National Agency for Food and Drug Act
National Agency for Food and Drug Act
ARRANGEMENT OF SECTIONS
PART I
Establishment of the National Agency for Food and Drug Administration and Control and its Governing
Council
SECTION
1. Establishment of the National Agency for Food and Drug Administration and
Control.
2. Establishment of the Governing Council.
3. Tenure of office.
4. Removal from office of members of the Council.
PART II
Functions and powers
5. Functions of the Agency.
6. Functions of the Council.
7. Powers of the Council.
PART III
Structure of the Agency
8. Structure of the Agency.
PART IV
Staff of the Agency
9. Appointment of Director-General and other staff of the Agency.
10. Pension.
11. Removal and discipline of senior staff.
12. Discipline of junior staff.
PART V
Financial provisions
13. Fund of the Agency.
14. Expenditure of the Agency.
15. Exemption from income tax.
16. Capital production income.
17. Disposal of surplus funds.
18. Annual estimates.
19. Accounts and audit.
20. Annual report.
PART VI
Miscellaneous
21. Offices and premises.
22. Power to borrow.
23. Power to accept gifts.
24. Power to enter the premises, etc.
25. Offences.
26. Conduct of proceedings.
27. Legal proceedings.
28. Power of Minister to give directives.
29. Dissolution of Food and Drug Administration and Control Department.
30. Power to make regulations.
31. Interpretation.
32. Short title.
SCHEDULES
FIRST SCHEDULE
Supplementary provisions relating to the Council and the Agency
SECOND SCHEDULE
Transitional provisions relating to the employees, assets and liabilities of the Food and Drugs
Administration and Control Department of the Federal Ministry of Health
CHAPTER N1
NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND
CONTROL ACT
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 and
chemicals.
[1993 No. 15.]
[1st October, 1992]
[Commencement.]
PART I
Establishment of the National Agency for Food and Drug Administration and Control and its Governing
Council
1. Establishment of the National Agency for Food and Drug Administration and
Control
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—
Shall be a body corporate with perpetual succession and a common seal; and
a) Shall be a body corporate with perpetual succession and a common seal; and
b) May sue and be sued in its corporate name.
(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.
[First Schedule.]
3. Tenure of office
(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.
PART II
Functions and powers
5. Functions of the Agency
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
[1999 No. 19.]
(t) Carry out such activities as are necessary or expedient for the performance of its functions
under this Act.
PART III
Structure of the Agency
8. Structure of the Agency
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.
PART IV
Staff of the Agency
9. Appointment of Director-General and other staff 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.
[Cap. C23.]
10. Pension
(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.
[Cap. P4.]
(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.
(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.
PART V
Financial provisions
13. Fund of the Agency
(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.
PART VI
Miscellaneous
21. Offices and premises
(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— [Cap. L5.]
(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.
25. Offences
(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.
[1999 No. 19.]
(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.
[1999 No. 62.]
31. Interpretation
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;
[1999 No. 19.]
“chairman” means the chairman of the Council;
“detergent powder” means a cleansing agent in powder or granulated form used primarily for
laundry purposes which— [1999 No. 19.]
(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;
[1999 No. 19.]
“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
[Cap. C23.]
“regulated products” means food, drugs, cosmetics, medical devices, detergents bottled water and
chemicals.
[1999 No. 19.]
Committees
5. (1) Subject to its standing orders, the Council may appoint such number of standing and ad
hoc committees as it thinks fit to consider and report on any matter with which the Agency is
concerned.
(2) Every committee appointed under the provisions of sub-paragraph (1) of this paragraph shall be
presided over by a member of the Council and shall be made up of such number of persons, not
necessarily members of the Council, as the Council may determine in each case.
6. The decision of a committee shall be of no effect until it is confirmed by the Agency.
Miscellaneous
7. The fixing of the seal of the Agency shall be authenticated by the signature of the chairman
and of the Director-General of the Agency or such other member authorised generally or specially by
the Council to act for that purpose.
8. Any contract or instrument, which, if made by a person not being a body corporate, would not
be required to be under seal, may be made or executed on behalf of the Agency by the Director-
General or by any other person authorised generally or specifically by the Council to act for that
purpose.
9. Any document purporting to be a contract, an instrument or other document signed or sealed
on behalf of the Agency shall be received in evidence and, unless the contrary is proved, be presumed
without further proof, to have been so signed or sealed.
10. The validity of a proceeding of the Council or of a committee thereof shall not be adversely
affected—
(a) by any vacancy in the membership of the Council; or
(b) by any defect in the appointment of a member of the Council; or
(c) by reason that a person not entitled to do so took part in the proceeding.
11. A member of the Council or committee who has a personal interest in any contract or
arrangement entered into or proposed to be considered by the Council or committee shall forthwith
disclose his interest to the Council or committee and shall not vote on any question relating to the
contract or arrangement.
Second Schedule
TRANSITIONAL PROVISIONS RELATING TO THE EMPLOYEES, ASSETS AND LIABILITIES OF THE FOOD
AND DRUGS ADMINISTRATION AND
CONTROL DEPARTMENT OF THE FEDERAL MINISTRY OF HEALTH
[Section 29 (2).]
1. By virtue of this Act, there shall be vested in the Agency immediately at the commencement of this
Act, without further assurance, all assets, funds, resources and other movable or immovable
property which immediately before the commencement of this Act were vested in the Food and
Drugs Administration and Control Department of the Federal Ministry of Health (in this Schedule
referred to as “the Department”).
2. As from the commencement of this Act—
(a) all rights, interests, obligations and liabilities of the Department existing immediately before
the commencement of this Act under any contract or instrument, or at law or in equity apart from any
contract or instrument, shall by virtue of this Act be assigned to and vested in the Agency;
(b) any contract or instrument as mentioned in sub-paragraph (a) of this paragraph shall be of
the same force and effect against or in favour of the Agency and shall be enforceable as fully and
effectively as if, instead of the Department, the Agency has been named therein or had been a part
thereto; and
(c) the Agency shall be subject to all obligations and liabilities to which the department was subject
immediately before the commencement of this Act, and all other persons shall as from the
commencement of this Act have the same rights, powers and remedies against the Agency as they
had against the Department immediately before the commencement of this Act.
3. Any proceeding or cause of action pending or existing immediately before the commencement
of this Act by or against the Department in respect of any right, interest, obligation or liability of the
Department may be commenced, continued or enforced by or against the Agency as if this Act had
not been made.
4. Notwithstanding the provisions of this Act but subject to such directions as may be issued by
the Agency, any person who immediately before the date of commencement of this Act held office in
the Department shall be deemed to have been transferred to the Agency on terms and conditions not
less favourable than those obtaining immediately before the commencement of this Act, and service
under the Department shall be deemed to be service under the Agency for purposes of pension.
5. The Minister, if he thinks fit, may, within the twelve months after the commencement of this
Act by order published in the Gazette, make additional or saving provisions for the better carrying out
of the objectives of this Schedule.
CHAPTER N1
NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND
CONTROL ACT
SUBSIDIARY LEGISLATION
1. National Agency for Food and Drug Administration and Control Tariff
Charges Regulations.
2. Drug Products Advertisement Regulations.
3. Pre-Packaged Food (Labelling) Regulations.
4. Bottled Water (Advertisement) Regulations.
5. Cosmetic Product (Prohibition of Bleaching Agents, etc.) Regulations.
6. Food Products Registration Regulations.
7. Bottled Water (Labelling) Regulations.
8. Pesticide Registration Regulations.
9. Non-nutritive Sweeteners in Food Products Regulations.
10. Non-nutritive Sweeteners in Drug Products (Prohibition) Regulations.
11. Food Products (Advertisement) Regulations.
12. Food Grade (Table or Cooking) Salt Regulations.
13. Cosmetics and Medical Devices (Advertisement) Regulations.
14. Bottled Water Registration Regulations.