PRE FINALS

• RA 7394 Consumer Act

• RA 7581 Price Act
• RA 9994 Expanded Senior Citizen’s Act of 2010
• RA 9502 Cheaper and Quality Medicines Act of 2008
• RA 8423 TAMA (Traditional and Alternative Medicines Act)
• RA 8172 ASIN
• AO 43 CGMP

Prepared by: Sheryl A. Silan, RPh

RA 7394 Consumer Act of the Philippines

• To protect the interest of the consumer, promote his

general welfare and to establish standards of conduct for
business and industry

• April 13, 1992

 RA 7394 Consumer Act of the Philippines
• Objectives:

– Protection against hazards to health and safety

– Protection against deceptive, unfair and unconscionable sales
acts and practices
– Provision of information and education to facilitate sound
choice and the proper exercise of rights by the consumer
– Provision of adequate rights and means of redress
– Involvement of consumer representatives in the formulation of
social and economic policies
 RA 7394 Consumer Act of the Philippines
• Definition of terms
– Advertisement – any form of mass medium, circulated
advertising matter.

– Advertising – business of conceptualizing, presenting or making

available to the public, through any form of mass media

– Advertising agency or Agent – service organization creating

promotional campaigns
 RA 7394 Consumer Act of the Philippines
• Definition of terms
– Agricultural Purpose – purpose related to the production,
harvest, processing, manufacture, distribution, storage,
transportation, marketing, exhibition, or disposition of
agricultural and fishery products.

– Amount financed – the cash price plus non finance charges

less the amount of down payment paid by the buyer.
RA 7394 Consumer Act of the Philippines
– Banned hazardous substance
1. Articles intended for use by children which are hazardous
2. Any hazardous substance intended in a form suitable for use in the
household

– Batch – quantity of any drug or device produced during a given

cycle of manufacture

– Business name, firm name or style – name or designation other

than the true name of a person, partnership or corporation
RA 7394 Consumer Act of the Philippines
– Business name, firm name or style – name or designation other
than the true name of a person, partnership or corporation
which is used in:
1. Any written or printed receipt
2. Any written or printed contract not verified by a notary public
3. Any written or printed evidence of any agreement or business
transaction
4. Any sign or billboard exhibited in plain view in or the place of the
business

– Cash price or delivered price – in case of trade transaction, it is

the amount of money which would constitute full payment upon
RA 7394 Consumer Act of the Philippines
– Chain Distribution Plans or Pyramid Sales Schemes – sales
devices whereby a person after making an investment , is
granted by the manufacturer a right to recruit for profit one or
more persons who will also be granted such right to recruit.

– Closing Out Sale – seller uses an announcement to create the

impression that he is willing to give large discounts in order to
reduce, dispose or close out his inventory and business.

– Commerce – the sale, lease, exchange, traffic or distribution of

goods, commodities, productions, services, tangible or
RA 7394 Consumer Act of the Philippines
– Consumer – natural person who is a purchaser, lessee,
recipient or prospective purchase, lease or recipient of
consumer products, services or credit.

– Consumer credit - means any credit extended by a creditor to

a consumer for the sale or lease of any consumer product or
service

– Consumer loan - means a loan made by the lender to a person

which is payable in installments for which a finance charge is or
may be imposed.
RA 7394 Consumer Act of the Philippines
– Consumer products and services - means goods, services and
credits, debts or obligations which are primarily for personal,
family, household or agricultural purposes

– "Corrosive" means any substance which on contact with living

tissue will cause destruction of tissue by chemical action.

– "Expiry or expiration date" means the date stated on the label

of food, drug, cosmetic, device or hazardous substance after
which they are not expected to retain their claimed safety,
efficacy and quality or potency and after which it is no longer
RA 7394 Consumer Act of the Philippines
– "Extremely flammable" means any substance which has a flash
point at or below negative six and six-tenths degrees
centigrade

– "combustible" shall apply to any substance which has a flash

point of above twenty-six and six-tenths degrees to and
including sixty-five and five-tenths

– "Generic name" is the identification of drugs and medicines by

their scientifically and internationally recognized active
ingredients or by their official generic name
RA 7394 Consumer Act of the Philippines
– Hazardous substance" means any substance or mixture of
substances which is toxic, corrosive, irritant, a strong sensitizer,
flammable or combustible, or generates pressure through
decomposition, heat or other means
RA 7394 Consumer Act of the Philippines
– "Highly Toxic" means any substance which has any of the
following effects: 
• produces death within fourteen days to one-half or more than one-half
of a group of ten or more laboratory white rats each weighing between
Two hundred and three hundred grams, at a single dose of fifty
milligrams or less per kilogram of body weight, when orally
administered
• produces death within fourteen days to one-half or more of a group of
ten or more laboratory white rats each weighing between two hundred
and three hundred grams, when inhaled continuously for a period of
one hour or less at an atmospheric concentration of two hundred parts
per million by volume or less of gas or vapor or two milligrams per liter
by volume or less of mist or dust
RA 7394 Consumer Act of the Philippines
– "Immediate container" means the container or package which is immediately after or
near the substance but does not include package liners.

– "Imminently hazardous product" means a consumer product which presents an

unreasonable risk of death, serious illness or severe personal injury.

–  "Irritant" means any substance not corrosive which, on immediate, prolonged or

repeated contact with normal living tissue will induce a local inflammatory reaction.

– "Materially defective product" means a product which, because of the pattern of the
defect, the number of defective products distributed in commerce and the severity of
the risk or otherwise, creates a substantial risk of injury to the public.
RA 7394 Consumer Act of the Philippines
– "Mislabeled hazardous substance" means any hazardous
substance intended, or packaged in a form suitable, for use in
households, the packaging or labeling of which is in violation of
the special packaging regulation

– "New Drugs" mean

1. any drug the composition of which is such that said drug is not
generally recognized among experts qualified by scientific training
and experience to evaluate the safety, efficacy and quality of drugs as
safe, efficacious and of good quality
2. any drug the composition of which is such that said drug, as a result
of its previous investigations to determine its safety, efficacy and good
RA 7394 Consumer Act of the Philippines
– "New Drugs" shall include drugs
• containing a newly discovered active ingredient;
• containing a new fixed combination of drugs, either by molecular or
physical combination;
• intended for new indications;
• an additional new mode of administration;
• in an additional dosage or strength of the dosage form, which meets
the conditions as defined under the new drug.
RA 7394 Consumer Act of the Philippines
– "New Product" means a consumer product which incorporates
a design, material or form of energy exchange which has not
previously been used substantially in consumer products and
as to which there exists a lack of adequate information to
determine the quality and safety of such product if used by the
consumers.

– "Poisonous substance" means any substance capable of

destroying life or seriously endangering health when applied
externally to the body or introduced internally in moderate
doses.
RA 7394 Consumer Act of the Philippines
– "Price tag" means any device, written, printed, affixed or
attached to a consumer product or displayed in a consumer
repair or service establishment for the purpose of indicating the
retail price per unit or service.

– "Principal display panel" means that part of the label that is

most likely to be displayed, presented, shown or examined
under normal and customary conditions of display for retail or
sale.

– "Private labeler" means an owner of a brand or trademark on

RA 7394 Consumer Act of the Philippines
– A consumer product bears a private label if
1. the product or its container is labeled with a brand or trademark of a
person other than its manufacturer;
2. the brand or trademark of the manufacturer of such product does not
appear on such label.

–  "Radioactive substance" means any substance which emits

ionizing radiation.

– "Retailer" means a person engaged in the business of selling

consumer products directly to consumers
RA 7394 Consumer Act of the Philippines
–  "Strong sensitizer" means any substance which will cause on
normal living tissue, allergy or photodynamic quality of
hypersensitivity which becomes evident on reapplication of the
same substance

– "Toxic substance" means any substance other than a

radioactive substance which can cause injury, illness or death
to man through ingestion, inhalation or absorption through any
body surface.
 RA 7394 Consumer Act of the Philippines
• Implementing Agencies:

– the Department of Health with respect to food, drugs,

cosmetics, devices and substances;

– the Department of Agriculture with respect to products related

to agriculture, and;

– the Department of Trade and Industry with respect to other

consumer products not specified above
 RA 7394 Consumer Act of the Philippines
• Whenever a product is found to be injurious, dangerous
and unsafe, the department shall:

– Recall
– Prohibit
– Seize from public sale
 RA 7394 Consumer Act of the Philippines
• Prohibited Acts
a) manufacture for sale, offer for sale, distribute in commerce, or import into the Philippines
any consumer product which is not in conformity with an applicable consumer product
quality or safety standard promulgated in this Act;
b) manufacture for sale, offer for sale, distribute in commerce, or import into the Philippines
any consumer product which has been declared as banned consumer product by a rule in
this Act;
c) refuse access to or copying of pertinent records or fail or refuse to permit entry of or
inspection by authorized officers or employees of the department;
d) fail to comply with an order issued under Article II relating to notifications of substantial
product hazards and to recall, repair, replacement or refund of unsafe products;
e) fail to comply with the rule prohibiting stockpiling.
 RA 7394 Consumer Act of the Philippines
• Penalties:

– a fine of not less than One thousand pesos (P1,000.00) but not more than Ten
thousand pesos (P10,000.00) or imprisonment of not less than two (2) months
but not more than one (1) year, or both upon the discretion of the court. If the
offender is an alien, he shall be deported after service of sentence and payment
of fine without further deportation proceedings.

– In case the offender is a naturalized citizen, he shall, suffer the penalty of

cancellation of his naturalization certificate and its registration in the civil register
and immediate deportation after service of sentence and payment of fine.
 RA 7394 Consumer Act of the Philippines
Minimum Labeling Requirements for Consumer Products
a) its correct and registered trade name or brand name;
b) its duly registered trademark;
c) its duly registered business name;
d) the address of the manufacturer, importer, repacker of the consumer product in the
Philippines;
e) its general make or active ingredients;
f) the net quality of contents, in terms of weight, measure or numerical count rounded of
to at least the nearest tenths in the metric system;
g) country of manufacture, if imported; and
h) if a consumer product is manufactured, refilled or repacked under license 
from a principal, the label shall so state the fact.
 RA 7394 Consumer Act of the Philippines
Additional Labeling Requirements for Food
a) expiry or expiration date, where applicable;
b) whether the consumer product is semi-processed, fully
processed, ready-to-cook, ready-to-eat, prepared food or
just plain mixture;
c) nutritive value, if any;
d) whether the ingredients use are natural or synthetic, as
the case may be;
e) such other labeling requirements as the concerned
department may deem necessary and reasonable.
 RA 7394 Consumer Act of the Philippines
Additional Labeling Requirements for Cosmetics

a) expiry or expiration date;

b) whether or not it may be an irritant;
c) precautions or contra-indications; and
d) such other labeling requirements as the concerned
department may deem necessary and reasonable.
RA 7394 Consumer Act of the Philippines
Labeling Requirements of Cigarettes

– "Warning" Cigarette Smoking is Dangerous to Your Health"

 RA 7581 THE PRICE ACT
• AN ACT PROVIDING PROTECTION TO CONSUMERS
BY STABILIZING THE PRICES OF BASIC
NECESSITIES AND PRIME COMMODITIES AND BY
PRESCRIBING MEASURES AGAINST UNDUE
PRICE INCREASES DURING EMERGENCY
SITUATIONS AND LIKE OCCASIONS

• May 27, 1992

 RA 7581 THE PRICE ACT
• The state shall:

(1) Develop, adopt and promulgate measures to promote productivity in basic necessities and prime
commodities;

(2) Develop an improved and efficient transport and distribution system;

(3) Develop, adopt and promulgate measures to stabilize prices at reasonable levels;

(4) Institute appropriate penalties for illegal price manipulation and other violations of this Act; and

(5) Establish a mechanism that will readily protect consumers from inadequate supply and
unreasonable price increase on occasions of calamities, emergencies and like occurrences.
 RA 7581 THE PRICE ACT
• Definition of Terms

– “Basic necessities” includes: rice; corn; bread; fresh, dried and

canned fish and other marine products, fresh pork, beef and
poultry meal; fresh eggs; fresh and processed milk; fresh
vegetables; root crops; coffee; sugar; cooking oil; salt; laundry
soap; detergents; firewood; charcoal; candles; and drugs
classified as essential by the Department of Health;
 RA 7581 THE PRICE ACT
– “Butter fund” means a contingent fund in the budget of the
implementing agency which shall not be used in its normal or
regular operations

– Implementing Agencies:
• The Department of Agriculture, with reference to agricultural crops, fish
and other marine products, fresh meat, fresh poultry and dairy
products, fertilizers, and other farm inputs;
• The Department of Health, with reference to drugs;
• The Department of Environment and Natural Resources, with reference
to wood and other forest products; and
• The Department of Trade and Industry, with reference to all other basic
 RA 7581 THE PRICE ACT
– Panic-buying” is the abnormal phenomenon where consumers
buy basic necessities and prime commodities grossly in excess
of their normal requirement resulting in undue shortages of
such goods to the prejudice of less privileged consumers;

– “Prevailing price” means the average price at which any basic

necessity has been sold in a given time within a month from the
occurrence of any of the conditions

– Price ceiling” means the maximum price at which any basic

necessity or prime commodity may be sold to the general public
 RA 7581 THE PRICE ACT
– “Prime commodities” include fresh fruits; flour; dried processed
and canned pork; beef and poultry meat; dairy products not
falling under basic necessities; noodles; onions; garlic; vinegar;
patis; soy sauce; toilet soap; fertilizer; pesticides; herbicides;
poultry; swine and cattle feeds; veterinary products for poultry,
swine and cattle; paper; school supplies; nipa shingles; sawali;
cement; clinker; GI sheets; hollow blocks; plywood; plyboard;
construction nails; batteries; electrical supplies; light bulbs;
steel wire; and all drugs not classified as essential drugs by the
Department of Health.
 RA 7581 THE PRICE ACT
• Illegal Acts of Price Manipulation:

1. Hoarding, which is the undue accumulation by a person or

combination of persons of any basic commodity beyond his or
their normal inventory levels 
2. Profiteering, which is the sale or offering for sale of any basic
necessity or prime commodity at a price grossly in excess of
its true worth.
3. Cartel, which is any combination of or agreement between two
(2) or more persons engaged in the production, manufacture,
processing, storage, supply, distribution, marketing, sale or
 RA 7581 THE PRICE ACT
• Automatic Price Control
1. That area is proclaimed or declared a disaster area or under a
state of calamity;
2. That area is declared under an emergency;
3. The privilege of the writ of habeas corpus is suspended in that
area;
4. That area is placed under martial law;
5. That area is declared to be in a state of rebellion; or
6. A state of war is declared in that area.
 RA 7581 THE PRICE ACT
• Mandated Price Ceiling:
– The impendency, existence, or effects of a calamity;
– The threat, existence, or effect of an emergency;
– The prevalence or widespread acts of illegal price
manipulation:
– The impendency, existence, or effect of any event that causes
artificial and unreasonable increase in the price of the basic
necessity or prime-commodity; and
– Whenever the prevailing price of any basic necessity or prime
commodity has risen to unreasonable levels.
 RA 7581 THE PRICE ACT
• Determination of Price Ceilings

– The average price, in the last three (3) months immediately

preceding the proclamation of the price ceiling, of the basic
necessity or prime commodity under consideration;
– The supply available in the market;
– The cost to the producer, manufacturer, distributor or seller
 RA 7581 THE PRICE ACT
• Price Coordinating Council Members:
(1) The Secretary of Trade and Industry, as Chairman;
(2) The Secretary of Agriculture;
(3) The Secretary of Health;
(4) The Secretary of Environment and Natural Resources;
(5) The Secretary of Local Government;
(6) The Secretary of Transportation and Communications;
(7) The Secretary of Justice;
(8) The Director General of the National Economic and Development Authority;
(9) One (1) representative from the consumers’ sector;
(10) One (1) representative from the agricultural producers’ sector;
(11) One (1) representative from the trading sector; and
(12) One (1) representative from the manufacturers’ sector.
 RA 7581 THE PRICE ACT
• Penalty for Acts of Illegal Price Manipulation. – Any
person who commits any act of illegal price manipulation
of any basic necessity or prime commodity under Section
5 hereof shall suffer the penalty of imprisonment for a
period of not less than five (5) years nor more than
Fifteen (15) years, and shall be imposed a fine of not less
than Five thousand pesos (P5,000) nor more than Two
million pesos (P2,000,000).
 RA 7581 THE PRICE ACT
•  Penalty for Violation of Price Ceiling. – Any person
who violates Section 6 or 7 of this Act shall suffer the
penalty of imprisonment for a period of not less than one
(1) year nor more than ten (10) years of a fine of note less
than Five thousand pesos (P5,000) nor more than One
million pesos (P1,000,000), or both, at the discretion of
the court.
 RA 9994 EXPANDED SENIOR CITIZENS ACT OF
2010
• AN ACT GRANTING ADDITIONAL BENEFITS AND
PRIVILEGES TO SENIOR CITIZENS, FURTHER
AMENDING REPUBLIC ACT NO. 7432

• JUNE 18, 2010

 RA 9994 EXPANDED SENIOR CITIZENS ACT OF
2010
• Objectives:
– To recognize the rights of senior citizens to take their proper place in society and make it
a concern of the family, community, and government;
– To give full support to the improvement of the total well-being of the elderly and their full
participation in society, considering that senior citizens are integral part of Philippine
society;
– To motivate and encourage the senior citizens to contribute to nation building;
– To encourage their families and the communities they live with to reaffirm the valued
Filipino tradition of caring for the senior citizens;
– To provide a comprehensive health care and rehabilitation system for disabled senior
citizens to foster their capacity to attain a more meaningful and productive ageing; and
– To recognize the important role of the private sector in the improvement of the welfare of
senior citizens and to actively seek their partnership.
RA 9994 EXPANDED SENIOR CITIZENS ACT
OF 2010
• The Act shall:
– establish mechanisms whereby the contributions of the senior
citizens are maximized;
– adopt measures whereby our senior citizens are assisted and
appreciated by the community as a whole;
– establish a program beneficial to the senior citizens, their
families and the rest of the community they serve: and
– establish community-based health and rehabilitation programs
for senior citizens in every political unit of society."
 RA 9994 EXPANDED SENIOR CITIZENS ACT
OF 2010
• Definition of Terms

– Senior citizen or elderly refers to any resident citizen of the Philippines at least sixty

(60) years old;

– Geriatrics refer to the branch of medical science devoted to the study of the biological
and physical changes and the diseases of old age;

– Nearest surviving relative refers to the legal spouse who survives the deceased senior
citizen: Provided, That where no spouse survives the decedent, this shall be limited to
relatives in the following order of degree of kinship: children, parents, siblings,
grandparents, grandchildren, uncles and aunts;
RA 9994 EXPANDED SENIOR CITIZENS ACT
OF 2010
–  Indigent senior citizen, refers to any elderly who is frail, sickly
or with disability, and without pension or permanent source of
income, compensation or financial assistance from his/her
relatives to support his/her basic needs, as determined by the
Department of Social Welfare and development (DSWD) in
consultation with the National Coordinating and Monitoring
Board."
 RA 9994 EXPANDED SENIOR CITIZENS ACT
OF 2010
• Privileges of Senior Citizen

20% discount and VAT Exempted on the sale and services

– on the purchase of medicines, including the purchase of influenza and

pnuemococcal vaccines, and such other essential medical supplies, accessories
and equipment to be determined by the Department of Health (DOH).

– on the professional fees of attending physician/s in all private hospitals, medical

facilities, outpatient clinics and home health care services;
RA 9994 EXPANDED SENIOR CITIZENS ACT
OF 2010
– on the professional fees of licensed professional health providing home health care
services as endorsed by private hospitals or employed through home health care
employment agencies

– on medical and dental services, diagnostic and laboratory fees in all private hospitals,
medical facilities, outpatient clinics, and home health care services, in accordance with
the rules and regulations to be issued by the DOH, in coordination with the Philippine
Health Insurance Corporation (PhilHealth);

– in actual fare for land transportation travel in public utility buses (PUBs), public utility
jeepneys (PUJs), taxis, Asian utility vehicles (AUVs), shuttle services and public railways,
including Light Rail Transit (LRT), Mass Rail Transit (MRT), and Philippine National
Railways (PNR);
RA 9994 EXPANDED SENIOR CITIZENS ACT
OF 2010
– in actual transportation fare for domestic air transport services
and sea shipping vessels and the like, based on the actual fare
and advanced booking;

– on the utilization of services in hotels and similar lodging

establishments, restaurants and recreation centers;

– on admission fees charged by theaters, cinema houses and

concert halls, circuses, leisure and amusement; and
 RA 9994 EXPANDED SENIOR CITIZENS ACT
OF 2010
• Privileges of Senior Citizen
–  exemption from the payment of individual income taxes of senior citizens who are
considered to be minimum wage earners

– grant of a minimum of five percent (5%) discount relative to the monthly utilization of
water and electricity supplied by the public utilities: 

–  exemption from training fees for socioeconomic programs;

– free medical and dental services, diagnostic and laboratory fees such as, but not limited
to, x-rays, computerized tomography scans and blood tests, in all government facilities,
subject to the guidelines to be issued by the DOH in coordination with the PhilHealth;
 RA 9994 EXPANDED SENIOR CITIZENS ACT
OF 2010
• Privileges of Senior Citizen

–  the DOH shall administer free vaccination against the influenza virus and
pneumococcal disease for indigent senior citizen patients;

– provision of express lanes for senior citizens in all commercial and government
establishments; in the absence thereof, priority shall be given to them; and

– death benefit assistance of a minimum of Two thousand pesos (Php2, 000.00) shall be
given to the nearest surviving relative of a deceased senior citizen which amount shall
be subject to adjustments due to inflation in accordance with the guidelines to be
issued by the DSWD
 RA 9994 EXPANDED SENIOR CITIZENS ACT OF
2010
• In the purchase of goods and services which are on
promotional discount, the senior citizen can avail of the
promotional discount or the discount provided herein,
whichever is higher.
RA 9994 EXPANDED SENIOR CITIZENS ACT
OF 2010
• Government Assistance

• (1) Social Pension

– "Indigent senior citizens shall be entitled to a monthly stipend
amounting to Five hundred pesos (Php500.00)

• (2) Mandatory PhilHealth Coverage

• (3) Social Safety Nets

 RA 9994 EXPANDED SENIOR CITIZENS ACT
OF 2010
• Penalties
– For the first violation, imprisonment of not less than two (2) years but not more
than six (6) years and a fine of not less than Fifty thousand pesos (Php50,000.00)
but not exceeding One hundred thousand pesos (Php100,000.00);
– For any subsequent violation, imprisonment of not less than two (2) years but not
more than six (6) years and a fine of not less than One Hundred thousand pesos
(Php100,000.00) but not exceeding Two hundred thousand pesos
(Php200,000.00); and
– Any person who abuses the privileges granted herein shall be punished with
imprisonment of not less than six (6) months and a fine of not less than Fifty
thousand pesos (Php50,000.00) but not more than One hundred thousand pesos
(Php100,000.00).
 RA 9502 Universally Accessible Cheaper and Quality
Medicines Act of 2008
• To protect public health and adopt appropriate measures
to promote and ensure access to affordable quality drugs
• April 29, 2008
RA 9502 Universally Accessible Cheaper and Quality
Medicines Act of 2008
• Compulsary License – license issued by the Director
General of the Intellectual Property Office to exploit a
patented invention without the permission of patent holder
RA 9502 Universally Accessible Cheaper and Quality
Medicines Act of 2008
• Non-Patentable Inventions
– discovery of a new form or new property of a known substance which does not
result in the enhancement of the known efficacy of that substance
– Discovery of any new property or new use for a known substance
– Discovery of use of known process unless such known process results in a new
product that employs at least one new reactant

 salts, esters, ethers, polymorphs, metabolites, pure form, particle size,

isomers, mixtures of isomers, complexes, combinations, and other
derivatives of a known substance shall be considered to be the same
unless they differ significantly in properties with regard to efficacy.
RA 9502 Universally Accessible Cheaper and Quality
Medicines Act of 2008
• President of the Phil. – upon the recommendation of the
Sec. of the DOH shall have the power to impose
maximum retail prices over any or all drugs and
medicines
• Sec. of the DOH – authorized to establish and initiate a
price monitoring and regulation system for drugs and
medicines, may also create such bodies, consultative
councils, from which advice may be sought, has the
power to recommend the Maximum Retail Price of Drugs
and Medicines
RA 9502 Universally Accessible Cheaper and Quality
Medicines Act of 2008
• Factors to be Considered in recommending max. retail
price
– Retail prices of drugs and meds that are subject to regulation
– Supply available in the market
– Cost to the manufacturer, importer, trader, distributor,
wholesaler or retailer of the following:
• Exchange rate of the peso
• Change in amortization cost of machinery
• Change in the cost of labor
• Change in the cost of transporting
RA 9502 Universally Accessible Cheaper and Quality
Medicines Act of 2008
• Penalty for violation of Maximum Retail Price
– Fine of not less than 50,000php but not more than 5Mphp
RA 9502 Universally Accessible Cheaper and Quality
Medicines Act of 2008
• List of Drugs and Medicines Subject to Price Regulation
– Drugs for chronic illnesses such as endocrine disorders,
cardiovascular diseases, pulmonary diseases, auto-immune
diseases, HIV AIDS
– Drugs indicated for prevention of diseases (vaccines)
– Drugs indicated for prevention of pregnancy
– Anesthetic agents
– IV fluids
– Drugs included in the PNDF Essential Drug List
RA 9502 Universally Accessible Cheaper and Quality
Medicines Act of 2008
• Penalty for Illegal Acts of Price Manipulation (Hoarding,
Profiteering)
– Imprisonment for a period of NLT 5 years but NMT 15 years or
a fine of NLT 100,000php but NMT 10Mphp
– The court may also order suspension or revocation of LTO
RA 9502 Universally Accessible Cheaper and Quality
Medicines Act of 2008

• The DOH shall publish annually in acceptable means of

public dissemination in at least 2 newspapers of
general circulation in the Phil. the generic names, and
the corresponding brand names under which they are
marketed, of all drugs and medicines available in the
Phil.
RA 9502 Universally Accessible Cheaper and Quality
Medicines Act of 2008
• All drug outlets are required to post in a conspicuous area
within their premises a clear copy of the MRP order.
 Hoarding
• The undue accumulation by a person or combination of
persons of any drug or medicine beyond their normal
inventory level
• The unreasonable limitation or refusal to dispose, sell or
distribute said drug or medicine
• The unjustifiable taking out of said drug from the channels
of production, trade, commerce and industry
 Prima Facie Evidence of Hoarding
• When a person has stocks of any drug or medicine 50%
higher than his usual inventory
• Unreasonably limits, refuses or fails to sell the same to
the general public at the time of discovery of the stocks
 Profiteering
• Sale or offering for sale of any drug or medicine at a price
grossly in excess of its true worth

 Prima Facie evidence

– When there is no price tag
– Misrepresented as to its weight or measurement
– Adulterated or diluted
– When a person raises the price by more than 10% of its price in
the immediately preceding month
 Cartel
• Any combination of, or agreement between, two or more
persons engaged in the production, manufacturing,
processing, storage, supply, distribution, marketing, sale
or disposition designed to artificially and unreasonably
increase or manipulate its price
 Prima Facie Evidence
– Perform uniform acts among themselves which tend to bring
about artificial and unreasonable increase in the price
– Simultaneously and unreasonably increase prices on their
competing products
 RA 8423 Traditional and Alternative Medicines Act

• Act creating the Philippine Institute of Traditional Health

Care (PITAHC) to accelerate the development of
traditional and alternative health care in the Philippines
• December 9, 1997
 RA 8423 Traditional and Alternative Medicines
Act
• Objectives:
– To encourage scientific research on and develop traditional and
alternative health care systems that have direct impact on
public health care.
– To promote and advocate the use of traditional, alternative,
preventive and curative health care modalities that have been
proven safe, effective, cost effective and consistent with
government standards.
– To develop and coordinate skills training courses for various
forms of traditional and alternative health care modalities.
– To formulate guidelines, standards and code of ethical practice
 RA 8423 Traditional and Alternative Medicines
Act
• Definition of Terms:
– Traditional and alternative health care – sum total of
knowledge, skills and practices on health care, other than
biomedicine, used in the prevention, diagnosis and elimination
of physical or mental disorder.

– Traditional Medicine – sum total of knowledge, skills and

practice on health care, not necessarily explicable in the
context of modern, scientific philosophical framework but
recognized by the people.
RA 8423 Traditional and Alternative Medicines
Act
– Alternative health care modalities – non-indigenous or imported
healing methods, though not necessarily practiced for centuries
nor handed down from one generation to another. Ex.
Reflexology, acupressure, chiropractics, nutritional therapy

– Herbal medicines – finished, labelled, medicinal products that

contain as active ing serial or underground parts of plant
whether in the crude state or as plant preparations

– Natural Product – those foods that grow spontaneously in

nature whether or not they are tended by man.
RA 8423 Traditional and Alternative Medicines
Act
– Traditional healers – relatively old, highly respected people with
a profound knowledge of traditional remedies.
 RA 8423 Traditional and Alternative Medicines
Act
• Traditional and Alternative Health Care Development
Fund
– 50M php for the 1st year
– 75M php for the 2nd year
– 100M php for the 3rd year from the earnings of Duty Free
Philippines
– Included in the annual General Appropriations Act thereafter
 RA 8172 ASIN Law
• Act for Salt Iodization Nationwide (ASIN)
• To protect and promote the health of the people, to
maintain an effective food regulatory system.
• To provide the entire population especially women and
children with proper nutrition
• July 24, 1995
 RA 8172 ASIN Law
• Definition of Terms:
– Micronutrient malnutrition – a disorder resulting from
deficiencies vitamin A, iron, iodine and other micronutrients
which the body needs in minute quantities everyday.

– Iodine Deficiency Disorders – broad spectrum of deficiencies

resulting from lack of iodine in the diet which leads to the
reduction of intellectual and physical capacity. May manifest as
goiter, mental retardation, physical and mental defects,
cretinism
 RA 8172 ASIN Law
– Food Fortification – the addition of nutrients to processed foods at levels above natural
state.

– Salt Iodization – addition of iodine to salt intended for human or animal consumption in
accordance with specifications as to form, fortificant, method, manner and
composition.

– Food Grade salt – salt for human and animal consumption as distinguished from
industrial salt.

– Industrial Salt – salt used in the treatment, processing, and manufacture of non food
commercial products.
 AO 43 Current Good Manufacturing
Practice Guidelines for Drug
• Objectives:
– Prescribe standard guidelines in the manufacture of drug
products

– Ensure that no person or establishment shall manufacture

drugs under substandard conditions
 AO 43 Current Good Manufacturing
Practice Guidelines for Drug
• Definition of terms:

Accuracy- nearest value obtained during measurement or analysis to the true value.

Actual Yield- quantity that is actually produced at any phase of production of a

particular drug product based on the initial input.

Airlock- an enclosed space with two or more doors, which is interposed between two
or more rooms of different standard of cleanliness for the purpose of controlling the air
flow between those rooms when they need to be entered. (anteroom, pass through
hatch)
 AO 43 Current Good Manufacturing
Practice Guidelines for Drug
Biogenerator- contained system, such as fermenter, into which
biological agents are introduced together with other materials in
order to effect their multiplication or their production of other
substances by reaction with other materials.

Microbiological Agents- genetically engineered

microorganisms, cell cultures, as well as endoparasites,
whether pathogenic or not.

Calibration- operations carried out to determine the accuracy of

measuring instruments, of “material measures” such as masses
 AO 43 Current Good Manufacturing
Practice Guidelines for Drug
Cell Culture- in vitro growing of cells isolated from multicellular
organisms.

Clean Area- area with defined environmental control of

particulate and microbial contamination, constructed and used
in such a way as to minimize the introduction, generation and
retention of contaminants within the area.

Contained Area- area constructed, operated and equipped with

air handling and filtration system in order to prevent
contamination of the external environment by biological agents
 AO 43 Current Good Manufacturing
Practice Guidelines for Drug
 Controlled Area- area constructed and operated to control the introduction of
potential contamination and the consequences of accidental release of living
organisms

Cryogenic vessel- container designed to store liquefied gas at extremely low

temperature

Cylinder – container designed to store gas at a high pressure

Good Manufacturing Practice- system of quality assurance aimed at ensuring that

products are consistently manufactured to a quality appropriate for their intended use
 AO 43 Current Good Manufacturing
Practice Guidelines for Drug
Infected (Man or Animal)- contaminated with extraneous
biological agents and therefore capable of spreading infection.

In process control- any processed substance or mixture of

substances which has to undergo one or more further stages of
processing to become finished product.

Precision- degree of variation between individual test results.

Two types:
Repeatability (within laboratory)
Reproducibility (between laboratories)
 AO 43 Current Good Manufacturing
Practice Guidelines for Drug
Primary Containment- a system of containment that prevents
the dispersal of a biological agent into the immediate working
environment.

Quarantine- act of holding off a material for use, or a product

for packaging or distribution by physically setting it apart.

Raw Material- substances whether active or excipients that are

employed in the processing of a finished product.
 AO 43 Current Good Manufacturing
Practice Guidelines for Drug
Recovery- incorporation of all or part of previous batches with
the required quality into another batch at a defined step of
production.

Rejected- status of material which are not permitted to be used

for processing, packaging or distribution.

Released or Passed- status of materials which are permitted to

be used for processing, packaging or distribution.
 AO 43 Current Good Manufacturing
Practice Guidelines for Drug
Sanitation- all measures taken to assure suitable or adequate
environmental conditions in compliance to GMP.

Secondary Containment- system of containment that prevents

the dispersal of a biological agent into the external environment
or into other working areas.

Sterile Room or Sterile Area- a room or area of defined

environmental condition with controlled particulate and
microbial contamination, constructed, equipped and used to
eliminate the introduction, generation or retention of
 AO 43 Current Good Manufacturing
Practice Guidelines for Drug
Sterilization- inactivation or reduction to an acceptable level of
all viable microorganisms by a suitable process.

Theoretical Yield- the quantity that is expected to be obtained at

any phase of production of a particular product, based on the
quantity of components to be used.
 BASIC GMP GUIDELINES
1. Personnel
1.1 Organization, Qualification and Responsibilities
1.2 Training
2. Premises
2.1 Location, Construction, Design and Lay-out
3. Equipment
3.1 Design and Construction
3.2 Installation and Location
3.3 Maintenance
3.4 Validation
 BASIC GMP GUIDELINES
4. Sanitation and Hygiene
4.1 Personnel
4.2 Premises
4.3 Equipment
5. Storage of Starting and Packaging Materials,
Intermediates, Bulk Products and Finished Products
 BASIC GMP GUIDELINES
6. Production
6.1 Basic Manufacturing requirements
6.2 Process Validation
6.3 Contamination
6.4 Batch and Lot Numbering System
6.5 Weighing and dispensing
6.6 Dry Materials and Products
6.7 Mixing and Granulation
6.8 Compression
6.9 Coating
6.10 Hard Capsule Filling
6.11 Liquids, Creams and Ointments
 BASIC GMP GUIDELINES
7. Packaging
8. Finished Product Quarantine and Delivery to Warehouse
9. Quality Control
10.Documentation
11.Self Inspection
12.Guidelines for Handling of Product Complaint, Product
Recall and Returned Product