9768 Results Found

NAFDAC Good Pharmacovigilance Practice Guidelines 2016

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

These guidelines apply to all entities that have the authorization to put medicinal products into the Nigerian market. These guidelines are intended to help all stakeholders comply with the provisions of the GVP regulations. They provide detailed guidance for marketing authorization holders on establishing and maintaining a pharmacovigilance system including its quality management, pharmacovigilance system master file, adverse reaction reporting, risk management, post-authorization safety studies, risk communication and pharmacovigilance audit.

Nigeria 2016 Health

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 Ports Inspection Directorate (PID) Guidelines for Issuance of Health Certificate for Exportation of Processed & Semi-Processed Food Commodities

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, exporters of processed and semi-processed food commodities. The document emphasizes that NAFDAC will not issue any export approval for products that have already left the shores of the country. it also outlines the procedures for application, inspection and issuance of health certificates.

Nigeria 2018 Health

NAFDAC Chemical Evaluation and Research Directorate (CER) Guidelines for Issuance of Permit to Import Restricted Chemicals and Agrochemicals

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

These guidelines are for the general public and in particular, persons intending to obtain a permit to import restricted agrochemicals. These guidelines prescribe the requirements for documentation, processing, personnel and timeline for obtaining a permit to import restricted agrochemicals.

Nigeria 2018 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Registration of Cosmetics 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 and in particular, manufacturers of cosmetics made in Nigeria. The document outlines guidelines for the application for registration of Cosmetic made in Nigeria, product approval meeting, issuance of notification and labelling information

Nigeria 2018 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Registration of Drug Products 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 and in particular, manufacturers of Pharmaceuticals made in Nigeria. The document outlines guidelines for application for Registration of drugs made in Nigeria, issuance of notification and labelling of drugs made in Nigeria.

Nigeria 2018 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Registration of Food Products & Packaged Water 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 and in particular, manufacturers of food products and packaged water made in Nigeria. The document emphasizes that no food product or packaged water 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 Act CAP N1 (LFN) 2004, other related Legislations and the accompanying Guidelines. It provides guidelines for application for Registration of food products and packaged water made in Nigeria, issuance of notification and labelling information.

Nigeria 2018 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Registration of Imported Animal Feeds 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 animal feed in Nigeria. The document emphasizes that no animal feed shall be manufactured, imported, exported, advertised, sold or distributed 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

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