Powered by ZigaForm version 3.9.8.8

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.

S/NTitleProduct TypeCategoryStatus
1Guidelines For Pre-Production Inspection Of Pharmaceutical Manufacturing Facilities In NigeriaDrugsGMP Requirement (DER)Published
2Guidelines For Pre- Registration Inspection Of Pharmaceutical Manufacturing Facilities In NigeriaDrugsGMP Requirement (DER)Published
3Guidelines for Registration of Animal Feed Made in NigeriaVeterinaryLocal Registration (R&R)Published
4Guidelines for Advertisement Control of Food Products in NigeriaFoodAdvert Guidelines (R&R)Published
5Guidelines for Registration of Imported Animal Feed in NigeriaVeterinaryImport Registration (R&R)Published
6Guidelines For Clinical Trial Process TimelinesDrugsClinical Trial (DER)Published
7Guidelines For Submission Of Clinical Trial Progress ReportDrugsClinical Trial (DER)Published
8NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021DrugsGMP Requirement (DER)Published
9NAFDAC Guidelines For Contract Manufacturing Of Finished Pharmaceutical Products In NigeriaDrugsGMP Requirement (DER)Published
10Reviewed NAFDAC Good Distribution Practices Guidelines For Pharmaceutical ProductsGeneralGDP Requirement (PVPMS)Published
11NAFDAC Good Pharmacovigilance Practice GuidelinesGeneralGPP Requirement (PVPMS)Published
12NAFDAC-LS-SG-001-01 SAMPLING GUIDE FOR NAFDAC REGULATED PRODUCTS Rc (1) (2)Regulated ProductsSampling PlanPublished
13Guidance on Regulatory Preparedness for Licensing or Access to COVID-19 VaccinesDrugsLicensing Access to Covid-19 Vaccines(DR&R)Published
14Current Good Manufacturing Practice Guidelines For Food And Food Products (Revised)FoodGMP Requirement (FSAN)Published
15Guidelines And Requirement For Inspection In Food Storage WarehouseFoodGMP Requirement (FSAN)Published
16NAFDAC Guidelines For Food Hygienic Practices (NGFHP)FoodGuidance Document (FSAN)Published
17Guidelines For Importation Of Active Pharmaceutical Ingredients (APIs)DrugsAPI Requirement (DER)
18Guidelines For Complaints And Appeals Against Regulatory Decisions QMS -GLD-001-01-1GeneralConsumer Complaints (QMS)Published
19Guidance Document for the Registration of Alcohol-based Hand Sanitizers Made in NigeriaGeneralGuidance Document (DR&R)
20Guidance to Applicants for Registration of Herbal Medicines Made in NigeriaHerbalGuidance Document (DR&R)
21NAFDAC Guidelines on Good Review PracticeRegulated ProductsQuality Guidelines (DR&R)Published
22Guidelines For Listing Of Chemical Manufacturers In Nigeria (New Applicants)ChemicalListing Requirement (CER)Published
23Guidance Document for Submission of Application in the CTD Format – Vaccines for Human UseDrugsGuidance Document (DR&R)Published
24Guideline For Approval To Import Donated Items By Non-Governmental OrganizationsGeneral Import Permit (PID)Published
25Guideline For Approval To Import Products By Government Agencies, International Bodies & Multinational companiesGeneral Import Permit (PID)Published
26Guideline for Approval To Import Raw material For Machine Trial Or Research PurposeGeneral Import Permit (PID)Published
27Guideline For Authorization To Open Form MGeneral GMP Requirement (PID)Published
28Guideline For Non Objection ApprovalGeneral GMP Requirement (PID)Published
29Guidelines For Complaints ResolutionGeneral Consumer Complaints (Reforms)Published
30NAFDAC Good Cold Chain Management For Vaccines & Biopharm. Products Guidelines 2021General GMP Requirement (DER)Published
31Guidelines on Variations to a Registered Vaccine for HumansGeneral Variation Guidelines (DR&R)Published
32Guidelines for Renewal of Certificate of Registration for Drugs Made in NigeriaDrugsRenewal Registration Requirement (DR&R)Published
33Guidelines for Renewal of Certificate of Registration for Medical Devices Made in NigeriaMedical DevicesRenewal Registration Requirement (DR&R)Published
34Guidelines for Renewal of Herbal Medicines and Dietary Supplements Made in NigeriaHerbalRenewal Registration Requirement (DR&R)Published
35Guidelines for Renewal of Certificate of Registration for Imported Herbal Remedies, Dietary Supplements in NigeriaHerbalRenewal Registration Requirement (DR&R)Published
36Guidelines for the Renewal of Certificate of Registration License for Imported DrugsDrugsRenewal Registration Requirement (R&R)Published
37Guideline for the Renewal of the Certificate of Registration License for Imported Medical DevicesMedical DevicesRenewal Registration Requirement (R&R)Published
38Guidelines For Registration of Imported Drugs Vaccines IVDs Under Collaborative Registration ProcedureDrugsRegistration Requirement (DR&R)Published
39Guidelines For Labeling Of Investigational Medicinal ProductsDrugsGMP Labeling (DER)Published
40Guidelines For Importation And Release Of Investigational Medicinal ProductsDrugsQuality Guidelines (DER)Published
41Guidelines For Conduct Of Clinical Trials During EmergenciesDrugsClinical Trial (DER)Published
42Guidelines For Clinical Trials Protocol DevelopmentDrugsClinical Trial(DER) Published
43NAFDAC Guidelines on Variations to a Registered Pharmaceutical ProductDrugsVariation Guidelines (DR&R)Published
44Guideline for Approval to Import Products by Government Agencies, International Bodies & Multinational OrganizationsGeneral Guidance Document (PID)Published
45Guideline for Form M Online Application 2019General Guidance Document (PID)Published
46Guideline for NOC Online Application 2019General Guidance Document (PID)Published
47Guidelines For Clinical Investigation Of Medicinal Products In Paediatric PopulationDrugsClinical Trial(DER)Published
48Biosimilar Guidance DocumentDrugsQuality Guidance Document (DR&R)Published
49Guidelines for Registration of Biosimilars in NigeriaDrugs Local Registration (DR&R)Published
50Quality Guidelines for Registration of Pharmaceutical Products26381DrugsQuality Guidelines (R&R)Published
51Guidelines for Issuance of Additional Permit to Import Laboratory and Industrial ChemicalsChemicalImport Permit (CER)published
52Guidelines for Issuance of Listing Certificate for Chemical Marketers (New applicants)ChemicalListing Certificate (CER)Published
53Guidelines for Issuance of Permit to Clear for Restricted and Agro ChemicalsChemicalClearance Permit (CER)Published
54Guidelines for Issuance of Permit to Import Laboratory and Industrial ChemicalsChemical Import Permit (CER)Published
55Guidelines for Renewal of Import Permit for Laboratory and Industrial ChemicalsChemical Import Permit Renewal (CER) Published
56Guidelines for the Issuance of Import Permit for Restricted and Agro ChemicalsChemical Import Permit (CER)Published
57Guidelines for the Renewal of Listing Certificate for Chemical MarketersChemicalListing Certificate Renewal (CER)Published
58Guidelines for Warehouse InspectionChemical Warehouse Inspection Requirement (CER)Published
59Guidelines for Obtaining Permit to Clear Narcotic drugs, Psychotropic Substances and Drug Precursors_NarcoticClearance Permit (NCS)Published
60Guidelines for Obtaining Permit to Clear Precursor ChemicalsNarcoticClearance Permit (NCS)Published
61Guidelines for Obtaining Permit to Import Narcotics, Drugs, Psychotropic Substances and Drug PrecursorNarcoticImport Permit (NCS)Published
62Guidelines for Obtaining Permit to Import Precursor ChemicalsNarcoticImport Permit (NCS)Published
63Guidelines for Obtaining Permit to Import Schedule 1 Narcotic DrugsNarcotic Import Permit (NCS)Published
64Guidelines for Warehouse InspectionNarcoticWarehouse Inspection Requirement (NCS)Published
65Guidelines for the Advertisement of NAFDAC Regulated ProductsGeneral Advert Guideline (R&R)Published
66Guidelines for the Registration of Imported Animal FeedsGeneral Import Registration (R&R)Published
67Guidelines for Registration of Imported Cosmetics in NigeriaCosmeticsImport Registration (DR&R)Published
68Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs)DrugsImport Registration (DR&R)Published
69Guidelines for Registration of Imported Food Products in NigeriaFoodImport Registration (R&R)Published
70Guidelines for Registration of Imported Herbal Remedies And Dietary Supplements in NigeriaHerbalImport Registration (DR&R)Published
71Guidelines for Registration of Imported Medical Devices in NigeriaMedical DeviceImport Registration (DR&R)Published
72Guidelines for Registration of Imported Pesticides in NigeriaChemicalImport Registration (DR&R)Published
73Guidelines for Registration of Herbal Medicines and Dietary Supplements Made in NigeriaHerbalLocal Registration (DR&R)Published
74Guidelines for Registration of Medical Devices made in NigeriaMedical DeviceLocal Registration (DR&R)Published
75Guidelines for Registration of Cosmetics Made in NigeriaCosmeticsLocal Registration (DR&R)Published
76Guidelines for Registration of Drug Products Made in Nigeria (Human and Veterinary Drugs)Drugs Local Registration (DR&R)Published
77Guidelines for Registration of Food Products and Packaged Water Made in NigeriaFoodLocal Registration (R&R)Published
78Guidelines for the Registration of Pesticides made in NigeriaChemicalLocal Registration (DR&R)Published
79Guidelines for the Inspection of WarehousesVeterinaryWarehouse Inspection (Inspection)Published
80Guidelines for the Inspection of Facilities for Manufacture of Veterinary DrugsVeterinaryGMP Requirement (Inspection)Published
81Guidelines for Listing of Animal Feed Toll Millers Requirements for the Toll Milling Facility RenewalVeterinaryListing Requirement (Renewal)Published
82Guidelines for Listing of Animal Feeds Toll Millers Requirements for Toll Milling FacilityVeterinaryGMP Requirement Published
83Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer RenewalVeterinaryListing Requirement Published
84Guidelines for Issuance of Permit to Import Field Trial SamplesVeterinaryImport PermitPublished
85Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrates Feed Additives Premixes Fish Meal RenewalVeterinaryImport PermitPublished
86Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrate Feed Additives Premixes Fish Meal New ApplicantVeterinaryImport PermitPublished
87Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and FertilizersVeterinaryImport PermitPublished
88Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and Fertilizers RenewalVeterinaryImport PermitPublished
89Guidelines for Inspection of Local Manufactured Animal Feed Pet Food PremixesVeterinaryGMP Requirement (Inspection)Published
90Guidelines for Inspection of Facility for the Manufacture of Veterinary Medicinal Cosmetics in NigeriaVeterinaryGMP Requirement (Inspection)Published
91Guidelines for Inspection of Facilities for the Manufacture of Medicated FeedVeterinaryGMP Requirement (Inspection)Published
92Guidelines for Inspection of Facilities for Manufacture of Veterinary CosmeticsVeterinaryGMP Requirement (Inspection)Published
93Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer RenewalVeterinaryListing Requirement Published
94Guidelines for Handling and Disposal of Unwholesome Medicines and Other NAFDAC Regulated ProductsDrugsListing Requirement (I&E)Published
95Guidelines for Production Inspection of Small-Scale Food Enterprises (New Applicants)FoodGMP Inspection Requirement (FSAN)Published
96Guidelines for Production Inspection of Micro Scale Food Manufacturing Facilities in Nigeria (New Applicants)Food GMP Inspection Requirement (FSAN)Published
97Guidelines for Inspection of Facilities for Manufacture of Food ProductsFoodGMP Inspection Requirement (FSAN)Published
98Guidelines for Inspection and Requirements for Bread Manufacturing FacilityFoodGMP Inspection Requirement (FSAN)Published
99Guidelines for Inspection and Requirements for Packaged Water Facility in NigeriaFoodGMP Inspection Requirement (FSAN)Published
100Guidelines for Clearance of Imported Donated Items at Ports of Entry in NigeriaGeneral Import Clearance Permit (PID)Published
101Guidelines for Clearing Imported Bulk Food, Animal Feed and Food Raw Materials at the Ports of EntryFoodImport Clearance Permit (PID)Published
102Guidelines for Clearing Imported Controlled Narcotics Substances, Pharm Raw Materials & Restrcited ChemicalsNarcoticsImport Clearance Permit (PID)Published
103Guidelines for Clearing Imported Finished Pharmaceutical, Nutraceutical & Herbal Products (Human & VeterinaryHerbalImport Clearance Permit (PID)Published
104Guidelines for Clearing Imported Regulated Food (Including Global Listing for Supermarket Items & Restuarant OperatorsFood Import Clearance Permit (PID)Published
105Guidelines for Clearing of Cosmetics and Medical DevicesCosmetic, Medical DevicesImport Clearance Permit (PID)Published
106Guidelines for Clearing of Imported General Chemicals and Raw MaterialsChemicalImport Clearance Permit (PID)Published
107Guidelines for Export Approval for NAFDAC Regulated Products and Food Stuff not Pre-packaged for Personal UseFood, Other Regulated ProductsExport PermitPublished
108Guidelines for Fast Track Clearance of Imported Regulated Products and Bulk Raw MaterialsGeneral Import Clearance Permit (PID)Published
109Guidelines for Issuance of Authorization on Letter of No-Objection and Approval to Open Form M & PAARGeneral Import Permit (PID)Published
110Guidelines for Issuance of Export Approval for Samples for Machine TrialsGeneral Export Permit (PID)Published
111Guidelines for the Issuance of Export Certificate for NAFDAC Regulated ProductsGeneral Export Permit (PID)Published
112Guidelines for the Issuance of Health Certificate for Exportation of Processed and Semi-Processed Food CommoditiesFood Export Permit (PID)Published
113Guidelines for Post Marketing Survelliance NigeriaGeneral GMP Requirement (PV/PMS)Published
114NAFDAC MAS GuidelinesGeneral Mobile Authentication Service (PV/PMS)Published
115NAFDAC Guidelines on Good Pharmacovigilance PracticeGeneral GMP Requirement (PV/PMS)Published
116Guidelines for Labelling General GMP Labelling (R&R)Published
117NAFDAC Guideline on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical ProductsDrugsRegistration Requirement (DR&R)Published
118NAFDAC GMP Guidelines For Cosmetics Products 2021 CosmeticsGMP Requirement (DER)Published
119Guidelines For Production Inspection Of Large And Medium Scale Cosmetics Manufacturing FacilitiesCosmeticsGMP Inspection (DER) Published
120Guidelines For Production Inspection Of Herbal Medicines And Nutraceuticals Manufacturing FacilitiesHerbalGMP Inspection (DER)Published
121NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021DrugsGMP Inspection (DER)Published
122Guidelines For Inspection Of Premises For Global Listing Of Cosmetics ProductsCosmeticsGMP Inspection (DER)Published
123Guidelines 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
124Guidelines For Clinical Trial Application In NigeriaDrugsClinical Trial (DER)Published
125Label Guidance For Herbal Medicines And Dietary SupplementHerbal GMP Labelling (DR&R)Published
126Guidelines for the Global Listing of Supermarket Items (GLSI)Regulated ProductsGlobal Listing (DR&R)Published
127Dossier Submission GuideGeneralGuidance Document (DR&R)Published
128Guidelines For Advertisement Of Medical Products, Cosmetics, Veterinary Products And Finished ChemicalsRegulated ProductsGMP Advertisement (DR&R)Published
129Guideline for Donated Medical Products in NigeriaRegulated ProductsGuidance Document (DR&R)Published
130Guideline for Operation of Service Drugs and Orphan Drug SchemeDrugsOperation Guidelines (DR&R)Published
131Guidelines for Renewal of Certificate of Registration for Imported Drug Products in Nigeria (Human & Veterinary Drugs)Regulated ProductsRenewal Registration Requirement (DR&R)Published
132Guidelines For The Preparation Of Product Dossiers` In The Common Technical Document (CTD) Format Quality PartGeneralQuality Guidance Document (DR&R)Published
133Guidance on Master Data Attributes for Pharmaceutical Products DGO-GDL-001-00DrugsTraceabilityPublished

Was this post helpful?