What are the exact deadlines and specifics surrounding pending serialization mandates?
Have an insight or suggestion?
Login or register to post a comment.
pharmamanufacturing Manufacturing Community Member 151 Posts
Re: Deadlines and specifics surrounding pending serialization mandates16 December 2015 at 4:23pm Last edited: 16 December 2015 at 5:31pmJames Cummings, VP Americas for Adents, a leading provider of versatile and easily deployable serialization and track-and-trace software solutions for the pharmaceutical and life sciences industries.
While it is a fairly well accepted view that by 2019 global serialization and/or tracking requirements will cover approximately 80% of the prescription pharmaceuticals, there are several major deadlines that cover some of the world’s biggest markets worth examining more closely.
January 2016: China moves to unit level tracking. This is arguably the world’s largest market and requires utilizing serial numbers issued from the Chinese government. A key difference in China’s requirement is the use of linear or 1D barcodes instead of 2D.
11/27/2017: The United States requires all Rx products to have a serial number and all homogenous cases to have a serial number. These items do not need to be associated or aggregated at this point, but the cases do need to be serialized. Lot, Expiry, and GTIN data must also be included in the barcode, but those are far simpler data elements to implement as they are static across a lot or batch.
2017: India has stated it will require unit level tracking. This has been an extremely fluid set of deadlines and scope of mandates.
2019 is a big year for mandates, as the EU is scheduled to implement following its previous delays. The United States will require returns to be serialized, which some feel will spur trading partners to require aggregation and data sharing ahead of 2023’s final deadline.
2023: Full aggregation and supply chain data exchange providing traceability in the United States.
It is extremely important to consider the aspect that trading partners may require or enhance requirement above and beyond what the regulations stipulate. A trading partner may, for example, feel that the 2019 requirement for returns in the U.S. cannot effectively be met without prohibitive cost or excessive risk unless they require all of its manufacturing customers to aggregate and exchange that data. In a situation such as this the supply chain network may demand this heightened track and trace procedure to reduce liability, despite the law not (or not yet) requiring it.