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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------- No.
44/2005/QD-BTC Hanoi,
July 12, 2005 DECISION PROVIDING FOR THE REGIME OF COLLECTION, REMITTANCE,
MANAGEMENT AND USE OF CHARGES FOR APPRAISING CONDITIONAL COMMERCIAL OPERATIONS
IN THE HEALTH SECTOR, CHARGES FOR APPRAISING CRITERIA AND CONDITIONS FOR
MEDICAL AND PHARMACEUTICAL PRACTICE, AND FEES FOR GRANTING IMPORT/EXPORT
PERMITS AND CERTIFICATES OF MEDICAL AND PHARMACEUTICAL PRACTICE THE
MINISTER OF FINANCE Pursuant to the Government’s Decree No. 57/2002/ND-CP of June 3,
2002, detailing the implementation of the Ordinance on Charges and Fees;
Pursuant to the Government’s Decree No. 103/2003/ND-CP of September 12, 2003,
detailing the implementation of a number of articles of the Ordinance on
Private Medical and Pharmaceutical Practice;
Pursuant to the Government’s Decree No. 77/2003/ND-CP of July 1, 2003, defining
the functions, tasks, powers and organizational structure of the Ministry of
Finance;
Pursuant to the Government’s Decree No. 11/1999/ND-CP of March 3, 1999 on goods
banned from circulation, commercial services banned from provision; and goods
and commercial services subject to business restriction or conditional
business;
Pursuant to the Prime Minister’s Decision No. 37/2002/QD-TTg of March 14, 2002,
on the Government’s program of action for the implementation of the Party
Political Bureau’s Resolution No. 07-NQ/TW of November 27, 2001, on
international economic integration;
After obtaining opinions of the Ministry of Health (in Official Letter No.
9543/YT-KT-TC of December 6, 2004);
At the proposal of the Director of the Tax Policy Department, ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
Article 1.- To issue together with this Decision
the table of rates of charges for appraising conditional commercial operations
in the health sector, charges for appraising criteria and conditions for
medical and pharmaceutical practice, and fees for granting import/export
permits and certificates of medical and pharmaceutical practice. Article 2.- Vietnamese and foreign organizations
and individuals shall pay charges or fees at the rates specified in the tables
issued together with this Decision when provided by the state management
agencies in the health sector the following services: 1. Appraisal of conditional commercial operations in the health sector; 2. Appraisal of criteria and conditions for the grant of certificates of
private medical and pharmaceutical practice; 3. Grant of permits for import and/or export of medical equipment,
facilities and devices without registration numbers according to the provisions
of law; 4. Grant of certificates of private medical practice, private
traditional medical or pharmaceutical practice; private pharmaceutical
practice, and vaccines and medical bio-products. Article 3.- State management agencies in the
health sector (the Ministry of Health and Provincial/Municipal Health Services)
which perform tasks defined in Article 2 of this Circular shall collect, remit,
manage and use charges and fees according to the provisions of this Decision
(hereinafter referred to as charge- and fee-collecting agencies). Article 4.- Charges for appraising conditional
commercial operations in the health sector, charges for appraising criteria and
conditions for medical and pharmaceutical practice, and fees for granting
import/export permits and certificates of medical and pharmaceutical practice
stipulated in this Decision shall constitute state budget revenues and be
managed and used as follows: 1. Charge- and fee-collecting agencies shall be allowed to deduct 80%
(eighty percent) of the total collected charge and fee amounts to cover charge
and fee collection expenses specified at Point 4-b, Section C, Part III of the
Finance Ministry’s Circular No. 63/2002/TT-BTC of July 24, 2002, guiding the
implementation of legal provisions on charges and fees; ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
1. This Decision takes effect 15 days after its
publication in “CONG BAO.” 2. The following circulars and provisions of the following documents are
hereby annulled: a/ Joint Circular No. 51/TTLB of July 3, 1995, of the Ministry of
Finance and the Ministry of Health, providing for the regime of collection,
remittance, management and use of fees for appraisal and grant of certificates
of qualification for setting up private medical and pharmaceutical establishments
and fees for the grant of drug registration numbers; b/ The Finance Ministry’s Circular No. 37 TC/TCT of June 25, 1997,
amending Joint Circular No. 51/TTLB of July 3, 1995, of the Ministry of Finance
and the Ministry of Health, providing for the regime of collection, remittance,
management and use of fees for appraisal and grant of certificates of
qualification for setting up private medical and pharmaceutical establishments,
and fees for grant of drug registration numbers; c/ Joint Circular No. 65-TT/LB of July 29, 1993, of the Ministry of
Finance and the Ministry of Health, providing for the collection of fees from
foreign companies applying for permits to import into Vietnam drugs and raw
materials for production of drugs; d/ Provisions on fees for appraisal of dossiers of application for
registration numbers in Section VII and the table of rates of preventive
medicine charges and fees, issued together with the Finance Minister’s Decision
No. 21/2000/QD-BTC of February 21, 2000, promulgating the rates of preventive
medicine charges and fees. 3. Other matters related to the collection, remittance, management and
use of charges and fees, receipts and publicization of collection regimes not
mentioned in this Decision shall comply with the guidance in the Finance
Ministry’s Circular No. 63/2002/TT-BTC of July 24, 2002, guiding the
implementation of legal provisions on charges and fees. Any problems arising in the course of implementation should be reported
to the Ministry of Finance for study and additional guidance. ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
TABLE OF
COLLECTION RATES OF CHARGES FOR APPRAISING CONDITIONAL COMMERCIAL OPERATIONS IN
THE HEALTH SECTOR, CHARGES FOR APPRAISING CRITERIA AND CONDITIONS FOR MEDICAL
AND PHARMACEUTICAL PRACTICE Ordinal
number Fees Unit
of calculation Rates
(in VND 1,000) I ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
1 Appraising contents of
advertisements for drugs and cosmetics Dossier 1,000 2 Appraising contents of
advertisements for medical equipment, facilities and instruments Dossier 1,000 3 ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
Dossier 700 4 Appraising and granting drug
registration numbers: a/ Western medicine Dossier ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
b/ Traditional medicine Dossier 200 5 Appraising and granting
cosmetics registration numbers Dossier 500 6 ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
Dossier 300 7 Appraising and granting circulation
registration numbers for vaccines and medical bio-products Dossier 1,000 8 Appraising and granting
circulation registration numbers for insecticidal and germicidal preparations
for household and medical use Dossier ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
a/ For re-registration or
registration of additional usage Dossier 500 9 Appraising qualifications for
testing insecticidal and germicidal chemicals and preparations for household
and medical use Dossier 1,000 II ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
1 Appraising criteria and
conditions for production of medicines, vaccines and medical bio-products
(referred to as GMP-registering establishments for short) Per
appraisal 20,000 2 Appraising criteria and
conditions for production of drugs from raw materials Per
appraisal 6,000 3 ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
Per
appraisal 14,000 4 Appraising criteria and
conditions for preservation of drugs, vaccines and medical bio-products
(referred to as GSP-registering establishments for short) Per
appraisal 14,000 5 Appraising criteria and
conditions for production, testing and preservation of drugs, vaccines and
medical bio-products (GMP-, GLP- and GSP-registering establishments) Per
appraisal ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
6 Appraising criteria and conditions
for production and testing drugs, vaccines and medical bio-products (GMP- and
GLP-registering establishments) Per
appraisal 19,000 7 Appraising criteria and conditions
for production and preservation of drugs, vaccines and medical bio-products
(GMP- and GSP-registering establishments) Per
appraisal 19,000 8 ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
Per
appraisal 14,000 9 Appraising foreign
enterprises’ criteria and conditions for conducting activities related to
drugs, raw materials for production of drugs, vaccines, medical bio-products
and raw materials for production of vaccines and medical bio-products Per
appraisal 25,000 10 Appraising criteria and
conditions for traditional medical and pharmaceutical practice and appraisal medical
equipment and devices of foreign individuals working in Vietnam Per
appraisal ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
11 Appraising criteria and
conditions for production of medical equipment, facilities and instruments Per
appraisal 3,000 12 Appraising criteria and
conditions for trading in, testing and preservation of medical equipment,
facilities and instruments for: a/ ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
Per
appraisal 3,000 b/ Agents Per
appraisal 500 Ordinal
number Charges ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
Rates
(in VND 1,000) Centrally-run
cities Delta
and midland provinces Mountainous,
deep-lying and remote provinces 13 Appraising criteria and
conditions for pharmaceutical practice for: ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
a/ Drug stores Establishment 300 240 180 ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
Drug sale agents of drug
dealing enterprises Establishment 150 120 90 14 Appraising criteria and
conditions for private medical establishments: ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
a/ Hospitals: - General hospitals ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
2,000 1,500 900 - Specialized hospitals Establishment 1,500 1,200 900 ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
- Traditional medicine
hospitals Establishment 1,000 900 600 b/ Maternity homes Establishment 500 ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
300 c/ Clinics: - General clinics ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
400 300 180 - Specialized clinics Establishment 350 240 180 ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
- Traditional medicine
consultation and therapy clinics Establishment 300 200 150 d/ Traditional medicine and
pharmacy application centers Center 500 ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
300 e/ Medical service
establishments: - Establishments providing injection,
bandage changing, pulse counting, temperature- and blood pressure-measuring
services ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
100 80 60 - Establishments providing
convalescence and rehabilitation services; testing laboratories; establishments
providing family planning services Establishment 300 240 180 ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
- Cosmetic surgery
establishments Establishment 1,500 1,200 900 - Dental clinics; establishments
providing domestic and overseas patient transportation services and other
medical services Establishment 500 ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
300 f/ Establishments providing
treatment, convalescence and functional rehabilitation services by
acupuncture, digital massage, respiratory training and medicated streaming Establishment 100 80 60 15 Appraising criteria and
conditions for establishments dealing in finished products of traditional
medicine; establishments dealing in unprocessed traditional medicines;
establishments dealing in pharmaceuticals not yet prepared; and traditional
medicine sale agency ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
300 240 180 TABLE OF RATES OF FEES FOR GRANTING IMPORT/EXPORT PERMITS
AND MEDICAL AND PHARMACEUTICAL PRACTICE CERTIFICATES
(Issued together with the Finance Minister’s Decision No. 44/2005/TT-BTC of
July 12, 2005) Ordinal
number Fees Unit
of calculation ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
I Fees
for granting import/export permits 1 Granting permits for
import/export of medical equipment and facilities: a/ Imported medical equipment
valued at under VND 1 billion One
goods item per appraisal ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
b/ Imported medical equipment
valued between VND 1 billion and 3 billion One
goods item per appraisal 1,000 c/ Import medical equipment
valued at over VND 3 billion One
goods item per appraisal 3,000 d/ ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
One
goods item per appraisal 200 2 Granting permits for
import/export of medicines without registration number Permit 500 II Grant
of medical and pharmaceutical practice certificates 1 ... ... ... Please sign up or sign in to your Pro Membership to see English documents.
Certificate 150
Quyết định 44/2005/QĐ-BTC ngày 12/07/2005 về chế độ thu, nộp, quản lý và sử dụng phí thẩm định kinh doanh thương mại có điều kiện thuộc lĩnh vực y tế, phí thẩm định tiêu chuẩn và điều kiện hành nghề y, dược, lệ phí cấp giấy phép xuất, nhập khẩu và cấp chứng chỉ hành nghề y, dược do Bộ trưởng Bộ tài chính ban hành
9.685
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