NAFDAC Guidelines for Renewal of Registration for Drugs Made in Nigeria
Guideline · Health
Guidelines outline the process for renewing registration of drugs made in Nigeria, including submission of documentation and compliance reviews. They target regulated entities, NAFDAC teams, and industry stakeholders, requiring updated product information and current GMP certificates. This ensures the maintenance of quality-assured Nigerian-made medicines.
NAFDAC Guidelines for Renewal of Registration for Drugs Made in Nigeria
What Is This Policy?
Guidelines for renewing the registration of pharmaceutical products manufactured in Nigeria, including documentation, compliance review, and updated product information.
Who Does It Target?
Nigerian pharmaceutical manufacturers whose domestic drug product registrations require periodic renewal; regulatory affairs and quality control personnel in pharmaceutical companies; NAFDAC's drug registration and evaluation teams; the Federal Ministry of Health
NAFDAC teams Industry stakeholders
What Does It Aim to Achieve?
Maintain the registration status of quality-assured Nigerian-made medicines.
Key Features
Renewal Application: Submission within prescribed period before registration expiry Updated Information: Any changes to formulation, labelling, or manufacturing site since last registration GMP Status: Current GMP certificate for the manufacturing facility Pharmacovigilance Report: Summary of adverse event reports during the registration period
Current Status
Rollout Stage: Active Coverage: All applicable entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply. Submit renewal application before expiry Provide updated product and facility documentation Maintain current GMP certification
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.