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January 12, 2026
Approximately 5 minutes
PharmNet.Bund – German Medicinal Products Information Network
PharmNet.Bund – German Medicinal Products Information Network
Overview and Purpose
PharmNet.Bund serves as the national electronic communication and data exchange platform for medicinal products in Germany. Managed by BfArM in cooperation with other competent authorities, it enables secure, standardised transmission of regulatory information, including notifications of adverse reactions, periodic safety update reports (PSURs), risk management plans, and variations to marketing authorisations. The system supports efficient pharmacovigilance and regulatory processes while ensuring data integrity and confidentiality. PharmNet.Bund - BfArM
Key Functions
- Notifications and Reporting: Marketing authorisation holders submit adverse reaction reports, PSURs, and other pharmacovigilance data electronically.
- Regulatory Submissions: Facilitates electronic submission of variation applications, renewals, and other regulatory procedures.
- Data Exchange: Supports secure exchange between BfArM, EMA, Paul-Ehrlich-Institut (PEI), and other national authorities.
- Standardised Formats: Uses EU harmonised formats (e.g., ICH E2B for individual case safety reports, eCTD for marketing authorisation applications).
- User Access: Registered users (MAHs, sponsors, authorities) access via secure portals with role-based permissions.
Technical and Legal Basis
PharmNet.Bund operates under German and EU legislation, including the German Medicines Act (AMG), EU pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU), and Good Pharmacovigilance Practices (GVP). It is fully integrated with the EU's EudraVigilance system for adverse reaction reporting and aligns with the EU Single Submission Portal (SSP) initiatives. The platform uses encrypted transmission and complies with data protection requirements (GDPR).
Practical Use and Access
- Marketing authorisation holders must register for PharmNet.Bund to fulfil electronic submission obligations.
- BfArM provides detailed guidance documents, technical specifications, and support for implementation.
- The system reduces paper-based processes, accelerates data processing, and enhances signal detection capabilities.
PharmNet.Bund plays a critical role in Germany's efficient and transparent medicinal products regulatory framework, contributing to timely safety monitoring and public health protection across the EU. PharmNet.Bund - BfArM
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