Serialization is in place, with traceability likely to follow.
The current law in Saudi Arabia includes barcoding and serialization stipulations, which went into effect in March 2015 and March 2017 respectively. Serialization follows GS1 standards All pharmaceuticals are impacted, including human and veterinary, with some exceptions around free samples and drugs produced for a single patient. The regulations apply to manufacturers though draft regulation updates were announced in January 2017, calling for increases in scope to WDs, dispensers.
There is an expectation that Saudi Arabia will move forward with traceability sometime by the end of 2018. A track and trace system, and compliance reports of interest, are expected to look similar to the model in place in Turkey.
Choosing a proven solution
TraceLink provides a solution for pharmaceutical companies and CMOs to meet the Saudi Arabia serialization demands. Master data management, serialization management, and serialized operations management are available to support your business and your supply network, and to reduce the time, cost, and risk associated with achieving compliance.