1477 Results Found
NAFDAC Investigation & Enforcement (I & E) Directorate Guidelines for Handling and Disposal of Unwholesome Medicines and NAFDAC Regulated Products (Food, Medicines, Medical Devices, Cosmetics ETC.) in Nigeria
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These guidelines are for the general public and in particular, companies that intend to dispose of unwholesome NAFDAC regulated products. It emphasizes that no regulated product shall be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless it has been registered under the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related legislations and the accompanying guidelines.
Nigeria • 2018 • Health
NAFDAC Guidelines for Importation and Release of Investigational Medicinal Products
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
Investigational medicinal products, which are unregistered medicines, can only be brought into the country after a positive ethical opinion is obtained, the clinical trial application has been approved and a letter of authorization has been issued by NAFDAC. Therefore, this guideline applies to all investigational medicinal products, including vaccines, which do not have marketing authorization in the country of intended use. It provides information on the responsibilities of the sponsor, labelling and packaging, importation and documentation procedures.
Nigeria • 2019 • Health
NAFDAC Food Safety & Applied Nutrition (FSAN) Directorate Guidelines for Inspection & Requirements for bread Manufacturing
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These guidelines have been designed for the general public and in particular, manufacturers of bread in Nigeria.
Nigeria • 2018 • Health
NAFDAC Food Safety & Applied Nutrition (FSAN) Directorate Guidelines for Inspection & Requirements for Packaged Water Facility in Nigeria (Fresh and Renewal Applications)
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These guidelines are for the general public and in particular, companies involved in the processing and packaging of drinking water in Nigeria. The document prescribes the minimum Good Manufacturing Practice (GMP) requirements for the facilities and controls to be used in the processing of water to ensure that it is safe and meets quality standards.
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 Food Safety & Applied Nutrition (FSAN) Directorate Guidelines for Pre-Packaged Food Manufacturing/Packaging Facilities in Nigeria
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These guidelines are for the general public and in particular, manufacturers and packers of pre-packaged food in Nigeria. The document prescribes the minimum current Good Manufacturing Practice (cGMP) requirements for the facilities and controls to be used in the manufacture or processing of products to ensure that they meet quality standards.
Nigeria • 2018 • 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 Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Inspection of Facilities for Manufacture of Veterinary Cosmetics 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 manufacturers of veterinary cosmetics in Nigeria. It provides information on the application for inspection, procedures for payment, submission of application, scheduling of inspection and inspection.
Nigeria • 2018 • Health
NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Conduct of Clinical Trials during Emergencies
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
This guideline is to provide requirements for the conduct of clinical trials during public health emergencies.
Nigeria • 2019 • Health
NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Inspection of Facilities for Manufacture Medicated 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 medicated feed in Nigeria. The document provides information on procedures for application, submission, scheduling of inspection, tariffs and labelling.
Nigeria • 2018 • Health
NAFDAC Quality Management System Guidelines for Complaints and Appeals against Regulatory Decisions
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These guidelines are for the interest of the general public, NAFDAC clients or stakeholders who wish to make a complaint or make an appeal in the case of a regulatory decision regarding products and/or issues relating to NAFDAC regulated products.
Nigeria • 2019 • 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 an Import permit and permit to clear where applicable.
Nigeria • 2018 • Health
Guidelines for Approval to Import Products by Government Agencies, International Bodies & Multinational Organizations
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, government agencies, international bodies & multinational companies who wish to import NAFDAC regulated products. It emphasizes that no food, drug, cosmetics, packaged water, detergent, the medical device shall be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless it has been registered 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 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 the 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 certificates of registration are not issued, who require authorization to open from 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 the application, payment, submission of application, review of the application, first endorsement, joint inspection of consignment, second endorsement, the release of consignment and tariff.
Nigeria • 2018 • Health
Nigeria Center for Disease Control Guidelines for Employers and Businesses in Nigeria (Version 5)
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
This document provides the implementation guidelines for containment of COVID-19 by the Federal Government of Nigeria at different phases of COVID-19 response measures. This is to curb the spread of coronavirus in work environments.
Nigeria • 2020 • 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 under the provisions of the 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 a listing certificate as a pesticide and agrochemical marketer from NAFDAC except under 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 the consignment.
Nigeria • 2018 • Health