842 Results Found

NAFDAC Herbal Medicine And Related Advertisement Regulations 2019

Ministry of Health, Nigeria

These regulations apply to all advertisements or promotion of herbal medicine and related product manufactured, imported, exported, distributed, advertised, sold, or used in Nigeria. The document emphasizes that no person shall advertise any herbal medicines and related products unless it has been registered by the Agency, herbal medicines and related products unless the advertisement has approval of the Agency, extemporaneous herbal medicines and related products and herbal medicines and related products as a cure, prevention, treatment for any disease conditions listed in schedule 1 of this document or as may be prescribed by the agency.

Nigeria 2019 Health

National Environmental Protection (Effluent Limitation) Regulations

Ministry of Health, Nigeria

This document provides for the Installation of anti‐pollution equipment, Waste water parameters, treatment of effluent, and additional sectorial effluent limitation treatment. The first schedule outlines the important waste water parameters for selected industrial classifications. Second schedule concerns the Effluent limitation guidelines in Nigeria for all categories of industries.

Nigeria 1991 Health

NAFDAC Herbal Medicine And Related Products Labelling Regulations 2019

Ministry of Health, Nigeria

These regulations shall apply to all labelling of complementary and alternative medicine manufactured, imported, exported, distributed, advertised, displayed for sale or used in Nigeria. The document emphasizes that no person shall manufacture, import, export, distribute, advertise or sell any complementary and alternative medicine unless it is labelled in accordance with the provision of these regulations.

Nigeria 2019 Health

National Environmental (Ozone Layer Protection) Regulations, 2009

Ministry of Health, Nigeria

This document provides regulations on national environment and clearly emphasizes that no person shall import, manufacture in part or in whole, install, offer for sale, sell or buy new or refurbished facilities intended to be used for the production of any ozone-depleting substance unless for recovery and recycling of substances already in use.

Nigeria 2009 Health

NAFDAC Food Fortification Regulations 2019

Ministry of Health, Nigeria

These regulations apply to all fortified foods manufactured, imported, exported, distributed, advertised, sold or used in Nigeria. The document emphasizes that no person can sell or advertise any food that is represented on the label to the general public as fortified with vitamins and mineral unless it is registered with the Agency, manufacture, import, export, advertise, sell, distribute, store or use any fortified food as treatment, preventive or curative for any of the diseases, disorders or abnormal physical states specified in schedule I to these regulations, sell or advertise any food to the general public as fortified with vitamins and minerals referred to in these regulations, if the Nutrient Reference Value (NRV) intake of that food by a person will result in the NRV by such a person of more than the quantity of vitamins and mineral nutrients specified in schedule II of these regulations and no food product for the purpose of global listing for supermarket Items and Restaurant Operators, shall be allowed unless it complies with the provisions of these regulations or as prescribed by the Agency. The Nutrient Reference Values are covered in schedule II.

Nigeria 2019 Health

Food and Drugs (Amendment) Decree 1999

Ministry of Health, Nigeria

The decree amends the Food and Drugs Act to provide, among other things, for the prohibition of sale or advertisement of food, etc. as treatment, etc. for certain diseases, including acquired immune deficiency syndrome.

Nigeria 1999 Health

Lagos State Environmental Protection Agency ( No. 9 of 1997).

Ministry of Health, Nigeria

This is a law to establish the Lagos State Environmental Protection Agency and for other matters incidental thereto or connected therewith (1997 No 9). The agency shall be a body corporate with perpetual succession and a common seal and shall have power to sue and be sued in its corporate name and to acquire, hold and dispose of its movable and immovable property for the purpose of carrying out its functions under this Law. Some of the functions of the agency are to advise the State Government on all environmental management policies, give direction to the affairs of the agency on all environmental matters, carry out public enlightenment and educate the general public on sound methods of environmental sanitation and management and so on.

Nigeria 1997 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Quality Guidelines for The Registration Of Pharmaceutical Products for Human Use In Nigeria

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

This document provides guidance for the preparation of regulatory submission for the registration of medicines for human use in Nigeria in line with the widely accepted format and common requirements achieved through the processes of the International Council for Harmonization (ICH) of regulatory requirement for the registration of medicinal products for human use. it provides guidance on the preparation of regulatory submission for pharmaceutical products by providing guidance on the organization and formatting of product dossier, The adoption of the Common Technical Document (CTD) as developed through the ICH processes and adopted by the World Health Organization in the WHO prequalification programme and the West African Health Organization in the promotion of the harmonization of regulatory requirement for the registration medicinal products for human use, elaborate on requirements for active pharmaceutical ingredients (API) and the finished pharmaceutical products, and promotion of a more transparent regulatory system.

Nigeria 2008 Health

NAFDAC Spirit Drinks Regulations 2019

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

These regulations apply to all spirit drinks, manufactured, imported, exported, distributed, advertised, sold or used in Nigeria. They also apply to the use of ethyl alcohol and distillates of agricultural origin in the production of alcoholic beverages and to the use of the names of spirit drinks in the presentation and labelling of foodstuffs.

Nigeria 2019 Health

NAFDAC Wine Regulation 2019

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

These regulations apply to wine manufactured, imported, exported, advertised, sold, distributed or used in Nigeria. It provides regulations on the use and limit of food additives, categories of grape vine, vintage dating, sugar content and labelling.

Nigeria 2019 Health

NAFDAC Registration & Regulatory Affairs (R &R) Directorate Guidelines On Variations To A Registered Vaccine for Humans

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

These guidelines apply to marketing authorization (MA) Holders intending to make changes to the quality section of the dossier as well as to the safety, efficacy and product labelling information for an antigen, intermediate or a finished vaccine product. This guidance should be read in conjunction with the NAFDAC guidelines on variations to a registered pharmaceutical product. It provides guidance for MA holders on the regulation of changes to the original MA dossier or product licence for an approved vaccine in terms of procedures and criteria for the appropriate categorization and reporting of changes, and the data required to enable NAFDAC to evaluate the impact of the change on the quality, safety and efficacy of the vaccine.

Nigeria Health

NAFDAC Guidelines for Procurement And The Management Of The Mobile Authentication Service (MAS) Scheme In Nigeria 2018

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

This document outlines procedures for effective the enrolment and implementation of the mobile authentication service MAS scheme. It provides guidelines for holders of a certificate of registration (HCR) – the applicant seeking to deploy MAS on their registered products, existing MAS providers deploying MAS technology; and MAS providers seeking entry as a NAFDAC approved service provider, and person(s) or group(s) requesting information, education and communication (IEC) materials on the MAS Scheme.

Nigeria 2018 Health

NAFDAC Fats And Oils Regulations 2019

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

These regulations apply to all foods containing fats and oils that are manufactured, imported, exported, advertised, sold, distributed or used in Nigeria. It provides guidance on vitamin A fortification, source, additives, impurities and labelling of fats and oils

Nigeria 2019 Health

Nigerian Radiation Safety in Diagnotics and Interventional Radiology Regulations, 2006

Ministry of Health, Nigeria

These regulations are practice-elaboration of the Nigeria basic ionizing radiation regulation, which is derived from the international basic safety standards for protection against ionizing radiation sources. They provide for the protection of patients, workers and the public from the harmful effects of exposure to ionizing radiation.

Nigeria 2006 Health

Nigerian Radiation Safety in Nuclear Medicine Regulations, 2006

Ministry of Health, Nigeria

These regulations are practice-elaboration of the Nigeria basic ionizing radiation regulation, which is derived from the international basic safety standards for protection against ionizing radiation sources. They provide for the protection of patients, workers and the public from the harmful effects of exposure to ionizing radiation.

Nigeria 2006 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Renewal of certificate of registration for Drugs Made in Nigeria

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

The National Agency for Food and Drug Administration and Control has the responsibility of ensuring that drugs made in Nigeria placed on the Nigerian market for use meet the requirements for quality, safety and efficacy throughout the lifecycle of the product. The procedure for registration of drugs made in Nigeria outlines the process to be followed and the technical requirements to be met before a product can be placed on the Nigerian market. The document is intended to provide guidance on the technical and other general data requirements when submitting an application for renewal of product licence for drug made in Nigeria.

Nigeria 2019 Health

NAFDAC Good Clinical Practice Guidelines 2016

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

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of humans. It provides unified standards for the conduct of clinical data in Nigeria. The guidelines describe the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and ethics committees.

Nigeria 2016 Health

NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines for Renewal of certificate of registration for Imported Drug Products in Nigeria (Human and Veterinary Drugs

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

The National Agency for Food and Drug Administration and Control has the responsibility of ensuring that imported drugs placed on the Nigerian market for use meet the requirements for quality, safety and efficacy throughout the lifecycle of the product. The procedure for registration of imported drugs outlines the process to be followed and the technical requirements to be met before a product can be placed on the Nigerian market. The document is designed to provide guidance on the technical and other general data requirements when submitting an application for renewal of product license for imported drugs.

Nigeria 2019 Health

NAFDAC Drug Evaluation & Research (DER) Directorate Good Manufacturing Practice Guidelines for Cosmetics Products 2018

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

These cosmetic Good Manufacturing Practice (GMP) guidelines are for the manufacture, storage and shipment of cosmetic products. The primary objective of the guidelines is to ensure that products are consistently manufactured in conformance with quality standard. It is concerned with all aspects of production and quality control.

Nigeria 2018 Health