Acrovision’s Online Validator Inspection System CAN!
100% Online Inspections for the Falsified Medicines Directive
What is FMD?
The Falsified Medicines Directive (FMD) is a European Directive which purpose is to protect the health and safety of patients, by reducing the risk of counterfeit pharmaceuticals entering the established medicines supply chain.
Who will this impact?
This will apply to all manufacturers, wholesales, distributors and everyone involved in this supply chain to allow the verification of the authenticity of a medicinal product.
Why is it necessary?
Falsified ‘fake’ medicines may contain poor quality ingredients or of the wrong strength that could lead to an increase of disease and potential fatalities on a global scale.
How can I be compliant?
To comply with the FMD, pharmaceutical companies must ensure the following are part of their dispensing process:
- Unique ID (UI) – typically a data matrix 2D code to determine authenticity;
- Check of Anti-tamper device – this is to ensure the medicine is intact before dispensing.
When do I need to comply?
The final phase is being rolled out in February 2019 however the EU recommends companies review their dispensing processes and ensure the right procedures are in place for compliance with the FMD.
- 100% check all 2D barcodes for authenticity.
- 100% check to inspect presence and position of the tamper device.
- Provides no read / wrong read / faulty label outputs to ensure fully compliant inspections throughout the supply chain.
- Multiple inspection lines can be networked together and controlled centrally.