Rwanda Pharmaceutical Traceability Compliance

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Global Regulations

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Labelling

Products are required to display information in writing.

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Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

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Central repository

The traceability documentation is required to be centralized in a unique system.

Summary

Rwanda has established a national framework for pharmaceutical traceability under the Rwanda Food and Drugs Authority (Rwanda FDA). The system is designed to improve medicine safety, strengthen supply chain visibility, and reduce the risk of falsified medicines in the market.

The regulatory framework requires the use of global identification standards and structured data sharing across the pharmaceutical supply chain. Rwanda’s traceability strategy is built on GS1 standards and includes product identification, location identification, and master data governance through a national product catalogue.

Manufacturers, importers, distributors, and supply chain partners must implement standardized identification and data capture processes to support product traceability from manufacturer to healthcare facilities.

Labelling Requirements 

Pharmaceutical products supplied to Rwanda must support standardized identification aligned with GS1 standards.

Key identification elements include:

  • GTIN for product identification
  • Batch or Lot Number
  • Expiry Date

The barcode used for pharmaceutical identification should support machine readable data capture and interoperability across supply chain systems.

Location identification must use Global Location Numbers (GLN) to uniquely identify supply chain actors such as manufacturers, importers, distributors, warehouses, and healthcare facilities.

Human readable information printed on packaging must match the encoded barcode data.

Regulatory Timeline 

2018 – Rwanda Food and Drugs Authority established under national legislation governing regulation of medicines and health products.

2022 – Rwanda FDA issued regulations governing identification, data capture, and data sharing for pharmaceutical traceability.

2022 August– National guidelines for pharmaceutical product identification and labelling issued.

2022 August– Guidelines for product and location master data sharing issued to support the National Product Catalogue.

2023 onward – Implementation of standardized identification and data sharing across pharmaceutical supply chain stakeholders.

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Reporting Requirements 

Rwanda Distribution Table
Operation
Data to Report
When to Report
Product Master Data Registration
GTIN and product attributes
Before product distribution in Rwanda
Location Identification Setup
GLN for supply chain entities
Before supply chain operations
Product Catalogue Data Submission
Product and supplier master data
During onboarding to the national catalogue
Distribution Traceability Records
Product identifiers, batch information and shipment documentation
During distribution and storage operations
Recall or Investigation Support
Product identifiers, batch information and distribution records
When required by regulatory authority

The framework ensures that traceability information can be accessed during regulatory inspections, investigations, and product recalls.

OperationData to ReportWhen to Report

Commission 
Aggregation 
Shipping 

GTIN, Serial, Batch, Expiry  
Parent SSCC, Child Serials  
Sender GLN, Receiver GLN, SSCC or Serial List
During packaging before shipment 
When creating cases or pallets 
Before dispatch 
ReceivingImport Clearance
Supply to Pharmacy
GTIN, Serial, Batch, Expiry  
Parent SSCC, Child Serials  
Sender GLN, Receiver GLN, SSCC or Serial List
During packaging before shipment 
When creating cases or pallets 
Before dispatch 
Returns 
Decommission 
Serial status and reference 
Reason and serials 
When return is approved 
When product is destroyed or removed 

Operational Timelines for Industry 

  • Obtain GS1 identifiers including GTIN for pharmaceutical products and GLN for supply chain locations.
  • Register product master data in the National Product Catalogue before supplying the Rwandan market.
  • Ensure packaging and labelling processes support machine readable product identification aligned with GS1 standards.
  • Maintain traceability records for product movement across manufacturing, importation, distribution, and storage operations.
  • Ensure distribution partners maintain proper documentation to support traceability and recall management.
  • Provide traceability information to Rwanda FDA when required during inspections, investigations, or safety alerts.

Reporting Hub

Rwanda operates a National Product Catalogue (NPC) that serves as the central reference system for pharmaceutical product and location master data.

The NPC stores standardized information including:

  • GTIN product identifiers
  • Product attributes and descriptions
  • Manufacturer and supplier details
  • GLN location identifiers

The catalogue enables consistent product identification across procurement systems, regulatory authorities, and supply chain stakeholders.

The national traceability framework supports data exchange and interoperability between supply chain systems using standardized identifiers and structured data.

Aggregation Requirements 

The Rwanda traceability framework supports packaging hierarchy identification and traceability across supply chain levels.

While a nationwide mandatory aggregation hierarchy is not explicitly defined for all pharmaceutical products, companies supplying the market are expected to support packaging level identification and traceability where required by supply chain operations.

Logistics units such as cases or pallets may use SSCC identifiers to enable tracking of shipment units across distribution channels.

Common Errors to Avoid 

  • Using internal product identifiers instead of globally recognized GTIN product identifiers.
  • Failure to assign GLN identifiers to supply chain locations involved in product handling or distribution.
  • Mismatch between barcode data and human readable product information on packaging.
  • Incomplete or inaccurate master data submission to the National Product Catalogue.
  • Lack of documented traceability procedures across distribution and storage operations.
  • Inability to provide batch level traceability information during regulatory inspections or recall events.

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