842 Results Found
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
Nigerian Nuclear Regulatory Authority Minimum Requiements for Authorizing Industrial Radiography Facility Administrative and Medical Requirements
Ministry of Health, Nigeria
This document provides guidance on application for a licence to possess and use an X-ray unit, equipment specification for enclosed exposure facilities and training requirement.
Nigeria • • 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 licence for drug made in Nigeria.
Nigeria • 2019 • Health
NAFDAC Good Clinical Practice Guidelines 2016
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of humans. It provides unified standards for the conduct of clinical data in Nigeria. The guidelines describe the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and ethics committees.
Nigeria • 2016 • 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 Drug Evaluation & Research (DER) Directorate Good Manufacturing Practice Guidelines for Cosmetics Products 2018
Ministry of Industry, Trade and Investment, National Agency for Food and Drug Administration and Control, Nigeria
These cosmetic Good Manufacturing Practice (GMP) guidelines are for the manufacture, storage and shipment of cosmetic products. The primary objective of the guidelines is to ensure that products are consistently manufactured in conformance with quality standard. It is concerned with all aspects of production and quality control.
Nigeria • 2018 • 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 licence for imported herbal products and dietary supplements.
Nigeria • 2019 • Health
NAFDAC Good Manufacturing Practice Guidelines for Pharmaceutical Products 2016
Ministry of Industry, Trade and Investment, National Agency for Food and Drug Administration and Control, Nigeria
Good manufacturing practice (GMP) is that part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by their marketing authorizations. These guidelines apply to pharmaceutical, biological, and veterinary products and they are intended to help all stakeholders comply with the provisions of the National Agency for Food and Drug Administration and Control (NAFDAC) good manufacturing Practice Regulations for pharmaceutical products.
Nigeria • 2016 • 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
NAFDAC Drug Evaluation & Research (DER) Directorate Good Cold Chain Management for Vaccines & Other Biopharmaceutical Products Guidelines 2019
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
Cold chain management is a specialized area of Biopharmaceutical products management which begins when a Biopharmaceutical product is manufactured, stored and moves through the distribution chain until it gets to the end user at the time of administration. It is required that the product be held and distributed in a controlled environment. It is necessary to have adequate control of all steps and procedures involved both in manufacturing and quality control, storage and distribution, to ensure that product quality is maintained. Therefore, this document was designed to provide guidance to importers and owners of storage facility for medicines that require cold chain management. This is to provide stakeholders the relevant regulatory requirements needed to maintain the compliance status of their operational activities.
Nigeria • 2019 • Health
NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Renewal of certificate of registration for Herbal Remedies/Dietary Supplement 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 herbal remedies/dietary supplements made in Nigeria products 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 herbal remedies/dietary supplements 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. It is intended to provide guidance on the technical and other general data requirements when submitting an application for the renewal of a product licence for herbal remedies/dietary supplements made in Nigeria.
Nigeria • 2019 • Health
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 Chemical Evaluation & Research Directorate (CER) Guidelines for Renewal of Listing Certificate for Chemical Marketers
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 herbal remedies/dietary supplements made in Nigeria products 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 herbal remedies/dietary supplements 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. It is intended to provide guidance on the technical and other general data requirements when submitting an application for the renewal of a product licence for herbal remedies/dietary supplements made in Nigeria.
Nigeria • 2018 • Health
NAFDAC Narcotics & Controlled Substances (NCS) Directorate 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, manufacturers’ importers, distributors of controlled drugs and precursor chemicals in Nigeria. The document provides guidance on the application for permit to import, inspection and timeline for the processes.
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 Chemical Evaluation & Research (CER) Directorate 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 public and in particular persons intending for warehouse inspection. Warehouse inspection is a prerequisite to the issuance of chemical import permit or listing certificate (authorization to market chemicals). Therefore, this document prescribes the minimum safety standard for chemical handling, documentation, personnel requirement, facility and timeline for warehouse inspection.
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 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 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 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