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THE MINISTRY OF
FINANCE OF VIETNAM
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No.:
59/2023/TT-BTC
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Hanoi, August 30,
2023
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CIRCULAR
PRESCRIBING
FEES IN MEDICAL SECTOR, AND COLLECTION, TRANSFER, MANAGEMENT AND USE THEREOF
Pursuant to the Law on Fees and Charges
dated November 25, 2015;
Pursuant to the Law on State
Budget dated June 25, 2015;
Pursuant to the Law on Tax Administration
dated June 13, 2019;
Pursuant to the Law on Medical Examination and
Treatment dated November 23, 2009;
Pursuant to the Government's Decree No.
120/2016/ND-CP dated August 23, 2016 elaborating the Law on Fees and Charges;
Pursuant to the Government's Decree No.
126/2020/ND-CP dated October 19, 2020 on elaboration of the Law on Tax
Administration; the Government's Decree No. 91/2022/ND-CP dated October 30,
2022 providing amendments to the Decree No. 126/2020/ND-CP;
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Pursuant to the Government’s Decree No.
155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on
investment and business conditions under the jurisdiction of the Ministry of
Health of Vietnam;
Pursuant to the Government’s Decree No.
14/2023/ND-CP dated April 20, 2023 defining functions, tasks, powers and
organizational structure of the Ministry of Finance of Vietnam;
At the request of the Director of the Tax Policy
Department;
The Minister of Finance of Vietnam promulgates
this Circular prescribing fees in medical sector, and the collection, transfer and
management thereof.
Article 1. Scope and regulated
entities
1. This Circular introduces regulations on fees in
medical sector, and the collection, transfer, management and use thereof. Such
fees in medical sector include:
a) Fees for processing of applications for
licenses/certificates for receipt/import/export of insecticidal and germicidal preparations for household and medical use;
b) Fees for processing of applications for
registration, import/export license or declaration of applied standards for medical
devices;
c) Fees for appraisal of fulfillment of eligibility
requirements for practicing and doing business in medical sector.
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Article 2. Payers
Payers are
organizations or individuals that receive processing/appraisal services from
regulatory authorities in respect of the matters specified in Clause 1 Article
1 of this Circular.
Article 3. Collectors
Collectors include the Ministry of Health of
Vietnam, the Ministry of National Defence of Vietnam, the Ministry of Public
Security of Vietnam or their affiliated units that are tasked with collecting
the fees prescribed in Clause 1 Article 1 hereof and Provincial Departments of
Health in charge of collecting the fees prescribed in Clause 1 Article 1
hereof.
Article 4. Fees
Fees in medical sector are prescribed in the Fee
Schedule enclosed herewith.
Article 5. Declaration and transfer
of collected fees
1. Fees shall be paid at the fee rates specified in
Article 4 of this Circular according to the forms prescribed in the Circular
No. 74/2022/TT-BTC dated December 22, 2022 of the Minister of Finance of
Vietnam prescribing forms and time limits for collection, transfer and
declaration of fees and charges within the jurisdiction of the Ministry of
Finance of Vietnam.
2. Each collector shall transfer total amount of
fees collected in the previous month to its dedicated account opened at the
State Treasury by the 05th of each month. Collectors shall declare,
collect, transfer and make statements of fees in accordance with the provisions
of the Circular No. 74/2022/TT-BTC.
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1. The collector that is the Ministry of National
Defence of Vietnam, the Ministry of Public Security of Vietnam or their
affiliated unit, may retain 80% of total amount of collected fees to cover the
expenses prescribed in Article 5 of the Government's Decree No. 120/2016/ND-CP
dated August 23, 2016. The remaining amount (20%) shall be transferred to state
budget according to chapters and sub-items of the applicable State Budget
Index.
2. For collectors that are the Ministry of Health
of Vietnam or their affiliated units and Provincial Departments of Health:
a) Each collector must pay total amount of
collected fees to state budget. Funding for covering costs of performing tasks
and collecting fees shall be derived from state budget and included in the
collector’s cost estimate in accordance with policies and limits on state
budget expenditures.
b) In case the collector is a regulatory authority
that is provided with a pre-determined funding for covering its operating
expenses from collected fees in accordance with the provisions of Clause 1
Article 4 of the Government’s Decree No. 120/2016/ND-CP, it may retain 80% of
total amount of collected fees for covering the expenses prescribed in Article
5 of the Decree No. 120/2016/ND-CP. The remaining amount (20%) shall be
transferred to state budget according to chapters and sub-items of the
applicable State Budget Index.
Article 7. Implementation
1. This Circular comes into force from October 16,
2023 and supersedes the Circular No. 278/2016/TT-BTC dated November 14, 2016 of
the Minister of Finance of Vietnam and the Circular No. 11/2020/TT-BTC dated
February 20, 2020 of the Minister of Finance of Vietnam.
2. Other contents concerning the collection,
transfer, management and use of fees, fee receipts, and disclosure of fee
collection regimes which are not mentioned in this Circular shall comply with
the provisions of the Law on Fees and Charges, the Law on Tax Administration,
the Decree No. 120/2016/ND-CP, the Decree No. 126/2020/ND-CP dated October 19,
2020, the Government’s Decree No. 91/2022/ND-CP dated October 30, 2022, the
Government’s Decree No. 11/2020/ND-CP dated January 20, 2020, the Government’s
Decree No. 123/2020/ND-CP dated October 19, 2020, the Circular No.
78/2021/TT-BTC dated September 17, 2021 of the Minister of Finance, and the
Government’s Decree No. 123/2020/ND-CP dated October 19, 2020.
3. If any documents referred to in this Circular
are amended, supplemented or superseded, the new ones shall apply.
4. Difficulties that arise during the
implementation of this Circular should be promptly reported to the Ministry of
Finance of Vietnam for consideration./.
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PP. MINISTER
DEPUTY MINISTER
Cao Anh Tuan
SCHEDULE
OF FEES IN MEDICAL SECTOR
(Enclosed with the
Circular No. 59/2023/TT-BTC dated August 30, 2023 of the Minister of Finance of
Vietnam)
No.
Description
Unit
Fee
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I
Fees for processing of applications for
licenses/certificates for receipt/import/export of insecticidal and
germicidal preparations for household and medical use
1
Processing of applications for license to test insecticidal and germicidal chemicals/preparations
for household and medical use
Application
3.500
2
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a
Applications for new certificates
Application
11.000
b
Applications for change of trade name
Application
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c
Applications for certificate extension
Application
4.000
d
Processing of applications for additional
registration in the following cases: change of name or address of
manufacturer/ applicant; change of registration certificate holder;
re-issuance of registration certificate; changes in manufacturing
location/factory; and changes in uses, quality criteria or direction for use
Application
2.500
3
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Application
600
4
Processing of applications for certificates of
free sale of insecticidal and germicidal chemicals/preparations for household
and medical use
Application
2.000
5
Processing of applications for license to import
insecticidal and germicidal preparations for household and medical use
Application
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6
Processing of applications for declaration of
eligibility for manufacturing/testing of insecticidal and germicidal
chemicals/preparations for household and medical use, or provision of
insecticidal and germicidal services
Application
300
II
Fees for processing of applications for
registration, import/export license or declaration of applied standards for
medical devices
1
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Of class A
Application
1.000
Of class B
Application
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2
Processing of applications for new registration
numbers for class-C or class-D medical devices.
Application
6.000
3
Processing of applications for license to import
medical devices
Application
2.000
4
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Application
1.000
III
Fees for appraisal of fulfillment of eligibility
requirements for practicing and doing business in medical sector
1
Processing of applications, submitted by the
following health facilities, for issuance or re-issuance of operating
licenses after revocation due to the reasons stated in Clause 1 Article 48 of
the Law on Medical Examination and Treatment; or upon change to organization
form or split-up, split-off, consolidation or merger; and for issuance of
operating licenses upon relocation or upon change to number of
departments/patient beds or organizational structure:
Application
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a
Hospitals
10.500
b
Polyclinics, maternity wards; infirmaries defined
in the Law on Medical Examination and Treatment; and family medicine facilities
(or health facilities operated in the principle of family medicine)
5.700
c
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- Specialized traditional medicine clinics.
- Communal-level health stations, infirmaries and
equivalent.
3.100
d
- Specialized clinics listed in Clause 3 Article
11 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018
(excluding traditional medicine diagnosis and treatment clinics and
specialized traditional medicine clinics stated in Point c Section 1 Part III
of the fee schedule enclosed herewith).
- Medical service providers listed in Clause 3
Article 11 of the Government’s Decree No. 155/2018/ND-CP.
- Health facilities of other types.
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2
Processing of applications for certificates of
eligibility to perform medical intervention procedures for sex reassignment
Application
10.500
3
Processing of applications for operating licenses
in case of loss, damage or revocation prescribed in Point a Clause 1 Article 48
of the Law on Medical Examination and Treatment; re-issuance of operating
licenses upon change of health facility’s name or replacement of person in
charge of professional aspects of health facility
Application
1.500
4
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Time
a
Health facilities mentioned in Points a, b, d
Section 1 Part III of the fee schedule
4.300
b
Health facilities mentioned in Point c Section 1
Part III of the fee schedule
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5
Processing of applications for issuance,
re-issuance or modification of medical practice certificates; re-issuance of
medical practice certificates after revocation due to the reasons stated in
Points c, d, dd, e, g Clause 1 Article 29 of the Law on Medical Examination
and Treatment
Application
430
Processing of applications for issuance of
medical practice certificates in cases of loss, damage or revocation stated in
Points a, b Clause 1 Article 29 of the Law on Medical Examination and
Treatment
Application
150
6
Appraisal of contents of program and movie
scripts contained in tapes, disks, software and other storage materials, and
documents used for medical service advertising
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1.000
7
Processing of applications for certificates of
traditional medicine practitioners
Application
2.500
8
Processing of applications for certificates of
family remedies/medicines
Application
2.500
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Appraisal of fulfillment of business conditions
in medical device sector (including medical device manufacturing, trading,
consulting and inspection services)
Application
3.000
10
Processing of applications for certificates of biosafety
laboratory (including biosafety level-3 and level-4 laboratories)
Application
9.000