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.

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 a permit to import, inspection and timeline for the processes.

These guidelines are for the public and in particular persons intending for warehouse inspection. Warehouse inspection is a prerequisite to the issuance of a 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.

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 is 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.

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.

This document guides application for a license to possess and use an X-ray unit, equipment specifications for enclosed exposure facilities and training requirements.

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.

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 standards. It is concerned with all aspects of production and quality control.

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.

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.

The 2017 appropriation act highlighting the various Expenditures for the ministry of transport

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.

These guidelines apply to marketing authorization (MA) Holders intending to make changes to the quality section of the dossier as well as to the safety, efficacy and product labelling information for an antigen, intermediate or a finished vaccine product. This guidance should be read in conjunction with the NAFDAC guidelines on variations to a registered pharmaceutical product. It provides guidance for MA holders on the regulation of changes to the original MA dossier or product license for an approved vaccine in terms of procedures and criteria for the appropriate categorization and reporting of changes, and the data required to enable NAFDAC to evaluate the impact of the change on the quality, safety and efficacy of the vaccine.

This document outlines procedures for effective enrolment and implementation of the mobile authentication service MAS scheme. It provides guidelines for holders of a certificate of registration (HCR) – the applicant seeking to deploy MAS on their registered products, existing MAS providers deploying MAS technology; and MAS providers seeking entry as a NAFDAC approved service provider, and person(s) or group(s) requesting information, education and communication (IEC) materials on the MAS Scheme.

These regulations apply to all foods containing fats and oils that are manufactured, imported, exported, advertised, sold, distributed or used in Nigeria. It guides vitamin A fortification, source, additives, impurities and labelling of fats and oils

These regulations are practice-elaboration of the Nigeria basic ionizing radiation regulation, which is derived from the international basic safety standards for protection against ionizing radiation sources. They provide for the protection of patients, workers and the public from the harmful effects of exposure to ionizing radiation.

These regulations are practice-elaboration of the Nigeria basic ionizing radiation regulation, which is derived from the international basic safety standards for protection against ionizing radiation sources. They provide for the protection of patients, workers and the public from the harmful effects of exposure to ionizing radiation.

This document provides a checklist for the commissioning and regular inspection of nuclear medicine facilities.

This document provides guidance for the preparation of regulatory submission for the registration of medicines for human use in Nigeria in line with the widely accepted format and common requirements achieved through the processes of the International Council for Harmonization (ICH) of regulatory requirement for the registration of medicinal products for human use. it provides guidance on the preparation of regulatory submission for pharmaceutical products by providing guidance on the organization and formatting of product dossier, The adoption of the Common Technical Document (CTD) as developed through the ICH processes and adopted by the World Health Organization in the WHO prequalification programme and the West African Health Organization in the promotion of the harmonization of regulatory requirement for the registration medicinal products for human use, elaborate on requirements for active pharmaceutical ingredients (API) and the finished pharmaceutical products, and promotion of a more transparent regulatory system.

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.