Notable Provisions Of The Food and Drugs Registration Act Of Nigeria

The Food and Drug Registration Act was passed into law to create a framework for the manufacture and certification of food and Drugs in Nigeria.

This article will be outlining the notable provisions of this act which center around topics that include :-

– The prohibition of the manufacture of unregistered processed food and drugs

– Applications for food and drug registrations

– Disclosure of information supplied by an applicant

– Suspension/Cancellation of certificate of registration

– Clinical Trials

– Offences

– Jurisdiction

– The food and drug registrations committee

Prohibition of The Manufacture Of Unregistered Processed Foods and Drugs

(1) No processed food, drug, drug product, cosmetic, medical device or water shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with the provisions of this Act or regulations made under it.

(2) Notwithstanding the provisions of subsection (1) of this section, the National Agency for Food and Drug Administration and Control (in this Act referred to as “the Agency”) may grant a permit for the importation or manufacture of a sample of drug, drug product, cosmetic or medical device for the purpose of registration or clinical trial, and the importation or manufacture shall be in accordance with the conditions specified in the permit.

Application For Registration

The act provides that :- 

(1) Application for the registration of a processed food, drug, drug product, cosmetic or medical device shall be made in writing to the Agency in such form as the Agency may, from time to time, prescribe and shall-

(a) contain the particulars and description of the processed food, drug, drug product, cosmetic or medical device in respect of which the application is made;

(b) be accompanied by such fee as the Agency may, from time to time, prescribe.

(2) The Agency, in considering an application-

(a) may ask the applicant to supply such other information as it may require to enable it to reach a decision on the application;

(b) shall satisfy itself that there is need to have the processed food, drug, drug product, cosmetic or medical device registered in Nigeria.

(3) Where the Agency is satisfied that there is need to register the processed food, drug, drug product, cosmetic or medical device it shall do so and issue to the applicant a certificate of registration, subject to such conditions as it may deem necessary

(4) The registration of a processed food drug, drug product, cosmetic or medical device under this Act shall, unless cancelled earlier, be valid for a period of five years and may be renewed.

(5) The Agency shall, from time to time, publish a notice in the Gazette notifying the registration of a processed food, drug, drug product, cosmetic or medical device under this Act.

Disclosure of information supplied by applicant 

The act provides that no person shall disclose an information supplied to the Agency in pursuance of section 2 of this Act except-

(a) with the written consent of the person who supplied the information; or

(b) in accordance with the directive of the Agency; or

(c) for the purpose of a proceeding under this Act.

Suspension or cancellation of certificate of registration

(1) The agency may suspend or cancel the registration of a processed food, drug, drug product, cosmetic or medical device if-

(a) the grounds on which the processed food, drug, drug product, cosmetic or medical device was registered were later found to be false or incomplete; or

(b) the circumstances under which the processed food, drug, drug product, cosmetic or medical device was registered no longer exist; or

(c) any of the conditions under which the processed food, drug, drug product, cosmetic or medical device was registered has been contravened; or

(d) the standard of quality, safety or efficacy as prescribed in the documentation for registration is not being complied with; or

(e) the premises in which the processed food, drug, drug product, cosmetic or medical device or part thereof is manufactured, assembled or stored by or on behalf of the holder of the certificate of registration are unsuitable for the manufacturing, assembling or storage of the processed food, drug, drug product, cosmetic or medical device.

(2) Where the registration of a processed food, drug, drug product, cosmetic or medical device is suspended or cancelled, the Agency shall order the withdrawal from circulation of that processed food, drug, drug product, cosmetic or medical device and shall accordingly cause the suspension, cancellation or withdrawal to be published in the Gazette.

Clinical trials

(1) No person shall, in the course of his business-

(a) import or supply a drug, drug product, cosmetic or medical device; or

(b) procure the importation or supply of a drug, drug product, cosmetic or medical device; or

(c) procure the manufacture or assembly of a drug, drug product, cosmetic or medical device,

for the purpose of a clinical test, unless he is a holder of a valid clinical trial, certificate and the trial is to be carried out in accordance with the terms of the certificate and the provisions of any regulation in force.

(2) Application for a clinical trial, certificate shall be made to the Agency in such from and manner as the Agency may prescribe by regulations.

Offences

(1) A person who contravenes a provision of this Act or a regulation made under it is guilty of an offence and liable on conviction-

(a) in the case of an individual, to a fine not exceeding N50,000 or to imprisonment for a term not exceeding two years or to both such fine and imprisonment; and

(b) in the case of a body corporate, to a fine not exceeding N100,000.

Offences by Bodies Corporate

The act provides that where an offence under this Act is committed by a body corporate or firm or other association of individuals :-

(a) every director, manager, secretary or other similar officer of the body corporate; or

(b) every partner or officer of the firm; or

(c) every trustee of the body concerned; or

(d) every person concerned in the management of the affairs of the association; or

(e) every person who was purporting to act in a capacity referred to in paragraphs (a) to (d) of this section,

is severally guilty of that offence and liable to be proceeded against and punished for that offence in the same manner as if he had himself committed the offence unless he proves that the act or omission constituting the offence took place without his knowledge, consent or connivance.

Forfeiture after conviction

(1) A person convicted of an offence under this Act or regulations made under it shall forfeit to the Federal Government-

(a) any asset or property constituting, or derived from any proceeds the person obtained, directly or indirectly, as a result of the offence;

(b) any of the person’s property or instrumentalities used in any manner to commit or to facilitate the commission of the offence.

(2) In this section, “proceeds” means any property derived or obtained, directly or indirectly, through the commission of the offence.

Jurisdiction

(1) The Tribunal established under the Special Tribunal (Miscellaneous Offences) Decree 1984, as amended, (in this Act referred to as “the Tribunal”) shall have jurisdiction to try offenders under this Act.

(2) The Tribunal shall have power, notwithstanding anything to the contrary in any other enactment, to impose the penalties provided for in this Act.

(3) Any part-heard proceeding, relating to a matter for which the Tribunal has jurisdiction, which is pending before any court on the date of the making of this Act shall be continued and completed as if this Act had not been made.

(4) All new proceedings shall be brought before the Tribunal in accordance with the provisions of the adopted Special Tribunal (Miscellaneous Offences) Decree 1984.

(5) A person who has been tried and convicted or acquitted for an offence charged under any other enactment shall not be tried a second time for the same offence, notwithstanding that he could be proceeded against in accordance with the provisions of this Act.

Forfeited Drugs

Any processed food, drug, drug product, cosmetic, medical device or water seized by the Agency shall be forfeited to the Federal Government and shall be dealt with in such manner as the Minister may, from time to time, determine.

The Food and Drug Registration Committee 

Under this act :-

(1) There is hereby established a committee to be known as the Food and Drug Registration Committee (in this Act referred to as “the Committee”) which shall consist of a chairman and such number of other persons as the Agency may deem necessary, who possess the knowledge and experience relevant to this Act.

(2) The Committee shall-

(a) evaluate the formation, method of preparation, packaging, labelling, safety, efficacy and usefulness of food, food products, drugs, drug products, cosmetics or medical devices for which application are made; and

(b) advise the Agency as appropriate in respect of those applications and the cancellation, withdrawal or suspension of any registration made in pursuance of the provisions of this Act.

(3) The Agency shall, on the appointment of the chairman and members of the Committee, specify their tenure of office.

(4) Subject to this section, the Committee shall determine its quorum and otherwise regulate its own procedure.

Regulations

 The Governing Council of the National Agency For Food and Drug Control (NAFDAC) may, with the approval of the Minister, make regulations for the purpose of giving effect to the provisions of this Act.