The Falsified Medicines Directive (FMD) is a European Union regulation (Directive 2011/62/EU) aimed at preventing the entry of falsified medicinal products into the legal supply chain. It represents a comprehensive approach to pharmaceutical security and patient safety.
The directive mandates specific safety features on prescription medicines and establishes a verification system to authenticate medicinal products throughout the supply chain, from manufacturer to patient.
Each prescription medicine package must carry a unique identifier, typically encoded in a GS1 DataMatrix 2D code containing product code, serial number, batch number, and expiry date.
Packaging must include an anti-tampering device to ensure the integrity of the packaging and provide visible evidence of tampering attempts.
Implementation of a system to verify the authenticity of medicinal products before dispensing to patients, involving all stakeholders in the supply chain.
Global Trade Item Number that uniquely identifies the specific medicine and its packaging configuration.
A unique alphanumeric code assigned to each individual package, making it distinguishable from all other packages.
Identifies the production batch, enabling traceability to specific manufacturing runs and quality control records.
Indicates the shelf life of the product, ensuring medicines are not dispensed beyond their safe use period.
The unique identifier is encoded in a GS1 DataMatrix 2D code, a two-dimensional barcode that can store significant amounts of data in a compact format. This format is specifically designed for pharmaceutical applications and provides high data integrity and readability.
The DataMatrix follows GS1 standards and uses Application Identifiers (AIs) to define the meaning and format of each data element, ensuring global interoperability and consistency.
In addition to the machine-readable 2D code, the packaging includes human-readable text showing the key information for verification purposes and regulatory compliance.
The anti-tampering device provides visible evidence of any attempt to tamper with the medicine packaging, ensuring the integrity of the product from manufacturer to patient.
ATDs can take various forms including breakable seals, tear strips, or other mechanisms that are irreversibly damaged when the packaging is opened, providing clear visual indication of tampering.
Pharmacists are required to check the integrity of the anti-tampering device before dispensing medicines, adding an additional layer of security to the verification process.
The FMD applies to all prescription medicines sold in the EU, with specific exemptions for certain categories such as homeopathic medicines and some traditional herbal medicines.
Requirements apply to manufacturers, wholesalers, pharmacies, and other entities involved in the distribution of prescription medicines.
The directive applies to all EU member states and is implemented through national legislation in each country.
Falsified Medicines Directive (2011/62/EU) was adopted by the European Parliament and Council.
Commission Delegated Regulation (EU) 2016/161 detailed the safety features and verification requirements.
FMD became effective on February 9, 2019, requiring all prescription medicines to bear safety features.
Pharmacists scan the GS1 DataMatrix barcode on prescription medicine packaging.
The unique identifier is verified against the European Medicines Verification System (EMVS).
System returns verification status: active, decommissioned, or unknown.
Based on verification result, pharmacist decides whether to dispense the medicine.
Information may be outdated. Always consult official documentation from EMVO, EMA, GS1, and national regulatory bodies for current requirements.