Packaging Innovation
Falsified Medicines Directive for pharma packaging  
February 6, 2018

Is your pharma packaging ready for February 2019?

Pharma packaging design is due for a makeover, thanks to a new EU regulation that will come into effect in February 2019. The Falsified Medicines Directive will cost the pharmaceutical industry more than 5 billion euros; a major investment for which patients can’t be charged. Reportedly 82 percent of manufacturers are taking the necessary measures as we speak and 18 percent have already finished implementing them.

Original closures and unique serial numbers

As the battle against counterfeit drug packaging continues, pharma manufacturers in all 28 European countries must comply with stringent standardized safety features starting next year. All packaging for prescription medication and drugs that are part of a reimbursement system will then have to be labeled with a unique serial number in the form of a 2D matrix code. Falsified Medicines Directive for pharma packaging The code will be scanned before the package leaves the manufacturer and once more at the point of sale. A database located in the cloud must allow pharmacies to verify the authenticity of each package. Additionally, original closures must seal the packaging to minimize the risk of counterfeiting across the entire supply chain.

Pharma packaging management software

Experts agree that it takes pharmaceutical companies at least one or two years to implement the new closure and serialization solutions as they require complex IT interfaces, and both software suppliers and pharma companies themselves are currently facing capacity bottlenecks. They recommend investing in GMP compliant packaging management software to automate as much as possible early on and easily create and adjust track and trace solutions in the long run. Read more on GMP compliant pharmaceutical packaging design.

A challenging and complex affair

Indeed, the US Food and Drug Administration (FDA) pushing back the deadline for the new US regulations by one year because many pharmaceutical manufacturers were insufficiently prepared proves that the level of complexity involved with the Falsified Medicines Directive is not to be underestimated. If your pharma packaging design is not yet compliant with the new directive, it’s high time to get cracking.   Inspired by Interpack