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 βsurprise, surprise β 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. Requirements may vary from country to country, but their essence is the same e. Tatmeen is just one more example in a very large regulatory ocean.
If you have questions about Tatmeen or complying with pharmaceutical serialization and traceability regulations in any country, contact us today. For even more information, check out our Global Compliance Page, download our Worldwide Pharmaceutical Compliance Requirements white paper, and catch up on other pharma news in our blog:. Tatmeen labeling and reporting requirements All conventional medicines sold, distributed, or stored in the UAE are regulated and must be serialized.
