application for changing the legal status Date: 30. June 2023 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Instructions for submission of an application for changing the legal status

Basis for the ongoing monitoring and improvement of drug safety Date: 01. July 2021 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Taking medicine can be associated with certain risks. All medicinal products are carefully monitored after having been placed on the EU market.

Reporting risks Date: 01. July 2021 Topics: Arzneimittelsicherheit Type: Article

Adverse drug reactions

In order to be able to identify risks associated with medicinal products as quickly as possible, the BfArM is dependent on reliable data and warning signs from practical experience.

DHPCs (Rote-Hand-Briefe) and Information Letters Date: 19. March 2020 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Here you will find Direct Healthcare Professional Communications - DHPCs (so-called "Rote-Hand-Briefe") and Information Letters sent out by pharmaceutical companies informing healthcare professionals about newly identified major drug-associated risks …

Other risk information Date: 19. March 2020 Topics: Arzneimittelsicherheit Type: Article

Other risk information

Risk Assessment Procedures Date: 19. March 2020 Topics: Arzneimittelsicherheit Type: Article

Here you will find information on the risk assessment procedures including national graduated plan procedures (“Stufenplanverfahren”).

Expert Advisory Committee for Pharmacy-Only Issues Date: 06. March 2020 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Meetings of the Expert Advisory Committee for Pharmacy-Only Issues (in accordance with section 53 German Medicines Act) take place as and when required.

Routine sessions pursuant to Section 63 German Medicines Act (AMG) Date: 06. March 2020 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Routine sessions pursuant to Section 63 AMG take place at the BfArM at least twice a year, where graduated plan stakeholders (Stufenplanbeteiligte) exchange information about current problems of pharmaceutical safety.