MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No.: 1730/QD-BYT
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Hanoi, May 16, 2014
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DECISION
PROMULGATING
GUIDELINES FOR VACCINE STORAGE
MINISTER OF HEALTH
Pursuant to the Government's Decree No.
63/2012/ND-CP dated August 31, 2012 defining the functions, tasks, powers and organizational
structure of the Ministry of Health;
Considering the suggestion of the Director of
National Institute of Hygiene and Epidemiology - Chairman of the Board of Specialties
for establishing vaccination guidelines at the Official Dispatch No. 311/VSDTTU-TCQG
dated March 24, 2014;
At the request of the Director General of the
General Department of Preventive Medicine - the Ministry of Health,
DECIDES:
Article 1. The
guidance for vaccine storage is promulgated under this Decision.
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Article 3. This
decision takes effect as of June 01, 2014.
Article 4. The
Chief of Ministerial Office, Ministerial Chief Inspector, Directors and Directors
General of Departments, Bureaus and General Departments directly under the
Ministry of Health; Directors of medical facilities directly under the Ministry
of Health; Directors of Services of Health of central-affiliated cities or
provinces; Heads of medical agencies of Ministries and sectors; Heads of
relevant units shall implement this Decision./.
PP. MINISTER
DEPUTY MINISTER
Nguyen Thanh Long
GUIDELINES
FOR
VACCINE STORAGE
(Promulgated
under the Decision No. 1730/QD-BYT dated May 16, 2014 of the Minister of Health)
1. Preface
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Vaccine may be damages and its potency may be
reduced or lost if it’s stored improperly. A certain types of liquid vaccines
such as Hepatitis B vaccine, DPT (diphtheria – pertussis – tetanus) vaccine, TD
(tetanus – diphtheria) vaccine, tetanus vaccine and typhoid vaccine, are sensitive
to low temperature and may spoil easily if being frozen. A certain types of
other attenuated vaccine such as oral polio vaccine (OPV), measles vaccine,
measles – rubella vaccine (MR), measles – mumps – rubella (MMR) may spoil if
touching high temperature or light.
If vaccine spoils, its uses may be reduced or
lost. Therefore, storing
vaccine at a suitable temperature is the most important condition to ensure
safety and effective vaccination.
2. General provisions
Regulated subjects
- Vaccines used in the Expanded Program on
Immunization (EPI)
- Vaccines used in immunization on demand.
- Vaccines used in epidemic disease control and
prevention affairs.
Vaccine storage temperature
- Vaccine must be stored at the exact
temperature as instructed by the manufacturer.
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Diluents storage and usage
A certain types of freeze-dried vaccines must
be reconstituted with attached diluents or other liquid vaccines before use.
- Diluents that is packaged together with
vaccine must be stored at temperature from +2oC to +8oC.
- If the diluents is packaged separately from
vaccine, it may be stored outside the cold chain provided that, before use and
reconstitution, it must be refrigerated for 01 day or a given necessary period
to have the same temperature with vaccine’s storage temperature as from +2oC
to +8oC.
- Not to freeze diluents.
- Diluents for what type of vaccine shall be
used for that vaccine only. It
should use vaccine and diluents of the same manufacturer.
- Freeze-dried vaccine, after reconstitution, is
used within 6 hours. Especially, BCG vaccine shall be used within 4 hours or
according to the manufacturer’s instruction.
3. Vaccine stored in
cold chain
General principle for storing vaccine in cold
chain
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- Vaccine with short term of use shall be used first,
it may be used according to order of receiving and/or according to vaccine vial
monitor (VVM).
- Keep unused vaccine vials brought back from
the immunization session and vaccine vials with vaccine vial monitor (VVM)
whose color has been changed due to touching with high temperature in boxes with
“To be used first” label. These vaccine vials shall be used first in the
following immunization sessions.
- Arrange vaccine boxes in correct location to
avoid freezing of vaccine and in a given distance in order that cold gas can
circulate among the vaccine boxes.
- Monitor daily temperature of cold –storage
room and refrigerator (including public holidays and days off) and record
information on the temperature monitoring table at least twice per day on the
morning when coming and the afternoon before leaving.
- Not store expired vaccines and reconstituted
vaccine vials after the immunization session and vaccine vials with VVM’s color
changed and requiring disposal in the cold chain.
- The cold chain is used for storing vaccine
only.
- Not to store drugs, chemicals, medical waste,
foods and beverage in the cold chain.
- Not to regularly open equipment of the cold
chain.
- Keep hygiene: keep clean hands before hold
any vaccine box or vial.
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c) Checking safe vaccine storage area on the
foundation of cold-storage room
- Arrange a pile of hollow carton boards with
the height of about 150 cm in shelf-added vaccine storage area. Put the
temperature recorder on such pile within at least 48 hours and check highest
and lowest temperature.
- Types of freeze-sensitive vaccines shall be
safely stored in area with temperature from + 20C to + 80C. Mark safe areas for
storing vaccines by paint or adhesive tape and ensure that the marked area
shall be suitable to dimension of shelves. Distance between shelves must be at
least 10cm to ensure the air flow.
- If the temperature is not in the aforesaid
limit, mark that area and conduct testing process at other locations until
limits of safe storage area are established.
- Repeat this checking process if refrigeration
equipment is replaced.
- It’s only advisable to use plastic shelves
because wooden shelves may have molds and fungi, keep such plastic shelves in
dry places in the warehouse for using in case of need.
- Arrange vaccine boxes on brackets of
positive-temperature and negative-temperature cold-storage rooms according to
types of vaccines, batches and expiry dates. Vertical distance between vaccines
boxes is 5cm for differentiation and ensuring the air flow. Labels of vaccine
boxes must be easily found out. Stick notes of names of vaccines,
manufacturers, batches and expiry dates on the angle of the bracket.
- Distance between vaccine boxes and distance
from the vaccines boxes to the wall of the cold-storage room is 5cm. Distance
away from the ceiling is above 10 cm. Not to place vaccines directly on the
foundation of cold-storage room.
- Certain vaccines that are stored in
three-layer boxes (a large box contains vaccine boxes) shall be untouched until
such boxes are opened for delivery of vaccines and moved to two-layer boxes (a
small box contains vaccine vials) to facilitate in warehouse management and inventory.
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- Place the shelves on marked area on the
foundation of the cold-storage room.
- Place vaccines on the shelves. Maximum
height is 150cm. The edges of the shelf are not concealed by vaccine
containers.
- Stick labels noting type of vaccine, manufacturer,
appearance, batch number and expiry date on the vaccine container placed on the
shelf.
- Move unused shelves out of the cold-storage
room to facilitate in moving around.
3.3. Process of storing vaccines in chest
refrigerators
- Put vaccines and diluents in the
refrigerator basket. Not to remove the refrigerator basket to increase storage
capacity. Leave space between lines of vaccine boxes to ensure stable air
circulation.
- Put thermometer and freeze tag together
with types of freeze-sensitive vaccines.
- If the refrigerator has a separate freezer
compartment, this compartment shall be used to freeze ice-packs. Not to put so
much of ice-packs.
- OPV, measles, BCG vaccines shall be put in
the bottom of the refrigerator.
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- Vaccines and diluents shall be placed as
guided in Annex 2 herewith.
3.4. Process of storing vaccines in upright
refrigerators
- If the refrigerator has a separate freezer
compartment, this compartment shall be used to freeze ice-packs. Not to put so
much of ice-packs.
- OPV, measles, BCG vaccines shall be arranged
on the top shelf near the freezer compartment.
- Types of vaccines which may spoil easily due
to freezing such as VGB, DPT, DT, Td, tetanus, DPT-VGB-Hib, typhoid, cholera
vaccines shall be placed on the middle shelves.
- Diluents shall be arranged next to vaccines
or in the bottom of the refrigerator.
- Avoid storing vaccines on the door of the
refrigerator. - The bottom compartment of the refrigerator
shall be filled with water bottles to keep temperature in case of the power
cut. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 3.5. Packaging and transporting vaccines in cold
boxes and vaccine carriers a) Preparing ice-packs Prepare full amount of required ice-packs. Calculate
necessary period for freezing ice-packs. Preparing ice-packs: - Step 1: Freezing the ice-packs: + Fill the ice-packs with water, leaving a
small space for air circulation only, and put the cap on tightly. + Hold each ice-pack upside down and squeeze
it to make sure it does not leak. + Put the ice-pack upright or slantingly in
the freezer compartment. + The refrigerator's freezer compartment can
freeze 6 large ice-packs or 12 ice-packs per day. It’s required more time to freeze a large
amount of ice-packs. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - Step 2: Take frozen ice-packs out of the freezer
compartment. - Step 3: Allow the frozen ice-packs to sit at
room temperature or dip such frozen ice-packs in a clean basin of water until
the ice begins to melt and water starts to form. Check to see if each ice-pack
has been prepared properly by shaking it and listening for the sound of water
moving around the ice inside. Ice-packs in which the ice has begun to melt are
called conditioned ice-packs. The following packaging method shall be used
in any weather conditions during the year and for all routes of transport. - Put conditioned ice-packs against each of
the four sides and also on the bottom of the cold box or vaccine carrier. - Packaging vaccine boxes with the lids of
vaccine vials towards to the top. - Put the vaccines and diluents into nylon
bags and put such bags in the middle of the cold box or vaccine carrier. - Put the thermometer next to vaccines
(outside the nylon bags). - In cold boxes, place conditioned ice-packs
on top of the vaccines. In vaccine carriers, place a foam pad on top of the
conditioned ice-packs. - Close the lid of the cold box or vaccine
carrier tightly. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - Put the ice into nylon bags and put such
bags in the bottom of the cold boxes or vaccine carriers. - Put cardboard to detach vaccines from ice. - Put vaccines boxes or vials and thermometer
into nylon bags (keep vaccine label unwetted and unpeeled. - Not to put ice on the vaccines. - Place a foam pad on top of the vaccine
carriers and close the lid. 3.6. Maintaining
vaccines during the immunization session a) Preparing vaccine
carriers: If vaccines have been stored in the refrigerator or cold boxes, vaccines
must be moved to vaccine carriers during the immunization session. b) Place vaccines in
vaccine carriers as guided in Annex 3.5 herewith. c) Maintaining vaccines during the
immunization session ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - Close the lid of vaccine carriers tightly
until you need to take vaccine out. - There are some cuts in the foam inside the
vaccine carriers to allow vaccine vials to be inserted in the pad. Opened
multi-dose vaccine vials must be inserted into the cuts of the foam pad during
the immunization session. - Keep conditioned ice-packs and thermometer
from +2°C to +8°C. - The ice-pack whose ice has quite melt
inside (or ice has quite melt inside vaccine carriers) should be replaced with
another ice-packs or added with much ice. - When the immunization session ends, unopened
vaccine vials should be placed into the refrigerator and in the boxes noting “first-to-use"
and should be used firstly in the following immunization session. 3.7. Reading vaccine vial monitor (VVM);
Freeze Tag; the shake test: As regulated in Annex 3 herewith 4.
Maintaining equipment and inspect vaccine storage in cold chain. - Cold chain equipment must be properly
maintained and cleaned. Refrigerator and cold-storage room must be defrosted
regularly. Always dry vaccine carriers and cold boxes after use. - Make plans for periodically inspecting operating
capacity of the cold chain equipment and make plans for properly repairing or
replacing in order to ensure that vaccines shall be safely kept during the storage,
transport and use. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 - Establish a plan providing against
emergencies (broken refrigerator, fire, flood, power cut), stating methods for
taking actions against emergencies, name and telephone number of technical
officer in charge. This plan must be approved by the leadership, disseminated
and glued at a noticeable and legible place. 5. Taking notes and
reports: Comply with the Circular No. 12/2014/TT-BYT
dated March 20, 2014 of the Minister of Health providing guidance on vaccine
usage in vaccination. Annex 1: Storage
temperature and period of a certain types of vaccines used in the Expanded
Program on Immunization (EPI) at all levels 1. Temperature for
storing vaccines in the EPI Types of vaccines Warehouses at
levels National warehouse Regional warehouse Provincial
warehouse ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Medical facilities OPV Temperature for
storing vaccines is between -15oC and -25oC Temperature for
storing vaccines is between +2oC and +8oC BCG Temperature for
storing vaccines is between +2oC and +8oC but vaccines
may be stored between -15oC and -25oC if there is not
enough space Measles MR Freeze-dried Hib ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Temperature for
storing vaccines is between +2oC and +8oC, avoid
freezing. Hepatitis B DPT DT/TT/Td DTP-VGB-Hib DTP-VGB-IPV-Hib 2. Storage period of
vaccines used in the EPI at levels - Regulations on period for storing vaccines at
levels are to make plans for ensuring the timely and continuous provision of
vaccines in the EPI. This storage period shall not cause influence on expiry
date or quality of vaccines that has been announced by the manufacturer. - Maximum storage period of vaccines at
warehouses is as follows: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 + Warehouses of protective medical centers of
provinces or cities: 6 months + Warehouses of protective medical centers of
districts: 3 months + Medical facilities: 1 month - Taking actions against the cases that vaccine
storage period at levels is over the storage period stipulated above because the
use of vaccines is suspended or vaccines were left from the EPI campaigns: + Vaccines that are unexpired and stored in a
proper manner as regulated shall be kept for further use or transferred to
another immunization session. + Vaccines that expire or are not allowed to
be kept for further use must be discarded as regulated. Annex 2. Guidelines for storing vaccines in chest
refrigerators and upright refrigerators Notes: ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- Avoid placing vaccines touched the walls of
the refrigerator. - Not to place freeze-sensitive vaccines or diluents
in the bottom. Annex 3. Guidelines for reading vaccine vial monitor
(VVM); Freeze Tag; and shake test 1.
Directions
for reading vaccine vial monitor (VVM) The
vaccine vial monitor (VVM) is a label that attaches to vaccine vial and changes
colour when the vaccine vial has been exposed to high temperature over a period
of time.
Before
opening a vaccine vial, the status of the VVM must be checked to see whether
the vaccine has been damaged by heat. Manufacturers
attach VVMs to vials of most vaccines. The VVM is printed on the label or cap
of vaccine vial. It looks like a square inside a circle. As the vaccine vial
is exposed to more heat, the square becomes darker. Only
use vaccine vial where the inner square in the VVM is lighter in
colour than the outside circle. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 Notes: VVM cannot tell that whether vaccine
has been exposed to freezing temperatures. 2. Directions for reading Freeze tag Freeze Tag is a device used to monitor whether
vaccine storing temperatures are under 0oC. If the freeze-tag is
exposed to a temperature below 0oC for 60 minutes, the display will
change from the V mark to the X mark, and in this case, the shake test should
be used to check whether freeze-sensitive vaccines have been damaged. ![](00305600_files/image001.png)
3. The shake test The shake test shows that
whether freeze-sensitive vaccines (DPT, DT, Td, UV or Hepatitis B) which may be
damaged by touching freezing temperatures must be discarded. After vaccines
have been frozen, precipitation occurs, it tends to leave sediments in the
bottom of the vial after shaking. The sedimentation may be quicker in frozen
vials than that of non-frozen vial of the same manufacturer. This test should
be used for all vaccine boxes whose freeze-tags show that vaccines have been
exposed to the temperatures below 0°C or recorded temperatures are lower than
allowed limits. To perform the shake test,
follow the steps below: -
Step 1: Prepare a frozen control
vial: Take a vial of vaccine of the same batch number as the
vaccine you want to test, and from the same manufacturer. Freeze the vial until
the inside contents are solid (at least 10 hours at -10°C) and then let it
thaw. This is the frozen control
vial. Mark the vial clearly so that it is easily identifiable and will not
be used by mistake. -
Step 2: Choose a test vial: Take
a vial (or vials) of vaccine from the batch that you suspect has been frozen. This
is the suspected frozen test vial. ... ... ... Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN. Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66 -
Step 4: Allow the vials to rest: Leave
both vaccine vials to rest by placing them on a table side by side and not
moving them further. -
Step 5: Compare the vials: View
both vials against the light to compare the sedimentation rate. If the vaccine
in the suspected test vial shows a much slower sedimentation rate than the
vaccine in the frozen control vial, it’s concluded that the test vaccine has
most probably not been frozen and can be used. If the sedimentation
rate is similar in the suspected test vial and the frozen control vial, it’s
concluded that the test vaccine has probably been frozen and the
vaccine should not be used. Some vials have large labels
that conceal the vial contents. In this case, turn the control and test vials
upside down and observe sedimentation taking place in the neck of the vials. If the shake test
shows that the test vaccine has been damaged by freezing, it should be promptly
reported to the supervisor. Vaccine vials that have probably been frozen must
be determined and placed separately for ensuring that such vaccines shall not
be distributed and used. Notes: Frozen test vaccine used in the shake
test must be taken from the same type and batch of vaccine, and from the same
manufacturer.
Quyết định 1730/QĐ-BYT ngày 16/05/2014 hướng dẫn bảo quản vắc xin do Bộ trưởng Bộ Y tế ban hành
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NỘI DUNG SỬA ĐỔI, HƯỚNG DẪN
Văn bản bị thay thế
Văn bản thay thế
Chú thích
Chú thích:
Rà chuột vào nội dụng văn bản để sử dụng.
<Nội dung> = Nội dung hai
văn bản đều có;
<Nội dung> =
Nội dung văn bản cũ có, văn bản mới không có;
<Nội dung> = Nội dung văn
bản cũ không có, văn bản mới có;
<Nội dung> = Nội dung được sửa đổi, bổ
sung.
Click trái để xem cụ thể từng nội dung cần so sánh
và cố định bảng so sánh.
Click phải để xem những nội dung sửa đổi, bổ sung.
Double click để xem tất cả nội dung không có thay
thế tương ứng.
Tắt so sánh [X] để
trở về trạng thái rà chuột ban đầu.
FILE ĐƯỢC ĐÍNH KÈM THEO VĂN BẢN
FILE ATTACHED TO DOCUMENT
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Địa chỉ:
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17 Nguyễn Gia Thiều, P. Võ Thị Sáu, Q.3, TP.HCM
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Điện thoại:
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(028) 3930 3279 (06 lines)
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E-mail:
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info@ThuVienPhapLuat.vn
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Mã số thuế:
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0315459414
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TP. HCM, ngày 31/05/2021
Thưa Quý khách,
Đúng 14 tháng trước, ngày 31/3/2020, THƯ VIỆN PHÁP LUẬT đã bật Thông báo này, và nay 31/5/2021 xin bật lại.
Hơn 1 năm qua, dù nhiều khó khăn, chúng ta cũng đã đánh thắng Covid 19 trong 3 trận đầu. Trận 4 này, với chỉ đạo quyết liệt của Chính phủ, chắc chắn chúng ta lại thắng.
Là sản phẩm online, nên 250 nhân sự chúng tôi vừa làm việc tại trụ sở, vừa làm việc từ xa qua Internet ngay từ đầu tháng 5/2021.
Sứ mệnh của THƯ VIỆN PHÁP LUẬT là:
sử dụng công nghệ cao để tổ chức lại hệ thống văn bản pháp luật,
và kết nối cộng đồng Dân Luật Việt Nam,
nhằm:
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Chúng tôi cam kết dịch vụ sẽ được cung ứng bình thường trong mọi tình huống.
THÔNG BÁO
về Lưu trữ, Sử dụng Thông tin Khách hàng
Kính gửi: Quý Thành viên,
Nghị định 13/2023/NĐ-CP về Bảo vệ dữ liệu cá nhân (hiệu lực từ ngày 01/07/2023) yêu cầu xác nhận sự đồng ý của thành viên khi thu thập, lưu trữ, sử dụng thông tin mà quý khách đã cung cấp trong quá trình đăng ký, sử dụng sản phẩm, dịch vụ của THƯ VIỆN PHÁP LUẬT.
Quý Thành viên xác nhận giúp THƯ VIỆN PHÁP LUẬT được tiếp tục lưu trữ, sử dụng những thông tin mà Quý Thành viên đã, đang và sẽ cung cấp khi tiếp tục sử dụng dịch vụ.
Thực hiện Nghị định 13/2023/NĐ-CP, chúng tôi cập nhật Quy chế và Thỏa thuận Bảo về Dữ liệu cá nhân bên dưới.
Trân trọng cảm ơn Quý Thành viên.
Tôi đã đọc và đồng ý Quy chế và Thỏa thuận Bảo vệ Dữ liệu cá nhân
Tiếp tục sử dụng
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