NAFDAC product registration guidelines

Knowledge documents to get you started

These guidelines are to enable applicants obtain detailed provisions of how to undertake their requested service from NAFDAC. 

The guidance documents are categorized based on product type and do provide detailed information on: Application, Facility Inspection, Documentation, Labelling, Tariff (Fees) and Timelines.

TitleProduct TypeCategory
Guideline For Lot Release Of Human Vaccines And Other Biologicals 2023Vaccines, Biologics & Medical DevicesLot release (VBM-LSD)
Guidance Document on Chemistry, Manufacturing, Control (CMC) And Lot Release For Finished Vaccine Or Biological Medicinal ProductVaccines, Biologics & Medical DevicesLot release (VBM-LSD)
Guidelines For Change In Formulation Of Food And Feed ProductsFoodGMP Requirement (FR&R)
Guidelines For The Registration Of Bulk/Semi Processed Food Product For ExportFoodExport Registration (FR&R)
Guideline For Production Inspection Of Chemical Manf Facilities.pdfChemicalGuidance Document (CER)
GMP Guidelines For Chemical And Chemical Products.pdfChemicalGMP Requirement (CER)
GMP Guidelines For Herbal Medicinal Products 2022HerbalGuidance Document (DER)
Guidelines For Pre-Production Inspection Of Pharmaceutical Manufacturing Facilities In NigeriaDrugsGMP Requirement (DER)
Guidelines For Pre- Registration Inspection Of Pharmaceutical Manufacturing Facilities In NigeriaDrugsGMP Requirement (DER)
Guidelines for Registration of Animal Feed Made in NigeriaVeterinaryLocal Registration (R&R)
Guidelines for Advertisement Control of Food Products in NigeriaFoodAdvert Guidelines (R&R)
Guidelines for Registration of Imported Animal Feed in NigeriaVeterinaryImport Registration (R&R)
Guidelines For Clinical Trial Process TimelinesDrugsClinical Trial (DER)
Guidelines For Submission Of Clinical Trial Progress ReportDrugsClinical Trial (DER)
NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021DrugsGMP Requirement (DER)
NAFDAC Guidelines For Contract Manufacturing Of Finished Pharmaceutical Products In NigeriaDrugsGMP Requirement (DER)
Reviewed NAFDAC Good Distribution Practices Guidelines For Pharmaceutical ProductsGeneralGDP Requirement (PVPMS)
NAFDAC Good Pharmacovigilance Practice GuidelinesGeneralGPP Requirement (PVPMS)
NAFDAC-LS-SG-001-01 SAMPLING GUIDE FOR NAFDAC REGULATED PRODUCTS Rc (1) (2)Regulated ProductsSampling Plan
Guidance on Regulatory Preparedness for Licensing or Access to COVID-19 VaccinesDrugsLicensing Access to Covid-19 Vaccines(DR&R)
Current Good Manufacturing Practice Guidelines For Food And Food Products (Revised)FoodGMP Requirement (FSAN)
Guidelines And Requirement For Inspection In Food Storage WarehouseFoodGMP Requirement (FSAN)
NAFDAC Guidelines For Food Hygienic Practices (NGFHP)FoodGuidance Document (FSAN)
Guidelines For Importation Of Active Pharmaceutical Ingredients (APIs)DrugsAPI Requirement (DER)
Guidelines For Complaints And Appeals Against Regulatory Decisions QMS -GLD-001-01-1GeneralConsumer Complaints (QMS)
Guidance Document for the Registration of Alcohol-based Hand Sanitizers Made in NigeriaGeneralGuidance Document (DR&R)
Guidance to Applicants for Registration of Herbal Medicines Made in NigeriaHerbalGuidance Document (DR&R)
NAFDAC Guidelines on Good Review PracticeRegulated ProductsQuality Guidelines (DR&R)
Guidelines For Listing Of Chemical Manufacturers In Nigeria (New Applicants)ChemicalListing Requirement (CER)
Guidance Document for Submission of Application in the CTD Format – Vaccines for Human UseDrugsGuidance Document (DR&R)
Guideline For Approval To Import Donated Items By Non-Governmental OrganizationsGeneralImport Permit (PID)
Guideline For Approval To Import Products By Government Agencies, International Bodies & Multinational companiesGeneralImport Permit (PID)
Guideline for Approval To Import Raw material For Machine Trial Or Research PurposeGeneralImport Permit (PID)
Guideline For Authorization To Open Form MGeneralGMP Requirement (PID)
Guideline For Non Objection ApprovalGeneralGMP Requirement (PID)
Guidelines For Complaints ResolutionGeneralConsumer Complaints (Reforms)
NAFDAC Good Cold Chain Management For Vaccines & Biopharm. Products Guidelines 2021GeneralGMP Requirement (DER)
Guidelines on Variations to a Registered Vaccine for HumansGeneralVariation Guidelines (DR&R)
Guidelines for Renewal of Certificate of Registration for Drugs Made in NigeriaDrugsRenewal Registration Requirement (DR&R)
Guidelines for Renewal of Certificate of Registration for Medical Devices Made in NigeriaMedical DevicesRenewal Registration Requirement (DR&R)
Guidelines for Renewal of Herbal Medicines and Dietary Supplements Made in NigeriaHerbalRenewal Registration Requirement (DR&R)
Guidelines for Renewal of Certificate of Registration for Imported Herbal Remedies, Dietary Supplements in NigeriaHerbalRenewal Registration Requirement (DR&R)
Guidelines for the Renewal of Certificate of Registration License for Imported DrugsDrugsRenewal Registration Requirement (R&R)
Guideline for the Renewal of the Certificate of Registration License for Imported Medical DevicesMedical DevicesRenewal Registration Requirement (R&R)
Guidelines For Registration of Imported Drugs Vaccines IVDs Under Collaborative Registration ProcedureDrugsRegistration Requirement (DR&R)
Guidelines For Labeling Of Investigational Medicinal ProductsDrugsGMP Labeling (DER)
Guidelines For Importation And Release Of Investigational Medicinal ProductsDrugsQuality Guidelines (DER)
Guidelines For Conduct Of Clinical Trials During EmergenciesDrugsClinical Trial (DER)
Guidelines For Clinical Trials Protocol DevelopmentDrugsClinical Trial(DER)
NAFDAC Guidelines on Variations to a Registered Pharmaceutical ProductDrugsVariation Guidelines (DR&R)
Guideline for Approval to Import Products by Government Agencies, International Bodies & Multinational OrganizationsGeneralGuidance Document (PID)
Guideline for Form M Online Application 2019GeneralGuidance Document (PID)
Guideline for NOC Online Application 2019GeneralGuidance Document (PID)
Guidelines For Clinical Investigation Of Medicinal Products In Paediatric PopulationDrugsClinical Trial(DER)
Biosimilar Guidance DocumentDrugsQuality Guidance Document (DR&R)
Guidelines for Registration of Biosimilars in NigeriaDrugsLocal Registration (DR&R)
Quality Guidelines for Registration of Pharmaceutical Products26381DrugsQuality Guidelines (R&R)
Guidelines for Issuance of Additional Permit to Import Laboratory and Industrial ChemicalsChemicalImport Permit (CER)
Guidelines for Issuance of Listing Certificate for Chemical Marketers (New applicants)ChemicalListing Certificate (CER)
Guidelines for Issuance of Permit to Clear for Restricted and Agro ChemicalsChemicalClearance Permit (CER)
Guidelines for Issuance of Permit to Import Laboratory and Industrial ChemicalsChemicalImport Permit (CER)
Guidelines for Renewal of Import Permit for Laboratory and Industrial ChemicalsChemicalImport Permit Renewal (CER)
Guidelines for the Issuance of Import Permit for Restricted and Agro ChemicalsChemicalImport Permit (CER)
Guidelines for the Renewal of Listing Certificate for Chemical MarketersChemicalListing Certificate Renewal (CER)
Guidelines for Warehouse InspectionChemicalWarehouse Inspection Requirement (CER)
Guidelines for Obtaining Permit to Clear Narcotic drugs, Psychotropic Substances and Drug Precursors_NarcoticClearance Permit (NCS)
Guidelines for Obtaining Permit to Clear Precursor ChemicalsNarcoticClearance Permit (NCS)
Guidelines for Obtaining Permit to Import Narcotics, Drugs, Psychotropic Substances and Drug PrecursorNarcoticImport Permit (NCS)
Guidelines for Obtaining Permit to Import Precursor ChemicalsNarcoticImport Permit (NCS)
Guidelines for Obtaining Permit to Import Schedule 1 Narcotic DrugsNarcoticImport Permit (NCS)
Guidelines for Warehouse InspectionNarcoticWarehouse Inspection Requirement (NCS)
Guidelines for the Advertisement of NAFDAC Regulated ProductsGeneralAdvert Guideline (R&R)
Guidelines for the Registration of Imported Animal FeedsGeneralImport Registration (R&R)
Guidelines for Registration of Imported Cosmetics in NigeriaCosmeticsImport Registration (DR&R)
Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs)DrugsImport Registration (DR&R)
Guidelines for Registration of Imported Food Products in NigeriaFoodImport Registration (R&R)
Guidelines for Registration of Imported Herbal Remedies And Dietary Supplements in NigeriaHerbalImport Registration (DR&R)
Guidelines for Registration of Imported Medical Devices in NigeriaMedical DeviceImport Registration (DR&R)
Guidelines for Registration of Imported Pesticides in NigeriaChemicalImport Registration (DR&R)
Guidelines for Registration of Herbal Medicines and Dietary Supplements Made in NigeriaHerbalLocal Registration (DR&R)
Guidelines for Registration of Medical Devices made in NigeriaMedical DeviceLocal Registration (DR&R)
Guidelines for Registration of Cosmetics Made in NigeriaCosmeticsLocal Registration (DR&R)
Guidelines for Registration of Drug Products Made in Nigeria (Human and Veterinary Drugs)DrugsLocal Registration (DR&R)
Guidelines for Registration of Food Products and Packaged Water Made in NigeriaFoodLocal Registration (R&R)
Guidelines for the Registration of Pesticides made in NigeriaChemicalLocal Registration (DR&R)
Guidelines for the Inspection of WarehousesVeterinaryWarehouse Inspection (Inspection)
Guidelines for the Inspection of Facilities for Manufacture of Veterinary DrugsVeterinaryGMP Requirement (Inspection)
Guidelines for Listing of Animal Feed Toll Millers Requirements for the Toll Milling Facility RenewalVeterinaryListing Requirement (Renewal)
Guidelines for Listing of Animal Feeds Toll Millers Requirements for Toll Milling FacilityVeterinaryGMP Requirement
Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer RenewalVeterinaryListing Requirement
Guidelines for Issuance of Permit to Import Field Trial SamplesVeterinaryImport Permit
Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrates Feed Additives Premixes Fish Meal RenewalVeterinaryImport Permit
Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrate Feed Additives Premixes Fish Meal New ApplicantVeterinaryImport Permit
Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and FertilizersVeterinaryImport Permit
Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and Fertilizers RenewalVeterinaryImport Permit
Guidelines for Inspection of Local Manufactured Animal Feed Pet Food PremixesVeterinaryGMP Requirement (Inspection)
Guidelines for Inspection of Facility for the Manufacture of Veterinary Medicinal Cosmetics in NigeriaVeterinaryGMP Requirement (Inspection)
Guidelines for Inspection of Facilities for the Manufacture of Medicated FeedVeterinaryGMP Requirement (Inspection)
Guidelines for Inspection of Facilities for Manufacture of Veterinary CosmeticsVeterinaryGMP Requirement (Inspection)
Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer RenewalVeterinaryListing Requirement
Guidance on Master Data Attributes for Pharmaceutical Products DGO-GDL-001-00DrugsTraceability
TitleProduct TypeCategory
Guidelines for Handling and Disposal of Unwholesome Medicines and Other NAFDAC Regulated ProductsDrugsListing Requirement (I&E)
Guidelines for Production Inspection of Small-Scale Food Enterprises (New Applicants)FoodGMP Inspection Requirement (FSAN)
Guidelines for Production Inspection of Micro Scale Food Manufacturing Facilities in Nigeria (New Applicants)FoodGMP Inspection Requirement (FSAN)
Guidelines for Inspection of Facilities for Manufacture of Food ProductsFoodGMP Inspection Requirement (FSAN)
Guidelines for Inspection and Requirements for Bread Manufacturing FacilityFoodGMP Inspection Requirement (FSAN)
Guidelines for Inspection and Requirements for Packaged Water Facility in NigeriaFoodGMP Inspection Requirement (FSAN)
Guidelines for Clearance of Imported Donated Items at Ports of Entry in NigeriaGeneralImport Clearance Permit (PID)
Guidelines for Clearing Imported Bulk Food, Animal Feed and Food Raw Materials at the Ports of EntryFoodImport Clearance Permit (PID)
Guidelines for Clearing Imported Controlled Narcotics Substances, Pharm Raw Materials & Restrcited ChemicalsNarcoticsImport Clearance Permit (PID)
Guidelines for Clearing Imported Finished Pharmaceutical, Nutraceutical & Herbal Products (Human & VeterinaryHerbalImport Clearance Permit (PID)
Guidelines for Clearing Imported Regulated Food (Including Global Listing for Supermarket Items & Restuarant OperatorsFoodImport Clearance Permit (PID)
Guidelines for Clearing of Cosmetics and Medical DevicesCosmetic, Medical DevicesImport Clearance Permit (PID)
Guidelines for Clearing of Imported General Chemicals and Raw MaterialsChemicalImport Clearance Permit (PID)
Guidelines for Export Approval for NAFDAC Regulated Products and Food Stuff not Pre-packaged for Personal UseFood, Other Regulated ProductsExport Permit
Guidelines for Fast Track Clearance of Imported Regulated Products and Bulk Raw MaterialsGeneralImport Clearance Permit (PID)
Guidelines for Issuance of Authorization on Letter of No-Objection and Approval to Open Form M & PAARGeneralImport Permit (PID)
Guidelines for Issuance of Export Approval for Samples for Machine TrialsGeneralExport Permit (PID)
Guidelines for the Issuance of Export Certificate for NAFDAC Regulated ProductsGeneralExport Permit (PID)
Guidelines for the Issuance of Health Certificate for Exportation of Processed and Semi-Processed Food CommoditiesFoodExport Permit (PID)
Guidelines for Post Marketing Survelliance NigeriaGeneralGMP Requirement (PV/PMS)
NAFDAC MAS GuidelinesGeneralMobile Authentication Service (PV/PMS)
NAFDAC Guidelines on Good Pharmacovigilance PracticeGeneralGMP Requirement (PV/PMS)
Guidelines for LabellingGeneralGMP Labelling (R&R)
NAFDAC Guideline on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical ProductsDrugsRegistration Requirement (DR&R)
NAFDAC GMP Guidelines For Cosmetics Products 2021CosmeticsGMP Requirement (DER)
Guidelines For Production Inspection Of Large And Medium Scale Cosmetics Manufacturing FacilitiesCosmeticsGMP Inspection (DER)
Guidelines For Production Inspection Of Herbal Medicines And Nutraceuticals Manufacturing FacilitiesHerbalGMP Inspection (DER)
NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021DrugsGMP Inspection (DER)
Guidelines For Inspection Of Premises For Global Listing Of Cosmetics ProductsCosmeticsGMP Inspection (DER)
Guidelines For Good Storage Practice (GSP) And Good Distribution Practice (GDP) Inspection Of Cold Chain Facilities For Storage Of Vaccines & BiologicsVaccines & BiologicsGSP & GDP Inspection (DER)
Guidelines For Clinical Trial Application In NigeriaDrugsClinical Trial (DER)
Label Guidance For Herbal Medicines And Dietary SupplementHerbalGMP Labelling (DR&R)
Guidelines for the Global Listing of Supermarket Items (GLSI)Regulated ProductsGlobal Listing (DR&R)
Dossier Submission GuideGeneralGuidance Document (DR&R)
Guidelines For Advertisement Of Medical Products, Cosmetics, Veterinary Products And Finished ChemicalsRegulated ProductsGMP Advertisement (DR&R)
Guideline for Donated Medical Products in NigeriaRegulated ProductsGuidance Document (DR&R)
Guideline for Operation of Service Drugs and Orphan Drug SchemeDrugsOperation Guidelines (DR&R)
Guidelines for Renewal of Certificate of Registration for Imported Drug Products in Nigeria (Human & Veterinary Drugs)Regulated ProductsRenewal Registration Requirement (DR&R)
Guidelines For The Preparation Of Product Dossiers` In The Common Technical Document (CTD) Format Quality PartGeneralQuality Guidance Document (DR&R)
Guidance on Master Data Attributes for Pharmaceutical Products DGO-GDL-001-00DrugsTraceability

Reference: Guidelines – NAFDAC