1321 Results Found
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 that 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 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 that 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 guide importers and owners of storage facilities for medicines that require cold chain management. This is to provide stakeholders with the relevant regulatory requirements needed to maintain the compliance status of their operational activities.
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 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 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 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 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 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 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 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 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 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 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 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 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 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 (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 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 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 license for herbal remedies/dietary supplements made in Nigeria.
Nigeria • 2019 • Health