Nigeria
| Regulatory Agency | National Agency for Food and Drug Administration and Control (NAFDAC) |
| Regulation Name | National Pharmaceutical Traceability Strategy |
| Compliance Dates | MAS mandatory since ~2012 for priority products (anti malarials, antibiotics). GS1 serialization phased implementation began ~2022–2024 (risk-based rollout, category dependent). |
| Applies to | These Regulations provides regulatory framework for the traceability Prescription medicines; priority OTC medicines (especially anti malarials, antibiotics); locally manufactured and imported medicines (phased expansion to all regulated medicines). |
(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)
| Barcode Symbology | GS1 Data Matrix (Proposed) |
| Barcode Content |
|
| Serial Number Randomization | Not Specified |
| Serial Number Reuse | Not Specified |
| Human Readable Expiry Date Format | Not Specified |
| Barcode Data Encoding | GS1 standard |
| Product Code Notes | NA |
| Free Samples must be marked? | No |
(A shipper containing one or more secondary packs)
| Barcode Symbology | SSCC Code | |
| Barcode Contents | SSCC (Serial Shipping Container Code) or aggregated GTIN + serials | |
| Parent-Child Mapping Aggregation Capture? | Yes (where aggregation is implemented) |
| Send Unit Data to Government Repository? | Yes (for serialized products under traceability regulation – phased) |
| Send Unit Data to Third-Party Repository? | Possible (via approved solution providers) |
| Send Unit Data to Trading Partner? | Yes (commercial requirement; not always regulatory mandate) |
| Send Aggregation Data to Government Repository? | Required under full traceability model (phased) |
| Send Aggregation Data to Third-Party Repository? | No Specified |
| Send Aggregation Data to Trading Partner? | No Specified |
| Who Offers Data Repository for Authentication? | NAFDAC MAS platform; approved MAS service providers |
| Manufacturers Must Register Shipments in Repository? | Yes |
| Downstream Trading Partners Must Authenticate on Receipt? | Required for MAS products (via SMS verification); broader digital verification evolving |
| Downstream Trading Partners Must Authenticate on Shipment? | Not universally mandated (depends on implementation phase) |
| Manufacturer Activity Reported? | Yes |
| Downstream Trading Partner Activity Reported? | No Specified |
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.
Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.
Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.
Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.
For Further Information, please contact our Compliance Team at info@kevision.in
