Rwanda's regulations require every sellable pharmaceutical unit to carry a distinctive digital fingerprint comprising four critical elements: Global Trade Item Number (GTIN), batch/lot number, expiration date, and a unique serial number of up to 20 characters. This comprehensive identification system, assigned during packaging by manufacturers, ensures that each product can be precisely tracked and authenticated throughout its journey from production to patient care.

The regulatory framework mandates strict adherence to internationally recognized GS1 General Specifications for encoding and constructing unique identifiers. Secondary packaging must feature GS1 Data Matrix codes, while tertiary packaging utilizes both GS1 Data Matrix and GS1-128 linear barcodes. This standardized approach ensures global interoperability while maintaining the highest quality and readability standards, with manufacturers required to implement documented quality control procedures subject to regulatory inspection.

All pharmaceutical traceability activities must be conducted through a centralized system overseen by the Rwanda FDA, ensuring end-to-end visibility and data integrity across the entire supply chain. Supply chain actors are mandated to share comprehensive master data, including product identification numbers and descriptive attributes, while maintaining real-time updates. This centralized approach enables both forward and backward traceability, providing authorities with unprecedented oversight capabilities.

The regulations encompass all pharmaceutical products intended for human use in Rwanda, including both registered and donated products, with carefully defined exceptions for personal imports, regulatory samples, and traditional medicines. From primary packaging in direct contact with products to tertiary packaging for transport and storage, every level of the supply chain is subject to these rigorous identification and tracking requirements, ensuring complete pharmaceutical ecosystem oversight.