Republic Act No.

9711 August 18, 2009

AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE

BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE TESTING
LABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT, AUGMENTING ITS
HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO RETAIN ITS INCOME,
RENAMING IT THE FOOD AND DRUG ADMINISTRATION (FDA), AMENDING CERTAIN
SECTIONS OF REPUBLIC ACT NO. 3720, AS AMENDED, AND APPROPRIATING FUNDS
THEREOF

Be it enacted by the Senate and House of Representatives of the Philippines in Congress

assembled::

Section 1. The Bureau of Food and Drugs (BFAD) is hereby renamed the Food and Drug
Administration (FDA).

Section 2. This Act shall be known as the "Food and Drug Administration (FDA) Act of 2009".

Section 3. It is hereby declared a policy of the State to adopt, support, establish, institutionalize,
improve and maintain structures, processes, mechanisms and initiatives that are aimed, directed and
designed to: (a) protect and promote the right to health of the Filipino people; and (b) help establish
and maintain an effective health products regulatory system and undertake appropriate health
manpower development and research, responsive to the country's health needs and problems.
Pursuant to this policy, the State must enhance its regulatory capacity and strengthen its capability
with regard to the inspection, licensing and monitoring of establishments, and the registration and
monitoring of health products.

Section 4. This Act has the following objectives:

(a) To enhance and strengthen the administrative and technical capacity of the FDA in the
regulation of establishments and products under its jurisdiction;

(b) To ensure the FDA's monitoring and regulatory coverage over establishments and products
under its jurisdiction; and

(c) To provide coherence in the FDA's regulatory system for establishments and products
under its jurisdiction.

SEC. 10. For the purposes of this Act, the term:

(y) 'Authorization' means a permission embodied in a document granted by the FDA to a natural or
juridical person who has submitted an application to implement the manufacture, importation,
exportation, sale, offer for sale, distribution, transfer, and/or, where appropriate, the use, testing,
promotion, advertising, or sponsorship of health products. The authorization can take the form of a
permit, a license, a certificate of registration, of accreditation, of compliance, or of exemption, or any
similar document.
"(ii) 'Licensing' means the process of approval of an application to operate or establish an
establishment prior to engaging in the manufacture, importation, exportation, sale, offer for sale,
distribution, transfer, and where applicable the use, testing, promotion, advertisement, and/or
sponsorship of health products.

Article 31. Licensing and Registration. –

a) No person shall manufacture, sell, offer for sale, import, export, distribute or transfer any
drug or device, unless an application filed pursuant to sub-article (b) hereof is effective with
respect to such drug or device.

b) Any person may file with the Department, through the Department, an application under
oath with respect to any drug or device subject to the provisions of sub-article (a) hereof. Such
persons shall submit to the Department: (1) full reports of investigations which have been
made to show whether or not such drug or device is safe, efficacious and of good quality for
use based on clinical studies conducted in the Philippines; (2) a full list of the articles used as
components of such drug or device; (3) a full statement of the composition of such drug or
device; (4) a full description of the methods used in and the facilities and controls used for the
manufacture of such drug or device; (5) such samples of such drug or device and of the
articles used as components thereof as the Department may require; (6) specimens of the
labeling proposed to be used for such drug or device; and (7) such other requirements as may
be prescribed by regulations to ensure safety, efficacy and good quality of such drug and
device.

c) Within one hundred eighty (180) days after the filing of an application under this sub-article,
or such additional period as may be agreed upon by the Department and the applicant, the
Department shall either (1) approve the application if he then finds that none of the grounds for
denying approval specified in sub-article (d) applies, or (2) give the applicant notice of an
opportunity for a hearing before the Department under sub-article (d) on the question whether
such application is approvable.

d) If the Department finds, after due notice to the applicant and giving him an opportunity for a
hearing, that (1) the reports of the investigations which are required to be submitted to the
Department pursuant to sub-article (b) hereof, do not include adequate tests by all methods
reasonably applicable to show whether or not such drug or device is safe, efficacious and of
good quality for use under the conditions prescribed, recommended or suggested in the
proposed labeling thereof; (2) the results of such test show that drug or device is unsafe,
inefficacious or of doubtful therapeutic value for use under such conditions or do not show that
such drug or device is safe, methods used in, and the facilities and controls used for the
manufacture of such drug or device are inadequate to preserve its identity, strength, quality
and purity; or (4) upon the basis of the information submitted to him as part of the application,
or upon the basis of any other information before him with respect to such drug or device, he
has insufficient information to determine whether such drug or device is safe, efficacious or of
good equality for use under such conditions; or (5) evaluated on the basis of the information
submitted to him as part of the application, and any other information before him with respect
to such drug or device, there is a lack of substantial evidence that the drug or device will have
the effect it purports or is represented to have under the conditions of use prescribed,
recommended or suggested in the proposed labeling thereof; or (6) based on a fair evaluation
 of all material facts, such labeling is false or misleading in any way; he shall issue an order
disapproving the application.

e) The effectiveness of an application with respect to any drug or device shall, after due notice
and opportunity for hearing to the applicant, by order of the Department be suspended if it
finds (1) that clinical experience, tests by new methods, or tests by methods not deemed
reasonably applicable when such application became effective show that such drug or device
is unsafe or ineffective for use under the conditions of use upon the basis of which the
application became effective, or (2) that the application contains any untrue statement of a
material fact. The order shall state the findings upon which it is based.

f) The Department shall promulgate regulations for exempting from the operation of this Article
drugs and devices intended solely for investigational used by experts qualified by scientific
training and experience to investigate the safety and effectiveness of drugs and devices.

g) No person shall manufacture, sell, offer for sale, import, export, distribute or transfer any
drug or device without first securing a license to operate from the Department after due
compliance with technical requirements in accordance with the rules and regulations
promulgated by the Department pursuant to this Act.

h) No drug or device shall be manufactured, sold, offered for sale, imported, exported,
distributed or transferred, unless registered by the manufacturer, imported or distributor
thereof, in accordance with rules and regulations promulgated by the Department pursuant to
this Act. The provisions of Article 31 (b), (d) and (e), to the extent applicable, shall govern the
registration of such drugs and devices.

i) The Department shall promulgate a schedule of fees for the issuance of the certificate of
product registration and license to operate provided for under this Article.

(kk) 'Registration' means the process of approval of an application to register health products prior to
engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and
where applicable, the use, testing, promotion, advertisement, and/or sponsorship of health products.

ONSUMER PRODUCT QUALITY AND SAFETY

Article 5. Declaration of Policy. – It shall be the duty of the State:

a) to develop and provide safety and quality standards for consumer products, including
performance or use-oriented standards, codes of practice and methods of tests;

b) to assist the consumer in evaluating the quality, including safety, performance and
comparative utility of consumer products;

c) to protect the public against unreasonable risks of injury associated with consumer products;

d) to undertake research on quality improvement of products and investigation into causes and
prevention of product related deaths, illness and injuries;

e) to assure the public of the consistency of standardized products.

Article 7. Promulgation and Adoption of Consumer Product Standards. – The concerned
department shall establish consumer product quality and safety standards which shall consist of one
or more of the following:

a) requirements to performance, composition, contents, design, construction, finish, packaging

of a consumer product;

b) requirements as to kind, class, grade, dimensions, weights, material;

c) requirements as to the methods of sampling, tests and codes used to check the quality of
the products;

d) requirements as to precautions in storage, transporting and packaging;

e) requirements that a consumer product be marked with or accompanied by clear and

adequate safety warnings or instructions, or requirements respecting the form of warnings or
instructions.

For this purpose, the concerned department shall adopt existing government domestic product quality
and safety standards: Provided, That in the absence of such standards, the concerned department
shall form specialized technical committees composed of equal number of representatives from each
of the Government, business and consumer sectors to formulate, develop and purpose consumer
product quality and safety standards. The said technical committees shall consult with the private
sector, which may, motu proprio, develop its own quality and safety standards that shall be subject or
agencies after public hearings have been conducted for that purpose; and shall likewise consider
existing international standards recognized by the Philippine Government.

Article 14. Certification of Conformity to Consumer Product Standards. – The concerned

department shall aim at having consumer product standards established for every consumer product
so that consumer products shall be distributed in commerce only after inspection and certification of
its quality and safety standards by the department. The manufacturer shall avail of the Philippine
Standard Certification Mark which the department shall grant after determining the product's
compliance with the relevant standard in accordance with the implementing rules and regulations.
 
AN ACT TO CONVERT THE DIVISION OF STANDARDS UNDER THE BUREAU OF COMMERCE
INTO A BUREAU OF STANDARDS, TO PROVIDE FOR THE STANDARDIZATION AND/OR
INSPECTION OF PRODUCTS AND IMPORTS OF THE PHILIPPINES AND FOR OTHER
PURPOSES
Section 1. The Division of Standards under the Bureau of Commerce is hereby converted into a
Bureau of Standards under the Department of Commerce and Industry.
Section 2. The Bureau shall have as its head a Director of Standards and two Assistant Directors,
one for technical matters and the other for administrative matters, who shall be appointed by the
President of the Philippines with the consent of the Commission on Appointments. There shall be in
the Bureau such officials and employees to be appointed by the Secretary of Commerce and Industry
as may be necessary to carry out the purpose of this Act: provided, that personnel of the Bureau
whose duties and functions are technical in nature shall be exempt from the operation of the Wage
and Position Classification Office.
Section 3. The Bureau shall have charge of the establishment of standards for, and inspection of, all
agricultural, forest, mineral, fish, industrial and all other products of the Philippines for which no
standards have as yet been fixed by law, executive order, rules and regulations; and the inspection
and certification of the quality of commodities imported into the Philippines, to determine the country
of origin of the articles which are the growth, raw materials, manufacture, process, or produce, and to
determine if they satisfy the buyer’s or importer’s requirements or specifications for domestic
consumption; and to prohibit the discharge and/or release of any article which are the growth, raw
materials, manufacture, process, or produce of countries without trade relations with the Philippine
government. Physical, biological and/or chemical tests or analyses necessary for the examination of
products under the provisions of this Act may be undertaken in any branch of the Government having
facilities for the purpose until such time as the Bureau may have its own facilities.
Section 4. Subject to the general supervision and control of the Secretary of Commerce and Industry,
the Director of Standards shall possess the general powers conferred by law upon Bureau Chiefs,
and the following specific powers and duties which he may perform personally or through his duly
authorized representatives:
(a) Under such rules and regulations as the Director of Standards may promulgate which the
Secretary of Commerce and Industry must approve within one year, to establish standards for the
products within the purview of Section three of this Act; to inspect in order to sample and determine
the standards of said products, and to certify the inspection and standard thereof:
(b) Before the government, including government owned or controlled corporation, make any
purchase of any of the products within the purview of Section three of this Acts, and/or the producer,
manufacturer and/or dealer offers for sale any commodity which affects the life, health and property of
the people, to inspect and sample in order to determine if, and to certify that the products satisfy the
requirements as to kind, class, grade, quality or standard in accordance with the provisions of sub-
section (a) above;
(c) Before the exportation or shipment abroad of any of the products within the purview of Section
three of this Act for which no standard has or shall have, as yet, been established in accordance with
the provisions of sub-section (a) above, to inspect and sample in order to determine if, and to certify
that, the whole shipment satisfies the buyer’s or importer’s requirements as to kind, class, grade,
quality or standard: provided, however, that shipments which are not standardized but conforms to
buyer’s or importer’s requirements, shall have their corresponding customs or shipping papers or
documents stamped conspicuously with caption “not under government commodity standardization”
and may be released by the Collector of Customs in accordance with the existing Tariff and Customs
Laws.
(d) Before any commodity imported into the Philippines is discharged and/or released by the Bureau
of Customs, to inspect such commodity in order to sample and determine the country of origin where
the articles are the growth, raw materials, manufacture, process or produce, and to certify that, the
whole shipment satisfies local buyer’s importer’s requirements as to kind, class, grade, quality or
standard which may be indicated on the corresponding customs or shipping papers or commercial
documents: provided, however, that imports which are not shown to be covered by, or do not conform
to, buyer’s or importer’s requirements, shall be labelled or stamped conspicuously with the caption
“do not conform to buyer’s or importer’s specifications”: provided, further, that imports of any article
which are the growth, raw materials, manufacture, process or produce of countries wherein the
Philippines has no trade agreement shall be confiscated and/or seized at the disposal of the
government.
(e) To fix and collect fees for the services of inspection and certification of inspection and standard,
and/or testing or analyzing samples and certification of tests or analyses, and other services, the
nature of which require scientific and/or technological knowledge and skill.
(f) To take testimony or evidence on matters of official business relating to the exercise of his powers,
the performance of his duties, and the accomplishment of the purpose of this Act or any of the rules
and regulations promulgated in accordance therewith.
(g) To initiate and undertake official investigation to determine the nature of organization and
business methods of any entrepreneur, person, corporation, association, partnership or firm engaged
in the manufacture, marketing and distribution of the products within the purview of Section three of
this Act: provided, however, that this power shall be exercised only in connection with any known or
reported violation of any provision of this Act, or non-compliance with any rule or regulation
promulgated in accordance therewith.
Section 5. Any person who fails or refuses to comply with a legal summon, or subpoena, or subpoena
duces tecum, of the Director of Standards or his duly authorized agent or representative, or refuses to
be sworn to, prior to giving testimony of refuses to answer pertinent questions, or gives false or
misleading data or information or willful concealment of a material fact, in any investigation made
pursuant to subsection (c), (d), (e), (f), and (g) of Section four of this Act, shall be punished by
imprisonment of not less than two or more than six months, and by a fine of not less than five
hundred nor more than one thousand pesos and deportation if he is an alien, after serving the entire
period of his imprisonment: provided, however, that, if the false or misleading data or information shall
have been given under oath, the maximum penalty for giving false testimony shall be imposed.
Section 6. No customs export entry, import entry, declaration, release certificate, manifest, clearance,
import permit, or permit to ship abroad and/or discharge shall be issued for any of the products within
the purview of Section three of this Act and/or imported commodity, unless it is first inspected in
accordance with provisions of sub-sections (b), (c), (d), and/or (e) of Section four of this Act: provided,
however, that no product of the Philippines for which a standard has been established and
promulgated by virtue of this Act shall be sold and/or disposed of in any manner and/or exported
unless and until its standard shall have been certified by the Director of Standards or his duly
authorized representatives as conforming to the standard set for, either for local distribution and/or for
export: provided, further, that no such certification shall be required upon application under oath by
the manufacturer and/or exporter to the Director of Standards that the shipment is in small quantity
and the product is not for sale but for private use or consumption only. It shall be the duty and the
responsibility of all collectors of customs to enforce the prohibition on the exportation and/or
importation of any product hereinabove referred to.
Section 7. Any public official, employee, individual, corporation, association, partnership, or firm
effecting or abetting the shipment abroad and/or facilitate the discharge of distribution and/or sale for
domestic consumption of any product in violation of any of the provisions of Section six of this Act or
any rules and regulations issued therewith, shall be punished by imprisonment of not less than six
months nor more than two years and by a fine of not less than one thousand nor more than five
thousand pesos, and deportation if he is an alien after serving the entire period of his imprisonment.
Whenever the violation is committed by a corporation, association, partnership, or firm, the President
and each one of the directors or managers of said corporation, association, partnership or firm who
shall have knowingly permitted or failed to prevent the commission of said violation shall be held
liable as principals thereof.
In case the offender is a naturalized citizen he shall, in addition to the penalty prescribed herein,
suffer the penalty of cancellation of his naturalization certificate and such registration in the civil
registry and immediate deportation.
In case the violation is committed by, or in the interest of a foreign judicial person duly licensed to
engage in business in the Philippines, such license to engage in business in the Philippines shall
immediately be revoked.
If the offender is a public officer or employee, he shall, in addition to the penalty of imprisonment and
fine prescribed herein, be dismissed from office and perpetually disqualified from holding public office.
Section 8. The Division of Standards under the Bureau of Commerce is hereby converted and its
personnel, appropriation, and share in the appropriations of the Bureau of Commerce, funds,
furniture, equipment, properties, supplies, records, assets and liabilities are hereby constituted to the
Bureau: and all powers conferred upon, and all duties, functions, and activities assigned to the said
division and to the Director of Commerce by virtue of the provisions of Sections one hundred fifty-five,
one hundred fifty-six and one hundred fifty-seven of Executive Order Numbered ninety-four, series of
nineteen hundred and forty-seven, together with the execution and enforcement of Commerce
Administrative Orders on Standardization and inspection of Philippine products already promulgated
in accordance with the provisions of the said sections of the executive order, are hereby transferred
to the Director of Standards.
Section 9. In addition to such funds and appropriation as may be transferred to the Bureau as
provided in
Section eight of this Act, there is hereby appropriated, out of any funds in the National Treasury not
otherwise appropriated, the amount of one million pesos for the salaries, wages, sundry and other
expenses, furniture, and equipment of such personnel of the Bureau as will be needed and required
to carry out the purpose of this Act.
Section 10. Twenty-five per centum of all receipts and collections accruing from the enforcement of
this Act and the rules and regulations on inspection and certificate of inspection and standard shall be
set aside and be available for disbursement for salaries, wages, sundry and other expenses,
furniture, and equipment of such additional personnel as may be needed and required to intensify or
extend the activities and services of the Bureau. Any amount thus set aside, or so much thereof as
may be needed for the intensification or extension of activities and services, shall be itemized in
special budget to be approved by the President upon recommendation of the Secretary of Commerce
and Industry; and any such special budget thus approved for the ensuing fiscal year for the
consideration of the Congress in its regular or special session. Unitemized and unexpended balances
of amounts thus set aside shall be cumulative from year to year, and shall constitute, a special fund to
be called “Philippine Standardization and Inspection Funds” to be used for the purposes herein
stated, and for such other aims and projects as may render the services of the Bureau efficient and
effective.
Section 11. All Acts, executive orders, administrative orders and proclamations or parts thereof
inconsistent with any of the provisions of this Act are hereby repealed or modified accordingly. If any
part of this Act shall, for any person, be adjudged by any court of competent jurisdiction to be invalid,
such judgment shall not affect the remainder thereof, but shall be confined in its operation to the part
directly involved in the controversy in which such judgment shall have been rendered.
Section 12. Effectivity. – This Act shall take effect upon its approval.
Approved, June 20, 1964.
 

ar) "Manufacture" means and any and all operations involved in the production, including preparation,
propagation, processing, formulating, filing, packing, repacking, altering, ornamenting, finishing or
otherwise changing the container, wrapper or labeling of a consumer product in the furtherance of the
distribution of the same from the original place of manufacture to the person who makes the final
delivery or sale to the ultimate consumer.
aq) "Label, labeling" means the display of written, printed or graphic matter on any consumer product
its immediate container, tag, literature or other suitable material affixed thereto for the purpose of
giving information as to identify, components, ingredients, attributes, directions for use, specifications
and such other information as may be required by law or regulations.

az) "Package" or "packaging" means any container or wrapping in which any consumer product is
enclosed for use in the delivery or display of that consumer product to retail purchasers, but does not
include:

1) shipping containers or wrappings used solely for the transportation of any consumer product
in bulk or in big quantities by manufacturers, packers, or processors to wholesale retail
distributors thereof;

2) shipping containers or outer wrappings used by retailers to ship or deliver any product to
retail costumers if such containers and wrappings bear no printed matter pertaining any
particular product;

3) The wrappers or containers of consumer products sold in small quantities by small retail
stores to the consumer which by tradition are wrapped with ordinary paper.