Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
January 19, 2026
Approximately 5 minutes
Implementation of the Falsified Medicines Directive in Germany by BfArM
Implementation of the Falsified Medicines Directive in Germany by BfArM
EU Falsified Medicines Directive Overview
The Falsified Medicines Directive (Directive 2011/62/EU) amends Directive 2001/83/EC to strengthen controls on the legal supply chain and prevent falsified medicines from reaching patients. It introduces mandatory safety features and verification requirements across the EU, fully applicable since February 2019. In Germany, BfArM is the competent authority responsible for implementation, supervision, and enforcement of these measures for human medicinal products. Falsified medicines directive - BfArM
Key Safety Features
- Unique Identifier (2D Data Matrix Code): A machine-readable code containing product code, serial number, batch number, and expiry date.
- Anti-Tampering Device (ATD): Tamper-evident packaging to indicate if the outer packaging has been opened or altered. These features must be applied to most prescription medicines and selected non-prescription medicines. BfArM verifies compliance during authorisation and inspection processes.
Verification and Decommissioning System
- Germany participates in the European Medicines Verification System (EMVS) via the national organisation securPharm.
- At the point of dispensing (mainly pharmacies), the unique identifier is scanned and verified against a central EU hub and national repository.
- Successful verification leads to decommissioning of the serial number to prevent reuse.
- Alerts on potential falsified products trigger immediate investigation by BfArM and supply chain actors.
Roles and Responsibilities
- Marketing Authorisation Holders (MAHs): Ensure products bear safety features, upload data to the repository, and manage decommissioning.
- Wholesalers and Pharmacies: Perform verification checks and report issues.
- BfArM: Supervises overall compliance, investigates alerts, coordinates with EMA and other Member States, and enforces penalties for non-compliance.
Practical Implementation and Support
BfArM provides guidance on technical specifications, transition periods, and derogations (e.g., for certain parallel imports or hospital supplies). It also monitors the effectiveness of the system through inspections and collaborates on EU-level initiatives to combat falsified medicines. These measures significantly enhance patient safety by ensuring only authentic, traceable medicines circulate in the German supply chain. Falsified medicines directive - BfArM
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Management of Supply Shortages of Medicinal Products at BfArM
BfArM monitors and manages supply shortages of authorised medicinal products in Germany by requiring marketing authorisation holders to notify actual or anticipated shortages, publishing information on the Federal Supply Shortage Database, and coordinating measures to mitigate impacts on patient care and public health.
Approximately 5 minutes
Fixed Reimbursement Amounts for Medicinal Products in Germany
BfArM sets fixed reimbursement amounts (Festbeträge) for groups of interchangeable medicinal products in Germany to control statutory health insurance expenditure, ensuring cost-effective prescribing while maintaining patient access to effective therapies within defined therapeutic classes.