NAFDAC PHARMACEUTICAL PRODUCTS TRACEABILITY REGULATIONS
Regulation · Health
An Act establishes a traceability system for pharmaceutical products in Nigeria to track items and fight counterfeits. It targets manufacturers, importers, distributors, pharmacies, hospitals, and patients. This combats substandard drugs and protects public health through supply chain monitoring.
What Is This Policy?
Regulations establishing a traceability system for pharmaceutical products in Nigeria to combat counterfeit medicines and ensure the integrity of the pharmaceutical supply chain.
Who Does It Target?
Pharmaceutical manufacturers, importers, distributors, pharmacies, hospitals, and patients.
What Does It Aim to Achieve?
Combat counterfeit and substandard pharmaceuticals, ensure drug safety, and protect public health through end-to-end supply chain traceability.
Key Features
Track and Trace System: Requires unique identification codes on pharmaceutical products. Supply Chain Monitoring: Enables real-time tracking of products from manufacturer to consumer. Anti-Counterfeit Measures: Helps identify and remove counterfeit products from the supply chain.
Current Status
Rollout Stage: Active with phased implementation. Coverage: All regulated pharmaceutical products in Nigeria. Funding: NAFDAC regulatory fees and industry contributions.
How to Access
Pharmaceutical companies must register with NAFDAC's traceability system and comply with labelling requirements. Register with NAFDAC's traceability platform Apply unique identification codes to products Report supply chain data as required Portal: nafdac.gov.ng
Important Terms
Non-compliance may result in product seizure, registration cancellation, or prosecution.
Impact & Metrics
Reduces counterfeit medicines in circulation and improves patient safety.
Official Resources
Website: https://www.nafdac.gov.ng Contact: NAFDAC Headquarters, Abuja
Legal Framework
Issued under the National Agency for Food and Drug Administration and Control Act 1993 (as amended). Operates alongside the Food and Drugs Act Cap F32 LFN 2004, the Pharmacists Council of Nigeria Act, the ICH Good Manufacturing Practice guidelines, WHO prequalification standards, and the Falsified Medicines guidelines adopted by Nigeria. Draws on WHO guidelines on track-and-trace systems for medicines, the ICH Q10 Pharmaceutical Quality System, and international serialisation standards for pharmaceutical supply chain integrity.