Last Friday marked one year to go for the start of the Falsified Medicines Directive (FMD) and the Delegated Regulation (EUDR) in the European Union (EU) (see “More Concerns With The FMD/EUDR Big Bang Start”). With the one year delay in the serialization and verification requirement of the Drug Supply Chain Security Act (DSCSA) in the US, the deadlines for these two markets are only about 10 weeks apart, assuming there won’t be any more delays. I don’t expect another delay in the manufacturer’s serialization and verification deadline in the US, and I haven’t talked with anyone who expects Continue reading FMD, One Year Out
Tag Archives: SecuringIndustry
Breaking News: The EC Has Published The Delegated Act
Phil Taylor of Securing Industry has scooped me on the publication of the Delegated Act on the safety feature that will eventually be required on all pharmaceutical packaging in the EU. Well done Phil! I’ve been traveling too much lately so I missed it until today! For the details, Continue reading Breaking News: The EC Has Published The Delegated Act
India’s Pharma Export Regulations Update And The NECC Story
I was more than a little disappointed when I saw that SecuringIndustry.com had beaten me in a race to publish an essay/article about the new crazy serialization and traceability requirements published last week by the government of India. That was to be my topic for next Monday. But after reading their excellent coverage—received just as I was sitting down to begin writing—I felt better. At least I had not yet started writing! Don’t miss Phil Taylor’s excellent coverage and his link to the source regulation. See if you agree how crazy it is. The deadlines are now Continue reading India’s Pharma Export Regulations Update And The NECC Story