FMD: Your Initial Upload To The EU Hub
Just got connected to the EU Hub? Now what?
Search Results for: delegated regulation
An Open Letter To The FDA: New NDC Format Public Meeting
My recommendation to the FDA about fixing the NDC system.
Aggregation Under the FMD
The EC finally recognized the need for aggregation data to meet the FMD. They suggested short-term and a long-term solutions.
How Will They Delay The FMD?
There is now little doubt that the Falsified Medicines Directive (FMD) will need to be delayed. The only question is, how will they do it? Let’s look at some facts and try to come up with a possible answer.
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, … Continue reading EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored
Personalized Medicines In A Serialized World
Do the DSCSA and the FMD apply to the new CAR-T cancer therapies?
DSCSA: Why FDA Will Not Mandate Blockchain, EPCIS Or Any Other Specific Technology
Without true interoperability, will DSCSA 2023 ever happen?
What’s So Hard About Unique Identifier Verification?
Verification is arguably the most important concept in drug serialization and tracing regulations. What makes it so hard to get right?
