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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

These guidelines are for the interest of the general public and in particular, manufacturers of medical devices made in 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.