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Policies / Policies from 2018

Policies from 2018

Policies with publication year 2018.

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

Nigeria2018HealthOther

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.

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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

Nigeria2018HealthOther

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.

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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

Nigeria2018HealthOther

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.

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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

Nigeria2018HealthOther

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.

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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

Nigeria2018HealthOther

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.

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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

Nigeria2018HealthOther

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

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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

Nigeria2018HealthOther

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.

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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

Nigeria2018HealthOther

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.

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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

Nigeria2018HealthOther

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.

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NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs)

Ministry of Industry, Trade and Investment, National Agency for Food and Drug Administration and Control

Nigeria2018HealthOther

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.

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