1477 Results Found

NAFDAC Food Safety & Applied Nutrition (FSAN) Directorate Guidelines for Production Inspection of Micro Scale Food Manufacturing Facilities in Nigeria (New Applicants)

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

These guidelines are for the general public and in particular, individuals intending to engage in the manufacture of packaged food products on a micro-scale. the document prescribes the minimum Good Hygiene Practices (GHP) requirements for the facilities, controls to be used in the manufacturing, processing and packaging of food products to ensure the safety of the product.

Nigeria 2018 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

Drug Evaluation & Research (DER) Directorate Guidelines for Inspection of Premises for Global Listing of Cosmetics Products

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

These guidelines are for the general public and in particular organizations intending to engage in the importation of cosmetics products under the global listing scheme. They cover small, medium, large and mega categories and also prescribe the minimum Good Hygiene Practice (GHP) and Good Storage Practice (GSP) requirements for the facilities used for storage and display of items cleared for global listing.

Nigeria 2018 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

NAFDAC Ports Inspection Directorate (PID) Guidelines for Clearing Imported Finished Pharmaceutical, Nutraceuticals and Herbal Products (Human and Veterinary) at Ports of Entry in Nigeria

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

These guidelines are for the interest of the general public and in particular importers of finished pharmaceutical, nutraceutical and herbal products (Human and Veterinary) into Nigeria. The document provides for payment, submission of documents for first endorsement, first endorsement, and joint inspection of consignment, second endorsement and release of the consignment.

Nigeria 2018 Health

NAFDAC Ports Inspection Directorate (PID) Guidelines for Clearing of Imported Regulated Food Products (Including Global Listing for Supermarket Items & Restaurant Operators) at Ports of Entry in Nigeria

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

These guidelines are for the interest of the general public and in particular, importers of food products into Nigeria. The document provides the procedures for application, verification of the application, payment, submission of application, review of the application, first endorsement, joint inspection of consignment, second endorsement, the release of consignment and tariff.

Nigeria 2018 Health

NAFDAC Ports Inspection Directorate (PID) Guidelines for Clearing of Imported Cosmetic (Including Global Listing for Supermarket Items) and Medical Devices at Ports of Entry in Nigeria

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

These guidelines are for the interest of the general public and in particular, importers of cosmetics and medical devices into Nigeria. The document emphasizes that no cosmetics and medical devices 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 (NAFDAC) Act CAP N1 (LFN) 2004, other related legislations and the accompanying guidelines.

Nigeria 2018 Health

NAFDAC Ports Inspection Directorate (PID) Guidelines for Clearance of Imported General Chemicals, Agrochemicals and Raw Materials at Ports of Entry in Nigeria

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

These guidelines are for the interest of the general public and in particular importers of general chemicals, agrochemicals and raw materials into Nigeria. The document emphasizes that no general chemicals, agrochemicals or raw materials shall be imported without obtaining an Import permit or approval. It provides for payment, submission of documents for first endorsement, joint inspection of consignment, second endorsement and release of the consignment.

Nigeria 2018 Health

NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Clinical trial Application in Nigeria

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 conduct clinical trials in Nigeria. This document emphasizes that no person shall import, procure or manufacture a drug product, cosmetic or medical device for a clinical test in Nigeria unless he is a holder of a valid clinical trial approval and the trial is to be conducted under the terms of the approval and the provisions of any regulations in force.

Nigeria 2019 Health

Guidelines for Approval to Import Products by Government Agencies, International Bodies & Multinational Organizations

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, government agencies, international bodies & multinational companies who wish to import NAFDAC regulated products. It emphasizes that no food, drug, cosmetics, packaged water, detergent, the 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.

Nigeria 2018 Health

NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Clinical Investigation of Medicinal Products in Paediatric Population

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

The guideline has an overall objective to encourage and facilitate timely paediatric medicinal product development in Nigeria. It provides an outline of critical issues in paediatric drug development and the approaches to the safe, efficient and ethical study of medicinal products in the paediatric population.

Nigeria 2019 Health

Guidelines for Issuance of Authorization to Open form M

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

This guideline document is for those importers of bulk food raw materials/importers of frozen fish, for which NAFDAC permits or certificates of registration are not issued, who require authorization to open from M.

Nigeria 2018 Health