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
GS1’s Serial Shipping Container Code, or SSCC, has been around a long time, but the logistics identifier has recently taken center-stage in a number of controversies related to meeting several country-specific pharma traceability regulations. I’ll cover these controversies in multiple essays—in this one, Brazil.
This controversy started when ANVISA, the pharma regulator in Brazil, indicated in their regulations that they expected companies to mark every “transport package” entering their supply chain with a unique identification code so that each serialized unit inside can be associated with it (the aggregation requirement).
The problem is, a homogeneous case of product can Continue reading ANVISA And The SSCC Controversy
I often write about the fact that drug manufacturers and repackagers that sell into the U.S. market must put “serial numbers”, or “serialize” their drug packages and homogeneous cases before November 27, 2017, but what exactly does that mean?
Let’s break it down. The Drug Supply Chain Security Act (DSCSA) defines the term “Product identifier” this way:
The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.” (Section 581)
Back in March of 2010—3 ½ years before Congress passed the DSCSA—the FDA published final guidance called “Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages”, which defined the term “standardized numerical identifier (SNI)” this way: Continue reading DSCSA “Serial Numbers”
This is the fourth installment of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization. The full series includes essays covering:
- GS1 Serial Number Considerations
- Properties of Randomization
- Threat Analysis
- Algorithmic Approach (this essay)
- Other Approaches to Randomization
In this installment, Ken explains the algorithmic approach to serial number randomization. – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 4: The Algorithmic Approach
Last Friday, the FDA published the long awaited guidance on their Standardized Numeric Identifier (SNI) for prescription drug packages. This was right on time since the FDA Amendments Act of 2007 gave the agency 30 months to develop a standard for SNI and they published, almost to the day, 30 months later. Well done.
The published guidance is not radically different from the draft guidance that the agency published under the same name in January of 2009. In fact, in my view, the only really important difference is how the Continue reading FDA Aligns with GS1 SGTIN For SNDC