10006 Results Found

NAFDAC Ports Inspection Directorate (PID) Guidelines for Clearing Imported Narcotic and Controlled Substances, Pharmaceutical Raw Materials and restricted chemicals 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 developed for the interest of the general public and in particular, importers of Narcotic and Controlled Substances, Pharmaceutical raw materials and restricted chemicals into Nigeria. The document emphasizes that pharmaceutical raw materials and restricted chemicals should not be imported without obtaining an Import permit and permit to clear where applicable.

Nigeria 2018 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

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

Nigerian Nuclear Regulatory Authority (NNRA) Minimum Requirements for Authorization of Diagnostic Radiology Facilities in Nigeria

Ministry of Energy and Natural Resources, Nigeria

This document provides the Nigerian Nuclear Regulatory Authority (NNRA) minimum requirements for authorization of diagnostic radiology facilities in Nigeria. It states that the requirements should be applied in addition to the Nigerian Basic Ionizing Radiation Regulations 2003; the Nigerian Radiation Safety in Diagnostic and Interventional Radiology Regulations 2006; the Nigerian Radiation Safety in Radiotherapy Regulations 2006; and the Nigerian Radiation Safety in Nuclear Medicine Regulations 2006.

Nigeria 2018 Energy

Nigerian Nuclear Regulatory Authority Requirement for Registration of Drilling Rig to a NNRA Authorized Client

Ministry of Power, Works and Housing, Nigeria

Nigerian Nuclear Regulatory Authority (NNRA) requirement for registration of drilling rig to an NNRA authorized client. It emphasizes that NNRA requires that rig owners intending to lease their rigs for storage or handling of radioactive sources to only one NNRA licensed client with valid authorization need to obtain a certificate of registration of premises for those rigs.

Nigeria 2018 Energy

National Agency for Food and Drug Product Administration and Control (NAFDAC) Drug and Related Products Advertisement Regulations 2019

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

These regulations apply to all advertisements or promotion of drug products both single and compound entities, manufactured, imported, exported, sold, distributed or used in Nigeria. It emphasizes that no person shall advertise any drug or related product unless it has been registered by the Agency. No person shall advertise any drug product unless the advertisement has the pre-clearance and approval of the Agency; and no person shall engage in consumer promotions of any kind, including but not limited to gifts or free samples of drug or related products to the consuming public.

Nigeria 2019 Health

Drug and Related Product Labelling Regulations 2019

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

These regulations apply to all labelling of drugs and related products manufactured, imported, exported, sold, distributed or used in Nigeria. No person can manufacture, import, export, distribute, advertise, display for sale or use any drug or drug product unless it is labelled per these regulations.

Nigeria 2019 Health

Drug and Related Products Registration Regulations 2019

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

These regulations apply to the registration of drugs and related products manufactured, imported, exported, advertised, sold, distributed or used in Nigeria. The document emphasizes that no drug product shall be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless it has been registered under the provisions of these regulations.

Nigeria 2019 Health

Food Additives Regulations 2019

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

These regulations apply to the labelling of food additives sold either by retail or others, including sales to caterers and food manufacturers. They also apply to food processing aids and also provide the prohibition regulation that no person can manufacture, import, export, distribute, advertise, display for sale or use any food additives, except food additives set out in the prescribed standards.

Nigeria 2019 Health

Food fortification Regulation 2019

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

These regulations apply to all fortified foods manufactured, imported, exported, distributed, advertised, sold or used in Nigeria. The regulatory document provides for the advertisement of foods to which no vitamin and/or mineral has been added, label declaration of food to which vitamin and/or mineral has been added, a statement relating to the mineral content of food, label declaration of food mandatorily fortified with vitamin A, labelling, packaging, penalty and forfeiture after conviction.

Nigeria 2019 Health

Food Irradiation Regulations 2019

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

These regulations apply to foods processed by ionizing radiation that is used in conjunction with applicable hygienic codes, food standards and transportation codes, manufactured, imported, exported, distributed, advertised, sold or used in Nigeria. The document provides information on the general requirement for food treatments, radiation sources, absorbed dose, facilities and control of the process, the wholesomeness of irradiated foods, packaging, quality assurance, inspection, re-irradiation, labelling, trade-in irradiated foods, importation, exportation, penalty, and forfeiture after conviction

Nigeria 2019 Health

Guidelines for Registration of Herbal Remedies/Dietary Supplements made 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 herbal remedies/dietary supplements made in Nigeria. The document emphasizes that no herbal remedies/dietary supplements 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

Guidance Document for Submission of Application in the Common Technical Document format - Vaccines for Human Use

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

This guideline is technically and structurally inspired by Health Canada’s guidance document on harmonized requirements for the licensing of vaccines and guidelines for the preparation of an application and the World Health Organization (WHO) working document on vaccine prequalification dossier. This guideline document has been developed in pursuance of the National Agency for Food and Drug Administration and Control (NAFDAC) Act Cap. N1, LFN 2014 and made to provide guidance to applicants on the organization of information to be provided to the agency in seeking marketing authorization for Vaccines for human use. The document applies to all vaccines to be authorized for human use, regardless of where they are manufactured.

Nigeria 2019 Health

Biosimilar Guidance Document (NAFDAC)

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

The intention of this document is to provide acceptable principles for the registration of biosimilar products that are claimed to be similar to RBP of assured quality, safety, and efficacy that have been licensed based on a full registration dossier by a stringent regulatory authority. On the basis of proven similarity, the registration of a biosimilar will rely, in part, on non-clinical and clinical data generated with an already licensed RBP.

Nigeria 2012 Health