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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.

S/NTitleProduct TypeCategoryStatus
1Guidelines for Registration of Animal Feed Made in NigeriaVeterinaryLocal Registration (R&R)Published
2Guidelines for Advertisement Control of Food Products in NigeriaFoodAdvert Guidelines (R&R)Published
3Guidelines for Registration of Imported Animal Feed in NigeriaVeterinaryImport Registration (R&R)Published
4Guidelines For Clinical Trial Process TimelinesDrugsClinical Trial (DER)Published
5Guidelines For Submission Of Clinical Trial Progress ReportDrugsClinical Trial (DER)Published
6NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021DrugsGMP Requirement (DER)Published
7NAFDAC Guidelines For Contract Manufacturing Of Finished Pharmaceutical Products In NigeriaDrugsGMP Requirement (DER)Published
8 NAFDAC Good Distribution Practices Guidelines For Pharmaceutical ProductsGeneralGDP Requirement (PVPMS)Published
9NAFDAC Good Pharmacovigilance Practice GuidelinesGeneralGPP Requirement (PVPMS)Published
10NAFDAC Sampling Guide 2019GeneralSampling Plan
11Guidance Document on Covid 19 Vaccine PreparednessDrugsLicensing Access to Covid-19 Vaccines(R&R)Published
12 Current Good Manufacturing Practice Guidelines For Food And Food ProductsFoodGMP Requirement (FSAN)Published
13Guidelines And Requirement For Inspection In Food Storage WarehouseFoodGMP Requirement (FSAN)Published
14Food Hygiene GuidelinesFoodGuidance Document (FSAN)Published
15Guidelines For Importation Of Active Pharmaceutical Ingredients (APIs)DrugsAPI Requirement (DER)
16Guidelines For Complaints And Appeals Against Regulatory Decisions QMS -GLD-001-01-1GeneralConsumer Complaints (QMS)Published
17Guidance Document For The Registration Of Alcohol Based Hand Sanitizers Made In NigeriaGeneralGuidance Document (R&R)
18Guidance To Applicants For Registration Of Herbal Medicines Made In NigeriaHerbalGuidance Document
19NAFDAC Good Review Practice (GRevP) Guideline Regulated ProductsQuality Guidelines (R&R)Published
20Guidelines For Listing Of Chemical Manufacturers In Nigeria (New Applicants)ChemicalListing Requirement (CER)Published
21Guidance Document for Submission of Application in CTD Format - Vaccines for Human UseDrugsGMP Requirement (R&R)Published
22Guideline For Approval To Import Donated Items By Non-Governmental OrganizationsGeneral Import Permit (PID)Published
23Guideline For Approval To Import Products By Government Agencies, International Bodies & Multinational companiesGeneral Import Permit (PID)Published
24Guideline for Approval To Import Raw material For Machine Trial Or Research PurposeGeneral Import Permit (PID)Published
25Guideline For Authorization To Open Form MGeneral GMP Requirement (PID)Published
26Guideline For Non Objection ApprovalGeneral GMP Requirement (PID)Published
27Guidelines For Complaints ResolutionGeneral Consumer Complaints (Reforms)Published
28Guidelines for complaints appeal QMS-GLD-001-00General Consumer Complaints (Reforms)Published
29NAFDAC Good Cold Chain Management For Vaccines Biopharm. Products Guidelines 2019General GMP Requirement (DER)Published
30NAFDAC Guidelines on Variations to a Registered Vaccine for Humans-1General Variation Guidelines (R&R)Published
31Guidelines for the Renewal of Certificate of Registration for Drug Products made in NigeriaDrugsRenewal Registration Requirement (R&R)Published
32Guidelines for the Renewal of Certificate of Registration License for Medical Devices made in NigeriaMedical DevicesRenewal Registration Requirement (R&R)Published
33Guidelines for the Renewal of Certificate of Registration of Herbal Remedies and Dietary Supplements made in NigeriaHerbalRenewal Registration Requirement (R&R)Published
34Guidelines for the Renewal of Certificate of Registration License for Imported Herbal Remedies and Dietary SupplementsHerbalRenewal Registration Requirement (R&R)Published
35Guidelines for the Renewal of Certificate of Registration License for Imported DrugsDrugsRenewal Registration Requirement (R&R)Published
36Guideline for the Renewal of the Certificate of Registration License for Imported Medical DevicesMedical DevicesRenewal Registration Requirement (R&R)Published
37Guidelines for Registration of Drugs Vaccines IVDs Under Collaborative Registration ProcedureDrugsRegistration Requirement (R&R)Published
38Guidelines For Labeling Of Investigational Medicinal Products - Rev. 01DrugsGMP Labeling (DER)Published
39Guidelines For Importation And Release Of Investigational Medicinal ProductsDrugsQuality Guidelines (DER)Published
40Guidelines For Clinical Trials In Emergencies In NigeriaDrugsClinical Trial (DER)Published
41Guidelines For Clinical Trial Protocol DevelopmentDrugsClinical Trial(DER) Published
42Guidelines on Variation To a Registered Pharmaceutical Product-26373DrugsVariation Guidelines (R&R)Published
43Guideline for Approval to Import Products by Government Agencies, International Bodies & Multinational OrganizationsGeneral Guidance Document (PID)Published
44Guideline for Form M Online Application 2019General Guidance Document (PID)Published
45Guideline for NOC Online Application 2019General Guidance Document (PID)Published
46GUIDELINES FOR CLINICAL TRIAL IN PAEDIATRIC POPULATIONS DrugsClinical Trial(DER)Published
47Biosimilar Guidance DocumentDrugsQuality Guidance Document (R&R)Published
48Guidelines For The Registration Of Biosimilars In NigeriaDrugs Local Registration (R&R)Published
49Quality Guidelines for Registration of Pharmaceutical Products26381DrugsQuality Guidelines (R&R)Published
50Guidelines for Issuance of Additional Permit to Import Laboratory and Industrial ChemicalsChemicalImport Permit (CER)published
51Guidelines for Issuance of Listing Certificate for Chemical Marketers (New applicants)ChemicalListing Certificate (CER)Published
52Guidelines for Issuance of Permit to Clear for Restricted and Agro ChemicalsChemicalClearance Permit (CER)Published
53Guidelines for Issuance of Permit to Import Laboratory and Industrial ChemicalsChemical Import Permit (CER)Published
54Guidelines for Renewal of Import Permit for Laboratory and Industrial ChemicalsChemical Import Permit Renewal (CER) Published
55Guidelines for the Issuance of Import Permit for Restricted and Agro ChemicalsChemical Import Permit (CER)Published
56Guidelines for the Renewal of Listing Certificate for Chemical MarketersChemicalListing Certificate Renewal (CER)Published
57Guidelines for Warehouse InspectionChemical Warehouse Inspection Requirement (CER)Published
58Guidelines for Obtaining Permit to Clear Narcotic drugs, Psychotropic Substances and Drug Precursors_NarcoticClearance Permit (NCS)Published
59Guidelines for Obtaining Permit to Clear Precursor ChemicalsNarcoticClearance Permit (NCS)Published
60Guidelines for Obtaining Permit to Import Narcotics, Drugs, Psychotropic Substances and Drug PrecursorNarcoticImport Permit (NCS)Published
61Guidelines for Obtaining Permit to Import Precursor ChemicalsNarcoticImport Permit (NCS)Published
62Guidelines for Obtaining Permit to Import Schedule 1 Narcotic DrugsNarcotic Import Permit (NCS)Published
63Guidelines for Warehouse InspectionNarcoticWarehouse Inspection Requirement (NCS)Published
64Guidelines for the Advertisement of NAFDAC Regulated ProductsGeneral Advert Guideline (R&R)Published
65Guidelines for the Registration of Imported Animal FeedsGeneral Import Registration (R&R)Published
66Guidelines for the Registration of Imported CosmeticsCosmeticsImport Registration (R&R)Published
67Guidelines for the Registration of Imported Drug ProductsDrugsImport Registration (R&R)Published
68Guidelines for Registration of Imported Food Products in NigeriaFoodImport Registration (R&R)Published
69Guidelines for the Registration of Imported Herbal Remedies, Dietary SupplementsHerbalImport Registration (R&R)Published
70Guidelines for the Registration of Imported Medical DevicesMedical DeviceImport Registration (R&R)Published
71Guidelines for the Registration of Imported PesticidesChemicalImport Registration (R&R)Published
72Gudelines for the Registration of Herbal Remedies and Dietary Supplements made in NigeriaHerbalLocal Registration (R&R)Published
73Guidelines for Registration of Medical DevicesMedical DeviceLocal Registration (R&R)Published
74Guidelines for the Registration of Cosmetics made in NigeriaCosmeticsLocal Registration (R&R)Published
75Guidelines for the Registration of Drugs made in NigeriaDrugs Local Registration (R&R)Published
76Guidelines for Registration of Food Products and Packaged Water Made in NigeriaFoodLocal Registration (R&R)Published
77Guidelines for the Registration of Pesticides made in NigeriaChemicalLocal Registration (R&R)Published
78Guidelines for the Inspection of WarehousesVeterinaryWarehouse Inspection (Inspection)Draft
79Guidelines for the Inspection of Facilities for Manufacture of Veterinary DrugsVeterinaryGMP Requirement (Inspection)Draft
80Guidelines for Listing of Animal Feeds Toll Millers & Requirments for Toll Milling FacilityVeterinaryListing RequirementDraft
81Guidelines for Listing of Animal Feed Toll Millers & Requirments for the Toll Milling Facility (Renewal)VeterinaryGMP Requirement (Renewal)Draft
82Guidelines for Lisiting as Pesticides, Agrochemicals, Fertilizers, Bio-Fertilizers & Bio-Pesticides Marketers (New Applicant)VeterinaryListing Requirement Draft
83Guidelines for Issuance of Permit to Import Field Trial SamplesVeterinaryImport PermitDraft
84Guidelines for Issuance of Permit to Import Feed Supplements, Feed Concentrates, Feed Additives, Premixes, Fish Meal (Renewal)VeterinaryImport PermitDraft
85Guidelines for Issuance of Permit to Import Feed Supplements, Feed Concentrate, Feed Additivies, Premixes, Fish Meal (New Applicant)VeterinaryImport PermitDraft
86Guidelines for Issuance of Permit to Import Bulk Pesticides, Agrochemicals and FertilizersVeterinaryImport PermitDraft
87Guidelines for Issuance of Permit to Import Bulk Pesticides, Agrochemicals and Fertilizers (Renewal)VeterinaryImport PermitDraft
88Guidelines for Inspection of Local Manufactured Animal Feed, Pet Food & PremixesVeterinaryGMP Requirement (Inspection)Draft
89Guidelines for Inspection of Facility for the Manufacture of Veterinary Medicinal Cosmetics in NigeriaVeterinaryGMP Requirement (Inspection)Draft
90Guidelines for Inspection of Facilities for the Manufacture of Medicated FeedVeterinaryGMP Requirement (Inspection)Draft
91Guidelines for Inspection of Facilities for Manufacture of Veterinary CosmeticsVeterinaryGMP Requirement (Inspection)Draft
92Guideline for Listing of Pesticides, Agrochemicals, Fertilizers, Bio-Fertilizer and Bio-Pesticides Marketer (Renewal)VeterinaryListing Requirement Draft
93Guidelines for Handling and Disposal of Unwholesome Medicines and Other NAFDAC Regulated ProductsDrugsListing Requirement (I&E)Published
94Guidelines for Production Inspection of Small-Scale Food Enterprises (New Applicants)FoodGMP Inspection Requirement (FSAN)Published
95Guidelines for Production Inspection of Micro Scale Food Manufacturing Facilities in Nigeria (New Applicants)Food GMP Inspection Requirement (FSAN)Published
96Guidelines for Inspection of Facilities for Manufacture of Food ProductsFoodGMP Inspection Requirement (FSAN)Published
97Guidelines for Inspection and Requirements for Bread Manufacturing FacilityFoodGMP Inspection Requirement (FSAN)Published
98Guidelines for Inspection and Requirements for Packaged Water Facility in NigeriaFoodGMP Inspection Requirement (FSAN)Published
99Guidelines for Clearance of Imported Donated Items at Ports of Entry in NigeriaGeneral Import Clearance Permit (PID)Published
100Guidelines for Clearing Imported Bulk Food, Animal Feed and Food Raw Materials at the Ports of EntryFoodImport Clearance Permit (PID)Published
101Guidelines for Clearing Imported Controlled Narcotics Substances, Pharm Raw Materials & Restrcited ChemicalsNarcoticsImport Clearance Permit (PID)Published
102Guidelines for Clearing Imported Finished Pharmaceutical, Nutraceutical & Herbal Products (Human & VeterinaryHerbalImport Clearance Permit (PID)Published
103Guidelines for Clearing Imported Regulated Food (Including Global Listing for Supermarket Items & Restuarant OperatorsFood Import Clearance Permit (PID)Published
104Guidelines for Clearing of Cosmetics and Medical DevicesCosmetic, Medical DevicesImport Clearance Permit (PID)Published
105Guidelines for Clearing of Imported General Chemicals and Raw MaterialsChemicalImport Clearance Permit (PID)Published
106Guidelines for Export Approval for NAFDAC Regulated Products and Food Stuff not Pre-packaged for Personal UseFood, Other Regulated ProductsExport PermitPublished
107Guidelines for Fast Track Clearance of Imported Regulated Products and Bulk Raw MaterialsGeneral Import Clearance Permit (PID)Published
108Guidelines for Issuance of Authorization on Letter of No-Objection and Approval to Open Form M & PAARGeneral Import Permit (PID)Published
109Guidelines for Issuance of Export Approval for Samples for Machine TrialsGeneral Export Permit (PID)Published
110Guidelines for the Issuance of Export Certificate for NAFDAC Regulated ProductsGeneral Export Permit (PID)Published
111Guidelines for the Issuance of Health Certificate for Exportation of Processed and Semi-Processed Food CommoditiesFood Export Permit (PID)Published
112Guidelines for Post Marketing Survelliance NigeriaGeneral GMP Requirement (PV/PMS)Published
113NAFDAC MAS Guidelines FinalGeneral Mobile Authentication Service (PV/PMS)Published
114NAFDAC Guidelines on Good Pharmacovigilance PracticeGeneral GMP Requirement (PV/PMS)Published
115Guidelines for Labelling General GMP Labelling (R&R)Published
116Guidelines on Registration Requirement To Establish Interchangeability of Generic Pharmaceutical Products DrugsRegistration Requirement (R&R)Published
117NAFDAC GMP Guidelines For Cosmetics ProductsCosmeticsGMP Requirement (DER)Published
118Guidelines For Production Inspection Of Large & Medium Scale Cosmetics Manufacturing FacilitiesCosmeticsGMP Inspection (DER) Published
119Guidelines For Production Inspection Of Herbal Medicines FacilitiesHerbalGMP Inspection (DER)Published
120Guidelines For Pre- Registration Inspection For Pharmaceutical FacilitiesDrugsRegistration (DER)Published
121NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021DrugsGMP Inspection (DER)Published
122Guidelines For Inspection Of Premises For Global Listing Of CosmeticsCosmeticsGMP Inspection (DER)Published
123Guidelines For GSP & GDP Inspection For Vaccines & BiologicsVaccines & BiologicsGSP & GDP Inspection (DER)Published
124GUIDELINES FOR CLINICAL TRIAL APPLICATIONDrugsClinical Trial (DER)Published

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