Where necessary, specialists will be consulted for professional opinion on various sections of. September 9, 20 as part of the regulations contained in the national agency for food and drug administration and control nafdac act, food and drug producers must take adequate steps to inform consumers of their products about the ingredients contained in bottled water and other beverages, prepackaged foods, herbal medicines, cosmetics. Nigerias commitment to universal health coverage was enshrined by the passage of the national health act of 2014 in response to the continued. Section 5 of the act prohibits various misleading practices relating to. Nafdac good pharmacovigilance practice guidelines, 2016 nigeria. Read this booklet carefully and take the practice tests well before test day. Also featured are a practice writing test, a sample answer document, answer keys, and selfscoring instructions.
It is necessary to emphasize that no regulated products shall be manufactured, imported, exported, advertised, sold or distributed in nigeria unless it has been registered in accordance with the provisions of act cap f33 lfn 2004 formerly decree 19 of. Together the npa and rulesregulations guide and govern nursing practice. Power of minister to obtain particulars in respect of certain substances. Ncc operates within the provisions of the ncc procedural manual that sets out. Moji adeyeye, has approved the production of chloroquine for clinical trial in nigeria, following the publication of two clinical trials in china and usa recently adeyeye made the disclosure in a press conference at the nafdac office, oshodi, lagos, on friday. The director general, national agency for food and drug administration and control nafdac prof. These guidelines are for the interest of the general public and in particular, industries in nigeria that have registered regulated products. National agency for food and drug administration and control. Health, nutrition and population global practice, world bank, washington, usa. The fair debt collection practices act as amended by pub.
Nafdac regulated products and licences registration of. Nafdac guidelines for advertisement of regulated products in. Physical therapists are licensed in all 50 states and the district of columbia, puerto rico, and the virgin islands. Nigeria national agency for food and drug administration and control nafdac act 1993 as amended 2009. The national agency for food and drug administration and control nafdac is one of the. In assessing pesticide products, nafdac considers the uses being proposed in determining the data required but generally, nafdacs dossier requirements for pesticide registration seeks to obtain data and information relating to the following. These guidelines are for the interest of the general public and in particular, pharmaceutical industries in nigeria. Act cap f33 lfn 2004 and of all the powers enabling it in that behalf, the governing council of the national agency for food and drug. Read each question carefully to make sure you understand the type of answer required. Fair debt collection practices act federal trade commission. An actual act english test contains 75 questions to be answered in 45 minutes.
Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. An act to establish the national agency for food and drug administration and control with the functions, among others, to regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, bottled water. Moji adeyeye, 2nd from right, flanked by directors of different units of the agency, at the press conference. If you choose to use a calculator, be sure it is permitted, is working on test day, and has reliable batteries. The responsibility for the regulation and control of advertisement of these products. The simple rules on product packaging and labelling in nigeria. National agency for food and drug administration and. Safe, competent nursing practice is grounded in the law as written in the state nurse practice act npa and the state rulesregulations. Data to identify the product identity, composition, analysis and manufacturer. Guidelines for importation of chemicals in nigeria. Data was gathered by a combination of the use of questionnaires. A committee of experts will be constituted at nafdac made up of regulatory officers from the registration and regulatory affairs directorate and other technical directorates of nafdac. The national agency for food and drug administration and.
Pdf evaluation of food safety and quality regulations in nigeria. Nafdac approves chloroquine production for clinical trial. It is necessary to emphasize that no processed food shall be manufactured, imported, exported, advertised, sold or distributed in nigeria unless it has been registered in accordance with provisions of decree 19 of 1993 as amended by food, drugs and related products. The national agency for food and drug administration and control nafdac is a federal agency under the federal ministry of health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water in nigeria. An act to provide for the control of the sale and distribution of fertilizer and for matters connected therewith. These guidelines are for the interest of the general public, and in particular, food and beverage inductries in nigeria. Out of the few that are aware, an even smaller number have an idea of how to enforce such rights. Regulation and enforcement of legislation on food safety. The nafdac gvp regulations describes the obligations of the marketing authorization holder to setup a system for pharmacovigilance in order to collect, collate and evaluate information about suspected.
Pdf copies of the following standards are available as well as regulatory compliance services connected with them for a fee. Fulllength practice tests, including a writing test information about the optional writing test strategies to prepare for the tests what to expect on test day effective through the 20112012testing year. It is my pleasure to present the national policy on food safety and its implementation strategy to all governments, national, international, nongovernmental agencies, healthcare providers and the general public. Keynote speech for the opening of the 4th meeting of the african vaccine regulatory forum avaref, delivered by dr paul orhii, directorgeneral, national agency for food and drug administration and control nafdac, lagos nigeria. How to register a product in nafdac information guide in. Administration and control nafdac by section 5 and 30 of the national agency for food and drug administration and control act 1993, as amended and of the powers enabling it in that behalf, the governing council of the national agency for food and drug administration and control with the approval of the honourable minister of health. Nafdac has also issued various guidelines which supplement the nafdac act. Even though some practice tests are old dating as far back as 2005, the format of the act hasnt changed much since then except for the introduction of a redesigned writing section in 2015, so youre basically still taking the same test from more than a decade ago. Nafdac recruitment 20202021 latest application updates.
The national agency for food and drug administration and control nafdac is responsible for the regulation and control of the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drug, cosmetics, medical devices, chemicals, packaged water and detergent at federal and state levels in nigeria. The nafdac act empowers nafdac to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, medical devices, bottled water and chemicals. Pdf nafdac information system for product registration. Apr 03, 2020 nafdac was established by decree 15 of 1993 as amended by decree 19 of 1999 and now the national agency for food and drug administration and control act cap n1 laws of the federation of nigeria, 2004. Control nafdac has the mandate through nafdac act capn1 lfn 2004 to regulate and control the manufacture, importation, exportation, advertisement, distribution, sale and use of foods, drugs, cosmetics, medical devices, bottled water and chemicals. This test option is not available through any other type of testing for example, testing outside the u. The act plus writing is available on national test dates and for special and arranged testing within the united states during designated testing windows. How to process a product registration with nafdac getting a food or drug product registered with nigerias regulator if the business youve chosen to go into involves the manufacture or importation of goods that fall within the description of food or drug, then be sure that you cannot legitimately carry on such trade without the appropriate registration of the products by the. Refer to the scientific information in the passage when answering the question. These guidelines are intended for persons, companies and other stakeholders involved in any act of importation of chemicals into nigeria.
The regulations contain the minimum good manufacturing practice requirements for methods, facilities and controls for the manufacture, processing, packaging, or holding of a pharmaceutical product for human or animal use. Some questions will ask you to base your decision on some specific element of writing, such as the tone or emphasis the. The primary objective of this study is to establish the factors that have contributed to the preponderance of counterfeit drugs in nigeria despite the laws. Nigeria food and agricultural import regulations and. Nafdac good practices for pharmaceutical quality control. An actual act science test contains 40 questions to be answered in 35 minutes. Nafdac recruitment 20202021 latest application updates portal. Act online prep has practice test questions, a practice essay with realtime scoring, a diagnostic test, and personalized study path. Find below regulations and guidelines of nafdac under the following headings or categories.
It is necessary to emphasize that, no drug shall be manufactured, imported. Licensure is required in each state in which a physical therapist practices and must be renewed on a regular basis, with a majority of. National policy on food safety and its implementation strategy. Nafdac act appears to make provisions forbidding the importation, sale and distribution of harmful drugs, food, cosmetics and medical devices for human consumption. The lack of or inadequate application of good agricultural practices gap. Nafdac ncs00200 a general 1 these guidelines are intended for persons, companies and other stake holders involved in any act of importation of chemicals into nigeria. The national agency for food and drug administration and control nafdac act cap n1, lfn 2004 empowers the agency to control and regulate the manufacture, importation, exportation, distribution, advertisement, sale and use of its regulated products. The national agency for food and drugs administration and control nafdac is a nigerian government agency under the federal ministry of health is mandated by decree 15 of 1993 as amended by decree 19 of 1999 constitution and the nafdac act cap n1 laws of nigeria, 2004 to regulate and control the importation, production, exportation, sales, advertisement, distribution and use of food, drugs, etc. An actual act mathematics test contains 60 questions to be answered in 60 minutes.
Nigerias commitment to universal health coverage was enshrined by the passage of the national health act. The agency therefore has developed nafdac good pharmacovigilance practice regulations to ensure safety of medicinal products that it regulates. Nigeria national agency for food and drug administration and control nafdac act 1993 as amended. Nafdac, in pursuant to the powers conferred on it by section 5 of the nafdac act, to regulate and control the manufacture, importation, exportation distribution sale, use and advertisement of medical devices, has taken some regulatory steps in the fight against covid19. Nafdac good manufacturing practice regulations for pharmaceutical products. The retention sample of radioactive medicinal products should be retained for. Be aware of the writing style used in each passage. An act to provide for the prohibition of sale and distribution of counterfeit, adulterated, banned or fake. Napams is an eregistration and data capture system that provides an online electronic medium for the application for products registration with nafdac and the data capture of all existing and current products approved by nafdac. Most nigerian consumers are unaware of their consumer rights. A manufacturer who intends to register a drug or related product in nigeria should first have the factory inspected by the establishment inspection directorate of nafdac. A written application for registration of imported drug should be made on the companys letter head paper to the directorgeneral nafdac, attention. Nafdac dossier requirements for pesticide registration in.
Nafdac good practices for pharmaceutical quality control laboratories 2016 the national agency for food and drug administration and control nafdac act cap n1, lfn 2004 empowers the agency to control and regulate the manufacture, importation, exportation, distribution, advertisement, sale and use of its regulated products. In exercise of the powers conferred on the governing council of the national agency for food and drug administration and control nafdac by sections 5 and 30 of the nafdac act cap n1 lfn 2004 and section 12 of the food, drugs and related products registration, etc. Under the provisions of the gon act no 19 of 1993 as amended and the food and related products registration act no. Read and consider all of the answer choices before you choose the one that best responds to the question. A manufacturer who intends to register a drug or related product in nigeria should first have the factory inspected by the establishment inspection directorate of nafdac and be assigned a certificate of. Nafdac act cap n1, lfn 2004 empowers the agency to control and regulate the. Act cap f32 lfn 2004 and of all the powers enabling it in that behalf, the governing council of the national.
Pdf clinical audit of drug prescriptions in nigeria. Nafdac good pharmacovigilance practice guidelines, 2016. Preparing for the act 6431 a copy of the full code may be obtained free of charge from act customer services, p. Nafdac envisions that by making these functions known, that its actions will be apparent in all sectors that deal with food, cosmetics, medical devices, bottled water, and chemicals to the extent of instilling extra need for caution and compulsion to respect and obey existing regulations both for 1 healthy, living and knowledge of certain sanctions or default. Consider the elements of writing that are included in each underlined portion of the passage. These guidelines are for the interest of all stakeholders involved in narcotics substances, psychotropic substances, precursor chemicals, controlled solvents and drugs controlled under the food and drugs act cap f32 lfn and the dangerous drug act cap 91 lfn. I appeal to all relevant stakeholders to work together in the successful implementation of this policy in nigeria. How to process a product registration with nafdac getting a food or drug product registered with nigerias regulator if the business youve chosen to go into involves the manufacture or importation of goods that fall within the description of food or drug, then be sure that you cannot legitimately carry on such trade without the appropriate registration of the products by the national agency.
The national agency for food and drug administration and control nafdac is. The national agency for food and drug administration and control nafdac has successfully commenced recruitment intake for 2020 session applicants this page will guide you on how to apply for the ongoing positions advertised by. Good clinical practice gcp is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human participants. Good pharmacovigilance practice regulations 2009 commencement in exercise of the powers conferred on the governing council of the national agency for food and drug administration and control nafdac by sections 5 and 29 of nafdac act 1993 as amended and all the powers enabling it in that behalf, the governing council. Find your nurse practice act the states duty to protect those who receive nursing care is the basis for a nursing license. The widespread lack of awareness, coupled with other factors in favour of the. An act to establish the national agency for food and drug administration and. The counterfeiting practices in developing communities include.