Thông tư 12/2014/TT-BYT

CIRCULAR

PROVIDING GUIDANCE ON MANAGEMENT OF VACCINE USAGE IN VACCINATION

Pursuant to Point d Clause 2 Article 30 of Law on prevention and control of infectious diseases;

Pursuant to Decree No. 63/2012/ND-CP dated August 31, 2012 of the Government defining the functions, tasks, entitlements and organizational structure of the Ministry of Health;

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

The Ministry of Health issues the Circular providing guidance on management of vaccine usage in vaccination,

Chapter 1.

GENERAL PROVISIONS

Article 1. Scope

This Circular stipulates:

1. Requirements applied to medical centers giving vaccination (hereinafter referred to as vaccination center)

2. Transport, receipt, storage and dispensation of vaccine;

3. Organizing a vaccination;

4. Observation and treatment for vaccine side effects

5. Procedures for issuing, reissuing, suspending, revoking the Certificate of eligibility to give vaccination

Article 2. Interpretation of terms

In this Circular, these terms below shall be construed as follows:

1. Vaccination means the act of putting the vaccine into the bodies of people in order that their bodies shall react against it and protect them from catching the disease.

2. Cold chain means the system of storing and transporting vaccines in the temperature recommended by the manufacturers to users, including cold chambers, refrigerated trucks, fridges, freezers, cold boxes, vaccine thermos.

3. Vaccine side effects means irregular phenomenons of health including symptoms appear at the injection site or whole body after vaccination, that is not necessarily attributable to the use of vaccine, including normal vaccine side effect and vaccine injury.

4. Vaccine injury means irregular reactions after receiving a vaccine which may cause a life-threatening response to those who are vaccinated (symptoms include dyspnea, anaphylactic shock, anaphylactoid shock, toxic shock syndrome, high fever and convulsions, prolonged infant crying, cyanosis, apnea) or leave sequelae or cause the death.

Article 3. Rules for management of vaccine usage

1. Only medical centers that are granted the Certificate of eligibility to give vaccination may give vaccination.

2. The Certificate of eligibility to give vaccination shall be only issued to fixed vaccination center.

3. Medical centers that are granted the Certificate of eligibility to give vaccination must comply with the requirements as prescribed in this Circular.

4. Government medical centers appointed to give vaccination must give vaccination as prescribed Medical examination and treatment centers having delivery rooms must give vaccination to infants as prescribed.

5. Vaccines in the Expanded Program on Immunization must not be used for profitable vaccination,

Chapter 2.

REQUIREMENTS APPLIED TO VACCINATION CENTERS

Article 4. Medical centers permitted to give vaccination

1. Hospitals, clinics, family clinics, maternity wards and medical stations in communes, wards and towns (hereinafter referred to as Commune medical stations) having the operation licenses under law on medical examination and treatment.

2. Preventive medicine centers.

Article 5. Requirements applied to fixed vaccination centers

1. Facilities:

a) The waiting area before giving injections must have at least 50 seats in a session of vaccination, ensure the protection against the rain, sun, wind and airiness;

b) The area where consultancy and screening is carried out must be at least 8 m²_;

c) The area where the vaccination is given must be at least 8 m²;

d) The area where vaccine side effects are observed and treated must be at least 15 m²;

dd) The following regulation shall apply to the area where Hepatitis B pediatric vaccine dosage is given at the medical centers having delivery rooms instead of Point a, b, c and d of this Clause: There is a injection room or a separate injection desk, there is a warm place for infants while giving vaccination, there is a selective medical examination area for infants and there is a area consulting mothers or relatives of the infants.

The areas prescribed in Point a, b, c and d must satisfy the requirements for hygiene, sufficient lighting and arrangement for unidirectional rule.

2. Equipment:

a) Compulsory vaccine storage equipment: fridges, temperature monitoring equipment at the place of storage and in the process of transporting vaccines. In case the Commune medical station have not had fridges, it must have vaccine thermos or cold boxes in order to store vaccine as prescribed in Article 9 in this Circular;

b) Injection equipment, antiseptic tools and chemicals and other essential materials;

c) Anaphylaxis Emergency Kit and Anaphylaxis Emergency Regimen hung up where vaccine side effects are observed and treated according to regulations of the Ministry of Health;

d) Instruments for containing empty vaccine vials, biomedical waste shall be prescribed in regulations of the Ministry of Health.

3. Personnel:

a) There must be at least 03 health workers, at least 01 of them holds a physician assistant qualification or above; if the vaccination center locates in a remote area or a severely disadvantaged area, there must be at least 02 health workers, at least 01 of them holds a physician assistant qualification or above;

b) The health worker who directly conducts the screening, consultancy, vaccination, observation and treatments of vaccine side effects must have the Certificate of training in vaccination issued by the authorities as prescribed in Article 30 and Article 31 of this Circular.

4. In case the vaccination center is the medical examination and treatment center, it must satisfy requirements in this Circular as well as regulations of law on medical examination and treatment.

5. The fixed vaccination center may arrange multiple vaccination clinics; each of them must satisfy the requirements as prescribed in Clause 1, 2 and 3 of this Article.

Article 6. Requirements applied to mobile vaccination clinic

1. Requirements applied to mobile vaccination clinic

a) A mobile vaccination clinic shall only be organized when organizing a vaccination campaign or in the remote area or the severely disadvantaged area as prescribed in the Decision of Director of the Department of Health of the central-affiliated cities and provinces (hereinafter referred to as the Department of Health of province), and only the vaccines of the Expanded Immunization Program shall be used;

b) It shall be applied by Commune medical station that is granted the Certificate of eligibility to give vaccination.

2. Minimum requirements applied to facilities:

a) There are consultancy desks, examination desks and vaccination desks;

b) There is the area where vaccine side effects have been observed and treated.

The vaccination clinic must satisfy requirements for hygiene, protection against rain, sun, wind, airiness and sufficient lighting. The areas as prescribed in Point a and Point b of this Article must be arranged for unidirectional rule.

3. Requirements applied to equipment: there are vaccine thermoses or cold boxes and it must satisfy the requirements as prescribed in Point b, c and d Clause 2 Article 5 of this Circular.

4. Requirements applied to personnel:

a) There must be at least 02 medical employees, at least 01 of them holds a physician assistant qualification or above.

b) Satisfy the requirements as prescribed in Point b Clause 3 Article 5 of this Circular.

Chapter 3.

RECEIPT, TRANSPORT, STORAGE AND DISPENSATION OF VACCINE

Article 7. Receipt and dispensation of vaccine

1. In case of vaccine receipt, the person in charge must check and store the information below at the vaccination center:

a) Date of receipt;

b) Type of vaccines;

c) Name of vaccines;

d) The number of Certificate of free sale (CFS) and the number of Import license.

dd) Certificate of factory production for each vaccine lots granted by the competent authorities (the copy);

e) Names of manufacturers, and countries of origins;

g) Names of suppliers;

h) Content, packing requirements;

i) The numbers of the lots;

k) Expiration date of every lot;

l) The number of doses of each lot;

m) Storage temperature;

n) Temperature monitor: Vaccine vial monitor (VVM), freeze tag temperature monitor (if applicable); temperature monitoring tag;

p) If there is the diluent accompanied, the information of diluent must be recorded as follows: manufacturers, countries of origins, suppliers, lot numbers and expiration date of every lot.

The vaccine shall not be accepted if any of the above information is unusual.

2. When dispensing vaccines, the person in charge must check and store the information below at the vaccination center:

a) Date of dispensation

b) Type of vaccines;

c) Name of vaccines;

d) The number of CFS and the number of Import license.

dd) Certificate of factory production for each vaccine lot granted by the competent authorities (the copy);

e) Name of manufacturers, countries of origins;

g) Content, packing requirements;

h) The numbers of the lots;

i) Expiration date of every lot;

k) The number of doses of each lot;

l) Receiving units;

m) Storage temperature;

n) Temperature monitor: Vaccine vial monitor (VVM), freeze tag temperature monitor (if applicable); temperature monitoring tag;

p) If there is diluent accompanied, the information of diluent must be recorded as follows: manufacturers, countries of origins, suppliers, lot numbers and expiration date of every lot.

In case any of the above information is unusual, a report on actual condition must be made as prescribed.

Article 8. Transport of vaccines

The vaccines must be stored in the cold chain as prescribed and in the appropriate temperature, which varies according to the type of vaccines, recommended by the manufacturers and the vaccine temperature must be monitored with specialized devices during the transport.

Article 9. Storage of vaccines

1. The vaccines must be stored in the exact temperature as registration of the manufacturer to the Ministry of Health.

2. The vaccines must be stored separately in the cold chain under regulations of vaccination centers; they must not be stored together with other products.

3. The vaccine information about temperature, daily storing condition must be monitored. The vaccines or diluents which are expired or unusable must be destroyed and a destruction report must be made.

Chapter 4.

ORGANIZING A VACCINATION

Article 10. Organizing a vaccination session

1. Before vaccination:

a) Consult with vaccinees and their families about efficacy and benefit of the vaccine and possible reactions after giving vaccination;

b) Have the vaccines undergo screening as prescribed;

c) Permit the vaccination, or refuse giving vaccination if contraindications are found, or delay the vaccination.

d) Provide information about types of vaccines, dose, expiration date to vaccinees or parents or legal guardians of them.

2. During vaccination:

a) Compare storage temperature, expiration date with vaccine indications;

b) Give vaccination in accordance with indications of each type of vaccines and regulations on safe injection;

c) Follow the steps before and during the vaccination as prescribed;

3. After vaccination:

a) Request the vaccinees to stay at the vaccination center for at least 30 minutes in order to observe;

b) Provide guidance and cooperate with vaccinees or their families in observing and taking care of the infants at home for at least 24 hours.

c) Record adequate information about the vaccinees into Vaccination book (kept at the vaccination center) and Immunization record and return it to the vaccinees or their families.

d) Do not use the vials that have been opened for a period of time longer than the permissible period;

dd) Properly preserve the unused vaccines and needles that remains after the vaccination session.

Article 11. Dose and administration route of vaccine

Dose and administration route of each type of vaccines must follow the instruction of manufacturers which is registered with the Ministry of Health, in case the manufacturers change dose and administration route of vaccine, they must be permitted by the Ministry of Health and notify that change to the vaccination centers.

Article 12. Organizing a vaccination campaign

1. A vaccination campaign must be organized as prescribed in regulations of the Ministry of Health on every campaign.

2. Only vaccination centers having the Certificate of eligibility to give vaccination may organize the vaccination campaign.

Chapter 5.

OBSERVATION OF VACCINE SIDE EFFECTS

Article 13. Detection and treatment for vaccine injury

1. After receiving vaccination, all vaccinees must be observed for at least 30 minutes at the vaccination clinic and for at least 24 hours at home in order to detect early signs of vaccine injury.

2. At the vaccination center: while giving vaccination, if vaccine injury occurs, the head of vaccination center must:

a) Stop the vaccination session;

b) Provide emergency care, diagnose the reason of vaccine injury; if the case is beyond the competence of the vaccination center, the patient must be sent to the nearest hospital.

c) Record adequate information:

- Name, age, address, phone number (if applicable) of the vaccinee. Names, addresses, phone numbers (if applicable) of the vaccinee’s parents (if the vaccinee is an infant);

- Date and time of vaccination;

- Type of vaccine; vaccine name; lot number; expiration date; manufacturers; vaccine suppliers; number of CFS or number of import license;

- Date and time of occurrence of the vaccine injury; major symptoms; treatment result and conclusion of the reason (if applicable);

d) Release statistics of the amount of used vaccines in the vaccination session; the amount of vaccinees sorted by vaccine type; vaccine name, lot number, expiration date; the heath condition of vaccinees;

dd) Release statistics of the amount of vaccine vials, injection needles used in the vaccination session;

e) Send a report to superior agencies as prescribed in Article 25 and Article 27 of this Circular.

3. The head of the facility where vaccinees suffering vaccine injury are received must:

a) Provide emergency care and administer treatment as prescribed;

b) Send a report to superior agencies as prescribed in Article 25 and Article 27 of this Circular.

4. Medical centers of districts and provinces: receive reports, collection information and send a report to superior agencies as prescribed in Article 25 and Article 27 of this Circular.

Article 14. Investigation into the vaccine injury

1. Within 24 hours, from the vaccine injury occurred, the Department of Health must investigate and evaluate the reason as follows:

a) Establish a Complication assessment council during the usage of vaccine, biological (hereinafter referred to as Complication assessment council) in provinces as prescribed in Circular No. 21/2011/TT-BYT dated June 7, 2011 of the Minister of Health on establishment, organization and operation of the Complication assessment council during the usage of vaccine, biological;

b) Carry out the investigation according to regulations of the Ministry of Health;

2. Complication assessment council must:

a) Collect, analyze, evaluate the reason of vaccine injury based on the result of investigation, result of verification, test or forensic examination (if the patient dies);

b) Report the evaluation of vaccine injury to the Department of Health.

3. Within 05 working days from the day on which the report on evaluation of vaccine injury is received, the Department of Health must hold a meeting for Complication assessment council in province in order to conclude the reason of vaccine injury and propose the measures in necessary cases. In case the verification, test or forensic examination is carried out but a result has not been given, the Complication assessment council must draw a preliminary conclusion and provide the final conclusion when the result is given.

4. In case the quality of the vaccine is doubted that it caused the vaccine injury, the Director of the Department of Health shall decide whether to use that lot of vaccine in the province based on agreement of Drug administration Department of the Ministry of Health. In case the quality of the vaccines did not cause the vaccine injury, the Director of the Department of Health decide whether to keep using such vaccine lot and notify the Drug administration Department of the Ministry of Health.

Article 15. Report and announcement of investigation result

1. Within 2 working days, from the day on which the conclusion of Complication assessment council is made, the Department of Health must announce the concluded reason to relevant agencies and report on investigation result together with The meeting minutes of the Council to the Ministry of Health (Preventive Medicine Department - Standing Complication assessment council).

2. Preventive Medicine Department shall receive the reports of Complication assessment council in provinces; it may suggest holding a ministerial meeting of Complication assessment council to consider the result of Complication assessment council in provinces where necessary.

3. In case the Complication assessment council in ministerial level considers the result of Complication assessment council in provinces, Preventive Medicine Department shall collect and notify the reasons of vaccine injury to relevant units and announce such matter.

Chapter 6.

PROCEDURES FOR ISSUING, REISSUING, SUSPENDING, REVOKING THE CERTIFICATE OF ELIGIBILITY TO GIVE VACCINATION (HEREINAFTER REFERRED TO AS THE CERTIFICATE)

Article 16. Competence in issuing, reissuing the Certificate and its duration

1. Director of the Department of Health shall issue, reissue the Certificate to fixed vaccination centers in the administrative division.

2. The Certificate shall be effective for 5 years, from the date of issue.

Article 17. The methods of issuing the Certificate

1. A new Certificate shall be issued in the cases below:

a) The medical center applies for the Certificate for the first time;

b) The time limit for reissuing the Certificate expires as prescribed in Point a Clause 2 of this Article;

c) The Certificate is revoked;

d) The medical center which is granted the Certificate changes its location, facilities, equipment or personnel.

2. The Certificate shall be reissued in cases below:

a) At least 60 days before the expiration date of the Certificate, the medical center must apply for reissuance of the Certificate. In case the time limit of reissuance of the Certificate expires, the medical center must apply for a new Certificate as prescribed in Point b Clause 1 of this Article.

b) The Certificate is still valid for at least 60 days but it is lost or damaged;

c) The Certificate is still valid for at least 60 days and the medical center changes its name but remains its location, facilities, equipment or staff.

Article 18. Application for a new Certificate

1. Application form for a new Certificate using the form No. 1 of Appendix 1 enclosed herewith.

2. Staff member list using the form provided in Appendix 2 enclosed herewith and certified true copy of documents below of every vaccination employee:

a) Employment decision or labor contract bearing the seal of the employer;

b) Qualification;

c) Certificate of attendance for vaccination courses.

3. The Certificate issued as prescribed in Point b Clause 1 Article 17 of this Circular;

4. The equipment declaration form as prescribed in Appendix 3 enclosed herewith.

5. Floor plan of location giving vaccination shall include: waiting area, consultancy area and selective examination area; vaccination area, area for observation and treatment for vaccine side effects.

6. The certified true copy documents proving the establishment and operation of medical center applying for the Certificate (hereinafter referred to as applicant) shall include:

a) The operation license (if the applicant is a medical examination and treatment center operating under law on medical examination and treatment);

b) Establishment Decision or Certificate of Business registration or Investment certificate with regard to other medical centers.

Article 19. Application for reissuance of the Certificate of eligibility to give vaccination

1. The application for reissuance of the Certificate as prescribed in Point a Clause 2 Article 17 shall include:

a) Application form for reissuing the Certificate using the Form No. 2 of Appendix 1 enclosed herewith;

b) The original of Certificate.

2. The application for reissuance of the Certificate as prescribed in Point b Clause 2 Article 17 shall include:

a) Application form for reissuing the Certificate using the Form No. 2 of Appendix 1 enclosed herewith;

b) The original of Certificate in case it is damaged.

3. The application for reissuance of the Certificate as prescribed in Point c Clause 2 Article 17 shall include:

a) Application form for reissuing the Certificate using the Form No. 2 of Appendix 1 enclosed herewith;

b) The original of Certificate.

c) Documents proving the change of the applicant’s name.

Article 20. Procedures for issuing, reissuing the Certificate

1. The medical center applying for issuing the Certificate shall submit 01 original application and 01 copy thereof to the Department of Health (Medical operation Office).

2. The Department of Health shall send the note of receipt of application to the applicant using the form provided in the Appendix 4 enclosed herewith.

3. In case the application for issuing a new Certificate is satisfactory, the Department of Health must:

a) Transfer the application for issuing a new Certificate to the Medical Office in towns, districts or provincial cities (hereinafter referred to as districts) where the applicant is located within 05 working days from the date of receipt.

b) Within 15 working days from the date on which the application for a new Certificate is received, the Medical office in town must send the assessment delegation and carry out the assessment as prescribed in Article 21 of this Circular. The assessment delegation shall include:

- The head of Medical office in town – Delegation leader;

- The representatives of medical centers in towns;

- The representatives of hospital in towns (with regard to towns having independent hospital);

- Specialists, relevant officers are invited at the request of the delegation leader.

c) After conducting the assessment, the delegation must make the assessment report using the form as prescribed of Appendix 5 enclosed herewith and send to the Department of Health (Medical operation office) within 03 working days, from the end date of assessment;

d) Within 07 working days from the receipt of assessment report, Director of the Department of Health must issue the Certificate using the form of Appendix 6 enclosed herewith. If the application is rejected, Director of the Department of Health must provide explanation.

4. In case the application for reissuance is satisfactory, Director of the Department of Health must reissue the Certificate using the Form of Appendix 6 enclosed herewith within 15 working days from the date of receipt. If the application is rejected, Director of the Department of Health must provide explanation in writing.

5. In case the application for reissuance is unsatisfactory, the Department of Health must request the applicant in writing to complete the application and specify necessary additions or rectifications.

6. After receiving the request in writing for completion of the application, the applicant must add or correct as the request and send it to the Department of Health. The date of receipt of new application shall be recorded in the Receipt of application.

7. In case the applicant added or corrected the application but it does not satisfy the requirements, the Department of Health shall notify such center that they must keep completing the application as prescribed in Clause 5 of this Article.

8. In case the new application satisfies the requirements, the Department of Health must issue or reissue the Certificate as prescribed in Clause 3 and Clause 4 of this Article.

Article 21. Evaluation procedures

1. Verification of application documents: facilities, equipment, human resources and specialist materials of the applicant.

2. The assessment shall be carried out at the medical center and assessment report shall be made in form as prescribed in Appendix 5 enclosed herewith. The assessment report shall be made in 3 copies: 01 copy in the Department of Health, 01 copy in Medical office in town and 01 copy in the location of applicant.

Article 22. Suspension of operation and reclaiming of the Certificate

1. The medical center shall have its operation suspended in following cases:

a) It fails to satisfy the requirements as prescribed in Article 5 of this Circular;

b) There are technical errors against instructions issued by the Minister of Health;

c) It fails to release statistics and report as prescribed more than 05 times.

2. The fixed vaccination center shall be revoked the Certificate in following cases:

a) The medical center which is granted the Certificate operates beyond its licensed scope;

b) The Certificate is issued ultra vires or unlawfully;

c) The medical center which is issued the Certificate goes bankrupt or is dissolved or merged into another entity;

d) The medical center still operates while the Certificate has expired;

dd) The medical center is suspended but it does not rectify the breaches as prescribed.

Article 23. Procedures, duration of suspended operation and procedures for revoking the Certificate

1. Procedures and duration of operation suspension:

a) During the inspection, if the vaccination center commits one of the breaches as prescribed in Clause 1 Article 22 of this Circular, the examiner shall make a report using the Form No. 19 enclosed with Decision No. 1131/2008/QD-TTCP dated June 18, 2008 of Inspector General on issuing forms in inspection operation, processing complaints and denunciation (hereinafter referred to as Decision No. 1131/2008/QD-TTCP) Within 05 working days from the receipt of report, Director of the Department of Health must make a decision on suspending operation of fixed vaccination center. In case the decision is not made, Director of the Department of Health must provide explanation to Inspectorate in writing.

b) In case other inspection authorities make a decision on suspension, they must notify the Department of Health which issued the Certificate to suspended medical center in writing:

c) Decision on suspension of operation shall be valid in 06 months at most from the day on which that decision is signed. This decision which is granted as prescribed in Form 6 enclosed with Decision No 1131/2008/QD-TTCP shall be sent to suspended medical center, Preventive medicine center in province, Medical office in towns and be announced.

d) In case the vaccination center which is suspended rectifies the breaches within 30 days at the latest, before the decision expires:

- Vaccination center which is suspended must report on rectifying breaches to Medical office in town and the Department of Health;

- The date of receipt of the report is the date of the stamp of the Department of Health.

dd) In case the suspended vaccination center rectified the breaches and complied with regulation of this Circular, within 5 working days from the day on which the report of the vaccination center is received, the Department of Health in province shall consider and decide to terminate the suspension of operation. Decision on suspension of operation using the Form No. 7 enclosed with Decision No. 1131/2008/QD-TTCP shall be sent to suspended center, Preventive medicine center in province, Medical Office in town and announced.

e) In case the time limit of suspension expires but the suspended center have not rectified the breaches or although it rectified the breaches, it still does not comply with regulation of this Circular, the Department of Health in province shall revoke the Certificate as prescribed in Clause 2 of this Article.

2. Procedures for revoking the Certificate of eligibility to give vaccination:

In case of any breaches is discovered as prescribed in Clause 2 of Article 22, the procedures for revoking shall be carried out as follows:

a) Within 10 working days, from the day on which the breaches are discovered, Director of the Department of Health shall make a decision on revoking the Certificate of eligibility to give vaccination;

b) Decision of Director of the Department of Health on revoking the Certificate using the Form No. 12 enclosed with Decision No. 1131/2008/QD-TTCP shall be sent to suspended medical center, Preventive medicine center in province, cities, Medical Office in town where such center is located and to be announced;

c) Within 05 working days, from the day on which Decision on revoking the Certificate is received, the vaccination center must submit the original of Certificate to the Department of Health.

Chapter 7.

REPORTING REQUIREMENTS AND DOSSIER MANAGEMENT

Article 24. Reporting requirements

1. Regular report: monthly report, quarterly report and annual report on vaccine usage, cases of regular vaccine side effects and other cases of vaccine injury;

2. Irregular report: the cases of vaccine injuries.

Article 25. Form and content of report

1. Form of report:

a) Regular report: in writing;

b) Irregular report: The report may be carried out via telephone, email or directly for emergencies and within 24 hours it must be made in writing.

2. Content of report:

a) Regular report:

- Report on using vaccines in the Expanded Program on Immunization using the Form No. 1 of Appendix 7 enclosed herewith;

- Report on using service vaccines using the Form No. 2 of Appendix 3 enclosed herewith;

- Report on regular vaccine side effects using the Form No. 8 of Appendix 3 enclosed herewith;

- Report on vaccine injury using the Form No. 9 enclosed herewith;

b) Irregular report: according to Point c Clause 2 Article 13 of this Circular or at the request of the authority suggesting the report.

Article 26. Procedures and time for regular report

1. With regard to vaccines in the Expanded Program on Immunization

a) The vaccination center: report the Medical center in town before the fifth of next month for monthly report, before the fifth of first month of next quarter for quarterly report and before January 15 of next year for annual report;

b) the Medical center in district: report the Preventative medicine center in provinces before the tenth of next month for monthly report, before the tenth of the first month of next quarter for quarterly report and before January 25 of next year for annual report;

c) The Preventative medicine center in province: report the Department of Health, the Project on the Expanded Program on Immunization in the National Institute of Hygiene and Epidemiology, Pasteur Institute of Ho Chi Minh City and Nha Trang Pasteur Institute (hereinafter referred to as Regional Institute) according to administrative division of the Minister of Health, concurrently report the Expanded Program on Immunization before the fifteenth of next month for monthly report, before the fifteenth of the first month of next quarter for quarterly report, before January 31 of next year for annual report;

d) The Project on the Expanded Program on Immunization collect the report and send to General Department of Preventive Medicine (the Ministry of Health) before the twentieth of next month for monthly report, before the twentieth of first month of next quarter for quarterly report and before February 15 of next year for annual report.

2. With regard to vaccines in profitable vaccination.

a) The vaccination center: report the Medical center in town before the fifth of next month for monthly report, before the fifth of first month of next quarter for quarterly report and before January 15 of next year for annual report;

b) the Medical center in district: report the Preventative medicine center in provinces before the tenth of next month for monthly report, before the tenth of first month of next quarter for quarterly report and before January 25 of next year for annual report;

c) The Preventative medicine center in province: report the Department of Health, Regional Institutes, General Department of Preventive Medicine before the fifteenth of next month for monthly report, before the fifteenth of the first month of next quarter for quarterly report, before January 31 of next year for annual report.

Article 27. Procedures and time of irregular report

1. Within 24 hours, from the time in which the vaccine injury is recorded, the vaccination center shall report Preventative medicine center in province and concurrently report the Medical center in district where vaccination center is located.

2. Within 24 hours, from receiving the report of the vaccination center, the Preventative medicine center in province shall report the Department of Health, Department of Preventative Medicine and Regional Institute.

3. Every week, after reporting as prescribed in Point a and Point b of this Clause:

a) The vaccination center must report the process of investigation and handling in that week on the second date of next week;

b) The Preventative medicine center in province must report the process of investigation and handling in that week on the fourth date of next week;

Article 28. Dossier management

1. Vaccination centers must store and manage specialized materials and dossier including:

a) Regulations and specialized guidance on vaccine usage;

b) Vaccination logbook for vaccinees;

c) Records and regular reports on vaccine usage; amount of used vaccines, regular vaccine side effects and vaccine injury;

2. the Department of Health, Preventative medicine center in province must store and manage the specialized materials and dossier including:

a) Regulations and specialized guidance on expanded immunization;

c) Regular reports on vaccine usage; amount of used vaccines, regular vaccine side effects and vaccine injury sent by units in the administrative area.

3. Regional institutes and The Project on the Expanded Program on Immunization must store and manage specialized materials and dossier including:

a) Regulations and specialized guidance on vaccine usage and vaccination;

b) Regular reports on vaccine usage; amount of used vaccines, regular vaccine side effects and vaccine injury sent by affiliated provinces and general monthly, quarterly or annual report of Regional institute and the Project on Expanded Program on Immunization.

4. Dossiers, reports and logbooks must be adequate, easy for finding and looking up. They must be managed and stored under law on achives.

Chapter 8.

RESPONSIBILITY FOR IMPLEMENTATION

Article 29. Responsibility of the Ministry of Health

1. Responsibility of General Department of Preventive Medicine:

a) Take charge of and cooperate with relevant Departments in guidance and inspection of vaccine usage on a national scale; propagation information about vaccination safety, efficacy of using vaccines and possible reactions after vaccination;

b) Take charge of, cooperate with relevant units provide specialized guidance on vaccine usage, observation and treatment and investigation of reason of vaccine injury;

c) Act as the Standing Steering committee on treatment for vaccination incident of the Ministry of Health;

d) Act as the Standing Complication assessment council during the vaccine usage, biological of the Ministry of Health.

dd) Conduct the inspection for specific purposes as prescribed.

2. Responsibility of Drug administrative Department:

a) Assess, approve and issue the number of CFS for vaccine; manage the vaccine export and import as prescribed;

b) Postpone and permit to keep using vaccines on the national scale, cooperate with the Department of Health consider to postpone the vaccine slot as prescribed in Clause 4 Article 14 of this Circular;

c) Control quality of vaccines in Vietnam;

d) Cooperate with relevant units in inspection of vaccine usage as prescribed.

3. Responsibility of Medical examination and treatment administrative Department:

a) Provide guidance on selective medical examination before injection, treatment for vaccine injury; request units in the system of medical examination and treatment to train and support the medical centers in selective medical examination before injection and treatment for vaccine injury;

b) Manage and inspect the operation of vaccination in the system of medical examination and treatment, handle the emergency, investigate the reasons of vaccine injury in cooperation;

c) Cooperate with relevant units in inspection of vaccine usage as prescribed.4. Responsibility of the Ministerial Inspectorate:

Cooperate with relevant units in inspection of vaccine usage on a national scale.

Article 30. Responsibility of the Project on the National expanded Program on Immunization and the Ministry of Health affiliated Institutes or Hospitals

1. The Project on Expanded program on immunization must:

a) Make a plan for demand for vaccine usage in the Expanded immunization; suggest the vaccines and vaccination schedule in Expanded immunization;

b) Purchase, receive and supply vaccines in Expanded immunization to users;

c) Investigate the reasons of vaccine injuries; administer the timely treatment to those who suffered vaccine injury;

d) Train Complication assessment council in provinces in observation and investigation of vaccine side effects.

dd) Propagate information about vaccination safety, benefit of vaccine usage and vaccine side effects.

2. Regional Institutes must:

a) Provide guidance on technical specialist, observe the vaccine usage in the areas according to administrative division of the Ministry of Health in order to ensure quality and safety in vaccination and observe vaccine side effects;

b)Organize training courses on vaccination regulations and issue the Certificate of attendance for vaccination courses provided in Appendix 10 enclosed herewith;

c) Investigate the reasons of vaccine injury; administer the timely treatment to those who suffered vaccine injury;

3. National institute of vaccine and biological verification must:

a) Verify and issue the Certificate of factory production with regard to domestic and import vaccine lots as prescribed before using them;

b) Make a plan; make regular or irregular observation on quality and safety of vaccines on a national scale;

c) Provide guidance on taking a sample of vaccine to verify in case of vaccine injury;

d) Cooperate with relevant units in inspection of vaccine usage.

4. Ministry of Health affiliated Hospitals of Obstetrics or Pediatrics must:

a) Organize the vaccination as prescribed;

b) Organize the training courses on selective medical examination for vaccination centers;

c) Handle emergency, diagnose and treat for the cases of vaccine injury;

d) Investigate and conclude the reason of the cases of vaccine injury in cooperation.

Article 31. Responsibility of the Department of Health, Preventive medicine center in province, Medical office in town, Medical center in town

1. The Department of Health must:

a) Organize the expanded program on immunization or profitable vaccination under regulations of the Ministry of Health;

b) Receive application and issue the Certificate of eligibility to give vaccination in its province;

c) Inspect the operation of vaccine usage in its province;

d) Evaluate the reasons, conclude and announce the reason of cases incurred vaccine injury in its province;

dd) Propagate information about vaccination safety, benefit of vaccine usage and vaccine side effects

e) Decide the location of mobile vaccination as prescribed in Article 6 of this Circular;

g) Decide the suspension and reuse of vaccines in its administrative division as prescribed in Clause 4 Article 14 of this Circular;

2. The Preventive medicine center in province must:

a) Provide guidance on and cooperation with Inspectorate of the Department of Health in operation of vaccination in its province;

b)Organize training courses on vaccination regulations and issue the Certificate of attendance for vaccination courses provided in Appendix 10 enclosed herewith;

c) Act as the Standing Complication assessment council during the vaccine usage, biological in province;

d) Use, store and distribute vaccine with quality assurance to satisfy citizen’s demand for vaccination with the aim of preventive healthcare.

3. Medical Office in districts must:

a) Cooperate with Medical center in town and relevant units in verifying vaccination centers in its districts and report verification result to the Department of Health in order to issue or revoke the Certificate of eligibility to give vaccination;

b) Inspect the operation of vaccine usage in its town;

4. Medical center in districts must:

a) Request Commune medical station to organize the vaccination and store vaccines as prescribed.

b) Participate in the assessment delegation which issues the Certificate of eligibility to give vaccination in its town;

c) Collect and report the vaccine usage in its town;

d) Cooperate with Medical office in districts in inspection of operation of vaccination in its districts;

Article 32. The vaccination center and the medical employee giving vaccination

1. The vaccination center must:

a) Take legal responsibility for performing professional operations relating to its functions and tasks;

b) Comply with process of technical profession on vaccine usage and vaccination safety; observe and report as prescribed;

c) Cooperate with organizations and unions in propagation and encouragement to citizens to receive vaccination;

d) Cooperate with relevant units in conducting and facilitating the investigation into reasons of vaccine injury.

2. The health worker giving vaccination must: comply with professional processes of the Ministry of Health on vaccination.

Chapter 9.

IMPLEMENTATION PROVISIONS

Article 33. Terms of reference

In case the documents as prescribed in this document are replaced or amended, the new documents shall be applied.

Article 34. Effect

This Circular shall take effect from June 1, 2014.

Decision No. 23/2008/QD-BYT dated July 7, 2008 of the Minister of Health on issuing regulations on vaccine usage, biological in prophylactic and therapeutic is annulled from the day on which this Circular takes effect.

Article 35. Terms of transition

1. With regard to medical centers which are established and operated before the day on which this Circular takes effect must complete the issuance of Certificate of eligibility to give vaccination before December 1, 2015.

2. With regard to medical centers which are established and operated after the day on which this Circular takes effect may be only used vaccines after the issuance of Certificate of eligibility to give vaccination.

Article 36. Responsibility for implementation

The Chiefs of the Ministry Office, Directors of General Department of Preventive Medicine, Directors or General Directors of the Ministry of Health, Heads of Ministry affiliated authorities, Directors of the Department of Health central-affiliated cities and provinces and Heads of medical units and relevant units shall take responsibility for implementation of this Circular.

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