NAFDAC Drugs and Related Products Labelling Regulations 2019
Regulation · Health
Policy date: 2019-01-01
Regulations prescribe labelling requirements for pharmaceutical products in Nigeria, including active ingredients, dosage, expiry dates, storage conditions, and safety warnings. They target pharmaceutical manufacturers, importers, pharmacies, and consumers. This ensures patient safety by supporting correct use and reducing medication errors.
NAFDAC Drugs and Related Products Labelling Regulations 2019
What Is This Policy?
Regulations that prescribe the labelling requirements for all pharmaceutical products sold in Nigeria, including active ingredients, dosage, expiry dates, storage conditions, and safety warnings.
Who Does It Target?
Pharmaceutical manufacturers and importers Hospital and retail pharmacies NAFDAC registration officers Patients and consumers
What Does It Aim to Achieve?
Ensure patient safety by requiring that all medicines carry clear, complete, and accurate labelling information that supports correct use and reduces medication errors.
Key Features
Active Ingredient Declaration: Generic name and strength of all active ingredients Dosage Information: Route of administration, recommended dose, and frequency Expiry Date and Batch: Manufacturing date, expiry date, and batch number for traceability Storage Conditions: Required storage temperature and handling instructions NAFDAC Registration: Valid NAFDAC registration number on all packaging
Current Status
Rollout Stage: Active Coverage: All pharmaceutical products in Nigeria Lead Agency: NAFDAC
How to Access
Products must meet labelling standards as a condition of registration. Submit label artwork during the product registration process Comply with all mandatory label elements
Official Resources
Website: nafdac.gov.ng Contact: NAFDAC, Abuja
Legal Framework
The NAFDAC Drugs and Related Products Labelling Regulations 2019 are issued under the NAFDAC Act and supersede earlier labelling regulations. They operate alongside the Pharmacy Council of Nigeria Act, the Medical and Dental Practitioners Act, and the Consumer Protection Council Act. International alignment is with WHO's Guidelines on Packaging of Medicines, the ICH Q6A Specifications, and ASEAN Common Technical Dossier labelling standards.