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NAFDAC GUIDANCE DOCUMENTS

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[PDF copies of the Following standards are available as well as regulatory compliance services connected with them – for a fee. Email lawnigeria@gmail.com & treentrees@gmail.com or info@lawnigeria.com. Or call/text +234 70 6710 2097. ]

 

Find below regulations and guidelines of NAFDAC under the following headings or categories:

Establishment Act Foods & Drinks Drug & Herbals Labeling
Guidance Documents Chemicals & Cosmetics Advertisement Draft Regulations

  

PUBLISHED GUIDELINES OF THE NATIONAL FOOD AND DRUG ADMINISTRATION AND CONTROL, NAFDAC [For Draft Guidelines, click HERE]

Title Product Type Category Status
NAFDAC Good Clinical Practice Guidelines 2016 Regulated Products (Clinical Trial) Quality Guidelines (DER) Published
Guidelines For Labeling Of Investigational Medicinal Products – Rev. 01 Medical Products GMP Labeling (DER) Published
Guidelines For Importation And Release Of Investigational Medicinal Products Medical Products Quality Guidelines (DER) Published
Guidelines For Clinical Trials In Emergencies In Nigeria Regulated Products (Clinical Trial) GMP Requirement (DER) Published
Guidelines For Clinical Trial Protocol Development Regulated Products (Clinical Trial) GMP Requirement (DER) Published
Guidelines on Variation To a Registered Pharmaceutical Product-26373 Regulated Products Variation Guidelines (R&R) Published
Guideline for Approval to Import Products by Government Agencies, International Bodies & Multinational Organizations Regulated Products Guidance Document (PID) Published
Guideline for Form M Online Application 2019 Regulated Products Guidance Document (PID) Published
Guideline for NOC Online Application 2019 Regulated Products Guidance Document (PID) Published
GUIDELINES FOR CLINICAL TRIAL IN PAEDIATRIC POPULATIONS Regulated Products (Clinical Trial) GMP Requirement (DER) Published

 

Title Product Type Category Status
Biosimilar Guidance Document Drugs (Medicines) Quality Guidance Document (R&R) Published
Guidelines For The Registration Of Biosimilars In Nigeria Drugs (Medicines) Local Registration (R&R) Published
Quality Guidelines for Registration of Pharmaceutical Products[26381] Drugs (medicines) 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

 

Title Product Type Category Status
Guidelines for the Registration of Imported Drug Products Drugs (medicines) Import Registration (R&R) Published
Guidelines for the Registration of Imported Food Food Import Registration (R&R) Published
Guidelines for the Registration of Imported Herbal Remedies, Dietary Supplements Herbal Import Registration (R&R) Published
Guidelines for the Registration of Imported Medical Devices Medical Device Import Registration (R&R) Published
Guidelines for the Registration of Imported Pesticides Regulated Products Import Registration (R&R) Published
Gudelines for the Registration of Herbal Remedies and Dietary Supplements made in Nigeria Herbal Local Registration (R&R) Published
Guidelines for Registration of Animal Feeds made in Nigeria Regulated Product Local Registration (R&R) Published
Guidelines for Registration of Medical Devices Medical Device Local Registration (R&R) Published
Guidelines for the Registration of Cosmetics made in Nigeria Cosmetics Local Registration (R&R) Published
Guidelines for the Registration of Drugs made in Nigeria Drugs (medicines) Local Registration (R&R) Published

 

Title Product Type Category Status
Guidelines for the 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 (R&R) Published
Guidelines for the Inspection of Warehouses Veterinary GMP Requirement (Inspection) Draft
Guidelines for the Inspection of Facilities for Manufacture of Veterinary Drugs Veterinary GMP Requirement (Inspection) Draft
Guidelines for Listing of Animal Feeds Toll Millers & Requirments for Toll Milling Facility Veterinary GMP Requirement Draft
Guidelines for Listing of Animal Feed Toll Millers & Requirments for the Toll Milling Facility (Renewal) Veterinary GMP Requirement (Renewal) Draft
Guidelines for Lisiting as Pesticides, Agrochemicals, Fertilizers, Bio-Fertilizers & Bio-Pesticides Marketers (New Applicant) Veterinary GMP Requirement (New Applicant) Draft
Guidelines for Issuance of Permit to Import Field Trial Samples Veterinary Import Permit Draft
Guidelines for Issuance of Permit to Import Feed Supplements, Feed Concentrates, Feed Additives, Premixes, Fish Meal (Renewal) Veterinary Import Permit Draft
Guidelines for Issuance of Permit to Import Feed Supplements, Feed Concentrate, Feed Additivies, Premixes, Fish Meal (New Applicant) Veterinary Import Permit Draft

 

Title Product Type Category Status
Guidelines for Issuance of Permit to Import Bulk Pesticides, Agrochemicals and Fertilizers Veterinary Import Permit Draft
Guidelines for Issuance of Permit to Import Bulk Pesticides, Agrochemicals and Fertilizers (Renewal) Veterinary Import Permit Draft
Guidelines for Inspection of Local Manufactured Animal Feed, Pet Food & Premixes Veterinary GMP Requirement (Inspection) Draft
Guidelines for Inspection of Facility for the Manufacture of Veterinary Medicinal Cosmetics in Nigeria Veterinary GMP Requirement (Inspection) Draft
Guidelines for Inspection of Facilities for the Manufacture of Medicated Feed Veterinary GMP Requirement (Inspection) Draft
Guidelines for Inspection of Facilities for Manufacture of Veterinary Cosmetics Veterinary GMP Requirement (Inspection) Draft
Guideline for Listing of Pesticides, Agrochemicals, Fertilizers, Bio-Fertilizer and Bio-Pesticides Marketer (Renewal) Veterinary GMP Requirement Draft
Guidelines for Handling and Disposal of Unwholesome Medicines and Other NAFDAC Regulated Products Drugs (medicines) GMP Requirement (I&E) Published
Guidelines for Inspection of Small Scale Enterprises Food GMP Inspection Requirement (FSAN) Published
Guidelines for Inspection of Micro Scale Enterprises in Nigeria Food GMP Inspection Requirement (FSAN) Published

 

Title Product Type Category Status
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 Regulated Product 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

 

Title Product Type Category Status
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 Regulated Products Import Clearance Permit (PID) Published
Guidelines for Issuance of Authorization on Letter of No-Objection and Approval to Open Form M & PAAR Regulated Products Import Permit (PID) Published
Guidelines for Issuance of Export Approval for Samples for Machine Trials Regulated Products Export Permit (PID) Published
Guidelines for the Issuance of Export Certificate for NAFDAC Regulated Products Regulated Products 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 Regulated Products GMP Requirement (PV/PMS) Published
NAFDAC MAS Guidelines Final Regulated Products Mobile Authentication Service (PV/PMS) Published
NAFDAC Guidelines on Good Pharmacovigilance Practice Regulated Products GMP Requirement (PV/PMS) Published
Guidelines for Labelling Regulated Products GMP Labelling (R&R) Published

 

Title Product Type Category Status
Guidelines on Registration Requirement To Establish Interchangeability of Generic Pharmaceutical Products Drugs Registration Requirement (R&R) Published
Guidelines on Variation To a Registered Pharmaceutical Product Drugs GMP Requirement (R&R) Published
NAFDAC GMP Guidelines For Pharmaceutical Products Drugs GMP Requirement (DER) Published
NAFDAC GMP Guidelines For Cosmetics Products Cosmetics GMP Requirement (DER) Published
Guidelines For Production Inspection Of Large & Medium Scale Cosmetics Manufacturing Facilities Cosmetics GMP Inspection (DER) Published
Guidelines For Production Inspection Of Herbal Medicines Facilities Herbal GMP Inspection (DER) Published
Guidelines For Pre- Registration Inspection For Pharmaceutical Facilities Drugs Registration (DER) Published
Guidelines For- Production Inspection Of Pharmaceutical Facilities Drugs GMP Inspection (DER) Published
Guidelines For Inspection Of Premises For Global Listing Of Cosmetics Cosmetics GMP Inspection (DER) Published
Guidelines For GSP & GDP Inspection For Vaccines & Biologics Vaccines & Biologics GMP Inspection (DER) Published

 

Title Product Type Category Status
GUIDELINES FOR CLINICAL TRIAL APPLICATION Regulated Products (Clinical Trial) GMP Requirement (DER) Published
GUIDELINES FOR CLINICAL TRIAL PROGRESS REPORT Regulated Products (Clinical Trial) GMP Requirement (DER) Published
GUIDELINES FOR CLINICAL TRIALS PROCESS TIMELINES Regulated Products (Clinical Trial) GMP Requirement (DER) Published

 

For related regulatory compliance services, general regulation/standard watch, advisory, intelligence or research support services, contact

Tree & Trees JusticeMedia Group
+234 706 710 2098
treentrees@gmail.com

 

 

LEGAL STANDARDS OF THE FEDERAL REPUBLIC OF NIGERIA
The Constitution National Legislations Treaties of the Federation
Federal Court Rules State Court Rules Court Judgments
MDA Regulations SON Standards Executive Orders
Nig. Nuclear Reg. Auth., NNRA NAFDAC NESREA
Dept of Pet. Res. DPR Securities & Exchange Comm., SEC NERC
Fed. Inland Rev. Service, FIRS Fed. Road Safety Corps., FRSC Central Bank of Nigeria, FBN
Nig. Communications Comm., NCC1 Nig. Broadcasting Comm., NBC Nig. Copyright Comm., NCC2
Bio-Chemical and Bio-Safety Service & Quality Others

 

 

STANDARDS AND SPECIFICATIONS OF THE STANDARDS ORGANISATION OF NIGERIA, SON
Agriculture Food Technology Packaging, Distribution of Goods
Audio, Video, Audio-Visual, Image & PrecisionTech. Generalities Paint & Colour Industry
Chemical Technology Glass & Ceramic Industries Paper Products and Technology
Civil Engineering Healthcare Technology Petroleum and Related Technology
Clothing Industry Image Technology Precision Mechanics
Construction Materials & Building Manufacturing Engineering Road Vehicle Engineering
Domestic & Commercial Equipment Information  Technology and Office Equipment Rubber, Plastic Tyre, Adhesives and Cellular Materials
Electrical Engineering Material handling Equipment Sociology Services
Electronics Manufacturing Engineering Telecommunications Engineering
Entertainment and Sports Metallurgy Testing
Environment & Health Protection Metrology & Measurement of Physical Phenomena Textile and Leather Technology
Fluid Systems, Pipelines & Components for General use Office Equipment Wood Technology

For regulation/standard watch, research or regulatory compliance support services, contact

Tree & Trees JusticeMedia Group
+234 706 710 2098
treentrees@gmail.com

 

 

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Law Nigeria Admin

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