Apparently, the National Agency of Sanitary Surveillance (ANVISA), Brazil’s pharma regulatory body, has passed a resolution that finally suspends all remaining serialization deadlines that were left over in their old RDC-54 regulation. Remember that they suspended the deadline for the 3-lot pilot from RDC-54 last year (see “The Official Suspension of the Three-Lot Pilot in Brazil“). I consider this news to be a “rumor” only because I have not yet seen the official word, despite having heard it from a very reliable source.
This is not a surprise. In fact, the old deadlines that were left over had to be eliminated at some point before the new pharma serialization law is passed by the Brazilian government (see “Proposed Pharma Serialization Regulation Progresses in Brazil“). That appears to be imminent now that this action has been taken.
Pharma serialization deadlines continue to march toward us. Don’t expect them to get suspended or delayed. The common thread between the two laws that were recently suspended in Brazil and China is that they were ill-conceived in the first place. Both laws had multiple things wrong with them. At this point, I can’t think of any other current pharma regulation that is anywhere near as bad as the old RDC-54 and the China regulation. Both had non-standard characteristics.
Fortunately, the next IQPC Pharmaceutical Traceability Forum is just around the corner and RxTrace is once again a media partner for the event. I currently plan to attend the event, which occurs from October 30 to December 2 in Philadelphia. The folks at IQPC have constructed this useful “Serial & Labeling Playbook 2016“ to help you find the many deadlines that are out there. Use this tool until the IQPC event where you will learn more about the new regulation that is coming in Brazil and updates from elsewhere.
See you there.