Ever since the E.U. Falsified Medicines Directive (FMD) was passed in 2011 my European friends have touted the fact that their government mandated solution would take a “bookend” approach. The implication was always that it would be much less complex than the ePedigree approaches that were being planned by various U.S. states, and then by the U.S. federal government with the passage in 2013 of the Drug Supply Chain Security Act (DSCSA).
My friends always liked to point out how simple Continue reading EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary
With the official publication of the European Union Delegated Act (EUDA), the clock starts for pharmaceutical manufacturers who supply drugs for the E. U. market to include two safety features on their drug packages. One safety feature is some type of tamper evident seal, and the other is a “unique identifier”, also known as “serialisation” (see “The ‘Unique Identifier’ in the EU Delegated Act“). Continue reading The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning
It’s time to think about what is likely to happen in 2016 with regard to pharma serialization and traceability. As part of that, let me remind you right off the top to fill out the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz. You don’t have to be a subscriber to respond and the results will also be open to everyone in the coming months.
So what about 2016? I think Continue reading RxTrace Preview of 2016
The European Commission published a discussion draft of the European Union Delegated Act (EUDA) about two weeks ago (See “Breaking News: The EC Has Published The Delegated Act“). The EUDA was called for in the Falsified Medicines Directive (FMD) back in 2011 and is primarily intended to define the “safety features” that must appear on most drugs three years after it is finalized. Assuming it gets finalized around the end of 2015, that means that manufacturers and repackagers targeting the European pharmaceutical market will need to begin placing the specified safety features on their drug packages near the end of 2018. EU Member States who already have an operational drug tracing law, like Italy and a few others, get an additional six years for companies to switch to the FMD and EUDA on drugs distributed there.
There are a lot of details Continue reading The ‘Unique Identifier’ in the EU Delegated Act
Phil Taylor of Securing Industry has scooped me on the publication of the Delegated Act on the safety feature that will eventually be required on all pharmaceutical packaging in the EU. Well done Phil! I’ve been traveling too much lately so I missed it until today! For the details, Continue reading Breaking News: The EC Has Published The Delegated Act
Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future. Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period. In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years. These include:
- In the U.S.:
- In the E.U.:
Continue reading The Future of Healthcare Supply Chain Security
Last week I published an overly long essay about how the supply chain provisions of the new U.S. Federal DQSA will and won’t protect the pharma supply chain. Believe it or not, I had more to say on the subject, but because that essay was already too long, I withheld my additional thoughts until now. Part 1 took another look at a number of supply chain crimes that have occurred over the last 5 to 6 years and attempted to determine how the new Drug Supply Chain Security Act (DSCSA) that is contained within the DQSA will add new protections that will or won’t help prevent crimes like them in the future.
In this Part 2 essay I want to look at the issue in a different way. I’d like to compare the approach that Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2