A revolution occurred last week. Not by guns—by referendum. Like most revolutions, it caught a lot of people by surprise. The most laughable surprise comes from those who voted for the UK to leave the European Union as a kind of protest vote, but immediately became sorry they voted that way after learning that they had “won”, because they really didn’t mean it! It’s also laughable to hear the cries of the people who didn’t bother to vote because they felt confident that the referendum would go their way. Now they would like to go back in time so they can cast their vote. Whoops, too late.
The European Commission published a discussion draft of the European Union Delegated Act (EUDA) about two weeks ago (See “Breaking News: The EC Has Published The Delegated Act“). The EUDA was called for in the Falsified Medicines Directive (FMD) back in 2011 and is primarily intended to define the “safety features” that must appear on most drugs three years after it is finalized. Assuming it gets finalized around the end of 2015, that means that manufacturers and repackagers targeting the European pharmaceutical market will need to begin placing the specified safety features on their drug packages near the end of 2018. EU Member States who already have an operational drug tracing law, like Italy and a few others, get an additional six years for companies to switch to the FMD and EUDA on drugs distributed there.
This is a new addition of major importance to the thin collection of public resources companies have available to understand the scope and the specifics of pharma serialization and traceability regulations around the world—and that’s just the first half of the document. In fact, that half is so complete and well written that it should be downloaded and read immediately by anyone facing those regulations anywhere in the world…especially if Continue reading InBrief: The Rx-360 Traceability Data Exchange Architecture White Paper→
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. 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 Dirk Rodgers.