Circular 34/2018/TT-BYT elaboration Decree 104/2016/ND-CP on vaccination

• Official number: 34/2018/TT-BYT
• Legislation Type: Circular
• Organization: The Ministry of Health
• Signer: Nguyen Thi Kim Tien
• Issued Date: 12/11/2018

MINISTRY OF HEALTH -------	THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ---------------
No. 34/2018/TT-BYT	Hanoi, November 16, 2018

CIRCULAR

ELABORATION OF SOME ARTICLES OF THE GOVERNMENT’S DECREE NO. 104/2016/ND-CP DATED JULY 01, 2016 ON VACCINATION

Pursuant to the Government’s Decree No. 104/2016/ND-CP DATED July 01, 2016 on vaccination;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, entitlements and organizational structure of the Ministry of Health;

At the request of the General Director of the General Department of Preventive Medicine;

The Minister of Health hereby promulgates a Circular to elaborate some Articles of the Government’s Decree No. 104/2016/ND-CP dated July 01, 2016 on vaccination.

Chapter I

GENERAL PROVISIONS

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This Circular provides for receipt, transport and storage of vaccines; vaccination organization; supervision and surveys into serious vaccine injuries; regulations on reporting and vaccination document management.

Article 2. Definitions

For the purposes of this Circular, the terms below shall be construed as follows:

1. “cold box” means a container that is lined with coolant packs to store vaccines and diluents during transport or storage for periods of 4 - 7 days depending on the model.

2. “insulated container” means a container that is lined with coolant packs to store vaccines and diluents during transport or storage for periods of 1 - 2 days depending on the model.

3. “vaccine vial monitor” (VVM) means a label attached to a vaccine vial and may change color when the vaccine is exposed to high temperature beyond the acceptable limit depending on the type of vaccine.

4. “electronic freeze indicator” means a device used to indicate that the vaccine storage equipment has been exposed to freezing temperatures.

5. “temperature logger” means a device used to record vaccine storage temperature during the transport and storage.

6. “common vaccine side effect” means a mild or self-limiting effect that occurs after vaccination, including local reactions such as pain, swelling or redness at the site of injection, systemic reactions such as fever lower than 39°C and other reactions (irritability, fatigue, loss of appetite).

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PROVISIONS ON RECEIPT, TRANSPORT AND STORAGE OF VACCINES

Article 3. Distribution and receipt of vaccines

1. When distributing vaccines, the distributor shall check and retain information by using the Form in the Appendix I hereof at the distributing unit. If any unclear information about vaccines is found, both parties shall make a record of vaccine conditions and take appropriate actions.

2. When receiving vaccines, the recipient shall check and retain information by using the Form in the Appendix I hereof. If any unclear information about vaccines is found, they must not be received.

Article 4. Storage of vaccines and diluents in cold chain equipment

1. Storage of vaccines:

Vaccines shall be stored in accordance with Article 8 of the Government’s Decree No. 104/2016/ND-CP dated July 01, 2016 on vaccination (hereinafter referred to as “the Decree No. 104/2016/ND-CP”) and the following specific provisions:

a) Vaccines should be kept in the cold chain equipment separate from other products;

b) Vaccines should be arranged in a designated location and vaccine freezing should be avoided;

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d) Cold chain temperature should be monitored on a daily basis (including public holiday or weekend) and recorded twice daily in the morning and at the end of the working day;

dd) Regarding vaccines in the Expanded Program on Immunization: in addition to the provisions mentioned in Points a, b, c and d of this Clause, there must be cool chamber temperature alarm device and log recording automatically temperature of the storage where vaccines in the central and regional expanded programs on immunization are kept; thermometers and electronic freeze indicators must be installed in the vaccine storages or vaccine refrigerators of the province and districts; thermometers must be installed in the vaccine refrigerators, cold boxes or insulated containers of communes.

2. Storage of diluents:

If diluents are not packaged with the vaccine, the product can be stored outside the cold chain equipment but is required to comply with the manufacturer's storage requirements and the following requirements:

a) Diluents should never be frozen;

b) Diluents should be cooled to +2°C to +8°C for 24 hours prior to use for reconstitution.

Article 5. Storage of vaccines during a vaccination session

1. Insulated containers, cold boxes or vaccine refrigerators should be used to store vaccines during a vaccination session as prescribed in Points a, b, c and d Clause 1 Article 4 of this Circular and maintain a temperature of +2°C to +8°C.

2. The vaccines vials that have not been opened after a vaccination session should be stored in the cold chain equipment and used first in the next session.

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1. Vaccines shall be transported as prescribed in Points b and d Clause 1 Article 8 of the Decree No. 104/2016/ND-CP.

2. Vaccines during transport shall be stored as prescribed in Points a, b and c Clause 1 Article 4 of this Circular. Storage temperature should be continuously maintained depending on the type of vaccine according to the instructions on the label or package insert during the transport.

3. Temperatures of vaccines in the Expanded Program on Immunization should be monitored using thermometers and electronic freeze indicators and recorded during the transport with respect to central, regional and provincial expanded programs on immunization. With respect to district and commune expanded programs on immunization, it is required to monitor vaccine temperatures using thermometers during the transport.

Article 7. Maintenance of cold chain equipment and supervision of storage of vaccines in cold chain

1. Cold chain equipment should be regularly inspected, periodically monitored and maintained according to the manufacturer’s instructions, and repaired and replaced in accordance with the manufacturer's technical requirements to ensure vaccines are always stored within the required temperature range during the storage, transport and use according to the instructions on the label or package insert.

2. Cold chain equipment and storage temperature monitoring equipment shall be periodically maintained and calibrated in accordance with regulations of the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016.

Chapter III

VACCINATION ORGANIZATION

Article 8. Vaccinee management

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2. Vaccines shall be reported and managed in writing and through the National Immunization Information System. Time for submitting reports using the National Immunization Information System shall be specified by the Ministry of Health.

Article 9. Arrangements made at fixed and mobile vaccination clinics

1. There must be no more than 50 vaccinees/vaccination clinic/vaccination session. In the cases where only a single type of vaccine is to be administered during a vaccination session, the number of vaccinees per session must not exceed 100. There must be adequate health workers in charge of performing screening examinations.

2. Each vaccination clinic is entitled to arrange from one to several fixed vaccination clinics and ensure adequate area, personnel, infrastructure and equipment.

3. Each vaccination clinic shall have a table of working arrangements.

4. A vaccination clinic shall be arranged according to a flow pattern: Waiting area → Registration and instruction table → Consultation and screening table → Vaccination table → Vaccination record keeping table → Post-vaccination monitoring and response area.

Article 10. Provision of screening examinations and consultancy before vaccination

1. Regarding children, conduct screening examinations in accordance with regulations of the Ministry of Health. Regarding adults, observe their general appearance and assess their medical condition.

2. Ask vaccinees and collect their information about medical history, allergies and vaccinations.

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4. Inform vaccines, parents or guardians of children about efficacy, dose and administration route of vaccines before vaccination.

Article 11. Giving vaccinations

1. Dose and administration route of each type of vaccine shall follow the instructions on the label or package insert.

2. Freeze-dried vaccines must be reconstituted as prescribed in the Appendix II hereof.

3. Vaccines shall be used according to the principle: short-dated vaccines must be used first, vaccines received first must be used first or vaccine vial temperature indicator must be used first according to the manufacturer's instructions or vaccines that have not been used up in the previous session must be stored as prescribed and used first.

4. Opened vials of liquid vaccines must be cooled at temperatures between +2 °C and +8 °C and used in a vaccination session.

5. Diluent of one vaccine is only used for such vaccine. Freeze-dried vaccines after reconstitution are only permitted for use within 6 hours or according to the manufacturer’s instructions.

6. Giving vaccination:

a) Check vaccines, diluents, syringes and needles prior to use;

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c) Give vaccination to the prescribed vaccinees, vaccine, does, administration route and time.

d) Put syringes, needles and sharp objects in a safety box after injection. Do not cover needles.

7. End of the vaccination session:

a) Store vaccines and diluents that have not been used shall be stored as prescribed in Article 4 of this Circular;

b) Syringes that have not been used shall be stored as prescribed for later use;

c) The opened multi-dose vaccine vials that have not been used up and have been used up after the vaccination session shall be handled as prescribed in the Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015 of the Ministry of Health and Ministry of Natural Resources and Environment;

d) Arrange additional vaccination session within month in the cases where vaccination under the Expanded Program on Immunization is postponed.

Article 12. Post-vaccination monitoring

1. Vaccinees should be monitored at least 30 minutes after vaccination at the vaccination clinic.

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a) Keep monitoring at home at least 24 hours after vaccination in terms of general appearance, mind, eating, sleep, breath, hives and symptoms at the injection site, and inform health workers in case of abnormal signs;

b) Immediately take the vaccinee to a hospital or health facility if one of the following signs occur after the vaccination: high fever (≥39°C), convulsion, child's bursting into loud wails, sniveling and crying for a long time, lethargy, poor feeding, breast refusal, dyspnea, cyanosis, hives and other abnormal signs or common reactions last for more than 24 hours after vaccination.

3. Recording:

a) Write all information in the vaccinees’ vaccination sheet/handbook and enter such information into the National Immunization Information System and make an appointment for the following vaccination session.

b) Enter the date of vaccination for each type of vaccine given to vaccinees and vaccine side effects into the National Immunization Information System.

Article 13. Organization of vaccination campaigns and mobile vaccination

1. Vaccination campaigns shall be organized under the guidance of the Ministry of Health provided for each campaign.

2. Only vaccination clinics that have submitted a declaration of eligibility for vaccination as prescribed in the Decree No. 104/2016/ND-CP are allowed to carry out vaccination campaigns.

3. A mobile vaccination clinic may only operate if it is participating in an expanded immunization program or vaccination against epidemic in the commune within a remote area or extremely disadvantaged area.

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SUPERVISION OF INVESTIGATION INTO CAUSES OF SERIOUS VACCINE INJURIES

Article 14. Discovery, response to and reporting of serious vaccine injuries

1. The discovery of and response to serious vaccine injuries shall comply with Clauses 2, 3 and 4 Article 5 of the Decree No. 104/2016/ND-CP.

2. Report all information concerning the serious vaccine injury after vaccination:

a) Full name, age, gender, address and phone number (if any) of the vaccinee or parents or guardian of child;

b) Date and time of vaccination;

c) Type of vaccine; name of vaccine; registration number or import license number; batch number; expiry date; manufacturer; supplier; storage conditions upon receipt of the vaccine;

d) Date and time of occurrence of the serious vaccine injury; main symptoms; treatment result; conclusion about the cause (if any).

3. Report the number of vaccines (names of the vaccines, batch number, expiry date) that have been used during the vaccination session; number of people that have been given vaccination according to each type of vaccine and number of batches of vaccines that have been used during the vaccination session, medical conditions of the vaccinees.

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a) provide emergency treatment as prescribed;

b) submit a report to the Provincial Department of Health as prescribed in Clause 3 Article 5 of the Decree No. 104/2016/ND-CP;

5. The vaccination authority of the district or province shall submit a consolidated report to the vaccination authority of higher level as prescribed in Articles 18 and 20 of this Circular.

Article 15. Investigation into causes of serious vaccine injuries

1. The Provincial Department of Health shall establish an inspectorate, including the chief who is a senior representative of the Center for Disease Control or preventive health center of the province or central-affiliated city (hereinafter referred to as “the Center for Disease Control”), members who are representatives of the Health Department affiliated to the Provincial Department of Health, the Department of Infectious Disease Control of the Center for Disease Control, Emergency Department, Obstetrics and Gynecology Department/Pediatrics Department of the Provincial General Hospital or Provincial Hospital of Obstetrics and Gynecology/Children’s Hospital and other relevant experts and staff.

2. Investigation procedures:

a) Take investigation steps provided in the Appendix III hereof;

b) Use the investigation form provided in the Appendix IV hereof;

c) Report investigation results to the Provincial Department of Health.

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a) Collect samples of vaccines related to serious vaccine injuries after vaccination;

b) Vaccine samples shall be collected, sealed, stored and sent as prescribed in the Appendix V hereof;

c) Vaccine quality shall be inspected if it is suspected that the serious injury is because of the vaccine or at the request of the advisory council for assessment of the cause of serious injury;

d) The vaccines that are not required to be inspected shall continue to be used.

4. The vaccination clinic that discovers the serious injury and receives the patient shall, where necessary, collect pathology specimens to identify the cause of the serious injury.

Article 16. Assessment of causes of serious vaccine injuries and announcement of assessment result

1. An assessment of the cause of a serious vaccine injury shall be carried out in the following cases:

a) A serious vaccine injury occurs after vaccination;

b) The rate of common vaccine side effects is higher than usual.

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2. The cause of the serious injury shall be assessed and classified using the forms in the Appendix VI and Appendix VII hereof respectively.

3. The Provincial Department of Health shall:

a) establish and hold a meeting with the provincial advisory council to assess the cause of the serious vaccine injury and make announcement thereof under Clauses 1 and 2 Article 6 of the Decree No. 104/2016/ND-CP and instructions of the Ministry of Health.

b) Causes of the cases mentioned in Points b and c Clause 1 of this Article shall be assessed.

Chapter V

REGULATIONS ON REPORTING AND DOCUMENT MANAGEMENT

Article 17. Reporting regulations

The following reports shall be submitted:

1. Periodic reports, including monthly, quarterly and yearly reports on use of vaccines, vaccination results, common vaccine side effects and serious vaccine injuries.

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3. Daily reports upon giving vaccinations against epidemic.

Article 18. Presentation and contents of reports

1. Presentation:

a) Periodic reports shall be submitted in writing and through the National Immunization Information System;

b) Regarding ad hoc reports, urgent matters may be presented directly, by call or email and ad hoc reports shall be submitted in writing within 24 hours;

c) Daily reports may be submitted in writing or electronically.

2. Contents of reports:

a) Periodic reports include:

- Report on use of vaccines in the Expanded Program on Immunization made using the Form No. 1 in the Appendix VIII hereof;

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- Report on vaccination result made using the Forms No. 1, 2 and 3 in the Appendix IX hereof;

- Report on common vaccine side effects made using the Form in the Appendix X hereof;

- Report on serious vaccine injuries made using the Form in the Appendix XI hereof.

b) Regarding ad hoc reports, vaccination clinics shall submit ad hoc reports using the Form in the Appendix XII hereof or at the request of a competent authority. Health facilities that receive patients suffering from serious vaccine injuries shall submit a report as prescribed in Clause 3 Article 5 of the Decree No. 104/2016/ND-CP.

c) Regarding daily reports, reports on number of vaccinees, vaccines, vaccination materials, common vaccine side effects and serious vaccine injuries upon giving vaccinations against epidemic shall be submitted.

Article 19. Procedures and time for submitting periodic reports

1. Regarding vaccines in the Expanded Program on Immunization:

a) The vaccination clinic shall submit monthly, quarterly and yearly reports to the heath center of the district before the 05^th of the succeeding month, 05^th of the first month of the succeeding quarter and January 15 of the succeeding year respectively;

b) The health center of the district shall submit monthly, quarterly and yearly reports to the Center for Disease Control before the 10^th of the succeeding month, 10^th of the first month of the succeeding quarter and January 25 of the succeeding year respectively;

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d) The national expanded immunization project management unit shall submit monthly, quarterly and yearly reports to the General Department of Preventive Medicine before the 20^th of the succeeding month, 20^th of the first month of the succeeding quarter and February 15 of the succeeding year respectively;

2. Regarding service vaccines:

a) The vaccination clinic shall submit monthly, quarterly and yearly reports to the heath center of the district before the 05^th of the succeeding month, 05^th of the first month of the succeeding quarter and January 15 of the succeeding year respectively;

b) The health center of the district shall submit monthly, quarterly and yearly reports to the Center for Disease Control before the 10^th of the succeeding month, 10^th of the first month of the succeeding quarter and January 25 of the succeeding year respectively;

c) The Center for Disease Control shall submit monthly, quarterly and yearly reports to the Provincial Department of Health, regional institutes and General Department of Preventive Medicine before the 15^th of the succeeding month, 15^th of the first month of the succeeding quarter and January 31 of the succeeding year respectively;

Article 20. Procedures and time for submitting ad hoc reports

1. Within 24 hours from the date on which the serious vaccine injury is recorded, the vaccination clinic or the health facility that receives the patient suffering from the serious vaccine injury shall submit a report to the Provincial Department of Health, Center for Disease Control and health center of the district where the clinic is located.

2. On a weekly basis, after submitting a report as prescribed in Clause 1 of this Article, if an investigation conclusion is yet to be available:

a) The vaccination clinic shall submit a report on the process of investigation and handling during a week on the second date of succeeding week;

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Article 21. Procedures and time for submitting daily reports

1. The vaccination clinic shall submit a daily report to the health center of the district before 17:00.

2. The health center of the district shall submit a daily report to the Center for Disease Control before 09:00 on the succeeding day.

3. The Center for Disease Control shall submit a daily report to the Provincial Department of Health, regional institutes and General Department of Preventive Medicine before 14:00 on the succeeding day.

Article 22. Document management

1. Every vaccination clinic shall retain and manage documents, including:

a) Regulations and specialized guidelines for use of vaccines, tables of working arrangements;

b) Vaccinees’ vaccination handbooks or information about vaccinees if information technology is applied to manage documents;

c) Handbooks and periodic, ad hoc and daily reports.

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a) Regulations and documents providing specialized guidelines for vaccination;

b) Periodic, ad hoc and daily reports submitted by the authorities under their management.

3. Institutes of Hygiene and Epidemiology, Pasteur Institutes and national expanded immunization project management units shall retain and manage documents, including:

a) Regulations and documents providing specialized guidelines for use of vaccines and vaccination;

b) Periodic, ad hoc and daily reports submitted by the authorities under their management.

4. Documents, reports and handbooks must be adequate, easy for search, managed and retained as prescribed by the law on archives.

Chapter VI

RESPONSIBILITY FOR IMPLEMENTATION

Article 23. Responsibilities of Departments and General Departments affiliated to the Ministry of Health

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a) take charge and cooperate with relevant Departments and General Departments in directing, providing guidelines and carrying out specialized inspections of uses of vaccines nationwide; disseminating information about safety and benefits of vaccination and possible vaccine side effects;

b) take charge or cooperate with relevant units in drawing up specialized guidelines for use of vaccines, supervising handling of and investigation into causes of serious vaccine injuries and submitting them to a competent authority for promulgation.

c) take charge of managing and providing guidelines for the implementation of the National Immunization Information System.

2. The Drug Administration of Vietnam shall:

a) provide counseling for leaders of the Ministry of Health on suspension of use and permission for re-use of vaccines nationwide, cooperate with the Provincial Departments of Health in suspending the use of vaccine batches as prescribed;

b) manage the supply of vaccines and vaccine quality sold in Vietnam;

c) cooperate with relevant units in inspecting the use of vaccines as prescribed;

d) provide guidelines for recall, storage and destruction of vaccines as prescribed;

dd) provide new list of vaccines and serums within 05 working days from the date on which vaccines are licensed for sale in Vietnam to the General Department of Preventive Medicine to update the National Immunization Information System.

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a) take charge and cooperate with Maternal and Child Health Department in providing guidelines for provision of screening examinations before vaccination to children and response to serious vaccine injuries. Direct health facilities to cooperate with the Center for Disease Control in assisting vaccination clinics in carrying out  screening examinations before vaccination, responding to serious vaccine injuries and investigating causes of serious vaccine injuries;

b) direct, inspect and supervise the vaccination by health facilities;

c) cooperate with relevant units in inspecting the use of vaccines as prescribed;

d) direct health facilities that have vaccination clinics or health facilities licensed to give vaccinations to apply the National Immunization Information System under the guidance of the Ministry of Health.

Article 24. Responsibilities of national expanded immunization project management units and institutes

1. National expanded immunization project management units shall:

a) prepare a plan for demand for use of vaccines, propose vaccines and vaccination schedule in the Expanded Program on Immunization:

b) purchase, receive, store and supply vaccines in the Expanded Program on Immunization to users as prescribed;

c) design and uniformly apply vaccination training documents approved by the competent authority. Provide training in expanded immunization program or vaccination against epidemic;

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dd) cooperate in providing training in supervision of and investigation into vaccine side effects to the provincial advisory council for assessment of causes of serious vaccine injuries;

e) submit consolidated reports on vaccination as prescribed;

g) organize the dissemination of information about safety and benefits of vaccination and vaccine side effects under the direction of the Ministry of Health;

h) manage and use compensation in the cases where compensation is paid by the State as prescribed in the Decree No. 104/2016/ND-CP;

i) provide guidelines, organize, inspect and supervise expanded vaccination and supervise diseases during expanded vaccination;

k) cooperate with the General Department of Preventive Medicine in directing and providing guidelines for the implementation of the National Immunization Information System under the guidance of the Ministry of Health;

l) act as a standing member of the Nation Steering Committee for Immunization.

2. Regional institutes shall:

a) provide technical guidelines and supervise the use of vaccines by areas assigned to manage by the Ministry of Health to ensure quality and safety of vaccination; supervise vaccine side effects;

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c) provide training in vaccination and use of vaccines in expanded immunization program or vaccination against epidemic;

d) cooperate in investigating and concluding causes of serious vaccine injuries within areas under their management, promptly respond to cases of serious vaccine injuries;

dd) submit consolidated reports on vaccination by areas under their management;

e) cooperate with the General Department of Preventive Medicine in providing guidelines for the implementation of the National Immunization Information System under the guidance of the Ministry of Health.

3. The National Institute for Control of Vaccine and Biologicals shall:

a) supervise quality and safety of vaccines nationwide;

b) cooperate with relevant units in inspecting the use of vaccines.

Article 25. Responsibilities of Provincial Departments of Health, Center for Disease Control, District Departments of Health and health centers of districts

1. Provincial Departments of Health shall:

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b) organize the assessment, conclusion and announcement of causes of serious vaccine injuries within their provinces;

c) direct the dissemination of information about safety and benefits of vaccination and vaccine side effects;

d) decide to suspend the use of vaccines on the basis of comments of the Drug Administration of Vietnam and re-use of vaccines within their provinces and inform the Drug Administration of Vietnam thereof.

dd) direct the implementation of the National Immunization Information System under the guidance of the Ministry of Health within their provinces.

2. The Center for Disease Control shall:

a) use, store and distribute vaccines that satisfy quality requirements to meet the people's demand for vaccination;

b) provide training and re-training in vaccination and use of vaccines in expanded immunization program or vaccination against epidemic;

c) participate in investigating and assessing causes of serious vaccine injuries within provinces;

d) Collect samples of vaccines upon occurrence of serious vaccine injuries;

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e) submit consolidated reports on vaccination within its area;

g) direct the implementation of and implement the National Immunization Information System under the guidance of the Ministry of Health within its area;

3. District Departments of Health shall:

a) cooperate with health centers of districts in directing the vaccination within their areas in accordance with regulations of Ministry of Health;

b) inspect the vaccination within their areas;

4. Health centers of districts shall:

a) store, transport and distribute vaccines that satisfy quality requirements and direct and instruct health centers of communes to use vaccines as prescribed;

b) cooperate with District Departments of Health in inspecting the vaccination within their districts;

c) The health centers of districts licensed to provide technical services related to preventive medicine, medical examination and treatment shall comply with Article 26 of this Circular;

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dd) direct and provide guidelines for the implementation of the National Immunization Information System under the guidance of the Ministry of Health within their districts.

Article 26. Responsibilities of state-owned hospitals of obstetrics and gynecology, children’s hospitals and general hospitals

State-owned hospitals of obstetrics and gynecology, children’s hospitals and general hospitals shall:

1. provide training in screening examinations for vaccination clinics under the guidance of Ministry of Health and Provincial Departments of Health.

2. cooperate in investigating and concluding causes of serious vaccine injuries.

3. give hepatitis B vaccines within 24 hours after birth (if the health facility has delivery rooms) as prescribed and give other vaccines in the Expanded Program on Immunization at the request of the competent authority.

4. implement the National Immunization Information System at vaccination clinics under the guidance of the Ministry of Health.

5. submit consolidated reports on their vaccination (if any).

Article 27. Responsibilities of vaccination clinics and vaccination givers

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a) be responsible to law for performance of tasks within their jurisdiction;

b) comply with technical procedures for use of vaccines and safety of vaccination;

c) give hepatitis B vaccines within 24 hours after birth (if the health facility has delivery rooms) as prescribed and give other vaccines in the Expanded Program on Immunization at the request of the competent authority;

d) cooperate with organizations in encouraging the people to participate in vaccination;

dd) cooperate with relevant units in investigating and facilitating the investigation into causes of serious vaccine injuries;

e) implement the National Immunization Information System under the guidance of the Ministry of Health;

g) submit consolidated reports on their vaccination.

2. Vaccination givers shall comply with clinical pathways for vaccination of the Ministry of Health and relevant regulations of this Circular.

Chapter VIII

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Article 28. Effect

1. This Circular comes into force from January 01, 2019.

2. The Circular No. 12/2014/TT-BYT dated March 20, 2014 of the Minister of Health is null and void from the effective date of this Circular.

Article 29. Reference clause

In the cases where any of the documents referred to in this Circular is amended or replaced, the newest one shall apply.

Article 30. Responsibility for implementation

Chief of the Ministry Office, General Director of General Department of Preventive Medicine, Directors and General Directors of Departments and General Departments affiliated to the Ministry of Health, Directors of Provincial Departments of Health, heads of health authorities, and organizations and individuals are responsible for the implementation of this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Heath for consideration./.

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THE MINISTER




Nguyen Thi Kim Tien