10006 Results Found

NAFDAC Registration & Regulatory Affairs (R &R) Directorate Guidelines On Variations To A Registered Vaccine for Humans

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

These guidelines apply to marketing authorization (MA) Holders intending to make changes to the quality section of the dossier as well as to the safety, efficacy and product labelling information for an antigen, intermediate or a finished vaccine product. This guidance should be read in conjunction with the NAFDAC guidelines on variations to a registered pharmaceutical product. It provides guidance for MA holders on the regulation of changes to the original MA dossier or product license for an approved vaccine in terms of procedures and criteria for the appropriate categorization and reporting of changes, and the data required to enable NAFDAC to evaluate the impact of the change on the quality, safety and efficacy of the vaccine.

Nigeria Health

NAFDAC Guidelines for Procurement And The Management Of The Mobile Authentication Service (MAS) Scheme In Nigeria 2018

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

This document outlines procedures for effective enrolment and implementation of the mobile authentication service MAS scheme. It provides guidelines for holders of a certificate of registration (HCR) – the applicant seeking to deploy MAS on their registered products, existing MAS providers deploying MAS technology; and MAS providers seeking entry as a NAFDAC approved service provider, and person(s) or group(s) requesting information, education and communication (IEC) materials on the MAS Scheme.

Nigeria 2018 Health

NAFDAC Fats And Oils Regulations 2019

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

These regulations apply to all foods containing fats and oils that are manufactured, imported, exported, advertised, sold, distributed or used in Nigeria. It guides vitamin A fortification, source, additives, impurities and labelling of fats and oils

Nigeria 2019 Health

Nigerian Radiation Safety in Diagnostics and Interventional Radiology Regulations, 2006

Ministry of Health, Nigeria

These regulations are practice-elaboration of the Nigeria basic ionizing radiation regulation, which is derived from the international basic safety standards for protection against ionizing radiation sources. They provide for the protection of patients, workers and the public from the harmful effects of exposure to ionizing radiation.

Nigeria 2006 Health

Nigerian Radiation Safety in Nuclear Medicine Regulations, 2006

Ministry of Health, Nigeria

These regulations are practice-elaboration of the Nigeria basic ionizing radiation regulation, which is derived from the international basic safety standards for protection against ionizing radiation sources. They provide for the protection of patients, workers and the public from the harmful effects of exposure to ionizing radiation.

Nigeria 2006 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Quality Guidelines for The Registration Of Pharmaceutical Products for Human Use In Nigeria

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

This document provides guidance for the preparation of regulatory submission for the registration of medicines for human use in Nigeria in line with the widely accepted format and common requirements achieved through the processes of the International Council for Harmonization (ICH) of regulatory requirement for the registration of medicinal products for human use. it provides guidance on the preparation of regulatory submission for pharmaceutical products by providing guidance on the organization and formatting of product dossier, The adoption of the Common Technical Document (CTD) as developed through the ICH processes and adopted by the World Health Organization in the WHO prequalification programme and the West African Health Organization in the promotion of the harmonization of regulatory requirement for the registration medicinal products for human use, elaborate on requirements for active pharmaceutical ingredients (API) and the finished pharmaceutical products, and promotion of a more transparent regulatory system.

Nigeria 2008 Health

NAFDAC Registration & Regulatory Affairs Directorate Guidelines for Registration of Imported Cosmetics in Nigeria

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

These guidelines are for the interest of the general public, and in particular, importers of cosmetics in Nigeria. The document emphasizes that no cosmetics products shall be manufactured, imported, exported, advertised, sold or distributed 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. It outlines guidelines for application for registration of imported cosmetics, import permits, submission of products for laboratory analysis, issuance of notification and labelling of imported cosmetics.

Nigeria 2018 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs)

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

These guidelines are for the interest of the general public and in particular importers of Pharmaceutical and Veterinary drugs in Nigeria. The document emphasizes that no drug 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. It outlines the guidelines for application for registration of the imported drug, import permits, submission of samples for laboratory analysis and labelling of imported drugs.

Nigeria 2018 Health

National Seed Policy

Ministry of Agriculture ,Ministry of Rural Development, Nigeria

The seed policy serves as a reference and guide to actors in the seed industry. It defines the role of the government on all imaginable staking points in the seed value chain.

Nigeria 2015 Agriculture and Rural Development

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Registration of Imported Food Products in Nigeria

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

These guidelines are for the interest of the general public and in particular importers of food in Nigeria. The document emphasizes that no food products 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. The document also provides guidelines for application for registration of imported food, import permit, issuance and labelling of imported products.

Nigeria 2018 Health

NAFDAC Registration & Regulatory Affairs (R &R) Directorate Guidelines for Registration of Imported Herbal Remedies/Dietary Supplements in Nigeria

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

These guidelines are for the interest of the general public and in particular, importers of herbal remedies/dietary supplements in Nigeria. The document emphasizes that no herbal remedies/dietary supplements shall be manufactured, imported, exported, advertised, sold or distributed 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 Registration and Regulatory Affairs (R & R) Directorate Guidelines for Registration of Imported Medicinal Devices in Nigeria

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

These guidelines are for the interest of the general public and in particular importers of medical devices in Nigeria. The document emphasizes that no 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. It provides information on the application for registration of imported medical devices, import permits, submission of products for laboratory analysis, issuance and labelling of imported devices.

Nigeria 2018 Health

NAFDAC Registration & Regulatory Affairs Directorate Guidelines for Registration of Imported Pesticides in Nigeria

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

These guidelines are for the interest of the general public and in particular, importers of Pesticides in Nigeria. It emphasizes that no pesticide product shall be manufactured, imported, advertised, sold, distributed or used in Nigeria unless it has been registered in accordance with the provisions of NAFDAC. The document outlines guidelines for the registration of imported pesticides, import permits and labelling

Nigeria 2018 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Registration of Pesticides made in Nigeria

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

These guidelines are for the interest of the general public in particular and manufacturers of pesticides made in Nigeria. The document emphasizes that no Pesticide product shall be manufactured, imported, advertised, offered for sale, 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 Registration & Regulatory Affairs (R & R) Directorate Guidelines for Renewal of certificate of registration for Drugs Made in Nigeria

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

The National Agency for Food and Drug Administration and Control has the responsibility of ensuring that drugs made in Nigeria placed on the Nigerian market for use meet the requirements for quality, safety and efficacy throughout the lifecycle of the product. The procedure for registration of drugs made in Nigeria outlines the process to be followed and the technical requirements to be met before a product can be placed on the Nigerian market. The document is intended to provide guidance on the technical and other general data requirements when submitting an application for renewal of product license for a drug made in Nigeria.

Nigeria 2019 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Renewal of certificate of registration for Imported Drug Products in Nigeria (Human and Veterinary Drugs

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

The National Agency for Food and Drug Administration and Control has the responsibility of ensuring that imported drugs placed on the Nigerian market for use meet the requirements for quality, safety and efficacy throughout the lifecycle of the product. The procedure for registration of imported drugs outlines the process to be followed and the technical requirements to be met before a product can be placed on the Nigerian market. The document is designed to provide guidance on the technical and other general data requirements when submitting an application for renewal of product license for imported drugs.

Nigeria 2019 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Renewal of certificate of registration for Imported Herbal/Dietary Supplements in Nigeria

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

The National Agency for Food and Drug Administration and Control has the responsibility of ensuring that imported herbal remedies/dietary supplements placed on the Nigerian market for use meet the requirements for quality, safety and efficacy throughout the lifecycle of the product. The procedure for registration of imported Herbal remedies/dietary supplements outlines the process to be followed and the technical requirements to be met before a product can be placed on the Nigerian market. It provides guidance on the technical and other general data requirements when submitting an application for the renewal of a product license for imported herbal products and dietary supplements.

Nigeria 2019 Health

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

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

The National Agency for Food and Drug Administration and Control has the responsibility of ensuring that medical devices made in Nigeria placed on the Nigerian market for use meet the requirements for quality, safety and efficacy throughout the lifecycle of the product. The procedure for registration of medical devices made in Nigeria outlines the process to be followed and the technical requirements to be met before a product can be placed on the Nigerian market. The guidelines are designed to provide guidance on the technical and other general data requirements when submitting an application.

Nigeria 2019 Health