NAFDAC Guidelines for Registration of Imported Herbal Remedies/Dietary Supplements in Nigeria
Guideline · Technology
Guidelines detail the procedures for registering imported herbal remedies and dietary supplements in Nigeria, mandating safety data and quality specifications. They target manufacturers, importers, and NAFDAC inspectors. This ensures these products are safe for consumers.
NAFDAC Guidelines for Registration of Imported Herbal Remedies/Dietary Supplements in Nigeria
What Is This Policy?
Guidelines for registering imported herbal remedies and dietary supplements with NAFDAC, including safety data, quality specifications, and documentation from the country of origin.
Who Does It Target?
Regulated entities as applicable NAFDAC inspection and compliance teams Industry stakeholders
What Does It Aim to Achieve?
Ensure imported herbal and dietary supplement products are safe and properly documented.
Key Features
Safety Evidence: Toxicological data and adverse event history from the country of origin Quality Specifications: Product specifications, stability data, and certificates of analysis Claims Restrictions: No disease cure claims; only permitted health or structure-function claims
Current Status
Rollout Stage: Active Coverage: All applicable regulated entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply with these guidelines. Obtain manufacturer and country documentation Submit registration application with safety evidence Comply with Nigerian labelling and claims rules
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 WHO monographs on selected medicinal plants and the African Pharmacopoeia standards for herbal medicinal products.