Tag Archives: serial numbers

EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored

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

Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution

As serialization mandates sweep the world you would think that drug manufacturers and repackagers would just deploy one generic “serialization application” and simply turn it on for any drugs that requires it, and turn it off for any that do not.  That’s probably what the legislatures and regulators who create the requirements think.  RxTrace readers know it’s not nearly that easy.

The problem is that every regulation requires something different.  The only common thread is that there is always a “serial number” requirement in there somewhere (thus the name).  But the serial number itself is usually defined differently and everything else that surrounds the serial number is often not the same.  It’s not a matter of just turning it on and off, it’s a matter of changing a bunch of parameters, which result in significantly more complexity in the setup, testing and validation of the system for each market. Continue reading Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution

Insufficient Transitional Measures Doom The FMD-EUDA

EU Member States
EU Member States. Source

The pharmaceutical supply chain in most markets is complex, but in my view, the one in the European Union easily takes the prize for being the most complex of any other.  The addition of unit-level serialization and verification of authenticity to that supply chain over the next few years as required by the Falsified Medicines Directive (FMD) and the Delegated Act (EUDA) is going to be difficult (see “Breaking News: The EC Has Published The Delegated Act“).  It represents a huge change to the way drugs are packaged and how they are handled by each entity in the supply chain.  It is vital that the transition Continue reading Insufficient Transitional Measures Doom The FMD-EUDA

Why Does ANVISA Embrace GS1 Standards, Except The Serial Number?

Brazil Ministry of Health logoIn Brazil, the National Agency of Sanitary Surveillance (ANVISA) has built their pharma serialization regulation around GS1 standards.  They embrace the GS1 Datamatrix and GS1-128, both encoded with GS1 Application Identifiers (AI) and using GS1 Human Readable Interpretation (HRI) (see my previous essay, “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”, for my thoughts on HRI), the GS1 Global Trade Item Number (GTIN) and the GS1 Serial Shipping Container Code (SSCC) to be specific.  But there is one GS1 standard they steer clear of:  the GS1 serial number.  Why is that? Continue reading Why Does ANVISA Embrace GS1 Standards, Except The Serial Number?

Identification Of Pharma Cases In The U.S.

5 BoxesLast week I discussed controversy over the use of GS1’s Serial Shipping Container Code (SSCC) in the Brazil pharma supply chain to meet regulatory requirements imposed by ANVISA.  But there are different controversies, or at least potential confusion, in the U.S. pharma supply chain surrounding case labels, and some of those are relate to the SSCC and its use.

A case product identification label is the label a manufacturer usually places on each homogeneous case at case-packing time to identify what is inside the corrugated box.  A “homogenous case” is a case that Continue reading Identification Of Pharma Cases In The U.S.

Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange?

????????????????????????????????????????I am confident that GS1’s Electronic Product Code Information Services (EPCIS) standard will take center stage in 2023 when the U.S. Drug Supply Chain Security Act (DSCSA) transitions into what that law calls the “Enhanced Drug Distribution System”, or EDDS.  That’s when the DSCSA mandates that supply chain changes of ownership of prescription drugs must be documented in an interoperable electronic system based on their unique serial numbers.

Each of the steps that must be implemented by the industry between now and Continue reading Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange?

Randomization—An Interview with Ken Traub—Part 5: Other Approaches

???????????????????This is the last of a five part interview with Ken TraubGS1 standards expert and independent consultant, on GS1 serial number randomization.  The full series includes essays covering:

  1. GS1 Serial Number Considerations
  2. Properties of Randomization
  3. Threat Analysis
  4. Algorithmic Approach
  5. 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 3: Threat Analysis

Hacker typing on a laptopThis is the third of a five part interview with Ken TraubGS1 standards expert and independent consultant, on GS1 serial number randomization.  The full series includes essays covering:

  1. GS1 Serial Number Considerations
  2. Properties of Randomization
  3. Threat Analysis (this essay)
  4. Algorithmic Approach
  5. 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