Tag Archives: Delegated Act

EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary

iStock_000016455220_SmallerEver 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

The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning

EC logoWith 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

RxTrace Preview of 2016

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 ‘Unique Identifier’ in the EU Delegated Act

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

The Future of Healthcare Supply Chain Security

Businessman looking through binocularsLet’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:

Continue reading The Future of Healthcare Supply Chain Security

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

Superhero right to leftLast 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

Sponsored: Transatlantic Alignment

Happy Martin Luther King day!  Today we have a special guest blog essay by Mark Davison of Blue Sphere Health in the U.K..   Mark is the author of the book, “Pharmaceutical Anti-Counterfeiting”, published by Wiley in 2011. – Dirk.

BPH.logo-lrg2Pharmaceutical traceability (in its various nuances of serialization, aggregation, track and trace, epedigree etc) has been proposed, debated, boosted and resisted for a very long time. The labyrinthine twists and turns have been examined in near real time on RxTrace and I won’t revisit them here. However, the passing of the Drug Quality and Security Act (DQSA) late last year opens a new chapter.  It means greater transatlantic clarity of future compliance requirements and (whether intentional or not) it also brings near synchrony of some key deadlines. Continue reading Sponsored: Transatlantic Alignment