The EU Delegated Regulation (EUDR) of the Falsified Medicines Directive (FMD) mandates that all serial numbers placed on non-exempt drugs entering the EU supply chain after February 9, 2019 must be ‘sufficiently randomised’. What is sufficient randomisation? The regulation says one thing, and the European Medicines Verification Organization (EMVO), the operator of the EU Hub, says something beyond that. What should drug manufacturers do? The EMVO recently updated their messaging. Let’s take another look at this important topic. Continue reading EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored
Category Archives: Randomization
Pharma Serial Number Randomization Under The Falsified Medicines Directive
Drug companies who serve markets within the European Union (EU) have until February 9, 2019 to add serial numbers within a Data Matrix barcode to their drug packages, among many other specific requirements (see “The ‘Unique Identifier’ in the EU Delegated Act”). The specific requirements are outlined in the EU Delegated Regulation (EUDR). I’ve written a lot about the EUDR over the last few years (see RxTrace: Delegated Regulation). Today I want to highlight and explain a problem that may be brewing in the implementation of the system of repositories as established by the non-profit European Medicines Verification Organization (EMVO). The potential problem is related to the way the EMVO Continue reading Pharma Serial Number Randomization Under The Falsified Medicines Directive
DSCSA: Congress Should Have Mandated Randomization
Congress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain. Let me explain.
The text of the Drug Supply Chain Security Act (DSCSA) was developed last year by Congressional staff in consultation/negotiation with various lobbying organizations—primarily the Prescription Drug Security Alliance (PDSA). The effect of the legislation is to create a way of protecting the U.S. pharmaceutical supply chain that relies primarily on product identifier authentication (PIA) (see “Product Identifier Authentication” and “The Aggregation Hoax and PIA”) for at least the first 10 years and possibly beyond. Continue reading DSCSA: Congress Should Have Mandated Randomization
Randomization—An Interview with Ken Traub—Part 5: Other Approaches
This is the last 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
- Other Approaches to Randomization (this essay)
This week Ken talks about other approaches to serial number randomization. – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 5: Other Approaches
Randomization—An Interview with Ken Traub—Part 4: The Algorithmic Approach
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
Randomization—An Interview with Ken Traub—Part 3: Threat Analysis
This is the third 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 (this essay)
- Algorithmic Approach
- Other Approaches to Randomization
This week Ken introduces the concept of threat analysis. – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 3: Threat Analysis
Randomization—An Interview with Ken Traub—Part 2: Properties of Randomization
This is the second 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 (this essay)
- Threat Analysis
- Algorithmic Approach
- Other Approaches to Randomization
This week Ken introduces three properties of randomization. — Dirk.
Continue reading Randomization—An Interview with Ken Traub—Part 2: Properties of Randomization
Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations
Over the next two weeks I have a very special treat for RxTrace readers. It is an interview with Ken Traub, GS1 standards expert and independent consultant. The subject is GS1 serial number randomization, something so important that I think pharma companies ought to give deep thought to it before they turn on their serial number applications.
Pharma manufacturer who sell into the E.U. and/or Brazil markets will be forced to randomize their serial numbers because of regulatory requirements, but even those who only sell into the U.S. market should strongly consider randomization. I’ll have more to say about why in a follow-up essay after this series is over.
Because the interview with Ken covers the topic so thoroughly, it is long. That’s good, because it provides readers with an easy to understand explanation of everything they need to know about randomizing. But it also makes for a very long essay, so I have broken the interview down into five RxTrace essays. Read sequentially, they contain the complete interview. The subtopics covered by those essays include: Continue reading Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations
