** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6
** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6 ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-6

Guidelines

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 TypeCategoryStatus
NAFDAC Laboratory Sampling Guide 2023.pdfRegulated ProductsSampling PlanPublished
Guidelines For Issuance Of Additional Permit (New Items Or Quantities) To Import Industrial And Laboratory ChemicalsChemicalImport Permit (CER)Published
Guidelines For Issuance Of Permit To Import Severely Restricted Chemicals (Pesticides, Agrochemicals And Fertilizers)ChemicalImport Permit (CER)Published
Guidelines For Labeling Of Chemicals Manufactured In NigeriaChemicalGMP Requirement Labeling (CER)Published
Guidelines For Obtaining Listing Certificate For Chemical Marketers (New Applicants)ChemicalListing Certificate New Applicants (CER)Published
Guidelines For Obtaining Permit To Import Industrial And Laboratory Chemicals (New Applicants)ChemicalImport Permit New Applicants (CER)Published
Guidelines For Renewal Of Listing Certificate For Chemical MarketersChemicalListing Certificate Renewal (CER)Published
Guidelines For Renewal Of Permit To Import Industrial And Laboratory ChemicalsChemicalImport Permit Renewal (CER)Published
Guidelines For Warehouse InspectionGeneralGMP Requirement (CER)Published
Permit For Clearance Of Imported Severely Restricted Chemicals (Pesticides, Agrochemicals And Fertilizers)ChemicalImport Permit (CER)Published
Reviewed NAFDAC Good Distribution Practices Guidelines For Pharmaceutical Products 2023GeneralGDP Requirement (PVPMS)Published
Guideline for Renewal of Certificate of Registration for Drug Products (Human and Veterinary Drugs) DR&R-GDL-025-02Regulated ProductRenewal Registration Requirement (DR&R)Published
Guidelines for the Preparation of Summary of Product Characteristics (SmPC) for drug products in NigeriaDrugsSMPC GuidelinesPublished
Patient Information Listing (PIL) Review ChecklistDrugsPIL ChecklistPublished
SMPC Review ChecklistDrugsSMPC ChecklistPublished
Guideline For Lot Release Of Human Vaccines And Other Biologicals 2023Vaccines, Biologics & Medical DevicesLot release (VBM-LSD)Published
Guidance Document on Chemistry, Manufacturing, Control (CMC) And Lot Release For Finished Vaccine Or Biological Medicinal Product Vaccines, Biologics & Medical DevicesLot release (VBM-LSD)Published
Guidelines For Change In Formulation Of Food And Feed ProductsFoodGMP Requirement (FR&R)
Guideline For Production Inspection Of Chemical Manf Facilities.pdfChemicalGuidance Document (CER)Published
GMP Guidelines For Chemical And Chemical Products.pdfChemicalGMP Requirement (CER)Published
Guidelines For Pre-Production Inspection Of Pharmaceutical Manufacturing Facilities In NigeriaDrugsGMP Requirement (DER)Published
Guidelines For Pre- Registration Inspection Of Pharmaceutical Manufacturing Facilities In NigeriaDrugsGMP Requirement (DER)Published
Guidelines for Registration of Animal Feed Made in NigeriaVeterinaryLocal Registration (R&R)Published
Guidelines for Advertisement Control of Food Products in NigeriaFoodAdvert Guidelines (R&R)Published
Guidelines for Registration of Imported Animal Feed in NigeriaVeterinaryImport Registration (R&R)Published
Guidelines For Clinical Trial Process TimelinesDrugsClinical Trial (DER)Published
Guidelines For Submission Of Clinical Trial Progress ReportDrugsClinical Trial (DER)Published
NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021DrugsGMP Requirement (DER)Published
NAFDAC Guidelines For Contract Manufacturing Of Finished Pharmaceutical Products In NigeriaDrugsGMP Requirement (DER)Published
NAFDAC Good Pharmacovigilance Practice GuidelinesGeneralGPP Requirement (PVPMS)Published
Guidance on Regulatory Preparedness for Licensing or Access to COVID-19 VaccinesDrugsLicensing Access to Covid-19 Vaccines(DR&R)Published
Current Good Manufacturing Practice Guidelines For Food And Food Products (Revised).pdfFoodGMP Requirement (FSAN)Uncontrolled
Food Hygienic Practices Guidelines NGFHP.pdfFoodGuidance Document (FSAN)Uncontrolled
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)Published
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)Published
Guidelines For Listing Of Chemical Manufacturers In Nigeria (New Applicants)ChemicalListing Requirement (CER)Published
Guidance Document for Submission of Application in the CTD Format – Vaccines for Human UseDrugsGuidance Document (DR&R)Published
Guideline For Approval To Import Donated Items By Non Governmental Organizations General Import Permit (PID)Published
Guideline For Approval To Import Products By Government Agencies, International Bodies & Multinational companiesGeneral Import Permit (PID)Published
Guideline for Approval To Import Raw material For Machine Trial Or Research PurposeGeneral Import Permit (PID)Published
Guideline For Authorization To Open Form MGeneral GMP Requirement (PID)Published
Guideline For Non Objection ApprovalGeneral GMP Requirement (PID)Published
Guidelines For Complaints ResolutionGeneral Consumer Complaints (Reforms)Published
NAFDAC Good Cold Chain Management For Vaccines & Biopharm. Products Guidelines 2021General GMP Requirement (DER)Published
Guidelines on Variations to a Registered Vaccine for HumansGeneral Variation Guidelines (DR&R)Published
Guidelines for Renewal of Certificate of Registration for Medical Devices Made in NigeriaMedical DevicesRenewal Registration Requirement (DR&R)Published
Guidelines for Renewal of Herbal Medicines and Dietary Supplements Made in NigeriaHerbalRenewal Registration Requirement (DR&R)Published
Guidelines for Renewal of Certificate of Registration for Imported Herbal Remedies, Dietary Supplements in NigeriaHerbalRenewal Registration Requirement (DR&R)Published
Guideline for the Renewal of the Certificate of Registration License for Imported Medical DevicesMedical DevicesRenewal Registration Requirement (R&R)Published
Guidelines For Registration of Imported Drugs Vaccines IVDs Under Collaborative Registration ProcedureDrugsRegistration Requirement (DR&R)Published
Guidelines For Labeling Of Investigational Medicinal ProductsDrugsGMP Labeling (DER)Published
Guidelines For Importation And Release Of Investigational Medicinal ProductsDrugsQuality Guidelines (DER)Published
Guidelines For Conduct Of Clinical Trials During EmergenciesDrugsClinical Trial (DER)Published
Guidelines For Clinical Trials Protocol DevelopmentDrugsClinical Trial(DER) Published
NAFDAC Guidelines on Variations to a Registered Pharmaceutical ProductDrugsVariation Guidelines (DR&R)Published
Guideline for Approval to Import Products by Government Agencies, International Bodies & Multinational OrganizationsGeneral Guidance Document (PID)Published
Guideline for Form M Online Application 2019General Guidance Document (PID)Published
Guideline for NOC Online Application 2019General Guidance Document (PID)Published
Guidelines For Clinical Investigation Of Medicinal Products In Paediatric PopulationDrugsClinical Trial(DER)Published
Biosimilar Guidance DocumentDrugsQuality Guidance Document (DR&R)Published
Guidelines for Registration of Biosimilars in NigeriaDrugs Local Registration (DR&R)Published
Quality Guidelines for Registration of Pharmaceutical Products26381DrugsQuality Guidelines (R&R)Published
Guidelines for Issuance of Additional Permit to Import Laboratory and Industrial ChemicalsChemicalImport Permit (CER)published
Guidelines for Issuance of Listing Certificate for Chemical Marketers (New applicants)ChemicalListing Certificate (CER)Published
Guidelines for Issuance of Permit to Clear for Restricted and Agro ChemicalsChemicalClearance Permit (CER)Published
Guidelines for Issuance of Permit to Import Laboratory and Industrial ChemicalsChemical Import Permit (CER)Published
Guidelines for Renewal of Import Permit for Laboratory and Industrial ChemicalsChemical Import Permit Renewal (CER) Published
Guidelines for the Issuance of Import Permit for Restricted and Agro ChemicalsChemical Import Permit (CER)Published
Guidelines for the Renewal of Listing Certificate for Chemical MarketersChemicalListing Certificate Renewal (CER)Published
Guidelines for Warehouse InspectionChemical Warehouse Inspection Requirement (CER)Published
Guidelines for Obtaining Permit to Clear Narcotic drugs, Psychotropic Substances and Drug Precursors_NarcoticClearance Permit (NCS)Published
Guidelines for Obtaining Permit to Clear Precursor ChemicalsNarcoticClearance Permit (NCS)Published
Guidelines for Obtaining Permit to Import Narcotics, Drugs, Psychotropic Substances and Drug PrecursorNarcoticImport Permit (NCS)Published
Guidelines for Obtaining Permit to Import Precursor ChemicalsNarcoticImport Permit (NCS)Published
Guidelines for Obtaining Permit to Import Schedule 1 Narcotic DrugsNarcotic Import Permit (NCS)Published
Guidelines for Warehouse InspectionNarcoticWarehouse Inspection Requirement (NCS)Published
Guidelines for the Advertisement of NAFDAC Regulated ProductsGeneral Advert Guideline (R&R)Published
Guidelines for the Registration of Imported Animal FeedsGeneral Import Registration (R&R)Published
Guidelines for Registration of Imported Cosmetics in NigeriaCosmeticsImport Registration (DR&R)Published
Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs)DrugsImport Registration (DR&R)Published
Guidelines for Registration of Imported Food Products in NigeriaFoodImport Registration (R&R)Published
Guidelines for Registration of Imported Herbal Remedies And Dietary Supplements in NigeriaHerbalImport Registration (DR&R)Published
Guidelines for Registration of Imported Medical Devices in NigeriaMedical DeviceImport Registration (DR&R)Published
Guidelines for Registration of Imported Pesticides in NigeriaChemicalImport Registration (DR&R)Published
Guidelines for Registration of Herbal Medicines and Dietary Supplements Made in NigeriaHerbalLocal Registration (DR&R)Published
Guidelines for Registration of Medical Devices made in NigeriaMedical DeviceLocal Registration (DR&R)Published
Guidelines for Registration of Cosmetics Made in NigeriaCosmeticsLocal Registration (DR&R)Published
Guidelines for Registration of Drug Products Made in Nigeria (Human and Veterinary Drugs)Drugs Local Registration (DR&R)Published
Guidelines for Registration of Food Products and Packaged Water Made in NigeriaFoodLocal Registration (R&R)Published
Guidelines for the Registration of Pesticides made in NigeriaChemicalLocal Registration (DR&R)Published
Guidelines for the Inspection of WarehousesVeterinaryWarehouse Inspection (Inspection)Published
Guidelines for the Inspection of Facilities for Manufacture of Veterinary DrugsVeterinaryGMP Requirement (Inspection)Published
Guidelines for Listing of Animal Feed Toll Millers Requirements for the Toll Milling Facility RenewalVeterinaryListing Requirement (Renewal)Published
Guidelines for Listing of Animal Feeds Toll Millers Requirements for Toll Milling FacilityVeterinaryGMP Requirement Published
Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer RenewalVeterinaryListing Requirement Published
Guidelines for Issuance of Permit to Import Field Trial SamplesVeterinaryImport PermitPublished
Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrates Feed Additives Premixes Fish Meal RenewalVeterinaryImport PermitPublished
Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrate Feed Additives Premixes Fish Meal New ApplicantVeterinaryImport PermitPublished
Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and FertilizersVeterinaryImport PermitPublished
Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and Fertilizers RenewalVeterinaryImport PermitPublished
Guidelines for Inspection of Local Manufactured Animal Feed Pet Food PremixesVeterinaryGMP Requirement (Inspection)Published
Guidelines for Inspection of Facility for the Manufacture of Veterinary Medicinal Cosmetics in NigeriaVeterinaryGMP Requirement (Inspection)Published
Guidelines for Inspection of Facilities for the Manufacture of Medicated FeedVeterinaryGMP Requirement (Inspection)Published
Guidelines for Inspection of Facilities for Manufacture of Veterinary CosmeticsVeterinaryGMP Requirement (Inspection)Published
Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer RenewalVeterinaryListing Requirement Published
Guidelines for Handling and Disposal of Unwholesome Medicines and Other NAFDAC Regulated ProductsDrugsListing Requirement (I&E)Published
Guidelines for Inspection & Requirements for Pre-Packaged Food Manufacturing Packaging Facilities in Nigeria.pdfFoodGMP Inspection Requirement (FSAN)Uncontrolled
Guidelines for Inspection and Requirements for Bread Manufacturing FacilityFoodGMP Inspection Requirement (FSAN)Uncontrolled
Guidelines for Inspection and Requirements for Packaged Water Facility in Nigeria.pdfFoodGMP Inspection Requirement (FSAN)Uncontrolled
Guidelines for Clearance of Imported Donated Items at Ports of Entry in NigeriaGeneral Import Clearance Permit (PID)Published
Guidelines for Clearing Imported Bulk Food, Animal Feed and Food Raw Materials at the Ports of EntryFoodImport Clearance Permit (PID)Published
Guidelines for Clearing Imported Controlled Narcotics Substances, Pharm Raw Materials & Restrcited ChemicalsNarcoticsImport Clearance Permit (PID)Published
Guidelines for Clearing Imported Finished Pharmaceutical, Nutraceutical & Herbal Products (Human & VeterinaryHerbalImport Clearance Permit (PID)Published
Guidelines for Clearing Imported Regulated Food (Including Global Listing for Supermarket Items & Restuarant OperatorsFood Import Clearance Permit (PID)Published
Guidelines for Clearing of Cosmetics and Medical DevicesCosmetic, Medical DevicesImport Clearance Permit (PID)Published
Guidelines for Clearing of Imported General Chemicals and Raw MaterialsChemicalImport Clearance Permit (PID)Published
Guidelines for Export Approval for NAFDAC Regulated Products and Food Stuff not Pre-packaged for Personal UseFood, Other Regulated ProductsExport PermitPublished
Guidelines for Fast Track Clearance of Imported Regulated Products and Bulk Raw MaterialsGeneral Import Clearance Permit (PID)Published
Guidelines for Issuance of Authorization on Letter of No-Objection and Approval to Open Form M & PAARGeneral Import Permit (PID)Published
Guidelines for Issuance of Export Approval for Samples for Machine TrialsGeneral Export Permit (PID)Published
Guidelines for the Issuance of Export Certificate for NAFDAC Regulated ProductsGeneral Export Permit (PID)Published
Guidelines for the Issuance of Health Certificate for Exportation of Processed and Semi-Processed Food CommoditiesFood Export Permit (PID)Published
Guidelines for Post Marketing Survelliance NigeriaGeneral GMP Requirement (PV/PMS)Published
NAFDAC MAS GuidelinesGeneral Mobile Authentication Service (PV/PMS)Published
NAFDAC Guidelines on Good Pharmacovigilance PracticeGeneral GMP Requirement (PV/PMS)Published
Guidelines for Labelling General GMP Labelling (R&R)Published
NAFDAC Guideline on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical ProductsDrugsRegistration Requirement (DR&R)Published
NAFDAC GMP Guidelines For Cosmetics Products 2021 CosmeticsGMP Requirement (DER)Published
Guidelines For Production Inspection Of Large And Medium Scale Cosmetics Manufacturing FacilitiesCosmeticsGMP Inspection (DER) Published
Guidelines For Production Inspection Of Herbal Medicines And Nutraceuticals Manufacturing FacilitiesHerbalGMP Inspection (DER)Published
NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021DrugsGMP Inspection (DER)Published
Guidelines For Inspection Of Premises For Global Listing Of Cosmetics ProductsCosmeticsGMP Inspection (DER)Published
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)Published
Guidelines For Clinical Trial Application In NigeriaDrugsClinical Trial (DER)Published
Label Guidance For Herbal Medicines And Dietary SupplementHerbal GMP Labelling (DR&R)Published
Guidelines for the Global Listing of Supermarket Items (GLSI)Regulated ProductsGlobal Listing (DR&R)Published
Dossier Submission GuideGeneralGuidance Document (DR&R)Published
Guidelines For Advertisement Of Medical Products, Cosmetics, Veterinary Products And Finished ChemicalsRegulated ProductsGMP Advertisement (DR&R)Published
Guideline for Donated Medical Products in NigeriaRegulated ProductsGuidance Document (DR&R)Published
Guideline for Operation of Service Drugs and Orphan Drug SchemeDrugsOperation Guidelines (DR&R)Published
Guidelines for Renewal of Certificate of Registration for Imported Drug Products in Nigeria (Human & Veterinary Drugs)Regulated ProductsRenewal Registration Requirement (DR&R)Published
Guidelines For The Preparation Of Product Dossiers` In The Common Technical Document (CTD) Format Quality PartGeneralQuality Guidance Document (DR&R)Published
Guidance on Master Data Attributes for Pharmaceutical Products DGO-GDL-001-00DrugsTraceabilityPublished
Guidelines for Registration of Packaged Edible Vegetable Oil by Dispensers Under Micro Scale in NigeriaFoodGMP Inspection Requirement (FSAN)Uncontrolled
Guidelines For Production Inspection Of Micro Scale Food Manufacturing Facilities In Nigeria (New Applicants)FoodGMP Inspection Requirement (FSAN)Uncontrolled
Guidelines For Production Inspection Of Small Scale Food Enterprises In Nigeria (New Applicants)Food GMP Inspection Requirement (FSAN)Uncontrolled

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