NAFDAC Guidelines for Registration of Herbal Remedies/Dietary Supplements Made in Nigeria
Guideline · Health
Guidelines specify requirements for registering herbal remedies and dietary supplements produced in Nigeria, including safety data and quality control. They target local manufacturers and traditional medicine producers. This ensures these products meet safety standards for consumers.
NAFDAC Guidelines for Registration of Herbal Remedies/Dietary Supplements Made in Nigeria
What Is This Policy?
Guidelines specifying the registration requirements for locally manufactured herbal remedies and dietary supplements, including documentation, safety data, quality control, and labelling standards.
Who Does It Target?
Local herbal medicine manufacturers Dietary supplement producers NAFDAC herbal products evaluation team Traditional medicine practitioners producing commercial products
What Does It Aim to Achieve?
Ensure that herbal remedies and dietary supplements produced in Nigeria meet safety and quality standards before they reach consumers.
Key Features
Application Dossier: Product formulation, safety data, stability studies, and quality specifications Facility Inspection: GMP compliance assessment of manufacturing premises Labelling Standards: Mandatory declarations including ingredients, dosage, and safety warnings Claims Restrictions: Products may not claim to cure or treat specific diseases unless supported by evidence Post-Market Surveillance: Ongoing monitoring of product safety after registration
Current Status
Rollout Stage: Active Coverage: All applicable regulated entities Lead Agency: NAFDAC Enforcement: NAFDAC inspections and compliance monitoring
How to Access
Regulated entities must comply with these guidelines. Submit registration application with complete product dossier Undergo facility GMP inspection Comply with labelling and claims requirements
Official Resources
Website: nafdac.gov.ng Contact: NAFDAC, Abuja
Legal Framework
Issued under the National Agency for Food and Drug Administration and Control Act 1993 (as amended). Operates alongside the Food and Drugs Act Cap F32 LFN 2004, the Pharmacists Council of Nigeria Act, the ICH Good Manufacturing Practice guidelines, WHO prequalification standards, and the Falsified Medicines guidelines adopted by Nigeria. Draws additionally on the WHO guidelines on good agricultural and collection practices for medicinal plants, the African Pharmacopoeia, and the ICH Q1 stability testing guidelines.