Originally, companies had to comply with Federal Law No. While this extra time will be helpful to pharma companies, given the complexity of Russia serialization requirements, it still may not be enough for pharma to prepare. Additionally, the law requires serialization on all medications, including over-the-counter OTC medications, and outlines special requirements regarding aggregation and separate serialization requirements for batches.
While individual units must be serialized and a 2D barcode must be placed on the box or bottle, each batch must also be serialized with a 2D barcode on the box. Aggregation will require members of the supply chain to report every change in individual batches. Reports must be produced around each change made to a batch, and supply chain actors must report how much of the batch is left together and where the removed units went.
Manufacturers shoulder most of the reporting responsibility under Russia serialization requirements. Foreign manufacturers have an even more rigorous set of requirements, and can expect to have to report up to 36 different compliance events. As a comparison, the FMD has a maximum of seven compliance events. Although serialization and traceability are required for prescription and OTC drugs by , Russia has two lists of crucial and expensive medicines that require serialization before then.
The first are medications used to treat a list rare and expensive-to-treat diseases, such as hemophilia, cystic fibrosis, and multiple sclerosis. The second includes medications considered vital and essential. Both potentially require serialization before Manufacturers need to act now to be compliant by the January 1, , deadline.
Manufacturers who produce OTC medications need to make sure that their lines are ready. Companies who have yet to start converting their lines need to start now. Furthermore, there will not only be more compliance events, but there will be a heavy emphasis on aggregation. Batches will be serialized just as individual units are, with multiple compliance events around aggregation and disaggregation.
