As ever, things are moving in the world of global serialisation legislation. Here are a few highlights from very recent activity.
We are one step closer to the new PL4096 serialisation law being published as it has passed the constitutionality committee check. It will now progress through the normal process for signature by the President, which is now likely in November. Following this, ANVISA will then publish regulations explaining how the law needs to be implemented, although it is not yet clear when this will happen.
Those companies involved in Russia’s serialisation pilot have been informed that the pilot will run throughout 2017 and that findings will be published in February 2018. Therefore, it is unlikely that implementation will be until later 2018 at the earliest.
The Taiwanese Food and Drug Administration, Ministry of Health and Welfare have apparently “published” requirements, although it is proving a challenge to get a copy of them. The implementation dates are being reported as:
- January 2019 for the application of GTIN, Lot and Expiry in a barcode
- January 2020 for the addition of serial numbers.
Draft regulations earlier in the year called for the supply chain to manage a traceability system and for APIs to have serialisation in 2021. I will update you when I see a copy of the final legislation.
Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me at Stephen.McIndoe@be4ward.com.
For more information on serialisation, go to our free download section.