What is FMD?

FMD stands for Falsified Medicines Directive and is an initiative of the European Union to guarantee the safety of medicines and to combat the trade in counterfeit medicines. It is intended to protect patients from the risks of using counterfeit medicines and to increase confidence in the pharmaceutical industry.

The FMD has been in force since February 9, 2019 and sets mandatory measures for the traceability of medicines within the European Union. Key aspects of the FMD include:

1. Safety features: The FMD requires all medicines sold in the European Union to carry mandatory safety features. This includes a unique identification code (unique serialization), an anti-tampering device on the packaging and a 2D matrix code for electronic identification.

2. Verification system: Pharmacies and other healthcare providers must have a verification system in place that allows them to verify the authenticity of the medicines before they are dispensed to patients. This system uses the unique identifier and other characteristics to verify the authenticity of the medicine.

3. European Database: A European database has been set up, called the European Medicines Verification System (EMVS), in which information about medicines and their verification is stored. This allows manufacturers, wholesalers, pharmacies and other healthcare providers to track and verify the traceability of medicines.

4. Collaboration and Enforcement: The FMD requires collaboration between all parties involved, including drug manufacturers, distributors, pharmacies and regulatory authorities. It is the responsibility of all parties to ensure that medicines are safe, legitimate and meet the requirements of the FMD.

The ultimate goal of the Falsified Medicines Directive is to ensure the safety of medicines for patients by improving the traceability of medicines and preventing falsified medicines from legal distribution channels. The implementation of the FMD gives patients confidence that the medicines they use are safe and authentic.