NAFDAC Guidelines for Renewal of Certificate of Registration for Herbal/Dietary Supplements Made in Nigeria

Guideline · Technology

Guidelines detail the renewal of registration for herbal and dietary supplements produced in Nigeria, involving updated documentation and quality data. They apply to regulated entities, NAFDAC teams, and industry stakeholders, mandating current stability data and batch testing results. This maintains the registration of quality Nigerian herbal products.

NAFDAC Guidelines for Renewal of Certificate of Registration for Herbal/Dietary Supplements Made in Nigeria

What Is This Policy?

Guidelines for renewing the registration of locally produced herbal remedies and dietary supplements.

Who Does It Target?

Nigerian manufacturers of herbal remedies, traditional medicine formulations, and dietary supplements; regulatory affairs managers in herbal product companies seeking to maintain market authorisation; NAFDAC's herbal and nutraceutical registration teams

NAFDAC teams Industry stakeholders

What Does It Aim to Achieve?

Maintain registration of quality-assured Nigerian herbal and nutraceutical products.

Key Features

Renewal Application: Updated product and facility documentation Quality Data: Current stability data and batch testing results

Current Status

Rollout Stage: Active Coverage: All applicable entities Lead Agency: NAFDAC

How to Access

Regulated entities must comply. Submit renewal application Provide updated product documentation

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.

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