The Federal Republic of Nigeria has introduced new regulations aimed at enhancing the traceability of pharmaceutical products within its supply chain. The NAFDAC (Pharmaceutical Products (Traceability)) Regulations, 2024, published on October 30, 2024, aim to strengthen the identification, tracking, and reporting of drugs and related products from manufacturing to dispensation.

The regulations, published under Government Notice No. 54, cover key areas including mandatory labeling, the use of unique identifiers, and data carriers to ensure product authenticity and facilitate easier tracking throughout the supply chain. This initiative, enforced by the National Agency for Food and Drug Administration and Control (NAFDAC), is designed to curb counterfeit drugs, improve consumer safety, and bolster Nigeria’s healthcare system.

Key provisions include the requirement for drugs to be labeled according to NAFDAC’s standards, with a unique identifier on each packaging level. These identifiers will include information such as the Global Trade Item Number (GTIN), batch number, expiry date, and serial number. Additionally, all pharmaceutical products will be required to feature machine-readable barcodes, with the GS1 standard ensuring global compatibility.

The regulations also mandate that manufacturers and supply chain stakeholders share data with NAFDAC for traceability, including details of production, distribution, and sales. In the event of discrepancies or errors in the data, stakeholders are required to report them within 48 hours.

The new law includes stringent penalties for non-compliance. Individuals found violating these regulations could face imprisonment or fines, while corporate bodies could be fined up to N5,000,000. Convicted individuals or companies may also forfeit assets linked to the offence.

The implementation of these regulations is seen as a critical step in protecting public health by preventing the circulation of counterfeit and substandard drugs. The Nigerian government urges all pharmaceutical manufacturers, importers, and distributors to comply with these new rules to ensure the safety and efficacy of drugs in the country.