The industry is rife with rumors that Brazil’s ANVISA has made the decision to push out their serialization deadline for multiple years—and perhaps redefine the requirements. I cannot confirm any of these rumors at this point and I do not recommend acting on rumors. I suggest you continue down the path of meeting the existing, known regulation until—if ever—you get the official word from an official publication of ANVISA. Who knows when that might occur. If/when you see something official, let me know.
As regular readers of RxTrace already know, I am not a fan of Brazil’s unnecessarily complex data exchange requirements, or their selective use of GS1’s serial number standard (see “Why Does ANVISA Embrace GS1 Standards, Except The Serial Number?” and “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”). An official delay and rethink of their requirements would be a welcome action. It’s always better to get it right before you implement on such a large scale (FDA, take note).
For companies who are trying to keep up with the latest deadlines and activities surrounding global pharma serialization and tracing regulations, there is an event coming up that you might want to look into. It is the Pharmaceutical Traceability Forum by IQPC in Boston on November 16-18. As a media partner of this event, RxTrace can help you get a 20% discount on your registration. Just use the Promo Code 2PTF_RXTRACE when you register.
The kind folks at IQPC have provided us with an infographic that provides their view of the coming serialization and barcoding deadlines for countries around the world. Click on the thumbnail on the left to get access to this infographic.
3 thoughts on “Sponsored: Pharma Serialization Deadlines In Flux”
Hi Dirk, Anvisa just decide (rigth now) to abort the 3 pilots batchs expected to be done until DEC/15. The other deadline (Dec/16) still working but looks like they will change soon. I am open to give you more details if you want.
Thanks Alexandre. Can you get that in writing?
It’s official. Brazil has now suspended their 3 lot serialization and tracing requirement that was to happen by December 10 of this year. See the following link for the official details. No more rumors! http://portal.anvisa.gov.br/wps/content/anvisa+portal/anvisa/sala+de+imprensa/menu+-+noticias+anos/2015/anvisa+suspende+prazo+para+apresentacao+de+lotes+piloto+rastreaveis
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