Traceability of medicines and the falsified medicines directive (FMD) is your organisation ready?

Oct 16, 2014, by Siobhain Duggan - Category: Pharma

Healthcare systems around the globe are facing challenges that affect the entire supply chain.  The sector is concerned primarily with two main issues: patient safety and greater supply chain efficiency and accuracy.  The facility to identify things uniquely and accurately is essential - be it a medication, an item of clinical equipment or even a patient.  The regulatory landscape continues to evolve globally.  New regulations in the EU, the US and elsewhere will have a major direct impact on the healthcare supply chain. 

Use of GS1 Standards enables traceability and promotes a safe and secure supply chain by providing greater visibility, accuracy and efficiency for the benefit of all parties.  Preventing medical errors, enabling traceability & recall and combating counterfeiting are key concerns facing the sector, and GS1 Standards are helping to solve these issues.

Key Benefits of adopting GS1 Standards in Healthcare:

  • Improving patient safety
  • Lowering costs through increased efficiency
  • Reducing medication errors
  • Enabling supply chain visibility
  • Facilitating effective product recalls
  • Tracking of pharmaceutical products/medical devices
  • Reducing introduction of counterfeit products
  • Enhancing inventory management
  • Linking critical product data to the patient record
  • Supporting regulatory compliance
  • Optimising order, invoice, sales reporting, and chargeback/rebate processes

Ensuring Regulatory Compliance

Product serialisation, compliance with EU, FDA and other international drug pedigree requirements and establishing anti-counterfeiting solutions are key priorities for the pharmaceutical industry.  The deadline for compliance with the European Falsified Medicines Directive (FMD) is 2017 for those countries that don’t have a pre-existing authentication system.  All manufacturers will be expected to print a 2D datamatrix with serialisation data on medicine packs and these packs then need to be verified at the point of dispense.  This requires significant changes for pharmaceutical manufacturers and will require IT development changes in hospitals and community pharmacies.

The proposed European and US FDA Unique Device Identification (UDI) regulations are to the fore in the medical device arena, as companies need to transform disparate medical identification methods into a standardised UDI system. 

Both pharmaceutical and medical device manufacturers are leveraging GS1 Standards and the support of GS1 experts to prepare for these new requirements and ensure regulatory compliance.

Get involved! Go to our Get Started page now to takethe first step.

BySiobhain Duggan, Director of Innovation & Healthcare, GS1 Ireland
Date16th Sept 2014
KeywordsSerialisation, Falsified, Medicines, Directive, FMD, Unique, Device, Identification, UDI, GS1, Standards, Patient, Safety, Efficiency, Tracking, regulatory, compliance.


Tags: Falsified, Medicines, Directive,