Last month, GS1 US published a report on a DSCSA barcode assessment they conducted last year with two of the largest wholesale distributors in the US, AmerisourceBergen and McKesson. The goal of the assessment was to take a “snapshot” of pharmaceutical manufacturer progress toward meeting the serialization requirement of the Drug Supply Chain Security Act (DSCSA) by analyzing drug packages actually in the market.
Pharmaceutical manufacturers are working non-stop to get the serialization systems in place necessary to meet the USA DSCSA mandate going live this November, and the EU FMD mandate going live the following February of 2019. If serialization projects aren’t in full flight at this time, there is a significant chance that a manufacturer will not meet the deadline, not be compliant and not be able to distribute product in those geographies.
It’s difficult to keep up to date on all the milestones and requirements of the Drug Supply Chain Security Act (DSCSA). Because the law contains 10 years’ worth of deadlines and detailed requirements for every segment of the supply chain, it’s easy to get lost and miss what your company should be working on now. Fortunately, most companies need only focus on what is coming up next, while keeping an eye on the long-term requirements. Toward that end, Systech has just introduced the first...
President of the Russian Federation, Vladimir Putin, signed a new law the last week of December 2017 that is important for pharmaceutical manufacturers distributing products to or manufacturing in Russia. It establishes January 1, 2020 as
The Healthcare Distribution Alliance (HDA) Traceability Seminar is always a great event to find out about the current industry response to the Drug Supply Chain Security Act (DSCSA), and ideas for where it is headed in the future. This year was particularly valuable for those who attended. Sessions included a DSCSA update from the FDA, HDA perspectives on DSCSA guidance, manufacturer perspectives on serialization, an update on HDA’s Verification Router Service (VRS) and other technology...
Systech is a member and strong supporter of GS1 Healthcare, the global group that promotes standardization in healthcare product and entity identification. On October 17, 2017 in Chicago, GS1 Healthcare held their fall Global Healthcare Conference.
Now let’s look at some of the complications for drug manufactures when meeting the Europe's Falsified Medicines Directive (FMD), and particularly the Delegated Regulation.
Companies who market prescription drugs in any part of Europe should pay close attention to the new requirements spelled out by the Falsified Medicines Directive (FMD) and Delegated Regulation (DR). The FMD/DR spell out new and complex requirements for applying randomized unique identifiers to almost all prescription drug packages marketed in the EU by February 9, 2019. That date is now less than 18 months away. And it’s not just the EU Member States because other European countries have...
Advisory firm KPMG recently conducted a detailed survey of executives from companies within a technology supply chain to find out how gray market trading was impacting them. The report and its findings are applicable in many commercial supply chains; and so, we recommend you download it from KPMG.