Are you compliant with the new Falsified Medicines Directive?

12 February 2019


by Sam Kay Consulting, Pharmaceutical and life sciences

Email +44 (0)7834 252251

A challenging road lies ahead for pharmaceutical firms and healthcare providers with the implementation of the EU Falsified Medicines Directive (FMD), a law aimed at preventing the introduction of falsified prescription medicines into the European supply chain. But for agile players, this could also create a perfect opportunity to use new data to optimise their supply chains and improve patient interactions.

The EU FMD came into force on 9 February 2019 and requires all prescription medicines entering the EU supply chain to be compliant. So how will you ensure you are compliant with FMD?Fmd

There are four key areas you can focus on:

  1. Serialisation - A unique identifier (UI) barcode must be implemented at the saleable pack level.
  2. Anti-tamper device - A seal/device to verify that the packaging has not been compromised.
  3. Data Reporting - The manufacturer must submit product master data and serialized pack data to the European Hub (EMVS).
  4. Verification - The product UI barcode must be scanned and verified against the national system before decommissioning by a pharmacy or wholesaler.

To enable a successful FMD implementation, these areas need to be explored strategically. There are significant opportunities for creating business value beyond FMD compliance:

  • Engaging with data management and linking the data to analytics can generate new procurement insights (e.g. predictive inventory management).
  • Maximising new technologies such as a distributed ledger can enhance trust and security in the supply chain.
  • Bringing the latest manufacturing technologies (e.g. robotic process automation) can optimise processes and reduce cost, despite more complex packaging requirements.

While implementation is difficult and costly, the smarter players in the market are taking this opportunity to improve medicines optimisation, by enabling reduced wastage and safer dispensation. It is never too late to optimise the supply chain with the new data and infrastructure in place for compliance. So - Are you FMD compliant? Please do get in touch.

by Sam Kay Consulting, Pharmaceutical and life sciences

Email +44 (0)7834 252251