WORKSHEET 1

DISCUSS THE MANDATE OF THE DEPARTMENT OF HEALTH (DOH) and FOOD AND
DRUG ADMINITRATION (FDA)

DEPARTMENT OF HELATH (DOH)

The DOH has three major roles in the health sector: (1) leadership in health; (2) enabler and capacity
builder; and (3) administrator of specific services. Its mandate is to develop national plans, technical
standards, and guidelines on health. Aside from being the regulator of all health services and products, the
DOH is the provider of special tertiary health care services and technical assistance to health providers
and stakeholders.

While pursuing its vision, the DOH adheres to the highest values of work, which are:
 Integrity – The Department believes in upholding truth and pursuing honesty, accountability, and
consistency in performing its functions.
 Excellence – The DOH continuously strive for the best by fostering innovation, effectiveness and
efficiency, pro-action, dynamism, and openness to change.
 Compassion and respect for human dignity – Whilst DOH upholds the quality of life, respect for
human dignity is encouraged by working with sympathy and benevolence for the people in need.
 Commitment – With all our hearts and minds, the Department commits to achieve its vision for the
health and development of future generations.
 Professionalism – The DOH performs its functions in accordance with the highest ethical standards,
principles of accountability, and full responsibility.
 Teamwork – The DOH employees work together with a result-oriented mindset.
 Stewardship of the health of the people – Being stewards of health for the people, the Department
shall pursue sustainable development and care for the environment since it impinges on the health of
the Filipinos.

FOOD AND DRUG ADMINISTRATION (FDA)

As a regulatory agency under the Department of Health, the Food and Drug Administration, created under
Republic Act No. 3720, series of 1963, as amended by Executive Order 175, series of 1987, otherwise
known as the “Food, Drugs and Devices, and Cosmetics Act”, and subsequently Republic Act No. 9711
otherwise known as “The Food and Drug Administration Act of 2009”, is mandated to ensure the safety,
efficacy or quality of health products which include food, drugs, cosmetics, devices, biologicals, vaccines,
in-vitro diagnostic reagents, radiation-emitting devices or equipment, and household/urban hazardous
substances, including pesticides and toys, or consumer products that may have an effect on health which
require regulations as determined by the FDA.

Among others, the FDA is also mandated to enforce the provisions of the following laws:
 RA 9502, or The Universally Accessible Cheaper and Quality Medicine Act of 2008
 RA 6675, or The Generics Act Of 1988,
 RA 10918, or The Pharmacy Law,
 RA 9211, or The Tobacco Regulation Act of 2003
 RA 7394, or The Consumer Act of the Philippines
 RA 7581/10623, or The Price Act
 RA 10611, or The Food Safety Act of 2013
 RA  8172, or The ASIN Law,
 RA 8203, or The Special Law on Counterfeit Drug
 RA 8976, or The Food Fortification Law
 RA 9165, or The Comprehensive Dangerous Drugs Act
 RA 9257, or The Expanded Senior Citizens Act of 2003
 PD No. 881, or The Household Hazardous Act
 EO No. 51, or The Milk Code of the Philippines
 RA 10354, or The Responsible Parenthood and Reproductive Health Bill of 2012
 PD 856, or The Code of Sanitation of the Philippines

Reference/s:
Department of Health (2022). DOH Profile. Retrieved from https://doh.gov.ph/profile#:~:text=Its
%20mandate%20is%20to%20develop,to%20health%20providers%20and%20stakeholders.
Food and Drug Administration (2022). About FDA. Retrieved from https://www.fda.gov.ph/about-fda/

WORKSHEET 2

DIFFERENTIATE THE FOLLOWING. TABULATE YOUR ANSWER.

MANUFACTURER means an establishment engaged in any and all
operations involved in the production of health
products including preparation, processing,
compounding, formulating, filling, packing,
repacking, altering, ornamenting, finishing and
labeling with the end in view of its storage, sale or
distribution.
TRADER means any establishment which is a registered
owner of a health product and procures the raw
materials and packing components and provides the
production monographs, quality control standards
and procedures, but subcontract the manufacture of
such product to a licensed manufacturer. In
addition, a trader may also engage in the
distribution and/or marketing of its products.
DISTRIBUTOR/IMPORTER means any establishment that imports raw
materials, active ingredients and/or finished
products for its own use or for wholesale
distribution to other establishments or outlets. If the
distributor/importer/exporter sells to the general
public, it shall be considered a retailer.
DISTRIBUTOR/EXPORTER means any establishment that exports raw
materials, active ingredients and/or finished
products for its own use or for wholesale
distribution to other establishments or outlets. If the
distributor/importer/exporter sells to the general
public, it shall be considered a retailer.
DISTRIBUTOR/WHOLESALER means any establishment that procures raw
materials, active ingredients and/or finished
products from local establishments for local
distribution on wholesale basis.
RETAILER means any establishment which sells or offers to
sell any health product directly to the general
public.
Reference/s:
Food and Drug Administration (2019). Guidelines for Manufacturers and Traders. Retrieved from
https://www.fda.gov.ph/wp-content/uploads/2019/09/Guidelines-for-Manufacturers-and-Traders.pdf
Food and Drug Administration (2019). Guidelines for Distributors. Retrieved from
https://www.fda.gov.ph/wp-content/uploads/2019/09/Guidelines-for-Distributors.pdf
Food and Drug Administration (2019). Guidelines for Retailers. Retrieved from
https://www.fda.gov.ph/wp-content/uploads/2019/09/Guidelines-for-Retailers.pdf