NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL ACT

There is hereby established a body to be known as the National Agency for Food and Drug Administration and Control (in this Act referred to as "the Agency") which-(a) shall be a body corporate with perpetual succession and a common seal; and
(b) may sue and be sued in its corporate name.

(1) There is hereby established for the Agency, a Governing Council which shall consist of-
(a) a chairman who shall be appointed by the President on the recommendation of the Minister;
(b) the Permanent Secretary of the Federal Ministry of Health or his representative;
(c) the Director and Chief Executive of the National Institute for Pharmaceutical Research and Development or his representative;
(d) the Director-General of the Standards Organisation of Nigeria or his representative;
(e) the chairman of the National Drug Law Enforcement Agency or his representative;
(f) the chairman of the Pharmacists Board of Nigeria or his representative;
(g) one person to represent the Pharmaceutical Group of the Manufacturers Association of Nigeria;
(h) one person to represent the Food Beverages Group of the Manufacturers Association of Nigeria;
(i) the Director-General of the Agency; and
(j) three other persons to represent public interest to be appointed by the Minister.
(2) A member of the Council, other than the chairman, shall be appointed by the Minister on the recommendation of the body, if any, he represents.
(3) The members of the Council shall be paid such allowances as the Federal Government may; from time to time, approve.
(4) The provisions of the First Schedule to this Act shall have effect with respect to the proceedings of the Council and the other matters mentioned therein.

(1) A member of the Council appointed, otherwise than by office, shall hold office for a term of four years, and subject to the provisions of subsection (2) of this section, shall be eligible for reappointment for only one further term of four years.
(2) The office of a member of the Council shall become vacant if-
(a) he resigns as a member of the Council by notice in writing under his hand addressed to the Minister; or
(b) the Minister is satisfied that it is not in the interest of the Agency for the person appointed to continue in office and notifies the member in writing to that effect.

(1) If it appears to the Council that a member of the Council, other than an ex-officio member, should be removed from office on the grounds of misconduct or inability to perform the functions of his office, the Council shall make a recommendation to the President.
(2) If the President, after making such inquiries as he considers necessary, approves the recommendation, the Minister shall, in writing, declare the office of such a member vacant.
(3) Notwithstanding the provisions of subsection (1) of this section, the President may remove any member of the Council if he is satisfied that it is in the public interest so to do.

The Agency shall have the following functions, that is, to-(a) regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, bottled water and chemicals;
(b) conduct appropriate tests and ensure compliance with standard specifications designated and approved by the Council for the effective control of the quality of food, drugs, cosmetics, medical devices, bottled water and chemicals and their raw materials as well as their production processes in factories and other establishments;
(c) undertake appropriate investigations into the production premises and raw materials for food, drugs, cosmetics, medical devices, bottled water and chemicals and establish relevant quality assurance systems, including certificates of the production sites and of the regulated products;
(d) undertake inspection of imported food, drugs, cosmetics, medical devices, bottled water and chemicals and establish relevant quality assurance systems, including certification of the production sites and of the regulated products;
(e) compile standard specifications and guidelines for the production, importation, exportation, sale and distribution of food, drug, cosmetics, medical devices, bottled water and chemicals;
(f) undertake the registration of food, drugs, cosmetics, medical devices, bottled water and chemicals;
(g) control the exportation and issue quality certification of food, drugs, cosmetics, medical devices, bottled water and chemicals intended for export;
(h) establish and maintain relevant laboratories or other institutions in strategic areas of Nigeria as may be necessary for the performance of its functions under this Act;
(i) pronounce on the quality and safety of food, drugs, cosmetics, medical devices, bottled water and chemicals after appropriate analysis;
(j) undertake measures to ensure that the use of narcotic drugs and psychotropic substances are limited to medical and scientific purposes;
(k) grant authorisation for the import and export of narcotic drugs and psychotropic substances as well as other controlled substances;
(l) collaborate with the National Drug Law Enforcement Agency in measures to eradicate drug abuse in Nigeria;
(m) advise Federal, State and local governments, the private sector and other interested bodies regarding the quality, safety, and regulatory provisions on food, drugs, cosmetics, medical devices, bottled water and chemicals;
(n) undertake and co-ordinate research programmes on the storage, adulteration, distribution and rational use of food, drugs, cosmetics, medical devices, bottled water and chemicals;
(o) issue guidelines on, approve and monitor the advertisement of food, drugs, cosmetics, medical devices, bottled water and chemicals;
(p) compile and publish relevant data resulting from the performance of the functions of the Agency under this Act or from other sources;
(q) sponsor such national and international conferences as it may consider appropriate;
(r) liaise with relevant establishments within and outside Nigeria in pursuance of the functions of the Agency;
(s) determine the suitability or otherwise of medicines, drugs, food products, cosmetics, medical devices or chemicals for human and animal use; and
(t) carry out such activities as are necessary or expedient for the performance of its functions under this Act.

The Council shall-(a) advise the Federal Government generally on the national policies on the control and quality specifications of food, drugs, cosmetics, medical devices, bottled water and chemicals;
(b) designate, establish and approve quality specifications in respect of food, drugs, cosmetics, medical devices, bottled water and chemicals, necessary for their certification;
(c) establish the relevant guidelines and measures for quality control of food, drugs, cosmetics, medical devices, bottled water and chemicals in conformity with the Agency's standard specifications;
(d) appoint, promote and discipline employees necessary for the proper discharge of the functions of the Agency;
(e) establish committees as may be expedient which shall be charged with specific functions delegated by the Council;
(f) establish appropriate programmes for the quality, safety and rational use of the food, drugs, cosmetics, medical devices, bottled water and chemicals;
(g) encourage and promote activities related to this process, standard specifications, guidelines on importation, exportation, sale and distribution of food, drugs, cosmetics, medical devices, bottled water and chemicals;
(h) utilise and promote the expansion of research, experiments, surveys and studies by public or private agencies, institutions and organisations concerning the quality, safety and use of food, drug, cosmetics, medical devices, bottled water and chemicals and such other matters related to this Act as the Agency may, from time to time, determine as necessary or useful;
(i) establish, encourage and promote training programmes for the employees of the Agency and other appropriate persons from public or private organisations; and
(j) carry out such other activities which are connected with its other functions.

The Council shall have power-(a) to open and operate ordinary and domiciliary accounts for the Agency in recognised banking institutions in Nigeria;
(b) subject to section 8 of this Act, to specify the management system of the Agency, including financial approval ceilings for officers of the agency;
(c) to enter into agreement with public or private organisations and individuals to develop, utilise, co-ordinate and share such information as is determined to be appropriate by the Council for the performance of its functions under this Act ; and
(d) to do such other things as are necessary for the successful performance of its functions under this Act.

The Agency shall have-(a) an Administration and Finance Directorate to be headed by a Director, who shall serve as the secretary of the Agency;
(b) a Planning, Research and Statistics Directorate to be headed by a Director;
(c) a Narcotics and Controlled Substances Directorate to be headed by a Director;
(d) a Regulatory and Registration Directorate to be headed by a Director;
(e) an Inspectorate Directorate to be headed by a Director;
(f) a Laboratory Services Directorate to be headed by a Director; and
(g) such other Directorates as may be required for the proper performance of the functions of the Agency.

(1) There shall be appointed for the Agency by the President, on the recommendation of the Minister, a Director-General who shall be a person with good knowledge of pharmacy, food and drugs.
(2) The Director-General shall be-
(a) the chief executive of the Agency;
(b) responsible for the day-to-day administration of the Agency and keep the books and records of the Agency; and
(c) subject to the supervision and control of the chairman and the Council.
(3) The Director-General shall hold office for a period of five years on such terms and conditions as may be specified in his letter of appointment and be eligible for reappointment for another period of five years.
(4) The Council may, from time to time, appoint such other persons as members of staff of the Agency as it may deem necessary, to assist the Agency in the performance of its functions under this Act.
(5) The members of staff of the Agency appointed under subsection (4) of this section shall be appointed on such terms and conditions of service as the Council may, after consultation with the Federal Civil Service Commissions determine.
(6) The members of staff of the Agency shall be public officers as defined in the Constitution of the Federal Republic of Nigeria, 1999.

(1) Service in the Agency shall be approved service for the purpose of the Pensions Act and, accordingly, officers and other persons employed in the Agency shall be entitled to pensions, gratuity and other benefits as are prescribed thereunder.
(2) Notwithstanding the provisions of subsection (1) of this section, the Agency may appoint a person to any office on terms which preclude the grant of a pension, gratuity or other retirement benefits in respect of that office.
(3) For the purpose of the application of the provisions of the Pensions Act, any power exercisable thereunder by a Minister or other authority of the Government of the Federation, other than the power to make regulations under section 23 thereof, is hereby vested in and shall be exercisable by the Agency and not by any other person or authority,

(1) If it appears to the Council that there are reasons for believing that any person employed as a member of the senior staff of the Agency, other than the Director-General, should be removed from office on grounds of misconduct or inability to perform the functions of his office, the Council shall-
(a) give notice of those reasons to the person concerned;
(b) afford the person an opportunity of making representation on the matter to the Council in person;
(c) if the person concerned or any three members of the Council so request within the period of one month beginning with the date of the notice, make arrangement-
(i) for a committee of the Council to investigate the matter and to report on it to the Council; and
(ii) for the person in question to be afforded an opportunity of appearing before and being heard by the investigating committee on the matter.
(2) If the Council, after considering the report of the investigating committee, is satisfied that the person in question should be removed as aforesaid, the Council may remove the person concerned by an instrument in writing signed on the direction of the Council.
(3) The Director-General of the Agency may, in a case of misconduct by a member of staff which in the opinion of the Director-General is prejudicial to the interest of the Council, suspend such member of staff and any such suspension shall forthwith be reported to the Council.
(4) For good cause, any member of staff may be suspended from office or his appointment may be terminated by the Council and for the purposes of this subsection, "good cause" means-
(a) any physical or mental incapacity which the Council after obtaining medical advice, considers to render the person concerned unfit for the discharge of the functions of his office; or
(b) conduct of a scandalous or other disgraceful nature which the Council considers to be such as to render the person concerned unfit to continue to hold his office; or
(c) conduct which the Council considers to be such as to constitute failure or inability of the person concerned to discharge the functions of his office or to comply with the terms and condition of his service.
(5) Any person suspended pursuant to this section shall be placed on half pay and the Council shall before the expiration of a period of three months after the date of such suspension consider the case against that person and come to a decision as to-
(a) whether to continue such person's suspension and if so on what terms (including the portion of his emoluments to be paid to him); or
(b) whether to reinstate such person to his office, in which case the Council shall restore his full emoluments to him with effect from the date of the suspension; or
(c) whether to terminate the appointment of the person in question in which case such a person shall not be entitled to the portion of his emolument withheld during the period of the suspension; or
(d) whether to take such lesser disciplinary action against such person (including the restoration of such portion of his emolument that might have been withheld) as the Council may determine.
(6) In any case where the Council, pursuant to this section, decides to continue a person's suspension or decides to take further disciplinary action against a person, the Council shall, before the expiration of a period of three months from such decision, come to a final determination in respect of the case concerning that person.
(7) It shall be the duty of any person who signed the instrument of removal by virtue of this section to serve or cause to be served on the person concerned, a copy of the instrument.
(8) Nothing in the foregoing provisions of this section shall prevent the Council from making such regulations for the discipline of other categories of staff and workers of the Council as it may think fit.

(1) If any junior member of the staff is accused of misconduct or inefficiency, the Director-General may suspend him for not more than three months and forthwith shall direct the matter to the Junior Staff Appointment and Promotion Committee to-
(a) consider the case; and
(b) make recommendation as to the appropriate action to be taken by the Director-General
(2) In all cases under this section, the junior member of the staff shall be informed in writing of the charges against him and be given reasonable opportunity to defend himself.
(3) The Director-General may, after considering the recommendation made pursuant to subsection (1) (b) of this section, dismiss, terminate, retire or downgrade the junior members of the staff concerned.
(4) Any person aggrieved by the Director-General's, decision under subsection (3) of this section may, within a period of 21 days from the date of receipt of the letter communicating the decision to him, address a petition to the Council to reconsider his case and the Council's decision thereon shall be final.

(1) The Agency shall establish a fund from which shall be defrayed all expenditure incurred by the Agency for the purposes of this Act.
(2) There shall be paid and credited to the fund of the Agency-
(a) fees charged for services rendered by the Agency;
(b) all sums accruing to the Agency by way of gifts, endowments, bequests or other voluntary contributions by persons and organisations;
(c) foreign aid and assistance from bilateral agencies; and
(d) subventions and extra-budgetary allocations from the Federal Government.

The Agency shall, from time to time, apply the funds at its disposal to-(a) the cost of establishing and maintaining the head office of the Agency at the Federal Capital Territory, Abuja and its other offices located in other places in Nigeria;
(b) pay allowances and other benefits of members of the Council and of its committee;
(c) pay the emoluments and entitlement of the Director-General and other members of staff of the Agency;
(d) pay the personnel, overhead, allowances, benefits and other administrative costs of the Agency;
(e) the training of members of staff of the Agency;
(f) provide scholarship and awards for specialised training of personnel;
(g) publicise and promote the activities of the Agency;
(h) support national and international scientific and professional organisations and pay annual and other contributions to such bodies;
(i) undertake any other activity in connection with all or any of the functions of the Agency.

All income derived by the Agency from the sources specified in section 13 (2) of this Act shall be exempt from income tax and all contributions to the fund of the Agency shall be tax deductible.

Subject to the approval of the Minister, the Agency may invest in the profitable procedure of capital goods by joint-venture, partnership, shareholding or as sole proprietor, as the case may be, and the net incomes so generated shall be paid into the fund of the Agency.

The Council may invest any surplus funds in profit yielding ventures, and notwithstanding that power, the Minister may issue to the Agency directives as he may think necessary as to the disposal of any surplus funds of the Agency.

The Council shall submit to the Minister, not later than 31 October each year, its programme of work and estimates of its income and expenditure for the following year.

(1) The Council shall keep proper accounts of the Agency and proper records in relation to those accounts.
(2) The accounts of the Agency shall be audited, not later than six months after the end of the year to which it relates, by auditors appointed by the Agency from the list and in accordance with the guidelines supplied by the Auditor-General for the Federation.

The Agency shall prepare and submit to the Minister, not later than 30 June in each year, a report on the activities of the Agency during the immediately proceeding year, and shall include in such report a copy of the audited accounts of the Agency for that year and the auditor's report thereon.

(1) For the purpose of providing offices and premises necessary for the performance of its functions, the Agency may, subject to the Land Use Act-
(a) purchase or take on lease any interest in land, building or property; and
(b) build, equip and maintain offices and premises.
(2) The Agency may, subject to the Land Use Act, sell or lease out any office or premises held by it, which is no longer required for the performance of its functions under this Act.

(1) The Agency may, from time to time, borrow by overdraft or otherwise such sums as it may require for the performance of its functions under this Act.
(2) The Agency shall not, without the approval of the Minister, borrow money which exceeds, at any time, the limit set by the Minister.
(3) Notwithstanding subsection (1) of this section, where the sum to be borrowed is in foreign currency the Agency shall not borrow the sum without the prior approval of the Minister.

(1) The Agency may accept gifts of land, money or other property, upon such terms and conditions, if any, as may be specified by the person or organisation making the gift.
(2) The Agency shall not accept any gifts if the conditions attached by the person or organisation making the gift are inconsistent with the functions of the Agency.

(1) An officer of the Agency may, in the course of his duty, at any reasonable time and on production of his certificate of designation if so required-
(a) enter (if need be by force) any premises in which he reasonably believes that any article to which this Act or the regulations apply is manufactured, prepared, preserved, packaged, stored or sold;
(b) examine any article in the premises which appears to him to be an article to which this Act or the regulations apply or anything in the premises which he reasonably believes is used or is capable of being used for the manufacture, preparation, preservation, packaging, storage or sale of any such article;
(c) take a sample or specimen of any article to which this Act or the regulations apply or which he has power to examine under paragraph (b) of this subsection;
(d) open and examine, while on the premises, any container or package which he reasonably believes may contain anything to which this Act or the regulations apply or which may help in his investigations;
(e) examine any book, document or other record found on the premises which he reasonably believes may contain any information relevant to the enforcement of this Act or the regulations and make copies thereof or extracts therefrom;
and
(f) seize and detain for such time as may be necessary for the purpose of this Act, any article by means of or in relation to which he reasonably believes any provision of this Act or regulations has been contravened.
(2) The owner or person in charge of any premises entered by an officer of the Agency in pursuant of this section, and every person found thereon, shall give all reasonable assistance in their power to the officer and shall make available to the officer all such information as the officer may reasonably require for the purposes of this Act.
(3) Any article seized under this Act shall be kept or stored in such a place as the officer of the Agency may direct and shall be returned to the owner or the person from whom it was seized if the article upon analysis or examination is found to conform with the requirements of this Act and regulations.
(4) Any article seized by an officer of the Agency pursuant to this Act or the regulations may be submitted to an analyst for analysis or examination and the analyst upon making such analysis or examination shall issue a certificate or report in the prescribed form setting forth the result of such analysis or examination, and the officer of the Agency shall on demand deliver a copy of such certificate or report to the owner of the article if the article is to be the subject of a proceeding under this Act.
(5) In this section, the expression "article to which this Act or the regulations apply" means-
(a) any food, drug, cosmetics, medical devices, bottled water or chemical;
(b) anything used for the manufacture, preparation, preservation, packaging or storage of any food, drug, cosmetics, medical device, bottled water or chemical; and
(c) any labelling or advertising material relating to or for use in connection with any food, drug, cosmetics, medical device, bottled water or chemical, but does not include a live animal

(1) A person who obstructs an officer of the Agency in the performance of his duties under section 24 of this Act shall be guilty of an offence and liable on conviction to a fine of N5,000 or to imprisonment for a term not exceeding two years or to both such fine and imprisonment.
(2) Any person who contravenes the provisions of any regulations made under this Act is guilty of an offence and liable on conviction to the penalties specified in the regulations.
(3) Where no penalty has been specified, the person shall be liable to a fine of N50,000 or imprisonment for a term of one year or to both such fine and imprisonment.
(4) Where an offence under this Act which has been committed by a body corporate is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of any director, manager, secretary or other similar officer of the body corporate or any person purporting to act in any of those capacities, he, as well as the body corporate, shall be deemed to be guilty of the offence and shall be liable on conviction to a fine of N100,000.
(5) The Federal High Court shall have exclusive jurisdiction to try offences under this Act.

(1) Subject to the provisions of section 174 of the Constitution of the Federal Republic of Nigeria 1999 (which relates to the power of the Attorney-General of the Federation to institute, continue or discontinue criminal proceedings against any person in a court of law), any officer of the Agency may, with the consent of the Attorney-General of the Federation, conduct criminal proceedings in respect of offences under this Act or regulations made under this Act.
(2) In a judicial proceeding for an offence under this Act or any regulation made under it, the provisions of the Criminal Procedure Act or depending on the venue, the Criminal Procedure Code shall, with such modifications as the circumstance may require, apply in respect of such matter to the same extent as they apply to the trial of offences generally.

(1) No suit shall be commenced against the Agency before the expiration of a period of one month after written notice of intention to commence the suit shall have been served on the Agency by the intending plaintiff or his agent and the notice clearly and explicitly states-
(a) the cause of action;
(b) the particulars of the claim;
(c) the name and place of abode of the intending plaintiff; and
(d) the relief which he claims.
(2) The notice referred to in subsection (1) of this section and any summons, notice or other document required or authorised to be served on the Agency under the provisions of this Act or any other enactment or law, may be served by-
(a) delivering the same to the Director-General; or
(b) sending it by registered post addressed to the Director-General at the head office of the Agency.
(3) In any action or suit against the Agency, no execution or attachment or process in the nature thereof shall be issued against the Agency, but any sums of money which may, by the judgment of the court, be awarded against the Agency shall, subject to any directives given by the Agency, be paid from the fund of the Agency.

The Minister may give directives of a general or special character to the Agency relating to the performance by the Agency of any or all of its functions under this Act, and it shall be the duty of the Agency to comply and give effect to the directives.

(1) On the commencement of this Act, the Food and Drug Administration and Control Department of the Federal Ministry of Health (in this section referred to as "the Department") shall cease to exist.
(2) Accordingly, the Department is hereby dissolved and the provision of the Second Schedule to this Act shall apply in relation to the employees in the Department, the assets and liabilities of the Department and the other matters connected with the Department set out therein.

The Council may, with the approval of the Minister, make regulations-(a) to prescribe the methodologies for private sector payments into the fund of the Agency;
(b) to prescribe the fees to be paid for services rendered by the Agency;
(c) generally for the purposes of carrying out or giving full effect to the provisions of this Act.

In this Act-
"Agency" means the National Agency for Food and Drug Administration and Control established by section 1 of this Act;
"Council" means the Governing Council of the Agency established by section 2 of this Act;
"cosmetic" includes any substance or mixture of substance intended to be rubbed, poured, sprinkled or sprayed, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the complexion, skin, hair or teeth and includes deodorants and detergent powder;
"chairman" means the chairman of the Council;
"detergent powder" means a cleansing agent in powder or granulated form used primarily for laundry purposes which-
(a) contains suitable ionic and non-ionic surface-active agent; and
(b) is produced from either sulphornation of suitable hydrocarbon or the sulphornation of various hydroxy compounds;
"drug" includes any substance of vegetable, animal or mineral origin or any preparation or admixture thereof manufactured, sold or advertised for use in-
(a) the diagnosis, treatment, mitigation or prevention of any disease, disorder, abnormal physical state or the symptom thereof, in man or animal;
(b) restoring, correcting or modifying organic functions in man or in animal;
(c) disinfection or the control of vermin, insects or pests; or
(d) contraception;
"medical device" means any instrument, apparatus or contrivance (including components, parts and accessories thereof) manufactured, sold or advertised for internal or external use in the diagnosis, treatment, mitigation or prevention of any disease, disorder, abnormal physical state or the symptom thereof, in man or in animal;
"member" means a member of the Council and includes the chairman;
"Minister" means the Minister charged with matters relating to health;
"President" means the President of the Federal Republic of Nigeria;
"public service" has the meaning assigned to it in the Constitution of the Federal Republic of Nigeria 1999; and
"regulated products" means food, drugs, cosmetics, medical devices, detergents bottled water and chemicals.

This Act may be cited as the National Agency for Food and Drug Administration and Control Act.