9768 Results Found

NAFDAC Regulatory and Registration of Biosimilars 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, pharmaceutical industries in Nigeria. The document provides guidelines for the registration of biosimilars in Nigeria.

Nigeria 2018 Health

NAFDAC Registration & Regulatory Affairs (R & R) Director Guidelines for Registration of Imported Drugs, Vaccines and In-Vitro Diagnostics Under WHO collaborative Registration Procedure (CRP)

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/importers of drugs, vaccines and in-vitro diagnostics into the county which has been prequalified by the World Health Organization. This guideline is based on NAFDAC’s regulatory reliance policy on the adoption of a regulatory reliance mechanism to make regulatory decisions as it relates to the granting of marketing authorization. Clinical trial approval and conduct of Good Manufacturing Practice (GMP) Inspections.

Nigeria 2019 Health

NAFDAC Chemical Evaluation & Research (CER) Directorate Guidelines for Renewal of Permit to Import Industrial and Laboratory Chemicals

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

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

Nigeria 2018 Health

NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Inspection of Facilities for Manufacture of Veterinary Drugs 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 drugs in Nigeria. The document outlines the application for inspection, the procedure for payment, scheduling of inspection, inspection and labelling information.

Nigeria 2018 Health

NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Warehouse Inspection

Ministry of Industry, Trade and Investment, 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 animal feeds, feed additives, feed concentrates, feed supplements, premixes, fish meal, pesticides, agrochemicals and fertilizers. The document outlines the application process, procedures of warehouse inspection etc.

Nigeria 2018 Health

NAFDAC Ports Inspection Directorate (PID) Guidelines for Issuance of Export Certificate for NAFDAC Regulated Products

Ministry of Industry, Trade and Investment, 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 drugs, food, cosmetics, medical devices and other regulated products intended for commercial purposes. The document emphasizes that National Agency for Food and Drug Administration and Control (NAFDAC) will not issue any Export Approval for products that have already left the shores of the country. It also outlines the procedures for application, inspection and issuance.

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 Issuance of Authorization on Letter of No Objection and Approval to Open form M and Pre-Arrival Assessment 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 Chemical Evaluation and Research Directorate Permit for Clearance of Imported Restricted and Agro-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 a permit to clear restricted chemicals and agrochemicals. They prescribe the requirement for documentation, processing, personnel requirement, and the timeline for obtaining a permit.

Nigeria 2018 Health

NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Issuance of Permit to Import Bulk Pesticides, Agrochemicals and Fertilizers (New Applicants)

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

These guidelines are for the interest of the general public, and in particular manufacturers and importers of pesticides, agrochemicals and fertilizers in Nigeria. The document emphasizes that no company can import bulk pesticide, agrochemical or fertilizer without due authorization. Therefore, it provides guidelines involved in the application, processing and issuance of permits.

Nigeria 2018 Health

NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Issuance of Permit to Import Bulk Pesticides, Agrochemicals and Fertilizers (Renewal)

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

These guidelines are for the interest of the general public, and in particular manufacturers and importers of pesticides, agrochemicals and fertilizers in Nigeria. The document emphasizes that no company can import bulk pesticide, agrochemical or fertilizer without due authorization.

Nigeria 2018 Health

NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Issuance of Permit to Import Feed Supplements, Feed Concentrates, Feed Additives, Premixes, Fish Meal (New Applicant)

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

These guidelines are for the interest of the general public, and in particular manufacturers and importers of feed supplements, feed concentrates, feed additives, premixes and fish meal in Nigeria. The document emphasizes that no company is allowed to import bulk feed supplements, feed concentrates, feed additives, premixes and a fish meal without due authorization.

Nigeria 2018 Health

NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guidelines for Issuance of Permit to Import Feed Supplements, Feed Concentrates, Feed Additives, Premixes, Fish Meal (Renewal)

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

These guidelines are for the interest of the general public, and in particular manufacturers and importers of feed supplements, feed concentrates, feed additives, premixes and fish meal in Nigeria.

Nigeria 2018 Health

NAFDAC Veterinary Medicines & Allied Products Directorate (VMAP) Guideline for Issuance of Permit to Import Field Trial Samples

Ministry of Industry, Trade and Investment, Nigeria

This guideline document is designed for the interest of the general public and in particular companies that want to conduct field trials on products for registration purposes. It should be emphasized that no fertilizers, bio-fertilizers, pesticides, bio-pesticides or premixes shall be manufactured for commercial purpose, imported, exported, distributed, sold or used in Nigeria except it has been subjected to field trials at an approved institute and monitored by the agency under the provisions of 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