The global push for pharmaceutical traceability and serialization continues at a furious pace. All conventional medicines sold, distributed, or stored in the UAE are regulated and must be serialized. These products are exempt:. And —surprise, surprise — UAE pharmaceutical products traceability requirements should sound familiar.
Secondary packaging must contain four data points in a GS1 DataMatrix code and in human-readable form:. Aggregation requirements should also ring a bell: All logistic units must be aggregated and labeled with a GS barcode encoded with a serial shipping container code SSCC.
Manufacturers are responsible for aggregation. Marketing authorization holders MAHs , brand owners, manufacturers, or their subsidiaries must register and upload the mandated product master data into the BrandSync platform.
Domestic and foreign manufacturers, third-party logistics providers, batch releasers, contract manufacturing organizations, distributors, licensing agents, and MAHs are responsible for collecting serialized product item traceability records and reporting them to Tatmeen.
This deadline passed on December 13, The next major deadline is December 13, We noted a few times that parts of the Tatmeen regulations should sound familiar. As we said right at the start today, the global push for pharmaceutical traceability and serialization continues at a furious pace.
