6519 Results Found

Road Infrastructure Development and Refurbishment Investment Tax Credit Scheme Order 2019

Ministry of Infrastructure, Nigeria

This scheme is a Public Private Partnership intervention that enables the Federal Government of Nigeria to leverage on private sector funding for the construction or refurbishment of eligible road infrastructure projects in Nigeria. It focuses on the development of eligible road infrastructure projects in an efficient and effective manner that creates value for money through private sector discipline and also guarantees participants in the scheme timely and full recovery of funds provided for the construction of refurbishment of eligible road infrastructure projects in the manner prescribed in this executive order.

Nigeria 2019 Infrastructure and Construction

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 permit, 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 permit 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 licence for 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 licence 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

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 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 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 Registration & Regulatory Affairs (R & R) Directorate Guideline on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical Products

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

This document is an adaptation of the World Health Organization (WHO) guidelines on registration requirements to establish interchangeability. It provides appropriate In vivo and In vitro requirements to assure interchangeability of the generic product without compromising the safety, quality and efficacy of the pharmaceutical product and generally applicable to orally administered generic products as well as to certain non-orally administered pharmaceutical products (e.g. transdermal delivery systems and certain parenteral, rectal and nasal pharmaceutical products.

Nigeria 2018 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines on Variations to a Registered Pharmaceutical Product

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

This guidance document is technically and structurally inspired by the World Health Organisation’s variation guideline on the details of the various categories of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products. The objectives of these guidelines are to assist applicants with the classification of changes made to the quality part of a registered Finished Pharmaceutical Product (FPP) and provide guidance on the technical and other general data requirements to support changes to the quality attributes of the Active Pharmaceutical Ingredient (API) or FPP.

Nigeria 2018 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 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 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 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