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Application FormsGuidance 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 (Fess) and Timelines.

Go ahead and filter the guidelines table below based on product type and activity (service) desired.

TitleProduct TypeCategoryStatus
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 Distribution Practices Guidelines For Pharmaceutical ProductsGeneralGDP Requirement (PVPMS)Published
NAFDAC Good Pharmacovigilance Practice GuidelinesGeneralGPP Requirement (PVPMS)Published
NAFDAC Sampling Guide 2019GeneralSampling Plan
Guidance Document on Covid 19 Vaccine PreparednessDrugsLicensing Access to Covid-19 Vaccines(R&R)Published
Current Good Manufacturing Practice Guidelines For Food And Food ProductsFoodGMP Requirement (FSAN)Published
Guidelines And Requirement For Inspection In Food Storage WarehouseFoodGMP Requirement (FSAN)Published
Food Hygiene GuidelinesFoodGuidance Document (FSAN)Published
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 (R&R)
Guidance To Applicants For Registration Of Herbal Medicines Made In NigeriaHerbalGuidance Document
NAFDAC Good Review Practice (GRevP) Guideline Regulated ProductsQuality Guidelines (R&R)Published
Guidelines For Listing Of Chemical Manufacturers In Nigeria (New Applicants)ChemicalListing Requirement (CER)Published
Guidance Document for Submission of Application in CTD Format - Vaccines for Human UseDrugsGMP Requirement (R&R)Published
Guideline For Approval To Import Donated Items By Non-Governmental OrganizationsGeneral 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
Guidelines for complaints appeal QMS-GLD-001-00General Consumer Complaints (Reforms)Published
NAFDAC Good Cold Chain Management For Vaccines Biopharm. Products Guidelines 2019General GMP Requirement (DER)Published
NAFDAC Guidelines on Variations to a Registered Vaccine for Humans-1General Variation Guidelines (R&R)Published
Guidelines for the Renewal of Certificate of Registration for Drug Products made in NigeriaDrugsRenewal Registration Requirement (R&R)Published
Guidelines for the Renewal of Certificate of Registration License for Medical Devices made in NigeriaMedical DevicesRenewal Registration Requirement (R&R)Published
Guidelines for the Renewal of Certificate of Registration of Herbal Remedies and Dietary Supplements made in NigeriaHerbalRenewal Registration Requirement (R&R)Published
Guidelines for the Renewal of Certificate of Registration License for Imported Herbal Remedies and Dietary SupplementsHerbalRenewal Registration Requirement (R&R)Published
Guidelines for the Renewal of Certificate of Registration License for Imported DrugsDrugsRenewal Registration Requirement (R&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 Drugs Vaccines IVDs Under Collaborative Registration ProcedureDrugsRegistration Requirement (R&R)Published
Guidelines For Labeling Of Investigational Medicinal Products - Rev. 01DrugsGMP Labeling (DER)Published
Guidelines For Importation And Release Of Investigational Medicinal ProductsDrugsQuality Guidelines (DER)Published
Guidelines For Clinical Trials In Emergencies In NigeriaDrugsClinical Trial (DER)Published
Guidelines For Clinical Trial Protocol DevelopmentDrugsClinical Trial(DER) Published
Guidelines on Variation To a Registered Pharmaceutical Product-26373DrugsVariation Guidelines (R&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 TRIAL IN PAEDIATRIC POPULATIONS DrugsClinical Trial(DER)Published
Biosimilar Guidance DocumentDrugsQuality Guidance Document (R&R)Published
Guidelines For The Registration Of Biosimilars In NigeriaDrugs Local Registration (R&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 the Registration of Imported CosmeticsCosmeticsImport Registration (R&R)Published
Guidelines for the Registration of Imported Drug ProductsDrugsImport Registration (R&R)Published
Guidelines for Registration of Imported Food Products in NigeriaFoodImport Registration (R&R)Published
Guidelines for the Registration of Imported Herbal Remedies, Dietary SupplementsHerbalImport Registration (R&R)Published
Guidelines for the Registration of Imported Medical DevicesMedical DeviceImport Registration (R&R)Published
Guidelines for the Registration of Imported PesticidesChemicalImport Registration (R&R)Published
Gudelines for the Registration of Herbal Remedies and Dietary Supplements made in NigeriaHerbalLocal Registration (R&R)Published
Guidelines for Registration of Medical DevicesMedical DeviceLocal Registration (R&R)Published
Guidelines for the Registration of Cosmetics made in NigeriaCosmeticsLocal Registration (R&R)Published
Guidelines for the Registration of Drugs made in NigeriaDrugs Local Registration (R&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 (R&R)Published
Guidelines for the Inspection of WarehousesVeterinaryWarehouse Inspection (Inspection)Draft
Guidelines for the Inspection of Facilities for Manufacture of Veterinary DrugsVeterinaryGMP Requirement (Inspection)Draft
Guidelines for Listing of Animal Feeds Toll Millers & Requirments for Toll Milling FacilityVeterinaryListing RequirementDraft
Guidelines for Listing of Animal Feed Toll Millers & Requirments for the Toll Milling Facility (Renewal)VeterinaryGMP Requirement (Renewal)Draft
Guidelines for Lisiting as Pesticides, Agrochemicals, Fertilizers, Bio-Fertilizers & Bio-Pesticides Marketers (New Applicant)VeterinaryListing Requirement Draft
Guidelines for Issuance of Permit to Import Field Trial SamplesVeterinaryImport PermitDraft
Guidelines for Issuance of Permit to Import Feed Supplements, Feed Concentrates, Feed Additives, Premixes, Fish Meal (Renewal)VeterinaryImport PermitDraft
Guidelines for Issuance of Permit to Import Feed Supplements, Feed Concentrate, Feed Additivies, Premixes, Fish Meal (New Applicant)VeterinaryImport PermitDraft
Guidelines for Issuance of Permit to Import Bulk Pesticides, Agrochemicals and FertilizersVeterinaryImport PermitDraft
Guidelines for Issuance of Permit to Import Bulk Pesticides, Agrochemicals and Fertilizers (Renewal)VeterinaryImport PermitDraft
Guidelines for Inspection of Local Manufactured Animal Feed, Pet Food & PremixesVeterinaryGMP Requirement (Inspection)Draft
Guidelines for Inspection of Facility for the Manufacture of Veterinary Medicinal Cosmetics in NigeriaVeterinaryGMP Requirement (Inspection)Draft
Guidelines for Inspection of Facilities for the Manufacture of Medicated FeedVeterinaryGMP Requirement (Inspection)Draft
Guidelines for Inspection of Facilities for Manufacture of Veterinary CosmeticsVeterinaryGMP Requirement (Inspection)Draft
Guideline for Listing of Pesticides, Agrochemicals, Fertilizers, Bio-Fertilizer and Bio-Pesticides Marketer (Renewal)VeterinaryListing Requirement Draft
Guidelines for Handling and Disposal of Unwholesome Medicines and Other NAFDAC Regulated ProductsDrugsListing Requirement (I&E)Published
Guidelines for Production Inspection of Small-Scale Food Enterprises (New Applicants)FoodGMP Inspection Requirement (FSAN)Published
Guidelines for Production Inspection of Micro Scale Food Manufacturing Facilities in Nigeria (New Applicants)Food GMP Inspection Requirement (FSAN)Published
Guidelines for Inspection of Facilities for Manufacture of Food ProductsFoodGMP Inspection Requirement (FSAN)Published
Guidelines for Inspection and Requirements for Bread Manufacturing FacilityFoodGMP Inspection Requirement (FSAN)Published
Guidelines for Inspection and Requirements for Packaged Water Facility in NigeriaFoodGMP Inspection Requirement (FSAN)Published
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 Guidelines FinalGeneral 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
Guidelines on Registration Requirement To Establish Interchangeability of Generic Pharmaceutical Products DrugsRegistration Requirement (R&R)Published
NAFDAC GMP Guidelines For Cosmetics ProductsCosmeticsGMP Requirement (DER)Published
Guidelines For Production Inspection Of Large & Medium Scale Cosmetics Manufacturing FacilitiesCosmeticsGMP Inspection (DER) Published
Guidelines For Production Inspection Of Herbal Medicines FacilitiesHerbalGMP Inspection (DER)Published
Guidelines For Pre- Registration Inspection For Pharmaceutical FacilitiesDrugsRegistration (DER)Published
NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021DrugsGMP Inspection (DER)Published
Guidelines For Inspection Of Premises For Global Listing Of CosmeticsCosmeticsGMP Inspection (DER)Published
Guidelines For GSP & GDP Inspection For Vaccines & BiologicsVaccines & BiologicsGSP & GDP Inspection (DER)Published
GUIDELINES FOR CLINICAL TRIAL APPLICATIONDrugsClinical Trial (DER)Published

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