Nigeria

Regulation name

NAFDAC Pharmaceutical Products Traceability Regulations

Serialization status

In progress – GS1 serialization now mandatory under S.I. 49/2024; anti-counterfeiting SMS codes (mPedigree/Sproxil) active since 2010

Country population

~220 million

Alert requirement: ICS/EPCIS events in central platform – active

Aggregation requirement:

Track & Trace requirement:

Official governing body:

Implementation deadline / enforcement date: Regulation gazetted Oct 16, 2024; full compliance required by Dec 31, 2024

Serialization type / level: Mandatory on primary, secondary, tertiary; SSCC for logistics, Primary, secondary, tertiary packaging; GTIN+SN+EXP+LOT+(NTIN): Unique identifier on packaging levels

MAH / CMO responsibilities: MAH or delegated 3PL/CMO uploads master & event data

Serialized product scope: Rx, OTC, veterinary, clinical trial, extemporaneous. All drugs and related products (manufactured, imported, distributed)

Penalties for non-compliance: ≤1yr jail or ₦800K fine; Corporates: ≤₦5M fine; asset forfeiture

Repackaging rules: Repackaged/co-packed items must be assigned new unique identifiers

Serialization exemption rules: Permits possible for personal import, clinical trial, research, extemporaneous prep

Market coding requirements:

GS1 DataMatrix on primary, secondary, tertiary (GTIN+SN+EXP+LOT), SSCC on logistics

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