Pharmaceutical serialization has become a crucial global initiative to combat counterfeit drugs, improve patient safety, and enhance supply chain transparency. While many countries have advanced serialization regulations in place, Oman’s progress has been more gradual.
The Sultanate of Oman’s Ministry of Health issued its initial serialization framework titled “Barcoding System” requirements under document MH/DGMS/DSS/M/7043, dated October 26, 2016. However, since this publication, there have been no official updates or timelines released for enforcement or nationwide implementation.
The National Health Policy 2025 outlines strategic goals aimed at strengthening Oman’s healthcare system. Of particular interest is Strategic Action Point #17, which states:
“Ensure pharmaceutical security (in terms of pharmaceutical safety and availability), encourage and support the national pharmaceutical industries, and work towards self-sufficiency.”
While this goal aligns with the principles of serialization, it does not offer explicit regulatory guidance. Nevertheless, any future implementation of serialization will likely begin with product registration and the procurement of identifiers that support a traceable supply chain.
Serialization in Oman will depend heavily on standards set by GS1 Oman, the country’s officially licensed organization for issuing GS1 identifiers (with the 607 prefix). These identifiers are essential for enabling traceability via barcodes and digital product records.
Before applying, manufacturers must evaluate how many Global Trade Item Numbers (GTINs) they need. Each GTIN is unique to a specific product configuration (including size, packaging, and ingredients) and cannot be reused for different products.
Choosing the correct package from the outset is critical because:
GS1 Oman provides an online tool to help determine your GTIN needs: GTIN Calculator
Begin your application online at: MyGS1 Application Portal
You'll need to submit the following documents:
Important Notes:
Once your documents are verified, you will receive login credentials for GS1 Activate, the platform through which you will manage your product identifiers.
Note: The assignment of barcodes to products is the sole responsibility of the manufacturer or member company.
Sultanate of Oman (Ministry of health) Timelines:
All pharmaceutical supplies (excluding surgical and lab items).
(01) GTIN
(17) Expiry Date
(10) Batch / Lot number
A HRI (Human Readable Interpretation) should be printed along with the GS1 Data Matrix Barcode.
Option 1: GS1 128 barcode with GTIN, Expiry Date and Batch/Lot Number.
A HRI (Human Readable Interpretation) should be printed along with the GS1 128 Data Matrix Barcode.
Option 2: GS1 Data Matrix with GTIN, Expiry Date and Batch/Lot Number.
A HRI (Human Readable Interpretation) should be printed along with the GS1 Data Matrix Barcode.
Timelines Were:
31 December 2017 for implementation of GS1 Data Matrix Barcode.
31 December 2018 for implementation of serialization.
Starting August 2017, manufacturers need to upload their product master data at least 30 days in advance of shipping their products to Oman.
While Oman has not yet enforced a mandatory serialization deadline, the direction is clear: traceability and pharmaceutical security are national priorities. Manufacturers are encouraged to proactively adopt serialization best practices in anticipation of future regulations.
Engaging early with GS1 Oman ensures that your products are ready for compliance and positioned for seamless supply chain integration within Oman and beyond.
For more information or support, you can contact GS1 Oman directly through their official website.
Stay tuned for the next blog in our series as we may come up with critical updates from Oman.
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This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.