NAFDAC DRUGS AND DRUGS PRODUCT LABELLING REGULATION 2019
Regulation · Health
Policy date: 2019-01-01
Regulations set labelling requirements for pharmaceutical products in Nigeria, ensuring clear information on composition, dosage, contraindications, storage, and expiry. They target pharmaceutical manufacturers, importers, pharmacists, healthcare providers, and regulatory authorities. This reduces medication errors and adverse events by promoting safe and effective use.
What Is This Policy?
Regulations specifying the labelling requirements for pharmaceutical products including prescription drugs, over-the-counter medicines, and combination products, ensuring that healthcare providers and patients have the information necessary for safe and effective use.
Who Does It Target?
Pharmaceutical manufacturers and importers Pharmacists and patent medicine dealers Healthcare providers recommending or dispensing medicines NAFDAC as the regulatory authority
What Does It Aim to Achieve?
To reduce medication errors and adverse drug events by ensuring that all drug product labels carry clear, accurate, and complete information on composition, dosage, contraindications, storage, and expiry.
Key Features
Mandatory Label Elements: Brand and generic names, strength, dosage form, indications, contraindications, and NAFDAC number are all required. Patient Information Leaflet: Prescription drugs must include an approved patient information leaflet. Batch and Expiry: Batch number and expiry date must be clearly printed and embossed where required. Storage Instructions: Appropriate storage conditions must be stated on the primary and secondary packaging. Controlled Drug Markings: Scheduled and controlled substances must carry prescribed symbols and security features.
Current Status
In force. Actively enforced by NAFDAC, with non-compliant pharmaceutical labelling subject to product recall, seizure, and regulatory sanctions against manufacturers and importers.
Submit label artwork for review during product registration Comply with format requirements for font size, colour, and placement Apply for label variation approval when product information changes Application method: NAFDAC headquarters, Abuja
Important Terms
Products with expired or non-compliant labels may not be sold Label changes require prior NAFDAC approval Counterfeit or falsified labels attract criminal prosecution
Official Resources
Website: www.nafdac.gov.ng Policy Summary Document | Federal Republic of Nigeria
Legal Framework
The NAFDAC Drugs and Drugs Product Labelling Regulations are issued under the NAFDAC Act and operate alongside the Pharmacy Council of Nigeria Act, the National Drug Policy, and the Consumer Protection Council Act. International alignment is with WHO's Guidelines on Packaging of Medicines, the ICH Q6A Specifications Standard, and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) guidelines on drug labelling standards.