FALSIFIED MEDICINES DIRECTIVE

OM Movianto and The Falsified Medicines Directive

By February 2019 all those who manufacture, sell or dispense medications within the European Union, will have to comply with the new track and trace regulations outlined in the Falsified Medicines Directive (FMD) [1].

The FMD is the principal guideline for the manufacturing and distribution of medicines within the EU, encompassing the main requirements of serialisation, compliance reporting and product verification. Whilst each EU Member state has the flexibility to apply their own requirements, OM Movianto are already fully engaged and working together to prepare for the Falsified Medicines Directive to come in 2019 across Europe to provide the consistency in approach our clients expect.

OM Movianto are 100% Healthcare focussed and with security and product integrity being central to our operation, we support the objective to further increase the security of the manufacturing and delivery of medicines in Europe, in turn providing greater protection to patients from falsified medicines in the legal supply chain of pharmaceuticals.

What will OM Movianto provide in line with the FMD by February 2019?

  • Interfacing with the appropriate verification databases/partners to fulfill FMD requirements [1]
  • Delivering products as your nominated distributor either to wholesalers or directly to healthcare institutions where individual packs will be checked, verified and decommissioned before being dispensed to patients
  • Provide you with FMD compliant manufacturing services, such as re-packing and overlabelling
  • Check, verify and decommission individual packs of your products for distribution to sites and Healthcare Professionals covered by Article 23 [2]
  • Manage recalls, withdrawals, returns, sampling, destruction, export and other services in line with FMD requirements

 


 

[1] Falsified Medicines Directive

[2] Article 23 L 32/13 COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015

 

Stefan

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FALSIFIED MEDICINES DIRECTIVE

FALSIFIED MEDICINES DIRECTIVE

The FMD, what is it and what does it mean? OM Movianto are already fully engaged and working together in preparation for February 2019.

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