Now that prominent compliance deadlines are nearing in the US, Saudi Arabia and Russia and with the Falsified Medicines Directive (FMD) now in force in Europe, what is going on around the world with serialisation? Allan Bowyer provides a rundown of current events and shares insights into the challenges businesses are facing to meet compliance.
Serialisation of pharmaceutical products to increase the security and quality of drugs in the supply chain will soon be a foregone conclusion. Working along similar timelines, the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other medicines-regulating bodies including Russia’s Roszdravnadzor and Saudi Arabia’s Food and Drug Authority (SFDA) have made considerable strides in recent years in enacting track-and-trace legislation.
Russia is still a bear
Russian regulators are implementing what many believe to be the most extensive track-and-trace regulation in the world. This is largely due to the cryptographic codes companies must include in the 2D data matrix barcode on packaging labels for all covered medicines before 1 January 2020.
In addition to Russia’s unique cryptography requirements, companies are required to track a wide range of product movements, transfers of custody, operational events and packaging changes, including aggregation and reporting modifications in parent-child relationships, the complexity of which far exceeds the requirements of other global compliance regulations.
Russia’s two-year implementation timeline is also incredibly short, especially in comparison to the EU FMD’s six-year window and the Drug Supply Chain Security Act (DSCSA), which has a phased 10-year implementation timeline.