NAFDAC Pharmaceutical Products (Traceability) Regulations, Statutory Instrument no. 49 of 2024.

These Regulations, made under section 30 of the National Agency for Food and Drug Administration and Control Act, Cap. N1, LFN, 2004 and section 12 of the Food, Drugs and Related Products (Registration, Etc.) Act, Cap. F33. LFN, 2004, provide a regulatory framework for the traceability of drugs and related products manufactured, imported, distributed, sold or used in Nigeria. According to the definitions, drug means any substances of vegetable, animal or mineral origin or any preparation or admixture manufactured, sold or advertised for use in the diagnosis, treatment, mitigation of pests and diseases, in man or animal, disinfections or the control of vermin, insects or pest, and contraception. Matters covered by these Regulations include: labelling information and identification of the product; data carrier and data carrier specifications; traceability of product; prohibition, offences and penalties.