It is a little surprising that the European Union Delegated Regulation (EUDR) uses a form of the word “decommission” 67 times, but not even once uses the opposite term, “commission”. Article 3.2(c) of the EUDR defines the term ‘decommissioning of a unique identifier’ as:
“… the operation changing the active status of a unique identifier stored in the repositories system referred to in Article 31 of this Regulation to a status impeding any further successful verification of the authenticity of that unique identifier;”
It is a striking omission to define how to change the active status of a drug to impede successful verification, but to fail to define the opposite operation that sets the active status to enable successful verification in the first place. Continue reading Decommissioning Under the FMD/EUDR→
This week I am posting one of my favorite essays from last fall because at this moment, I am in the middle of moving my home and office from one side of the Chicago metro area to the other to be closer to our kids. Also at this moment, the FDA is almost eight months late in publishing the grandfathering guidance that was mandated by the DSCSA. Here it is again.
Don’t worry. It is not my intention to change this pharma/regulatory/technology blog into a political platform, but after the events of last week, I think it is appropriate for all of us to step back and examine how we can make our country better. I believe I can make a positive contribution by explaining my sincere interpretation of #BlackLivesMatter. I first heard the phrase “Black Lives Matter” back in 2012 when Travon Martin was killed by George Zimmerman in Sanford, Florida. Like most people, when I first heard the phrase, I thought it was clearly wrong. I thought, what they should say, is “all lives matter”. Continue reading #BlackLivesMatter Explained By A White Guy→
I started writing RxTrace seven years ago on July 4, 2009 (see “Welcome to rxTrace”). Not much has changed in my goals since then. My interests still revolve around the intersection between the healthcare supply chains, track and trace technology, standards and global regulatory compliance. I still like exploring ideas, including those that might not be mainstream yet. My only regret is Continue reading Seven→
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of RxTrace. The material contained in RxTrace is not legal advice. The writers of RxTrace are not lawyers. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than RxTrace.