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.

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

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

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.

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.

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 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.

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.

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.

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.

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.

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 importers of Pharmaceutical and Veterinary drugs in Nigeria. The document emphasizes that no drug 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 outlines the guidelines for application for registration of the imported drug, import permits, submission of samples for laboratory analysis and labelling of imported drugs.

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.

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 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.

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.