Libro III. Infracciones contra la salud y sus sanciones

Any act or omission involving violation of legal norms of a substantive or formal nature, relating to prevention, promotion, recovery, rehabilitation in health matters or non-compliance with the special provisions in force for the commercialization of products intended for human consumption, constitutes a violation punishable by the Ministry of Health, to the extent and with the scope established in this Code, its regulations and other health laws.

If, from the investigation conducted by the Public Prosecutor's Office, the commission of a crime defined in criminal laws is presumed, its cognizance and sanction correspond to the competent tribunals.

Public officials and employees of the Ministry of Health who, in the exercise of their functions, become aware of the commission of an act that may constitute a crime, must report it immediately to the competent authority, under penalty of incurring liability.

If there should exist a conflict of laws in matters of violations and sanctions against health, the provisions of this Code shall prevail over those of any other nature.

Individual or juridical persons who directly or indirectly incur the violations established in this Code and other health laws shall be considered liable perpetrators. Legal representatives, professionals or technicians and dependent personnel who cooperate in the active or passive commission of the violations shall also be considered liable perpetrators.

The following sanctions shall be imposed for the violations established in this Code, its regulations and other health laws, rules and provisions in force:

a)Written warning, to be issued by the public official or employee duly authorized by the Ministry of Health, previously and in writing, in accordance with the procedural rules established in this Book.

b)Fine, which shall be graduated between the equivalent of two to one hundred fifty current minimum monthly wages for non-agricultural activities, provided it does not exceed one hundred percent of the value of the good or service, except for the exceptional cases established in this Code.

c)Temporary closure of the establishment for a period of not less than five days and not more than six months, with the respective suspension of the sanitary license and, where applicable, of the reference sanitary registration of the products manufactured or marketed by the offender.

d)Cancellation of the sanitary registration for commercial purposes of products subject to control under this Code.

e)Permanent closure of the establishment.

f)Confiscation and destruction of the raw materials, foodstuffs, medicines, instruments, materials, goods and other objects related to the violation committed. When the seized objects are not of lawful commerce, the authority shall order their confiscation, even when they belong to a third party. In such cases, the Ministry of Health shall, under its responsibility, carry out the necessary proceedings in order to achieve their immediate destruction.

g)Temporary prohibition from engaging in any activity or occupation.

h)Publication, at the offender's expense, in the two most widely circulated daily newspapers, of the final decision recording the sanction imposed, in the cases established by the respective regulation.

If the offender does not correct the fault with the written warning, when legally applicable, one or more of the sanctions established in this article shall be imposed on the offender, taking into account the type of violation, the risk or damage caused to the health of persons, its significance to the population and the value of the goods that are the subject of the violation.

A repeat offender is a person who, after having been sanctioned for a health violation, commits the same violation.

In the case of violations sanctioned with a fine, the repeat offender shall additionally be sanctioned with an increase of one hundred percent of the first fine imposed, or another type of sanction of those indicated in Article 219 of this Code shall be imposed on such person.

Liability for violations and the sanctions established in this Code, its regulations, other health laws, applicable rules and provisions, are extinguished in the following cases:

a)Compliance with the sanction;

b)Limitation period of the liability; and

c)Limitation period of the sanction.

Liability for violations and the sanctions established in this Code and other health laws shall lapse upon the passage of a time limit of five years, which shall begin to run from the date on which the violation was committed and, if any sanction has been imposed, from the date on which the decision imposing it was notified to the violator.

The time limit for the limitation period is interrupted by:

a)The notification to the violator of the order of instruction of the procedure to determine their liability.

b)The notification of the decision determining the liability of the violator and the sanction imposed on them.

c)The express or tacit acknowledgment, by the person identified as violator, that they committed the violation.

d)By any written act or written filing by the person identified as violator within the administrative file, or any other type of action performed by a public official or professional vested with public faith.

e)The violator waives the completed limitation period in their favor when, after the time limit thereof has elapsed, they agree to pay or pay, in whole or in part, the fine imposed if this were the sanction or agree to comply with the imposed sanction if it were of another of the types regulated in this Code, its regulations, other health laws, applicable rules and provisions.

Whoever contravenes the provisions established in this Code, its regulations, other laws that promote health, or applicable norms or provisions commits a violation against the promotion of health. Whoever commits any of these violations shall be sanctioned with the corresponding fine in accordance with the values indicated in Article 219, subparagraph b) of this law.

The following actions constitute special cases of violations against health promotion:

1.Selling alcoholic beverages, tobacco in any of its forms or commercial formulations with toxic substances, to minors.

2.Allowing the consumption of alcoholic beverages or tobacco in any of its forms, by minors, in any establishment, closed or open, or on public thoroughfares.

3.Omitting on the container or on the product label or in each advertisement for alcoholic beverages, the indication, in legible type, that excess consumption is harmful to health.

4.Omitting on the product pack or in each advertisement for cigarettes and other tobacco-derived products, the indication, in legible type and in Spanish, that its consumption is harmful to health.

5.Smoking in government establishments, public or private collective transportation, pre-primary, primary and secondary-level educational centers, and at gas stations.

6.Smoking in public and private medical care centers and places for the preparation and consumption of food, except when done in areas designated for that purpose.

7.Smoking in those places where it is clearly indicated that smoking is prohibited.

8.Contracting and disseminating advertising spaces containing messages harmful to the individual or collective health of the population.

Whoever commits these and the violations set forth in Article 51 of this Code shall be sanctioned with the corresponding fine in accordance with the values indicated in Article 219, subsection b) of the Health Code. The violation of the prohibition on sale to minors under eighteen years of age shall give rise to the imposition of a fine of FIVE THOUSAND QUETZALES ( Q. 5, 000.00), in the case of commercial establishments, and of ONE HUNDRED THOUSAND QUETZALES ( Q. 100,000.00) when the sale is promoted or carried out directly by manufacturers, importers and distributors, through promotions or distributions to the public. The same sanction shall apply when such distribution, in any of its forms, is carried out by other agents for propaganda or promotional purposes. The Ministry of Public Health and Social Assistance shall ensure compliance with what is provided in this provision.

In the above cases, recidivism shall cause double the fine imposed the first time to be applied, and if the law continues to be infringed, action shall proceed in accordance with Article 229 of the Health Code.

Whoever contravenes the mandatory or prohibitory provisions established in this Code, its regulations, other laws that prevent or protect health, and applicable norms and provisions commits a violation against the prevention or protection of health.

Whoever commits any of these violations shall be sanctioned with the corresponding fine in accordance with the values indicated in Article 219 literal b of this Code.

The following actions constitute special cases of violations against health prevention:

1.To omit, by the responsible public officials and employees of public or private health institutions and establishments, the notification of preventable, transmissible diseases including diseases related to public and veterinary health, of which they have knowledge.

2.To omit, by the competent health authority, to inform the establishment in which a person works, when it is detected that such person suffers from a venereal disease or any other sexually transmitted disease.

3.To omit, by the person in charge of establishments whose activity increases the risk of contagion of venereal diseases or any other sexually transmitted disease, the entry in the register of the persons who work therein, before the competent health authority.

4.To omit, by the competent health authority, the periodic supervision of the establishments in which, due to their activity, the risk of contagion of venereal disease or any sexually transmitted disease is greater.

5.To fail to comply, by the health personnel of the different public or private institutions who handle organs, organic fluids and blood derivatives, and by those who perform acupuncture, piercings and tattoos or any other procedure that implies the possibility of contagion of the acquired immunodeficiency virus, with the universally accepted biosafety standards and those established by the Ministry of Health.

6.To perform tests for the clinical diagnosis of the acquired immunodeficiency virus, outside the exceptional cases regulated in the law on the matter.

7.To omit, by the professionals involved in the management of acquired immunodeficiency disease, to inform the Ministry of Health of infection cases, for purposes of their entry in the register, in accordance with the law on the matter.

8.To fail to comply, by agro-industrial companies or companies of any other nature, with access to drinking water services for their workers and economic dependents.

9.To fell trees within the twenty-five meters adjacent to the banks of rivers, streams, lakes, lagoons, springs and water sources.

10.To authorize or permit the felling of trees within the twenty-five meters adjacent to the banks of rivers, streams, lakes, lagoons, springs and water sources.

11.For individuals or public or private legal entities to omit the purification of water intended for the supply of populations.

12.To put water supply projects into operation without having the certificate issued by the Ministry of Health, which records its potability for human consumption.

13.For individuals or public or private legal entities to connect drinking water services without observing the corresponding regulatory standards.

14.To suspend water service to populations, except in cases of force majeure or when delinquency in payment or fraudulent consumption by the user is duly proven.

15.To use contaminated water for the cultivation of vegetables or the preparation of food products for human consumption.

16.To prevent the public officials or employees of the Ministry of Health from inspecting drinking water supplies and provisions at any hour of the day.

17.To discharge contaminants of industrial origin or to use untreated wastewater without the favorable opinion of the competent authority, in rivers, streams, lakes, lagoons, springs or water sources.

18.To discharge untreated wastewater into rivers, lakes, streams and lagoons or water springs, whether surface or underground.

19.To dispose of excreta in public places, communal lands or vacant lots,

20.To build private systems for the disposal of excreta without complying with the provisions established on the matter by the Ministry of Health.

21.To exploit thermal waters, to build, install or put into operation swimming pools and public baths, without having the opinion and approval of the competent authorities.

22.To fail to comply with the health standards established for the construction of works for the elimination and disposal of excreta and sewage.

23.To issue construction, repair or modification licenses for public or private works intended for the elimination or disposal of excreta without having the favorable technical opinion of the Ministry of Health.

24.To omit, by real property owners, to connect the sanitary facilities thereof to the public sewer system, in populations where a sanitary sewer system exists.

25.To fail to comply, by real property owners in those populations where there is no sanitary sewer system, with the standards established by the Ministry of Health for the use of private systems for the disposal of excreta.

26.To use places for the disposal of solid waste without requesting a prior opinion from the Ministry of Health and the National Environment Commission.

27.For the responsible public official or employee to fail to comply with issuing an opinion within the legal time limits, when such opinion is requested for the exploitation of thermal waters, the construction of swimming pools or public baths, or the disposal of solid waste.

28.To build private systems for the disposal of excreta without complying with the standards established on the matter by the Ministry of Health.

29.To throw or accumulate solid waste of any type in unauthorized places, around inhabited areas or in sites where damage to the health of the population, to public adornment or to the landscape may be caused; to use inadequate means for its transportation and storage; or to proceed to its use, treatment or final disposal, without the corresponding municipal authorization.

30.For owners or possessors of premises, sites or open spaces in urban and rural sectors to keep solid waste, weeds and stagnant water.

31.To store or eliminate organic materials or toxic, radioactive substances or substances capable of disseminating pathogenic elements and waste produced in normal hospital activities, public or private, in a manner and in places different from those established in the respective regulation.

32.For industrial and commercial companies to store, transport, transform or dispose of any type of residues or solid waste, without having for such purposes adequate systems, established in the respective regulation.

33.To omit, by public and private hospitals, the installation of incinerators for the handling and final disposal of hospital waste.

34.To create sources of environmental contamination through non-observance of the standards governing the activities of collection, transportation, deposit or elimination of solid waste from agricultural and fishing activities.

35.To permanently install stables for equine, bovine, porcine livestock and sheds in urban areas.

36.To temporarily install stables for equine, bovine, porcine livestock and sheds without having authorization from the competent authority.

37.To put into operation food processing plants of all kinds for human consumption, without having the favorable opinion of the competent authority.

38.To oppose inspections related to the processing, distribution, marketing and, in general, the quality and safety control of food.

39.To market a food product under a trade name without having the health authorization, register or certification issued by the Ministry of Health.

40.To fail to comply with health standards or regulations to the detriment of the quality or safety of a food product registered under a trade name.

41.To identify the content, composition and specific health indications of food products in a language other than Spanish.

42.To modify the characteristics of the product in relation to the specifications established in the reference health register or mandatory registration of food, medicines, cosmetics, personal and household hygiene products, household pesticides, narcotics, psychotropics, phyto- and zootherapeutic products, homeopathic or similar products, healing material or dental materials and equipment.

43.To advertise or label food with different information or information that may mislead as to the nature, ingredients, quality, content, property or origin thereof.

44.To use containers or packaging that negatively alter the quality of food products.

45.To modify or relocate establishments for the preparation or sale of food without the corresponding authorization.

46.To omit the permanent accreditation of the health status of persons working in food establishments or outlets.

47.To fail to comply with or to permit non-observance of the health standards or regulations or technical specifications established for the operation of a food establishment.

48.To prevent the health inspection of establishments and temporary storage places, the taking of product samples and the health control thereof.

49.To distribute or permit the distribution of donated food whose safety and quality are not guaranteed.

50.To import toxic, radioactive or hard-to-degrade waste.

51.To fail to comply with the provisions issued by the Ministry of Energy and Mines on direct and indirect ionizing radiation.

52.To omit, in establishments using radioactive products, compliance with precautionary, protection or periodic health monitoring measures for personnel exposed to radiation.

53.To import and market radioactive articles, electronic devices or goods for trade or industry that emit radiation in non-permitted doses.

54.To omit information to the user on the risks to health posed by the use of radioactive articles and electronic devices.

55.To market or distribute radioactive articles or electronic devices prohibited in the country of origin.

56.To import, export, manufacture, store, transport, market, supply or use for medical, research, industrial, commercial or defense purposes, radioactive sources or equipment generating ionizing and non-ionizing radiation, without authorization from the Ministry of Energy and Mines, or where applicable from the Ministry of Health.

57.To expose persons to ionizing and non-ionizing radiation in doses not internationally accepted, or not approved by the Ministry of Energy and Mines.

58.To market or distribute radioactive articles or electronic devices without indications in Spanish on the type of radiation they emit and warnings as to their hazardousness.

Whoever commits any of these violations shall be sanctioned with the corresponding fine in accordance with the amounts indicated in Article 219, subparagraph b), of this Code.

Whoever contravenes the mandatory or prohibitive provisions established in this Code, its regulations, other health laws, applicable norms and provisions, which regulate the recovery and rehabilitation of health, commits a violation against the recovery and rehabilitation of health. Whoever commits any of these violations shall be sanctioned with the corresponding fine in accordance with the values indicated in Article 219 literal b) of this Code.

The following actions constitute special cases of violations against health recovery and rehabilitation:

1.Putting private health services into operation without holding the certificate of quality accreditation issued by the Ministry of Health.

2.Advertising or commercially promoting food, medicines, cosmetics, personal or household hygiene products, household pesticides, phytotherapeutic, homeopathic or similar products, medical-surgical, dental equipment or laboratory reagents, with incomplete, inaccurate, outdated or differing information on their nature, ingredients, quality, content, property or origin, which prevents the user from exercising their judgment and taking the action most in line with their interests.

3.Marketing food, medicines, cosmetics, personal or household hygiene products, household pesticides, narcotics, psychotropics, phytotherapeutic, homeopathic or similar products, medical-surgical, dental equipment or laboratory reagents for diagnostic use, with characteristics different from the standard recorded in the reference sanitary registration or mandatory registration, or failing to comply in their manufacture with quality and safety standards.

4.Marketing cosmetics, personal or household hygiene products, phytotherapeutic, homeopathic or similar products, medical-surgical material, materials, products or dental equipment without having been registered with the Ministry of Health.

5.Marketing food with a trade name, medicines or pharmaceutical products, narcotics, psychotropics or household pesticides without holding the reference sanitary registration.

6.Unjustifiably delaying or obstructing the registration, reference sanitary registration or issuance of the sanitary certification for food, medicines, cosmetics, personal or household hygiene products, household pesticides, narcotics, psychotropics, phytotherapeutic, homeopathic or similar products, medical-surgical material, materials, products or dental equipment or laboratory reagents.

7.Packaging or marketing medicines without observing the standards and regulations issued by the Ministry of Health, relating to the supply, prescription, promotion, presentation, labeling, package insert and appropriate use thereof.

8.Giving or offering economic or material benefits to the owners or employees of medicine distribution or sale centers, so that they influence the consumer's disposition toward the substitution of medicines prescribed by prescription with others.

9.For the owners or employees of medicine distribution or sale centers to receive economic or material benefits in exchange for influencing the consumer's disposition toward the substitution of medicines prescribed by prescription with others.

10.For the university-trained professional of the field and other responsible persons contemplated in the respective regulation to omit supervision of a pharmaceutical establishment while it is open to the public or carries out its operations.

11.Putting pharmaceutical establishments into operation without prior authorization from the Ministry of Health.

12.Installing or putting public or private health laboratories into operation without the corresponding authorization.

13.Transplanting organs or tissues between living persons without the prior consent of the donor and recipient in express written form.

14.Performing transplants of organs and tissues from human beings or cadavers without a favorable opinion from at least three physicians and surgeons specializing in the field, recognized as such by the College of Physicians and Surgeons.

15.Putting organ and tissue banks into operation without the corresponding authorization from the Ministry of Health.

16.Failing to comply with the requirements established by the Ministry of Health for the operation of organ and tissue banks.

17.Using cadavers of known persons for transplant, research or teaching purposes without the prior consent given during life and not revoked, or that of relatives within the degrees established by law, in the absence of consent given during life.

18.Using organs, tissues, instruments, equipment, substances, products or devices that may be harmful to the health of the donor or recipient.

19.For transfusion medicine services and blood banks to select blood donors without observing the requirements, standards and techniques established in the respective regulation.

20.Selling or buying blood and its derivatives for therapeutic or scientific research purposes.

21.Supplying blood or its derivatives for use outside the country, except for the exceptions established in the specific law regulating the matter.

22.Putting transfusion medicine services and blood banks into operation without the corresponding authorization from the Ministry of Health.

23.Failing to comply with the requirements established by the Ministry of Health for the operation of transfusion medicine services and blood banks.

24.Importing, manufacturing, marketing or supplying equipment, instruments, prostheses, orthoses, aids and other supplies for health care without the corresponding authorization.

25.Importing, marketing or supplying, including in the form of donation, equipment, instruments, prostheses, orthoses, aids and other supplies for health care that are prohibited in the country of origin, in poor condition, with operating defects or without indication of their nature, characteristics and instructions in Spanish for their correct use and warnings about the risks they may cause.

Whoever commits any of these violations shall be sanctioned with the corresponding fine in accordance with the amounts indicated in Article 219 literal b) of this law.

Whoever commits, among others, any of the following violations shall be sanctioned, in addition to the corresponding fine, with temporary closure of the establishment for a period of five days to six months:

1.Failing to comply with the sanitary standards established for the operation of establishments engaged in sexual commerce.

2.Keeping in operation health laboratories that are not under the permanent responsibility, direction and supervision of a specialist professional in the subject matter.

3.Failing to comply with the requirements or technical exigencies established by the Ministry of Health for the operation of health laboratories.

4.Failing to comply with the requirements established by the Ministry of Health for the operation of organ and tissue banks.

5.Failing to comply with the requirements established by the Ministry of Health for the operation of Transfusion Medicine Services and blood banks.

6.Establishing, by means of sanitary inspection, the presence of an imminent danger to the health of the users or workers of the establishment due to force majeure or fortuitous event, or due to non-compliance with the sanitary norms or regulations, or technical specifications established for the opening or operation of a food establishment.

7.Recidivism on more than two occasions in the breach or violation of the prohibitory norms and provisions referred to in numerals 1, 2, 3 and 8 of Article 224 of this Code shall cause the offender to be subjected, in addition to the established sanctions, to temporary closure of the establishment in which the violation was committed. Upon completion of the term of the closure or suspension, the reopening shall be carried out under authorization of the Ministry of Public Health and Social Assistance.

Whoever commits, among others, any of the following violations shall be sanctioned, in addition to the corresponding fine, with closure of the establishment:

1.Permitting a person infected with venereal disease or other sexually transmitted disease to engage in sexual commerce.

2.Implementing a water supply project without having the authorization and the corresponding certificate issued by the Ministry of Health.

3.Putting into operation processing plants or other type of establishment for foods of any kind for human consumption, without having the health license issued by the competent authority.

4.Installing pharmaceutical establishments without the authorization of the Ministry of Health.

5.Installing or putting into operation public or private health laboratories without the corresponding authorization.

6.Putting into operation public or private health services without having the certificate of quality accreditation issued by the Ministry of Health.

7.Putting into operation public or private health care establishments without having prior authorization from the Ministry of Health.

8.Putting into operation organ and tissue banks without having the corresponding authorization from the Ministry of Health.

9.Putting into operation transfusion medicine services and blood banks without having the corresponding authorization from the Ministry of Health.

10.Keeping in operation organ and tissue banks that represent a serious danger to the health of donors or recipients.

11.Keeping in operation transfusion medicine services and blood banks that represent a serious danger to the health of donors or recipients.

12.Selling or commercializing any human organ or tissue.

13.Acquiring blood and its derivatives for consideration.

14.Exposing persons, in establishments that use radioactive products, to ionizing and non-ionizing radiation, in doses not internationally accepted or established at the national level by the competent authority of the Ministry of Energy and Mines.

15.Omitting, in establishments that use radioactive products, compliance with precautionary, protection or periodic health monitoring measures for personnel exposed to radiation.

Any person who reoffends in the commission of the following violations shall be sanctioned, in addition to the corresponding fine, with the cancellation of the reference sanitary register or of the mandatory registration:

1.Failing to comply with sanitary norms or regulations to the detriment of the quality or safety of a food product registered under a trade name.

2.Identifying the content, composition and specific sanitary indications of food products in a language other than Spanish.

3.Marketing foods, medicines, cosmetics, personal or household hygiene products, household-use pesticides, narcotics, psychotropics, phytotherapeutic, homeopathic or similar products, medical-surgical equipment, dental equipment or laboratory reagents for diagnostic use, with characteristics different from the standard recorded in the reference sanitary register or mandatory registration, or failing to comply in their manufacture with quality and safety standards,

4.Advertising or labeling foods with different information or information that may mislead as to the nature, ingredients, quality, content, property or origin thereof.

5.Using containers or packaging that negatively alter the quality of food products.

In addition to the corresponding fine, forfeiture of objects deriving from, among others, any of the following violations shall be applied:

1.Using raw materials, containers or packaging, instruments, materials and objects that alter the quality or safety of food products.

2.Distributing foods of national production or imported foods that do not meet quality or safety requirements, or when their content, composition and specific health indications are not described in Spanish.

3.Distributing or permitting the distribution of donated foods whose safety and quality are not guaranteed.

4.Packaging or marketing medications without observing the regulatory standards issued by the Ministry of Health, relating to supply, prescription, promotion, presentation, labeling, package leaflet and appropriate use thereof.

5.Marketing cosmetics, personal or household hygiene products, phytotherapeutic, homeopathic or similar products, medical-surgical material, materials, products or dental equipment without having been entered in the Ministry of Health.

6.Marketing foods, medicine or pharmaceutical product, narcotics, psychotropics, household pesticides or laboratory reagents, without having the reference registration.

7.Using organs, tissues, instruments, equipment, substances, products or devices that may be harmful to the health of the donor or recipient.

8.Importing, exporting, manufacturing, storing, transporting, marketing, supplying or using for medical, research, industrial, commercial or defense purposes, radioactive sources or equipment generating ionizing or non-ionizing radiation, without authorization from the Ministry of Energy and Mines and, when applicable, from the Ministry of Health.

9.Importing and marketing radioactive articles, electronic devices or goods for trade or industry, that emit radiation in doses not permitted.

10.Marketing or distributing radioactive articles or electronic devices prohibited in the country of origin.

Whoever commits any of the following violations shall be sanctioned with prohibition from engaging in any activity or occupation for a time limit of one to six months:

1.Working in establishments for the manufacture, preparation or sale of food, without complying with the personal health requirements that guarantee the safety of the food.

2.Repealed.

3.Repealed.

The provisions of this chapter shall be applicable to violations, sanctions and crimes in health matters and shall have no retroactive effect, except where they favor the offender.

Notwithstanding the foregoing, in the case of falsified medicines, falsified pharmaceutical products, medical devices and falsified medical surgical material, adulterated medicine and clandestine establishments or laboratories, what is established in Article 240 Ter of the Penal Code, Decree Number 17-73; Code of Criminal Procedure, Decree Number 51-92; Law Against Organized Crime, Decree Number 21-2006; and Law of Extinction of Domain, Decree Number 55-2010 of the Congress of the Republic of Guatemala, shall apply in pertinent part. Criminal conduct in this matter shall be considered permanent as long as such medicines, products, devices or materials are in use or circulation, or their harmful effects subsist or continue.

The application of the sanctions established in this Code, its regulations, other health laws, applicable norms and provisions corresponds to the Ministry of Health, in accordance with the jurisdiction assigned in the respective regulation to the bodies comprising it, except in cases that constitute a crime. In the administrative proceeding conducted to determine the commission of a sanitary violation, the competent authority must observe the principles of ex officio action, celerity, impartiality and specialty of the proceedings.

Public action is granted to report before the competent authorities of the Ministry of Health the commission of acts that may constitute violations against health, determined in this Code, its regulations, other health laws, applicable norms and provisions. Documented record shall be made of the facts that may constitute violations and the instruction of the corresponding procedure shall be ordered within a time limit not exceeding three days.

Every procedure shall be initiated by a public official or employee duly authorized by the Ministry of Health. This status shall be accredited before the alleged offender. The latter, their representative, employees or dependents who are present, may intervene and request that what they deem pertinent be recorded.

In case of refusal of any act of inspection or appearance, a record shall be drawn up stating such fact. The records signed by public officials and public employees in the exercise of their offices constitute full evidence unless the contrary is proven, and shall be presented to the competent authority within the twenty-four hours following the conclusion of their action.

For the imposition of sanctions for the commission of violations against health, a hearing shall be granted to the alleged offender for a non-extendable time limit of five days. If, upon responding to the hearing, the opening to evidence is requested, it shall be granted for a peremptory time limit of five days, which shall begin to run from the date of the request, without need for any decision or notification. Upon expiration of the time limit for responding to the hearing or upon elapse of the evidence period, the competent administrative authority shall decide without further proceedings within the following three days and shall proceed to notify the decision, no later than within the two subsequent days.

Non-compliance by competent public officials and employees with the time limits established in this chapter shall be sanctioned in accordance with the disciplinary regime established in the Civil Service Law, without prejudice to any criminal or civil liability they may incur.

The written warning referred to in Article 219 of this law shall be issued to one who has committed for the first time a violation of the provisions of this Code, its regulations, other health laws, current rules and provisions, and if it is established that it has not had effect within the time limit to be fixed, the applicable sanctions shall be imposed. The written warning shall not be necessary in cases in which the violation committed constitutes an imminent danger to the life, health and safety of persons.

When the sanction decision has become final, procedure shall be as follows:

1.If the sanction consists of the imposition of a fine, it shall be paid within the five following days, in the fiscal collection offices, with specific charge to the Ministry of Health and shall be allocated exclusively to increasing health prevention programs. In case of non-compliance the file shall be referred to the Office of the Attorney General of the Nation, for purposes of collection through economic-coercive proceedings, the following documents constituting an enforcement title:

a)Certification of the decision containing the fine imposed.

b)Certification of the document in which the acknowledgment of the debt for the fine is recorded, made by the offender or his legal representative before a competent public official or employee.

c)Notarial record or transcript of the public instrument drawn up by a notary, in which the acknowledgment of the debt for the fine is recorded, made by the offender or his legal representative.

d)Any other document which by legal provision has enforcement force.

2.If the sanction consists of temporary closure of the establishment, upon expiry of the time limit set in the decision and at the request of the offender, its opening and operation shall be authorized, after verification that the violations that gave rise to the imposition of this sanction have ceased.

3.If the sanction consists of closure or definitive shutdown of the establishment, at the request and expense of the offender, the delivery and receipt of the property, furniture, furnishings and equipment incorporated into the establishment shall be authorized, a record of which shall be made and the archiving of the file shall be ordered.

If the sanction consists of cancellation of the health license, the offender shall be required to surrender it and it shall be referred to the department that issued it to make the corresponding annotation. In case of refusal a report shall be referred so that it proceeds in the same manner.

4.If the sanction consists of confiscation of objects and they are of lawful commerce, they may be donated to public or private charitable centers, or sold at public auction, provided that the product meets the quality and safety requirements. The funds obtained shall be deposited in the fiscal collection offices with specific charge to the department of the Ministry of Health that generated them, which shall allocate them exclusively to increasing the training, instruction and updating programs for the human resource working in the hospital network.

If they are illicit property or products that do not meet the quality and safety requirements, they shall be placed at the disposal of the peace judge of the locality to proceed in accordance with the law.

5.Repealed.

The form of administrative acts and the exercise of the right of petition and defense of persons subject to administration are governed by the provisions of the Contentious Administrative Law.

Falsification of medicines and pharmaceutical products, adulteration of medicines, falsification of medical devices and medical-surgical material and clandestine establishments or laboratories.

The production, fabrication, manufacturing, conditioning, packing, labeling, commercialization, distribution, storage, transportation, sale, import, export, smuggling or making available to the public by any means, including computer or electronic means, of falsified medicines, falsified pharmaceutical products, adulterated medicines, falsified medical devices and medical-surgical material, as well as clandestine establishments or laboratories, shall be punished in accordance with the provisions of the Penal Code, Decree Number 17-73; Code of Criminal Procedure, Decree Number 51-92; Law Against Organized Crime, Decree Number 21-2006; and Law of Extinction of Domain, Decree Number 55-2010 of the Congress of the Republic of Guatemala.

Added by Article 7 of Decree of the Congress Number 28-2011 of 17-12-2011.

In the event that the competent authority of the Ministry of Public Health and Social Assistance identifies that in any of the establishments that hold a sanitary license for their operation, falsified medicines, falsified pharmaceutical products, adulterated medicines, medical devices and falsified medical-surgical material are produced, manufactured, prepared, conditioned, packed, labeled, stored, distributed, marketed, sold or made available to the public by any means, including electronic means, it shall proceed as follows:

a)It shall suspend for an indefinite period the sanitary license, import or marketing permits for pharmaceutical or related products.

b)It shall file the corresponding complaint before the Public Prosecutor's Office, submitting the respective analysis of the adulterated or falsified product; the Public Prosecutor's Office must immediately request the advance of evidence from the competent judge, securing the sample quantity as evidence of the falsified medicines, falsified pharmaceutical products, adulterated medicines, medical devices and falsified medical-surgical material, and the destruction of the falsified medicines, falsified pharmaceutical products, adulterated medicines, medical devices and falsified medical-surgical material, in accordance with the procedure established for their destruction in the respective regulation. It shall proceed in the same manner with the raw material, equipment and/or instruments and machinery, containers, packaging, packing, labels, printed or advertising material and any other means that has been used in such products.

In the case of a search carried out in accordance with the Code of Criminal Procedure, Decree Number 51-92 of the Congress of the Republic of Guatemala, any person found at the scene of the events who is suspected of having committed any of the unlawful acts contained in this Law shall be placed at the disposal of the authorities.

c)It shall inform the holder of the right relating to the trademark or trademarks or its licensee or the holder of the register or the sanitary license whose rights may be being harmed or infringed through the falsified products, so that it may adopt the applicable measures.

The Public Prosecutor's Office is relieved from constituting a guarantee, furnishing bond or security of any nature, when it requests such measures.

The interim protective measures ordered by the competent tribunal and the preventive measures adopted by the Ministry of Public Health and Social Assistance shall remain in force until the competent judge finally decides on the matter.