Tag Archives: Pharma serialization

EU FMD, EUDA

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 →

Global Alignment

The Next Markets To Impose Pharma Serialization and Tracing?

5 Comments

Digital WorldThe pharmaceutical markets that currently have a serialization and/or tracing regulation on the books include the United States, the European Union, China, Brazil, India, Italy, Turkey, South Korea, Argentina, Saudi Arabia and Jordan.  Not all are fully operational yet, but they are official.  This list may be about to grow by two. Continue reading The Next Markets To Impose Pharma Serialization and Tracing? →

Aggregation, serialization

Aggregation –> Chargeback Accuracy –> ROI

3 Comments

Last week I attended my favorite annual conference on pharma serialization and tracing in the U.S.:  The Healthcare Distribution Management Association’s (HDMA) Traceability Seminar.  They call it a “seminar” because the subject of the sessions are generally the same every year, but it is better than any other third-party conference, primarily because the right people attend it:  lots of people from drug manufacturers, wholesale distributors and some dispensers.  With this ideal spectrum of attendees, it is very easy to get your questions answered, in the hallway between sessions if not in the sessions themselves.

Of course, every year the folks from the FDA who are directly responsible for writing regulations related to the Drug Supply Chain Security Act (DSCSA) provide Continue reading Aggregation –> Chargeback Accuracy –> ROI →

ANVISA

Brazil Suspends Pharma Serialization And Tracing Requirements

1 Comment

ANVISA logoLast week, Brazil’s pharma industry regulatory agency, the National Agency of Sanitary Surveillance (ANVISA), announced that they were “suspending” at least part of RDC-54/2013, the declaration that mandated drug serialization and tracing, until further notice.  Thank you to all who forwarded the link to the official announcement.  I was able to translate and read it on Thursday, and I submitted a comment on my own last essay, “Pharma Serialization Deadlines In Flux“, to include the link.  Apparently shortly after that essay was published, ANVISA  Continue reading Brazil Suspends Pharma Serialization And Tracing Requirements →