NAFDAC Guidelines for Registration of Imported Drug Product in Nigeria (Human and Veterinary Drugs)
Guideline · Health
Guidelines establish the process for registering imported human and veterinary drugs in Nigeria, requiring a Common Technical Document dossier and GMP certificates. They target importers, manufacturers, and NAFDAC compliance teams. This ensures imported medicines are safe and effective for public use.
NAFDAC Guidelines for Registration of Imported Drug Product in Nigeria (Human and Veterinary Drugs)
What Is This Policy?
Guidelines for registering imported human and veterinary pharmaceutical products in Nigeria, specifying the dossier requirements, GMP evidence, and evaluation process.
Who Does It Target?
Regulated entities as applicable NAFDAC inspection and compliance teams Industry stakeholders
What Does It Aim to Achieve?
Ensure imported medicines available in Nigeria are safe, effective, and of assured quality.
Key Features
CTD Dossier: Common Technical Document format with quality, safety, and efficacy data GMP Evidence: Current GMP certificate from the country of manufacture Bioequivalence: Bioequivalence or biowaiver data for generic products Labelling: Nigerian market labelling in English with required safety information
Current Status
Rollout Stage: Active Coverage: All applicable regulated entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply with these guidelines. Prepare complete CTD dossier Obtain GMP and free sale certificates from country of origin Submit application through NAFDAC portal
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.