6519 Results Found
NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Conduct of Clinical Trials during Emergencies
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
This guideline is to provide requirements for the conduct of clinical trials during public health emergencies.
Nigeria • 2019 • Health
Nigerian Nuclear Regulatory Authority (NNRA) Minimum Requirements For Accreditation To Sale And Supply Ionizing Radiation Generating Equipment – Radiotherapy/Diagnostic Radiology For Medical Applications
Ministry of Power, Works and Housing, Nigeria
This document details on the minimum requirements for accreditation to sale and supply ionizing radiation generating equipment – Diagnostic Radiology for medical applications. It emphasizes that the requirements should be applied in additions to 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
National Agency for Food and Drug Product Administration and Control (NAFDAC) Cocoa and Cocoa Products Regulations 2019
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These regulations apply to cocoa and cocoa products that are manufactured, imported, exported, advertised, sold, distributed or used in Nigeria. The document provides information on labels, conditions for claims that food is cocoa based, prohibitions, maximum limits of contaminants, permitted additives, penalty, and forfeiture after conviction.
Nigeria • 2019 • Health
National Agency for Food and Drug Product Administration and Control (NAFDAC) Controlled Medicines Regulations 2019
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These regulations apply to procedures and processes that will ensure appropriate importation, exportation, manufacturing, storage, warehousing, distribution, inspection, use for medical and scientific purposes, disposal as well as documentation of controlled medicines in Nigeria, in such a manner as to maintain the security and integrity of the product throughout the supply chain. They provide information on prohibition, application of registration, validity, Suspension or cancellation of certificate of registration, permit or authorization, importation of controlled medicines, labelling, storage facility, distribution, procurement, selection and quantification, inspection, dispensing, disposal of controlled medicines, penalty, and forfeiture after conviction.
Nigeria • 2019 • Health
National Agency for Food and Drug Product Administration and Control (NAFDAC) Cosmetic Products Advertisement Regulation 2019
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These regulations apply to all advertisements and promotion of cosmetics products (both single and compound entity) manufactured, imported, exported, sold, distributed or used in Nigeria. The provide information on nature of advertisement, non-referential advertisement, application for the approval of advertisement, validity of approval, withdrawal of an approval, reference to professional body or association, contravention of ethical standards not permitted, unfairly disparage competition, and restriction.
Nigeria • 2019 • Health
Comestics Products Labelling Regulations 2019
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These regulations provide for the registration of all cosmetics manufactured, imported, exported, advertised, sold, distributed or used in Nigeria. It provides information on labelling information and net content of cosmetic product.
Nigeria • 2019 • Health
Cosmetic Products (Prohibition of Bleaching Agents) Regulations 2019
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
These regulations guide the manufacture, import, export and distribution of safe cosmetics product and penalties for offenders of the regulations.
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 additions 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 (NNRA) Requirements for Authorization of Diagnostic Radiology Practice.
Ministry of Power, Works and Housing, Nigeria
This document provides the Nigerian Nuclear Regulatory Authority (NNRA) requirements for authorization of diagnostic radiology practice.
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 a 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 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 entity, 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 in accordance with 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 in accordance with 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 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, statement relating to 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, 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 in accordance with 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
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 to 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 registration of bio similar 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 bio similar will rely, in part, on non-clinical and clinical data generated with an already licensed RBP.
Nigeria • 2012 • Health
Guidelines for Issuance of approval to Import Donated Items by Non-governmental Organizations
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
This document is for the interest of the general public and in particular, non-governmental organization who wish to import NAFDAC regulated items. It emphasizes that no food, drug, cosmetics, packaged water, detergent, 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