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SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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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,

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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;

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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.

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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

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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

...

...

...

Dossier

700

4

Appraising and granting drug registration numbers:

a/

Western medicine

Dossier

...

...

...

b/

Traditional medicine

Dossier

200

5

Appraising and granting cosmetics registration numbers

Dossier

500

6

...

...

...

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

...

...

...

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

...

...

...

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

...

...

...

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

...

...

...

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

...

...

...

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

...

...

...

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/

...

...

...

Per appraisal

3,000

b/

Agents

Per appraisal

500

Ordinal number

Charges

...

...

...

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:

...

...

...

a/

Drug stores

Establishment

300

240

180

...

...

...

Drug sale agents of drug dealing enterprises

Establishment

150

120

90

14

Appraising criteria and conditions for private medical establishments:

...

...

...

a/

Hospitals:

- General hospitals

...

...

...

2,000

1,500

900

- Specialized hospitals

Establishment

1,500

1,200

900

...

...

...

- Traditional medicine hospitals

Establishment

1,000

900

600

b/

Maternity homes

Establishment

500

...

...

...

300

c/

Clinics:

- General clinics

...

...

...

400

300

180

- Specialized clinics

Establishment

350

240

180

...

...

...

- Traditional medicine consultation and therapy clinics

Establishment

300

200

150

d/

Traditional medicine and pharmacy application centers

Center

500

...

...

...

300

e/

Medical service establishments:

- Establishments providing injection, bandage changing, pulse counting, temperature- and blood pressure-measuring services

...

...

...

100

80

60

- Establishments providing convalescence and rehabilitation services; testing laboratories; establishments providing family planning services

Establishment

300

240

180

...

...

...

- 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

...

...

...

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

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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

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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

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...

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/

...

...

...

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

...

...

...

Certificate

150