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MINISTRY OF
HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No: 1273/QD-BYT
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Hanoi, April 04,
2017
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DECISION
ON
PROMULGATION OF AMENDED ADMINISTRATIVE PROCEDURES SPECIFIED IN THE GOVERNMENT’S
DECREE NO. 103/2016/ND-CP DATED JULY 1, 2016 ON BIOSAFETY IN LABORATORIES AND
THE GOVERNMENT’S DECREE NO. 104/2016/ND-CP ON VACCINATION
MINISTER OF HEALTH
Pursuant to the Government’s Decree No.
63/2012/ND-CP dated August 31, 2012 defining Functions, Tasks, Powers and
Organizational Structure of Ministry of Health;
Pursuant to the Government’s Decree No.
63/2010/ND-CP dated June 8, 2010 on control of administrative procedures;
Pursuant to the Government’s Decree No.
48/2013/ND-CP dated May 14, 2013 amending and supplementing a number of
articles of decrees relating to control of administrative procedures;
At the request of the Director General of the
Ministry of Health’s General Department of Preventive Medicine,
HEREBY DECIDES:
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Article 2. This Decision is in effect from the date of signing.
Article 3. Chief of the Ministry Office, General Directors of
Departments, Ministerial and General Departmental Inspectors, provincial
Departments of Health and the Ministry’s affiliated units have the
responsibility to implement this Decision./.
ON BEHALF OF THE MINISTER
DEPUTY MINISTER
Nguyen Thanh Long
APPENDIX
ADMINISTRATIVE PROCEDURES UNDER THE MINISTRY OF HEALTH’S
JURISDICTION
(Issued together with the Minister of Health’s Decision No. 1273/QD-BYT
dated April 4, 2017)
Part
I
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No.
Name of
procedure
Field
Implementing
authorities
Notes
I. Administrative procedures of local
authorities
1
Declaration of biosafety level I (BSL-1) and
level II (BSL-2) laboratory
Preventive
healthcare
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Procedure promulgated in accordance with Decree
No. 103/2016/ND-CP
2
Declaration of eligibility for vaccine
administrations
Preventive
healthcare
Provincial Departments of Health
Procedure promulgated in accordance with Decree
No. 104/2016/ND-CP
3
Identification of eligibility for compensation
due to vaccine injuries
Preventive
healthcare
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Procedure promulgated in accordance with Decree
No. 104/2016/ND-CP
Part
II
SPECIFICS OF EACH ADMINISTRATIVE PROCEDURE UNDER THE
MINISTRY OF HEALTH’S JURISDICTION
1- Procedure
Declaration of biosafety level I (BSL-1) and
level II (BSL-2) laboratory
Implementation sequence
Step 1. The laboratory's legal
representative sends the self-declaration of biosafety (form no. 8 in the
Appendix under Decree No. 103/2016/ND-CP dated July 1, 2016) to the
Department of Health.
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Implementation methods
Send by post or hand in directly.
Components and quantity of application
I. Type of documents:
Self-declaration of biosafety (form no. 8 in the Appendix
under Decree No. 103/2016/ND-CP dated July 1, 2016).
II. Quantity of documents: Not specified
Processing period
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Laboratories are allowed to carry out tests
within their professional capacity after declaring biosafety.
Subjects of the administrative procedure
Public and private laboratories.
Implementing authorities
Provincial Departments of Health.
Result of the administrative procedure
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Fees
None.
Forms (attached under this procedure)
Form no. 1: Self-declaration of biosafety (form no.
8 in the Appendix under Decree No. 103/2016/ND-CP dated July 1, 2016).
Requirements
Article 3 of Decree No. 103/2016/ND-CP.
Conditions applied to biosafety level I in laboratories
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1. Infrastructure
requirements:
a) The floor, walls, lab table are flat,
resistant to water, heat corrosive chemicals and easy to clean;
b) There are washing basins, emergency eye wash
equipment, first aid box;
d) There are clean water; the pipelines supplying
water directly to the testing area have anti-backflow equipment to avoid
contaminating the public water system;
e) There is fire safety equipment;
f) Lighting is sufficient for carrying out tests.
2. Equipment requirements:
a) The testing equipment must be technically
appropriate for the specimens or microorganisms being tested on;
b) There are packages, tools and storage
equipment for medical waste in accordance with regulations;
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d) Personal protective gear is appropriate for
testing techniques carried out in biosafety-level-I laboratories
3. Personnel requirements:
a) Number of personnel: There are at least two
testers. The testers who directly conduct tests on microorganisms
(hereinafter referred to as testers) must have diplomas and certificates
appropriate for the types of test carried out by that laboratory;
b) The laboratory must assign a person in charge
of biosafety;
c) Testers and the one in charge of biosafety
must be trained in biosafety level I or above;
d) Others working in the testing area must
receive biosafety training that is appropriate for their tasks.
4. Practice regulations
conditions:
a) There are regulations on testing area entry
and exit;
b) There are regulations on reporting;
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d) There are testing processes which are
technically appropriate for the specimens or microorganisms being tested on;
dd) There are instruction manuals for testing
equipment;
e) Has decontamination and waste treatment
processes;
g) There are regulations on health and medical
surveillance.
Article 6 of Decree No. 103/2016/ND-CP.
Conditions applied to biosafety level II in laboratories
The testing area must fulfill the following
conditions:
1. Infrastructure requirements:
a) Requirements specified in Clause 1, Article 5
of this Decree;
b) There are wastewater collection and processing
system and processing equipment. Laboratories which are already in operation
before this Decree comes into effect must have wastewater treatment test
results in accordance with the national technical regulations on the
environment before disposing wastewater into the common wastewater container;
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d) There is a biohazard sign on the testing
area's door, as specified by Sample no. 1 in the Appendix under this Decree.
2. Equipment requirements:
a) Requirements specified in Points a and b,
Clause 2, Article 5 of this Decree;
b) There is a biosafety cabinet;
c) There are moist heat or other sterilization
equipment for medical waste carrying communicable diseases;
d) Personal protective gear is appropriate for
testing techniques carried out in biosafety-level-II laboratories.
3. Personnel requirements:
a) Requirements specified in Points a, b and d,
Clause 3, Article 5 of this Decree;
b) Testers and the one in charge of biosafety
must be trained in biosafety level II or above;
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a) Requirements specified in Clause 4, Article 5
of this Decree;
b) There is a training plan for employees working
in the testing area;
c) There are regulations on retention of
specimens and communicable disease pathogens in the laboratory;
d) There are plans for assessment of biohazard
risks, biohazard prevention and handling.
Legal basis of the administrative procedure
1. Law No. 03/2007/QH12
dated November 21, 2007 on Prevention of Infectious Diseases.
2. Law on Investment No.
67/2014/QH13 dated November 26, 2014.
3. Government’s Decree No. 103/2016/ND-CP
dated July 1, 2016 on Biosafety in Laboratories.
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SPECIMEN
OF THE SELF-DECLARATION OF BIOSAFETY LABORATORY
…….[1].……..
……[2]..........
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SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
---------------
No:
/…[3]…
…….…[4]……., [month, day, year]
SELF-DECLARATION
OF BIOSAFETY LABORATORY
To:………………[5]………………….
Laboratory name:…………………………………………………………………………………
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Head of laboratory:……………………………………………………………………………….
Contact number: …………………………………….Email (if
any):……………………………
Pursuant to Article ……[7]…… of the
Government’s Decree No. ……/2016/ND-CP dated…, we have fulfilled the biosafety
level ……[8]…… conditions regarding our infrastructure, equipment,
personnel and regulations on biosafety practice in laboratories .
We would like to have the information above
published in accordance with the regulations.
We commit ourselves to carry out tests within our
professional capacity and take legal responsibility for our actions./.
Head of unit
(Signature and stamp)
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2 Name of the laboratory.
3 Initials of the laboratory’s name.
4 Place.
5 Name of the authority the self-declaration
is addressed to.
6 Full address of the laboratory.
7 Article 5 for BSL-1, Article 6 for
BSL-2.
8 Biosafety level.
2- Procedure
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Implementation sequence
Step 1. Before carrying out vaccination,
the vaccination center must declare its eligibility for vaccine
administration to the local Department of Health in writing (form no. 1 in
the Appendix under the Government’s Decree No. 104/2016/ND-CP dated July 1,
2016).
Step 2. In 10 days from the date the
declaration of eligibility for vaccine administration is received, the
Department of Health must publish the name, address and head of the
aforementioned vaccination center on the Department’s website (the time
limit’s starting date is based on the Department’s stamp of receipt).
Implementation methods
Send by post or hand in directly.
Components and quantity of application
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The declaration of eligibility for vaccine
administration (form no. 1 in the Appendix under Decree No. 104/2016/ND-CP
dated July 1, 2016.
II. Quantity of documents: Not
specified
Processing period
The vaccination center is allowed to administer
vaccines after submitting the declaration of eligibility.
Subjects of the administrative procedure
Public and private vaccination centers.
Implementing authorities
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Provincial Departments of Health.
Result of the administrative procedure
The name, address and head of the eligible vaccination
center become available on the Department of Health's website.
Fees
None
Forms (attached under this procedure)
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Requirements
Article 9 of Decree No. 104/2016/ND-CP.
Conditions applied to stationary vaccination centers
1. Infrastructure:
a) The waiting area must have sufficient seats
for one vaccination session, be shielded from rain, sunlight, wind and
well-ventilated;
b) The consultation and screening area has the
minimum area of 8 m2;
c) The vaccination area has the minimum area of 8
m2
d) The post-vaccination monitoring area has the
minimum area of 15 m2;
dd) In the case of hepatitis-B vaccination for
infants in medical facilities with maternity wards, the following conditions
shall apply instead of those specified in Points a, b, c and d of this
Clause: Separate vaccination room or table is available, the vaccination
place must be able to keep the infants warm, a place for infant screening and
consultation for mothers or guardians must be available;
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2. Equipment:
a) Has a refrigerator, insulated vaccine
containers or chilled containers, temperature monitoring devices at the
storage place and during vaccine transportation;
b) There are sufficient injection devices, tools
and chemicals for antisepsis and other necessary materials;
c) There are anti-shock boxes and treatment
regimens at post-vaccination monitoring in accordance with the Minister of
Health's regulations;
d) There are tools for containing medical waste
in accordance with the Minister of Health's regulations.
3. Personnel:
a) Number: There are a minimum of 3 health
workers, at least one of whom has a medical assistant diploma or above; for
vaccination centers in remote or disadvantaged regions, a minimum of 2
employees having associate degree in medicine is required, at least one of
whom has a medical assistant diploma or above;
b) The health staff participating in vaccination
activities must undergo professional training in vaccination beforehand.
Employees directly carrying out screening, consultation, post-vaccination
complication monitoring and handling must have professional capacities being
physician or above; employees practicing vaccination must have at least associate
degree in nursing or above.
Article 10 of Decree No. 104/2016/ND-CP.
Conditions applied to mobile vaccination clinics
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a) Only applicable for the Expanded Program for
Immunization or anti-epidemic immunization;
b) Must be carried out by vaccination centers
which declared their eligibility vaccine administration as specified in
Article 11 of this Decree;
c) There are insulated vaccine containers,
sufficient vaccination tools which fulfill the conditions specified in Points
b, c and d, Clause 2, Article 9 of this Decree;
d) The personnel meet the conditions specified in
Point d, Clause 2 of this Article.
2. Conditions applied to
other mobile vaccination clinics:
a) Must be carried out by vaccination centers
which declared their eligibility for vaccine administration as specified in
Article 11 of this Decree;
Infrastructure: There are consultation table,
screening area, vaccination table, post-vaccination complication monitoring
and handling place and all of them must be arranged in accordance with the
one-way principle. The vaccination clinic has to ensure all sanitation
conditions are fulfilled, be shielded from rain, sunlight and wind,
well-ventilated and well-lit.
Equipment: c) Has insulated vaccine containers or
chilled containers which fulfill the conditions specified in Points b, c and
d, Clause 2, Article 9 of this Decree;
Legal basis of the administrative procedure
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1. Law No. 03/2007/QH12 dated
November 21, 2007 on Prevention of Infectious Diseases.
2. Law on Investment No.
67/2014/QH13 dated November 26, 2014.
3. Government’s Decree No.
104/2016/ND-CP dated July 1, 2016 on Vaccination.
SPECIMEN
OF THE APPLICATION FOR THE CERTIFICATE OF ELIGIBILITY FOR VACCINE
ADMINISTRATION
…….[1].……..
……[2]..........
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SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
---------------
No: /…[3]…
…….…[4]……., [month, day, year]
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APPLICATION FOR THE
CERTIFICATE OF ELIGIBILITY FOR VACCINE ADMINISTRATION
To:
………………[5]………………….
Facility name:………………………………………………………………………………………
Address:…………………………………………………[6]……………………………………….
Head of Center:……………………………………………………………………………
Contact number: …………………………………….Email
(if any):………………………….
Pursuant to the Government’s Decree No.
104/2016/ND-CP dated July 1, 2016 on vaccination, we would like to have the
information published in accordance with the regulations.
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______________
1 Name of the vaccination center’s
supervising authority
2 Name of the vaccination center
3 Initials of the vaccination center’s
name
4 Place
5 Name of the authority the application
is addressed to
6 Address of the vaccination center
3- Procedure
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Implementation sequence
Step 1. The person who believes that
himself/herself or his/her family member suffers from serious vaccine
injuries as specified in Clause 2, Article 15 of Decree No.
104/2016/ND-CP has to prepare the compensation claim and send it to the
Department of Health.
Step 2. In 5 working days from the date
the claim and valid documents are received, the Department of Health must
receive the case and notify the claimant in writing. If the documents are
insufficient, the Department of Health shall give instructions on amendments
to the claimant.
Step 3. In 15 days from the date the
claimant’s request form is received, the Department of Health must finish identifying
the cause of injury, damage level and notify both the claimant and the
Ministry of Health in writing.
Implementation methods
Send by post or hand in directly.
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I. Type of documents:
a) The request for identification of cause of
injury and damage level;
b) Confirmation of immunization using the
relevant vaccine;
c) Release from hospital confirmation, receipts
for diagnosis, treatment, rehabilitation and transport of patient (original or
certified copy);
d) Death certificate (in case of death);
dd) Other documents corroborating the injuries or
other damages (if any)
II. Quantity of documents: Not specified
Processing period
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15 working days after receiving sufficient and valid
documents.
Subjects of the administrative procedure
The person receiving vaccination or their family
members.
Implementing authorities
Departments of Health
Result of the administrative procedure
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Fees
None
Forms
None
Requirements
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1. Law No. 03/2007/QH12
dated November 21, 2007 on Prevention of Infectious Diseases.
2. Law on Investment No.
67/2014/QH13 dated November 26, 2014.
3. Government’s Decree No.
104/2016/ND-CP dated July 1, 2016 on Vaccination.