Circular No. 12/2014/TT-BYT guiding the management and use of vaccines in immunization

CIRCULAR

Guidelines for the management and use of vaccines in immunization

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On the basis of Currency Exchange Agent No. 1 d Clause 2 Article 30 Law on Prevention and Control of Infectious Diseases;

Pursuant to DecreeNo. Decision No. 63/2012/NĐ-CP dated August 31, 2012 of the Government detailing the functions, tasks, and regulations"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."Theo đề nghị của Vụ trưởng Vụ Tín dụngof the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home AffairsFor traditional medicine doctors, traditional medicine practitioners, licensed traditional medicine practitioners, and those with hereditary prescriptions or hereditary treatment methods, the scope of professional activities shall be implemented according to another Circular issued by the Minister of Health.

Considering the proposal of the Director of the Preventive Health Department|||;

The Minister of Health issues this Circular to guide the management and use of vaccines in immunization,

Chapter I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates on:

1. Conditions for healthcare facilities implementing immunization (hereinafter referred to as immunization facilities);

2. Procedures for transportation, receipt, storage, and distribution of vaccines;

3. Organization of immunization;

4. Surveillance and handling of adverse reactions following immunization;

5. Authority, files, procedures for issuing, reissuing, suspending, and revoking certificates of eligibility for immunization.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

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

2. Cold chain is a system of equipment designed to store and transport vaccines at the correct temperature from the manufacturer to the user, including cold rooms, refrigerated vehicles, refrigerators, freezers, cold boxes, vaccine carriers.

3. Adverse reaction following organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.immunization is an abnormal health phenomenon including local and systemic manifestations occurring after immunization, not necessarily caused by the use of vaccines, including common adverse reactions following immunization and severe adverse events following immunization.

4. Severe adverse event following immunization is an abnormal reaction following immunization that may threaten the life of the vaccinated person (including symptoms such as difficulty breathing, anaphylactic shock, toxic shock syndrome, high fever convulsions, prolonged crying in infants, cyanosis, respiratory arrest) or leave sequelae or result in the death of the vaccinated person.

Article 3. Principles of vaccine management and use

1. Only healthcare facilities that have been issued a certificate of eligibility for immunization are permitted to carry out immunization activities.

2. Certificates of eligibility for immunization are only issued to fixed immunization facilities.

3. Healthcare facilities that have been issued a certificate of eligibility for immunization must regularly maintain conditions to conduct immunization activities in accordance with this Circular.

4. State-owned healthcare facilities with immunization functions must organize and implement immunization activities in accordance with regulations. Hospitals and clinics with delivery rooms must provide immunization services for newborns as prescribed.

5. Vaccines under the Expanded Program on Immunization shall not be used for paid immunization services.

Chapter II

CONDITIONS FOR IMMUNIZATION FACILITIES

Article 4. Healthcare facilities eligible to perform immunization

1. Hospitals, multi-specialty clinics, family doctor clinics, midwifery houses, and Commune Health Stations, Ward Health Stations, Town Health Stations (hereinafter referred to as Commune Health Stations) that have operating licenses in accordance with laws on medical examination and treatment.

2. Preventive healthcare facilities.

Article 5. Conditions for fixed immunization facilities

1. Infrastructure:

a) Waiting area before vaccination must be arranged with sufficient seating for at least 50 individuals during one vaccination session, ensuring protection from rain, sun, wind, and ventilation;

b) Consultation and classification examination area must have a minimum area of 8 square meters;²;

c) Vaccination implementation area must have a minimum area of 8 square meters;²;

d) Observation and adverse reaction management area must have a minimum area of 15 square meters;².

đ) For hepatitis B vaccine injection points in healthcare facilities with delivery rooms, they do not follow points a, b, c, and d of this clause but instead follow the following provisions: Arrange a separate vaccination room or table, ensure warmth for the child, have a place for child examination, and counseling for mothers or guardians.

The areas specified in points a, b, c, and d must meet hygiene conditions, adequate lighting, and be arranged in a one-way flow.

2. Equipment:

a) Vaccine storage equipment as prescribed: refrigerators, temperature monitoring devices at storage locations and during vaccine transportation. For Commune Health Stations without refrigerators, they must have vaccine carriers or cold boxes to store vaccines as prescribed in Article 9 of this Circular;

b) Injection equipment, sterilization chemicals, and other necessary supplies;

c) Shock prevention kit and shock prevention protocol hung in the observation and adverse reaction management area according to the Ministry of Health's regulations;

d) Containers for vaccine vials and medical waste as prescribed by the Ministry of Health.

3. Personnel:

a) Number: at least three healthcare professionals, including at least one professional with a level of expertise from a licensed practical nurse or higher; for immunization facilities in remote, difficult, and extremely difficult areas, there must be at least two healthcare professionals, including at least one professional with a level of expertise from a licensed practical nurse or higher;

b) Directly involved personnel in screening, counseling, vaccination, observation, and adverse reaction management must hold training certificates in immunization issued by the facilities specified in Article 30 and Article 31 of this Circular;

4. In cases where the immunization facility is a medical examination and treatment facility, in addition to meeting the conditions of this Circular, it must also comply with the laws on medical examination and treatment.

5. Fixed immunization facilities can arrange multiple vaccination points, each point must meet the conditions stipulated in Articles 1, 2, and 3 of this Article.

Article 6. Conditions for mobile vaccination points

1. Conditions for applying mobile vaccination points:

a) Only to be implemented for vaccines under the Expanded Immunization Program during vaccination campaigns or in remote, mountainous, and particularly difficult areas as decided by the Health Department of provinces and centrally-administered cities (hereinafter referred to as the Provincial Health Department).

b) To be carried out by Commune Health Stations that have been certified as meeting vaccination conditions.

2. Minimum conditions regarding infrastructure:

a) There must be consultation tables, examination tables, and vaccination tables;

b) There must be an area for monitoring and handling post-vaccination reactions.

The vaccination point must ensure hygiene conditions, protection from rain and sun, windproofing, ventilation, and adequate lighting. The areas specified in Point a and b of this Clause must be arranged in a one-way flow principle.

3. Equipment conditions: Must have vaccine refrigerators or cold boxes and meet the conditions stipulated in Points b, c, and d of Clause 2, Article 5 of this Circular.

4. Personnel conditions:

a) Quantity: At least 02 health professionals, including at least 01 staff member with a professional level of medical assistant or higher.

b) Must meet the conditions stipulated in Point b of Clause 3, Article 5 of this Circular.

Chapter III

RECEIVING, TRANSPORTING, STORING AND DISTRIBUTING VACCINES

Article 7. Procedures for receiving and distributing vaccines

1. When receiving vaccines, the receiving staff must check and retain the following information at the vaccination facility:

a) Date of receipt;

b) Type of vaccine;

c) Name of vaccine;

d) Registration permit number or import permit number;

đ) Certificate of production release for each batch of vaccines issued by the competent authority (copy);

e) Manufacturer's name, country of manufacture;

g) Supplier's name;

h) Content, packaging specifications;

i) Batch number;

k) Expiry date of each batch;

l) Number of doses received for each batch;

m) Storage temperature status;

n) Temperature monitoring indicators: vaccine bottle temperature indicator, frozen storage temperature indicator upon receipt (if applicable); temperature tracking card;

p) If there is accompanying diluent, record the information on the diluent including: manufacturer, country of manufacture, supplier, batch number, expiry date of each batch.

Vaccines shall not be accepted if any abnormality is detected in the above information or conditions.

2. When distributing vaccines, the distribution staff must check and retain the following information at the distribution unit:

a) Distribution date;

b) Type of vaccine;

c) Name of vaccine;

d) Registration permit number or import permit number;

đ) Certificate of production release for each batch of vaccines issued by the competent authority (copy);

e) Manufacturer's name, country of manufacture;

g) Content, packaging specifications;

h) Batch number;

i) Expiry date of each batch;

k) Number of doses distributed for each batch;

l) Receiving unit;

m) Storage temperature status;

n) Temperature monitoring indicators: vaccine bottle temperature indicator, frozen storage temperature indicator (if applicable); temperature tracking card when distributing.

p) If there is accompanying diluent, record the information on the diluent including: manufacturer, country of manufacture, supplier, batch number, expiry date of each batch.

In case of any abnormalities in the above information or conditions, a record of the actual situation must be made and handled according to regulations.

Article 8. Transporting vaccines

Vaccines must be stored in a cold chain as prescribed and at appropriate temperatures for each type of vaccine as required by the manufacturer, equipped with temperature monitoring devices for the vaccines during transportation.

Article 9. Storing vaccines

1. Vaccines must be stored at the correct temperature registered with the Ministry of Health by the manufacturer.

2. Vaccines must be stored separately in a cold chain as prescribed at the vaccination facility, not stored together with other products.

3. Vaccines must be monitored daily for temperature and storage conditions. Expired or abnormal vaccines that cannot be used must be destroyed and a destruction record must be kept.

Chapter IV

ORGANIZATION OF VACCINATION

Article 10. Vaccination Organization

1. Prior to vaccination:

a) Advise the family and the person to be vaccinated about the effects, benefits of using vaccines, and possible reactions after vaccination;

b) Conduct screening examinations for the person to be vaccinated in accordance with regulations;

c) Prescribe vaccination or exclude cases with contraindications or delay vaccination;

d) Provide information on the type of vaccine, dosage used, expiration date to the person to be vaccinated or their parents or guardians.

2. During vaccination:

a) Check the storage temperature, expiration date, and compare with the instructions for vaccine use;

b) Carry out vaccination strictly according to the instructions for each type of vaccine and safe injection regulations;

c) Follow the regulations regarding pre-vaccination and during-vaccination procedures.

3. After vaccination:

a) Require the person to be vaccinated to stay at the vaccination facility for a minimum of 30 minutes for observation;

b) Guide and coordinate with the family or the person vaccinated on how to monitor and care for the child at home for at least 24 hours after vaccination;

c) Record complete information about each vaccination case in the vaccination logbook (kept at the vaccination facility) and the vaccination card or individual vaccination logbook returned to the family or the person vaccinated;

d) Vaccine vials that have been opened beyond the specified time period shall not be allowed to be used further;

đ) Unused vaccines and syringes remaining after the vaccination session must be stored according to regulations.

Article 11. Dosage and Route of Administration of Vaccines

The dosage and route of administration of each type of vaccine must comply with the manufacturer's usage instructions registered with the Ministry of Health. Any changes to the dosage or route of administration must be approved by the Ministry of Health, and the manufacturer has the responsibility to notify the production of its products to vaccination facilities.

Article 12. Organization of Vaccination Campaigns

1. The organization of vaccination campaigns is carried out according to specific guidelines issued by the Ministry of Health for each campaign.

2. Only vaccination facilities certified as meeting vaccination conditions may carry out vaccination campaigns.

Chapter V

MONITORING REACTIONS AFTER VACCINATION

Article 13. Detection and Management of Severe Adverse Reactions After Vaccination

1. All individuals after vaccination must be observed for a minimum of 30 minutes at the vaccination site, followed by continued monitoring at home for at least 24 hours after vaccination to detect severe adverse reactions promptly.

2. At the vaccination facility: when severe adverse reactions occur during the implementation of vaccinations, the head of the vaccination facility must direct the following actions:

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;

b) Emergency treatment, diagnosis of the cause of severe adverse reactions after vaccination; if beyond capability, transfer the person suffering from severe adverse reactions to the nearest hospital;

c) Record complete information:

- Name, age, gender, address, phone number (if available) of the person vaccinated. Name of father, mother, address, phone number (if available) for children;

- Date and time of vaccination;

- Type of vaccine; name of vaccine; batch number; expiration date; manufacturer; supplying unit; registration circulation number or import permit number;

- Date and time of occurrence of severe adverse reactions after vaccination; main symptoms; treatment results; conclusion on the cause (if any);

d) Statistics on the total quantity of vaccines used during the vaccination session; number of people vaccinated by type of vaccine; name of vaccine, batch number, expiration date of vaccine; health status of those vaccinated;

đ) Statistics on the total number of vaccine vials and syringes used during the vaccination session;

e) Report to higher levels as stipulated in Articles 25 and 27 of this Circular.

3. At the location receiving cases of severe adverse reactions after vaccination, the head of the receiving location must direct the following actions:

a) Emergency care, handling, and treatment in accordance with regulations;

b) Report to higher levels as stipulated in Articles 25 and 27 of this Circular.

4. District and provincial level: receive reports, compile information, report to higher levels as stipulated in Articles 25 and 27 of this Circular.

Article 14. Investigation of Severe Adverse Events Following Immunization

1. Within twenty-four hours from the occurrence of severe adverse events following immunization, the Department of Health shall be responsible for organizing the investigation and assessing the causes as follows:

a) Establishing the Provincial Expert Advisory Committee on Adverse Event Assessment during Vaccine and Medical Product Use (hereinafter referred to as the Provincial Expert Advisory Committee) in accordance with Circular No. 21/2011/TT-BYT dated June 7, 2011, issued by the Minister of Health, regarding the establishment, organization, and operation of the Expert Advisory Committee on Adverse Event Assessment during Vaccine and Medical Product Use.

b) Conducting the investigation according to the guidelines of the Ministry of Health.

2. The Provincial Expert Advisory Committee on Adverse Event Assessment during Vaccine and Medical Product Use shall perform the following tasks:

a) Compiling, analyzing, and evaluating the causes of severe adverse events following immunization based on the results of the investigation, information collected, testing results, forensic examination results in cases of death (if applicable).

b) Submitting the report on the assessment of severe adverse events following immunization to the Department of Health.

3. Within five working days from receiving the report on the assessment of severe adverse events following immunization, the Department of Health must convene a meeting of the Provincial Expert Advisory Committee to conclude the causes leading to severe adverse events following immunization and propose remedial activities if necessary. In cases where samples for testing or forensic examination have been sent but results are not yet available, preliminary conclusions should be made and full conclusions must be supplemented when test or forensic examination results are available.

4. If the cause of severe adverse events following immunization is suspected to be due to vaccine quality, the Director of the Department of Health decides to temporarily suspend the use of the batch of vaccines related to severe adverse events following immunization within their jurisdiction based on the agreement of the Drug Administration Department of the Ministry of Health. When there is a conclusion that it is unrelated to vaccine quality, the Director of the Department of Health decides to allow the resumption of use of that batch of vaccines and notify the Drug Administration Department of the Ministry of Health.

Article 15. Reporting and Announcing Investigation Results

1. Within two working days from the date of the conclusion by the Provincial Expert Advisory Committee, the Department of Health officially announces the conclusion on the cause to relevant agencies and reports the investigation results along with the minutes of the committee meeting to the Ministry of Health (Preventive Medicine Department - Permanent Office of the Expert Advisory Committee on Adverse Event Assessment during Vaccine and Medical Product Use under the Ministry of Health).

2. The Preventive Medicine Department receives reports from the Provincial Expert Advisory Committee, and in cases where necessary, proposes convening a National Expert Advisory Committee meeting to review the assessment results of the Provincial Expert Advisory Committee.

3. In cases where the National Expert Advisory Committee reviews the results of the Provincial Expert Advisory Committee, the Preventive Medicine Department compiles and announces the cause of severe adverse events following immunization to relevant units and publicly discloses this issue.

Chapter VI

AUTHORITY, FILES, PROCEDURES FOR ISSUING NEW, REISSUING, SUSPENDING AND REVOKING CERTIFICATES OF ELIGIBILITY FOR IMMUNIZATION

Article 16. Authority to Issue New and Reissue Certificates of Eligibility for Immunization and Validity Period of Such Certificates

1. The Director of the Department of Health issues new and reissues certificates of eligibility for immunization for fixed vaccination facilities located within their jurisdiction.

2. The certificate of eligibility for immunization is valid for five years from the date of issuance.

Article 17. Forms of Issuing Vaccination Condition Certificates

1. Issue new vaccination condition certificates in the following cases:

a) Healthcare facilities applying for a vaccination condition certificate for the first time;

b) The expiration of the period for reissuing a vaccination condition certificate as stipulated in Point a, Clause 2 of this Article;

c) A vaccination condition certificate being revoked;

d) Changes in location, infrastructure, equipment, and personnel of healthcare facilities that have been issued vaccination condition certificates.

2. Reissue vaccination condition certificates applicable in the following case:

a) Within at least 60 days before the expiration of the validity period of the vaccination condition certificate, healthcare facilities that have been issued vaccination condition certificates must submit applications for reissuance. If the application is not submitted within this period, they must follow the procedures for issuing new vaccination condition certificates as stipulated in Point b, Clause 1 of this Article.

b) The vaccination condition certificate remains valid but is lost or damaged and still has more than 60 days left until its expiration date;

c) Change of name of healthcare facilities that have been issued vaccination condition certificates when the certificate still has more than 60 days left until its expiration date, provided that the location, infrastructure, equipment, and personnel remain unchanged.

Article 18. Application Documents for Issuing New Vaccination Condition Certificates

1. An application form for a vaccination condition certificate according to Form No. 1 prescribed in Appendix No. 1 attached hereto.

2. A list of staff members according to the prescribed form in Appendix No. 2 attached hereto and certified copies of the following documents of each vaccination staff member:

a) Employment decision or labor contract stamped with the seal of the employing entity;

b) Professional qualification certificates;

c) Certificate of participation in training on vaccination.

3. The previously issued vaccination condition certificate for the case stipulated in Point b, Clause 1 of Article 17 of this Circular.

4. A list of equipment according to the prescribed form in Appendix No. 3 attached hereto.

5. Floor plan of the vaccination area including waiting, counseling, and classification zones; vaccination, observation, and post-vaccination reaction management zones.

6. Certified copies of documents proving the establishment and operation of the facility applying for a vaccination condition certificate including:

a) Operating permit for medical examination and treatment facilities in accordance with laws on medical examination and treatment;

b) Establishment decision or business registration certificate or investment certificate for other healthcare facilities.

Article 19. Application Documents for Reissuing Vaccination Condition Certificates

1. Application documents for reissuing vaccination condition certificates for the case stipulated in Point a, Clause 2 of Article 17 include:

a) An application form for reissuing a vaccination condition certificate according to Form No. 2 prescribed in Appendix No. 1 attached hereto;

b) Original copy of the previously issued vaccination condition certificate.

2. Application documents for reissuing vaccination condition certificates for the case stipulated in Point b, Clause 2 of Article 17 include:

a) An application form for reissuing a vaccination condition certificate according to Form No. 2 prescribed in Appendix No. 1 attached hereto;

b) Original copy of the previously issued vaccination condition certificate for the case of damage.

3. Application documents for reissuing vaccination condition certificates for the case stipulated in Point c, Clause 2 of Article 17 include:

a) An application form for reissuing a vaccination condition certificate according to Form No. 2 prescribed in Appendix No. 1 attached hereto;

b) Original copy of the previously issued vaccination condition certificate;

c) Documents proving the change of name of the healthcare facility that has been issued a vaccination condition certificate.

Article 20. Procedures for Issuing and Reissuing Vaccination Condition Certification

1. The entity requesting issuance of the vaccination condition certification shall submit one original set and one copy set of the application to the Department of Health (Health Affairs Division).

2. Upon receipt of the application, the Department of Health shall issue to the entity requesting the vaccination condition certification an application receipt form according to the model prescribed in Appendix 4 attached to this Circular.

3. In cases where the new application is complete and valid, the Department of Health shall be responsible for:

a) Transferring the application for issuance of the vaccination condition certification to the District Health Office (hereinafter referred to as the district) where the healthcare facility requesting the certification is located within five working days from the date of receiving the application for on-site review.

b) Within fifteen working days from the date of receiving the application for issuance of the vaccination condition certification, the District Health Office shall establish a review team and conduct the review in accordance with the provisions of Article 21 of this Circular. The review team shall consist of:

- The leader of the District Health Office - Team Leader;

- A representative of the District Health Center;

- A representative of the District Hospital (for districts that have separated the District Hospital as an independent entity);

- Relevant experts and staff invited at the request of the Team Leader.

c) After completing the review, the Review Team shall prepare a review record according to the model prescribed in Appendix 5 attached to this Circular and send it back to the Department of Health (Health Affairs Division) within three working days from the end of the review;

d) Within seven working days from the date of receiving the review record, the Director of the Department of Health must issue the vaccination condition certification according to the model prescribed in Appendix 6 attached to this Circular. If not issued, there must be a written response stating the reasons.

4. In cases where the application for reissuance of the vaccination condition certification is complete and valid, the Director of the Department of Health must reissue the vaccination condition certification according to the model prescribed in Appendix 6 attached to this Circular within fifteen working days from the date of receiving the application. If not issued, there must be a written response stating the reasons.

5. In cases where the application is incomplete or invalid, within five working days from the date of receiving the application, the Department of Health must notify the entity requesting the vaccination condition certification in writing to complete the application and specify in detail the contents that need to be supplemented or modified.

6. Upon receiving the written request to complete the application, the entity requesting the vaccination condition certification shall be responsible for making corrections and supplements according to the requirements and submitting them to the Department of Health. The date of receipt of the corrected and supplemented application shall be recorded on the Application Receipt Form.

7. In cases where the entity requesting the vaccination condition certification has made corrections and supplements but they do not meet the requirements, the Department of Health will notify the entity to continue completing the application in accordance with the provisions of Clause 5 of this Article.

8. In cases where the corrected and supplemented application meets the requirements, the Department of Health must proceed with issuing or reissuing the vaccination condition certification in accordance with the provisions of Clauses 3 and 4 of this Article.

Article 21. Procedure for assessing the issuance of certificates of qualification for vaccination

1. Assessment of the application: check the conditions regarding infrastructure, equipment, personnel, and specialized documents of the entity applying for the certificate of qualification for vaccination.

2. On-site assessment at the entity and preparation of the assessment record according to the model prescribed in Appendix No. 5 issued together with this Circular. The assessment record shall be made in three copies: one copy retained by the Department of Health, one copy retained by the District Health Office, and one copy retained by the entity applying for the certificate of qualification for vaccination.

Article 22. Cases of suspension of activities and revocation of certificates of qualification for vaccination

1. Cases for suspension of activities:

a) Failure to comply with the conditions stipulated in Article 5 of this Circular;

b) Technical errors according to professional guidelines issued by the Minister of Health;

c) Failure to conduct statistics and report as required five times or more.

2. Cases of revocation of certificates of qualification for vaccination for fixed vaccination facilities:

a) The facility that has been granted a certificate of qualification for vaccination operates beyond the permitted scope of expertise;

b) The certificate of qualification for vaccination was issued without proper authority or contains content contrary to the law;

c) The facility that has been granted a certificate of qualification for vaccination goes bankrupt, is dissolved, or is merged;

d) The facility operates when the certificate of qualification for vaccination has expired;

đ) The facility is suspended from operation but fails to rectify the violations as prescribed.

Article 23. Procedures and time limits for suspending operations and procedures for revoking certificates of qualification for vaccination

1. Procedures and time limits for suspending operations:

a) During the inspection process, if any of the violations specified in Clause 1 of Article 22 of this Circular are discovered, the inspecting agency must prepare Record Form No. 19 issued pursuant to Decision No. 1131/2008/QĐ-TTCP dated June 18, 2008, of the Government Inspector General on the issuance of models of documents in inspection activities, complaint resolution, and denunciation handling (hereinafter referred to as Decision No. 1131/2008/QĐ-TTCP). Within five working days from the date of receipt of the record, the Department of Health must issue a decision to suspend operations for the fixed vaccination facility. In cases where a decision to suspend operations is not issued, a written notice must be sent to the inspection team explaining the reasons.

b) If another competent inspection agency issues a decision to suspend operations, it must notify the Department of Health that issued the certificate of qualification for vaccination to the suspended vaccination facility.

c) The decision to suspend operations shall have a maximum duration of six months from the date of issuance and shall be sent to the suspended vaccination facility, the Provincial Preventive Health Center, the District Health Office, and simultaneously published publicly according to Model No. 6 issued pursuant to Decision No. 1131/2008/QĐ-TTCP.

d) If the suspended vaccination facility has taken corrective actions, no later than thirty days before the expiration of the suspension decision:

- The suspended vaccination facility must submit a report on the corrective actions taken to the District Health Office and the Department of Health.

- The date of receipt of the corrective action report is calculated based on the stamp of the Department of Health's receipt of the document.

đ) If the suspended vaccination facility has taken corrective actions and met the requirements of this Circular, within five working days from the date of receipt of the report from the vaccination facility, the Provincial Department of Health shall consider and decide to terminate the suspension of operations. The decision to terminate the suspension of operations according to Model No. 7 issued pursuant to Decision No. 1131/2008/QĐ-TTCP shall be sent to the suspended facility, the Provincial Preventive Health Center, the District Health Office, and simultaneously published publicly.

e) If the suspended vaccination facility does not take corrective actions or takes them but still fails to meet the requirements of this Circular upon the expiration of the suspension period, the Provincial Department of Health shall revoke the certificate of qualification for vaccination according to Clause 2 of this Article.

2. Procedures for revoking certificates of qualification for vaccination:

Upon discovering any of the violations stipulated in Clause 2 of Article 22, the revocation procedure shall be carried out as follows:

a) Within ten working days from the date of discovery of the violation, the Director of the Department of Health shall issue a decision to revoke the certificate of qualification for vaccination;

b) The decision to revoke the certificate of qualification for vaccination by the Director of the Department of Health according to Model No. 12 issued pursuant to Decision No. 1131/2008/QĐ-TTCP shall be sent to the suspended facility and the Provincial Preventive Health Center, city center, and District Health Office where the facility is located and simultaneously published publicly;

c) Within five working days from the date of receipt of the decision to revoke the certificate of qualification for vaccination, the vaccination facility must submit the original certificate of qualification for vaccination to the Department of Health.

Chapter VII

REPORTING SYSTEM AND RECORD MANAGEMENT

Article 24. Reporting system

1. Regular reports: monthly, quarterly, and annual reports on vaccine usage, common reactions, and severe adverse events following vaccination;

2. Ad hoc reports: severe adverse events following vaccination.

Article 25. Form and Content of Reports

1. Forms of reports:

a) Periodic reports: in writing;

b) Emergency reports: in urgent cases, reporting may be done by telephone, email, or directly, and within 24 hours, a written report must be submitted.

2. Content of the report:

a) Periodic reports:

- Report on the use of vaccines under the Expanded Immunization Program according to Form No. 1 of Appendix No. 7 issued together with this Circular;

- Report on the use of service-based immunization vaccines according to Form No. 2 of Appendix No. 7 issued together with this Circular;

- Report on common adverse events following immunization according to the form set out in Appendix No. 8 issued together with this Circular;

- Report on serious adverse events following immunization according to the form prescribed in Appendix No. 9 issued together with this Circular.

b) Emergency reports: contents as stipulated in Point c Clause 2 Article 13 of this Circular or as required by the requesting agency.

Article 26. Procedures and Timeframes for Periodic Reporting

1. For vaccines under the Expanded Immunization Program

a) Vaccination facility: report to the District Health Center before the 5th day of the next month for monthly reports, on the 5th day of the first month of the next quarter for quarterly reports, and before January 15 of the following year for annual reports;

b) District health center: report to the Provincial Preventive Health Center before the 10th day of the next month for monthly reports, on the 10th day of the first month of the next quarter for quarterly reports, and before January 25 of the following year for annual reports;

c) Provincial Preventive Health Center: report to the Department of Health, the Expanded Immunization Project at the Central Institute of Hygiene and Epidemiology, Ho Chi Minh City Pasteur Institute, Nha Trang Pasteur Institute, and the Central Institute of Hygiene and Epidemiology (hereinafter referred to as Regional Institutes) under the management area of the Minister of Health, and simultaneously report to the National Expanded Immunization Project before the 15th day of the next month for monthly reports, on the 15th day of the first month of the next quarter for quarterly reports, and before January 31 of the following year for annual reports;

d) National Expanded Immunization Project: consolidate the reports and submit them to the Preventive Health Administration (Ministry of Health) before the 20th day of the next month for monthly reports, on the 20th day of the first month of the next quarter for quarterly reports, and before February 15 of the following year for annual reports.

2. For service-based immunization vaccines.

a) Vaccination facility: report to the District Health Center before the 5th day of the next month for monthly reports, on the 5th day of the first month of the next quarter for quarterly reports, and before January 15 of the following year for annual reports;

b) District health center: report to the Provincial Preventive Health Center before the 10th day of the next month for monthly reports, on the 10th day of the first month of the next quarter for quarterly reports, and before January 25 of the following year for annual reports;

c) Provincial Preventive Health Center: report to the Department of Health, Regional Institutes, and the Preventive Health Administration - Ministry of Health before the 15th day of the next month for monthly reports, on the 15th day of the first month of the next quarter for quarterly reports, and before January 31 of the following year for annual reports.

Article 27. Procedures and Timeframes for Emergency Reporting

1. Within 24 hours from the time of recording serious adverse events following immunization, the vaccination facility shall report to the Provincial Preventive Health Center, and simultaneously report to the District Health Center where the vaccination facility is located.

2. Within 24 hours from the time of receiving the report from the vaccination facility, the Provincial Preventive Health Center shall report to the Department of Health, the Preventive Health Administration, and the Regional Institutes.

3. Weekly, after implementing the reporting procedures as stipulated in Points a and b of this Clause:

a) The vaccination facility must submit a report on the progress of the investigation and handling process for the week on the second day of the following week;

b) The Provincial Preventive Health Center must report on the progress of the investigation and handling process during the week on the fourth day of the following week.

Article 28. Management of Records

1. Vaccination facilities must store and manage professional documents and records including:

a) Regulations and professional guidance on vaccine usage;

b) Vaccination follow-up record for individuals receiving vaccinations;

c) Monthly, quarterly, and annual documentation regarding vaccine usage; quantity of vaccines used and cases of common reactions and severe adverse events following vaccination at the facility.

2. The Department of Health, Provincial Centers for Preventive Medicine must store and manage professional materials and records including:

a) Regulations and professional guidance materials on expanded immunization programs;

b) Monthly, quarterly, and annual reports on vaccine usage; quantity of vaccines used and cases of common reactions and severe adverse events following vaccination of units under their management area.

3. Regional Institutes and Expanded Immunization Projects must store and manage professional materials and records including:

a) Regulations and professional guidance materials on vaccine usage and vaccination;

b) Monthly, quarterly, and annual reports on vaccine usage; quantity of vaccines used and cases of common reactions and severe adverse events following vaccination of provinces within their responsibility area and consolidated reports monthly, quarterly, and annually of the Institute, Expanded Immunization Project.

4. Records, reports, and follow-up logs must be complete, easily searchable, and managed and stored according to legal regulations on archiving.

Chapter VIII

RESPONSIBILITIES FOR IMPLEMENTATION

Article 29. Responsibilities of the Ministry of Health

1. Responsibilities of the Center for Preventive Medicine:

a) Lead and coordinate with relevant Departments and Bureaus to direct, guide, and inspect vaccine usage nationwide; provide information and promote awareness about safe vaccination, benefits of vaccine usage, and possible reactions after vaccination;

b) Lead and coordinate with relevant units to develop professional guidelines on vaccine usage, monitor and investigate causes of severe adverse events following vaccination;

c) Serve as the Secretariat of the Steering Committee for addressing incidents related to vaccination under the Ministry of Health;

d) Serve as the Secretariat of the Expert Advisory Council for evaluating adverse events during vaccine usage and medical products under the Ministry of Health.

đ) Organize specialized inspections and audits according to the Law.

2. Responsibilities of the Drug Administration Department:

a) Review, approve, and issue registration numbers for vaccine circulation; manage vaccine exports and imports according to regulations;

b) Temporarily suspend and allow resumption of vaccine usage nationwide, coordinate with the Department of Health to consider suspending batches of vaccines as stipulated in Clause 4, Article 14 of this Circular;

c) Manage the quality of circulating vaccines in Vietnam;

d) Coordinate with relevant units in conducting inspections and audits on vaccine usage according to regulations.

3. Responsibilities of the Bureau of Medical Examination and Treatment:

a) Guide pre-vaccination screening examinations, handle severe adverse events following vaccination, direct units in the healthcare system to train and support vaccination facilities in pre-vaccination screening and handling severe adverse events following vaccination;

b) Direct and supervise vaccination activities in the healthcare system, direct emergency response work, and cooperate in investigating causes of severe adverse events following vaccination;

c) Coordinate with relevant units in conducting inspections and audits on vaccine usage according to regulations.

4. Responsibilities of the Inspectorate of the Ministry:

Lead and coordinate with relevant units in conducting inspections on vaccine usage nationwide.

Article 30. Responsibilities of the National Expanded Immunization Project and Institutes, Hospitals under the Ministry of Health

1. Responsibilities of the National Expanded Immunization Project:

a) Develop plans for vaccine usage needs in the Expanded Immunization Program, propose vaccines and vaccination schedules for the Expanded Immunization Program;

b) Organize procurement, receipt, and supply of Expanded Immunization vaccines to using units;

c) Investigate causes of severe adverse events following vaccination, promptly address severe adverse events following vaccination;

d) Train provincial Expert Advisory Councils on post-vaccination reaction surveillance and investigation;

đ) Organize information dissemination and promotion about safe vaccination, benefits of vaccine usage, and post-vaccination reactions.

2. Responsibilities of Regional Institutes:

a) Provide technical direction, supervise vaccine usage in regions managed by the Ministry of Health to ensure quality and safety in vaccination work; monitor post-vaccination reactions;

b) Organize training on vaccination regulations and issue certificates of attendance for vaccination training according to the model specified in Appendix 10 issued together with this Circular;

c) Participate in investigating causes of severe adverse events following vaccination in regions managed by the Ministry of Health, promptly address severe adverse events following vaccination;

3. Responsibilities of the National Institute for Vaccine and Medical Biological Control:

a) Inspect and issue certificates of factory release for domestic and imported vaccine batches according to regulations before market use;

b) Develop plans and implement regular and ad hoc monitoring of vaccine quality and safety nationwide;

c) Develop guidelines for sampling vaccines for inspection in cases of severe adverse events following vaccination;

d) Coordinate with relevant units in conducting inspections and audits on vaccine usage.

4. Responsibilities of Obstetric and Pediatric Hospitals under the Ministry of Health:

a) Implement vaccine administration according to regulations;

b) Organize training on pre-vaccination screening for vaccination facilities;

c) Conduct emergency treatment, diagnosis, and treatment of severe adverse events following vaccination;

d) Cooperate in investigating and concluding causes of severe adverse events following vaccination.

Article 31. Responsibilities of the Department of Health, Provincial Preventive Health Center, District Health Departments, and District Health Centers

1. Responsibilities of the Department of Health:

a) Direct the implementation of expanded immunization activities and service-based immunizations in accordance with the regulations of the Ministry of Health;

b) Organize the acceptance of applications, issuance of certificates confirming eligibility for immunization within the province;

c) Organize inspections and audits of vaccine usage activities within the province;

d) Organize the evaluation of causes, conclusions, and public announcement of causes of severe adverse events following immunization within the province;

e) Organize information dissemination and promotion regarding safe immunization, benefits of using vaccines, and post-immunization reactions;

f) Decide on the deployment of mobile vaccination points in accordance with Article 6 of this Circular;

g) Decide on the suspension and resumption of vaccine use within the managed area in accordance with Clause 4, Article 14 of this Circular;

2. Responsibilities of the Provincial Preventive Health Center:

a) Direct, guide implementation, and coordinate with the Health Department Inspectorate to inspect and audit vaccine usage activities at localities;

b) Organize training on immunization and issue certificates of attendance for such training according to the model specified in Appendix 10 attached to this Circular;

c) Serve as the permanent member of the provincial expert advisory council for evaluating adverse events during vaccine and medical product use;

d) Implement vaccine use, storage, and distribution to ensure quality and meet the immunization needs for disease prevention among the population;

3. Responsibilities of the District Health Department:

c) Take the lead and coordinate with district health centers and related units to assess vaccination facilities under management, report assessment results to the Department of Health for consideration in issuing or revoking certificates confirming eligibility for immunization;

b) Inspect and audit immunization activities within the managed area;

4. Responsibilities of the District Health Center:

a) Direct commune health stations to implement immunization and vaccine storage in accordance with regulations;

b) Participate in the assessment team for issuing certificates confirming eligibility for immunization within the managed area;

c) Summarize and report vaccine usage within the managed area;

d) Coordinate with district health departments to inspect and audit immunization activities within the managed area;

Article 32. Responsibilities of vaccination facilities and vaccinators

1. Responsibilities of vaccination facilities:

a) Be responsible under the law for implementing professional activities in accordance with assigned functions and tasks;

b) Adhere to professional technical procedures for vaccine use and safe immunization; monitor and report as required;

c) Collaborate with organizations and associations to promote and mobilize people to participate in preventive immunization;

d) Collaborate with related units to facilitate investigations into causes of severe adverse events following immunization;

2. Responsibilities of vaccinators: Adhere strictly to the immunization procedures established by the Ministry of Health;

Chapter IX

IMPLEMENTING PROVISIONS

Article 33. Cross-referencing Provisions

In cases where the referenced documents in this document are replaced or amended, implementation shall be in accordance with the replacement or amended document.

Article 34. Effective Date

This Circular takes effect from June 1, 2014;

Decision No. 23/2008/QD-BYT dated July 7, 2008, of the Minister of Health on the regulations for the use of vaccines and medical products in prevention and treatment shall cease to be effective from the date this Circular comes into force;

Article 35. Transitional Provisions

1. For facilities established and operating before the date this Circular takes effect, they must complete the issuance of certificates confirming eligibility for immunization by December 1, 2015;

2. For facilities established and operating after the date this Circular takes effect, they may only use vaccines after obtaining a certificate confirming eligibility for immunization;

Article 36. Responsibility for Implementation

The Head of the Ministry's Office, Directors of the Preventive Health Bureau, Heads of Departments, Bureaus, General Administrations under the Ministry of Health, Heads of subordinate agencies and units of the Ministry, Directors of Health Departments of provinces and centrally-administered cities, and Heads of healthcare units under various Ministries, sectors, and related units are responsible for implementing this Circular;

During implementation, if there are difficulties or obstacles, please report them to the Ministry of Health for research and resolution./.