Have only two years to prepare for FMD compliance. EU FMD specifically outlines how the EU will track and trace medications using serialisation, government reporting, and verification components. This time last year (February 2016) the Delegated Act was published on safety features in response to an increased risk of counterfeit & falsified medications.
EU FMD contains three major government requirements:
- Serialisation
- Verification and safety features (2D barcode, Anti-tampering technologies)
- Compliance reporting
February 2019 is the deadline.
If you are not ready by the deadline your product(s) might get rejected by government authorities. Get ready!