9768 Results Found

NAFDAC Chemical Evaluation & Research (CER) Directorate Guidelines for Obtaining Permit to Import Industrial and Laboratory Chemicals (New Applicants)

Ministry of Industry, Trade and Investment, Nigeria

These guidelines are for the general public and in particular persons intending to obtain a permit to import industrial and laboratory chemicals. They prescribe the requirements for documentation, processing, personnel and timeline for obtaining a permit to import laboratory and industrial chemicals.

Nigeria 2018 Health

NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Labelling of Investigational Medicinal Products

Ministry of Health, Nigeria

Labelling is an important and integral part of the approval of a medicinal product. This also applies to the Investigational Medicinal Product (IMP) in Clinical Trials (CTs). The purpose of regulatory labelling requirements for investigational medicinal products (IMPs) in Clinical Trials (CTs) is to provide added value regarding the protection of the subjects, Identification of the IMP, traceability of the IMP, proper use of the IMP, identification of trial and proper documentation of the trial.

Nigeria 2019 Health

NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Listing as Animal Feed Toll Miller & Requirements for Toll Milling Facility

Ministry of Health, Nigeria

These guidelines are for the interest of the general public and in particular, animal feed toll millers in Nigeria. The document emphasizes that no unbranded animal feeds shall be produced in Nigeria unless the production facility and process have been inspected and the facility listed by NAFDAC except under the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related Legislations and the accompanying guidelines.

Nigeria 2018 Health

NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Listing as Animal Feed Toll Miller & Requirements for Toll Milling Facility (Renewal)

Ministry of Industry, Trade and Investment, Nigeria

These guidelines are for the interest of the general public and in particular to animal feed toll millers in Nigeria. It emphasizes that no unbranded animal feeds shall be produced in Nigeria unless the production facility and process have been inspected and the facility listed by NAFDAC under the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related legislations and the accompanying guidelines.

Nigeria 2018 Health

NAFDAC Chemical Evaluation & Research (CER) Directorate Guidelines for Listing of Chemical Manufacturers in Nigeria (New Applicants)

Ministry of Industry, Trade and Investment, Nigeria

These guidelines are for the interest of the general public and in particular, persons or organisations in Nigeria intending to be listed as a Chemical manufacturer. The document aims to explain in simple terms the obligations on documentation, personnel requirement, safety standard and provides useful specifications with requirements on how to be listed as a manufacturer.

Nigeria 2018 Health

NAFDAC Narcotics & Controlled Substances (NCS) Directorate Guidelines for Obtaining Permit To Clear Narcotic Drugs, Psychotropic Substances and Drug Precursors

Ministry of Health, 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 narcotic drugs, controlled/psychotropic substances and drug precursors into Nigeria. The document emphasizes that narcotics, controlled/psychotropic substances and/or drug precursors should not be imported without obtaining an import permit and a permit to clear where applicable.

Nigeria 2018 Health

NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Submission of Clinical Trial Progress Report

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

These guidelines are for the interest of the general public and in particular individuals and organizations intending to submit progress reports of ongoing clinical trials in Nigeria. The document emphasizes that progress reports on ongoing clinical trials in Nigeria should be submitted using the report template in This guideline.

Nigeria 2019 Health

NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Clinical Trials Protocol development

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

This document defines the terms “objective” and “study endpoint”. It clearly states that for purposes of registration and reporting, the terms objectives and endpoints as used in this template provided in this document align with the terms primary purpose and outcome measures in clinicaltrials.gov, respectively. Individuals should provide a description of the study objectives and endpoints, as well as a justification for selecting the particular endpoints, in the table format included in the statement of compliance 3.0 of the document. This will provide clear articulation on how the selected primary and secondary endpoint(s) are linked to achieving the primary and secondary objectives and an explanation of why endpoint(s) were chosen. Data points collected in the study should support an objective or have a regulatory purpose. Therefore, careful consideration should be given prospectively to the amount of data needed to support the study’s objectives.

Nigeria 2019 Health

NAFDAC Port Inspection Directorate (PID) Guidelines for Export Approval for NAFDAC Regulated Products and Food Stuff for Personal Use

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

These guidelines are for the interest of the general public and in particular, for travellers wishing to obtain export approval for NAFDAC regulated products including food stuff not pre-packaged (e.g. crayfish, pepper, etc.) for personal use. It emphasizes that NAFDAC will not issue any export approval for products that have already left the shores of the country.

Nigeria 2018 Health

NAFDAC Ports Inspection Directorate (PID) Guidelines for Fast Track Clearing of Imported NAFDAC Regulated Products and Bulk Raw Material

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

Fast track is an initiative of the Federal Government to facilitate trade and it is aimed at building local capacity in manufacturing and decongesting the ports. It is for the clearing of registered regulated products, bulk raw materials and packaging materials for registered regulated products. Therefore, this document provides information on the application, verification of application, payment, submission and review of the application, endorsement, joint inspection of consignment, and release of the consignment.

Nigeria Health

Drug Evaluation & Research (DER) Directorate Guidelines for Good Storage Practice (GSP)/ Good Distribution Practice (GDP) Inspection of Cold Chain Facilities for Storage of Vaccines & Biologics

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

Vaccines and biologics should not be imported into Nigeria unless the facility has been inspected and found to comply with good storage practices and good distribution practices. Therefore, these guidelines prescribe the minimum requirements necessary for the inspection of a facility for compliance with GSP and GDP for the registration of vaccines, biologics and related products.

Nigeria 2018 Health

NAFDAC Investigation & Enforcement (I & E) Directorate Guidelines for Handling and Disposal of Unwholesome Medicines and NAFDAC Regulated Products (Food, Medicines, Medical Devices, Cosmetics ETC.) in Nigeria

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

These guidelines are for the general public and in particular, companies that intend to dispose of unwholesome NAFDAC regulated products. It emphasizes that no regulated product shall be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless it has been registered under the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related legislations and the accompanying guidelines.

Nigeria 2018 Health

NAFDAC Guidelines for Importation and Release of Investigational Medicinal Products

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

Investigational medicinal products, which are unregistered medicines, can only be brought into the country after a positive ethical opinion is obtained, the clinical trial application has been approved and a letter of authorization has been issued by NAFDAC. Therefore, this guideline applies to all investigational medicinal products, including vaccines, which do not have marketing authorization in the country of intended use. It provides information on the responsibilities of the sponsor, labelling and packaging, importation and documentation procedures.

Nigeria 2019 Health