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Orion GxP consuting

Orion Consulting

The illegal supply chain, counterfeiting and the Falsified Medicines Directive

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Supply chain integrity is always knowing the source and destination of your medicines

As consumers, we are increasingly tempted to turn to online sources for medicines nowadays due to our changing shopping patterns and as a side effect of the recent pandemic. But, unfortunately, there are always those less scrupulous in society looking to take advantage of this and introduce falsified or counterfeit products that can range from unlicensed copies to ineffective and even dangerous fake medicines.
Counterfeiting is a global problem and one that the industry and regulators have been working on for many years, with early work focussing on making packs tamper-evident.

However, more sophisticated measures have been introduced in recent years, such as the unique identifiers brought in as part of the Drug Supply Chain Security Act (DSCSA) in the US; and through the Falsified Medicines Directive (FMD) and Commission Delegated Regulation (EU) 2016/161 in the EU.   The key to this technology has been the randomised nature of the unique identifier coded in the serialised barcode which is very difficult to forge.  Once in place on medicines packs, secondary wholesalers and point of dispense in hospitals and pharmacies use this to verify that the medicines they are handling are genuine.

As manufacturers and distributors of medicinal products we have an obligation to ensure that our supply chains are tightly managed, and that the opportunity for diverting medicines or introducing falsified medicine into the supply chain is as difficult as possible.  As a result, the legislation and guidance ensure that we map the supply chain of our drugs right from starting material through to the end wholesalers who sell the finished medicines to hospitals and pharmacies.  In addition, we are required to conduct frequent periodic checks (bona fides) to ensure that all steps in the supply chain are appropriately authorised and that they remain compliant and actively vigilant of potential cases of falsification.

Orion GXP Consulting have QP’s, RP’s and subject matter experts embedded with our clients and we work closely on training and QMS revisions to ensure that we embed industry best practice and compliance for our clients.  

If your company would like to review the processes you have place for compliance to DSCSA or FMD, or would simply need assistance with mapping supply chains and completing bona fides checks, then we can assist.

To discuss your needs further please don’t hesitate to reach out – or call +353 7198 10101.