Regulatory Agency

European Medicines Agency (EMA)

Regulation Name

Falisified Medicines Directive (FMD) and the associated Delegated Regulation (DR)

FMD Requirements and Timeline

  • July 2011
    • The FMD was adopted and published by the Official Journal of the European Union. It contained four delegated acts on: safety features, active pharmaceutical ingredients traceability, good distribution and manufacturing practices,
    • and Internet sales.
  • October 2015
    • The Delegated Regulation 2016/161 was adopted by the European Union.
  • February 2016
    • It supplemented the original Directive, detailing the characteristics of the safety features and the obligations of supply chain stakeholders.
  • February 2019
    • Retail and hospital pharmacies in Europe must comply with the FMD by conducting systematic verification and decommissioning of prescription medicines using unique identifiers (UI).
    • The legislation applies to all medicines manufactured after this date.
  • 2025
    • European countries with a similar system already in place, such as Belgium, Italy and Greece, will have until 2025 to harmonize their systems with the European strategy.

The origins of the Falsified Medicines Directive can be traced to 2001, with the publication of the Directive 2001/83/EU, directed towards medicines for human use in Europe. This directive was amended in June 2011 by the European Parliament and of the Council, to become the Directive 2011/62/EU. This amendment was made in response to the increasing threat of falsified medicines entering the legal supply chain.

Manufacturers must apply two specific safety features on each unit of medicinal products subject to FMD:

  • An anti-tampering device that can determine if the package has been opened or tampered with
  • A unique identifier carried by a 2D barcode that allows pharmacy staff to verify and decommission the unit without having to type information manually

This unique identifier (UI) must contain the product number, the batch number, the expiry date, the serial number and finally the national reimbursement number, if requested by Member States.

These numbers must also be printed in human-readable characters, in case the barcode is too damaged to be scanned.

Verification of medicines at point of dispense

At the point of dispense, the medicine will be scanned, checked and verified for authenticity against a national (or supranational) repository. If the UI on the pack matches the information in the repository, the pack is decommissioned and supplied to the patient. Otherwise, if there is a warning related to this pack, the system will highlight this as an exceptional event and the package will not be supplied to the patient. An investigation needs to determine whether the pack has been falsified or not.