842 Results Found

Guidelines for Issuance of Authorization on Letter of no Objection

Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria

This guideline document is for the interest of the general public and in particular, holders of NAFDAC certificate of registration for regulated products, who may wish to grant authorization (No objection) for the importation of their registered products by another company.

Nigeria 2018 Health

NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Submission of Clinical Trial Progress Report

Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria

These guidelines are for the interest of the general public and in particular individuals and organizations intending to submit progress reports of ongoing clinical trials in Nigeria. The document emphasizes that progress reports on ongoing clinical trials in Nigeria should be submitted using the report template in This guideline.

Nigeria 2019 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Renewal of certificate of registration for Imported Medical Devices in Nigeria

Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria

These guidelines are intended to provide guidance on the technical and other general data requirements when submitting an application for renewal of product licence for imported medical devices. It outlines the process to be followed and the technical requirements to be met before a product can be placed on the Nigerian market.

Nigeria 2019 Health

NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Clinical Trials Protocol development

Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria

This document defines the terms “objective” and “study endpoint”. It clearly states that for purposes of registration and reporting, the terms objectives and endpoints as used in this template provided in this document align with the terms primary purpose and outcome measures in clinicaltrials.gov, respectively. Individuals should provide a description of the study objectives and endpoints, as well as a justification for selecting the particular endpoints, in the table format included in the statement of compliance 3.0 of the document. This will provide clear articulation on how the selected primary and secondary endpoint(s) are linked to achieving the primary and secondary objectives and an explanation of why endpoint(s) were chosen. Data points collected in the study should support an objective or have a regulatory purpose. Therefore, careful consideration should be given prospectively to the amount of data needed to support the study’s objectives.

Nigeria 2019 Health

NAFDAC Ports Inspection Directorate (PID) Guidelines for Clearing of Imported Donated Items at Ports of Entry in Nigeria

National Agency for Food and Drug Administration and Control,Ministry of Industry, Trade and Investment, Nigeria

These guidelines are for the interest of the general public and in particular importers of donated products into Nigeria. The document provides information on the documentation for clearance, physical examination, and release of the consignment from the port of entry.

Nigeria 2018 Health

NAFDAC Ports Inspection Directorate (PID) Guidelines for Clearing of Imported Finished Bulk Food, Food Raw Materials and Animal Feed at Ports of Entry in Nigeria

National Agency for Food and Drug Administration and Control,Ministry of Industry, Trade and Investment, Nigeria

These guidelines are for the interest of the general public and in particular, importers of finished bulk food, food raw materials and animal feed into Nigeria. The document emphasizes that no finished bulk food and/or food raw materials should be imported without obtaining Import Permit. It also provides for payment, submission of documents for first endorsement, joint inspection of consignment, second endorsement, release of consignment and tariff.

Nigeria 2018 Health

NAFDAC Ports Inspection Directorate (PID) Guidelines for Clearing Imported Narcotic and Controlled Substances, Pharmaceutical Raw Materials and restricted chemicals at Ports of Entry in Nigeria

National Agency for Food and Drug Administration and Control, Ministry of Industry, Trade and Investment,, Nigeria

These guidelines are developed for the interest of the general public and in particular, importers of Narcotic and Controlled Substances, Pharmaceutical raw materials and restricted chemicals into Nigeria. The document emphasizes that pharmaceutical raw materials and restricted chemicals should not be imported without obtaining Import permit and permit to clear where applicable.

Nigeria 2018 Health

NAFDAC Ports Inspection Directorate (PID) Guidelines for Clearing Imported Finished Pharmaceutical, Nutraceuticals and Herbal Products (Human and Veterinary) at Ports of Entry in Nigeria

National Agency for Food and Drug Administration and Control, Ministry of Industry, Trade and Investment,, Nigeria

These guidelines are for the interest of the general public and in particular importers of finished pharmaceutical, nutraceutical and herbal products (Human and Veterinary) into Nigeria. The document provides for payment, submission of documents for first endorsement, first endorsement, and joint inspection of consignment, second endorsement and release of consignment.

Nigeria 2018 Health

Guidelines for Issuance of Authorization to Open form M

Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria

This guideline document is for those importers of bulk food raw materials / importers of frozen fish, for which NAFDAC permits or certificate of registration are not issued, who require authorization to open form M.

Nigeria 2018 Health

NAFDAC Ports Inspection Directorate (PID) Guidelines for Clearing of Imported Regulated Food Products (Including Global Listing for Supermarket Items & Restaurant Operators) at Ports of Entry in Nigeria

National Agency for Food and Drug Administration and Control, Ministry of Industry, Trade and Investment,, Nigeria

These guidelines are for the interest of the general public and in particular, importers of food products into Nigeria. The document provides the procedures for application, verification of application, payment, submission of application, review of application, first endorsement, joint inspection of consignment, second endorsement, release of consignment and tariff.

Nigeria 2018 Health

NAFDAC Ports Inspection Directorate (PID) Guidelines for Clearing of Imported Cosmetic (Including Global Listing for Supermarket Items) and Medical Devices at Ports of Entry in Nigeria

National Agency for Food and Drug Administration and Control, Ministry of Industry, Trade and Investment,, Nigeria

These guidelines are for the interest of the general public and in particular, importers of cosmetics and medical devices into Nigeria. The document emphasizes that no cosmetics and medical devices shall be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless it has been registered in accordance with the provisions of National Agency for Food and Drug Administration and Control (NAFDAC) Act CAP N1 (LFN) 2004, other related legislations and the accompanying guidelines.

Nigeria 2018 Health

Veterinary Medicines & Allied Products Directorate (VAMP) Guidelines for listing as Pesticides, AgroChemicals, Fertilizers, Bio-Pesticides and Bio-Fertilizers Marketers

Ministry of Health, National Agency for Food and Drug Administration and Control, Ministry of Agriculture ,Ministry of Rural Development, Nigeria

These guidelines are for the interest of the general public and in particular to marketers of pesticides, agrochemicals, fertilizers, bio-pesticides and bio-fertilizers in Nigeria. It emphasizes that no importation shall be made by any importer of pesticides, agrochemicals, fertilizers bio-pesticides and bio-fertilizers without obtaining listing certificate as a pesticide and agrochemical marketer from NAFDAC except in accordance with the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related Legislations and the accompanying guidelines.

Nigeria 2018 Health

NAFDAC Ports Inspection Directorate (PID) Guidelines for Clearance of Imported General Chemicals, Agrochemicals and Raw Materials at Ports of Entry in Nigeria

National Agency for Food and Drug Administration and Control, Ministry of Industry, Trade and Investment,, Nigeria

These guidelines are for the interest of the general public and in particular importers of general chemicals, agrochemicals and raw materials into Nigeria. The document emphasizes that no general chemicals, agrochemicals or raw materials shall be imported without obtaining an Import permit or approval. It provides for payment, submission of documents for first endorsement, joint inspection of consignment, second endorsement and release of consignment.

Nigeria 2018 Health

Food fortification Regulation 2019

Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria

These regulations apply to all fortified foods manufactured, imported, exported, distributed, advertised, sold or used in Nigeria. The regulatory document provides for advertisement of foods to which no vitamin and/or mineral has been added, label declaration of food to which vitamin and/or mineral has been added, statement relating to mineral content of food, label declaration of food mandatorily fortified with vitamin A, labelling, packaging, penalty and forfeiture after conviction.

Nigeria 2019 Health

Food Irradiation Regulations 2019

Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria

These regulations apply to foods processed by ionizing radiation that is used in conjunction with applicable hygienic codes, food standards and transportation codes, manufactured, imported, exported, distributed, advertised, sold or used in Nigeria. The document provides information on the general requirement for food treatments, radiation sources, absorbed dose, facilities and control of the process, wholesomeness of irradiated foods, packaging, quality assurance, inspection, re-irradiation, labelling, trade in irradiated foods, importation, exportation, penalty, and forfeiture after conviction

Nigeria 2019 Health

National Agency for Food and Drug Product Administration and Control (NAFDAC) Cocoa and Cocoa Products Regulations 2019

Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria

These regulations apply to cocoa and cocoa products that are manufactured, imported, exported, advertised, sold, distributed or used in Nigeria. The document provides information on labels, conditions for claims that food is cocoa based, prohibitions, maximum limits of contaminants, permitted additives, penalty, and forfeiture after conviction.

Nigeria 2019 Health

Guidelines for Registration of Herbal Remedies/Dietary Supplements made in Nigeria

Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria

These guidelines are for the interest of the general public and in particular, manufacturers of herbal remedies/dietary supplements made in Nigeria. The document emphasizes that no herbal remedies/dietary supplements shall be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless it has been registered in accordance with the provisions of National Agency for Food and Drug Administration and Control (NAFDAC) Act CAP N1 (LFN) 2004, other related Legislations and the accompanying guidelines.

Nigeria 2018 Health

National Agency for Food and Drug Product Administration and Control (NAFDAC) Controlled Medicines Regulations 2019

Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria

These regulations apply to procedures and processes that will ensure appropriate importation, exportation, manufacturing, storage, warehousing, distribution, inspection, use for medical and scientific purposes, disposal as well as documentation of controlled medicines in Nigeria, in such a manner as to maintain the security and integrity of the product throughout the supply chain. They provide information on prohibition, application of registration, validity, Suspension or cancellation of certificate of registration, permit or authorization, importation of controlled medicines, labelling, storage facility, distribution, procurement, selection and quantification, inspection, dispensing, disposal of controlled medicines, penalty, and forfeiture after conviction.

Nigeria 2019 Health