Nigeria Mandates Pharmaceutical Track AND Trace for Pregabalin Products from January 2027
The National Agency for Food and Drug Administration and Control (NAFDAC) has classified all Pregabalin-containing products as nationally controlled medicines in Nigeria, introducing stricter import controls and new pharmaceutical traceability requirements.
According to a directive signed by Mrs. Rametu Momodu, Director of Narcotics and Controlled Substances, on behalf of the Director-General of NAFDAC, the decision follows growing evidence of dependence, misuse and abuse associated with Pregabalin, as well as recent seizures of significant quantities of unapproved Pregabalin brands across the country.
Key Regulatory Requirements
🔹 Import Controls: An import permit is now mandatory before Pregabalin products can be brought into Nigeria. A permit to clear is also required before the products can be released from ports
🔹 Mandatory Track AND Trace: Effective 1 January 2027, all Pregabalin formulations must carry traceability features on their secondary packaging.
🔹 Required Identification and Serialization: Manufacturers and importers will be required to include:Global Trade Item Number (GTIN)Global Location Number (GLN)Serialization codes
These measures aim to strengthen product traceability and help prevent the diversion of controlled medicines.
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