v.28 – Q4 2023

v.28 Q4 2023 update: Expecting requirements to be issued following final government review of legislation

Market Executive Summary No final Traceability Regulation yet
In 2014, requirements to apply security labels allowing verification of serial numbers applicable for antimalarials and antibiotics were put in place. Otherwise, inactive market for Serialization.

May 2020: Publication of the “Nigeria National Pharmaceutical Traceability Strategy” aiming for additional serialization and traceability requirements and a 5-year roadmap.

2022: expected developments following the proposed high-level milestones (relating to May 2020 strategy paper):

  • Coding guidance within 6 to 12 months
  • Outline of traceability requirements within 12 to 18 months
  • Leading to implementation within 5 years

August 2022: Draft legislation published and open for public consultation review until October 2022

December 2022: Consultation closed and under review; no feedback yet.

Dec 2023: final version which is currently undergoing internal governmental approval before it is published.

Ambition states that “it is expected that traceability becomes fully operational in the Nigerian Pharmaceutical Supply Chain by the end of the year 2024” but no firm requirements yet for medicines.

Key Dates 2014: Security labels on antimalarials and antibiotics.

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