Consolidated Document number 06/VBHN-BYT on vaccination activities

DECREE

Provisions on vaccination activities

Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government stipulates on vaccination activities, which took effect from July 1, 2016, has been amended and supplemented by:

Decree No. 155/2018/NĐ-CP dated May 12, 2018 of the Government amending and supplementing certain provisions related to investment and business conditions under the management of the Ministry of Health, which took effect from November 12, 2018;

||| Pursuant to the Law on Organization of the Government dated June 19, 2015;

Based on the Law on Prevention and Control of Infectious Diseases dated November 21, 2007;

On the basis of the Investment Law dated November 26, 2014;

At the proposal of the Minister of Health;

The Government promulgates the Decree stipulating on vaccination activities.1

Chapter I. GENERAL PROVISIONS

Article 1. Scope of Regulation

This Decree stipulates on vaccination safety and compensation when using vaccines.

Article 2. Scope of Application

1. This Decree applies to healthcare facilities implementing vaccination with vaccines in the Expanded Immunization Program and epidemic control vaccination.

2. Organizations and individuals operating vaccination services must meet the following requirements: Ensuring vaccination safety as prescribed in this Decree, implementing reporting procedures as prescribed, having plans to ensure sufficient vaccine supply for vaccination activities at their facilities.

Article 3. Explanation of Terms

1. Vaccination is the act of administering vaccines into the human body with the purpose of creating immune response capability to prevent diseases.

2. Epidemic control vaccination is free-of-charge vaccination organized by the State for people at risk of contracting infectious diseases in epidemic areas, or those sent to epidemic areas by competent state authorities.ướ3. Cold chain equipment is a system of equipment for preserving, monitoring temperature, and transporting vaccines from manufacturers to vaccination points.

4. Adverse events following immunization is an unusual health condition including local or systemic manifestations occurring after vaccination, not necessarily caused by the use of vaccines, including common reactions after vaccination and severe adverse events following immunization.

5. Severe adverse events following immunization is an adverse event following immunization that may threaten the life of the vaccinated person, leave lasting effects, or result in death of the vaccinated person.

6. A vaccination facility is a healthcare facility meeting the conditions and having announced its eligibility for vaccination according to this Decree.

VACCINATION SAFETY

Chapter II. Section 1. VACCINATION PROCEDURES

Article 4. Management of Vaccination Subjects

1. The management of vaccination subjects includes:

a) Name, date of birth, and permanent address of the vaccination subject;

b) Name of father or mother or guardian in cases where the vaccination subject is a child;

c) Vaccination history and medical history related to vaccination indication.

 The People's Committee of communes, wards, and towns is responsible for directing the Health Stations to investigate and compile lists of compulsory vaccination subjects as prescribed by the Law on Prevention and Control of Infectious Diseases and notify the subjects to participate in vaccination according to schedule and dosage.

2. of the National Assembly;3. Vaccination facilities are responsible for:

a) Issuing and recording individual vaccination tracking books or electronic vaccination records;

b) Compiling lists of subjects vaccinated at the facility.

 If the vaccinated person already has a citizen identification number, there is no need to collect information as prescribed in point a and point b of Clause 1 of this Article.

4. In caseArticle 5. Vaccination Procedures

1. Vaccination must be carried out through the following steps:

a) Before vaccination: Conduct screening examination and counseling for the vaccination subject. In cases where the vaccination subject is a child, counseling should be conducted with the child's parents or guardian;

b) During vaccination: Administer the vaccine according to prescription, ensuring safety;

c) After vaccination: Monitor the vaccinated person for at least 30 minutes post-vaccination and guide the family or vaccination subject to continue monitoring for at least 24 hours post-vaccination.

2. When a severe adverse event following immunization occurs during vaccination implementation, the head of the vaccination facility is responsible for:

a) Immediately stopping the vaccination session;

b) Providing emergency treatment, diagnosing the cause of the severe adverse event following immunization; if beyond capacity, transfer the affected person to the nearest healthcare facility;

c) Fully documenting all relevant information about the severe adverse event according to the regulations of the Minister of Health and report to the Department of Health within 24 hours from the time of occurrence of the adverse event.

3. Healthcare facilities receiving cases of severe adverse events following immunization must provide emergency treatment, care, and report to the Department of Health within 24 hours from the time of receiving the affected person.

4. In cases of severe adverse events following immunization with vaccines outside the Expanded Immunization Program and epidemic control vaccination, the facility where the severe adverse event occurred is responsible for reporting to the Department of Health of the location where the facility is based according to Clause 2 of this Article and implement compensation according to civil law regulations if there is fault causing the severe adverse event following immunization.

4. In case of serious adverse events following immunization with vaccines outside the Expanded Immunization Program and epidemic control immunization, the facility where the serious adverse event occurs shall report to the Department of Health at the location of the facility's headquarters in accordance with Clause 2 of this Article and shall implement compensation in accordance with the provisions of civil law if there is negligence causing the serious adverse event following immunization.

Article 6. Investigation, reporting, and announcing the results of investigation and handling serious adverse events following immunization

1. Within twenty-four hours from the occurrence of serious adverse events following immunization, the Department of Health shall be responsible for organizing the investigation, and within five working days from receiving the investigation report on serious adverse events following immunization, the Department of Health must organize a meeting of the specialized advisory board to assess the causes of adverse events following immunization in the locality (hereinafter referred to as the provincial specialized advisory board) to:Not deposited into temporary accountfor serious adverse events following immunization, the Department of Health shall be responsible for organizing the investigation and withinnot05 working days from the date of receiving the investigation report,Not deposited into temporary accounta) Evaluate and conclude the cause of serious adverse events following immunization;

b) Determine eligibility for compensation in accordance with Clause 6, Article 30 of the Law on Prevention and Control of Infectious Diseases and Clause 2, Article 15 of this Decree;

b) DetermineNot deposited into temporary accountwhether compensation is provided in accordance with Clause 6 of Article 30 of the Law on Prevention and Control of Infectious Diseases andc) Determine the responsibility of organizations and individuals involved in the production, business operation, storage, and use of vaccines and medical products related to serious adverse events following immunization.;

2. Within twenty-four hours from the time the minutes of the provincial specialized advisory board meeting are recorded, the Director of the Department of Health shall be responsible for:

a) Publicly announcing and reporting to the Ministry of Health on the cause of serious adverse events following immunization;

b) Informing the family of the person who suffered serious adverse events following immunization about the cause of the adverse event.

3. In cases where there is suspicion that the cause of serious adverse events following immunization is due to vaccine quality, the Director of the Department of Health must issue a decision to temporarily suspend the use of the related vaccine batch in the managed area after obtaining written approval from the Ministry of Health. When the provincial specialized advisory board concludes that the cause of serious adverse events is not related to vaccine quality, the Director of the Department of Health decides to resume the use of that vaccine batch and report to the Ministry of Health.

4. If necessary, the Ministry of Health will organize a meeting of the specialized advisory board under the Ministry of Health to re-evaluate the conclusions of the provincial specialized advisory board.

5. The Minister of Health shall be responsible for detailing this provision.

Section 2. MANAGEMENT OF VACCINES

Article 7. Supply of vaccines for immunization activities

1. Vaccines for immunization activities under the Expanded Immunization Program and epidemic control immunization programs shall be guaranteed in quantity and type suitable for annual needs and stored for six months by the State.

1. Vaccinesusefor activities under the Expanded Immunization Program and epidemic control immunization shall be guaranteed in quantity and type suitable for annual needs and shall be stored for 6 months.

2. Based on the number of people to be vaccinated, the time frame, and usage quotas for each type of vaccine, vaccination facilities shall be responsible for preparing the forecasted vaccine demand stipulated in Clause 1 of this Article for the entire year and submit it to the management agency at the district and provincial levels before November 30 each year to direct the supply of vaccines according to the plan.REGULARsubmitted to the Department of Health before November 30 each year to direct vaccine distribution according to the plan.

3. Based on the forecasted vaccine demand of vaccination facilities, the Department of Health shall be responsible for compiling and submitting the plan to the Ministry of Health before December 15 each year for approval of the vaccine supply plan and distribution based on the approved plan.

4. In case of local shortages or surpluses of vaccines at vaccination facilities, the Department of Health shall assist the provincial authorities in directing the redistribution of vaccines among facilities within the locality to ensure adequate, timely, and continuous supply of vaccines and report to the Ministry of Health on the use of vaccines on a monthly basis.of the National Assembly;the people's committee of the province shall direct the coordination of vaccines among vaccination facilities within its jurisdiction to ensure adequate, timely, and continuous supply of vaccines and report to the Ministry of Health on the situation of vaccine usage monthly.

5. In case of local shortages or surpluses of vaccines in some provinces, the Minister of Health shall be responsible for directing relevant units to redistribute vaccines among provinces.

Article 8. Receiving, transporting, storing vaccines

1. Vaccines must be stored in a cold chain from production to when they areuseand at temperatures suitable for each type of vaccine according to the manufacturer's requirements in the registration dossier with the Ministry of Health, specifically as follows:

a) Vaccine storage warehouses must comply with good storage practices for medicines;

b) Transporting vaccines from storage warehouses to vaccination points must be carried out using refrigerated vehicles, cool boxes, or vaccine carriers;

c)2 (abolished);

d)3 There must be temperature monitoring equipment for vaccines during transportation, storage, use, and full documentation during transportation and delivery. At vaccine storage facilities, temperature monitoring must be conducted at least twice a day;

d) The Minister of Health shall provide guidance on receiving, transporting, and storing vaccines.

2. When receiving vaccines, the recipient has the responsibility to check the storage conditions and other information as prescribed by the Minister of Health.

Section 3. CONDITIONS FOR VACCINATION FACILITIES

Article 9. Conditions for fixed vaccination facilities

1. Infrastructure:

a)4 The vaccination area must ensure protection from rain, sun, wind, ventilation, and be arranged in a one-way flow from reception, guidance, counseling, preliminary examination, vaccination, observation, and post-vaccination reaction management;

b)5 (abolished);

c)6 (abolished);

d)7 (abolished);

đ)8 (abolished);

e)9 (abolished);

2. Equipment:

a) Refrigerators, vaccine carriers, or cool boxes, and temperature monitoring devices at storage locations and during vaccine transportation;

b)10 (abolished);

c) Shock-resistant boxes and shock management protocols displayed at observation and post-vaccination reaction management areas as prescribed by the Minister of Health;

d)11 (abolished);

3. Personnel:

a) Quantity: There must be a minimum of three medical staff members, including at least one member with a professional level of at least a medical assistant; for vaccination facilities in remote, mountainous, and particularly difficult areas, there must be a minimum of two staff members with a professional level of at least a junior college degree in medicine, including at least one member with a professional level of at least a medical assistant;

b)12 Medical personnel participating in vaccination activities must be trained in vaccination. Directly involved personnel in preliminary examinations, counseling, observation, and post-vaccination reaction management must have a professional level of at least a medical assistant; personnel performing vaccinations must have a professional level of at least a junior college degree in medical science or nursing-midwifery;

Article 10. Conditions for mobile vaccination points

1. Home-based vaccination can only be carried out in communes in remote, mountainous, and particularly economically disadvantaged areas when meeting the following conditions:

a) Only applicable to vaccination activities under the Expanded Immunization Program and epidemic control vaccination;

b)13 ((to be abolished);

c)14 Must have vaccine carriers and shock-resistant boxes as prescribed by the Minister of Health;

d) Personnel must meet the conditions stipulated in point d, clause 2 of this Article.

2. Conditions for other mobile vaccination points:

a) Must be organized by vaccination facilities that have been certified to meet the vaccination conditions stipulated in Article 11 of this Decree to implement;

b)15 Infrastructure: Arranged in a one-way flow from reception, guidance, counseling, preliminary examination, vaccination, observation, and post-vaccination reaction management;

c)16 Equipment: Must have vaccine carriers or cool boxes and shock-resistant boxes as prescribed by the Minister of Health;

d)17 Personnel: Must have a minimum of two medical staff members meeting the conditions stipulated in point b, clause 3 of Article 9 of this Decree.

Article 11. Announcement of Vaccination Facilities Meeting Conditions

1. Prior to conducting vaccination activities, vaccination facilities must submit a notification of meeting vaccination conditions according to the form prescribed in the Appendix accompanying this Decree to the Department of Health where the vaccination facility is located.

2.18 Within three working days from the date of receipt of the notification of meeting vaccination conditions, the Department of Health must publish information about the name, address, and head of the facility that has announced meeting vaccination conditions on the Department of Health's electronic information website (the time for publishing information is determined based on the stamp of the received official document of the Department of Health).

3. A facility may only conduct vaccination activities after completing the announcement of meeting vaccination conditions, and the head of the facility conducting vaccinations who self-declares meeting vaccination conditions shall be responsible under the law for their self-declaration.

4. During inspections and checks of vaccination conditions at vaccination facilities, if it is found that the vaccination facility does not comply with the conditions stipulated in Article 9 or Article 10 of this Decree then the inspection team must prepare a temporary suspension record and recommend the competent authority to decide on handling according to the provisions of the law while sending one copy of the record to the Department of Health where the vaccination facility is located.

5. Within five working days from the date of receipt of the temporary suspension record specified in Clause 3 of this Article (the receipt date is determined based on the stamp of the received official document of the Department of Health), the Department of Health must remove the facility's name from the list of self-declared facilities published on the Department of Health's electronic information website.

Section 4. CONDITIONS TO ENSURE VACCINATION WORK

Article 12. Vaccination Service Supply System

1. State medical facilities must carry out vaccination with vaccines in the Expanded Immunization Program, epidemic prevention vaccination, and ensure vaccination conditions as prescribed in this Decree according to their assigned functions and tasks.

2. State medical facilities other than those stipulated in Clause 1 of this Article; private medical facilities that have declared meeting vaccination conditions according to this Decree are permitted to register with the local Department of Health to conduct vaccination with vaccines in the Expanded Immunization Program and must organize epidemic prevention vaccination when requested by the competent state management agency.

Article 13. Vaccination Service Fee

1. The vaccination service fee is calculated based on the following factors:

a) Vaccine purchase price;

b) Transportation and storage costs for vaccines;

c) Vaccination service costs.

2. Vaccination service costs are calculated separately for each type of vaccine, number of doses, or oral administrations, and include the following direct and indirect cost factors:

a) Fees for screening, counseling, administration, and post-vaccination monitoring;

b) Consumable material costs;

c) Electricity, water, fuel, medical waste treatment, and environmental sanitation costs directly related to the provision of vaccination services;

d) Depreciation of fixed assets; interest payment costs according to loan contracts, fundraising toa) For PPP projects, the tenderer shall post the selection results of investors and attach the approval decision on the System no later than ten days from the date the document is issued in accordance with point b of Clause 2, Article 4 of Decree No. 35/2021/NĐ-CP.purchase equipment for implementing vaccination services (if applicable) are included and allocated to the costs of services using these funds;

đ) Indirect departmental costs and other lawful costs necessary to ensure the operation of the vaccination facility.

3. Costs already guaranteed by the state budget for vaccines in the Expanded Immunization Program and epidemic prevention vaccination shall not be included in the vaccination service fee.

4. The Minister of Health shall specify the detailed vaccination service fees for vaccines in the Expanded Immunization Program and epidemic prevention vaccination.

Article 14. Sources of funds for vaccination activities

1. Sources of funds formed for vaccination activities:

a) State budget;

b) Sponsorship from organizations and individuals both within and outside the country;

c) The Health Insurance Fund;

d) Other lawful income sources as prescribed by law.

2. The state budget ensures funding for:

a) Using vaccines and medical products for the subjects specified in Clause 3, Article 28 and Clause 4, Article 29 of the Law on Prevention and Control of Infectious Diseases;

b) Investing in cold chain systems for the Expanded Immunization Program and Epidemic Vaccination Program;

c) Information, education, communication, inspection, and supervision of vaccination activities, training costs, research expenses to apply new techniques and methods in vaccination;

d) Compensation when using vaccines in the Expanded Immunization Program and Epidemic Vaccination Program causing serious health impacts or resulting in loss of life of the vaccinated person.

Chapter III. COMPENSATION WHEN USING VACCINES IN THE EXPANDED IMMUNIZATION PROGRAM AND EPIDEMIC VACCINATION PROGRAM CAUSING SERIOUS HEALTH IMPACTS OR LOSS OF LIFE OF THE VACCINATED PERSON

Article 15. Cases eligible for compensation

1. When using vaccines in the Expanded Immunization Program and Epidemic Vaccination Program, if severe adverse events occur that seriously impact the health or result in loss of life of the vaccinated person, the State shall be responsible for compensating the person who has suffered losses.

2. Cases eligible for State compensation include:

a) The vaccinated person suffers severe adverse events leaving permanent disabilities;

b) The vaccinated person dies.

Article 16. Damages, scope, and level of compensation

1. Damage due to permanent disabilities caused by severe adverse events is compensated with 30 months of the basic salary and other costs stipulated in Clauses 3 and 4 of this Article.

2. Damage to life is supported as follows:

a) Costs stipulated in Clause 3 of this Article before death;

b) Funeral expenses equal to 10 months of the basic salary as prescribed by the State;

c) Compensation for mental distress is 100,000,000 VND for relatives of the person who has suffered losses;

d) Costs due to lost or reduced income as stipulated in Clause 4 of this Article.

3. Costs for medical examination and treatment at healthcare facilities:(i) Name, headquarters address, contact phone number of the parties signing the contract;health:

a) In cases where the vaccinated person is entitled to State compensation and holds a health insurance card to examine and treat at healthcare facilities, the payment of examination and treatment costs, and rehabilitation services shall be carried out according to the regulations of the law on health insurance. The portion of costs that the insured person must co-pay and additional services with costs exceeding the insurance reimbursement limit or outside the insurance reimbursement scope shall be paid according to the price list (the maximum amount does not exceed the service fee registered with the Ministry of Health);issuedfee (the maximum not exceeding the service fee registered with the Ministry of Health);

b) In cases where the vaccinated person is entitled to State compensation but does not hold a health insurance card to examine and treat at healthcare facilities, the payment of examination and treatment costs, rehabilitation services, and patient transportation shall be carried out according to the current service fee regulations for public healthcare facilities and accompanied by a receipt;forservice fee for medical examination and treatment for public health facilities and havingissuedthe vaccinated person entitled to State compensation

c)In casemust be hospitalized for treatment, during the treatment process, if other unrelated diseases are discovered, the individual must pay the examination and treatment costs for those diseases according to the regulations on service fees for medical examination and treatment. If the person has a health insurance card, the payment of examination and treatment costs for those diseases shall be carried out according to the regulations on health insurance;compensationIf hospitalization is required during treatment and other unrelated diseases are discovered, the individual must pay the costs of medical examination and treatment for those diseases in accordance with the law on service fees for medical examination and treatment. If the person has a health insurance card, the payment for medical examination and treatment of that disease will be carried out in accordance with the law onforhealth insurance.

4. Damage due to lost or reduced income:

a) Material damage support for one person who must take leave without pay to care for the person entitled to State compensation is provided based on actual income equivalent to the social insurance contribution rate of the previous month, specifically:

b) If the caregiver for the person entitled to State compensation cannot determine their actual income, the support level is determined as follows:Not deposited into temporary accountMinimum wage in the region where the caregiver resides at the time of compensation settlement

c) In cases where the person entitled to State compensation is a worker as defined by labor laws, they are supported for actual lost or reduced income during the period of treatment. The support level is similar to that for caregivers as stipulated in points a and b of this Clause.hỗ trợfor the caregiver is specified in point a and point b of this Clause.

Article 17. Documents and Procedures for Determining Compensation Cases

1. Medical facilities where serious adverse events affecting health or causing life-threatening damage occur must prepare complete files and relevant documents to assist the provincial specialized advisory board in determining compensation cases.

2. In cases where the vaccinated person or their relatives believe that they or their relatives fall under the provisions of thisc) Determine the responsibility of organizations and individuals involved in the production, business operation, storage, and use of vaccines and medical products related to serious adverse events following immunization. then they must prepare and submit to the Department of Health a file including the following documents and papers:

a) A request form to determine the cause of the adverse event and the extent of injury;

b) Vaccination confirmation forms and records related to the vaccine in question;

c) Discharge certificates, medical bills for examination, treatment, rehabilitation, and patient transportation costs (original or certified copies);

d) Death certificate (if applicable);

e) Other relevant documents proving the adverse event or other damages (if any).

3. Within five working days from the date of receipt of the application and valid documents, if the Department of Health determines that the request falls within its responsibility, it must accept the case and notify the injured party or their relatives (hereinafter referred to as the injured party) in writing about the acceptance of the application. If the file is incomplete, the Department of Health shall issuea written notice guiding the injured party to supplement the missing information.

4. Within fifteen days from the date of receipt of the application from the injured party,the Department of Health must complete the determination of the cause of the adverse event, the extent of injury, and notify the applicant in writing while reporting to the Ministry of Health.

Article 18. Compensation Procedures

1. Within five working days from the date of receipt of the conclusion of the provincial specialized advisory board (the receipt date is calculated based on the receipt stamp of the Department of Health), the Department of Health must issue a decision to resolve compensation for cases eligible for state compensation as stipulated in this Decree.

2. The compensation resolution decision must include the following main contents:

a) Name and address of the person being compensated;

b) Summary of reasons for compensation;

c) Amount of compensation;

d) Effectiveness of the compensation resolution decision.

3. The compensation resolution decision must be sent to the injured party, the person at fault, or the organization responsible for the damage (if any).

4. The compensation resolution decision becomes effective fifteen days after the injured party receives the decision, except in cases where the injured party disagrees and initiates a lawsuit.

Article 19. Procedures for Issuing and Paying Compensation Funds

1. Within five working days from the date the compensation resolution decision takes legal effect, the Department of Health must send a letter to the National Expanded Immunization Program requesting funding for compensation along with the legally effective compensation resolution decision.

2. Within ten days from the date of receipt of the request for funding for compensation, the National Expanded Immunization Program must provide funds to the Department of Health to pay the injured party.

3. Within five working days from the date of receipt of the funds provided by the National Expanded Immunization Program, the Department of Health must implement the payment of compensation to the injured party.

Payment must be made in one lump sum in cash to the injured party or transferred according to the injured party's request. In case if the injured party requests payment by transfer, it shall be carried out according to the request and notified in writing to the injured party. If compensation is paid in cash, the injured party must be notified at least two days in advance, and the receipt of compensation must be recorded in two copies, each party involved in the transaction retains one copy.

Article 20. Procedures and Liability for Compensation

1. Within five working days from the date of receipt of the opinion of the provincial specialized advisory council in accordance with point c, Clause 1, Article 6 of this Decreeconclude,the Department of Health shall issue a decision requiring compensation to the State.2. The decision requiring compensation must include the following main contents:

a) Name and address of the organization or individual responsible for causing damage;

b) Summary of reasons for requesting compensation;

c) Amount of compensation;

d) Effectiveness of the decision requiring compensation.

3. The decision requiring compensation must be sent to the organization or individual responsible for causing damage.

4. The decision requiring compensation becomes effective fifteen days after the organization or individual receives the decision, except in cases where the organization or individual disagrees and files a lawsuit with the court.organization5. Organizations or individuals responsible for causing damage as stipulated in Clause 2 of this Article shall be responsible for paying compensation to the National Expanded Immunization Program and submitting receipts to the authority issuing the decision requiring compensation.

6. In cases where the competent authority has issued a decision requiring compensation but the organization or individual responsible does not comply, they will be handled according to the provisions of the law.organizationArticle 21. Responsibilities of the People's Committee of the Provinceorganization1. Direct and organize the implementation of immunization activities in accordance with this Decree on its territory.

2. Ensure resources and local budget for immunization activities on its territory.

3. Direct organizations to inspect, supervise, and handle violations related to immunization activities on its territory.

Chapter IV. RESPONSIBILITIES FOR IMPLEMENTATION

Article 22. Responsibilities of the Ministry of Health

1. Develop and implement annual plans for vaccine usage and immunization; develop short-term, medium-term, and long-term plans in the field of vaccines and immunization.

2. Develop regulations and professional guidelines on immunization.

3. Direct organizations to inspect and supervise the use of vaccines nationwide.

4. Implement information technology applications in managing immunization activities.

5. Provide specific guidance on organizing vaccination sessions; monitor, investigate, report, and notify causes of serious adverse events following immunization; specify reporting and management systems for immunization subjects and vaccine supply for immunization activities.

Article 23. Responsibilities of Ministries and Sectors

1. The Ministry of Education and Training shall be responsible for:

a) Directing educational institutions to check the vaccination status of preschool and primary school students when enrolling, while promoting and encouraging parents and legal guardians

of students to complete vaccinations for those who have not been fully vaccinated, and coordinating with institutions

to implement vaccination work;

b) Inspect and supervise educational institutions in implementing vaccination work.

2. The Ministry of Defense shall be responsible for coordinating with the Ministry of Health to implement vaccination activities in remote, border, island, and military medical facilities.for3. The Ministry of Finance shall be responsible for ensuring funding for expanded vaccination programs and disease control vaccinations in accordance with the Law on State Budget.4. Vietnam Television, Voice of Vietnam Radio, Vietnam News Agency, mass media agencies, and grassroots information agencies shall be responsible for organizing communication activities about the benefits of vaccination to encourage people to vaccinate fully and on schedule.5. Other ministries and sectors shall be responsible for coordinating with the Ministry of Health to implement this Decree in accordance with their assigned functions and tasks.insuranceto implement vaccination activities;

b) Inspect and supervise educational institutions in the implementation of vaccination activities.

2. The Ministry of National Defense shall be responsible for coordinating with the Ministry of Health to implement vaccination activities in remote areas, border regions, islands, and military and civilian hospitals.

3. The Ministry of Finance shall be responsible for ensuring funds for the Expanded Immunization Program and epidemic control immunization in accordance with the provisions of the Law on State Budget.

4. Vietnam Television, Voice of Vietnam, Vietnam News Agency, mass media organizations, and grassroots information agencies shall be responsible for organizing communication activities about the benefits of vaccination to encourage the public to fully and timely comply with vaccination schedules.

5. Other ministries and sectors shall be responsible for performing their assigned functions and duties in coordination with the Ministry of Health to implement this Decree.coordinatewith the Ministry of Health to implement this Decree.

Article 24. Responsibilities of Vaccination Facilities

1. Vaccination facilities must ensure compliance with legal regulations, professional guidelines on vaccination safety, management of vaccinated individuals, and reporting as prescribed.

2. Maintain and manage documentation and records related to vaccinations and post-vaccination reactions as prescribed.

Article 25. Responsibilities of Vaccination Personnel

1. Provide comprehensive counseling to the person being vaccinated or the family of the child being vaccinated regarding the benefits and potential risks associated with vaccination.

2. Guide the person being vaccinated or the family of the child being vaccinated on how to monitor and handle post-vaccination reactions.

3. Adhere strictly to professional regulations during vaccination.

Article 26. Responsibilities of Parents or Guardians of Children and Individuals Receiving Vaccinations

1. Parents or guardians of children must register for vaccination for the child after birth or at the first vaccination visit and bring the child for vaccination as prescribed.

2. Individuals within the expanded immunization program must proactively register for vaccination with local healthcare facilities and complete all required vaccinations as prescribed.

3. Coordination, comply fully with the guidance provided by healthcare staff during vaccination and post-vaccination monitoring and handling.

4. Report fully and truthfully all health information during the vaccination period and after vaccination.

5. Must undergo vaccination uponNot deposited into temporary account professional indication.

6. Maintain and store personal vaccination tracking records. Provide information about the child's vaccination status to educational institutions specified inpoint a clause 1 Article 23 of this Decree upon request.

Chapter V. IMPLEMENTING PROVISIONS

Article 27. Effective Date19

This Decree takes effect from July 1, 2016.

Article 28. Transitional Provisions and Implementation Timeline20

1. For vaccination facilities that have been issued a certificate of qualification for vaccination before the effective date of this Decree, they may continue operations until the expiration date on the certificate and must complete the announcement of their qualification for vaccination as prescribed in(i) Name, headquarters address, contact phone number of the parties signing the contract; before the certificate expires.Article 11 of this Decree2. For vaccination facilities that submitted applications for a certificate of qualification for vaccination before the effective date of this Decree but have not yet received the certificate, the Department of Health shall be responsible for guiding these facilities to complete the announcement of their qualification for vaccination as prescribed in

 within sixty days from the effective date of this Decree.Article 11 of this Decree1. The Ministers, Heads of Ministries equivalent to Ministries, Heads of Government Agencies, Chairmen of Provincial People's Committees are responsible for implementing this Decree.

Article 29. Responsibility for Implementation

2. The Minister of Health, within the scope of his duties and authority, shall coordinate with relevant ministries and sectors to provide detailed regulations and guidance on the implementation of the provisions assigned in this Decree to meet state management requirements for vaccination activities./.of the National Assembly;Number: 06/VBHN-BYT

- Minister Nguyen Thi Kim Tien (for reporting);

ANNEX

Number: ……/….
……, day…. month…. year 20….At the proposal of)

NOTICE

Head of Facility: …

Respectfully submitted to: ...²⁵………………………………

Contact Phone:… Email (if available): …

Address: …²⁶................................................

Based on Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government on vaccination activities, we respectfully request the relevant authorities to consider and publish the information as prescribed.

 Name of the supervising agency proposing the announcement of qualification for vaccination

 Name of the facility proposing the announcement of qualification for vaccination

___________________

²¹ Abbreviation of the name of the facility proposing the announcement of qualification for vaccination(i) Name, headquarters address, contact phone number of the parties signing the contract; Location

²² Name of the agency receiving the application for the announcement of qualification for vaccination

²³ Specific address of the

²⁴Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to investment and business conditions under the Ministry of Health's jurisdiction is based on the following:

²⁵The Government promulgates the Decree amending and supplementing certain provisions related to investment and business conditions under the Ministry of Health's jurisdiction.”

²⁶This Clause is repealed according to point a, Clause 2, Article 14 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.ofThis Clause is amended according to point a, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.(i) Name, headquarters address, contact phone number of the parties signing the contract; Location

1 This Clause is amended according to point b, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

"On the basis of the Law on Government Organization dated June 19, 2015;

Considering the proposal of the Minister of Health;

This Clause is repealed according to point b, Clause 2, Article 14 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

2 This Clause is repealed according to point c, Clause 2, Article 14 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

3 This Clause is amended according to point c, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

4 This Clause is repealed according to point d, Clause 2, Article 14 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

5 This Clause is amended according to point d, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

6 This Clause is amended according to point d, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

7 This Clause is amended according to point d, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

8 This Clause is amended according to point d, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

9 This Clause is amended according to point d, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

10 This Clause is amended according to point đ, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

11 This Clause is amended according to point đ, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

12 This Clause is amended according to point e, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

13 This Clause is amended according to point g, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

14 This Clause is amended according to point h, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which takes effect from November 12, 2018.

15 The Ministers, Heads of Ministries equivalent to Ministries, Heads of Government Agencies, Chairmen of Provincial People's Committees directly under the Central Government are responsible for implementing this Decree./.”

16 This Clause was amended in accordance with point e, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which took effect from November 12, 2018.

17 This Clause was amended in accordance with point g, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which took effect from November 12, 2018.

18 This Clause was amended in accordance with point h, Clause 3, Article 15 of Decree No. 155/2018/NĐ-CP, which took effect from November 12, 2018.

19 Articles 20 and 22 of Decree No. 155/2018/ND-CP, which shall take effect from November 12, 2018, are stipulated as follows:

Article 20. Effective Date

This Decree takes effect from the date of issuance.

Article 22. Responsibility for enforcement

Ministers, heads of ministerial-level agencies, heads of government-affiliated agencies, Chairmen of provincial People's Committees directly under the central government are responsible for implementing this Decree./.”

20 Clause 3, Article 21 of Decree No. 155/2018/ND-CP, effective from November 12, 2018, provides as follows:

"Article 21. Transitional Provisions

3. Transitional provisions for Decree No. 104/2016/ND-CP:

a) Vaccination facilities that have been issued certificates of compliance with vaccination conditions must continue to maintain the conditions stipulated in the certificate's validity period and complete the self-declaration of compliance with vaccination conditions before the certificate expires, in accordance with Decree No. 104/2016/ND-CP and this Decree;

b) For vaccination facilities that have declared compliance with vaccination conditions, they must continue to maintain the conditions stipulated in Decree No. 104/2016/ND-CP and this Decree;

c) For vaccination facilities operating after the effective date of this Decree, they must meet the conditions stipulated in Decree No. 104/2016/ND-CP and this Decree."