HERBAL MEDICINES AND RELATED PRODUCTS REGISTRATION REGULATIONS 2019
Regulation · Trade
Policy date: 2019-01-01
Regulations establish the requirements for registering herbal medicines and related products with NAFDAC to ensure they meet safety and quality standards. They target manufacturers, importers, and traditional medicine practitioners. This protects consumers from unsafe or fraudulent remedies.
What Is This Policy?
Regulations establishing the requirements and process for registering herbal medicines and related products with NAFDAC before they may be manufactured, imported, or sold in Nigeria, ensuring safety, quality, and efficacy standards are met.
Who Does It Target?
Manufacturers and importers of herbal medicines, dietary supplements, and related products Traditional medicine practitioners commercialising products NAFDAC as the registration authority
What Does It Aim to Achieve?
To ensure that herbal products entering the Nigerian market have been assessed for safety and quality, bear accurate labels, and are manufactured under adequate conditions, protecting consumers from unsafe or fraudulent remedies.
Key Features
Product Dossier Submission: Applicants submit full dossiers including formulation, manufacturing process, safety, and efficacy data. GMP Inspection: Manufacturing sites must be inspected and certified as meeting Good Manufacturing Practice standards. Efficacy Requirements: Evidence of traditional use or clinical data is required to support claimed indications. Label Review: Labels are reviewed during registration for compliance with labelling regulations. NAFDAC Number: Registered products receive a unique NAFDAC number that must appear on the label.
Current Status
In force. Actively implemented by NAFDAC, which requires all herbal medicines and related products to be registered before legal sale or distribution in Nigeria.
Complete the online or paper registration application form Submit the required dossier documents and product samples Pay the prescribed registration fees and facilitate GMP inspection of the manufacturing site Application method: NAFDAC headquarters, Abuja, or zonal offices
Important Terms
Registration must be renewed every five years Post-market adverse event reports must be submitted to NAFDAC Selling unregistered herbal products is a criminal offence
Official Resources
Website: www.nafdac.gov.ng Policy Summary Document | Federal Republic of Nigeria
Legal Framework
The Herbal Medicines and Related Products Registration Regulations are issued under the National Agency for Food and Drug Administration and Control (NAFDAC) Act, which grants NAFDAC authority to regulate all food and drug products. They operate alongside the Counterfeit and Fake Drugs Act, the Standards Organisation of Nigeria Act, and the National Policy on Traditional Medicine. International alignment is with WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems.