Nghị định 45/2005/ND-CP

DECREE

OF THE GOVERMENT NO.45/2005/ND-CP DATED APRIL 06, 2005 STIPULATING ON ADMINISTRATIVE SANCTION IN THE SECTOR OF HEALTH

THE GOVERNMENT

Pursuant to the December 25, 2001 Law on Organization of the Government;

Pursuant to the Law on Protection of the People’s Health dated June 30, 1989;

Pursuant to the Ordinance on Sanction of Administrative violations dated July 02, 2002;

Pursuant to the Ordinance on Ordinance on the Prevention and Control of Human Immune-Deficiency Virus and Acquired Immune-Deficiency Syndrome (HIV/AIDS) dated May 31, 1995;

Pursuant to the Ordinance on Private Medical and Pharmaceutical Practice dated February 25, 2003;

Pursuant to the Ordinance on Food Hygiene and Safety dated July 26, 2003;

At the proposal of the Minister of Health,

DECREES:

Chapter 1:

GENERAL PROVISIONS

Article 1. Scope of governing

1. This Decree stipulates on handling of administrative violations in the health sector.

2. Administrative violations in the health sector are the acts implemented intentionally or unintentionally by organizations and individuals violating the provisions of law on state management in the health sector which are not crime and according to the provisions of law, they shall be sanctioned administratively.

3. Administrative violations in the field of state management on health stipulated in this Decree include:

a) Violation of regulations on hygiene and prevention and control of epidemic;

b) Violation of regulations on food hygiene and safety;

c) Violation of regulations on vaccines – medical biological products;

d) Violating the regulations on medical examination and treatment including medical examination and treatment by traditional medicine;

e) Violation of regulations on drug of prevention and treatment of human diseases, including traditional medicines and cosmetics directly affecting human health;

f) Violation of regulations on medical equipment.

Article 2. Subjects of application

1. This Decree applies to Vietnamese organizations and individuals having administrative violations in the health sector.

2. This Decree also applies to foreign organizations or individuals operating or residing in Vietnam having administrative violations in the health sector. Where the international agreements which Vietnam is a party otherwise provided for, the provisions of such international agreements shall be applied.

Article 3. Principle of handling

1. Principles for handling of administrative violations in the health sector are applied under the provisions in Article 3 of the Ordinance on Handling of Administrative Violations.

2. The handling of administrative violations in the health sector is implemented by the competent person complying with the provisions of Article 45, 46 and Article 47 of this Decree.

3. The handling of violations to the persons who are competent to handle administrative violations in the health sector must comply with the provisions of Article 121 of the Ordinance on Handling of Administrative Violations.

Article 4. Extenuating, aggravating circumstances

The extenuating circumstances, aggravating circumstances are applied in administrative sanction for the violations provided for in Chapter II of this Decree shall comply with the provisions of Article 8 and Article 9 of the Ordinance Handling of Administrative Violations.

Article 5. Prescription of sanction

1. The prescription for sanctioning administrative violation in the health sector is 01 year from the date that administrative violation is made.

2. For administrative violations in the health sector related to export, import, production of counterfeit goods, the statute of prescription for sanctioning administrative violations shall be 02 years from the date that administrative violations are made.

Article 6. The term considered as not yet sanctioned for administrative violations

If the individuals and organizations that have been sanctioned for administrative violations in the health sector for more than one year from the date of completely serving the decision to sanction or the expiry date of the decision to sanction without recidivism is considered as not yet sanctioned for administrative violations in the health sector.

Article 7. Forms of handling

1. The application of forms of handling of administrative violations and remedies for administrative violations based on specific provisions on sanctions to be applied for each administrative violation.

2. For each administrative violation, the violating individuals and organizations must submit one of the following forms of administrative sanctions: a warning or a fine.

a) Application of warning form for minor administrative violations, for the first time, with extenuating circumstances or for any administrative violations implemented by the minors aged between full 14 years old and under 16 years old.

b) Application of fine form:

The fine levels are based on the nature and seriousness of violations, the person of violator and the extenuating circumstances and aggravating circumstances in the fine bracket specified for each such violation.

When sanctioning by the fine form, the specific fine level for an administrative violation is the average level of the fine bracket prescribed for such act; if the violation has the extenuating circumstances, the fine level may be reduced lower but not exceeded lowest level of the fine bracket; if the violation has aggravating circumstances, the fine level can be higher than but not exceeded the maximum level of the fine bracket.

3. Depending on the nature and seriousness of violations, individuals and organizations committing administrative violations in the field of state management on health may also be subject to additional sanctions as follows:

a) Stripping the right to use licenses or practice certificates, certificates of sufficient conditions to practice from 6 months to 12 months or stripping the right to use for indefinite duration;

b) Confiscating material evidences and means used for administrative violations.

4. Apart from the above forms of sanctions, the individuals and organizations committing administrative violations may also be applied to one or more remedies as follows:

a) Forced to restore the initial state changed due to administrative violations;

b) Forced to apply the measures to overcome the environmental pollution, spread of epidemic disease due to administrative violations;

c) Forced to bring out of the territory of Vietnam or re-export goods, products, or means;

d) Recycled or forced to destroy products causing harmful to human health;

e) Other remedies specified in this Decree.

5. Form of administrative sanction can be applied independently or together with additional sanctions or remedies. The application of remedies can not be applied independently but only used together with the main sanction, unless specified in Article 69 of the Ordinance on Handling of Administrative Violations.

6. For the state organizations that are sanctioned, they must execute the decision to sanction. After executing the decision to sanction, the sanctioned organizations identify individuals with faults who have caused administrative violations while on duty for disciplinary action and claim damages for which the organization has done as prescribed by law regulations.

Chapter 2:

ACTS OF ADMINISTRATIVE VIOLATIONS IN THE SECTOR OF HEALTH, FORMS, AND LEVELS OF SANCTION

ITEM 1: ACTS OF ADMINISTRATIVE VIOLATIONS ON HYGIENE, PREVENTION AND CONTROL OF EPIDEMIC AND OF HIV/AIDS, FORMS, AND LEVELS OF SANCTION

Article 8. Violation of regulations on water hygiene and air

1. A warning or fine of between 50,000 VND and 200,000 VND shall be imposed for acts of discharging litter, waste, human and animals waste into water sources used for food and living.

2. A fine of between 5,000,000 and 10,000,000 VND shall be imposed for one of the following acts:

a) Failing to comply with provisions on testing to monitor water quality of the organizations and individuals who provide water for food, drinking, and daily living.

b) Supply of water for food, drinking, and daily living without ensuring the provisions on water hygiene and water source protection.

3. A fine of between 10,000,000 and 15,000,000 VND shall be imposed for one of the following acts:

a) To let waste, sewage cause contamination of water sources used for food, drinking, daily living of the people;

b) To discharge toxic fumes, toxic gases causing harmful to the health of the people around.
4. Remedies:

a) Forced to implement the remedies prescribed in point b clause 4 Article 7of this Decree for the violations specified in clause 1, point b clause 2 and clause 3 of this Article;

b) Forced to comply with the technical procedures according to provisions for the violations specified in point a clause 2 of this Article.

Article 9. Violation of regulations on the prevention and control of infectious disease causing epidemic

1. A warning or a fine between VND 50,000 to 200,000 shall be imposed for the act of failing to implement vaccination for disease prevention or incomplete vaccination under the program of expanded vaccination to human upon request by the health agency requirements.

2. A fine of between 200,000 and 500,000 VND shall be imposed for one of the following acts:

a) Failing to declare under regulations when the person or members of family, agencies, organizations, units getting epidemic-causing infectious disease;

b) Declaring untruthfully or refusing to declare according to regulations when the person or members of family, agencies, organizations and units getting epidemic-causing infectious disease or hiding the infectious disease current state causing epidemic of the person, family, agencies, organizations and units;

c) Failing to perform or performing insufficiently measures for prevention and combat of infections intermediary vectors as required by health agencies.

3. A fine of between 500,000 and 1,000,000 VND shall be imposed for one of the following acts:

a) Defecating, discharging improper provisions of materials and items likely to spread epidemic-causing infectious disease;

b) Failing to perform the measures of prophylaxis treatment (chemotherapy) as prescribed;

c) Failing to take measures for disinfection, disinfection of waste, clothing, furniture, environment, means of transportation of patients as prescribed;

d) Failing to isolate when getting the infectious diseases causing dangerous epidemic disease in accordance with provisions;

đ) Allowing or creating conditions for patients, pathogen carriers, and persons who are suspected to get epidemic-causing infectious disease to do something leading to the spread of infectious diseases;

e) Transmitting the disease to others;

g) Refusing or failing to abide by the administrative command to participate in the control of epidemic as prescribed;

h) Failing to dispose corpses getting the most dangerous infectious disease as prescribed.

i) Failing to perform or performing insufficiently the provisions against the spread of epidemic-causing infectious disease for others as the person, family having people suffering from these diseases.

4. A fine of between 1,000,000 and 2,000,000 VND shall be imposed for one of the following acts:

a) Obstructing or failing to implement measures for prevention and control of emergency epidemic of the competent state agencies;

b) Informing epidemic-causing infectious diseases not in compliance with competence according to regulations.

5. Additional sanctions: individuals, organizations committing violations in clause 3 and clause 4 of this Article may also be applied one of the forms of additional sanctions as stipulated in clause 3 Article 7 of this Decree.

6. Remedies: individuals or organizations committing violations in clause 3 of this Article may be subject to the remedies as prescribed in point b clause 4 Article 7 of this Decree.

Article 10. Violation of regulations on border medical quarantine

1. A fine of between 1,000,000 and 2,000,000 VND shall be imposed for one of the following acts:

a) Failing to declare in accordance provisions on medical quarantine with the quarantine agencies before the exit, entry, export and import for owners of means of transportation, goods owners or representatives of the goods owners;

b) Using certificates of rat destruction, rat destruction waiver not in compliance with regulations;

c) Using food, trading food serving for guests at the border gates not meeting standards of food hygiene and safety.

2. A fine of between 2,000,000 and 5,000,000 VND shall be imposed for one of the following acts:

a) Refusing to quarantine medical or failing to implement the requirements of medical quarantine officers for the objects required to quarantine;

b) Failing to inform signal asking for medical quarantine in accordance with provisions for owners of means of transportation entering by waterways;

c) Failing to take measures against rats on the means of sea transportation when they anchor at the ports.

3. A fine of between 5,000,000 and 10,000,000 VND shall be imposed for one of the following acts:

a) Amending or forging certificate of medical quarantine;

b) Transporting corpses, bones, ashes, special products such as biological products, bacteria, tissues, body parts, blood and blood components through the border gates but not yet inspected and granted quarantine certificates by the medical quarantine agency;

c) Exporting and importing waste, old objects, the means used without declaring with the medical quarantine agencies, without quarantine certificates of the medical quarantine agency;

d) Disposing wastes not in compliance with places as prescribed for the means of transportation as entering and exiting;

e) Concealing or removing the current state required to quarantine.

4. A fine of between VND 10,000,000 and 15,000,000 for acts of removing the ballast water not in compliance with provisions of law, disposing waste with pathogens and toxic elements before the medical quarantine agency implements medical treatment.

5. Remedies: forced to implement the remedies as prescribed in point d clause 4 Article 7 of this Decree for violations specified in point đ clause 3 of this Article.

Article 11. Violation of regulations on occupational sanitation

1. A fine of between 500,000 and 1,500,000 VND shall be imposed for one of the following acts:

a) Failing to perform health examination for employees before recruiting or performing health examination but having no record of health;

b) Failing to perform the regulations on occupational health care for women;

c) Failing to compile record of cleaning factory; record of periodic health examination; records of declaring occupational diseases and registering occupational hygiene examination every year or periodically;

d) Failing to arrange health workers, having no technical facilities and equipment for first aid, emergency plans, and rescue for hazardous, dangerous occupations and prone to occupational accidents in accordance with provisions;

đ) Failing to train on occupational hygiene, occupational disease prevention, and first aid on site for employees;

e) Failing to make payment of medical expenses from the first aid till complete treatment for people of occupational accidents or occupational diseases.

2. A fine of between 5,000,000 and 10,000,000 VND shall be imposed for one of the following acts:

a) Failing to ensure occupational hygiene regulations on radiation and electromagnetic fields;

b) Having no measures and equipment for handling toxic product, noxious gases, dust, toxic waste, industrial waste and other harmful elements; failing to ensure the regulations on occupational hygiene, temperature, humidity, light and noise, vibration, dust, toxic gas and other harmful elements;

c) Failing to organize periodical health examination for detection of occupational diseases for the laborers; failing to complete the dossiers and procedures for person who gets occupational diseases to be assessed occupational diseases; failing to organize the treatment, convalesce for laborers suffering from occupational diseases and arrange other works in accordance with their health.

3. Remedies:

a) Forced to perform the remedies as prescribed in point b clause 4 Article 7of this Decree for the violations provided for in point a, b, clause 2 of this Article;

b) Forced to organize the training on occupational hygiene, occupational disease prevention and first aid on site to employees for the violations specified in point đ clause 1 of this Article.

Article 12. Violation of regulations on management of chemicals, insecticides, bactericides for family and medical uses

1. A fine of between 1,000,000 and 3,000,000 VND shall be imposed for one of the following acts:

a) Failing to comply with the provisions on the conditions of manufacturing and trading chemicals, insecticides, bactericides for family and medical uses;

b) Failing to comply with regulations on packaging, storage and transportation of chemicals, insecticides, bactericides for family and medical uses.

2. A fine of between 5,000,000 and 10,000,000 VND shall be imposed for one of the following acts:

a) Producing and trading chemicals, insecticides, bactericides for family and medical uses that the certificate of registration for circulation of these products has expired;

b) Producing and trading of chemicals, insecticides, bactericides for family and medical uses not in compliance with standards as announced;

c) Producing and trading chemicals, insecticides, bactericides for family and medical uses that have not been issued a certificate of registration for circulation in Vietnam;

d) Advertising chemicals, insecticidal, bactericides for family and medical uses without the receipt of registration dossiers for advertisement of the competent health agency or advertising not in compliance with the registered contents or failing to modify the content of advertising at the request of the competent health agency.

3. A fine of between VND 8,000,000 and 12,000,000 shall be imposed for acts of trading chemicals, insecticidal, bactericides for family and medical uses which have expired.

4. A fine of between VND 10,000,000 and 15,000,000 shall be imposed for acts of manufacturing and trading chemicals, insecticidal, bactericides for family and medical uses which were banned to use in Vietnam.

5. Forms of additional sanctions: stripping the right to use certificate of registration for circulation of chemicals, insecticidal, bactericides for family and medical uses from 6 months to 12 months for the violations specified in clause 2 and clause 3 of this Article.

6. Remedies:

a) Forced to apply the remedies prescribed in point d clause 4 Article 7 of this Decree for violations specified in point b clause 1, point b clause 2, clause 3 and clause 4 of this Article;

b) The cost for the application of the remedies specified in clause 6 of this Article shall be paid by the violating establishment.

Article 13. Violation of other provisions on hygiene

1. A fine from 200,000 VND to 800,000 VND shall be imposed for the organizations and individuals violating regulations on hygiene to prevent and combat epidemic disease.

2. A fine of between 500,000 and 1,000,000 VND shall be imposed for one of the following acts:

a) Violation of regulations on environmental hygiene in offices, hospitals, schools, kindergartens and other public places;

b) Tables and chairs in schools with size inconsistent with the stature of students, not enough natural or artificial light in the classroom; not ensuring the area standards per student; not enough drinking water, wash water, sanitary latrines for the students as prescribed.

3. A fine of between 2,000,000 and 5,000,000 shall be imposed for acts of producing and trading all kinds of learning tools and facilities, toys causing harmful to the health of children, students.

4. Forced to apply the remedies as prescribed in point d clause 4 Article 7of this Decree for the violations specified in clause 3 of this Article.

Article 14. Violation of regulations on the prevention and control of HIV/AIDS

1. A fine of between 2,000,000 and 5,000,000 VND shall be imposed for one of the following acts:

a) Disclosing secret on testing and notifying testing results for HIV to the tested person or to others without permission;

b) Violating regulations on keeping secret the names, ages, addresses and photographs of people infected with HIV;

c) Providing information on the mass media for the names, ages, addresses and pictures of the HIV-infected people without the consent of those persons or of their relatives in the case the HIV-infected people who have died, or without capacity for civil acts;

d) Refusing the treatment for the HIV-infected people.

2. A fine of between 5,000,000 and 10,000,000 VND shall be imposed for one of the following acts:

a) Violating regulations on blood transfusion, sterilization, disinfection and other regulations on the professional treatment of HIV infection;

b) Notifying the results of positive HIV tests not in compliance with subjects of notice as prescribed;

c) Based on the results of HIV tests to recruit the laborers or for school admission, unless special cases as prescribed by law;

d) The facilities of production, business fail to provide information on HIV infection prevention for employees;

đ) Notifying results to the HIV tested persons for the facilities that have not been yet accredited to have the qualified laboratories to assert cases of HIV-positive by the Health Ministry;

e) Dismissal of employees or expulsion of pupils and students because of their HIV infection.

3. Remedies: forcing the employer to receive the the HIV-infected laborers to arrange the other works properly according to provisions or forcing the schools to receive the HIV-infected pupils and students for continuing to study at school in case of violation specified in point e clause 2 of this Article.

ITEM 2: ACTS OF ADMINISTRATIVE VIOLATIONS ON FOOD HYGIENE AND SAFETY, FORMS, AND LEVELS OF SANCTION

Article 15. Violation of regulations on food hygiene and safety

1. A fine of between 100,000 and 300,000 VND shall be imposed for one of the following acts:

a) Failing to wear special clothing when directly engaging in production, processing and sale of food or without a certificate of training on food hygiene and safety;

b) Place putting ready-to-eat food has no glass for cover or sanitary package;

c) Failing to use its own equipment to pick up, ladle, and contain all kinds of instant food;

d) Trading instant food without enough clean water for cleaning equipment, hand hygiene of the sellers;

đ) The tools of containing, picking up, ladling, processing food not ensuring hygiene;

e) Failing to perform or performing the cleaning of equipment, tools, selling place of food not complying with regulations of the Ministry of Health;

g) Failing to ensure hygiene standards of safe vegetables according to provisions for the business facilities of safe vegetables.

2. A fine of between 300,000 and 600,000 VND shall be imposed for one of the following acts:

a) Producing and selling food, raw materials, and food additives in the environment not ensuring hygiene;

b) Failing to store food sample in accordance with provisions or sampling but not in compliance with regulations;

c) Failing to supervise the observance of regulations on food hygiene and safety for the collective kitchens cooking at the facilities.

3. A fine of between 500,000 and 2,000,000 VND shall be imposed for one of the following acts:

a) Raw materials and water used for manufacturing, processing food fail to meet the standards of food hygiene and safety as prescribed by the Ministry of Health;

b) Reusing packaging containing oil, grease, or milk to contain food processed industrially;

c) Manufacturing equipment used for food, packaging for packaging directly food from the raw materials, additives not on the permitted list published by the Ministry of Health;

d) Using equipment, containers, packaging, means of transportation, storage with surfaces in direct contact with food that are made of materials not guaranteeing food hygiene and safety.

4. A fine of between 2,000,000 to 6,000,000 VND shall be imposed for one of the following acts:

a) Producing and selling food from animal origin that has not gone through animal quarantine or has been inspected unsatisfactory;

b) Producing and trading farm products with pesticide residues exceeding material limits;

c) Failing to publish the quality standards of food hygiene and safety for food before being circulated or food products circulated on the market but not guaranteeing the standards of food hygiene and safety as announced;

d) Failing to publish the quality standards of food hygiene and safety for the food required publishing quality standards of food hygiene and safety as prescribed by law or announced but the publication has expired;

đ) Building the facilities of manufacturing, processing food in the environment not guaranteeing food safety and hygiene;

e) Producing and using ice for food, drink not ensuring the standards of food hygiene and safety as prescribed by the Ministry of Health;

g) Failing to observe the regulations on hygiene and safety in storage and transportation of food;

h) Those that direct produce and process food are getting infectious diseases, skin diseases or other diseases as prescribed by the Ministry of Health.

5. A fine of between 10,000,000 and 15,000,000 VND shall be imposed for one of the following acts:

a) Producing and trading food which has been degenerated, contaminated, or with strange contaminants or contaminated with toxic substance affecting human health;

b) Producing and trading food with pathogenic parasites, pathogenic microorganisms which are not permitted in food or exceeding the permitted limits;

c) Producing and trading food or products made from poultry, livestock, fisheries, fruits and vegetables due to illness, poisoned, died with unknown cause or impregnated with chemicals not permitted in use;

d) Having no certificate of sufficient conditions of food hygiene and safety granted by the competent agencies for the facilities of manufacturing, trading food at high risk;

đ) Producing and trading food additives, supporting substance for processing food, micronutrients, functional food, food with high-risk, food preserved by irradiation, food genetically modified but have not been permitted by the competent State management agencies;

e) Producing and trading food using food additives, the micronutrients, the supporting substance for processing food not permitted to use or used prescribed improper dose, limit or unknown origin;

g) Producing and trading food expired or failing to ensure hygiene standards;

h) Producing and trading food preserved by irradiation, but not recorded on the label the contents in Vietnamese or the international symbol as food preserved by irradiation;

i) Producing and trading irradiated food beyond the list of food permitted irradiation or food on the list of radiation but using beyond the radiation dosages in accordance with law regulations;

k) Producing and trading food using gene technology or materials using gene technology but recorded on the label in Vietnamese as "Food used gene technology";

l) Producing and trading food from materials which are not food, failing to ensure food hygiene and safety or outside the list of chemicals permitted for use in food;

m) Trading farm products with pesticide residues, fertilizer exceeding the permitted limit;

n) Labeling goods or advertising under any kinds on food which is effective alternative medicines;

o) Changing, relabeling, or changing the date of manufacture, expiry date on food labels which have been shipped and circulated;

p) Producing and trading food which are mixed, colored, mixed powder, to cover, dye and process in order to mask the state of decay, deterioration of the food;

q) Producing and trading food consisting of whole or part of materials damaged, to be poor quality or other material not suitable to food, whether or not that material has been processed;

r) Using contaminated facilities and means which transported hazardous substance for transporting food;

s) Failing to report when food poisoning happens to the medical establishment or the nearest People's Committee of locality to take preventive measures and remedy timely;

t) Failing to fully implement the precaution and handle promptly upon the occurrence of food poisoning and diseases transmitted through food.

6. A fine of between 5,000,000 and 10,000,000 VND shall be imposed for one of the following acts:

a) Advertising food, food additives which have not been published quality standards of food hygiene and safety; food, food additives of low quality, not guaranteeing hygiene and safety or advertising without the receipt of registration dossiers for advertisement of the competent health agencies or falsely advertising content registered or not modifying the content of advertisement at the request of the competent health agencies;

b) Advertising food, food additives dishonestly, unclearly and inconsistent with published content; improper or in excess of character, nature, value, material, advantage composition, safety, purity, weight, rate, origin and composition of food.

7. Remedies: application of remedies as prescribed in point d clause 4 Article 7 of this Decree for the violations provided in point a, b, c, d, e and point g clause 4; point a, b, c, d, đ, e, g, i, l, m, o, p, q and point r clause 5 of this Article.

Article 16. Violation of regulations on the prevention and combat of the harmful effects of tobacco

1. A warning or a fine of between 50,000 and 100,000 VND shall be imposed for one of the following acts:

a) Smoking cigarette, rustic tobacco in public places such as in the theaters, cinemas, conference rooms, working room, hospitals, libraries, waiting rooms of railway stations, bus stations, airports, ports, on public means of transport or in other banned public places;

b) Selling cigarettes, rustic tobacco to children under 16 years old.

2. A fine of from between 4,000,000 VND and 6,000,000 VND shall be imposed for the acts violating the regulations on the marking of tobacco products, regulations on content of warning and location recording warnings on cigarette packages.

3. A fine of between VND 20,000,000 and 30,000,000 shall be imposed for acts of tobacco production with content of the substances Tar, Nicotine exceeding the level specified.

4. Remedies: application of the remedies as prescribed in point d clause 4 Article 7 of this Decree for the violations specified in clause 3 of this Article.

Article 17. Violation of regulations on production, sale, and use of breast milk substitutes

1. A fine of between 500,000 VND and 1,000,000 VND shall be imposed for the act of issuing the documents and information and education on feeding new born baby, infants under the following circumstances:

a) Having pictures or words to encourage the feeding-bottle or discourage the breeding by breast milk;

b) Having name or symbol of breast milk substitutes, feeding-bottles, teats and dummies.

2. A fine of between 3,000,000 and 5,000,000 shall be imposed for one of the following acts:

a) Giving the mothers who have just born new baby or members in their family the product samples in order to encourage the use of such products to replace breast milk;

b) Trading breast milk substitutes which have not been published the quality standards of food hygiene and safety;

c) Trading breast milk substitutes not guaranteeing quality of food hygiene and safety as announced.

3. A fine of between 5,000,000 and 10,000,000 VND shall be imposed for one of the following acts:

a) Providing information, advertising false the use of breast milk substitutes;

b) Comparison of breast milk substitutes is equivalent to or better than breast milk;

c) The production facilities of breast milk substitutes fail to publish quality of food hygiene and safety;

d) Giving or receiving medical equipment, instruments, feeding-bottles, teats and dummies or other objects having trademarks of the facilities of manufacturing, trading breast milk substitutes; aiding finance or receiving scholarships, funding or receiving funds for scientific research, training, conferences, seminars, courses, concerts, advisory service by telephone or other forms of financing to encourage the use of breast milk substitutes;

đ) Advertising breast milk substitutes for infants over 6 months old without the words "Breast milk is the best for the health and development of newborns and children."

4. A fine of between 10,000,000 and 15,000,000 VND shall be imposed for one of the following acts:

a) Trading breast milk substitutes which have expired, unlabeled, unidentified or without packaging;

b) Advertising breast milk substitutes for infants from birth to 6 months old, feeding-bottles, teats and dummies in all forms; advertising inserting images of breast milk substitutes for infants from birth to 6 months old.

5. The remedies: forced to apply the remedies prescribed in point d clause 4 Article 7 of this Decree for the violations specified in point c clause 2 and point a clause 4 of this Article.

Article 18. Violation of regulations on the manufacture and supply of iodized salt for human consumption

1. A fine of between 300,000 VND and 800,000 VND shall be imposed for organizations and individuals producing or trading salt (iodized salt) which have one of the following acts:

a) Failing to comply with regulations on personal hygiene for employees;

b) Using the employees suffering from infectious diseases, skin diseases to directly produce salt;

c) Failing to train the employees on food hygiene and safety.

2. A fine of between 1,000,000 and 3,000,000 VND shall be imposed for one of the following acts:

a) Failing to test iodine content in salt before shipping;

b) Failing to equip with enough tools and chemicals for testing;

c) Using those who have no or improper qualifications, certificate of testing in the management positions on technical professional skill or testing of the salt production facilities;

d) Trading salt not meeting iodine content as prescribed.

3. A fine of between VND 3,000,000 and 5,000,000 shall be imposed for the acts of failing to publish goods quality standards according to provisions for the facilities of producing and trading salt.

4. A fine of between 5,000,000 and 8,000,000 VND shall be imposed for one of the following acts:

a) Producing salt not meeting the quality standards prescribed by the State;

b) Using the package labeling iodized salt for common salt (not iodized salt).

5. Remedies: Forced to reprocess salt not meeting quality standards as specified in point d clause 2 and point a clause 4 of this Article.

ITEM 3: ACTS OF ADMINISTRATIVE VIOLATIONS ON VACCINE, MEDICAL BIOLOGIC PRODUCTS, FORMS, AND LEVELS OF SANCTION

Article 19. Violation of regulations on the use of certificates of practicing vaccines, medical biological products

1. A fine of between VND 1,000,000 and 3,000,000 shall be imposed for the acts of failing to implement the authorization in accordance with the law regulations when the head or the professional manager of the facility is absent.

2. A fine of between VND 2,000,000 and 5,000,000 shall be imposed for one of the following acts:

a) Practicing without certificate of practice or use the certificate which has expired;

b) Renting, borrowing or renting out or lending the certificate of practice.

3. Forms of additional sanction: stripping the right to use certificate of practice in an indefinite duration for the violations specified in point b clause 2 of this Article.

Article 20. Violation of regulations on the use of certificates of sufficient conditions to practice, qualifications

1. A fine of between 2,000,000 and 5,000,000 VND shall be imposed for one of the following acts:

a) Trading vaccines and medical biological products without certificate of sufficient conditions to practice vaccines, medical biological products, or using the certificate which has expired;

b) Renting, borrowing or renting out or lending the certificate of sufficient conditions to practice;

c) Having no qualifications as prescribed for those who work on vaccines and medical biological products.

2. Forms of additional sanction: stripping the right to use certificate of sufficient conditions to practice vaccines and medical biological products in an indefinite duration for the violations specified in point b clause 1 of this Article.

Article 21. Violation of regulations on the production of vaccines and medical biological products

1. A fine of between 5,000,000 and 10,000,000 VND shall be imposed for one of the acts of producing vaccines and medical biological products not ensuring equipment of maintenance, means of transportation or not ensuring the requirements for prevention, fire, explosion, occupational safety and environmental sanitation.

2. A fine of between VND 10,000,000 and 15,000,000 shall be imposed for one of the acts of producing vaccines and medical biological products having no registration number or with registration number has expired, or the producing vaccines and medical biological products inconsistent with the content as registered in the dossier approved for circulation on the market.

3. A fine of between VND 15,000,000 and 30,000,000 shall be imposed for the acts of production and put into circulation on markets vaccines and medical biological products not meeting quality standards as registered.

4. Forms of additional sanction: stripping the right to use certificate of sufficient conditions to practice vaccines, medical biological products from 6 months to 12 months for the violations in clause 2 and clause 3 of this Article.

5. Remedies:

a) Forced to apply the remedies as prescribed in point d clause 4 Article 7 of this Decree for the violations specified in clause 2, clause 3 of this Article;

b) Funding for the destruction of vaccines and medical biological products paid by the violating individuals or organizations.

Article 22. Violation of regulations on the preservation and testing of vaccines and medical biological products

1. A fine of between VND 1,000,000 and 3,000,000 shall be imposed for one of the following acts:

a) Failing to meet the regulations on material facilities, technology and equipment;

b) Having no complete technical records, books, and documents of management of export and import for the facilities storing vaccines and medical biological products.

2. A fine of between 5,000,000 and 10,000,000 VND shall be imposed for one of the following acts:

a) Testing not to be of permitted professional scope;

b) Receiving storage and transportation of vaccines and medical biological products which have not been allowed to circulate.

3. Form of additional sanction: stripping the right to use certificate of sufficient conditions to practice vaccines, medical biological products from 6 months to 12 months for the violations provided in clause 2 of this Article.

Article 23. Violation of regulations on trading vaccines and medical biological products

1. A fine of between VND 1,000,000 and 3,000,000 shall be imposed for one of the following acts:

a) Trading vaccines and medical biological products incorrect address which has been permitted by the competent agencies;

b) Failing to implement the authorization in accordance with the law regulation when the head or professional manager of the establishment is absent;

c) Having no storage, refrigerator meeting standards, technique according to regulations for preservation of vaccines and medical biological products;

d) Having no books to monitor the purchase of vaccines and medical biological products, books to monitor expiration, vaccination, control of product quality;

e) Failing to ensure enough conditions on material facilities, equipment and requirements on the prevention of fire, explosion, occupational safety, environmental sanitation.

2. A fine of between VND 2,000,000 and 5,000,000 shall be imposed for the acts of trading vaccines and medical biological products beyond the permitted expertise.

3. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following acts:

a) Trading vaccines, medical biological products of unknown origin, no longer original pakaging;

b) Trading vaccines, medical biological products without circulation permits or circulation permits which has expired or not yet permitted for circulation by the Ministry of Health;

c) Trading vaccines, medical biological products which have expired.

4. A fine of between VND 10,000,000 and 15,000,000 shall be imposed for one of the following:

a) Importing finished or semi- finished vaccines and medical biological products which have not been circulated lawfully;

b) Importing vaccines, medical biological products of foreign companies that have not been issued licenses of operation in the field of vaccines and medical biological products in Vietnam by the Ministry of Health;

c) Using vaccines and medical biological products in the expanded vaccination program not in compliance with provisions of the Ministry of Health.

5. The remedies:

a) Forced to apply the remedies prescribed in point d clause 4 Article 7 of this Decree for the violations specified in clause 3 and point a clause 4 of this Article;

b) Funding for the destruction of vaccines and medical biological products is paid by the violating individuals or organizations.

Article 24. Violation of regulations on information and advertisement of vaccines, medical biological products

1. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following acts:

a) Advertising vaccines and medical biological products which have not had the receipt of registration dossiers for advertisement of the competent health agency;

b) Providing information, advertising vaccines and medical biological products which have not yet permitted for circulation in Vietnam;

c) Content of information, advertising vaccines, and medical biological products not in compliance with registered records or failing to modify the content of advertising at the request of the competent health agency;

d) Providing information, advertising vaccines and medical biological products when the permit of registering circulation of vaccines, medical biological products has expired;

e) Putting in circulation on the market the vaccines and medical biological products without label printed expiry date, name and address of the manufacturer and manual in Vietnamese.

2. Remedies: forced to comply with the provisions of the law on labels for the violations specified in point đ clause 1 of this Article before putting products in circulation on the market.

ITEM 4: ADMINISTRATIVE VIOLATIONS ON MEDICAL EXAMINATION AND TREATMENT, INCLUDING MEDICAL EXAMINATION AND TREATMENT BY TRADITIONAL MEDICINE AND FORMS AND LEVELS

Article 25. Violation of regulations on use of the certificates of practice

1. A fine of between VND 1,000,000 and 3,000,000 shall be imposed for one of the following acts:

a) Using certificate of practice which has expired;

b) Practicing without certificate of practice;

c) Renting or borrowing certificate of practice to practice;

d) Allowing another person to rent or borrow certificate of practice;

đ) Having no degree or appropriate professional certification;

e) Failing to make authorization as prescribed by law for the head of the facility when he/she is absent.

2. Form of additional sanction: stripping the right to use certificate of practice in an indefinite period for the violations specified in point c, d clause 1 of this Article.

Article 26. Violation of the provisions on practice conditions and use of certificate of sufficient conditions to practice medicine, traditional medicine (collectively referred to as a certificate of sufficient conditions to practice)

1. A fine of between VND 300,000 and 1,000,000 shall be imposed for one of the following acts:

a) The practice facility’ address is not in compliance with the one stated in the certificate of sufficient conditions to practice;

b) Failing to ensure conditions on technical equipment as prescribed;

c) The facility practices together with family’s living or with other business;

d) The facility fails to satisfy conditions on housing and environmental sanitation;

đ) The practice facility has no signboard in accordance with the regulations;

e) Failing to open the books of statistics tracking the number of patients, customers supplied service of daily medical technique, failing to archive prescribing records.

2. A fine of between VND 1,000,000 and 3,000,000 shall be imposed for one of the following acts:

a) Practicing medical examination, treatment; providing medical services without certificate of sufficient conditions to practice granted by the competent medical authority;

b) Renting, borrowing or renting out or lending the certificate of sufficient conditions to practice;

c) Practicing as the certificate of sufficient conditions to practice has expired;

d) Failing to list health service prices or listing price but charging higher prices;

đ) Failing to keep the books of tracking of toxic drugs, psychotropic drugs.

3. A fine of between VND 3,000,000 and 8,000,000 shall be imposed for the acts of practice beyond their expertise, not complying with the scope defined in the certificate of sufficient conditions to practice.

4. Forms of additional sanction: stripping the right to use certificates of sufficient conditions to practice in an indefinite period for the facilities committing violations specified in point b clause 2 and clause 3 of this Article.

Article 27. Violation of regulations on technical expertise

1. A fine of between VND 500,000 and 1,000,000 shall be imposed for one of the following acts:

a) Leaving the on-duty places;

b) Failing to wear name tag; clothing is improper provision while are on duty;

c) Failing to hold a consultation for the emergency surgical cases;

d) Having imperious attitude, harassment, inconvenience for patients;

đ) Failing to self-criticize mortality within 15 days from the date of patient’s death;

e) Failing to perform three tests, five comparison before prescribing to patients;

g) Failing to classify and collect medical waste as prescribed.

2. A fine of between VND 2,000,000 and 5,000,000 shall be imposed for one of the following acts:

a) Failing to give first aid patients urgently;

b) Those that do professional works have no professional qualification consistent with the works assigned;

c) Prescribing as well as selling drugs outside of base number of emergency medicine as prescribed by the health agencies (except for medical examination and treatment by traditional medicine);

d) Prescribing drugs improper treatment;

đ) Prescribing unnecessary expensive special drugs in order to get difference profit from the drug-trading facilities;

e) Failing to comply with regulations on septic as conducting surgery, operation;

g) Taking advantage of occupation to practice superstition;

h) Taking advantage of occupation to have the act of sexual harassment with the patient;

i) Failing to treat wastes in hospital in accordance with provisions.

3. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following acts:

a) Violating regulations on medical technical expertise causing harm to the health of patients;

b) Using the methods of medical examination, treatment, equipment, pharmaceuticals without permission from the Ministry of Health;

c) Foreigners doing the professional work in the medical facilities, traditional medicine facilities without permission from the Ministry of Health.

4. Forms of additional sanction:

a) Stripping the right to use certificates of practice in an indefinite duration for the violations prescribed in point e, g clause 2, and point b clause 3 of this Article;

b) Stripping the right to use certificates of practice from 6 months to 12 months for the violations prescribed in point a clause 3 of this Article.

5. Remedies: forced to comply with the waste treatment processes according to the provisions for the violations in point g clause 1 and point i clause 2 of this Article.

Article 28. Violation of regulations on health care

1. A fine of between VND 400,000 and 1,000,000 shall be imposed for one of the following acts:

a) Failing to engage in health activities on primary health care and the dissemination, guidelines of people to protect their health, disease prevention and treatment as required by the agency of local health management;

b) Failing to comply with periodic report regime to the State management agencies on health according to regulations;

c) Failing to report to the local health agencies as detecting people who get sexually-transmitted diseases;

d) Failing to implement management measures as prescribed for the patients suffering from dangerous contagious diseases.

2. A fine of between 500,000 VND and 2,000,000 VND shall be imposed for the acts of failing to report promptly to the medical establishment of the State in accordance with provisions as detecting infectious diseases required to be quarantined, strange diseases, mass poisoning.

3. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following acts:

a) Advertising not in compliance with the expertise ability and scope of practice defined in the certificate of sufficient conditions to practice; advertising without receipt of registration dossiers for advertisement of the competent health agencies; advertising not in compliance with the register contents which have been approved or failing to modify the content of advertising at the request of the competent health agencies;

b) Failing to obey the order to mobilize of the competent health agencies when natural disasters and epidemics happen.

4. A fine of between VND 1,000,000 and 3,000,000 shall be imposed for one of the following acts:

a) Using foreigners for medical examination, treatment without knowing Vietnamese and without interpreter;

b) Using interpreters for foreigners in the activity of medical examination, treatment without guaranteeing expertise qualification or foreign language as prescribed by law;

c) The foreigners who examine; treat diseases without implementing prescription by Vietnamese and other countries’ language in accordance with provisions.

Article 29. Violation of regulations on technical expertise in the field of traditional medicine

1. A fine of between VND 500,000 and 1,000,000 shall be imposed for one of the following acts:

a) Medicine cabinet, bottles containing medicine without lids, stating clearly the name of the drug or stating the false name of the drug;

b) Having mould drug, borers drug.

2. A fine of between VND 1,000,000 and 2,000,000 shall be imposed for one of the following acts:

a) Failing to comply with regulations on sterilization and disinfection in acupuncture, injection and other operations in medical examination, treatment;

b) Prescribing drugs not appropriate to the disease.

3. A fine of between VND 2,000,000 and 5,000,000 shall be imposed for one of the following acts:

a) The establishment of traditional medicine has the act of trading medicine;

b) Having drug of expiry, drug which has been recalled, drug which has not had the registration number of manufacturing or drug which has not been allowed for importation.

4. A fine of between VND 5,000,000 and 8,000,000 shall be imposed for the use of methods of medical examination, treatment, equipment, and pharmaceuticals without permission of the competent health agencies.

5. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for the medical examination and treatment facilities by traditional medicine (including the facilities relating to foreign elements) having one of the following acts:

a) Advertising not in compliance with the expertise ability and scope of practice defined in the certificate of sufficient conditions to practice;

b) Advertising without receipt of registration dossiers for advertisement of the competent health agencies or advertising not in compliance with the registered contents or failing to modify the content of advertising at the request of the competent health agencies.

6. Forms of additional sanction: Stripping the right to use certificates of practice, stripping the right to use certificates of sufficient conditions to practice in an indefinite duration for the violations specified in clause 4 of this Article.

7. Remedies: forced to implement the remedies prescribed in point d clause 4 Article 7 of this Decree for the violations specified in point b clause 1, point b clause 3 and clause 4 of this Article.

Article 30. Violation of the provisions on conditions to practice massage, acupuncture points, medicine steaming

1. A fine of between VND 300,000 and 500,000 shall be imposed for one of the following acts:

a) Having no signs in the massage parlor;

b) The service staffs fail to wear uniforms, fail to have professional certificate of the competent authorities, and fail to wear name tags in accordance with regulations.

2. A fine of between VND 500,000 and 1,000,000 shall be imposed for one of the following acts:

a) The massage bed is not secured in accordance with prescribed standards;

b) Failing to install the alarm for emergency in the steam room of medicine;

c) Failing to ensure light, sanitation as prescribed;

d) Failing to ensure the area of practice as prescribed;

đ) Having no means of emergency as doing massage, pressing acupuncture points, medicine steaming.

3. A fine of between VND 3,000,000 and 5,000,000 shall be imposed for one of the following acts:

a) The system doors of the parlors of massage, pressing acupuncture points, acupuncture, medicine steaming not in compliance with provisions;

b) Staffs of massage, acupuncture points, acupuncture fail to comply with technical professional regulations;

c) The steam system of medicine is not ensured safety;

d) Taking advantage of the occupation to carry out the other activities not for the purpose of restoring and improving health.

4. Remedies: forced to overcome the lack of safety for steam systems specified in clause 2 and point a, and c clause 3 of this Article.

Article 31. Violation of regulations on birth by the scientific method

1. A fine of between VND 10,000,000 and 15,000,000 shall be imposed for one of the following acts:

a) Disclosing information on names; addresses and images of people who give or receive sperm and embryos;

b) To implement the giving, reception of ovule; sperm; embryos when has not been permitted for the implementation;

c) Failing to ensure the conditions to implement technical assistance of birth in accordance with provisions.

2. A fine of between VND 20,000,000 and 30,000,000 shall be imposed for one of the following acts:

a) Surrogacy;

b) Cloning.

3. Remedies: forced to overcome the status of not ensuring conditions for implementing technical assistance of birth as prescribed for the violation in point c clause 1 of this Article.

ITEM 5: ACTS OF ADMINISTRATIVE VIOLATION ON DRUG OF PREVENTION AND TREATMENT FOR PEOPLE, INCLUDING TRADITIONAL MEDICINE AND COSMETICS DIRECT EFFECTING TO HUMAN HEALTH, FORMS, AND LEVELS

Article 32. Violation of regulations on the use of certificate of pharmaceutical practice

1. A fine of between VND 1,000,000 and 3,000,000 shall be imposed for one of the following acts:

a) Trading drugs without certificate of practice or with certificate of practice has expired;

b) Renting, borrowing or renting out or lending the certificate of practice or professional qualification;

c) Failing to implement the authorization in accordance with the law regulations for the head or professional manager of the facility as he/she is absent.

2. Forms of additional sanction: Stripping the right to use the practice certificate for an indefinite duration for the violations provided in point a, b clause 1 of this Article.

Article 33. Violation of the provisions on the conditions to practice and use of certificate of sufficient conditions for private pharmaceutical practice (collectively referred to as certificate of sufficient conditions to practice)

1. A fine of between VND 500,000 and 1,000,000 shall be imposed for one of the following acts:

a) The facility practices not compliance with address stated in the certificate of sufficient conditions to practice, having no signs as prescribed;

b) Failing to ensure the enough conditions on infrastructure and environmental sanitation;

c) Failing to open the books of statistics, or failing to keep records and documents relating to narcotic drugs and psychotropic drug and narcotic drugs prescription.

2. A fine of between VND 2,000,000 and 5,000,000 shall be imposed for one of the following acts:

a) Practicing beyond the professional ability or not in accordance with the scope of professional practice prescribed in the certificate of sufficient conditions to practice;

b) Renting, borrowing or renting out or lending the certificate of sufficient conditions to practice;

c) Trading drugs without the certificate of sufficient conditions to practice or with the certificate of sufficient conditions to practice has expired.

3. Forms of additional sanction:

a) Stripping the right to use the certificate of sufficient conditions to practice from 6 months to 12 months for the violations of the provisions in point a clause 2 of this Article;

b) Stripping the right to use the certificate of sufficient conditions to practice for an indefinite duration for the violations provided in point b and c of clause 2 of this Article.

Article 34. Violation of regulations on drug trafficking

1. A warning or a fine of between 100,000 VND and 200,000 VND shall be imposed for the acts of drug sellers not wearing the clothing, name badges as prescribed.

2. A fine of between VND 1,000,000 and 3,000,000 shall be imposed for one of the following acts:

a) The sellers of drug do not obtain the prescribed standards;

b) Failing to authorize or appoint a substitute in accordance with provisions when the pharmacy owner, the agent owner or manager of the professional activities of pharmaceutical establishments are absent.

3. A fine of between 500,000 VND and 2,000,000 VND shall be imposed for act of selling wrong medicines.

4. A fine of between VND 1,000,000 and 3,000,000 shall be imposed for one of the following acts:

a) Sales of drugs required for prescriptions without prescriptions of doctor or selling without prescription for purposes of profit;

b) Trading non-commercial drugs, drug with packaging not containing all the information as prescribed.

5. A fine of between VND 3,000,000 and 5,000,000 shall be imposed for one of the following acts:

a) Trading drug without permission for circulation.

b) Trading drug without obtaining quality standard or expired drugs with a quantity of smaller than or equal to 50 pills or equal to 10 tubes, equal to 10 jars or equal to 10 times for drugs which are not poison drugs, narcotic drugs, psychotropic substances, precursor substances, radioactive pharmaceutical substances.

6. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following acts:

a) Trading drug without obtaining quality standard or expired drugs with a quantity of more than 50 pills or more than 10 tubes or more than 10 jars or more than 10 bottles for drugs which are not poison drugs, narcotic drugs, psychotropic substances, precursor substances, radioactive pharmaceutical substances;

b) Trading drugs without obtaining quality standard or expired drugs for the drugs which are poisons, narcotics drugs, psychotropic substances, precursor substances, radioactive pharmaceutical substances.

7. Forms of additional sanction:

a) Stripping the right to use the practice certificate, certificate of sufficient conditions to practice from 6 months to 12 months for violations of the provisions in clause 5 and point a clause 6 of this Article;

b) Stripping the right to use the practice certificate, certificate of sufficient conditions to practice for an indefinite duration for the violating practice facilities specified in point b clause 6 of this Article.

8. Remedies:

a) Forced to apply the remedies prescribed in point d clause 4 Article 7 of this Decree for the violations specified in point b clause 4, clause 5 and clause 6 of this Article;

b) Funding for the destruction of drugs shall be paid by the violating individuals or organizations, except for the cases required to seize material evidence, physical evidence for further processing.

Article 35. Violation of regulations on the drug manufacture

1. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following acts:

a) Manufacture of drugs does not ensure the condition of sanitation;

b) Manufacture of drugs without adequate production facilities.

2. A fine of between VND 10,000,000 and 20,000,000 shall be imposed for one of the following acts:

a) Manufacture of drugs without registration number of the competent health agency;

b) Manufacture of drugs when the registration number has expired;

c) Manufacture of drugs not in accordance with the drug registration dossiers.

3. A fine of between VND 20,000,000 and 30,000,000 shall be imposed for the production of drugs not meeting quality standards has been registered.

4. Forms of additional sanction: Stripping the right to use the certificate of sufficient conditions to practice pharmacy for an indefinite duration for the violations of the provisions in clause 2 and clause 3 of this Article.

5. Remedies:

a) Forced to apply the remedies prescribed in point d clause 4 Article 7 of this Decree for the violations specified in clause 2 and clause 3 of this Article;

b) Funding for the destruction of drugs shall be paid by the violator.

Article 36. Violation of regulations on the preservation of drug, drug materials and drug testing

1. A fine of between VND 1,000,000 and 3,000,000 shall be imposed for one of the following acts:

a) Failing to meet the requirements for preservation of drug and drug materials;

b) Having no technical documents and books of record of drugs and drug materials in accordance with regulations.

2. A fine of between VND 5,000,000 and 8,000,000 shall be imposed for the business establishment of drug testing services, storage services not meeting the professional and technical requirements.

3. Forms of additional sanction: stripping the right to use the certificate of practice from 6 months to 12 months for the violations specified in clause 2 of this Article.

4. Remedies: forced to apply technical professional measures to remedy violations of the provisions in clause 1 of this Article.

Article 37. Violation of regulations on trading export and import of drugs and drug-making materials

1. A fine of between VND 20,000,000 and 30,000,000 shall be imposed for one of the following acts:

a) Importing drug or drug-making materials without permission of the Ministry of Health;

b) Importing drug or drug-making materials after the producing country published to ban from circulation on the market;

c) Importing drug or drug-making materials not in the original packaging;

d) Exporting drugs to be of the list of drugs banned from export.

2. Forms of additional sanction: stripping the right to use the certificate of practice from 6 months to 12 months for the violations in point a, b and d clause 1 of this Article.

3. Remedies:

a) Forced to apply the remedies prescribed in point d clause 4 Article 7 of this Decree for the violations of the provisions in point a, b, c and d clause 1 of this Article, except for rare drugs (both medicine and traditional medicine) prescribed in point a, c clause 1 certified as quality assurance of use by the drug-testing agency;

b) Funding for the destruction of drugs shall be paid by the violating individuals or organizations.

Article 38. Violation of the regulations on poisons, narcotic drugs, psychotropic drugs, precursor substances, radioactive pharmaceutical substances

1. A fine of between 4,000,000 VND and 8,000,000 VND shall be imposed for acts of prescribing and using poisons, narcotic drugs, psychotropic drugs, precursor substances, radioactive pharmaceutical substances not in compliance with regulations of the Ministry of Health.

2. A fine of between VND 20,000,000 and 30,000,000 shall be imposed for the acts of producing, processing, storing, trading poisons, narcotic drugs, psychotropic drugs, precursor substances, radioactive pharmaceutical substances not in compliance with regulations of the Ministry of Health.

3. Forms of additional sanction: stripping the right to use the certificate of sufficient conditions to practice pharmacy from 6 months to 12 months for the violations specified in clause 1 and clause 2 of this Article.

Article 39. Violation of the regulations on information and drug advertising and labeling

1. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following acts:

a) Advertising drug without the receipt of registration dossiers for advertisement issued by the competent health agency;

b) Providing information, advertising drug which has not been permitted for circulation in Vietnam;

c) Contents of information, advertising of drugs not in accordance with the registered records or failing to modify the content of advertising at the request of the competent health agency or printing, issuing or providing information, advertising drug when the registration number of drug has expired;

d) Using the drug label which is not approved by the competent health agency or printing drug label not in compliance with the approved form;

đ) Putting in circulation on the market the drugs which are not labeled with expiry, name and address of manufacturer, name of the importer and the import permit number (drugs without registration number) for foreign drug and having no instruction manual in Vietnamese or additional label as prescribed for drug imported from abroad.

2. Forms of additional sanction: stripping the right to use the certificate of sufficient conditions to practice pharmacy from 6 months to 12 months for the violations of the provisions in point a, b clause 1 of this Article.

3. Remedies: forced to apply the remedies prescribed in point d clause 4 Article 7 of this Decree for the violations prescribed in point d, đ, clause 1 of this Article.

Article 40. Violation of regulations on cosmetics directly affecting human health

1. A fine of between VND 3,000,000 and 5,000,000 shall be imposed for one of the following acts:

a) Imitating the labels of other products which were allowed to circulate;

b) The cosmetics’ label is not enough contents as prescribed;

c) Producing and trading cosmetics which have not been registered for circulation or have not been published quality standards as prescribed.

2. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following acts:

a) Manufacturing and importing cosmetics not guaranteeing quality;

b) Producing and trading cosmetics with ingredients of substances banned from use in cosmetics or exceeding the permitted limits for substances required to restrict concentration, content of use;

c) Advertising cosmetics without circulation registration numbers or which have not yet published quality standards or not in compliance with registration documents;

d) Contents of information, advertising of cosmetics are not in compliance with registered dossiers or failing to modify the content of advertising at the request of the competent health agencies;

đ) Trading cosmetics not ensuring quality, expired, without registration numbers;

e) Advertising cosmetics without the receipt of registration dossiers for advertisement of the competent health agency;

g) Import and trading cosmetics which are not in the original packages.

3. A fine of between VND 10,000,000 and 15,000,000 shall be imposed for acts of importing cosmetics or raw material for producing cosmetics which have been published to ban from circulation on the market by the producing countries.

4. Remedies:

a) Forced to apply the remedies prescribed in point d clause 4 Article 7 of this Decree for violations of the provisions in point a, b, c, d, đ, g clause 2 and clause 3 of this Article;

b) The funding for destruction of cosmetics shall be paid by the violating individuals or organizations.

Article 41. Violation of regulations on management of drug

1. A fine of between VND 200,000 and 500,000 shall be imposed for the act of failing to list the prices of drugs as prescribed.

2. A fine of between VND 500,000 and 2,000,000 shall be imposed for the act of selling drugs at prices higher than the listed one.

3. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for the act of taking advantage of difficulties, natural disasters or other special circumstances to raise drug prices, squeeze drug prices causing damage to consumers.

4. A fine of between VND 8,000,000 and 12,000,000 shall be imposed for the violation of regulations on drug price support policy of the State.

5. A fine of between VND 10,000,000 and 20,000,000 shall be imposed for acts of selling drugs more than the price prescribed by the competent agency.

6. Forms of additional sanction:

a) Stripping the right to use certificates of sufficient conditions to practice for an indefinite duration for the facilities of pharmaceutical practice committing violations specified in clause 3, 4 and clause 5 of this Article;

b) Stripping the right to use the certificate of registration of pharmaceutical business for an indefinite duration when the facilities have violated 2 times the provisions in clause 4 of this Article;

c) Confiscating the entire price difference due to sell higher prices stipulated in clause 2, 3, 4 and clause 5 of this Article.

ITEM 6: ACTS OF ADMINISTRATIVE VIOLATIONS ON MEDICAL EQUIPMENT, FORMS, AND LEVELS OF SANCTION

Article 42. Violation of the provisions on conditions of medical equipment practice

1. A fine of between VND 3,000,000 and 8,000,000 shall be imposed for one of the following acts:

a) Failing to comply with regulations for business registration of medical equipment;

b) The material facilities, and technique, personnel for the production and sales of medical equipment are not in accordance with provisions of the Ministry of Health;

c) The facilities of trading medical equipment fail to list price or list prices but selling higher price the listed one.

2. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following acts:

a) Trading medical equipment without circulation registration numbers; without permission for import by the Ministry of Health or of unknown origin;

b) Trading fake medical equipment;

c) Trading beyond the permitted scope.

3. Forms of additional sanction: Confiscating medical equipment for the violations in point a, and b clause 2 of this Article.

Article 43. Violation of regulations on the production of medical equipment

1. A fine of between 2,000,000 and 5,000,000 shall be imposed for the acts of producing medical equipment without certificate of sufficient conditions to practice medical equipment or using the certificate which was expired.

2. A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following acts:

a) Producing medical equipment without registering the circulation number of products;

b) Producing medical equipment when the circulation registration number of products on the market has expired;

c) Producing medical equipment not meeting the standard of quality as announced.

3. Remedies: forced to apply the remedies prescribed in point d clause 4 Article 7 of this Decree for the violations of the provisions in point a, and c clause 2 of this Article.

Article 44. Violation of regulations on information and advertisement of medical equipment

A fine of between VND 5,000,000 and 10,000,000 shall be imposed for one of the following acts:

1. Advertisement of medical equipment is not in accordance with features and effects of medical equipment.

2. Advertising medical equipment without receipt of registration dossiers for advertisement of the competent health agencies or which has not yet permitted for circulation in Vietnam.

3. Contents of information, advertising of medical equipment are not in compliance with registered records or failing to modify the content of advertising at the request of the competent health agencies.

Chapter 3:

COMPETENCE, PROCEDURES FOR HANDLING OF ADMINISTRATIVE VIOLATIONS

Article 45. The competence of sanction of the specialized inspectors of hygiene, medical examination, treatment, and medicine in the health sector

1. While on duty, specialized inspectors of hygiene, medical examination, treatment and pharmacy within its scope of functions are entitled to warn or fine up to 200,000 VND and confiscate material evidences and means used for administrative violation with value of up to VND 2,000,000 and apply the remedies specified in point a, b and d clause 4 Article 7 of this Decree.

2. Chief Inspector of the Health Department is entitled to warn or fine up to VND 20,000,000, strip the right to use the certificates of sufficient conditions practice, certificates of practice granted by the Ministry of Health or the Department of Health, confiscate material evidences and means used for administrative violations, request the competent agencies to withdraw the business registration certificate and apply the remedies specified in point a, b and d clause 4 Article 7 of this Decree.

3. Chief Inspector of the Ministry of Health is entitled to warn or fine up to a maximum level of VND 30,000,000 for the administrative violations in the health sector, strip the right to use the practice certificates, the certificates of sufficient conditions practice granted by the Ministry of Health or the Department of Health and confiscate material evidences and means used for administrative violations, request the competent agencies to withdraw the business registration certificate and apply the remedies prescribed in point a, b and d clause 4 Article 7 of this Decree.

Article 46. The competence to sanction of the Presidents of the People's Committees at all levels

1. Presidents of the commune-level People's Committees are competent to warn, fine up to VND 500,000, confiscate material evidences and means used for administrative violations with value of up to VND 500,000, force to performance of the remedies specified in points a, b and d clause 4 of Article 7 of this Decree.

2. Presidents of the District-level People's Committees are competent to warn, fine up VND 20,000,000 and confiscate material evidences and means used for administrative violations; strip the right to use practice certificates, certificates of sufficient conditions to practice granted by the Ministry of Health or the Departments of Health, certificates of business registration; apply the remedies prescribed in points a, b and d clause 4 Article 7of this Decree.

3. Presidents of the provincial-level People's Committees are competent to warn, fine up to maximum of VND 30,000,000 for the administrative violations in the health sector, strip the right to use practice certificates, certificates of sufficient conditions to practice granted by the Ministry of Health or the Departments of Health, certificates of business registration; confiscate material evidences and means used for administrative violations; apply the remedies prescribed in clause 4 Article 7 of this Decree.

Article 47. Competence to sanction of other agencies

1. Apart from the persons specified in Article 45 and Article 46 of this Decree, the others in accordance with the Ordinance on Handling of Administrative Violations in the functions and duties assigned that detect administrative violations specified in this Decree to be of their management fields or areas, are entitled to sanction.

2. In the case of administrative violations under the jurisdiction of many agencies, the handling shall be implemented by the first agency.

Article 48. Procedures for handling of administrative violations

Procedures for handling of administrative violations in the health sector is applied under the Ordinance on Handling of Administrative Violations and Chapter IV, Procedures for handling of administrative violations of the Decree No.134/2003/ND-CP dated November 14, 2003 of the Government detailing the implementation of a number of Articles of the 2002 Ordinance on Handling of administrative Violations.

Chapter 4:

IMPLEMENTATION PROVISIONS

Article 49. Effect

This Decree takes effect 15 days after its publication in the Official Gazette. Annulling Decree No. 46/CP dated August 06, 1996 of the Government on sanction of administrative violations in the field of state management on health.

Article 50. Responsibility of implementation

The ministers, heads of ministerial-level agencies, heads of governmental agencies, Presidents of the People’s Committees of provinces and cities directly under the Central Government are responsible for the implementation of this Decree.

This translation is translated by LawSoft, for reference only.
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