CIRCULAR

ON THE FEES FOR VERIFYING CONDITIONAL LINES OF BUSINESS; THE FEES FOR VERIFYING THE STANDARDS AND CONDITIONS FOR MEDICAL PRACTICE AND PHARMACY PRACTICE; THE FEES FOR ISSUING LICENSE TO IMPORT, EXPORT MEDICAL EQUIPMENT AND PHARMACEUTICAL PRODUCTS; AND THE FEES FOR LICENSING MEDICAL FACILITIES

Pursuant to the Law on Pharmacy No. 34/2005/QH11;

Pursuant to the Law on Medical examination and treatment No. 40/2009/QH12;

Pursuant to the Ordinance on Fees and Charges No. 38/2001/PL-UBTVQH10;

Pursuant to the Government's Decree No. 57/2002/ND-CP dated June 03, 2002, detailing the implementation of the Ordinance on Fees and Charges; the Government's Decree No. 24/2006/ND-CP dated March 06, 2006, amending and supplementing a number of articles of the Decree No. 57/2002/ND-CP

Pursuant to the Government's Decree No. 118/2008/ND-CP dated November 27, 2008, defining the functions, tasks, powers and organizational structure of the Ministry of Finance ;

At the proposal of the Tax Policy Department,

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Article 1. Fee payers

When Vietnamese or foreign organizations and individuals having the works related to the health sector done by State management agencies, that are specified in the Tariff enclosed with this Circular shall pay fees

Article 2. Fee rates

The fee rates in the health sector are specified in the Tariff enclosed with this Circular.

Article 3. The collection, payment, management, and use of fees

1. The Ministry of Health, the Ministry of National Defense, and Services of Health of central-affiliated cities and provinces that do the charged works in this Circular are the fee collectors.

2. The fee collectors may extract 80% of the money collected to defray the cost of the works related to the verification and licensing before paying to the State budget, in particular:

a) The amounts prescribed in the Circular No. 63/2002/TT-BTC dated July 24, 2002 of the Ministry of Finance, guiding the implementation of the laws on fees and charges; the Circular No. 45/2006/TT-BTC dated May 25, 2006, amending and supplementing the Circular No. 63/2002/TT-BTC;

b) The cost of sending Vietnamese experts overseas and inviting foreign experts to Vietnam for the purpose of mutual inspection and recognition for the production conditions and product quality that serve the works, verification, and fee collection;

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3. The remaining 20% shall be paid to the State budget by the fee collectors in accordance with the current List of the State budget.

4. Other contents related to the collection, payment, management, use, and announcement of the regime for fee collection in the health sector that are not mentioned in this Circular must comply with the guidance in the Circular No. 63/2002/TT-BTC dated July 24, 2002 of the Ministry of Finance, guiding the implementation of the laws on fees and charges, the Circular No. 45/2006/TT-BTC dated May 25, 2006, amending and supplementing the Circular No. 63/2002/TT-BTC, and the Circular No. 28/2011/TT-BTC dated February 28, 2011 of the Ministry of Finance, guiding the implementation of a number of articles of the Law on Tax administration, the Government's Decree No. 85/2007/ND-CP dated May 25, 2007, and the Government's Decree No. 106/2010/ND-CP dated October 28, 2010.

Article 4. Implementation organization

1. This Circular takes effect on March 01, 2013.

2. The Decision No. 44/2005/QD-BTC  dated July 12, 2005 of the Minister of Finance, on the fees for verifying conditional lines of business in the health sector; the fees for verifying the standards and conditions for medical practice and pharmacy practice; the fees for issuing Export and import Licenses and Licenses for medical and pharmacy practice; and the Decision No. 59/2008/QD-BTC dated July 21, 2008, amending and supplementing the Decision No. 44/2005/QD-BTC dated July 12, 2005 are annulled.

3. Organizations and individuals are recommended to report the difficulties arising during the course of implementation to the Ministry of Finance for consideration and settlement./.

PP THE MINISTER
DEPUTY MINISTER




Vu Thi Mai

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FEES IN HEALTH SECTOR

(Enclosed with the Circular No.  03/2013/TT-BTC dated January 08, 2013 of the Ministry of Finance)

No.

Name of fee

Unit

Rate (1,000 VND)

I

Fees for verifying conditional lines of business in the health sector

1

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Dossier

1,800

2

Verifying contents of advertisements for medical equipment.

Dossier

1,000

3

Verifying medicine registration numbers (pharmaceuticals, vaccines, medicinal products, herbal medicines)

Dossier

...

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...

Medicines that require data confidentiality

6,000

Medicines that require bioequivalence dossiers and/or clinical dossiers

5,500

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4,500

Changing the medicines that already have registration numbers in circulation

1,000

4

Fee for verifying import invoice of finished medicines that do not have registration numbers (except for the imported medicines without registration numbers that are exempt from paying licensing fees)

Dossier

...

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5

Announcing cosmetic products (including inspection of production conditions and quality supervision)

Dossier

500

6

Verifying the License to trade medical equipment.

Dossier

300

7

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Dossier

2,000

8

Fee for verifying the application for the Certificate of Official registration of domestic and medical chemicals, pesticides, and germicides

Dossier

8,000

9

Fee for verifying the application for the re-circulation of chemicals, pesticides, and germicides

Dossier

...

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10

Fee for verifying the contents of advertisements for domestic and medical chemicals, pesticides, and germicides

Dossier

1,000

11

Fee for verifying the application for the Certificate of Free sale of domestic and medical chemicals, pesticides, and germicides

Time

2,000

12

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Time

The method of packing is changed, the appearance or content of the label is changed, the address of the producer or the applicant is changed, the ownership of the Certificate of Sale registration is changed; new producing facilities are added

1,000

The packing and bottling location is moved from abroad to Vietnam, the effects, quality criteria, or usage is changed.

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13

Fee for verifying the Certificate of Free sale applicable the medical equipment produced at home without Certificate of Sale registration

Dossier

2,000

II

Fee for verifying standards and conditions for pharmacy practice

1

 Verifying standards and conditions for producing medicines, cosmetics, and pharmaceutical packages (that applied for GMP registration)

Time

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2

 Verifying standards and conditions for producing oriental medicines and herbal medicines that follow GMP:

Time

a

Enterprises

6,000

b

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3,000

3

 Verifying standards and conditions for testing medicines (applicable to the units that applied for GMP registration)

Time

14,000

4

 Verifying standards and conditions for preserving medicines (applicable to the units that applied for GMP registration)

Time

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5

Verifying standards and conditions for manufacturing, testing, and preserving medicines (applicable to the units that applied for GMP, GLP, and GSP registration)

Time

20,000

6

Verifying standards and conditions for manufacturing, testing, and preserving medicines (applicable to the units that applied for GMP, GLP, and GSP registration)

Time

19,000

7

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Time

19,000

8

Verifying standards and conditions for testing and preserving medicines (applicable to the units that applied for GLP and GSP registration)

Time

14,000

9

Verifying standards and conditions for pharmacy practice, medicinal materials, ingredients of vaccine and medicinal products in Vietnam, applicable to foreign enterprises

Time

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10

Verifying standards and conditions for traditional medicine, medical equipment of foreign individuals working in Vietnam

Time

3,000

11

Verifying standards and conditions for trading medicines of wholesalers (GDP):

Time

a

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4,000

b

Agents

1,000

12

Verifying the application for the pharmacy practice certificate

Time

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13

Verifying the standards of Good Pharmacy Practice (GPP), or standards and conditions for pharmacy practice, applicable to the medicine retailers for which the GPP are not mandatory

Time

For areas suffering from difficulties

500

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1,000

14

Verifying standards and conditions for pharmacy practice, applicable to the pharmacies that trade in herbal medicines (including herbs), and oriental medicines

Pharmacy

- 500 (applicable to central-affiliated cities and provinces; provinces in the plains and midlands)

- 200 (applicable to highland provinces and remote areas)

15

Fee of verifying an issuing the certificate of handed-down remedies or handed-down therapies

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2,500

16

Fee for issuing the Certificate of Oriental physician

Time

2,500

III

Fee for verifying and issuing the operation license and License for medical examination and treatment

1

Fee for verifying and issuing or reissuing a operation license that was revoked as prescribed in Clause 1 Article 48 of the Law on Medical examination and treatment; when changing the organization, splitting, consolidating, merging a medical facility; issuing an operation license when changing the location of a medical facility; issuing the operation license when changing the scale of the medical facility or the organizational structure:

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- Hospitals;

10,500

- General clinics, maternity wards;

5,700

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- Specialized clinics

- Oriental medical clinics;

- Medical imaging labs;

- Clinical laboratories;

- Medical service centers;

- Other forms of medical examination and treatment.

4,300

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3,100

2

Fee for verifying standards and conditions for a medical facility to make medical intervention  for sex reassignment

Time

10,500

3

Fee for verifying and issuing a operation license that has been lost, damaged, or revoked as prescribed in Point a Clause 1 Article 48 of the Law on Medical examination and treatment; for reissuing a license when changing the name of a medical facility

Time

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4

Fee for inspecting a medical facility when changing its specialized operation, updating the list of technical specialties, changing the scale, or the organizational structure.

Time

4,300

5

Fee for verifying and issuing or reissuing the medical practice certificate to a person who had it revoked as prescribed in Clause 1 Article 29 of the Law on Medical examination and treatment.

Time

360

6

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Time

150

IV

Fee for verifying and issuing the Certificate of Biosafety laboratory

1

For biosafety level 3 and level 4 laboratories

Time

9,000

2

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Time

4,500

V

Fees

1

For issuing the License to import medical equipment.

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1 article/time

500

The imported medical equipment priced 1 - 3 billion VND

1 article/time

1,000

The imported medical equipment priced at over 3 billion VND

1 article/time

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Imported medical equipment and implantation supplies

1 article/time

200

2

Fee for issuing the license to import medicines without registration numbers

License

200

3

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Product/exporting country

200

4

Fee for issuing the Certificate of Free sale to cosmetics (for 2 years)

License

200

5

Fee for issuing or reissuing the License for medical examination and treatment

License

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6

Fee for issuing or reissuing the operation license to a medical facility

License

350