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ORGANIC HEALTH LAW
Law 67
Official Gazette Supplement 423 of December 22, 2006
Last modification: Jan 24, 2012
Status: Current

THE NATIONAL CONGRESS
Considering:
That numeral 20 of article 23 of the Political Constitution of the Republic, establishes the
health as a fundamental human right and the State recognizes and guarantees
people the right to a quality of life that ensures health, food and nutrition,
drinking water, environmental sanitation, ...;
That article 42 of the Political Constitution of the Republic, provides that "The State
guarantee the right to health, its promotion and protection, through the development of
food security, provision of drinking water and basic sanitation, promotion of
of healthy environments in the family, work and community, and the possibility of access
permanent and uninterrupted health services, in accordance with the principles of equity,
universality, solidarity, quality and efficiency. ";
That the Health Code approved in 1971 contains outdated provisions in
in relation to advances in public health, human rights, science and technology,
the health and disease situation of the population, among others;
That the current Health Code has undergone multiple partial reforms that
they have become a dispersed and disintegrated body of law;
That in the face of the current reform processes of the State, the health sector and globalization,
in which our country is immersed, the legislation must prioritize the interests of
the health of the population over commercial and economic ones;
That Ecuador has ratified international conventions and treaties that determine
important commitments of the country in different matters such as human rights,
sexual and reproductive rights, rights of children and adolescents, among others;
That it is necessary to update normative concepts in health, through the
promulgation of an organic law that guarantees supremacy over other laws in this
matter; Y,
In exercise of its constitutional and legal powers, it issues the following.

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ORGANIC HEALTH LAW
PRELIMINARY TITLE
CHAPTER I
The right to health and its protection
Art. 1 .- The purpose of this Law is to regulate the actions that allow
make effective the universal right to health enshrined in the Political Constitution of the
Republic and the law. It is governed by the principles of equity, integrality, solidarity,
universality, inalienability, indivisibility, participation, plurality, quality and
efficiency; with a rights, intercultural, gender, generational and bioethical approach.
Art. 2 .- All members of the National Health System for the execution of the
activities related to health, will be subject to the provisions of this Law, its
regulations and standards established by the national health authority.
Art. 3.- Health is the complete state of physical, mental and social well-being and not only
the absence of conditions or diseases. It is an inalienable, indivisible human right,
inalienable and unenforceable, whose protection and guarantee is the primary responsibility of the
Condition; and, the result of a collective process of interaction where State, society,
family and individuals converge for the construction of environments, settings and styles of
healthy life.
CHAPTER II
Of the national health authority, its powers and
Responsibilities
Art. 4 .- The national health authority is the Ministry of Public Health, entity to which
the exercise of the health stewardship functions corresponds; as well as the responsibility
of the application, control and monitoring of compliance with this Law; and, the rules that
dictate for its full validity will be mandatory.
Art. 5.- The national health authority will create the necessary regulatory mechanisms
so that the resources destined for health from the public sector, organizations do not
governmental and international organizations, whose beneficiary is the State or the
public sector institutions, are oriented towards the implementation, monitoring and
evaluation of policies, plans, programs and projects, in accordance with the
requirements and health conditions of the population.
Art. 6.- It is the responsibility of the Ministry of Public Health:
1. Define and enact the national health policy based on the principles and approaches
established in article 1 of this Law, as well as to apply, control and monitor its
compliance;
2. Exercise the rectory of the National Health System;

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3. Design and implement comprehensive and quality care programs for people
during all stages of life and in accordance with their particular conditions;
4. Declare the mandatory nature of immunizations against certain diseases,
in the terms and conditions that the national and local epidemiological reality requires;
define the standards and the basic national immunization scheme; and, provide at no cost to
the population the elements necessary to fulfill it;
5. Regulate and monitor the application of technical standards for detection, prevention,
comprehensive care and rehabilitation, of communicable and non-communicable diseases,
chronic degenerative diseases, disabilities and declared public health problems
priority, and determine the communicable diseases of mandatory notification,
guaranteeing the confidentiality of the information;
5-A.- Dictate, regulate and control the correct application of the regulations for the care of
pathologies considered as catastrophic diseases, as well as directing the effective
application of their care programs.
6. Formulate and implement policies, programs and actions for the promotion, prevention and
comprehensive sexual and reproductive health care according to the life cycle that
allow the validity, respect and enjoyment of rights, both sexual and reproductive,
and declare the obligation of your attention in the terms and conditions that the reality
national and local epidemiological required;
7. Establish prevention programs and comprehensive health care against violence in
all its forms, with an emphasis on vulnerable groups;
8. Regulate, control and monitor the donation, obtaining, processing, storage,
distribution, transfusion, use and quality of human blood, its components and
derivatives, in public and private institutions and organizations, for profit and non-profit,
authorized to do so;
9. Regulate and control the functioning of cell, tissue and blood banks; plants
industrial blood products and apheresis establishments, public and private; Y,
promote the creation of these in their health services;
10. Issue policies and standards to regulate and avoid the consumption of tobacco, beverages
alcoholics and other substances that affect health;
11. Determine health alert zones, identify population groups at serious risk
and request the declaration of the state of sanitary emergency, as a consequence of
epidemics, disasters or others that put collective health at serious risk;
12. Prepare the health plan for disaster risk management and its consequences, in
coordination with the National Directorate of Civil Defense and other agencies
competent;
13. Regulate, monitor and take measures designed to protect human health against
risks and damages that environmental conditions can cause;
14. Regulate, monitor and control the application of biosafety standards, in
coordination with other competent bodies;
15. Regulate, plan, execute, monitor and inform the population about activities of
health concerning the quality of water, air and soil; and, promote spaces and
healthy environments, in coordination with sectional agencies and other
competent;

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16. Regulate and monitor, in coordination with other competent bodies, the rules of
safety and environmental conditions in which they carry out their activities
workers, for the prevention and control of occupational diseases and reduce the
minimal risks and accidents at work;
17. Regulate and monitor actions aimed at eliminating and controlling the proliferation of
fauna harmful to human health;
18. Regulate and carry out sanitary control of production, import, distribution,
storage, transportation, marketing, dispensing and sale of food
processed, medicines and other products for human use and consumption; as well as the
systems and procedures that guarantee their innocuousness, safety and quality, through the
National Institute of Hygiene and Tropical Medicine Dr. Leopoldo Izquieta Pérez and others
dependencies of the Ministry of Public Health;
19. To dictate, in coordination with other competent bodies, the policies and standards for
ensure food and nutrition security, including prevention of disorders
caused by micronutrient deficiencies or alterations caused by disorders
food, with a life cycle approach and monitor compliance with them;
20. Formulate policies and develop strategies and programs to guarantee access and
availability of quality drugs, at the lowest cost for the population, with an emphasis
in generic drug programs;
21. Regulate and control all forms of advertising and promotion that threaten health and
induce behaviors that negatively affect it;
22. Regulate, control or prohibit when necessary, in coordination with other
competent bodies, the production, import, marketing, advertising and use
of toxic or dangerous substances that pose a risk to people's health;
23. Regulate, monitor and control, in coordination with other competent bodies, the
production and marketing of products for animal and agricultural use and consumption that
affect human health;
24. Regulate, monitor, control and authorize the operation of the establishments and
health services, public and private, for-profit and non-profit, and others subject to
sanitary control;
25. Regulate and execute the licensing and certification processes; and, establish the
standards for the accreditation of health services;
26. Establish policies to develop, promote and enhance the practice of medicine
traditional, ancestral and alternative; as well as research, for your good practice;
27. Determine the professions, higher technical levels and health auxiliaries that
they must register for their exercise;
28. Design in coordination with the Ministry of Education and Culture and other
competent organizations, health promotion and education programs, to be
applied in state, private, municipal and educational establishments
fiscomisionales;
29. Develop and promote strategies, plans and programs for information, education and
social communication in health, in coordination with institutions and organizations
competent;
30. To dictate, in its sphere of competence, the sanitary regulations for the operation of
the premises and public and private establishments of attention to the population;
31. Regulate, control and monitor the processes of donation and transplantation of organs, tissues

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and human anatomical components and establish mechanisms that promote
voluntary donation; as well as regulate, control and monitor the use of orthoses, prostheses and
other synthetic implants in the human body;
32. Participate, in coordination with the competent national body, in the investigation
and the development of science and technology in health, safeguarding the validity of
human rights, under bioethical principles;
33. Issue the sanitary norms and regulations for the installation and operation of
cemeteries, crypts, crematoriums, funeral homes, viewing rooms and funeral homes;
34. Comply with and enforce this Law, the regulations and other legal provisions and
techniques related to health, as well as international instruments of the
which Ecuador is a signatory.
These actions will be executed by the Ministry of Public Health, applying principles and
deconcentration and decentralization processes; Y,
35. The others provided for in the Political Constitution of the Republic and other laws.
Note: Number 5-A added by Law No. 0, published in Official Gazette 625 of December 24
January 2012.
CHAPTER III
Rights and duties of individuals and of the State in
relationship with health
Art. 7 .- Every person, without discrimination for any reason, has in relation to health,
the following rights:
a) Universal, equitable, permanent, timely and quality access to all actions and
Health services;
b) Free access to public health programs and actions, providing care
preferential in public and private health services, to vulnerable groups
determined in the Political Constitution of the Republic;
c) Live in a healthy environment, ecologically balanced and free from contamination;
d) Respect for their dignity, autonomy, privacy and intimacy; to their culture, practices and
cultural uses; as well as their sexual and reproductive rights;
e) Be timely informed about treatment alternatives, products and
services in the processes related to your health, as well as in uses, effects, costs and
quality; to receive counseling and advice from trained personnel before and after the
procedures established in medical protocols. The members of the towns
indigenous people, if applicable, will be informed in their mother tongue;
f) Have a unique medical history written in precise, understandable and
complete; as well as the confidentiality regarding the information contained therein already
have his epicrisis delivered to him;
g) Receive, by the health professional responsible for their care and empowered
to prescribe, a prescription that must first contain the name
generic of the prescribed drug;

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h) Exercise the autonomy of their will through written consent and take
decisions regarding your health status and diagnostic and treatment procedures,
except in cases of urgency, emergency or risk to people's lives and to the
public health;
i) Use with opportunity and efficiency, in the competent authorities, the actions to
process administrative or judicial complaints and claims that guarantee compliance with
Your rights; as well as timely reparation and compensation for damages
caused, in those cases that warrant it;
j) To be attended immediately with professional emergency services, supply of
medicines and supplies necessary in cases of imminent risk to life, in
any public or private health establishment, without requiring commitment
economic or prior administrative procedure;
k) Participate individually or collectively in health activities and monitor the
compliance with health actions and the quality of services, through the
creation of citizen oversight bodies or other mechanisms of social participation; And be
informed about the prevention and mitigation measures of threats and situations
of vulnerability that put their life at risk; Y,
l) Not be subject to tests, clinical trials, laboratory or research, without your
knowledge and prior written consent; nor be subjected to tests or exams
diagnoses, except when expressly determined by law or in an emergency or
urgency in which his life is in danger.
Art. 8 .- They are individual and collective duties in relation to health:
a) Comply with the prevention and control measures established by the authorities of
Health;
b) Provide timely and truthful information to the health authorities, when it is
of diseases declared by the national health authority as notification
mandatory and take responsibility for actions or omissions that put health at risk
individual and collective;
c) Comply with the treatment and recommendations made by health personnel to
their recovery or to avoid risks to their family or community environment;
d) Participate individually and collectively in all health activities and monitor
the quality of services through the creation of citizen oversight bodies and contribute
to the development of healthy environments at work, family and community level; Y,
e) Comply with the provisions of this Law and its regulations.
Art. 9 .- It is the responsibility of the State to guarantee the right to health of the people, for
which has, among others, the following responsibilities:
a) Establish, comply with and enforce the policies of the State, social protection and
health insurance in favor of all the inhabitants of the national territory;
b) Establish public health programs and actions at no cost to the population;
c) Prioritize public health over commercial and economic interests;
d) Adopt the necessary measures to guarantee, in the event of a health emergency, the
access and availability of supplies and medicines necessary to face it, making

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use of the mechanisms provided in international conventions and treaties and the
current legislation;
e) Establish, through the national health authority, the mechanisms that allow
the person as a subject of rights, permanent and uninterrupted access, without
obstacles of any kind to quality health actions and services;
f) Guarantee the population access and availability of quality medicines at low
cost, with emphasis on generic drugs in the appropriate presentations, according to the
age and timely provision, at no cost for the treatment of HIV-AIDS and diseases
such as hepatitis, dengue, tuberculosis, malaria and other communicable diseases that put
collective health;
g) Promote the participation of society in individual health care and
collective; and, establish mechanisms of oversight and accountability in the
public and private institutions involved;
h) Guarantee the fiscal allocation for health, in the terms indicated by the
Political Constitution of the Republic, the timely delivery of resources and their
distribution under the principle of equity; as well as the human resources necessary to
provide comprehensive quality care for individual and collective health; and,
i) Guarantee investment in infrastructure and equipment of health services that
allow permanent access of the population to comprehensive, efficient, quality and
timely to respond adequately to epidemiological needs and
community.
BOOK I
Of health actions
TITLE I
CHAPTER I
Common provisions
Art. 10 .- Those who are part of the National Health System will apply the policies,
programs and standards of comprehensive and quality care, which include actions of
promotion, prevention, recovery, rehabilitation and palliative health care
individual and collective, subject to the principles and approaches established in the article
1 of this Law.
Art. 11 .- The study programs of public and private education establishments,
municipal and fiscal, at all levels and modalities, will include content
that promote knowledge of the duties and rights in health, habits and styles of
healthy lives, promote self-care, gender equality, co-responsibility
personal, family and community to protect health and the environment, and discourage and
prevent harmful behavior.
The national health authority, in coordination with the Ministry of Education and
Culture, will ensure that public, private, municipal and educational establishments
fiscomisionales, as well as their personnel, guarantee the care, protection, mental health and

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physics of their learners.
Art. 12 .- Social communication in health will be aimed at developing in the population
healthy habits and lifestyles, discourage harmful behaviors, promote equality
between genders, develop awareness of the importance of self-care and self-care
citizen participation in health.
The social communication media, in compliance with the provisions of the law, will assign
permanent spaces, at no cost to the State, for the dissemination of programs and messages
educational and informative health programs aimed at the population, according to the
productions that compulsorily, for this purpose, will elaborate and deliver
quarterly the national health authority.
The national health authority will regulate and control the dissemination of programs or
messages, to prevent their contents from being harmful to physical health and
psychological of people, especially children and adolescents.
Concordances:
• CHILDHOOD AND ADOLESCENCE CODE, Arts. 27, 46

Art. 13 .- The health plans and programs for vulnerable groups indicated in the
Political Constitution of the Republic, will incorporate the development of self-esteem,
will promote the fulfillment of their rights and will be based on the recognition of their
particular needs on the part of the members of the National Health System and the
society in general.
Art. 14 .- Those who are part of the National Health System, will implement plans and
mental health programs, based on comprehensive care, privileging groups
vulnerable, with a family and community approach, promoting the social reintegration of
people with mental illness.
Art. 15 .- The national health authority in coordination with other institutions
competent authorities and social organizations, will implement programs for the prevention
timely, diagnosis, treatment and recovery of growth disorders and
growth.
CHAPTER II
Of food and nutrition
Art. 16 .- The State will establish an intersectoral policy of food security and
nutritional, which tends to eliminate bad eating habits, respects and encourages
traditional food knowledge and practices, as well as the use and consumption of
products and food typical of each region and will guarantee people, access
permanent to healthy, varied, nutritious, safe and sufficient food.

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This policy will be especially aimed at preventing disorders caused by
micronutrient deficiencies or alterations caused by eating disorders.
Art. 17 .- The national health authority together with the members of the System
National Health Department, will encourage and promote breastfeeding during the first
six months of life of the child, seeking its extension until two years of
age.
It will guarantee access to safe breast milk or milk substitutes for the children of
HIV-AIDS carrier mothers.
Concordances:
• CHILDHOOD AND ADOLESCENCE CODE, Arts. 30

Art. 18 .- The national health authority, in coordination with the sectional governments,
the production chambers and university centers will develop activities of
information, education, communication and community participation aimed at
knowledge of the nutritional value of food, its quality, sufficiency and safety,
in accordance with the technical standards issued for this purpose by the competent body
and of this Law.
Art. 19 .- The national health authority will ensure the protection of health in the control
of iodine deficiency diseases, through the control and monitoring of the
salt iodization for human consumption.
CHAPTER III
Of sexual health and reproductive health
Art. 20 .- The policies and programs of sexual health and reproductive health will guarantee the
access of men and women, including adolescents, to actions and health services that
ensure gender equity, with a multicultural approach, and will contribute to eradicating
risk behaviors, violence, stigmatization and exploitation of sexuality.
Art. 21.- The State recognizes maternal mortality, adolescent pregnancy and the
unsafe abortion as public health problems; and, guarantees access
to public health services at no cost to users in accordance with what
provides the Law on Free Maternity and Child Care.
Public health problems require comprehensive care, which includes
prevention of risk situations and encompass educational solutions,
health, social, psychological, ethical and moral, privileging the guaranteed right to life
by the Constitution.

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Concordances:
• CIVIL CODE (BOOK I), Arts. 61
• LAW OF FREE MATERNITY AND CHILD CARE, Arts. 1

Art. 22 .- The public and private health services have the obligation to attend to
obstetric emergencies as a priority and provide safe blood when
patients require it, without the requirement of financial commitment or administrative procedure
previous.
Concordances:
• CHILDHOOD AND ADOLESCENCE CODE, Arts. 30

Art. 23.- Family planning programs and services will guarantee the right to
men and women to decide freely, voluntarily, responsibly, autonomously, without
coercion, violence or discrimination regarding the number of children they can procreate,
maintain and educate, under equal conditions, without the need for the consent of
third parties; as well as to access the necessary information for this.
Concordances:
• CHILDHOOD AND ADOLESCENCE CODE, Arts. 9

Art. 24.- Contraceptives imported by the national health authority will require
of the national sanitary registry in addition to the sanitary registry of the country of origin, as well as the
quality control and product safety, prior to distribution.
Art. 25 .- The members of the National Health System will promote and respect the
traditional knowledge and practices of indigenous and Afro-Ecuadorian peoples, of the
alternative medicines, in relation to pregnancy, childbirth, puerperium, as long as not
compromise the life and physical and mental integrity of the person.
Art. 26 .- The members of the National Health System will implement actions of
prevention and comprehensive, sexual and reproductive health care, aimed at women and
men, with an emphasis on adolescents, at no cost to users in institutions
public.
Art. 27 .- The Ministry of Education and Culture, in coordination with the authority
national health, with the state agency specialized in gender and other competent,
develop policies and educational programs that are mandatory for implementation in
educational establishments at the national level, for dissemination and guidance on the

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sexual and reproductive health, in order to prevent adolescent pregnancy, HIV-AIDS
and other sexually transmitted diseases, the promotion of fatherhood and motherhood
responsible and the eradication of sexual exploitation; and, will allocate the resources
enough for it.
The media must comply with the guidelines issued by the authority
national health service so that the content they disseminate does not promote violence
sexuality, disrespect for sexuality and discrimination based on gender, sexual orientation or
any other.
Concordances:
• CHILDHOOD AND ADOLESCENCE CODE, Arts. 46, 47

Art. 28 .- The sectional governments, in coordination with the national health authority,
develop promotion, prevention, education and participation activities
community in sexual and reproductive health, in accordance with the norms that she
dictate, considering your local reality.
Art. 29.- This Law empowers the public and private health services to interrupt a
pregnancy, solely and exclusively in the cases provided for in article 447 of the Code
Penal. They may not refuse to care for women with ongoing or unavoidable abortions,
duly diagnosed by the professional responsible for the care.
Art. 30 .- The national health authority, with the members of the National System of
Health, will encourage and promote family planning, with mutual responsibility and in
equal footing.
CHAPTER IV
Of violence
Art. 31 .- The State recognizes violence as a public health problem.
It is the responsibility of the national health authority, the health services,
sectional bodies, other competent bodies and society as a whole,
contribute to the reduction of all types of violence, including gender,
intrafamily, sexual and its impact on health.
Art. 32 .- In all cases of domestic and sexual violence, and its consequences,
comprehensive health care will be provided to affected people.
Health services personnel have the obligation to attend to cases of violence
intrafamily and sexual.
They should provide, among others, emergency contraception, perform the

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procedures and apply the necessary prophylactic and therapeutic schemes, to
detect and prevent the risk of contracting sexually transmitted infections, especially
HIV and hepatitis B, after counseling and advising the affected person, with their
informed consent expressed in writing.
Concordances:
• LAW AGAINST VIOLENCE TO WOMEN AND THE FAMILY, Arts. two

Art. 33.- The national health authority in coordination with the Public Prosecutor's Office and others
competent bodies will implement actions to harmonize the standards of care and
instruments for registering the different types of violence and sexual crimes,
unifying them in a manual of mandatory application procedures in the different
health levels and in the National Health System.
CHAPTER V
Of the accidents
Art. 34 .- The national health authority, in coordination with the National Council of
Land Transit and Transportation, the Ministry of Labor and Employment, other agencies
competent, public and private, and sectional governments, will promote and develop
policies, programs and actions to prevent and reduce traffic accidents,
labor, domestic, industrial and others; as well as for care, recovery,
rehabilitation and social reintegration of affected people.
The State recognizes traffic accidents as a public health problem, in
when its consequences affect the physical and mental integrity of people.
CHAPTER VI
From disasters
Art. 35 .- The national health authority will collaborate with the sectional governments and with
the competent bodies to integrate into the respective current plan the component of
health in risk management in emergencies and disasters, to prevent, reduce and control
the effects of natural and man-made disasters and phenomena.
Art. 36 .- The members of the National Health System will implement, in collaboration
with the competent bodies, a permanent and updated information system,
training and education in risk management in emergencies and disasters, with the
participation of society as a whole.
Art. 37 .- All public and private institutions and establishments of any
nature, they must have an emergency plan, mitigation and attention in cases of
disasters, in accordance with the plan formulated for this purpose.

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CHAPTER VII
From tobacco, alcoholic beverages, psychotropics, narcotics and other substances that
generate dependency
Art. 38 .- Declared as a public health problem the consumption of tobacco and consumption
excessive alcoholic beverages, as well as the consumption of narcotic substances and
psychotropic, outside the therapeutic field.
It is the responsibility of the national health authority, in coordination with other
competent bodies, adopt measures to avoid the consumption of tobacco and beverages
alcoholics, in all their forms, as well as providing the population with a healthy environment,
to promote and support the abandonment of these habits harmful to human health,
individual and collective.
The health services will carry out comprehensive care actions aimed at people
affected by the consumption and exposure to tobacco smoke, alcoholism, or
harmful use of psychotropics, narcotics and other substances that generate
dependency, aimed at their recovery, rehabilitation and social reintegration.
Concordances:
• CHILDHOOD AND ADOLESCENCE CODE, Arts. 27, 78
• LAW ON NARCOTICS AND PSYCHOTROPIC SUBSTANCES, Arts. 1

SECTION I
CONTROL OF THE CONSUMPTION OF TOBACCO PRODUCTS
Art. 39 .- The national health authority in coordination with the Ministry of Education
and Culture, universities, sectional governments and civil society, will design and
implement plans and programs for education and prevention of tobacco consumption and its
products.
Art. 40. -Note: Article repealed by Law No. 00, published in Official Gazette 497 of
July 22, 2011.
Art. 41. -Note: Article repealed by Law No. 00, published in Official Gazette 497 of
July 22, 2011.
Art. 42. -Note: Article repealed by Law No. 00, published in Official Gazette 497 of
July 22, 2011.
Art. 43. -Note: Article repealed by Law No. 00, published in Official Gazette 497 of
July 22, 2011.

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Art. 44 .- The rights and obligations established in this Law do not exclude or
oppose those contained in the legislation intended to regulate the protection of being
human exposure to tobacco smoke, from before birth, from the environment
environment and sustainable development and other laws related to the control of consumption
of tobacco.
Concordances:
• CIVIL CODE (BOOK I), Arts. 61

Art. 45.- Foreign tobacco companies that market their products in the
Ecuador, must have a legal representative in the country with full powers to
exercise rights and fulfill obligations derived from the application of this Law.
Concordances:
• LAW OF COMPANIES, Arts. 6, 415

SECTION II
OF THE PREVENTION OF THE CONSUMPTION OF ALCOHOLIC BEVERAGES
Art. 46 .- The national health authority in coordination with the Ministry of Education
and Culture, universities, sectional governments and civil society, will design and
will execute education and prevention programs and plans for the consumption of beverages
alcoholic.
Art. 47.- The distribution or delivery of alcoholic beverages is prohibited, either free of charge.
or onerous, to persons under 18 years of age; as well as its sale and consumption in
educational, health and drug dispensing establishments.
Concordances:
• CHILDHOOD AND ADOLESCENCE CODE, Arts. 27

Art. 48 .- The advertising of alcoholic beverages for no reason will be linked to health,
sports success or the image of women as a sex symbol. The health authority
National will monitor and control compliance with this provision.
Art. 49 .- The containers of alcoholic beverages, must include in a clear, visible and
understandable, the warning of its harmful nature to health; and, for printing
the warning, the specifications provided in the regulation will be followed
correspondent.

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Art. 50.- Except in the acts authorized by the competent authority, it is prohibited to consume
alcoholic and moderate beverages, in public institutions, establishments
educational, whether public or private, health services, workplaces, media
public transportation, movie theaters and theater, and other spaces that are defined in the
corresponding regulations issued by the national health authority. In these
establishments, visible warnings will be placed indicating the prohibition of
consumption of alcoholic beverages.
Concordances:
• WORK CODE, Arts. 46

SECTION III
OF THE USE AND CONSUMPTION OF PSYCHOTROPICS, NARCOTICS AND OTHERS
SUBSTANCES THAT GENERATE DEPENDENCE
Art. 51.- The production, commercialization, distribution and consumption of
narcotic and psychotropic drugs and other addictive substances, except for therapeutic and
under medical prescription, which will be controlled by the national health authority,
in accordance with the provisions of the relevant legislation.
Concordances:
• LAW ON NARCOTICS AND PSYCHOTROPIC SUBSTANCES, Arts. 27, 30

TITLE II
Prevention and control of diseases
CHAPTER I
Of immunizations
Art. 52 .- The national health authority will provide health establishments with the
biologicals and supplies for the immunopreventable diseases contemplated in the
basic national vaccination scheme, in a timely and permanent manner, ensuring its
quality and conservation, at no cost to the end user.
Art. 53.- It is the obligation of the health services and other institutions and establishments.
public and private, immunize workers who are exposed to risks
preventable by vaccination, in accordance with the regulations issued by the authority
national health.
Concordances:
• WORK CODE, Arts. 410

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Art. 54 .- The State will guarantee and transfer in a timely manner, through the agency
competent authority, sufficient financial resources to carry out the actions of the
Expanded Immunization Program, in accordance with the provisions of the law.
Art. 55.- Biologicals imported by the State through the Revolving Fund or the
government-to-government agreements do not require a national sanitary registration, being
mandatory that of the country of origin and verification of the quality and safety of the product
before distribution and use.
Art. 56.- Biologics acquired in any way by public institutions or
private, produced in the country or imported, will be subjected to the established processes
by the national health authority for batch release in order to preserve their
quality and safety.
Art. 57 .- Biologics imported by the Ministry of Public Health upon arrival in the country,
must pass to the National Vaccine Bank, within a period of no more than forty-eight
hours, ensuring the maintenance of the cold chain and the quality of the
products, this being the responsibility of the customs authority and the
national health.
Art. 58.- Public and private health institutions will administer, at no cost to the
population, according to what is established by the applicable regulations, biological
contemplated in the basic national vaccination scheme, when these have been
supplied by the national health authority.
Public and private institutions will compulsorily report to the health authority
national information on immunized people.
Art. 59 .- The parents, guardians or legal representatives of the children,
girls and adolescents, educational entities, public and private institutions with
captive population at risk, have the obligation and responsibility to ensure that
apply and comply with the basic national vaccination scheme established by the authority
national health.
Concordances:
• CIVIL CODE (BOOK I), Arts. 268

Art. 60.- Public and private institutions for the administration and sale of
biologicals must have the authorization of the national health authority and comply
with the established requirements to guarantee a safe vaccine.
CHAPTER II
Of communicable diseases

Page 17

Art. 61.- Public and private institutions, health professionals and the population
In general, they will report in a timely manner the existence of suspected, probable,
compatible and confirmed diseases declared by the health authority
national as mandatory notification and those of international report. The
institutions and health professionals, will guarantee the confidentiality of the information
delivered and received.
Art. 62.- The national health authority will elaborate the norms, protocols and
procedures that must be complied with and used for surveillance
epidemiology and the control of communicable, emerging and
re-emerging mandatory notification, including those of sexual transmission.
It will guarantee in its health services, attention, access and availability of medicines,
with an emphasis on generics, screenings and follow-up, for diseases
indicated in the preceding paragraph, which must also guarantee the national system of
social Security.
Art. 63 .- The national health authority in coordination with other agencies
competent authorities will carry out information and education campaigns aimed at
health and the population in general, to eradicate discriminatory attitudes against
people affected by communicable diseases.
Art. 64.- In cases of suspicion or diagnosis of the existence of diseases
communicable, health personnel are obliged to take biosecurity measures and
others necessary to prevent transmission and propagation in accordance with the
provisions established by the national health authority.
Art. 65.- Sectional governments must comply with the provisions issued by the
national health authority to prevent the proliferation of vectors, the spread of
communicable diseases and ensure their control.
Art. 66.- Natural and legal persons, national and foreign, who are
in Ecuadorian territory must comply with the regulatory provisions that the government
dictates and the measures that the national health authority orders in accordance with the
International Health Regulations, the international conventions signed and ratified
throughout the country, in order to prevent and avoid the international spread of diseases
transmissible.
Concordances:
• CIVIL CODE (PRELIMINARY TITLE), Arts. 13

Art. 67.- The State recognizes the contagion and transmission of HIV-AIDS, as a problem
public health.

Page 18

The national health authority will guarantee in its health services to people
living with HIV-AIDS specialized care, access and availability of
antiretroviral and opportunistic disease medications with an emphasis on
generic drugs, as well as reagents for screening tests and
tracing.
The responsibilities indicated in this article also correspond to the system
national social security.
Art. 68.- The corresponding contraception will be provided, with prior consent.
informed, HIV-positive women and those living with AIDS. This includes
emergency contraception when the case requires it, in the opinion of the professional
responsible for care.
CHAPTER III
Of non-communicable diseases
Art. 69.- Comprehensive care and control of non-communicable diseases, chronic degenerative, congenital, hereditary and the problems declared a priority for the
public health, will be carried out through the coordinated action of all members of the
National Health System and the participation of the population as a whole.
It will understand the investigation of its causes, magnitude and impact on health,
epidemiological surveillance, promotion of healthy habits and lifestyles, prevention,
recovery, rehabilitation, social reintegration of affected people and care
palliative.
The members of the National Health System will guarantee the availability and access to
programs and medications for these diseases, with an emphasis on medications
generic, prioritizing vulnerable groups.
CHAPTER III-A
OF CATASTROPHIC AND RARE OR ORPHAN DISEASES
Note: Chapter added by Law No. 0, published in Official Gazette 625 of January 24
from 2012 .
Art. ... (1) .- The Ecuadorian State shall recognize diseases of national interest
catastrophic and rare or orphan; and, through the national health authority,
will implement the necessary actions for the health care of the sick who
suffer them, in order to improve their quality and life expectancy, under the principles of
availability, accessibility, quality and warmth; and, quality standards, in the promotion,
prevention, diagnosis, treatment, rehabilitation, habilitation and cure.
People who suffer from these diseases will be considered in double conditions

Page 19

vulnerability.
Note: Article added by Law No. 0, published in Official Gazette 625 of January 24
from 2012 .
Art. ... (2) .- The obligations of the national health authority are:
a) Issue protocols for the care of these diseases, with the participation of the
scientific societies, the same that will establish the guidelines, criteria and
diagnostic and treatment procedures for patients suffering from
rare or orphan diseases;
b) Promote, coordinate and develop, together with specialized organizations
national and international public and private, research for the study of the
rare or orphan and catastrophic diseases in order to favor diagnoses
and early treatments for a better quality and life expectancy;
In those cases in which the National Health System finds it impossible to issue the
definitive diagnosis of a disease, the national health authority will implement
all actions so that these cases are investigated in international institutions
of health in order to obtain the corresponding diagnosis and treatment.
c) Control and regulate, in coordination with the competent bodies, the companies
insurance companies and pre-paid medicine service providers in relation to the offer of
coverage for diseases considered rare or orphan.
Insurance companies and private health and pre-paid medicine companies, in the
framework of the policies defined by the national health authority and of this Law,
They will be obliged to comply with the coverage promised in the respective contracts of
insurance without being able to deny said coverage on the pretext of the subsequent appearance of
diseases considered catastrophic and rare or orphan.
d) Controlling that health service providers maintain an active search for
cases related to rare or orphan and catastrophic diseases, of
compliance with the Epidemiological Surveillance System that includes the registry of
patients suffering from this type of illness.
e) Implement the necessary measures that facilitate and allow the acquisition of
medicines and special supplies for the care of diseases considered rare
or orphans in a timely, permanent and free way for the care of people
suffering from rare or orphan diseases.
f) Establish, in conjunction with patient and scientific organizations,
actions to disseminate and promote knowledge of rare diseases and
orphans.
Note: Article added by Law No. 0, published in Official Gazette 625 of January 24
from 2012 .

Page 20

Art. ... (3) .- The national health authority will create and implement a system of registration and
information of patients suffering from rare or orphan diseases and will require the
reports that must be submitted by all institutions that provide the
health services of the public and private sectors with respect to patients who are
diagnosed or those in which the definitive diagnosis cannot be made.
The body in charge of migration policy and diplomatic institutions
coordinate with the national health authority and with the ministry in charge of
economic and social inclusion, the implementation of the registry of people residing in the
foreigner suffering from rare or orphan diseases, in order to provide care
timely in the country of residence and, if applicable, in the national territory.
Note: Article added by Law No. 0, published in Official Gazette 625 of January 24
from 2012 .
Art. ... (4) .- The national health authority shall promote actions aimed at the
training, at the undergraduate, postgraduate and continuing education levels, for the entire
health personnel and professionals, in order to disseminate scientific knowledge of the
rare or orphan diseases.
Note: Article added by Law No. 0, published in Official Gazette 625 of January 24
from 2012 .
Art. ... (5) .- The national Health Authority shall regulate the production and importation of
medicines and special supplies to treat diseases considered rare or
orphans; and, through the regulations issued for this purpose, the provision will be made
sufficient and necessary of such drugs for patients according to their needs.
The national Health Authority will promote the mechanisms that allow the
patients suffering from these diseases, access to medicines and supplies
special for your treatment.
Note: Article added by Law No. 0, published in Official Gazette 625 of January 24
from 2012 .
CHAPTER IV
From blood, its components and derivatives
Art. 70.- The availability of safe blood and its
components.
The State, through the national health authority, will take the necessary measures to
ensure the availability and access to safe blood and components in quantities
enough for those who need it, its provision being mandatory in the institutions
public, private and autonomous, in case of imminent risk to life,
regardless of ability to pay.

Page 21

The national health authority is obliged to promote voluntary donation and
altruistic of blood.
Art. 71 .- The national health authority will dictate the rules relating to the processes of
donation, transfusion, use and monitoring of the quality of human blood with its
components and derivatives, in order to guarantee equitable, efficient access,
sufficient and safe, the preservation of the health of donors and the maximum protection of
recipients as well as health personnel.
Art. 72.- The national health authority will license, through the competent authority, to
blood services (blood centers, banks, warehouses and transfusion services) and to
industrial plasma fractionation plants, public and private, according to the
regulations in force.
Art. 73.- Blood centers, banks, warehouses and blood transfusion services
human resources, they must maintain internal and external quality control and management programs, as well as
how to comply with the other norms and provisions that the authority dictates for this purpose
national health.
Art. 74.- The commercialization, publicity of the same and the profit in the process is prohibited.
donation, obtaining, processing, distribution and use of blood, its
derivatives and components, by natural or legal persons, public or private.
The institutions that carry out the processes indicated in the preceding paragraph may
recover only what corresponds to operating expenses of the procedures that
are made; Any overcharging will be penalized.
Art. 75.- The establishments authorized to collect blood units, previously
to its use in transfusions, they are obliged to carry out tests to determine the
blood group and factor and the presence of irregular antibodies, as well as
serological for infection markers, determined in regulation
corresponding according to the local, regional and national epidemiological profile and the
technological advances.
The separation of components will be carried out in compliance with the applicable technical standards
in order to ensure their therapeutic function.
Art. 76 .- The transfusion of blood and its components must be prescribed by a doctor,
legally authorized to practice the profession, practiced under their responsibility and
supervision, under conditions that guarantee the safety of the procedure and
compliance with the provisions of technical standards.
Art. 77.- Acceptance or refusal for transfusion of blood and its components must
be done in writing by the potential recipient or through the person legally
able to exercise their representation, except in cases of emergency or urgency.

Page 22

Concordances:
• CIVIL CODE (PRELIMINARY TITLE), Arts. 28
• CIVIL CODE (BOOK IV), Arts. 1463

Art. 78 .- Voluntary blood donation requires express free authorization,
voluntary and in writing of the donor.
Concordances:
• CIVIL CODE (BOOK IV), Arts. 1461

Art. 79 .- The export of plasma for industrial processing may only be carried out
towards accredited processing plants and provided that the derivatives obtained are
recovered for national consumption.
Art. 80 .- The export of blood and its components is prohibited, except for express cases of
donation originated for emergency and humanitarian reasons as indicated in the
previous article.
TITLE III
On transplants of organs, tissues and disposal of cadavers
CHAPTER I
Of organ and tissue transplants
Art. 81.- The commercialization of anatomical components of living people or
deceased. No person may offer or receive benefits directly or indirectly
economic or otherwise, for the delivery or procurement of organs and other components
anatomical of living or deceased people.
Concordances:
• ORGANIC LAW OF DONATION AND TRANSPLANTATION OF ORGANS, TISSUES AND CELLS, Arts. 73

Art. 82. -Note: Article repealed by Law No. 00, published in Official Gazette 398 of 4
March 2011.
Art. 83. -Note: Article repealed by Law No. 00, published in Official Gazette 398 of 4
March 2011.
Art. 84.- The national health authority will regulate, license and control the

Page 23

operation of specialized public and private health services, for the
exercise of activities related to the transplantation of organs or other components
anatomical. It will also control the professional practice of those who carry out said
activities.
Art. 85 .- The national health authority will regulate the organization of tissue banks
and of cells, under the technical and standard parameters established for this purpose.
The allocation of organs or other anatomical components should be done under the
national and international parameters, established by a national system created to
this effect.
Concordances:
• ORGANIC LAW OF DONATION AND TRANSPLANTATION OF ORGANS, TISSUES AND CELLS, Arts. 3, 10, 48

Art. 86 .- Xenotransplants may only be performed when they are guaranteed
scientific and technological conditions that ensure the quality of the procedure with
subject to bioethical principles, and will be subject to the authorization of the health authority
national through the competent body.
CHAPTER II
Disposal and handling of corpses
Art. 87.- The installation, construction and maintenance of cemeteries, crypts,
crematoriums, morgues or corpse preservation sites, may be done by entities
public and private, for which the standards established in this
Law.
Previously, the location and infrastructure to be used will be verified and not
constitute a health risk. They must have the environmental impact study and the
corresponding environmental license.
Cemeteries and crypts are the only authorized burial sites for
corpses and must comply with the standards established by the national health authority and the
corresponding municipality.
Art. 88.- Once the necropsy has been performed, the corpse must be compulsorily treated, buried
or cremated.
No corpse may be kept unburied or without undergoing cremation for more than
seventy-two hours, except when there is a court order or they are not recognized or
claimed by their relatives or beneficiaries, in which case their
maintenance in authorized sites and in adequate conservation conditions that
do not compromise the integrity of the corpse or alter the possible evidence.

Page 24

Concordances:
• GENERAL LAW OF CIVIL REGISTRY IDENTIFICATION AND CEDULATION, Arts. 2. 3

Art. 89.- Unidentified corpses or corpses that were not claimed within the term of
thirty days after his death, they will be delivered as a donation to the
Faculties of Medical or Health Sciences legally established giving preference to
the state ones, or they will be buried in accordance with the pertinent provisions.
From the unidentified corpses, prior to their donation or burial, they will be extracted
samples that allow obtaining the genetic profile of the person. This information will be
registered in a database of unidentified corpses.
Art. 90 .- It will not be possible to proceed to the burial or cremation of a corpse without
have the medical certificate that confirms the death and establishes its possible
causes, according to your diagnosis. This responsibility corresponds to the cemeteries or
crematoria as appropriate.
Concordances:
• GENERAL LAW OF CIVIL REGISTRY IDENTIFICATION AND CEDULATION, Arts. 2. 3

Art. 91 .- The exhumation for legal purposes may be practiced at any time for
order of competent authority.
Art. 92.- The transfer of corpses, within the country, in the cases and conditions
established in the regulations of this Law, as well as their entry into the national territory
requires authorization from the national health authority, who will establish the standards of
conservation and security.
Art. 93.- Autopsies must be performed under the responsibility of pathologists.
or forensic, except in locations where these professionals do not exist, in which case
will be carried out in accordance with the provisions of the Code of Criminal Procedure, without
cost to relatives or relatives in public institutions.
Art. 94 .- Necropsy is mandatory when:
a) The cause of death is unknown;
b) By sudden death;
c) The Public Ministry orders it;
d) In cases of health emergency;
e) For public health reasons; Y,
f) By request and consent of the legal representative or closest relative until the

Page 25

fourth degree of consanguinity and second degree of affinity.
BOOK II
Health and environmental safety
Common layout
Art. 95 .- The national health authority in coordination with the Ministry of the Environment,
establish the basic standards for the preservation of the environment in related matters
with human health, the same that will be mandatory for all
natural persons, public, private and community entities.
The State, through the competent bodies and the private sector, is obliged to
provide the population with adequate and truthful information regarding the impact
environmental and its consequences for individual and collective health.
SOLE TITLE
CHAPTER I
Of water for human consumption
Art. 96 .- Declared a national priority and of public utility, water for consumption
human.
It is the obligation of the State, through the municipalities, to provide the population of
quality drinking water, suitable for human consumption.
Every natural or legal person has the obligation to protect aquifers, sources and
hydrographic basins that serve to supply water for human consumption.
It is prohibited to carry out activities of any kind, which put at risk of contamination
the sources of water catchment. The national health authority, in coordination with
other competent bodies, shall take measures to prevent, control, mitigate,
remedy and sanction the contamination of water sources for human consumption.
To ensure quality and safety, all drinking water supplies
human, is subject to the surveillance of the national health authority, to whom
It corresponds to establish the norms and regulations that ensure the protection of
human health.
CHAPTER II
Of common, infectious, special waste and ionizing radiation and not
ionizing
Art. 97.- The national sanitary authority will dictate the norms for the handling of all kinds
of wastes and residues that affect human health; standards that will be complied with
mandatory for natural and legal persons.

Page 26

Art. 98 .- The national health authority, in coordination with public entities or
will promote information and education programs and campaigns for the management of
of waste and residues.
Art. 99 .- The national health authority, in coordination with the municipalities of the country,
will issue the regulations, standards and technical procedures of mandatory compliance
for the proper management of infectious waste generated by the establishments of
health services, public or private, outpatient or inpatient, veterinary and
esthetic.
Art. 100.- The collection, transport, treatment and final disposal of waste is
responsibility of the municipalities that will carry it out in accordance with the laws, regulations
and ordinances issued for this purpose, in compliance with biosafety standards
and control determined by the national health authority. The State will deliver the
resources necessary to comply with the provisions of this article.
Art. 101.- The dwellings, educational and health establishments and buildings in
In general, they must have adequate sanitary systems for the disposal of excreta and
sewage evacuation.
Educational establishments, public and private, will have the number of batteries
sanitary that is provided in the respective regulatory standard.
The State will deliver to public establishments the necessary resources for the
compliance with the provisions of this article.
Art. 102 .- It is the responsibility of the State, through the municipalities of the country and in
coordination with the respective public institutions, equip the population with systems
sanitary sewerage, rainwater and other disposal of excreta and sewage that
do not affect individual and collective health and the environment; as well as systems of
sewage treatment.
Art. 103.- Any person, natural or legal, is prohibited from unloading or depositing water
served and residuals, without the appropriate treatment, as provided in the
corresponding regulation, in rivers, seas, canals, streams, lagoons, lakes and others
similar sites. Its use in animal husbandry or activities is also prohibited.
agricultural.
Infectious, special, toxic and health hazardous wastes must be
technically treated prior to their elimination and the final deposit will be made at the sites
special established for the effect by the municipalities of the country.
For the elimination of domestic waste, the established provisions will be complied with
for the effect.

Page 27

The health authorities, in coordination with the municipalities, will be responsible for
enforce these provisions.
Art. 104 .- Every industrial, commercial or service establishment has the obligation
to install polluted water and toxic waste treatment systems that are
produced as a result of their activities.
The health authorities, in coordination with the municipalities, will be responsible for
enforce this provision.
Art. 105 .- The natural or legal persons that own facilities or buildings,
public or private, located in the coastal and insular areas, will use the networks of
sewerage to eliminate sewage and wastewater product of the activities
that they develop; and, in cases that inevitably require disposal at sea,
should treat them previously, having to have impact studies for the effect
environmental; as well as using submarine outfalls that comply with sanitary standards
and corresponding environmental.
Art. 106 .- The land through which sewer networks pass or must pass,
aqueducts or pipes, will be compulsorily constituted in servant estates, according to
what is established by law.
The health authorities, in coordination with the municipalities, will be responsible for
enforce this provision.
Concordances:
• CIVIL CODE (BOOK II), Arts. 868, 903

Art. 107 .- The national health authority in coordination with other agencies
competent authorities, will dictate the rules for the handling, transportation, treatment and disposal
end of special waste. Radioactive waste will be treated in accordance with
the standards issued by the competent body in the matter or accepted through
international agreement.
Art. 108 .- Corresponds to the national health authority, in coordination with the
Ecuadorian Atomic Energy Commission and other competent organizations, monitor the
compliance with the standards established in the matter of ionizing radiation and not
ionizing.
Art. 109 .- No person shall be subjected to or exposed to ionizing radiation and shall not
ionizing beyond the permissible doses or limits, in accordance with the relevant standards.
Diagnostic and therapeutic equipment that uses ionizing radiation and does not
ionizers will be installed in buildings that are technically appropriate and that comply with

Page 28

health and safety requirements, established by the national health authority and the
Ecuadorian Atomic Energy Commission; will be subject to rigorous maintenance and
newspapers, and must have quality control certificates.
Art. 110.- Importers of electronic articles and devices that issue
non-ionizing radiation, they must ensure that they comply with the standards
current health services, are not prohibited in their country of origin or in other countries; and, take the
labeling of precautions and clear indications on its use.
CHAPTER III
Air quality and noise pollution
Art. 111.- The national health authority, in coordination with the environmental authority
national and other competent bodies, will dictate technical standards to prevent and
control all types of fumes that affect the respiratory, auditory and
visual.
All natural and legal persons must compulsorily comply with said
rules.
Art. 112 .- The municipalities will develop programs and activities for monitoring the
air quality, to prevent its contamination by emissions from sources
fixed, mobile and natural phenomena. The monitoring results will be reported
periodically to the competent authorities in order to implement
information and prevention aimed at the community.
Art. 113.- All labor, productive, industrial, commercial, recreational and
fun; as well as the houses and other facilities and means of transport, must
comply with the provisions of the respective rules and regulations on prevention and
control, in order to avoid noise pollution, which affects human health.
CHAPTER IV
Pesticides and other chemicals
Art. 114 .- The national health authority, in coordination with the Ministry of
Agriculture and Livestock and other competent bodies, will dictate and implement the
regulatory standards for the use and control of pesticides, fungicides and others
chemical substances for domestic, agricultural and industrial use that affect health
human.
Art. 115 .- The national and international norms and regulations must be complied with for
the production, import, export, commercialization, use and manipulation of
pesticides, fungicides and other types of chemical substances whose inhalation, ingestion or
Contact can cause harm to people's health.
Art. 116.- The production, importation, commercialization and use of pesticides is prohibited,

Page 29

fungicides and other chemical substances, vetoed by national sanitary regulations and
international, as well as their acceptance and use as donations.
CHAPTER V
Health and Safety at Work
Art. 117 .- The national health authority, in coordination with the Ministry of Labor and
Employment and the Ecuadorian Institute of Social Security, will establish the health and
occupational safety to protect workers' health.
Concordances:
• WORK CODE, Arts. 410

Art. 118 .- Employers shall protect the health of their workers, providing them with
sufficient information, protective equipment, appropriate clothing, safe environments
work, in order to prevent, reduce or eliminate risks, accidents and the appearance of
occupational diseases.
Concordances:
• WORK CODE, Arts. 42

Art. 119 .- Employers have the obligation to notify the authorities
competent authorities, work accidents and occupational diseases, without prejudice to the
actions taken by both the Ministry of Labor and Employment and the Institute
Ecuadorian Social Security.
Concordances:
• WORK CODE, Arts. 348, 386

Art. 120 .- The national health authority, in coordination with the Ministry of Labor
and Employment and the Ecuadorian Institute of Social Security, will monitor and control the
working conditions, so that they are not harmful or unhealthy during the
periods of pregnancy and lactation of working women.
Employers have the obligation to comply with the rules and adapt activities
work of pregnant and lactating women.
Concordances:
• CHILDHOOD AND ADOLESCENCE CODE, Arts. 30

Page 30

• WORK CODE, Arts. 138, 155

Art. 121.- Public or private institutions whose staff is exposed to radiation
ionizing and non-ionizing emissions, are required to provide care devices
and control of radiation and safety conditions at work that prevent risks
to health.
Non-compliance with this provision by employers, which causes damage to
the health of the worker, will give rise to the application of the sanction determined by law.
Concordances:
• WORK CODE, Arts. 42, 410

CHAPTER VI
On the control of noxious fauna and zooanthroposis
Art. 122 .- The national health authority will organize campaigns to eradicate the
proliferation of vectors and other animals that pose a risk to individual health
and collective.
Natural and legal persons will collaborate with these campaigns.
Art. 123.- It is the obligation of the owners of domestic animals to vaccinate them against
rabies and other diseases that the national health authority declares susceptible to
cause epidemics, as well as maintain them in conditions that do not constitute risk to the
human health and hygiene of the environment.
The control and management of stray animals is the responsibility of the municipalities, in
coordination with health authorities.
Art. 124 .- It is forbidden within the urban perimeter to install stables or farms to raise or
to house cattle, horses, cattle, goats, pigs, as well as poultry and other
species.
Art. 125.- The slaughter, transport, industrialization and commercialization of
dead or slaughtered animals that have suffered from diseases harmful to the
Human health.
Art. 126 .- The entry of animals to the country is subject to compliance with the provisions
legal and normative issued by the corresponding authorities, the agreements
international laws and other laws that regulate animal trafficking.
The entry into the country of animals affected by diseases communicable to the

Page 31

population or suspected of being, or that are carriers of pathogens whose
dissemination may constitute a danger to human health.
Art. 127 .- Every person shall proceed to the extermination of arthropods, rodents and other species
harmful to health that exist in your home, other buildings and annexes of your
property or its use.
It will also be the obligation of the national health authority to promote massive campaigns
to make effective the fulfillment of this purpose.
Art. 128 .- Companies that are dedicated to the extermination or control of pests and vectors
transmitters of diseases such as dengue, rabies and malaria, must obtain the
respective permit issued by the national health authority to operate. All the
Chemicals used by said companies must be approved by said authority.
BOOK III
Health surveillance and control
Common provisions
Art. 129 .- Compliance with the standards of health surveillance and control is mandatory
for all institutions, bodies and public and private establishments that
carry out activities of production, import, export, storage,
transportation, distribution, marketing and sale of products for use and consumption
human.
The observance of the sanitary surveillance and control standards also apply to
public and private health services, for-profit and non-profit, autonomous, community
and from private health and prepaid medicine companies.
Art. 130.- Establishments subject to sanitary control for their operation
They must have the permission granted by the national health authority. Permission of
operation will be valid for one calendar year.
Art. 131 .- Compliance with the standards of good manufacturing practices,
storage, distribution, dispensing and pharmacy, will be controlled and certified by
the national health authority.
Art. 132.- The activities of sanitary surveillance and control include those of control of
quality, safety and security of processed products for human use and consumption,
as well as the verification of compliance with the technical and sanitary requirements in the
establishments dedicated to the production, storage, distribution,
commercialization, import and export of the indicated products.
Art. 133.- The national health authority may delegate to the municipalities, within their
functions, the exercise of the necessary actions for sanitary control, who the

Page 32

They will be carried out in accordance with the provisions and standards issued by said authority.
Art. 134 .- The installation, transformation, expansion and transfer of industrial plants,
food processors, pharmaceutical establishments, biological production establishments,
of the elaboration of processed natural products for medicinal use, of the production of
homeopathic, pesticides, dental products, cosmetic companies and products
hygienic, are subject to obtaining, prior to their use, the permission granted by the
national health authority.
Art. 135.- It is the responsibility of the national health authority to authorize the importation of all
product registered in the sanitary registry, including medical samples and those
destined for internal consumption from free zones.
The importation of products will not be authorized, not even for promotional purposes, if
previously they do not have the national sanitary registry, except for the certain exceptions
in this Law.
Art. 136.- Raw materials for the elaboration of products subject to sanitary registration,
they do not require for their import to comply with this registry, as long as they justify their
use in such products.
SOLE TITLE
CHAPTER I
Of the sanitary registry
Art. 137.- Processed foods, additives are subject to sanitary registration.
food, medicines in general, nutraceutical products, biological products,
natural processed medicinal use, homeopathic medicines and products
dental; medical devices, biochemical and diagnostic reagents, products
hygienic, pesticides for domestic and industrial use, manufactured in the territory
national or abroad, for import, export, commercialization,
dispensing and dispensing, including those received as donations.
Donations of products subject to sanitary registration will be subject to authorization and
requirements established in the regulations that the health authority dictates for this purpose
national.
Art. 138 .- The national health authority through its competent body, Institute
National of Hygiene and Tropical Medicine Dr. Leopoldo Izquieta Pérez, who will exercise his
functions in a decentralized manner, will grant, suspend, cancel or re-enroll the
health registration certificate, after compliance with the procedures, requirements and
terms indicated in this Law and its regulations, in accordance with the guidelines and standards
issued by the national health authority, which will set the payment of an amount
for the registration and re-registration of said health registration certificate, whose values
will be aimed at institutional development, which will include as a priority a

Page 33

national program for quality control and post-registration safety.
The national health authority will exercise administrative, technical and financial control of the
National Institute of Hygiene and Tropical Medicine Dr. Leopoldo Izquieta Pérez and
It will annually evaluate the results of the management for the pertinent purposes.
The analytical technical report for the granting of the sanitary registration, as well as the
post-registration quality control analysis, must be prepared by the National Institute
of Hygiene and Tropical Medicine, Dr. Leopoldo Izquieta Pérez, and by laboratories,
universities and polytechnic schools, previously accredited by the body
competent, in accordance with applicable regulations, procedures that are subject to
to the payment of the amount established by the national health authority.
Art. 139 .- The sanitary registration will be valid for five years, counted from the date of
date of its grant. Any change in the condition in which the product was approved in
the sanitary registry must be obligatorily notified to the national sanitary authority
through the National Institute of Hygiene and Tropical Medicine Dr. Leopoldo Izquieta
Pérez and, will give rise to the procedure indicated by the law and its regulations.
For the sanitary registration process, the patent of the
products.
The health registration of medicines does not give the right of exclusivity in the use of
formula.
Art. 140.- The import, export, commercialization and sale of
processed products for human use and consumption that do not comply with obtaining
prior to the sanitary registration, except for the exceptions provided in this Law.
Art. 141.- The sanitary registration will be suspended or canceled by the sanitary authority.
national through the National Institute of Hygiene and Tropical Medicine Dr. Leopoldo
Izquieta Pérez, at any time if it is found that the product or its manufacturer does not
comply with the requirements and conditions established in this Law and its regulations or
when the product could cause damage to health, and the rest will be applied
sanctions indicated in this Law.
In all cases, the owner of the record or the responsible natural or legal person,
must fully compensate any damage that occurs to third parties, without prejudice to
other legal actions that may arise.
Art. 142 .- The national health authority through its competent bodies,
periodically carry out post-registration controls of all products subject to registration
sanitary by taking samples for quality control and safety analysis, be it
in the places of manufacture, storage, transport, distribution or sale.
It will also carry out inspections of the establishments. If I detect that any entity
commercial or industrial I will use an unauthorized health registration number for that

Page 34

product, the national health authority will suspend the marketing of the
products, without prejudice to the sanctions of law.
Art. 143 .- The advertising and promotion of products subject to sanitary registration must
conform to its true nature, composition, quality or origin, in such a way that
avoid any misconception of its qualities or benefits, which will be controlled by
the national health authority.
Advertising by any means of drugs subject to sale under
prescription.
Art. 144 .- The national health authority may authorize the importation of
drugs, biological products, medical devices, biochemical reagents and
diagnosis not registered in the health registry, in cases of health emergency or for
people who require specialized treatments not available in the country, to
people suffering from catastrophic, rare or orphan diseases, as well as for purposes
of human clinical research, subject to compliance with the established requirements
for the effect. Medicines, biologicals, medical devices, reagents
Biochemical and diagnostic authorized will be specific for each situation.
Note: Article amended by Law No. 0, published in Official Gazette 625 of December 24
January 2012.
CHAPTER II
Of food
Art. 145 .- It is the responsibility of the producers, vendors and other agents who
intervene during the production-consumption cycle, comply with the standards established in
this Law and other provisions in force to ensure the quality and safety of the
food for human consumption.
Art. 146.- Regarding food, it is prohibited:
a) The use of additives to hide, attenuate or correct the technological deficiencies of
production, manipulation or preservation and to fraudulently highlight their
features;
b) The use, importation and commercialization of raw materials not suitable for
human consumption;
c) The inclusion of harmful substances that make them dangerous or potentially
harmful to the health of consumers;
d) The use of raw materials and products treated with ionizing radiation or that have
been genetically modified in the manufacture of infant formulas and foods
infantile;
e) Processing and handling in unsanitary conditions;
f) The use of containers that do not comply with the approved technical specifications
for the effect;

Page 35

g) The offer of a processed food with names, brands, graphics or labels that
make false statements or omit data in a way that is misleading or misleading
to the consumer;
h) The storage of raw materials or processed foods in premises where
find harmful or dangerous substances;
i) Any form of falsification, contamination, alteration or adulteration, or any
procedure that produces the effect of making them harmful or dangerous to health
human; Y,
j) The display and sale of products whose useful life has expired.
Art. 147 .- The national health authority, in coordination with the municipalities,
establish health education programs for producers, handlers and
consumers of food, promoting hygiene, individual and collective health and
environmental Protection.
Concordances:
• CHILDHOOD AND ADOLESCENCE CODE, Arts. 28

Art. 148 .- The control of the sale of food and beverages on public roads will be carried out
municipalities, in coordination with the national health authority and in accordance with
what is established in the Organic Law of Municipal Regime.
Art. 149.- The development, treatment, elaboration, production, application, manipulation,
use, storage, transport, distribution, import, commercialization and sale
food for human consumption that is or contains genetically derived products
modified, it will be carried out when it is demonstrated before the competent authority, through
technically and scientifically advanced studies, its innocuousness and safety for
consumers and the environment.
To fulfill this purpose, the national health authority must coordinate with the
corresponding public and private technical organizations.
Art. 150.- The donation of food that contains genetically products
modified, as well as their utilization, use and management in plans and programs and
food aid, will be accepted if through technical procedures and
scientifically advanced, demonstrate their innocuousness and safety before the authority
national health.
To fulfill this purpose, the national health authority will act in accordance
with the universal principles in matters of public health and the provisions of subsection
second of the preceding article.
Art. 151.- The packaging of products that contain genetically engineered foods
modified, whether domestic or imported, must necessarily include, in the form

Page 36

visible and understandable on their labels, the indication of this condition, in addition to the
other requirements established by the national health authority, in accordance with the law
and the regulatory norms that are dictated for the effect.
Art. 152 .- The national health authority, in coordination with the agencies
competent authorities, establish and implement an integrated national system to guarantee the
food safety.
CHAPTER III
Of medications
Art. 153 .- All medication must be legally marketed in establishments.
authorized.
For sale to the public, a prescription issued by professionals authorized to
do so, with the exception of over-the-counter drugs, classified as such with
strict adherence to updated pharmacological regulations, in order to guarantee the safety of
its use and consumption.
Art. 154.- The State will guarantee the access and availability of quality medicines and
its rational use, prioritizing the interests of public health over the economic and
commercial.
It will promote the production, importation, commercialization, dispensing and sale of
generic drugs with an emphasis on essential drugs, in accordance with regulations
current in the matter. Its use, prescription, dispensing and dispensing is mandatory in the
public health institutions.
Art. 155.- Medicines in general, including products that contain new
chemical entities that obtain national sanitary registration and are not commercialized
for a period of one year, they will be subject to cancellation of said sanitary registration.
Art. 156 .- The national health authority will authorize the importation of drugs in
general, in the quantities necessary to obtain the sanitary requirement, of
in accordance with the provisions of the corresponding regulation.
Art. 157.- The national health authority will guarantee the quality of the medicines in
general and will develop drug surveillance programs and studies on the use of
medications, among others, to protect the safety of their use and consumption.
In addition, it will periodically carry out post-registration controls and studies on the use of
medicines to evaluate and control quality, safety and efficacy standards and
sanction those who market products that do not meet these standards,
falsify or adulterate pharmaceutical products.
Art. 158.- The development, production, handling, use, storage, transportation,

Page 37

distribution, import, commercialization and sale of nutraceutical products, will be
allowed when technically and scientifically demonstrated before the health authority
national, its safety for the consumer and the environment. Health registration and control
of these products will be subject to current regulations for drugs.
Art. 159.- It is the responsibility of the national health authority to fix, review and control
prices of medicines for human use and consumption through the National Council of

Setting and Review of Prices of Medicines for Human Use, in accordance with the
law.
The commercialization of the above-mentioned products is prohibited without fixing or review
of prices.
Art. 160 .- In no case may promotion and advertising expenses be considered
as part of the cost structure for pricing analysis.
Note: Article replaced by Law No. 00, published in the Official Gazette Supplement 555
of October 13, 2011
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RS&spx=1&nmx=555&f
cx = 13-10-2011 & pgx = 1.
Art. 161 .- For the setting and review of prices of imported drugs,
will consider the price at the port of shipment (FOB) of the country of origin of the product, the
same that may not be higher than the sale prices to the distributor or wholesaler of the
country of origin.
Art. 162.- The prices of sale to the public must be printed on the containers in a
that cannot be removed. It is prohibited to alter prices or affix labels that
modify.
Art. 163.- Pharmaceutical laboratories, pharmaceutical distributors,
representation of drugs, medical devices, dental products, reagents
biochemicals and diagnostics, in sales made to public institutions
they will discount a percentage not less than 15% of the sale price to the pharmacy.
CHAPTER IV
Of processed natural products for medicinal use
Art. 164.- Processed natural products for medicinal use will be produced,
They will store, market and import as long as they have a sanitary registration
national, in accordance with the law and the corresponding regulations and under the rules of
quality issued by the national health authority.
CHAPTER V
Of pharmaceutical establishments

Page 38

Art. 165 .- For legal and regulatory purposes, pharmaceutical establishments are those
pharmaceutical laboratories, medicine representation houses, distributors
Pharmaceuticals, pharmacies and medicine cabinets, which are found throughout the national territory.
Art. 166 .- Pharmacies must serve the public at least twelve hours a day,
uninterrupted and compulsorily fulfill the shifts established by the authority
national health. They necessarily require the address for their operation
technique and responsibility of a professional chemist, pharmaceutical or biochemical
pharmacist, who will provide specialized pharmaceutical care.
The kits will be in charge of qualified and certified people for the handling of
medicines. The authorization for its operation is temporary and revocable.
The national health authority will implement pharmacies and institutional medicine cabinets,
properly equipped, in all its operating units according to the level of
complexity.
Art. 167 .- The prescription issued by health professionals empowered by law to
To do so, it must first and foremost contain the generic name of the
prescribed medication.
Whoever sells must inform the buyer about the existence of the
generic drug and its price.
Illegible, altered or code prescriptions will not be accepted.
Art. 168 .- They are human health professionals empowered to prescribe
medications, doctors, dentists and midwives.
Art. 169.- The sale of medicines to the retail public can only be carried out in
establishments authorized for this purpose.
Art. 170 .- Medicines, for sale must meet the following requirements:
a) Be duly identified and labeled, without alterations or amendments;
b) Contain on their labels the national health registration number, the sale price at
public and the expiration date;
c) Not be expired;
d) Do not come from social service institutions, state social programs,
donations or be medical samples;
e) Not having been smuggled into the country;
f) Not be falsified or adulterated; Y,
g) Not having elements placed on the labels that impede the visibility of the
product information, including those containing prices.
Art. 171 .- The sale of drugs containing psychotropic substances is prohibited.

Page 39

and narcotics that do not have a prescription issued by professionals authorized to
prescribe them. When the prescription and sale of drugs containing
these substances, will be carried out in accordance with the standards issued by the health authority
national law and the Law on Narcotic and Psychotropic Substances.
Concordances:
• LAW ON NARCOTICS AND PSYCHOTROPIC SUBSTANCES, Arts. 43

Art. 172 .- In pharmacies and medicine cabinets it will not be possible to offer or give medical consultation,
obstetric, dental, apply treatments, take samples or have
clinical laboratories.
Art. 173 .- Every pharmaceutical establishment must have technical responsibility
from a professional pharmaceutical chemist or pharmaceutical biochemist, who may have
under its technical responsibility one or more pharmaceutical establishments,
conformity with what the regulation establishes.
The application regulations of this Law will regulate what is related to this service, in the
places where there are not enough professionals or pharmaceutical establishments.
Art. 174.- Pharmacy vendors are prohibited from recommending the use of
medicines requiring a prescription or changing the prescribed active substance, without the
written authorization of the prescriber.
Art. 175.- Sixty days before the expiration date of the medications, the
Pharmacies and medicine cabinets will notify their providers, who have the obligation to
withdraw said products and exchange them in accordance with what is established by the regulations
correspondent.
Art. 176.- Expired medications referred to in the previous article must be
destroyed and disposed of by manufacturers or importers, in accordance with the
procedures established by the national health authority and under its supervision.
CHAPTER VI
Other establishments subject to sanitary control
Art. 177 .- It is the responsibility of the national health authority to issue standards and
control the hygienic and sanitary conditions of care service establishments
to the public and others subject to sanitary control, for the granting or renewal of the
operating permit.
In the case of public and private educational establishments, it will monitor, control and
periodically evaluate the infrastructure and hygienic-sanitary conditions requirements
necessary for its operation.

Page 40

Art. 178.- Establishments for the production, storage, packaging or sale of
natural products for medicinal use and homeopathic medicines, require for their
installation and operation of the permit granted by the national health authority.
Art. 179.- Representation houses and distributors of dental products,
medical devices, biochemical and diagnostic reagents, for their operation
they must obtain permission from the national health authority.
BOOK IV
Of the health services and professions
SOLE TITLE
CHAPTER I
Of the health services
Art. 180.- The national health authority will regulate, license and control the
operation of public and private health services, for profit and not for profit,
autonomous, community and private companies of health and prepaid medicine and
will grant its operating permit.
It will regulate the licensing and accreditation processes.
It will regulate and control compliance with the regulations for the construction, expansion and
operation of these establishments according to the typology, based on the
resolutive capacity, levels of attention and complexity.
Art. 181 .- The national health authority will regulate and monitor that the health services
public and private, for-profit and non-profit, self-employed and private health companies
and prepaid medicine, guarantee timely, efficient and quality care according to the
approaches and principles defined in this Law.
Art. 182 .- The national health authority will regulate and approve the rates of services
health services and those of the plans and programs of the health and medical services companies
prepaid, in accordance with the regulations issued for this purpose.
Art. 183.- The contract for the provision of prepaid medicine services must be
approved by the national health authority.
It is the obligation of the prepaid medicine companies to obtain said approval and do it
be included in the respective contract.
Art. 184.- It is the obligation of the health services to exhibit in visible places for the
public, the fees charged for their services, the same that must be approved
by the national health authority.

Page 41

Art. 185 .- The health services will function, in accordance with their scope of
competence, under the technical responsibility of a health professional.
Art. 186 .- It is the obligation of all health services that have emergency rooms,
receive and care for patients in a state of emergency. It is prohibited to require the patient or
to the related persons a payment, economic commitment or administrative procedure,
as a precondition for the person to be received, cared for and stabilized in their health.
Once the patient has overcome the emergency, the private health facility
You may demand payment for the services you received.
Art. 187 .- The values ​not recovered by the health service for the care of a
patient in a state of emergency, whose inability to pay is duly
proven, will be deducted from income tax in accordance with the provisions
of the Internal Tax Regime Law.
Concordances:
• ORGANIC LAW OF INTERNAL TAX REGIME, LORTI, Arts. 16

Art. 188 .- The national health authority will regulate and monitor that the health services
public and private apply infection prevention and control standards
nosocomial.
CHAPTER II
Of traditional and alternative medicines
Art. 189 .- The members of the National Health System will respect and promote the
development of traditional medicines, will incorporate the intercultural approach in
health care policies, plans, programs, projects and models, and will integrate the
knowledge of traditional and alternative medicines in teaching processes
- learning.
Art. 190 .- The national health authority will promote and encourage the exchange of
knowledge among the different agents of traditional medicines, will promote
research processes of its diagnostic and therapeutic resources within the framework of the
principles established in this Law, protecting the collective rights of the peoples
indigenous and black or Afro-Ecuadorian.
Art. 191 .- The national health authority will implement regulation and control processes,
to prevent the practices of traditional medicines from damaging the health of the
people.
Art. 192 .- The members of the National Health System will respect and promote the

Page 42

development of alternative medicines within the framework of comprehensive health care.
Alternative medicines must be practiced by health professionals with degrees
recognized and certified by CONESUP and registered with the health authority
national.
Alternative therapies require for their exercise, the permission issued by the authority
national health.
CHAPTER III
Of the health and related professions and their practice
Art. 193 .- Health professions are those whose third or third degree university training
fourth level is specifically and fundamentally aimed at providing professionals with
knowledge, techniques and practices, related to individual and collective health and to the
control of its conditioning factors.
Art. 194 .- To practice as a health professional, it is required to have obtained a degree
third-level university, conferred by one of the established universities and
legally recognized in the country, or by one from abroad, revalidated and endorsed. In one
and another case must be registered with CONESUP and by the national health authority.
Art. 195 .- The degrees of higher technical or technological level as well as those of assistants
in different branches of health, for their qualification they must be registered in the instances
respective and registered with the national health authority.
Art. 196 .- The national health authority will analyze the different aspects related to
with the training of human resources in health, taking into account the needs
national and local, in order to promote among the training institutions of
human resources in health, reforms in training plans and programs and
training.
Art. 197 .- For the authorization of professional practice and the corresponding registration, the
Health professionals must carry out a year of practice in rural parishes or
marginal urban areas, with remuneration, in accordance with the model of care and
conformity with the corresponding regulations in the places designated by the authority
national health system, at the end of which the certification that accredits the
fulfillment of the obligation that this article establishes.
The national health authority in coordination with sectional agencies and
grassroots organizations, will control the allocation and compliance with the mandatory year
by professionals who complete the rural health year.
The exercise of rural practice is prohibited in urban operating units of second and third
third level.

Page 43

Art. 198 .- Higher level professionals and technicians who carry out activities
related to health, they are obliged to limit their actions to the area that the title
assign.
Art. 199 .- It is the responsibility of the national health authority to investigate and sanction the
illegal practice, negligence, inexperience, recklessness and non-observance in the exercise of
health professions, without prejudice to the action of ordinary justice.
Art. 200.- The professional who protects with his title or with his signature the exercise of the
health professions to unauthorized persons, without prejudice to the provisions of this
Law, will be sanctioned in accordance with the applicable legislation.
Art. 201 .- It is the responsibility of health professionals to provide quality care,
with warmth and efficiency, within the scope of its competences, seeking the greatest benefit
for the health of its patients and the population, respecting human rights and
bioethical principles.
It is your duty to demand basic conditions for the fulfillment of what is indicated in subsection
preceding.
Art. 202 .- It constitutes an infringement in the exercise of the health professions, any act
individual and non-transferable, not justified, that causes harm to the patient and is the result
from:
a) Failure to comply with the rules;
b) Inappropriateness, in the performance of the health professional with total or partial lack of
technical knowledge or experience;
c) Recklessness, in the performance of the health professional with omission of care or
due diligence; Y,
d) Negligence, in the performance of the health professional with omission or delay
unjustified in their professional obligation.
Note: Article 17 of the Comprehensive Organic Criminal Code provides: "
exclusively as criminal offenses those typified in this Code. Shares u
Punishable omissions, penalties or criminal proceedings provided for in other regulations
They will not have any legal validity, except in matters of childhood and adolescence.
Art. 203 .- The health services will be civilly co-responsible for the actions of
the health professionals who work in them.
Art. 204.- The consent or authorization of the patient or the person who represents him
legally, it does not exempt the professional or the health service from responsibility in those
cases determined in article 202 of this Law.
CHAPTER IV
Of sanitary training

Page 44

Art. 205 .- Create the health career for human resources of the National System of
Health, based on the classification criteria by levels of training and structure
occupational, with the purpose of establishing their obligations and rights, as well as the
incentives to ensure equity, quality of care and service,
adequate and sufficient allocation of human resources in the different areas of the country.
The national health authority will promote and develop, within the health career,
a national plan for permanent education with a gender and multicultural approach, to
improve productivity, quality of job performance and promotion of your resources
humans.
Art. 206 .- The national health authority will establish training and evaluation plans
permanent staff of health professionals and human resources and will implement
promotions and incentives.
BOOK V
SOLE TITLE
Scientific research in health, genetics and the health information system
CHAPTER I
From scientific research in health
Art. 207.- Scientific research in health as well as the use and development of
biotechnology, will be carried out oriented to national priorities and needs, with
subject to bioethical principles, with pluricultural, rights and gender approaches,
incorporating traditional and alternative medicines.
Art. 208 .- Technological scientific research in health will be regulated and controlled by
the national health authority, in coordination with the competent bodies, with
subject to bioethical and rights principles, prior informed consent and by
written, respecting confidentiality.
CHAPTER II
Of human genetics
Art. 209 .- The national health authority will regulate, license and control the
operation of specialized public and private health services, for the
carrying out activities related to research and development of genetics
human. It will also control the professional practice of those who carry out said
activities, which must necessarily have a specialty in the area of ​genetics or
related.
Art. 210 .- Only human identification, filiation and
antigen compatibility for:

Page 45

a) Transplants;
b) Mutational studies;
c) Genetic linkage;
d) Predictive tests of genetic diseases.
e) Tests to detect genetic predisposition to a disease;
f) Therapeutic purposes; Y,
g) Others that are developed for genetic health purposes.
These tests must have specialized genetic counseling and supervision,
following scientifically proven procedures, with subjection and respect to the
bioethical principles.
Art. 211.- All forms of discrimination against a person because of their
genetic heritage.
It is mandatory to keep confidentiality regarding the individual genome of the person.
Art. 212.- Genetic intervention on cells of the germ line and cells is prohibited.
mother, for experimentation and profit.
Interventions may be carried out on the human genome, germ line cells and
stem cells solely for predictive, preventive, diagnostic or
therapeutic, provided that specialized genetic counseling is available,
scientifically proven and safe procedures, prior informed consent,
express and written of the person and that is of social and eugenic benefit.
Art. 213 .- Natural human genes or cell derivatives may not be patented.
Concordances:
• LAW OF INTELLECTUAL PROPERTY, Arts. 151

Art. 214.- The cloning practices of human beings are prohibited, as well as the
obtaining human embryos for experimental purposes.
The national health authority will seek and promote integration and cooperative work
of genetics research and development centers.
Concordances:
• LAW OF INTELLECTUAL PROPERTY, Arts. 126

CHAPTER III

Page 46

Of the common information system
Art. 215 .- The national health authority with the participation of the members of the
National Health System, will implement the common information system in order to
know the health situation, identify the risks for people and the environment,
dimension the available resources and the production of services, to guide the
political and managerial decisions and articulate citizen participation in all
levels, among others.
This system will incorporate pluricultural, multiethnic, gender,
regional and population peculiarities, as well as the political-administrative division
from the country.
BOOK SIX
Jurisdiction, competence, procedure, sanctions and definitions
CHAPTER I
Of jurisdiction and competence
Art. 216.- Jurisdiction and administrative competence in matters of health are born from
this law.
Art. 217 .- They have jurisdiction to know, judge and impose the sanctions provided in
this Law and other regulations in force, the following health authorities:
a) The Minister of Public Health;
b) The Director General of Health;
c) The provincial directors of health; Y,
d) The health commissioners.
Art. 218 .- The health commissioners must be doctors in jurisprudence or lawyers with
minimum experience of three years of professional practice.
Art. 219 .- The Minister of Public Health and the Director General of Health have
competition throughout the national territory.
Provincial health directors and health commissioners have competence in the
provincial scope.
Art. 220 .- The Public Force is obliged to collaborate with the health authorities to
enforce the provisions of this Law, when their intervention is required.
CHAPTER II
Of the procedure
Art. 221 .- The health authorities indicated in the previous Chapter, will act ex officio,

Page 47

by complaint or report to know and sanction the infractions indicated in this Law.
Complaints will be presented verbally or in writing.
Art. 222 .- The health authorities indicated in Article 217, which do not comply
adequately its obligation to know, judge and impose the sanctions provided for in this
Law, will be sanctioned in accordance with the corresponding regulations and other
norms pertaining to the matter, without prejudice to administrative, civil and
penalties that may arise.
Art. 223.- Public action is granted to report any infraction to the
provisions of this Law.
Art. 224 .- When acting ex officio or by means of a report or complaint, the authority of
corresponding health will dictate an initial order that will contain:
a) The succinct relationship of the facts and the way in which they came to his knowledge;
b) The order to summon the alleged offender, providing that he indicate the address to deliver
the notifications, under prevention that he will be judged in absentia in case of not
appear;
c) The order to add to the file the report or complaint, if they exist, and that
take the necessary steps to verify the infringement;
d) The appointment of the day and time for the trial hearing to take place; Y,
e) The appointment of the secretary who will act in the process.
Art. 225.- It corresponds to know and resolve the causes in the first instance:
a) To the health commissioner, the infractions sanctioned in articles 241, 242, 243, 244
and 245 of this Law;
b) To the provincial director of health, the infractions sanctioned in articles 246, 247,
248 and 256 of this Law; Y,
c) To the Director General of Health, the infractions sanctioned in articles 249, 250,
251, 252, 254 and 255 of this Law.
If the authority is not competent, it will refrain from knowing the cause and will send it ex officio,
To whom it may concern.
Art. 226.- In the event that the offense has indications of criminal responsibility, the
file will be sent to the competent authority.
Art. 227 .- The summons with the initial order will be made personally to the offender, in his
address or place of work; if he is not found, he will be summoned by three ballots
left at home or workplace, on different days, stating the reason for the
citation.
Concordances:

Page 48

• CODE OF CIVIL PROCEDURE, Arts. 77

Art. 228 .- In the trial hearing, the offender will be heard, who will intervene on his own or
through your lawyer; the evidence you submit will be received and added to the process,
of which a record will be left signed by the appearing party, the health authority
corresponding and the secretary.
Concordances:
• CODE OF CIVIL PROCEDURE, Arts. 40

Art. 229 .- If requested by any of the parties or ex officio, in the same diligence,
will open the case to trial for a term of six days, in which all the
evidence requested.
Concordances:
• CODE OF CIVIL PROCEDURE, Arts. 121

Art. 230 .- If no request has been made to open the trial, the health authority
corresponding will proceed to issue the resolution within five days.
Art. 231.- Once the trial term has expired and all the proceedings have been carried out.
timely requested and ordered, the corresponding health authority will dictate its
resolution within five days.
Art. 232 .- Of the decisions of the health commissioner, an appeal may be made to the director
provincial health; of those dictated by the provincial director of health, before the Director
General Health; and, of those of this authority before the Minister of Public Health, being
these decisions of second and final instance.
The resolutions may be appealed within a term of three days after being
notified to the parties; the higher authority within the term of eight days from when
avoca knowledge must issue the corresponding resolution.
Only decisions of first instance, those of second instance, may be appealed.
instance will cause execution.
Concordances:
• CODE OF CIVIL PROCEDURE, Arts. 296, 323

Page 49

Art. 233 .- Once the resolution is executed, the payment order will be issued, the
the same that if it is not paid by the taxpayer, it will be charged by the coercive means by the
Ministry of Public Health in accordance with the provisions of article 941 of the Code of
Civil Procedure, in which the State and its institutions are granted, action and
coercive jurisdiction at the national level.
Art. 234 .- The goods and products that were seized and can be used, are
will be delivered to the charitable institutions of the provincial jurisdiction where
has committed the offense, in accordance with the regulations issued for that purpose by the
national health authority.
Art. 235 .- The goods and products that cannot be used will be destroyed by the
corresponding authority, leaving evidence in the minutes that will be signed jointly with

the secretary, whose original will be sent to the immediate superior authority for
knowledge.
Art. 236 .- In everything not provided for in this Law, action will be taken in accordance with the provisions
in the Penal and Civil Codes; and, of Criminal and Civil Procedure.
CHAPTER III
Of the sanctions
Art. 237.- Infractions in health matters will be sanctioned in accordance with the
provisions contained in this Law and its regulations, without prejudice to the sanctions
civil, administrative and penal to which there was place.
Art. 238 .- In the concurrence of more than one infringement of the provisions of this Law and
its regulations, the person will be judged for all committed.
Art. 239 .- The recidivism in the breach of this Law and its regulations, will be
repressed with twice the maximum of the sanction for each case, without prejudice to the
civil or criminal penalties that may be applicable.
Art. 240.- The infractions determined in this law will be sanctioned with:
a) Fine;
b) Suspension of the permit or license;
c) Suspension of professional practice;
d) Confiscation; Y,
e) Partial, temporary or permanent closure of the corresponding establishment.
CHAPTER IV
Of the infractions
Art. 241 .- It will be sanctioned with a fine of a unified basic salary of the worker in

Page 50

general, non-compliance with the provisions of articles 32, 53, 61, 64, 74 subsection
second, 101, 111 second paragraph, 115, 120 second paragraph, 122, 123, 167, 195, 198 and
202 literal a) of this Law.
Art. 242 .- It will be sanctioned with a fine of a unified basic salary of the worker in
general and temporary or permanent closure of the corresponding establishment, the
non-compliance with the provisions of articles 40, 47, 58 second paragraph, 97, 103 and 124
of this Law.
Art. 243 .- It will be sanctioned with a fine of five unified basic salaries of the worker.
in general, non-compliance with the provisions of articles 50, 57, 60, 74 subsection
first, 90, 118, 163, 175, 184 and 202 literal b), of this Law.
Art. 244 .- It will be sanctioned with a fine of five unified basic salaries of the worker.
in general and temporary or permanent closure of the corresponding establishment, the
non-compliance with the provisions of articles 105, 109, 166, 169, 172, 174, 178, 194,
200 and 212 of this Law.
Art. 245 .- It will be sanctioned with a fine of five unified basic salaries of the worker.
in general and confiscation, non-compliance with the provisions of article 125 and first
subsection of article 153 of this Law.
Art. 246 .- It will be sanctioned with a fine of ten unified basic salaries of the worker.
in general, non-compliance with the provisions of articles 12, second paragraph, 22, 29,
41, 48, 80, 110, 173 and 202 literal c), of this Law.
Art. 247 .- It will be sanctioned with a fine of ten unified basic salaries of the worker.
in general and temporary or permanent closure of the corresponding establishment, the
non-compliance with the provisions of articles 104, 116, 121, 143, 159 second paragraph,
186 and 192 subsections second and third, of this Law.
Art. 248 .- It will be sanctioned with a fine of ten unified basic salaries of the worker.
in general, confiscation and temporary or permanent closure of the establishment
corresponding, non-compliance with the provisions of articles 42, 49, 137, 140, 141
first paragraph, 146, 164 and 170 of this Law.
Art. 249 .- It will be sanctioned with a fine of twenty unified basic salaries of the worker.
in general, non-compliance with the provisions of articles 27, second paragraph, 75, 162 and
202 literal d) of this Law.
Art. 250.- It will be sanctioned with a fine of twenty unified basic salaries of the worker.
in general and temporary or permanent closure, failure to comply with the provisions of the
Articles 149 and 183, second paragraph, of this Law.
Art. 251 .- It will be sanctioned with a fine of twenty unified basic salaries of the worker.
in general, confiscation and temporary or permanent closure of the establishment

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corresponding, non-compliance with the provisions of articles 150 and 151 of this Law.
Art. 252. -Note: Article repealed by Law No. 00, published in Official Gazette 398 of
March 4, 2011
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RO&spx=0&nmx=398&f
cx = 04-03-2011 & pgx = 1.
Art. 253 .- The infringement of the provisions of articles 213 and 214, will be sanctioned with
suspension of professional practice, fine of one hundred unified basic salaries of the
worker in general and definitive closure of the establishment, without prejudice to the
civil and criminal penalties that may be applicable.
Art. 254 .- It will be sanctioned with a fine of five unified basic salaries of the worker.
in general, non-compliance with the provisions of articles 130 and 134 of this Law.
Art. 255 .- It will be sanctioned with the suspension of professional practice for five years and
temporary or permanent closure of the corresponding establishment, failure to comply with
the provisions of article 210 of this Law.
Art. 256.- It will be sanctioned with temporary or definitive closure of the establishment.
corresponding, non-compliance with the provisions of article 185 of this Law.
Art. 257.- The product of the fines that are collected for infractions to the provisions of
this Law and its regulations, will be used in the respective jurisdiction where the
imposed, having to allocate it for the attention and improvement of health services
of the respective provincial direction.
Art. 258 .- For compliance with the provisions established in this Law, the
Health authorities will have free access to the places where they must fulfill their
inspection and control functions, being able to require the intervention of the force
public, if necessary.
CHAPTER V
From the definitions
Art. 259 .- For the purposes of this Law, it is understood by:
Accreditation of health services.- It is the voluntary process carried out regularly and
periodicity, of a reserved nature, through which a health service,
Regardless of its level, it is evaluated by a qualified technical body,
according to a set of standards that describes the activities and structures that
contribute directly to the desired outcomes for patient-users, the
compliance with these standards seeks to achieve an optimal level of quality of care
taking into account available resources.
Food additives.- They are substances or mixtures of substances of natural origin or

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artificial, which by themselves are not consumed directly as food, whether or not they have
nutritional value and are added within permitted limits during production, handling,
manufacture, elaboration, treatment or preservation of food.
Agents of traditional medicines.- They are those healers who intervene in
different areas of health, whose names are particular to each of the
nationalities and peoples, and their recognition comes from the communities themselves
where they provide their services. The formal and temporary conditions and characteristics of
their training are typical of their tradition and ancestral culture.
Food.- It is any natural or artificial product that ingested contributes to the organism of
humans or animals, materials and energy necessary for development
of biological processes.
It also includes substances and mixtures thereof that are ingested by habit or
habit, whether or not they have nutritional value.
Genetically modified foods.- They are those that contain or are composed
by genetically modified organisms or have been produced from them.
Natural food.- It is that which is used as it is presented in nature without having
suffered transformation in its characters or in its composition, being able to be subjected to
processes prescribed for hygienic reasons, or those necessary for the separation of parts
not edible.
Processed food.- It is any natural or artificial food material that is for consumption
human has been subjected to technological operations necessary for its transformation,
modification and conservation, which is distributed and sold in containers labeled under
a certain brand.
The term processed food extends to alcoholic and non-alcoholic beverages, water
table, condiments, spices and food additives.
Pharmaceutical care.- It is the assistance to the patient by the pharmaceutical chemist or
pharmaceutical biochemist in the follow-up of therapeutic drug treatment, directed
to contribute with the doctor and other health professionals, in the achievement of the
expected results and achievement of maximum therapeutic benefit.
Blood banks.- They are health services, technical, specialized and qualified,
responsible for carrying out the extraction, preparation, conservation, storage and
supply of human blood, its components and derivatives.
Tissue banks.- They are technical, specialized and qualified health services that
Their mission is to guarantee the quality of the fabrics from their obtaining to their
clinical use.

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First-aid kits.- They are pharmaceutical establishments authorized to sell to the public,
only the list of drugs and other products determined by the authority
national health; work in rural areas where there are no pharmacies and should
adhere to proper storage practices at all times.
Representation houses.- They are the pharmaceutical establishments authorized to
carry out medical promotion, import and wholesale of products to third parties
made by their represented. They must comply with good practices of
storage and distribution determined by the national health authority.
They require for their operation the responsible technical direction of a professional
pharmaceutical chemist or pharmaceutical biochemist.
Production - consumption cycle.- These are the stages or phases involved in production,
handling, storage, transportation, distribution, import, export,
marketing, sale and consumption of products.
Anatomical components.- They are the organs, tissues, cells, their derivatives and in general
all parts of the human organism.
Waste.- They are the waste or waste in any state of matter, product of
industrial, commercial and community activities; they are classified in common,
infectious and special or dangerous.
Common wastes.- Are those that do not represent a risk to human health,
animal or environment.
Hazardous waste.- Are those resulting from a production process,
transformation, recycling, use or consumption and that have some compound with
reactive, flammable, corrosive, infectious or toxic characteristics, presenting a
risk to human health, natural resources and the environment.
Infectious wastes.- They are those that contain pathogenic germs and represent
health risk; are generated in human health establishments, veterinarians,
morgues and others.
Medical devices.- They are the articles, instruments, devices, artifacts or inventions
mechanical, including its components, parts or accessories, manufactured, sold or
recommended for use in diagnosis, curative or palliative treatment, prevention of a
disease, disorder or abnormal physical condition or its symptoms, to replace or
modify or control anatomy or a physiological process. They include amalgams,
varnishes, sealants and more similar dental products.
Pharmaceutical distributors.- They are pharmaceutical establishments authorized to
carry out import, export and wholesale of medicines in general from
human use, pharmaceutical specialties, products for the pharmaceutical industry,
medical-surgical aids, medical devices, medical supplies, cosmetics and

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hygienic products. They must comply with good storage practices and
distribution determined by the national health authority. They will operate under the
representation and technical responsibility of a pharmaceutical chemist or biochemist
pharmacist.
Donor.- It is the person from whom, during his life or after his death, the
anatomical components in good functional condition, to be transplanted into another person or
use them for therapeutic or research purposes.
Catastrophic disease.- It is one that meets the following characteristics:
a) That implies a high risk to the life of the person;
b) That it is a chronic disease and therefore that its care is not emergent; Y,
c) That your treatment can be scheduled or that the average value of your treatment
monthly is greater than that determined in the Ministerial Agreement of the Sanitary Authority.
Rare and Orphan Diseases: Rare or orphan diseases, including those of
genetic origin, are those life-threatening diseases, or debilitating to
long-term, low prevalence and high complexity.
Note: Definitions of Catastrophic, Rare and Orphan Diseases added by Law
No. 0, published in Official Gazette 625 of January 24, 2012
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RO&spx=0&nmx=625&f
cx = 01-24-2012 & pgx = 1.
Health emergency.- It is any situation of risk of health condition caused by
natural disasters or by actions of people, climatic phenomena, absence or
precarious conditions of basic sanitation that favor an increase in
communicable diseases. It requires the special intervention of the State with
mobilization of human, financial or other resources, aimed at reducing the risk or
mitigate the impact on the health of the most vulnerable populations.
The health emergency must be declared by the President of the Republic in accordance with
It is mandated by the Political Constitution.
Pharmacies.- They are pharmaceutical establishments authorized for the dispensing and
sale of medicines for human use and consumption, pharmaceutical specialties,
processed natural products for medicinal use, biological products, inputs and
medical devices, cosmetics, dental products, as well as for the preparation and
sale of official and magisterial formulas. They must comply with good practices of
pharmacy. They require for their operation the technical direction and responsibility of a
Pharmaceutical chemist or pharmaceutical biochemist professional.
Genetics.- It is the science that deals with reproduction, inheritance, variation both in state
normal as abnormal or disease, and the set of phenomena and problems
relating to the offspring.

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Pharmaceutical laboratories.- They are pharmaceutical establishments authorized to
produce or manufacture medicines in general, pharmaceutical specialties, biological
for human or veterinary use; must comply with the rules of good practice of
manufacturing determined by the national health authority; and, they will be under the direction
technique of pharmaceutical chemists or pharmaceutical biochemists.
Licensing of health services.- It is the mandatory procedure for
means of which the national health authority grants the operating permit to the
institutions providing health services, public or private, according to their capacity
resolution, levels of care and complexity, after verification of compliance with the
Essential minimum requirements or standards.
Food raw material.- It is the substance or mixture of substances, natural or artificial
allowed by the national health authority, which is used for the preparation of
food and drinks.
Medication.- It is any preparation or pharmaceutical form, whose composition formula
expressed in units of the international system, it is constituted by a substance or
mixture of substances, with constant weight, volume and percentages, made in
legally established pharmaceutical laboratories, packaged or labeled to be
distributed and marketed as effective for diagnosis, treatment, mitigation and
prophylaxis of a disease, physical abnormality or symptom, or the restoration, correction
or modification of the balance of the organic functions of human beings and
animals.
By extension this definition applies to the association of substances of dietary value,
with therapeutic indications or specially prepared foods, which replace
special diets.
Over-the-counter medicine.- It is the oral or topical medicine that due to its composition and
Due to the pharmacological action of its active principles, it is authorized to be dispensed or
dispensed without a prescription.
Generic drug.- It is one that is registered and marketed with the Denomination
International Common (INN) of the active principle, proposed by the World Organization
Of the health; or in its absence, with a recognized conventional generic name
internationally. These drugs must maintain quality levels,
safety and efficacy required for branded ones.
Homeopathic medicine.- It is the pharmaceutical preparation obtained by technical
homeopathic, according to the rules described in the official pharmacopoeias accepted in
the country, in order to prevent disease, alleviate, cure, treat and rehabilitate a
patient. Containers, labels, labels and packaging are an integral part of the
medicine, inasmuch as they guarantee its quality, stability and proper use. Must
be prescribed by professionals authorized for the purpose and dispensed or issued in

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places authorized for this purpose.
Alternative medicines.- They are the set of scientifically proven medicines,
exercised by medical professionals, with a fourth-level degree in the field and recognized
by the national health authority.
Traditional medicines.- They are the set of ancestral knowledge and practices of the
nationalities, peoples, indigenous, mestizo and Afro-descendant communities that
over time they have constituted a specific knowledge, maintained and disseminated in a
cultural context, of interrelation of natural, ethical, spiritual, mental,
psychological and affective and that is explained and works in that same cultural universe. Their
practices correspond to knowledge, techniques and procedures of their own
worldview and are exercised by healers of traditional medicines, recognized
by their communities and registered by the national health authority.
Necropsy or autopsy.- It is the technical procedure by which it is observed and analyzed
a corpse, externally and internally to establish the causes of the death of the
person.
New chemical entity.- It is the drug, ingredient or active principle of use or
human consumption that has never been used for any therapeutic indication in the
world level. A new chemical entity will not be considered among others, new uses or
second uses, nor the news or change of the following aspects: forms
pharmaceuticals, indications or second indications, new combinations of entities
known chemistries, formulations, dosage forms, routes of administration,
modifications of any kind that do not affect the mechanism of action, conditions
marketing and packaging and in general, those that involve new
presentations.
Genetically modified organisms, GMOs or living modified organism LMO.Any living organism, with the exception of humans, that has acquired a
novel genetic combination, generated through the specific use of techniques of the
modern biotechnology.
Operation permit.- It is the document granted by the health authority
national to establishments subject to health control and surveillance that comply with
all the requirements for its operation, established in the regulations
corresponding.
Food processing plants.- These are establishments in which
selection, purification and transformation of raw materials for the
food production, packaging and labeling.
Processed natural product for medicinal use.- It is the finished medicinal product and
labeling, whose active ingredients are made up of any part of the resources
natural drugs for medicinal use or their combinations, as a crude drug, extract or in a

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recognized pharmaceutical form, used for therapeutic purposes
It is not considered a processed natural product for medicinal use, if the natural resource of
medicinal use is combined with active substances defined from the point of view
chemical, including constituents of natural resources, isolated and chemically
defined.
Nutraceutical product.- Also called functional or bioactive compound, it is any
product similar in appearance to a conventional food that has one or more
intentional benefits, beyond providing adequate nutrition, such as a
better health or a reduction in the risk of a certain disease.
Tobacco products.- Covers products prepared totally or in part using
as raw material tobacco leaves and intended to be smoked, sucked, inhaled,
chewed or used as snuff.
Biochemical reagents.- They are all substances or products that are used with
special machines or not, to react with liquids or organic matter and help in
the diagnosis, monitoring, control and treatment of diseases of beings
humans.
Receptor.- It is the person in whose body anatomical components are implanted
coming from himself, from another person or from another species.
Sanitary registry.- It is the certification granted by the national sanitary authority, for the
import, export and commercialization of products for human use and consumption
indicated in article 137 of this Law. Said certification is granted when
meet the requirements for quality, safety, efficacy and fitness to consume and use
said products complying with the procedures established in this Law and its
regulations.
Environmental health.- They are the knowledge that deals with the forms of life, substances,
forces and conditions in the human environment that can exert harmful effects
about your health and well-being, as well as actions to prevent or reduce them, in the
framework for the promotion and development of healthy environments.
Reproductive health.- It is the general state of physical, mental and social well-being and not merely
absence of diseases or ailments, in all aspects related to the system
reproductive system, its functions and processes and implies the right of people to take
decisions regarding her.
Sexual health.- It is the general state of physical, mental and social well-being and not mere
absence of diseases or ailments, which allows the person to freely and
responsible enjoy a full, pleasant sexual life, free from sexual abuse, coercion
or harassment and sexually transmitted diseases.

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Environmental sanitation.- It is the set of activities dedicated to conditioning,
control and protect the environment in which humans live, in order to protect their health.
Health services.- Are those that are intended to provide health benefits,
promotion, prevention, recovery and rehabilitation on an outpatient basis,
domiciliary or hospitalization, are classified according to the resolution capacity,
levels of care and complexity.
Alternative therapies.- Set of methods, techniques and systems used to
prevention or treatment of diseases and are aimed at balancing the body in its
physical, mental or spiritual aspects, and to establish a balance between the individual and the
environment.
Organ transplantation.- It is the substitution for therapeutic purposes of components
anatomical in a person, by other equal and functional from the same
recipient or a living or dead donor.
Violence.- It is any action, omission or intentional use of physical force or power, real or
by threat, of a person, group or institution in order to harm another against
his will, characterized by aggression against physical, sexual, and psychological integrity,
symbolic or cultural.
GENERAL DISPOSITION
FIRST.- The control services, inspections, authorizations, permits, licenses,
records and others of a similar nature provided by the national health authority, will satisfy
the payment of fees in accordance with the respective regulations.
FIRST-A.- The ministry in charge of the field of economic and social inclusion
will execute care and social protection programs for families who have between
its members to patients suffering from diseases considered rare or orphaned and
catastrophic through the application of policies of inclusion and social cohesion, equality
and comprehensive protection in coordination with the National Health Authority.
Note: Provision added by Law No. 0, published in Official Gazette 625 of 24
January 2012
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RO&spx=0&nmx=625&f
cx = 01-24-2012 & pgx = 1.
SECOND.- The President of the Republic shall issue the general regulations for the
application of this Law, within a maximum period of ninety days.
THIRD.- Derogatory.- Repeal all the norms, general provisions or
that are opposed to this Law, in matters of health.
Expressly revoke:

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The Health Code, issued by Executive Decree No. 188, published in the
Official Gazette No. 158 of February 8, 1971
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RO&spx=0&nmx=158&f
cx = 02-08-1971 & pgx = 1and all its reforms.
Articles 8, 9, 10, 11 and Chapter VIII of the Law of Production, Import,
Marketing and Sales of Generic Medicines for Human Use, published in
Official Gazette No. 59 of April 17, 2000
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RO&spx=0&nmx=59&fc
x = 04-17-2000 & pgx = 1.
Article 99 of the Law for the Promotion of Investment and Citizen Participation,
published in the Official Gazette Supplement No. 144, of August 18, 2000
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RS&spx=1&nmx=144&f
cx = 18-08-2000 & pgx = 1.
Article 11 of the Law on Organ and Tissue Transplants, published in the Registry
Official 492 of July 27, 1994
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RO&spx=0&nmx=492&f
cx = 07-27-1994 & pgx = 1.
FOURTH.- Make the following reforms:
a) In article 2 of the Production, Import, Marketing and Sales Law
of Generic Medicines for Human Use, published in Official Gazette No. 59 of
April 17, 2000
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RO&spx=0&nmx=59&fc
x = 04-17-2000 & pgx = 1 , replace the word: "... employ", by: "commercialize ...";
b) In the entire Law on Patient Rights and Protection, replace: "health centers" with:
"Health services";
c) In article 98 of the Civil Registry, Identification and Cedulation Law, a
continuation of numeral 13, add the following:
"14. Express authorization of the citizen to be an organ donor or other
anatomical components, in accordance with the provisions of article 83 of the Law
Organic Health. ";
d) Replace articles 1 and 2 of the Law on Supply and Use of
Blood and its Derivatives, published in Official Gazette 559 of November 7, 1986
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RO&spx=0&nmx=559&f
cx = 07-11-1986 & pgx = 1 , by the following.
" Art. 1 .- The surveillance and control of the supply and use of blood and its
derivatives in Ecuador, will be the responsibility of the national health authority.

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It will organize in coordination with the Ecuadorian Red Cross, the national banking system
and deposits of blood, in the cities and health services that require them, provided that
have the technical conditions for it.
The Ecuadorian Red Cross, the Ministry of Public Health, the Ecuadorian Institute of
Social Security, the Armed Forces and the Guayaquil Charity Board
will continue to administer the blood banks and deposits attached to their
Health.
Art. 2 .- The export of blood and its derivatives is prohibited, except as indicated in the
Article 79 of the Organic Health Law. "; and,
e) Following the fifth paragraph of article 46 of the Organic Customs Law,
Include another paragraph with the following text:
"The following are also excepted from verification at origin: vaccines, biologicals,
medicines and supplies imported by the Ministry of Public Health.
FIFTH.- All provincial capitals, without exception, will have at least one
public tertiary care hospital, with the infrastructure, equipment, goods,
suitable, sufficient and permanent inputs, budgets and human resources, empowered
to provide a solution to the needs of the population, in accordance with reality
local epidemiological.
SIXTH.- In accordance with the provisions of paragraph 10 of article 35 of the Constitution
Policy of the Republic, the paralysis is prohibited, for any title or for any reason,
of the public health service, under prevention of applying sanctions to those responsible
provided for in the laws that regulate the employment relationship and the Penal Code.
TRANSITORY DISPOSITIONS
Note: Denomination of title amended by Law No. 0, published in the Official Gazette
625 of January 24, 2012
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RO&spx=0&nmx=625&f
cx = 01-24-2012 & pgx = 1.
The regulations that are in force on health matters will continue to apply in all
what is not opposed to the present Law, until when others are dictated.
Dada, in the city of San Francisco de Quito, Metropolitan District, in the
sessions of the National Congress of Ecuador, on the fourteenth day of the month of December
year two thousand six.
FIRST.- Once the Organic Law Reformation to the Organic Law of
Health to include the Treatment of Rare or Orphan and Catastrophic Diseases,
the Ministry of Public Health will issue and update the list of diseases considered

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rare or orphan, at least every two years taking into account diseases
considered rare or ultra rare by the World Health Organization / Organization
Panamericana de la Salud.
Within a period of one hundred and eighty days, the Ministry of Public Health will issue the agreements,
resolutions and other technical standards for the effective application of the Organic Law
Reform of the Organic Health Law to Include the Treatment of Diseases
Rare or Orphan and Catastrophic.
Note: First provision added by Law No. 0, published in Official Gazette 625 of
January 24, 2012
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RO&spx=0&nmx=625&f
cx = 01-24-2012 & pgx = 1.
SECOND.- Once the Organic Law Reforming the Organic Law of
Health to include the Treatment of Rare or Orphan and Catastrophic Diseases,
all ongoing catastrophic disease care programs
in any public agency, they will become dependent on the Ministry of Public Health,
who will be in charge of continuing with its execution.
Note: Provision added by Law No. 0, published in Official Gazette 625 of 24

January 2012
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RO&spx=0&nmx=625&f
cx = 01-24-2012 & pgx = 1.
THIRD.- Once the Organic Law Reformation to the Organic Law of
Health to include the Treatment of Rare or Orphan and Catastrophic Diseases,
the Ministry of Finance will proceed to carry out the corresponding reclassification
budget, within the General State Budget, so that the Ministry of
Public Health has the necessary funds and can meet the obligations
determined in this Law.
Note: Provision added by Law No. 0, published in Official Gazette 625 of 24
January 2012
../AppData/Local/_ImageVisualizer/imageSearchRes.aspx?tpx=RO&spx=0&nmx=625&f
cx = 01-24-2012 & pgx = 1 .

