6519 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 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 Drug Evaluation & Research (DER) Directorate Guidelines for Production Inspection of Herbal Medicines and Nutraceuticals ManufActuring Facilities
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These guidelines are for the interest of individuals intending to engage in manufacturing of herbal medicines and related products in Nigeria. This guidance document prescribes the minimum Good Manufacturing Practice (GMP) requirements for the facilities and controls to be used in the manufacture of herbal medicines and related products to ensure quality and safety. It also prescribes the minimum requirements necessary for inspection of a facility for compliance with good manufacturing practices for the registration of herbal medicine and related products.
Nigeria • 2018 • Health
NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Production Inspection of Large and Medium Scale Cosmetics ManufActuring Facilities
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These guidelines are for the interest of individuals intending to engage in manufacturing of cosmetics and related products in Nigeria. the document prescribes the minimum Good Manufacturing Practice (GMP) requirements for the facilities and controls to be used in the manufacture of these products to ensure quality and safety. It also prescribes the requirements for conducting a production inspection of the cosmetics manufacturing facility.
Nigeria • 2018 • Health
NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Registration of Animal Feeds 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 animal feed made in Nigeria. They emphasize that, no animal feed 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 Regulatory and Registration of Biosimilars 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, pharmaceutical industries in Nigeria. The document provides guidelines for the registration of biosimilars in Nigeria.
Nigeria • 2018 • Health
NAFDAC Registration & Regulatory Affairs (R & R) Director Guidelines for Registration of Imported Drugs, Vaccines and In-Vitro Diagnostics Under WHO collaborative Registration Procedure (CRP)
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/importers of drugs, vaccines and in-vitro diagnostics into the county which have been prequalified by the World Health Organization. This guideline is based on NAFDAC’s regulatory reliance policy on adoption regulatory reliance mechanisms to make regulatory decisions as it relates to the granting of marketing authorization. Clinical trial approval and conduct of Good Manufacturing Practice (GMP) Inspections.
Nigeria • 2019 • Health
NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Registration of Medical Devices 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 medical devices made in Nigeria.
Nigeria • 2018 • Health
NAFDAC Chemical Evaluation & Research (CER) Directorate Guidelines for Reneval of Permit to Import Industrial and Laboratory Chemicals
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 renew permits to import industrial and laboratory chemicals. These guidelines prescribe the requirement for documentation, processing, personnel requirement, and timeline for obtaining a permit.
Nigeria • 2018 • Health
NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Advertisement of NAFDAC Regulated Products 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, industries in Nigeria that have registered regulated products. The document outlines the guidelines for the advertisement of NAFDAC regulated products
Nigeria • 2018 • Health
NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Inspection of Facilities for Manufacture of Veterinary Drugs 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 veterinary drugs in Nigeria. The document outlines the application for inspection, procedure for payment, scheduling of inspection, inspection and labelling information.
Nigeria • 2018 • Health
NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Warehouse Inspection
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 feeds, feed additives, feed concentrates, feed supplements, premixes, fish meal, pesticides, agrochemicals and fertilizers. The document outlines the application process, procedures of warehouse inspection etc.
Nigeria • 2018 • Health
NAFDAC Ports Inspection Directorate (PID) Guidelines for Issuance of Export Certificate for NAFDAC Regulated Products
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 drugs, food, cosmetics, medical devices and other regulated products intended for commercial purpose. The document emphasizes that National Agency for Food and Drug Administration and Control (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.
Nigeria • 2018 • 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 certificate.
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 and agro chemicals. These guidelines prescribe the requirements for documentation, processing, personnel and timeline for obtaining a permit to import restricted and agro chemicals.
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 in accordance with the provisions of 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 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
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 permit, 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 imported drug, import permit, submission of samples for laboratory analysis and labelling of imported drugs.
Nigeria • 2018 • Health