6519 Results Found
NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Pre-Registration Inspection of Pharmaceutical ManufActuring Facilities 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 the pharmaceutical manufacturing companies in Nigeria. The document prescribes the minimum requirements necessary for the inspection of a facility for compliance with good manufacturing practices for the registration of pharmaceutical products.
Nigeria • 2018 • Health
NAFDAC Quality Management System Guidelines for Complaints and Appeals against Regulatory Decisions
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These guidelines are for the interest of the general public, NAFDAC clients or stakeholders who wish to make a complaint or make an appeal in the case of a regulatory decision regarding products and/or issues relating to NAFDAC regulated products.
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 travelers 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 application, verification of application, payment, submission and review of application, endorsement, joint inspection of consignment, and release of 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 practice and good distribution practice. 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 in accordance with 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 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 bread Manufacturing
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These guidelines have been designed for the general public and in particular, manufacturers of bread in Nigeria.
Nigeria • 2018 • 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 application for inspection, procedure 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 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 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 importation of cosmetics products under 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 Food Safety & Applied Nutrition (FSAN) Directorate Guidelines for Production Inspection of Small scale Food Enterprises 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, for manufacturers of pre-packaged food products on a small scale in Nigeria. It prescribes the minimum Good Hygiene Practices (GHP) and Good Manufacturing Practice (GMP) requirements for the facilities, controls to be used in manufacturing, processing and packaging of food products to ensure the safety of the product.
Nigeria • 2018 • Health
NAFDAC Chemical Evaluation & Research (CER) Directorate Guidelines for Issuance of Additional Permit to Import Industrial and Laboratory Chemicals
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These guidelines are for the general public and in particular persons intending to obtain additional permits to import Industrial and laboratory chemicals. These guidelines prescribe the requirements for documentation, processing, personnel and timeline for obtaining additional permits to import industrial and laboratory chemicals.
Nigeria • 2018 • Health
NAFDAC Ports Inspection Directorate (PID) Guidelines for Issurance of Authorization on Letter of No Objection and Approval to Open form M and Pre-Arrival Assesment Report (PAAR)
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, holders of NAFDAC certificates of registration for regulated products, who wish to grant authorization (no objection) for the importation of their registered products by another company. These guidelines are also for those importers of NAFDAC regulated products, for which NAFDAC Permits or certificates of registration are not issued, who require authorization to open form M and pre-arrival assessment report (PAAR).
Nigeria • 2018 • Health
NAFDAC Ports Inspection Directorate (PID) Guidelines for Issuance of Export Approval of Samples for Machine Trials (Research)
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, exporters of samples for machine trials. They provide information on application and issuance of export approval.
Nigeria • 2018 • Health