v. 28 – Q4 2023

Market Executive Summary Regulation enforced- phased implementation, see key dates.

Regulations governing the implementation of identification, data capture and data sharing for traceability of pharmaceutical products (DFAR/HMDAR/TRG/003) came into effect on August 15, 2022.
Rwanda is implementing Track and Trace Serialization to align with the Emerging Global Standard (EGS). Key elements are phased implementation, starting with Master data sharing, 2D coding through consolidation on GS1 standards to serialization and finally expected traceability based on database operated by Rwanda FDA.

The scope of this implementation will include all pharmaceutical products intended for human use including products registered and/or donated as pharmaceutical products (see section 2 for exceptions).

Key Dates
  • August 15, 2024: Master data for all authorized medicinal products, their packaging levels, and their associated locations and legal entities and medicinal products shall be shared with the Authority.
  • August 15, 2025: Products shall be identified with a GTIN, batch/lot number, and expiration date encoded in the specified data carrier.
  • August 15, 2026: Products shall be identified with a GTIN, batch/lot number, expiration date, and serial number.
  • August 15, 2027: Logistic units shall be identified with a SSCC.

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