Reporting of Risks and Adverse Reactions to BfArM

Legal Obligations for Reporting

In Germany, the reporting of suspected adverse drug reactions (ADRs) and other relevant risks is governed by the German Medicines Act (AMG) and EU pharmacovigilance legislation (Directive 2001/83/EC as amended, Regulation (EU) No 1235/2010). Marketing authorisation holders (MAHs), healthcare professionals, and patients have legal duties to report information that may influence the benefit-risk balance of medicinal products. BfArM, as the competent authority, receives and evaluates these reports to support national and EU-wide safety monitoring. Reporting risks - BfArM

Who Must Report and What to Report

• Marketing Authorisation Holders (MAHs): Must report all suspected serious ADRs (including from non-EU countries) within 15 days (serious) or 90 days (non-serious) to BfArM/PEI and EMA via EudraVigilance.
• Healthcare Professionals: Encouraged and legally obliged to report suspected ADRs directly to BfArM or PEI, especially serious or unexpected reactions.
• Patients: Can report suspected ADRs directly via the BfArM online portal or by post; reports are welcomed to capture real-world experiences.

Reportable information includes:

• Suspected ADRs (serious/non-serious)
• Lack of efficacy in serious indications
• New risks or changes in frequency/severity
• Medication errors, misuse, abuse, overdose
• Off-label use with adverse outcomes

Reporting Channels and Systems

• Electronic Reporting: Preferred method via EudraVigilance (for MAHs) or BfArM’s web portal for healthcare professionals and patients.
• Red-Hand-Letter System: BfArM uses red-hand letters to communicate important new safety information to healthcare professionals.
• Signal Detection: BfArM continuously analyses reports, literature, and other sources to detect safety signals and takes regulatory actions when needed.

Timelines and Follow-up

• Serious ADRs: Immediate awareness and 15-day expedited reporting.
• Non-serious ADRs: Included in periodic safety update reports (PSURs) or ad-hoc as required.
• MAHs must follow up on reports to obtain complete information and submit updates promptly.

Practical Guidance

BfArM provides detailed guidance on report forms, coding (MedDRA), and causality assessment. Healthcare professionals and patients are encouraged to report even when causality is uncertain, as reports contribute to overall signal detection and risk management. Timely and complete reporting helps maintain the safety profile of medicines and protects public health in Germany and the EU. Reporting risks - BfArM