9738 Results Found

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

NAFDAC Food Safety & Applied Nutrition (FSAN) Directorate Guidelines for Inspection & Requirements for Packaged Water Facility in Nigeria (Fresh and Renewal Applications)

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

These guidelines are for the general public and in particular, companies involved in the processing and packaging of drinking water in Nigeria. The document prescribes the minimum Good Manufacturing Practice (GMP) requirements for the facilities and controls to be used in the processing of water to ensure that it is safe and meets quality standards.

Nigeria 2018 Health

NAFDAC Food Safety & Applied Nutrition (FSAN) Directorate Guidelines for Pre-Packaged Food Manufacturing/Packaging Facilities 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, manufacturers and packers of pre-packaged food in Nigeria. The document prescribes the minimum current Good Manufacturing Practice (cGMP) requirements for the facilities and controls to be used in the manufacture or processing of products to ensure that they meet quality standards.

Nigeria 2018 Health

NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Inspection of Facilities for Manufacture of Veterinary Cosmetics 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 manufacturers of veterinary cosmetics in Nigeria. It provides information on the application for inspection, procedures for payment, submission of application, scheduling of inspection and inspection.

Nigeria 2018 Health

NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Inspection of Facilities for Manufacture Medicated 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 manufacturers of medicated feed in Nigeria. The document provides information on procedures for application, submission, scheduling of inspection, tariffs and labelling.

Nigeria 2018 Health

NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Inspection of Facilities for Manufacture of Veterinary Medicinal Cosmetics 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 manufacturers of veterinary medicinal cosmetics in Nigeria. The document outlines the procedure for payment, submission of applications, scheduling of inspection, inspection and labelling.

Nigeria 2018 Health

NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Inspection of Locally Manufactured Animal Feed, Pet Food & Premixes

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, manufacturers of local animal feed, pet food and premixes. The document outlines the procedures for payment and application, inspection and labelling requirements.

Nigeria 2018 Health

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

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