** NAFDAC joins the Federal Ministry of Health and Social Welfare, nutrition partners, and the rest of the world in celebrating World Breastfeeding Week 2024 from 1st to 7th August. The theme for this year is ' Closing the gap: Breastfeeding Support for All'. Let us all join hands to protect, promote, and support breastfeeding. Happy World Breastfeeding Week! ** 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
** NAFDAC joins the Federal Ministry of Health and Social Welfare, nutrition partners, and the rest of the world in celebrating World Breastfeeding Week 2024 from 1st to 7th August. The theme for this year is ' Closing the gap: Breastfeeding Support for All'. Let us all join hands to protect, promote, and support breastfeeding. Happy World Breastfeeding Week! ** 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
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.
| Title | Product Type | Category | Status |
|---|---|---|---|
| NAFDAC Laboratory Sampling Guide 2023 | Regulated Products | Sampling Plan | Published |
| Guidelines For Issuance Of Additional Permit (New Items Or Quantities) To Import Industrial And Laboratory Chemicals | Chemical | Import Permit (CER) | Published |
| Guidelines For Issuance Of Permit To Import Severely Restricted Chemicals (Pesticides, Agrochemicals And Fertilizers) | Chemical | Import Permit (CER) | Published |
| Guidelines For Labeling Of Chemicals Manufactured In Nigeria | Chemical | GMP Requirement Labeling (CER) | Published |
| Guidelines For Obtaining Listing Certificate For Chemical Marketers (New Applicants) | Chemical | Listing Certificate New Applicants (CER) | Published |
| Guidelines For Obtaining Permit To Import Industrial And Laboratory Chemicals (New Applicants) | Chemical | Import Permit New Applicants (CER) | Published |
| Guidelines For Renewal Of Listing Certificate For Chemical Marketers | Chemical | Listing Certificate Renewal (CER) | Published |
| Guidelines For Renewal Of Permit To Import Industrial And Laboratory Chemicals | Chemical | Import Permit Renewal (CER) | Published |
| Guidelines For Warehouse Inspection | General | GMP Requirement (CER) | Published |
| Permit For Clearance Of Imported Severely Restricted Chemicals (Pesticides, Agrochemicals And Fertilizers) | Chemical | Import Permit (CER) | Published |
| Guidelines for Inspection and Requirements for Bread Manufacturing Facility-1.pdf | Food | GMP Requirement (FSAN) | Uncontrolled |
| Guidelines for inspection & requirements for packaged water facility in Nigeria Fresh application | Food | GMP Requirement (FSAN) | Uncontrolled |
| Reviewed NAFDAC Good Distribution Practices Guidelines For Pharmaceutical Products 2023 | General | GDP Requirement (PVPMS) | Published |
| Guidelines for Inspection & Requirements for Pre-Packaged Food Manufacturing Packaging Facilities in Nigeria | Food | GMP Requirement (FSAN) | Uncontrolled |
| Guidelines for Registration of Packaged Edible Vegetable Oil by Dispensers Under Micro Scale in Nigeria | Food | Registration Requirement (FSAN) | Uncontrolled |
| Guideline for Renewal of Certificate of Registration for Drug Products (Human and Veterinary Drugs) DR&R-GDL-025-02 | Regulated Product | Renewal Registration Requirement (DR&R) | Published |
| Guidelines for the Preparation of Summary of Product Characteristics (SmPC) for drug products in Nigeria | Drugs | SMPC Guidelines | Published |
| Patient Information Listing (PIL) Review Checklist | Drugs | PIL Checklist | Published |
| SMPC Review Checklist | Drugs | SMPC Checklist | Published |
| Guideline For Lot Release Of Human Vaccines And Other Biologicals 2023 | Vaccines, Biologics & Medical Devices | Lot release (VBM-LSD) | Published |
| Guidance Document on Chemistry, Manufacturing, Control (CMC) And Lot Release For Finished Vaccine Or Biological Medicinal Product | Vaccines, Biologics & Medical Devices | Lot release (VBM-LSD) | Published |
| Guidelines For Change In Formulation Of Food And Feed Products | Food | GMP Requirement (FR&R) | |
| Guidelines For The Registration Of Bulk/Semi Processed Food Product For Export | Food | Export Registration (FR&R) | Uncontrolled |
| Guideline For Production Inspection Of Chemical Manf Facilities.pdf | Chemical | Guidance Document (CER) | Published |
| GMP Guidelines For Chemical And Chemical Products.pdf | Chemical | GMP Requirement (CER) | Published |
| GMP Guidelines For Herbal Medicinal Products 2022 | Herbal | Guidance Document (DER) | Uncontrolled |
| Guidelines For Pre-Production Inspection Of Pharmaceutical Manufacturing Facilities In Nigeria | Drugs | GMP Requirement (DER) | Published |
| Guidelines For Pre- Registration Inspection Of Pharmaceutical Manufacturing Facilities In Nigeria | Drugs | GMP Requirement (DER) | Published |
| Guidelines for Registration of Animal Feed Made in Nigeria | Veterinary | Local Registration (R&R) | Published |
| Guidelines for Advertisement Control of Food Products in Nigeria | Food | Advert Guidelines (R&R) | Published |
| Guidelines for Registration of Imported Animal Feed in Nigeria | Veterinary | Import Registration (R&R) | Published |
| Guidelines For Clinical Trial Process Timelines | Drugs | Clinical Trial (DER) | Published |
| Guidelines For Submission Of Clinical Trial Progress Report | Drugs | Clinical Trial (DER) | Published |
| NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021 | Drugs | GMP Requirement (DER) | Published |
| NAFDAC Guidelines For Contract Manufacturing Of Finished Pharmaceutical Products In Nigeria | Drugs | GMP Requirement (DER) | Published |
| NAFDAC Good Pharmacovigilance Practice Guidelines | General | GPP Requirement (PVPMS) | Published |
| Guidance on Regulatory Preparedness for Licensing or Access to COVID-19 Vaccines | Drugs | Licensing Access to Covid-19 Vaccines(DR&R) | Published |
| Current Good Manufacturing Practice Guidelines For Food And Food Products (Revised) | Food | GMP Requirement (FSAN) | Published |
| Guidelines And Requirement For Inspection In Food Storage Warehouse | Food | GMP Requirement (FSAN) | Published |
| NAFDAC Guidelines For Food Hygienic Practices (NGFHP) | Food | Guidance Document (FSAN) | Published |
| Guidelines For Importation Of Active Pharmaceutical Ingredients (APIs) | Drugs | API Requirement (DER) | |
| Guidelines For Complaints And Appeals Against Regulatory Decisions QMS -GLD-001-01-1 | General | Consumer Complaints (QMS) | Published |
| Guidance Document for the Registration of Alcohol-based Hand Sanitizers Made in Nigeria | General | Guidance Document (DR&R) | |
| Guidance to Applicants for Registration of Herbal Medicines Made in Nigeria | Herbal | Guidance Document (DR&R) | |
| NAFDAC Guidelines on Good Review Practice | Regulated Products | Quality Guidelines (DR&R) | Published |
| Guidelines For Listing Of Chemical Manufacturers In Nigeria (New Applicants) | Chemical | Listing Requirement (CER) | Published |
| Guidance Document for Submission of Application in the CTD Format – Vaccines for Human Use | Drugs | Guidance 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 companies | General | Import Permit (PID) | Published |
| Guideline for Approval To Import Raw material For Machine Trial Or Research Purpose | General | Import Permit (PID) | Published |
| Guideline For Authorization To Open Form M | General | GMP Requirement (PID) | Published |
| Guideline For Non Objection Approval | General | GMP Requirement (PID) | Published |
| Guidelines For Complaints Resolution | General | Consumer Complaints (Reforms) | Published |
| NAFDAC Good Cold Chain Management For Vaccines & Biopharm. Products Guidelines 2021 | General | GMP Requirement (DER) | Published |
| Guidelines on Variations to a Registered Vaccine for Humans | General | Variation Guidelines (DR&R) | Published |
| Guidelines for Renewal of Certificate of Registration for Medical Devices Made in Nigeria | Medical Devices | Renewal Registration Requirement (DR&R) | Published |
| Guidelines for Renewal of Herbal Medicines and Dietary Supplements Made in Nigeria | Herbal | Renewal Registration Requirement (DR&R) | Published |
| Guidelines for Renewal of Certificate of Registration for Imported Herbal Remedies, Dietary Supplements in Nigeria | Herbal | Renewal Registration Requirement (DR&R) | Published |
| Guideline for the Renewal of the Certificate of Registration License for Imported Medical Devices | Medical Devices | Renewal Registration Requirement (R&R) | Published |
| Guidelines For Registration of Imported Drugs Vaccines IVDs Under Collaborative Registration Procedure | Drugs | Registration Requirement (DR&R) | Published |
| Guidelines For Labeling Of Investigational Medicinal Products | Drugs | GMP Labeling (DER) | Published |
| Guidelines For Importation And Release Of Investigational Medicinal Products | Drugs | Quality Guidelines (DER) | Published |
| Guidelines For Conduct Of Clinical Trials During Emergencies | Drugs | Clinical Trial (DER) | Published |
| Guidelines For Clinical Trials Protocol Development | Drugs | Clinical Trial(DER) | Published |
| NAFDAC Guidelines on Variations to a Registered Pharmaceutical Product | Drugs | Variation Guidelines (DR&R) | Published |
| Guideline for Approval to Import Products by Government Agencies, International Bodies & Multinational Organizations | General | Guidance Document (PID) | Published |
| Guideline for Form M Online Application 2019 | General | Guidance Document (PID) | Published |
| Guideline for NOC Online Application 2019 | General | Guidance Document (PID) | Published |
| Guidelines For Clinical Investigation Of Medicinal Products In Paediatric Population | Drugs | Clinical Trial(DER) | Published |
| Biosimilar Guidance Document | Drugs | Quality Guidance Document (DR&R) | Published |
| Guidelines for Registration of Biosimilars in Nigeria | Drugs | Local Registration (DR&R) | Published |
| Quality Guidelines for Registration of Pharmaceutical Products26381 | Drugs | Quality Guidelines (R&R) | Published |
| Guidelines for Issuance of Additional Permit to Import Laboratory and Industrial Chemicals | Chemical | Import Permit (CER) | published |
| Guidelines for Issuance of Listing Certificate for Chemical Marketers (New applicants) | Chemical | Listing Certificate (CER) | Published |
| Guidelines for Issuance of Permit to Clear for Restricted and Agro Chemicals | Chemical | Clearance Permit (CER) | Published |
| Guidelines for Issuance of Permit to Import Laboratory and Industrial Chemicals | Chemical | Import Permit (CER) | Published |
| Guidelines for Renewal of Import Permit for Laboratory and Industrial Chemicals | Chemical | Import Permit Renewal (CER) | Published |
| Guidelines for the Issuance of Import Permit for Restricted and Agro Chemicals | Chemical | Import Permit (CER) | Published |
| Guidelines for the Renewal of Listing Certificate for Chemical Marketers | Chemical | Listing Certificate Renewal (CER) | Published |
| Guidelines for Warehouse Inspection | Chemical | Warehouse Inspection Requirement (CER) | Published |
| Guidelines for Obtaining Permit to Clear Narcotic drugs, Psychotropic Substances and Drug Precursors_ | Narcotic | Clearance Permit (NCS) | Published |
| Guidelines for Obtaining Permit to Clear Precursor Chemicals | Narcotic | Clearance Permit (NCS) | Published |
| Guidelines for Obtaining Permit to Import Narcotics, Drugs, Psychotropic Substances and Drug Precursor | Narcotic | Import Permit (NCS) | Published |
| Guidelines for Obtaining Permit to Import Precursor Chemicals | Narcotic | Import Permit (NCS) | Published |
| Guidelines for Obtaining Permit to Import Schedule 1 Narcotic Drugs | Narcotic | Import Permit (NCS) | Published |
| Guidelines for Warehouse Inspection | Narcotic | Warehouse Inspection Requirement (NCS) | Published |
| Guidelines for the Advertisement of NAFDAC Regulated Products | General | Advert Guideline (R&R) | Published |
| Guidelines for the Registration of Imported Animal Feeds | General | Import Registration (R&R) | Published |
| Guidelines for Registration of Imported Cosmetics in Nigeria | Cosmetics | Import Registration (DR&R) | Published |
| Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs) | Drugs | Import Registration (DR&R) | Published |
| Guidelines for Registration of Imported Food Products in Nigeria | Food | Import Registration (R&R) | Published |
| Guidelines for Registration of Imported Herbal Remedies And Dietary Supplements in Nigeria | Herbal | Import Registration (DR&R) | Published |
| Guidelines for Registration of Imported Medical Devices in Nigeria | Medical Device | Import Registration (DR&R) | Published |
| Guidelines for Registration of Imported Pesticides in Nigeria | Chemical | Import Registration (DR&R) | Published |
| Guidelines for Registration of Herbal Medicines and Dietary Supplements Made in Nigeria | Herbal | Local Registration (DR&R) | Published |
| Guidelines for Registration of Medical Devices made in Nigeria | Medical Device | Local Registration (DR&R) | Published |
| Guidelines for Registration of Cosmetics Made in Nigeria | Cosmetics | Local 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 Nigeria | Food | Local Registration (R&R) | Published |
| Guidelines for the Registration of Pesticides made in Nigeria | Chemical | Local Registration (DR&R) | Published |
| Guidelines for the Inspection of Warehouses | Veterinary | Warehouse Inspection (Inspection) | Published |
| Guidelines for the Inspection of Facilities for Manufacture of Veterinary Drugs | Veterinary | GMP Requirement (Inspection) | Published |
| Guidelines for Listing of Animal Feed Toll Millers Requirements for the Toll Milling Facility Renewal | Veterinary | Listing Requirement (Renewal) | Published |
| Guidelines for Listing of Animal Feeds Toll Millers Requirements for Toll Milling Facility | Veterinary | GMP Requirement | Published |
| Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer Renewal | Veterinary | Listing Requirement | Published |
| Guidelines for Issuance of Permit to Import Field Trial Samples | Veterinary | Import Permit | Published |
| Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrates Feed Additives Premixes Fish Meal Renewal | Veterinary | Import Permit | Published |
| Guidelines for Issuance of Permit to Import Feed Supplements Feed Concentrate Feed Additives Premixes Fish Meal New Applicant | Veterinary | Import Permit | Published |
| Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and Fertilizers | Veterinary | Import Permit | Published |
| Guidelines for Issuance of Permit to Import Bulk Pesticides Agrochemicals and Fertilizers Renewal | Veterinary | Import Permit | Published |
| Guidelines for Inspection of Local Manufactured Animal Feed Pet Food Premixes | Veterinary | GMP Requirement (Inspection) | Published |
| Guidelines for Inspection of Facility for the Manufacture of Veterinary Medicinal Cosmetics in Nigeria | Veterinary | GMP Requirement (Inspection) | Published |
| Guidelines for Inspection of Facilities for the Manufacture of Medicated Feed | Veterinary | GMP Requirement (Inspection) | Published |
| Guidelines for Inspection of Facilities for Manufacture of Veterinary Cosmetics | Veterinary | GMP Requirement (Inspection) | Published |
| Guideline for Listing of Pesticides Agrochemicals Fertilizers Bio Fertilizer and Bio Pesticides Marketer Renewal | Veterinary | Listing Requirement | Published |
| Guidelines for Handling and Disposal of Unwholesome Medicines and Other NAFDAC Regulated Products | Drugs | Listing Requirement (I&E) | Published |
| Guidelines for Production Inspection of Small-Scale Food Enterprises (New Applicants) | Food | GMP 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 Products | Food | GMP Inspection Requirement (FSAN) | Published |
| Guidelines for Inspection and Requirements for Bread Manufacturing Facility | Food | GMP Inspection Requirement (FSAN) | Published |
| Guidelines for Inspection and Requirements for Packaged Water Facility in Nigeria | Food | GMP Inspection Requirement (FSAN) | Published |
| Guidelines for Clearance of Imported Donated Items at Ports of Entry in Nigeria | General | Import Clearance Permit (PID) | Published |
| Guidelines for Clearing Imported Bulk Food, Animal Feed and Food Raw Materials at the Ports of Entry | Food | Import Clearance Permit (PID) | Published |
| Guidelines for Clearing Imported Controlled Narcotics Substances, Pharm Raw Materials & Restrcited Chemicals | Narcotics | Import Clearance Permit (PID) | Published |
| Guidelines for Clearing Imported Finished Pharmaceutical, Nutraceutical & Herbal Products (Human & Veterinary | Herbal | Import Clearance Permit (PID) | Published |
| Guidelines for Clearing Imported Regulated Food (Including Global Listing for Supermarket Items & Restuarant Operators | Food | Import Clearance Permit (PID) | Published |
| Guidelines for Clearing of Cosmetics and Medical Devices | Cosmetic, Medical Devices | Import Clearance Permit (PID) | Published |
| Guidelines for Clearing of Imported General Chemicals and Raw Materials | Chemical | Import Clearance Permit (PID) | Published |
| Guidelines for Export Approval for NAFDAC Regulated Products and Food Stuff not Pre-packaged for Personal Use | Food, Other Regulated Products | Export Permit | Published |
| Guidelines for Fast Track Clearance of Imported Regulated Products and Bulk Raw Materials | General | Import Clearance Permit (PID) | Published |
| Guidelines for Issuance of Authorization on Letter of No-Objection and Approval to Open Form M & PAAR | General | Import Permit (PID) | Published |
| Guidelines for Issuance of Export Approval for Samples for Machine Trials | General | Export Permit (PID) | Published |
| Guidelines for the Issuance of Export Certificate for NAFDAC Regulated Products | General | Export Permit (PID) | Published |
| Guidelines for the Issuance of Health Certificate for Exportation of Processed and Semi-Processed Food Commodities | Food | Export Permit (PID) | Published |
| Guidelines for Post Marketing Survelliance Nigeria | General | GMP Requirement (PV/PMS) | Published |
| NAFDAC MAS Guidelines | General | Mobile Authentication Service (PV/PMS) | Published |
| NAFDAC Guidelines on Good Pharmacovigilance Practice | General | 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 Products | Drugs | Registration Requirement (DR&R) | Published |
| NAFDAC GMP Guidelines For Cosmetics Products 2021 | Cosmetics | GMP Requirement (DER) | Published |
| Guidelines For Production Inspection Of Large And Medium Scale Cosmetics Manufacturing Facilities | Cosmetics | GMP Inspection (DER) | Published |
| Guidelines For Production Inspection Of Herbal Medicines And Nutraceuticals Manufacturing Facilities | Herbal | GMP Inspection (DER) | Published |
| NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021 | Drugs | GMP Inspection (DER) | Published |
| Guidelines For Inspection Of Premises For Global Listing Of Cosmetics Products | Cosmetics | GMP Inspection (DER) | Published |
| Guidelines For Good Storage Practice (GSP) And Good Distribution Practice (GDP) Inspection Of Cold Chain Facilities For Storage Of Vaccines & Biologics | Vaccines & Biologics | GSP & GDP Inspection (DER) | Published |
| Guidelines For Clinical Trial Application In Nigeria | Drugs | Clinical Trial (DER) | Published |
| Label Guidance For Herbal Medicines And Dietary Supplement | Herbal | GMP Labelling (DR&R) | Published |
| Guidelines for the Global Listing of Supermarket Items (GLSI) | Regulated Products | Global Listing (DR&R) | Published |
| Dossier Submission Guide | General | Guidance Document (DR&R) | Published |
| Guidelines For Advertisement Of Medical Products, Cosmetics, Veterinary Products And Finished Chemicals | Regulated Products | GMP Advertisement (DR&R) | Published |
| Guideline for Donated Medical Products in Nigeria | Regulated Products | Guidance Document (DR&R) | Published |
| Guideline for Operation of Service Drugs and Orphan Drug Scheme | Drugs | Operation Guidelines (DR&R) | Published |
| Guidelines for Renewal of Certificate of Registration for Imported Drug Products in Nigeria (Human & Veterinary Drugs) | Regulated Products | Renewal Registration Requirement (DR&R) | Published |
| Guidelines For The Preparation Of Product Dossiers` In The Common Technical Document (CTD) Format Quality Part | General | Quality Guidance Document (DR&R) | Published |
| Guidance on Master Data Attributes for Pharmaceutical Products DGO-GDL-001-00 | Drugs | Traceability | Published |