Updated Sept 24 2020.
As of September 24, 2020 Class I medical devices needed to meet the FDA’s Unique Device Identification Final Rule. However, that date was postponed by the FDA in July with the publication of a new Policy Guideline document. That means the FDA will not begin enforcing the UDA Final Rule on these devices until September 24, 2022. By this new date,
Serialization was introduced by governments as a mechanism to protect the pharmaceutical supply chain over 10 years ago. Major serialization mandates in the US, EU and other regions are now live. Now is a good time to reflect back on this massive undertaking and review some “lessons learned”. We say this because serialization isn’t “over” in pharma.
Crime has no moral code. If you have a high-demand product, people will likely counterfeit it. Itcomes as no surprise that during this time of pandemic, counterfeiters are targeting everythingfrom hand sanitizer to COVID-19 test kits. I recently blogged about this situation here.
I have written and spoken about global counterfeiting issues many times. Pretty much in every single one, I’ve said something like “if you have a successful product, it will be counterfeited.” Illicit counterfeit rings have infiltrated pharmaceuticals, consumer goods, cosmetics, fragrances, automobile parts, aircraft parts, clothing, footwear, wine, spirits and more. The riches and rewards from producing and distributing counterfeit products in most cases far outweigh the penalties of...
The fight against counterfeiting and diversion is at a crossroad. Never has there been such a loss of revenue due to these global supply chain threats and it’s only getting worse. Companies are spending over $105 billion annually to combat these issues, yet this “gray market” of products is projected to surpass $2.8 trillion globally by 2022… That’s a 100% increase over ten years!
Near the end of 2019, there were rumors that the Russian Federation would extend its regulatory deadlines for pharmaceutical serialization and traceability past its initial January 1, 2020 deadline, which called for full serialization using Russian Crypto Codes and government reporting...
Change is afoot, we are entering a new phase of activity within the pharmaceutical sector. The next stage of patient protection is starting to take shape across the industry, and it is a case of going back to the future. Though, no DeLorean, TARDIS or even a hot tub time machine are needed to make this change, we are not going to have hover boards or give cousin Chuck Berry a new sound. Instead of fighting Daleks we are going to wage war on counterfeiters and grey marketeers.
Virtually all brands—from the utmost recognized to the newly eager—face threats of product counterfeiting and gray market trading. In emerging countries, this menace is bold and audacious with outright fakes appearing in the open marketplace. In developed countries, the problem is equally insidious due to online sales of counterfeit products through e-commerce platforms.
In this Packaging Europe clip from AIPIA World Congress, Systech’s Alastair Taylor talks about the value of active intelligent packaging for a truly secure supply chain. We propose our brand protection suite is actually the perfect anti-counterfeiting solution. See why.
I recently participated in a national campaign to warn consumers about the prevalence of counterfeit products—they are virtually everywhere. And more importantly, to let people know that there isn’t one failsafe method at this time to guarantee the authenticity of the products you purchase.