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CIRCULAR NO 2782016TT BTC DATED NOVEMBER 14, 2016, PROVIDING FOR FEES IN MEDICAL SECTOR, AND THE COLLECTION, TRANSFER, MANAGEMENT AND USE THEREOF 278 2016 TT BTC 336588

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MINISTRY OF FINANCE ---SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom – Happiness CIRCULAR PROVIDING FOR FEES IN MEDICAL SECTOR, AND THE COLLECTION, TRANSFER, MANAGEMENT AND USE T

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MINISTRY OF FINANCE

-SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom – Happiness

CIRCULAR

PROVIDING FOR FEES IN MEDICAL SECTOR, AND THE 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 Government's Decree No 120/2016/ND-CP dated August 23, 2016 detailing and guiding the implementation of a number of articles of the Law on fees and charges;

Pursuant to the Government's Decree No 215/2013/ND-CP dated December 23, 2013 defining the functions, tasks, powers and organizational structure of Ministry of Finance;

At the request of the Director of the Tax Policy Department,

Minister of Finance promulgates this Circular to provide for fees in medical sector, and the

collection, transfer and management thereof

Article 1 Scope and regulated entities

1 This Circular provides regulations on fees in medical sector, and the collection, transfer,

management and use thereof

2 This Circular applies to payers and collectors of the fees in medical sector, and other

organizations and individuals involved in the collection, transfer, management and use thereof

Article 2 Payers

Any organizations/ individuals submitting applications to state authorities for processing issues in medical sector as prescribed in the Fee Schedule enclosed herein must pay fees

Article 3 Collectors

Affiliates of Ministry of Health, affiliates of Ministry of National Defence, Departments of Health

of provinces/ central-affiliated cities shall be responsible for collecting fees in compliance with regulations herein

Article 4 Fee

Fees in medical sector are prescribed in the Fee Schedule enclosed with this Circular

Article 5 Declaration and transfer of fees

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1 Not later than the 05th day of every month, each collector must transfer the fees collected in the previous month into the designated state budget account which is opened at the State Treasury

2 The collectors shall declare and transfer collected fees on a monthly basis, and make statement of fees on an annual basis in accordance with regulations in Clause 3 Article 19 and Clause 2 Article

26 of the Circular No 156/2013/TT-BTC dated November 06, 2013 by Minister of Finance guiding the implementation of a number of articles of the Law on tax management, the Law on amendments

to the Law on tax management and the Government's Decree No 83/2013/ND-CP dated July 22, 2013

Article 6 Management and use of fees

1 A collector that is an agency affiliated to the Ministry of National Defence may retain 80% of the sum of collected fees in order to cover its expenditures in accordance with regulations in Clause 2 Article 5 of the Government’s Decree No 120/2016/ND-CP dated August 23, 2016 The remaining amount (20%) must be transferred to state budget according to chapters and sub-items of the

applicable State Budget Index

2 The management and use of fees by collectors that are affiliates of Ministry of Health or

Departments of Health of provinces/ central-affiliated cities:

a) Each collector must transfer the whole amount of collected fees to the state budget, except for the case prescribed in Point b Clause 2 of this Article Expenditure for carrying out the fee collection activities shall be covered by the state budget and specified in the collector’s estimate in accordance with the policies and spending limits regulated by laws

b) If the collector is allocated funding for operation derived from collected fees in accordance with regulations in Clause 1 Article 4 of the Government’s Decree No 120/2016/ND-CP dated August

23, 2016, that collector may retain 80% of the sum of collected fees in order to cover its

expenditures as prescribed in Article 5 of the Government’s Decree No 120/2016/ND-CP dated August 23, 2016 The remaining amount (20%) must 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 as of January 01, 2017 and supersedes the Circular No

03/2013/TT-BTC dated January 08, 2013 by Minister of Finance providing for fees for processing applications for certificate of eligibility for conducting conditional business activities, fees for verifying standards and conditions for practicing in medical and/or pharmaceutical sectors, fees for processing applications for license to import/ export medical equipment/ pharmaceutical products, medical practicing certificates and operating license for health facilities

2 Other contents related to the collection, transfer, management and use of fees, receipts and announcement of regulations on the fee collection, which are not provided for in this Circular, shall

be performed in conformity with regulations in the Law on fees and charges, the Government's Decree No 120/2016/ND-CP dated August 23, 2016, the Circular No 156/2013/TT-BTC dated November 06, 2013 by Minister of Finance, the Circular by Minister of Finance providing for the printing, issuance, management and use of receipts of fees and charges which are the government revenues, and other documents on amendments and supplements thereof (if any)

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

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PP MINISTER DEPUTY MINISTER

Vu Thi Mai

SCHEDULE OF FEES IN MEDICAL SECTOR

(Enclosed to the Circular No 278/2016/TT-BTC dated November 14, 2016 by Minister of Finance)

Fee/ charge

(VND 1,000 thousand)

I

Fees for processing applications for license to

receive/ import/ export insecticidal and

germicidal chemicals and preparations for

household and medical use, and certificates

thereof

1

Fee for processing applications for license to

conduct experiments on insecticidal and germicidal

chemicals and preparations for household and

medical use

Application 2,000

2

Fee for processing applications for sale registration

certificates of insecticidal and germicidal chemicals

and preparations for household and medical use

a Registration of new preparations/ chemicals Application 8,000

c Application for extension of registration number Application 1,000

d Appraisal of applications for additional registration of preparations/ chemicals Time

Change of name, address of manufacturer/ applicant;

change of the ownership of sale registration

certificate; re-issuance of sale registration certificate

1,000

Change of manufacturing location, manufacturer and

change in effects, quality criteria or method of using

preparations/ chemicals

2,000

3

Fee for processing applications for certificate of

advertising contents for insecticidal and germicidal

chemicals and preparations for household and

medical use

Application 1,000

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Fee for verifying the eligibility for Certificate of

Free Sale of insecticidal and germicidal chemicals

and preparations for household and medical use

5

Fee for processing applications for license to import

insecticidal and germicidal preparations for

6

Declaration of eligibility to produce preparations, to

conduct testing/ experiment for/ on preparations, or

to provide preparations-used insecticidal and

germicidal service

II Fees for processing applications for license to sell/

import/ manufacture/ declare medical equipment

1

Fees for processing applications for license to sell or

declaration of applicable standards of medical

equipment/ in vitro diagnosis medical devices

a New license/ declaration

b Application for extension of license Application 2,000

2 Fees for processing applications for license to importmedical equipment Application 2,000

3 Fees for processing applications for license to exportmedical equipment Application 1,000

III

Fees for processing applications for certificate of

eligibility to conduct business activities in medical

equipment

Application

3,000

IV Fees for verifying operating conditions, standards

and conditions for practicing in medical sector

1

Verifying conditions to issue/ re-issue operating

license due to the revocation of license in

accordance with regulations in Clause 1 Article 48

of the Law on medical examination and treatment;

upon the change of form of organization, division,

consolidation or merging of health facilities;

verifying conditions to issue the operating license

when changing the location of health facility;

verifying conditions to issue the operating license

when changing scale of ward/ room, the number of

hospital beds, or organizational structure of health

facility:

Time

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General clinics, maternity wards, infirmaries of

people’s public security forces, family medical

examination and treatment facilities (or medical

examination and treatment facilities using family

remedies)

5,700

Specialty clinics

Preventive medical consulting, examination and

treatment clinics

Clinics of occupational diseases

Medical imaging clinics, X-ray clinics

Testing clinics

Medical service providers

Health facilities of other forms of organization

4,300

Traditional medicine facilities

Communal-level health stations, infirmaries and

health facilities of equivalent level

3,100

2

Verifying the satisfaction of eligibility requirements

of health facility to make medical intervention for

sex reassignment

3

Verifying conditions to issue operating license due

to loss or damage or revocation of license in

accordance with regulations in Clause 1 Article 48

of the Law on medical examination and treatment;

re-issue operating license due to change of name of

health facility, or change of person taking charge of

professional and technical aspects of the health

facility

4

Verifying the satisfaction of eligibility requirements

of health facility upon its change of specialized

sectors or addition of professional and technical

items

5

Verifying conditions to issue, re-issue or modify

practicing certificate in medical examination and

treatment for persons whose practicing certificates

are revoked in accordance with regulations in Clause

1 Article 29 of the Law on medical examination and

treatment

6

Verifying contents of television advertisements,

programs recorded on tapes, disks, software or other

materials, and documents used in the advertisement

for medical examination and treatment services

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Verifying conditions to re-issue practicing certificate

in medical examination and treatment in cases where

practicing certificates are lost, damaged or revoked

in accordance with regulations in Points a, b Clause

1 Article 29 of the Law on medical examination and

treatment

8 Verifying the satisfaction of eligibility requirements

for certificates of traditional medicine practitioners Time 2,500

9 Verifying the satisfaction of eligibility requirements

to grant certificates of family remedies or medicines Time 2,500

V

Fees for verifying the satisfaction of eligibility

requirements to grant certificate of biosafety

laboratory

-This translation is made by L aw S oft and for reference purposes only Its copyright is owned by

L aw S oft and protected under Clause 2, Article 14 of the Law on Intellectual Property.Your

comments are always welcomed

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