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FMD - Falsified Medicines Directive - Need help to comply?

(03 Oct 2018)

FMD - Falsified Medicines Directive - Are you ready? Do you need help?

 

The Falsified Medicines Directive deadline of the 9th February 2019 is fast approaching. Are you ready for FMD and what it means for the Pharmaceutical Industry? Can your systems comply with the legisation?

 

FMD Deadline

The Falsified Medicines Directive (FMD) - which comes into force on the 9th February 2019, as directed by the European Commission, will mean some big changes for the Pharmaceutical Industry throughout Europe.

As outlined in our blog, "Traceability, Falsified Products and New Legislation", The Falsified Medicines Directive legislative measures include:

  • An obligatory authenticity feature on the outer packaging of certain prescription-only medicines. 
  • A common, EU-wide logo to identify legal online pharmacies. 
  • Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients.
  • Strengthened record-keeping requirements for wholesale distributors.

In practical terms, this will lead to substantial changes to working practices, systems and business processes surrounding warehouse management, stock control, distribution and dispensing for various stakeholders in the Pharmaceutical Industry in Europe.

 

AWARDS-BA³ & FMD

The AWARDS-BA³ system, a Microsoft .NET WMS system, which provides full product traceability from source through to end-user, has been designed with the Falsified Medicines Directive in mind. 

For more information about the AWARDS-BA³ system and the capabilities of the system with regard to the Falsified Medicines Directive, contact us on +353 (0)1 827 0650 or email us at info@bds.ie

 

Help us with our FMD requirements...



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Ireland
Eircode: D15 H34C
Phone: +353 (0)1 827 0650
Email: info@bds.ie

 

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