Quyết định 23/2008/QD-BYT

Decision No. 23/2008/QD-BYT of July 7, 2008, promulgating the regulation on use of vaccines and medical biologicals in prophylaxis and therapy.

Decision No. 23/2008/QD-BYT of July 7, 2008, promulgating the regulation on use of vaccines and medical biologicals in prophylaxis and therapy. đã được thay thế bởi Circular No. 12/2014/TT-BYT guidance on management of vaccine usage in vaccination và được áp dụng kể từ ngày 01/06/2014.

Nội dung toàn văn Decision No. 23/2008/QD-BYT of July 7, 2008, promulgating the regulation on use of vaccines and medical biologicals in prophylaxis and therapy.


THE MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No. 23/2008/QD-BYT

Hanoi, July 7, 2008

 

DECISION

PROMULGATING THE REGULATION ON USE OF VACCINES AND MEDICAL BIOLOGICALS IN PROPHYLAXIS AND THERAPY

THE MINISTER OF HEALTH

Pursuant to the Government's Decree No. 188/ 2007/ND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to November 21, 2007 Law No. 03/ 2007/QH12 on Prevention and Control of Infectious Diseases;
At the proposal of the director of the Preventive Medicince and Environment Department,

DECIDES:

Article 1.- To promulgate together with this Decision the Regulation on use of vaccines and medical biologicals in prophylaxis and therapy.

Article 2.- This Decision takes effect 15 days after its publication in "CONG BAO "

Article 3.-The director of the Office, the Chief Inspector, directors of Departments, directors of Bureaus and general directors of General Departments, of the Ministry of Health, directors of provincial/municipal Health Services, heads of units under the Ministry of Health, and heads of health agencies of branches shall implement this Decision.

 

 

THE MINISTER OF HEALTH




Nguyen Quoc Trieu

 

REGULATION

ON USE OF VACCINES AND MEDICAL BIOLOGICALS IN PROPHYLAXIS AND THERAPY
(Promulgated together with the Health Minister's Decision No. 23/2008/QD-BYT of July 7, 2008)

Chapter I

GENERAL PROVISIONS

Article 1.- Scope of regulation

The Regulation on use of vaccines and medical biologicals in prophylaxis and therapy (below referred to as the Regulation) provides for the conditions for health establishments to use vaccines and medical biologicals; the order of receiving, transporting, preserving and distributing vaccines and medical biologicals; the process of safe vaccination; and the supervision and treatment of post-vaccination reactions.

Article 2.- Subjects of application

This Regulation applies to domestic and foreign agencies, organizations and individuals using vaccines and medical biologicals in prophylaxis and therapy.

Article 3.- Interpretation of terms

In this Regulation, the terms below are construed as follows:

Vaccination means the introduction in different forms of vaccines and medical biologicals into human bodies for the purpose of creating the responsive immunity.

Post-vaccination reaction means an abnormal health status occurring after vaccination related to vaccines.or faults in vaccination, or due to coincidences or other causes.

3. Freezing chain means a system of equipment for preserving and transporting vaccines and medical biologicals from manufacturers to users at required temperatures.

Article 4.- Principles for-use of vaccines and medical biologicals

Vaccines and medical biologicals to be used must satisfy the conditions specified in Article 27 of the Law on Prevention and Control of Infectious Diseases.

Chapter II

CONDITIONS FOR HEALTH ESTABLISHMENTS TO BE PERMITTED FOR VACCINATION

Article 5.- Conditions on personnel, material foundations and equipment for fixed vaccination establishments

1. Conditions on minimum material foundations:

a/ To have sufficient space for contraindication-exclusive consultancy and examination, vaccination and post-vaccination supervision;

b/ To have professional documents in service of vaccination (instructions for preservation, use, supervision and handling of incidents) and vaccination-related legal documents;

c/ To have books recording the receipt, distribution and expiry date of each lot of vaccines or medical biologicals; books recording vaccination for each person, prescribed vaccination report forms; and vaccination slips and records for vaccinated persons;

d/ To satisfy conditions on waste treatment and environmental sanitation according to law.

2. Conditions on minimum equipment:

a/ To have equipment and devices for transporting, preserving and storing vaccines and medical biologicals in freezing chains as required by manufacturers: containers of used bottles of vaccines and medical biologicals and syringes;

b/ To have sufficient sterile vaccination devices;

c/ To have an anti-shock drug box. To post the anti-shock process at the place of vaccination according to Appendix 1 to this Regulation (not printed herein).

3. Conditions on personnel:

Vaccinators must be trained in safe vaccination requirements and possess training certificates according to Clause 1. Article 23 and Clause 2, Article 24 of this Regulation.

Article 6.- Conditions on personnel, material bases and equipment for outside-health center vaccination points during vaccination campaigns

1. Principles of application:

To apply only in expanded vaccination campaigns or in cases of necessity.

2. Conditions on minimum material bases:

a/ To have desks for contraindication-exclusive consultancy and examination and vaccination and a place for supervision of post-vaccination reactions;

b/ To have vaccination record books and vaccination slips and records for vaccinated persons and other necessary equipment for the vaccination session.

3. Conditions on minimum equipment:

a/ To have equipment for transporting, preserving and storing vaccines and medical biologicals in freezing chains as required by manufacturers, containers of used bottles of vaccines and medical biologicals and syringes;

b/ To have sufficient sterile vaccination devices;

c/ To have an anti-shock drug box and the anti-shock process.

4. Conditions on personnel:

Vaccinators must be trained in safe vaccination requirements and possess training certificates.

Article 7.- Establishments permitted to use vaccines and medical biologicals for vaccination

1. Epidemiology Institutes, Pasteur Institutes, and provincial- and district-level preventive medicine centers meeting the requirements specified in Articles 5 and 6 of this Regulation may inoculate vaccines and medical biologicals.

2. State-run healthcare establishments, private hospitals and polyclinics, and family health clinics possessing certificates of satisfaction of private medical practice conditions and meeting requirements specified in Articles 5 and 6 of this Regulation may provide vaccinations and use vaccines and medical biologicals within their licensed scope of professional operations (inoculation of vaccines and medical biologicals).

3. Prior to providing vaccination, all vaccination establishments shall produce a written commitment on compliance with the provisions of Article 5 of this Regulation. This commitment must be posted at vaccination establishments.

4. Units under the Ministry of Health shall send their written commitments on compliance with vaccination regulations to the Ministry of Health (the Preventive Medicine and Environment Department); commune-level vaccination establishments, to district health divisions; and other health establishments, to provincial Health Services.

Article 8.- Provisions on inspection, examination

The Ministry of Health, provincial/municipal Health Services and district Health Sections shall examine and inspect the establishments defined in Clauses 1 and 2, Article 7 of this Regulation.

Chapter III

ORDER OF RECEIVING, TRANSPORTING PRESERVING AND DISTRIBUTING VACCINES AND MEDICAL BIOLOGICALS

Article 9.-Order of receiving and distributing vaccines and medical biologicals

1. Upon receipt of vaccines and medical biologicals, to check and record the following information on the receipt slip or book:

a/ Date of receipt;

b/ Type of vaccines or medical biologicals;

c/ Name of vaccines or medical biologicals;

d/ Content and packing specifications of vaccines or medical biologicals;

e/ Quantity of doses;

f/ Manufacturing establishment and country of origin;

g/ Manufacture lot number;

h/ Expiry date for each lot;

i/ Name of supplier;

j/ Circulation registration permit number or import permit number;

k/ Status of temperature indicators such as temperature indicator of vaccine or medical biological bottle, temperature-monitoring card and indicator of freezing-point (if any) upon the arrival of vaccines and medical biologicals;

l/ Lyophilized vaccines and medical biologicals enclosed with water for reinstitution of those vaccines and medical biologicals. The following information on water for restitution must be recorded: type of water for restitution, volume, manufacturing establishment, manufacturer, lot number, expiry date for each lot; and name of supplier;

m/ If there is anything abnormal about vaccines and medical biologicals, the receiving unit shall clearly record it and return them to the supplier.

2. The distribution of vaccines and medical biologicals should be examined and fully recorded in receipt-deliver) books or vaccine and medical biological management books. This job must be done at the time of distribution to ensure the accuracy of recorded information. The following information must be recorded upon distribution:

a/ Date of distribution;

b/ Type of vaccines or medical biologicals;

c/ Name of vaccines or medical biologicals;

d/ Content and packing specifications of vaccines or medical biologicals;

e/ Distributed quantity (quantity of doses, number of bottles, number of packs);

. f/ Manufacturing establishment, country of origin;

g/ Expiry date of each lot;

h/ Circulation registration permit number or import permit number;

i/ Status of temperature indicators of bottles of vaccines or medical biologicals (if any) or preservation status upon delivery from storage facilities.

Article 10.- Provisions on transportation of vaccines and medical biologicals

In the course of transportation, vaccines and medical biologicals shall be preserved in freezing chains in accordance with Appendix 2 to this Regulation (not printed herein) and devices for monitoring temperatures of vaccines and medical biologicals must be available in the course of transportation.

Article 11.- Provisions on preservation of vaccines and medical biologicals

1. All vaccines and medical biologicals shall be preserved at required temperatures from manufacture through use until their expiry dates according to Appendix 2 to this Regulation (not printed herein).

2. Vaccines and medical biologicals shall be preserved separately in freezing chains at health establishments, not together with other products.

3. In the course of preservation, information on vaccines and medical biologicals and preservation conditions shall be regularly monitored. All vaccines and medical biologicals and water for reinstitution with expired dates or improper preservation shall be destroyed. Their destruction shall be recorded in writing. To apply the principle of earlier use of vaccines and medical biologicals with shorter use term.

Article 12.- Provisions on remedy of incidents

Establishments preserving, transporting and using vaccines and medical biologicals shall have schemes to remedy incidents in the .course of preservation, transportation and use

Chapter IV

ORDER OF SAFE VACCINATION

Article 13.- Safe vaccination

1. Pre-vaccination

a/ To provide consultancy on the effects, benefits and risks of disease-preventing vaccination for to-be-vaccinated persons and/or their families:

b/ To conduct pre-vaccination medical examination to preclude contraindication cases: to check temperatures and inquire about medical history of to-be-vaccinated persons.

c/ To check vaccines and medical biologicals prior to vaccination.

2. During vaccination:

a/ To strictly follow indications and contraindications for each type of vaccine or medical biological;

b/ To conduct vaccination according to Appendix 3 to this Regulation (nor printed herein).

3. Post-vaccination:

a/ To supervise the health status of vaccinated persons for at least 30 minutes at vaccination establishments;

b/ To provide guidance on home care according to Appendix 4 to this Regulation (not printed herein ).

c/ To keep used bottles of vaccines, medical biologicals and water for restitution (if any) and syringes for at least 14 days after vaccination;

d/ At the end of a vaccination session, to destroy all opened bottles of vaccines and medical biologicals according to regulations, to continue preserving and using unopened bottles of vaccines and medical biologicals under the guidance specified in Appendix 3 to this Regulation (not printed herein).

Article 14.- Injection route, dose and position for each type of vaccine or medical biological

The injection route, dose and position and vaccination schedule for each type of vaccine or medical biological must strictly comply with manufacturers' instructions for use which have been registered with the .Ministry of Health or the Ministry of Health's regulations. Any change in injection route, dose and position must be permitted by the Ministry of Health and manufacturers shall notify health establishments using their vaccines and medical biologicals according to Appendix 5 to this Regulation (not printed herein).

Chapter V

SUPERVISION AND TREATMENT OF POST-VACCINATION REACTIONS

Article 15.- Detection of post-vaccination reactions

All vaccinated persons shall be supervised for at least 30 minutes after vaccination at the place of vaccination. Relatives of children shall then be provided with guidance on supervision of their children for at least 24 hours after vaccination and report on any abnormal reaction to medical workers of the commune or ward where they reside.

Article 16.- Handling of post-vaccination reactions

1. At places where reactions occur or where cases of reaction are first received

a/ Medical workers shall supervise in order to early detect cases of post-vaccination reactions for handling and report to a higher-level health agency according to Articles 18 and 19 of this Regulation;

b/ In case of serious post-vaccination reactions which fall beyond the handling capacity of medical workers, medical examination and treatment by a specialized doctor is required;

c/To fully record information in the monitoring book according to Appendix 6 to this Regulation (not printed herein):

- Information on persons suffering post-vaccination reactions;

- Date and time of inoculation, type of used vaccines or medical biologicals. name of vaccines or medical biologicals, lot number, expiry date, manufacturer, supplier and water for restitution (if any);

- Date and time of occurring reactions, description of main syndromes (on the whole body, at injection position and other special signs). Developments of reactions and methods of treatment which have been applied according to Appendix 7 to this Regulation (not printed herein).

2. Required activities when serious post-vaccination reactions occur in a vaccination session

a/ At grassroots level:

- To promptly stop the vaccination session;

- To seal off all vaccines and medical biologicals and preserve them under the conditions specified in Article 11 of this Regulation; to seal off syringes used in the vaccination session;

- To make a written record on the temperature and preservation conditions of vaccines and medical biologicals at the time of occurring serious reactions;

- To make statistics on the total quantity of received and used vaccines and medical biologicals and the number of children vaccinated with each type of vaccine or medical biological in the vaccination session where serious reactions occur;

- To report to a higher-level health agency according to Article 18 of this Regulation.

b/ At district, provincial, regional and national levels: To receive reports and carry out investigation according to Article 18 of this Regulation;

c/ Hospitals shall coordinate in handling cases of post-vaccination reactions.

Article 17.- Provisions on suspension of use of vaccines and medical biologicals

1. At vaccination establishments: Upon serious post-vaccination reactions causing serious impacts on the health or life of vaccinated persons, vaccination establishments shall suspend the use of vaccines or medical biologicals.

2. At district and provincial levels: Upon reactions, leaders of provincial Health Services shall decide to suspend the use of a type or lot of vaccines or medical biologicals within a district or province pending a higher-level health agency's direction and investigation results.

3. At central level: The Pharmaceuticals Management Department shall decide to suspend the use of a lot of vaccines or medical biologicals related to serious reactions based on a Science-Professional Council's conclusions evaluating the use of vaccines under the expanded vaccination project or local health agencies' conclusions.

4. When causes of reactions are concluded as not related to vaccines and medical biologicals, the agency deciding on the suspension of use of vaccines and medical biologicals shall announce the resumed use of those vaccines and medical biologicals.

Article 18.- Reports on cases of post-vaccination reactions

1. Vaccination establishments and units and establishments receiving cases of post-vaccination reactions shall, within 24 hours, report on serious cases, including anaphylactic shock, toxic shock syndrome, suspected faults in vaccination and death, to a higher-level health agency and a provincial Health Service for prompt handling and investigation. They may report to a higher-level health agency via telephone, fax, email or by post.

2. Cases of mild reactions whose number, however, exceeds the normal rate shall be also reported according to Clause 1 of this Article.

Article 19.- Supervision on and investigation into cases of post-vaccination reactions

1. When receiving an urgent report from a vaccination establishment, a provincial Health Service shall study it before deciding on the investigation. Vaccination establishments and concerned units shall create favorable conditions for the investigation into causes of post-vaccination reactions.

2. Upon post-vaccination reactions which seriously affect the health or life of vaccinated persons, to immediately suspend the use of relevant type of vaccine or medical biological and promptly investigate and evaluate causes. An investigation must cover the following steps according to Appendix 8 to this Regulation (not printed herein):

a/ Setting up a scientific-professional council for evaluation of use of vaccines under the expanded vaccination project to evaluate the use of vaccines and medical biologicals of a province. The council is composed of leaders of the provincial Health Service, representatives of the Epidemiology Institute, Pasteur Institute, preventive medicine center, treatment establishments and concerned units and consultants when necessary to evaluate causes of post-vaccination reactions;

b/ To formulate questionnaire forms according to Appendices 9 and 10 to this Regulation (not printed herein);

c/ To carry out investigation, collect vaccine and medical biological samples, syringes and other related medical samples;

d/ To verify samples of vaccines and medical biologicals, test medical samples and syringes;

e/ To synthesize, analyze and conclude on the causes of serious reactions;

f/ To propose directions for continued solution and remedies.

3. When necessary, to coordinate with or invite specialists and concerned units (forensic medicine agencies, international organizations) to support investigation and tests.

4. The professional council evaluating the use of vaccines and medical biologicals shall designate a spokesperson to supply information on investigation progresses and results.

Chapter VI

REPORTING REGIME AND ARCHIVES

Article 20.- Reporting regime

Within its assigned functions, tasks and scope of operation, each vaccination establishment shall report on a quarterly and extraordinary basis to a higher-level state management agency on vaccines and medical biologicals and vaccination.

A periodical report must cover the following information:

1. The number of persons inoculated with vaccines and medical biologicals for disease prevention and treatment;

2. The quantity of used vaccines and medical biologicals; types of vaccines and medical biologicals, names of vaccines and medical biologicals and their manufacturers;

3. Post-vaccination reactions (if any).

Article 21.- Archives at vaccination establishments

Each health establishment providing vaccination for disease prevention shall have a system of file archives meeting the following requirements:

1.. Files include:

a/ Documents on vaccines and medical biologicals used at the health establishment:

b/ Books on vaccination monitoring;

c/ Documents on instructions for safe vaccination practice.

2. The files must be complete, easy for search and reference, confidential and in security.

3. The files shall be kept for 5 years counting from the date of updating the last information.

Chapter VII

ORGANIZATION OF IMPLEMENTATION

Article 22.- Responsibilities of the Ministry of Health

1. The Preventive Medicine and Environment Department shall assume the prime responsibility for, and coordinate with concerned Departments and Bureaus in, directing, guiding and examining the inoculation of vaccines and medical biologicals nationwide; propagate information on safe vaccination, supplement the list of diseases required of compulsory vaccination and the age of to-be-vaccinated children under the expanded vaccination program in each specific period. To receive written commitments of vaccination establishments under the Ministry.

2. The Drug Administration of Vietnam shall appraise, approve and issue circulation registration numbers for, and manage the quality of, vaccines and medical biologicals, permit the export and import of vaccines and medical biologicals used in vaccination for disease prevention; suspend or ban the use of vaccines and medical biologicals for disease prevention.

3. The Medical Examination and Treatment Management Department shall coordinate with the Preventive Medicine and Environment Department and concerned Departments and Bureaus in directing, examining and supervising vaccination activities in the healthcare system, and direct the first-aid treatment of post-vaccination reactions.

4. The Ministry's Inspectorate shall assume the prime responsibility for, and coordinate with the Preventive Medicine and Environment Department and concerned Departments and Bureaus in, organizing the inspection of vaccination activities nationwide.

5. The Planning-Finance Department shall assume the prime responsibility for, and coordinate with concerned agencies in. guiding financial regimes for vaccination activities.

6. The Office of the Ministry shall coordinate in formulating vaccination-related legal documents and regulations.

Article 23.- Responsibilities of institutes

1. Epidemiology Institutes and Pasteur Institutes shall provide professional and technical guidance for localities to ensure the quality and safety of vaccination, organize and direct the training on vaccination regulations and grant of training certificates to vaccinators inside and outside the expanded vaccination program according to Appendix 12 to this Regulation (not printed herein).

2. The National Institute for Vaccine and Medical Biological Accreditation shall supervise on a regular and irregular basis the quality and safety of vaccines and medical biologicals for disease-preventing vaccination; and coordinate with Departments and Bureaus of the Ministry of Health in inspecting vaccination activities nationwide.

Article 24.- Responsibilities of Health Services and Preventive Medicine Centers of provinces and centrally run cities and district Health Sections

1. Health Services of provinces and centrally run cities shall direct, guide, examine and inspect vaccination activities within their provinces, receive written commitments of health establishments under their management; and organize the evaluation of causes of post-vaccination reactions.

2. Preventive Medicine Centers of provinces and centrally run cities shall direct, guide and coordinate with Health Service inspectors in inspecting vaccination activities within their provinces, organize the training on safe vaccination regulations for medical workers inside and outside the expanded vaccination program and grant of training certificates to them; use. preserve and distribute vaccines and medical biologicals for disease prevention to ensure vaccination quality and meet people's demand for vaccination according to Appendix 12 to this Regulation (not printed herein).

3. District Health Sections shall coordinate with district Health Centers in examining and inspecting vaccination activities within their localities and receive written commitments of health establishments under their management.

Article 25.- Responsibilities of concerned units and agencies

1. Vaccine and medical biological trading establishments shall buy, sell, export, import, preserve and transport vaccines and medical biologicals according to law.

2. Establishments having the vaccination functions and tasks shall:

a/ Make written commitments on and take responsibility before law for their professional operations according to their assigned functions and tasks, suitable to their existing conditions, material foundations, personnel and equipment and in compliance with the technical-professional process for using vaccines and medical biologicals and safe vaccination; supervise and report on cases of post-vaccination reactions to competent health management agencies;

b/ Coordinate with mass organizations in mobilizing people to join vaccination programs;

c/ Treatment establishments shall coordinate with vaccination establishments in handling incidents of vaccination and propagating the use of vaccines and medical biologicals for disease prevention.

 

APPENDICES

 (Promulgated together with the Decision No. 23/2008/QD-BYT dated July 07, 2008 of the Minister of Health)

Appendix 1. Guidance on emergency treatment for anaphylactic shock

Appendix 2. Guidance on preservation of vaccines and biologicals in the cold chain

Appendix 3. Guidance on safe vaccination

Appendix 4. Guidance on responding to post-vaccination reactions

Appendix 5. Guidance on the use of vaccine and biologicals in expanded vaccination programmes

Appendix 6. Logbook of post-vaccination reactions

Appendix 7. Report on post-vaccination reactions

Appendix 8. Guidance on assessment of post-vaccination reactions

Appendix 9. Investigation form for post-vaccination reactions

Appendix 10. Vaccine and biological specimen delivery note

Appendix 11. Commitment of qualified vaccination center

Appendix 12. Certificate of training in safe vaccination

 

APPENDIX 1

GUIDANCE ON EMERGENCY TREATMENT FOR ANAPHYLACTIC SHOCK
Provided for in the Circular No. 08/1999-TT-BYT dated May 04, 1999 on emergency treatment for anaphylactic shock of the Ministry of Health

 

APPENDIX 2

GUIDANCE ON PRESERVATION OF VACCINE AND BIOLOGICALS IN THE COLD CHAIN
 (Promulgated together with the Decision No. 23/2008/QD-BYT dated July 07, 2008 of the Minister of Health)

Vaccine, biologicals

National storage

Local storage

Region

Province

District

Medical facility

Vaccination center

6 – 9 months

3 - 6 months

No more than 3 months

1 - 3 months

No more than 1 month

According to vaccination plan

OPV

-15°C to -25°C

+2°C to +8°C

BCG

Measles

MMR

MR

Lyophilized Hib

Preserved at 2°C to 8°C, or -15°C to -25°C in cramped conditions.

+2°C to +8°C

Hepatitis B

Preserved at +2°C to +8°C. Do not freeze

Preserved at +2°C to +8°C. Do not freeze

DTP-VGB

Hib solution

DTP

DT/TT/Td

DTaP

DTP-VBG-Hib

DTP-VBG-IPV-Hib

Other vaccines and biologicals shall be preserved under the instructions of producers.

Vaccines and biologicals that are packed together with diluents shall be preserved at +20C to +80C. They may be preserved without the cold chain if diluents are not packed with vaccines, but they must be cooled one day or a sufficient period of time before use to ensure that vaccines, biologicals, and diluents are at +20C to +80C when reconstituting.

Vials of vaccines and biologicals that are opened shall be put on the foam in the vaccine pack.

 

APPENDIX 3

GUIDANCE ON SAFE VACCINATION
 (Promulgated together with the Decision No. 23/2008/QD-BYT dated July 07, 2008 of the Minister of Health)

1. Before vaccination:

1.1. Preparation for the vaccination day:

- Planning the vaccination day:

- Personnel: at least 02 health workers trained in vaccination (1 person in charge of diagnosis, consultancy, and shock prevention; 1 person in charge of injection)

- Preparation of vaccines, biologicals, and necessary tools:

Soap and water for hand washing

Vaccination book

Pens and papers

Vaccination notes

Table and chairs

70 alcohol and cotton wool

Trash can

Shock prevention kit

Safety box

Saw

1.2. Advising patients and their family:

- Benefits and effects of vaccinations.

- Side effects and risks.

- Indications.

- Contraindications.

1.3. Examine the patient to identify the cases subject to contraindications and provide appropriate indications according to the instructions of the vaccine or biological.

2. Vaccination:

2.1. Vaccination steps

Step 1: Wash hands with clean water and soap

Step 2: Check the preservation temperature and expiration date of the vial of vaccine or biological.

Step 3: Open the vial of vaccine or biological.

Step 4: Check the diluent vial (only use the diluent packed with the vaccine or biological by the producer).

Step 5: Open the diluent vial

Step 6: Draw diluent into a syringe.

Step 7: Reconstitute the vaccine or biological. Remove this syringe and needle to a safety box after use.

Step 8: Inject vaccine or biological

- Disinfect the area where injection is given.

- Give injection properly and at proper position.

- Have the parent or the patient use clean and dry wool to press the injection area for a few second if it bleeds. Do not rub the injection area.

2.2. Some principles

a) When injecting vaccines and biologicals

- Do not touch the rubber cap and the needle when drawing vaccine or biological into the syringe.

- Do not touch the rubber cap and the needle when drawing vaccine or biological into the syringe.

- The reconstituted vaccines and biologicals shall be preserved at 20C to 80C and used within 4 – 6 hours according to the instructions of the producers.

- Use a new sterile needle for each reconstitution.

b) Injecting various vaccines and biologicals in one vaccination day

- If a child needs multiple vaccines and biologicals, they may be injected in the same day at various positions. Do not give injections on the same side of thigh or arm.

- If the interval between injections exceeds the interval of the vaccination schedule, the next injection shall be given without giving injections from the beginning.

- If the first injection is later than the vaccination schedule, the dose and interval between injections must be maintain according to the vaccination schedule.

- Prepare all injections to give one after another. Do not mix various vaccines and biologicals in the same syringe.

c) Use lock syringes.

- Do not pull the plunger backwards to check for blood.

- Immediately put the needle cap in the safety box – Do not put the cap back on the needle.

3. After vaccination:

3.1. Monitor the conditions of the patient for at least 30 minutes at the vaccination center.

3.2. Provide guidance on caring at home according to Appendix 4 to this Regulation.

3.3. Fill the vaccination note and vaccination book:

- Write the vaccination date on the vaccination note and give the note to the patient or their parent.

- Write the vaccination date of each vaccine and biological to the vaccination book.

3.4. Handling vials of injecting vaccines and biologicals after vaccination:

- If the ice of the ice chest has not melted, unopened vials of vaccines and biologicals shall be preserved in a separate box in the cold chain (+2oC to +8oC ) before the next vaccination day.

- Destroy all vaccines and biologicals if the ice has melted, except for the vaccines and biologicals of which preservation temperatures show that they are still usable. Preserve the vials of vaccines and biologicals in the cold chain for the next vaccination day.

- The opened vials of vaccine or biological must be destroyed.

- The vials of used vaccines, biologicals and diluents shall be kept for 14 days and then destructed.

3.4. Handling needles that remain after vaccination

- Unused needles shall be preserved for later use.

- Used needles shall be kept for 14 days and then destructed.

 

APPENDIX 4

GUIDANCE ON RESPONDING TO POST-VACCINATION REACTIONS
 (Promulgated together with the Decision No. 23/2008/QD-BYT dated July 07, 2008 of the Minister of Health)

Post-vaccination reaction

Vaccine, biological

Clinical symptom

Response

Acute Flaccid Paralysis (due to vaccine)

OPV

Acute flaccid paralysis happens within 4 – 30 days after the administration of OPV, or within 4 – 75 days after contact with people that use OPV and nerve damage that lasts up to 60 days or death

No treatment, only provide supporting care

Acute hypersensitivity reactions

All vaccines

Acute hypersensitivity reaction happens within 2 hours after vaccination with one or multiple signs below:

- Intermittent wheezing due to trachea, bronchial, and larynx spasm, larynx oedema.

- Topical signs.

e.g. facial oedema, rash, or systemic oedema. Less severe allergic reactions do not have to be reported.

- Use antihistamines, give 100% oxygen therapy. Treat severe reactions similarly to anaphylaxis.

- The symptoms disappear themselves in some cases

Anaphylaxis

All vaccines

Immediate allergic reactions (within 01 hour) that lead to circulatory failure with or without bronchial spasm and/or larynx spasm or oedema (Appendix 1)

According to the regimen (Appendix 1)

Arthralgia

Rubella, Measles-Mumps-Rubella

Arthralgia, including peripheral minor joints

Persistent (more than 10 days) or transient (10 days or shorter)

- Use painkillers

- The symptoms disappear themselves in some cases

Arm neuritis

Tetanus

Dysfunction of the nerves at the arms and shoulder-blades that are not related to the nervous system. Deep pain, usually tenderness that persists many days at the shoulder-blade and the arms; the muscles there are weaken and contracted Indistinct numbness is possible. The symptoms may occur at the injection site or the opposite side or on both arms.

Use painkillers

Disseminated BCG infection

BCG

Disseminated infection occurs within 1 – 12 months after the injection, and diagnosed by isolating mycobacteria. This usually happen to people suffering from immunodeficiency

Treat with anti-tuberculosis medicines such as isoniazid and rifampicin

Brain syndrome, meningitis

Measles DPT

The reaction is acute with 2 out of 3 symptoms below:

- Paroxysms.

- Disordered consciousness that last from 1 to many days.

- Major behavioral changes that last from 1 to many days.

The reactions to DPT vaccines occur within 48 hours for DPT vaccine; the reaction to measles vaccines occur within 7 – 12 days

Provide treatment and supporting care

Fever

All vaccines

The fevers are classified into 3 levels:

- Mild (380C to 38.90C)

- High (390C to 40.40C)

- Very high (40.50C or above)

Fevers do not have to be reported

Treat with Paracetamol

Hypotonia, hyporeflexia, dizziness.

Usually DPT; other vaccines are rarely attributable

The reaction occurs within 48 hours after vaccination (usually within 12 hours) and last for from 1 minutes to many hours, at children under 10 years of age:

- Fatigue (hypotension)

- Hyporesponsiveness

- Pale or cyanosis or fainting

The symptoms are transient and will disappear themselves. No special treatment is necessary. This is not a contraindication to the next vaccinations.

Some cases need monitoring and intensive treatment like shocks in general.

Abscess at the injection site

All vaccines

The injection site is soft or leaking. Bacteria are the cause if bacterial contamination is proved (e.g. pus, signs of inflammation, fever, bacterial cultures), or sterile abscess if the symptoms above do not appear.

Make incision and drainage; use antibiotics if bacterial contamination is the cause.

Lymphadenitis, including purulent lymphadenitis

BCG

1 swollen lymph node bigger than 1.5 cm (the size of an adult’s finger) or a leaking hole on 1 lymph node.

This mostly caused by BCG, and occur within 2 – 6 months after BCG injection at the same side with the injection site (usually in the arm pit)

The symptom will disappear itself (after months). It is best to not treat unless the injury adheres to the skin or leaking. Drain and apply anti-tuberculosis medicines on the site in this case. Systemic treatment with anti-tuberculosis medicines is not effective.

Bone/bone marrow inflammation

BCG

Bone inflammation due to Mycobacterium bovis of BCG

Treat with anti-tuberculosis medicines such as isoniazid and rifampicin

Prolonged and relentless crying

DPT

Prolonged and relentless crying for more than 3 hours, associated with screaming

The crying will diminish after 1 day. Painkillers may be used at this time.

Convulsion

All vaccines, especially DPT and measles

Full body convulsions without signs and symptoms, with or without fevers.

The symptoms will disappear themselves; provide medical car; use paracetamol and apply a cold compress if a fever occurs; anti-convulsion medicines are rarely used. Emergency treatment is as necessary as convulsions in general; watch out for tongue biting and remove phlegm.

Septicemia

All vaccines

The reaction is acute, systemic, and severe due to bacterial contamination and blood cultures (if any) This must be reported as soon as possible because errors in vaccination are attributable

It must be detected and treated as soon as possible. Send the patient to a hospital for infusion and antibiotics.

Severe localized reaction

All vaccines

Redness and/or swelling at the injection site and one or multiple symptom below:

- Swelling at the nearest joint to the injection site

- Soreness, redness, and swelling for more than 3 days

The symptoms will disappear themselves within a few days or 1 week Treat the symptoms with painkillers. Do not use antibiotics.

Low platelet count

Measles-Mumps-Rubella

Low platelet count (smaller than 50,000/ml) leads to bruises and/or bleeding.

The symptom is usually mild and transient. Sometimes steroid and platelet infusion are necessary

Toxic shock syndrome

All vaccines

Sudden fever, vomiting and diarrhea within a few hours after vaccination. This usually leads to death within 24 – 48 hours. This must be reported as soon as possible because errors in vaccination are attributable

It must be detected and treated as soon as possible. Send the patient to a hospital for infusion and antibiotics.

 

APPENDIX 5

GUIDANCE ON THE USE OF VACCINE AND BIOLOGICALS IN EXPANDED VACCINATION PROGRAMMES
 (Promulgated together with the Decision No. 23/2008/QD-BYT dated July 07, 2008 of the Minister of Health)

No.

Vaccine

Dose

Route of administration

Injection place

1

BCG (against tuberculosis)

0.1ml

Intradermal injection

Upper left arm

2

BH – HG – UV (DPT)

0.5ml

Intramuscular injection

Vastus lateralis

3

Hepatitis B

0.5ml

Intramuscular injection

Vastus lateralis

4

Oral polio vaccine

2 drops

Oral administration

Mouth

5

Measles

0.5ml

Subcutaneous injection

Upper arm

6

Tetanus

0.5ml

Intramuscular injection

Upper arm

7

Japanese B Encephalitis

0.5ml (1 - ≤ 3 years of age)

1ml (≥ 3 years of age)

Subcutaneous injection

Upper arm

8

Typhoid

0.5ml

Intramuscular injection

Upper arm

9

Cholera

1.5ml

Oral administration

Mouth

1. BCG vaccine: intradermal injection in the upper left arm.

a. Have the parent hold the child in the lap; remove the top to expose the arm and shoulder.

b. Have parent support the head and hold the child’s arm tightly.

c. Hold the syringe in the right hand, bevel side up.

d. Use the thumb and index finger of the left hand to spread the skin taut at the injection site.

e. Place the syringe and needle almost flat against the arm.

f. Insert the needle through and in the skin surface, just a bit pass the bevel.

g. Hold the needle flat against the skin surface so that the needle is only inserted to the inner part of the skin. Keep the bevel up.

h. Do not push so deep. Do not … the needle to avoid reaching the subcutaneous tissues and the injection would be subcutaneous instead of intradermal.

i. Hold the needle at the right position, place the thumb of the left hand on the needle hub. Do not touch the needle.

j. Use the index finger and middle finger of the right hand to hold the end of the syringe. Use the thumb of the right hand to push the plunge to inject the vaccine.

k. Withdraw the needle when 0.1 ml vaccine is injected.

2. DPT and VGB vaccine: intramuscular injection in the thigh

a. Have parent hold the child in the lap, expose the child’s thigh.

b. Have the child’s left arm embrace the parent.

c. Have parent use one hand support the head and hold the child’s right arm, and hold the child’s leg by the other hand.

d. Use the thumb and index finger to spread the thigh skin (outer middle)  taut at the injection site.

e. Quickly insert the needle at 90 degrees through the skin to the muscle. Slowly inject the vaccine to minimize pain.

3. Oral polio vaccine

a. Have the parent support the child’s head so that it slightly tilts backwards.

b. Gently open the child’s mouth. Use a thumb to press the chin (for infants) or use 2 fingers to gently press the child’s cheeks.

c. Drop 2 drops of vaccine to the child’s tongue. Do not let the vial touch the child.

4. Measles vaccine: subcutaneous injection in the upper right arm.

a. Have parent hold the child in the lap, expose the child’s arm.

b. Have the child’s left arm embrace the parent.

c. Have parent use one hand to support the head and hold the child’s left arm where vaccine is given; hold 2 legs of the child by the other hand.

d. Use fingers to hold below the child’s arm the stretch the skin taut.

e. Quickly insert the needle in the taut area.

f. Use the thumb and the index finger to hold the needle hub to direct the needle. Do not touch the needle.

5. Giving tetanus vaccine injection to women

Giving tetanus vaccine injection to pregnant women and women from 15 – 35 years of age in areas facing high risks.

a. Have the patient sit down.

b. Have the woman to expose the shoulder and put the arm to the back or against the hip. The arm muscles shall be relaxed this way and less pain is felt during the injection.

c. Put the fingers and the thumb at upper anterior part of the woman’s arm.

d. Use the left hand to press the muscle of the patient’s arm.

e. Quickly insert the needle through the skin between the fingers. Insert the needle deep into the muscle.

f. Use the thumb to push the plunger to inject vaccine.

g. Quickly withdraw the needle and have the woman press a sterile cotton ball against the injection site if it bleeds.

 

APPENDIX 6

LOGBOOK TO MONITOR POST-VACCINATION REACTIONS
 (Promulgated together with the Decision No. 23/2008/QD-BYT dated July 07, 2008 of the Minister of Health)

Medical facility: ..............................................

Year: ..............................................

Case 1:

1. Full name: .................................................................................... Gender: .......................

2. Date of birth: .....................................................................................................................

3. Full name of parent (for children): ..............................................................

4. Address: .........................................................................................................................

5. Vaccination date: ............................................................................

6. Type of vaccine/biological: ............................................................................

7. Name of vaccine/biological: ............................................................................

8. Lot number: ..................................................................................... Date of expiry: ..................

9. Producer: ................................................................................................................

10. Supplier: ............................................................................

11. Circulation or import license number:..........................................

12. Reaction time: .......................................................................................

13. Primary symptoms: .........................................................................................................................

14. Treatment result: ............................................................................................................

15. Conclusion: ............................................................................................................

 

 

Reporting date: ................................
Report maker

 

Case 2:

........................................

 

APPENDIX 7

POST-VACCINATION REACTION REPORT
 (Promulgated together with the Decision No. 23/2008/QD-BYT dated July 07, 2008 of the Minister of Health)

1. General information

Full name:                                                                              Number: ..........................

Date of birth (age):                  Gender:                        Race: ....................................

Full name of parent (for children): ..............................................................

Address: .........................................................................................................................

2. Types of vaccines/biologicals used: ............................................................................

Type of vaccine, biologicals

Times

Route

Injection site

Administered by

Injection time

Reaction time

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3. Information about the types of vaccines/biologicals and solvents used

Type of vaccine, biologicals

Name of vaccine, biologicals

Producer

Supplier

Lot number

Date of expiry

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4. Description of reaction

.........................................................................................................................................

.........................................................................................................................................

.........................................................................................................................................

5. Medical record (including history of similar reactions or other allergies):

.........................................................................................................................................

.........................................................................................................................................

.........................................................................................................................................

6. Current conditions

Healthy ....................................................................................... Sequela: .............................

Dead ...................................................................................... Other (specify): ……………..

 

 

Report maker
(Signature and full name)

Date: ……………………………………..

Certification of the center
(Signature and seal)

 

APPENDIX 8

GUIDANCE ON ASSESSMENT OF POST-VACCINATION REACTIONS
 (Promulgated together with the Decision No. 23/2008/QD-BYT dated July 07, 2008 of the Minister of Health)

1. Stages of investigation into post-vaccination reactions

Stage

Actions

1) Confirm information in the report

+ Collect medical record of the patient.

+ Examine the medical record for information about the patient and reactions.

+ Collect information omitted in the report.

+ Identify other cases that need investigation.

2) Investigation and collection of information

- About the patient

+ The history of vaccination.

+ The history of illness, including the history of similar reactions or other allergies.

+ The history of similar reactions of patient’s relatives.

- About the reaction

+ The medical record, clinical description, all tests related to reaction, and diagnoses.

+ Treatment and result

- Suspicious vaccines and biologicals

+ Transport conditions, preservation conditions, and temperature log.

+ Method of preserving vaccines and biologicals before the vaccination (previous cold chain and preservation temperature).

- About other people

+ Are other people given the same vaccine or biological that causes reactions?

+ Do other people have similar reactions? Do other people use the same vaccine or biological?

+ Investigate the vaccination service.

3) Assess the vaccination center by enquiring about:

The method of preserving vaccines and biologicals (including opened vials), the distribution and disposal of vaccines and biologicals.

+ The method of preserving and distributing solvents.

+ The reconstitution of vaccines and biologicals (techniques and useful life after reconstitution)

+ The use and sterilization of syringes and needles.

+ Details about training in vaccination and supervision of vaccination techniques.

+ Was the number of patients higher than usual?

Observing vaccination process

+ What are preserved in the cooler apart from vaccines and biologicals (record the similar vials that may cause confusion)? Which vaccines, biologicals, or solvents are stored together with other medicine? Was there any vial without label?

+ The vaccination process (reconstitution, vial opening, injection techniques, safety of syringes and needles, disposal of opened vials).

+ Which opened vials are suspicious of infection?

4) Making assumptions

+ Certainty or possibility of causes of reactions

5) Questioning assumptions

+ Did the case accord with the assumptions?

+ Tests hardly help identify causes.

6) Conclusion

+ Conclusion about the cause

+ Complete the investigation form

+ Carry out reorganization and suggest necessary tasks.

2. Tests serving investigation according to assumptions

Assumed errors

Sent specimen

Test for

Transport or preservation of vaccines and biologicals

Vials of biologicals and vaccines

Composition (for frozen biological and vaccines)

Errors in reconstitution

Vials of vaccines, biologicals or vials of solvents

Sterility or chemical composition

Unsterile vaccination

Needles, vials of vaccines, biologicals and vials of solvents

Sterility

Defective vials of biologicals and vaccines

Vials of biologicals and vaccines

Composition

3. Actions to protect the community during investigation

Investigation stage

Actions

Discover reactions

- Approach and investigate depending on the urgency.

-  Stop using the lot of vaccines or biologicals locally or nationwide depending on the seriousness.

Commence investigation

- Ensure resources for investigation.

- Enhance supervision to identify similar cases

- Identify suspected vaccines and biologicals

Make assumptions

- Do not accept assumptions if they are not proved.

- Rectify the errors that match the assumptions.

- Stop using defective vaccines and biologicals.

Confirm supposition

- Announce the causes and action plans

4. Actions taken after investigation

Reactions of vaccines and biologicals

Collect more information from the producer and consult with WHO if the reaction rate of a lot is higher than expected:

- Discard that lot

- Change the technical standards of production or inspection

- Use vaccines and biologicals of other producers

Errors in vaccination

Rectify the causes of errors:

- Change the supply of vaccines and biologicals

- Change the regulations of the medical facility

- Provide training for health workers

Enhance inspection; supervise all actions taken and make sure errors are rectified.

Coincidence

The primary task is to convince people that it is just a coincidence. This might be challenging if a majority of people belief the vaccination process is accounts for those reactions.

Sometimes, it is recommended to carry out deeper investigation to convince the people that it is really just a coincidence.

The potential damage to the vaccination campaign cause by wrong beliefs is great.

Unidentified

Investigation may be carried out by experienced persons depending on the persistence or developments of reactions

However in some cases, the nebulous relation between the reaction and the vaccination must be acknowledged.

 

APPENDIX 9

INVESTIGATION FORM FOR POST-VACCINATION REACTIONS
 (Promulgated together with the Decision No. 23/2008/QD-BYT dated July 07, 2008 of the Minister of Health)

1. General information

Full name:........................................................... Number:............................................

Date of birth (age):…………………….. Gender: ………………… Race: .........................

Full name of parent (for children): ..............................................................

Address:

2. Types of vaccines/biologicals injected: ............................................................................

Type of vaccine, medicinal products

Times

Route

Injection site

Administered by

Injection time

Reaction time

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3. Information about the types of vaccines/biologicals and solvents injected

Type of vaccine, biological

Name of vaccine, biological

Producer

Supplier

Lot number

Date of expiry

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4. Post-vaccination reactions:

Localized reaction

Systemic reaction

 

Severe localized reaction

 (swelling that spreads more than 5 cm from the injection site, or redness and swelling for more than 3 days)

 

Hospitalization is required

 

Swollen lymph nodes

 

Brain disease for 7 days

 

Abscess at the injection site

 

Shock for 48 hours

Tick all signs that are present

 

A fever of 40.5 0C for 48 hours

 

Recurrent convulsions for 3 days

Specific description (when reactions occur)

....................................................................................................................................

....................................................................................................................................

....................................................................................................................................

....................................................................................................................................

5. Community investigation:  Yes ¨    No ¨

Description: ................................................................................................................

6. Testing: Yes ¨    No ¨

Result (if any): ............................................................................................................

7. Medical record (including history of similar reactions or other allergies):

....................................................................................................................................

....................................................................................................................................

....................................................................................................................................

....................................................................................................................................

8. Causes reaction (check all that apply)

¨ Errors in vaccination

¨ Reaction of vaccine

¨ Coincidence

¨ Unidentified

¨ Unsterile injection

¨ Defective vaccine

¨ Similar reactions of unvaccinated people

 

¨ Improper vaccine preparation

¨ Reaction rate is usual

¨ Other causes

 

¨ Route/injection site

¨ Other causes

 

 

¨ Vaccine transport/preparation

 

 

 

¨ Other causes

 

 

 

9. Concluded major causes:

10. Current conditions:

¨ Healthy

¨ Sequelae

¨ Dead

¨ Other (specify):

11. Rectifications:

12. Suggestions:

 


Investigator
(Signature and full name)

Date: ……………………..
Certification of the center
(Signature and seal)

 

APPENDIX 10

VACCINE AND BIOLOGICAL SPECIMEN DELIVERY NOTE
 (Promulgated together with the Decision No. 23/2008/QD-BYT dated July 07, 2008 of the Minister of Health)

Sender: ......................................................................................................................

Reasons: ...................................................................................................................

Assumptions made after investigation: .....................................................................

Date of delivery: ........................................................................................................

Recipient: ..................................................................................................................

Name of vaccine, biological

Producer

Lot number

Date of expiry

Place of sampling

Date of sampling

Quantity

State of label, cap, color (used, reconstituted, etc.)

Notes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Notes:

- The specimens sent must comply with the cold chain and enclosed with the report and investigation form for post-vaccination reactions.

- Lyophilized vaccines must be sent together with their diluents.

 

 

Sender
(Signature and full name)

 

APPENDIX 11

COMMITMENT OF QUALIFIED VACCINATION CENTER
 (Promulgated together with the Decision No. 23/2008/QD-BYT dated July 07, 2008 of the Minister of Health)

Name of the vaccination center: ..............................................

Address: ...................................................................................................................

Phone number: ........................................................................................................

Fax: .........................................................................................................................

Full name of the Director of the vaccination center:

Address: ..................................................................................................................

Phone number: ........................................................................................................

We hereby commit ourselves to comply with the Regulation on the use of prophylactic and therapeutic vaccines and biologicals promulgated together with the Decision No. … /2008/QD-BYT dated … of the Minister of Health)

 

 

Location and date: ………………
Representative of the center
(signature and seal)

 

APPENDIX 12

CERTIFICATE OF TRAINING IN SAFE VACCINATION
 (Promulgated together with the Decision No. 23/2008/QD-BYT dated July 07, 2008 of the Minister of Health)

NAME OF TRAINING CENTER
-----

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
-------

 

CERTIFICATE

Issued to: ..................................................................................................................

Date of birth: .............................................................................................................

At :.............................................................................................................................

Has finished the training course in safe vaccination

From … to …

At:..............................................................................................................................

..................................................................................................................................

 

 

Location and date: ……………………
Representative of the training center
(signature and seal)

 

 

 

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Số hiệu23/2008/QD-BYT
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Ngày ban hành07/07/2008
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Lược đồ Decision No. 23/2008/QD-BYT of July 7, 2008, promulgating the regulation on use of vaccines and medical biologicals in prophylaxis and therapy.


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              Decision No. 23/2008/QD-BYT of July 7, 2008, promulgating the regulation on use of vaccines and medical biologicals in prophylaxis and therapy.
              Loại văn bảnQuyết định
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                    Văn bản gốc Decision No. 23/2008/QD-BYT of July 7, 2008, promulgating the regulation on use of vaccines and medical biologicals in prophylaxis and therapy.

                    Lịch sử hiệu lực Decision No. 23/2008/QD-BYT of July 7, 2008, promulgating the regulation on use of vaccines and medical biologicals in prophylaxis and therapy.