1477 Results Found

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

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

Drug Evaluation & Research Directorate (Guidelines for Inspection of Micro Scale Cosmetics, Herbal and Household Products Facilities in Nigeria)

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

These guidelines prescribe the minimum Good Manufacturing Practice (GMP) requirements for the facilities and controls to be used in the manufacture of products approved for this scheme to ensure the quality and safety of the products. It states that regulated products should not be manufactured in Nigeria unless the facility has been inspected and a Certificate of Recognition as a manufacturer is issued by NAFDAC. The document highlights the only products to be manufactured and how to apply for inspection.

Nigeria 2018 Health

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 the 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 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 guide the technical and other general data requirements when applying for renewal of product licenses 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 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

Food Additives Regulations 2019

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

These regulations apply to the labelling of food additives sold either by retail or others, including sales to caterers and food manufacturers. They also apply to food processing aids and also provide the prohibition regulation that no person can manufacture, import, export, distribute, advertise, display for sale or use any food additives, except food additives set out in the prescribed standards.

Nigeria 2019 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 the 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, a statement relating to the 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, the 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

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 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

Guidance Document for Submission of Application in the Common Technical Document format - Vaccines for Human Use

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

This guideline is technically and structurally inspired by Health Canada’s guidance document on harmonized requirements for the licensing of vaccines and guidelines for the preparation of an application and the World Health Organization (WHO) working document on vaccine prequalification dossier. This guideline document has been developed in pursuance of the National Agency for Food and Drug Administration and Control (NAFDAC) Act Cap. N1, LFN 2014 and made to provide guidance to applicants on the organization of information to be provided to the agency in seeking marketing authorization for Vaccines for human use. The document applies to all vaccines to be authorized for human use, regardless of where they are manufactured.

Nigeria 2019 Health

Biosimilar Guidance Document (NAFDAC)

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

The intention of this document is to provide acceptable principles for the registration of biosimilar products that are claimed to be similar to RBP of assured quality, safety, and efficacy that have been licensed based on a full registration dossier by a stringent regulatory authority. On the basis of proven similarity, the registration of a biosimilar will rely, in part, on non-clinical and clinical data generated with an already licensed RBP.

Nigeria 2012 Health

Guidelines for Issuance of approval to Import Donated Items by Non-governmental Organizations

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

This document is for the interest of the general public and in particular, a non-governmental organization that wish to import NAFDAC regulated items. 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

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

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

Cosmetics Products Labelling Regulations 2019

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

These regulations provide for the registration of all cosmetics manufactured, imported, exported, advertised, sold, distributed or used in Nigeria. It provides information on labelling information and the net content of cosmetic products.

Nigeria 2019 Health