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THE MINISTRY OF FINANCE |
SOCIALIST REPUBLIC OF VIET NAM |
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No. 59/2008/QD-BTC |
Hanoi, July 21, 2008 |
DECISION
AMENDING AND SUPPLEMENTING THE FINANCE MINISTER’S DECISION No. 44/2005/QD-BTC OF JULY 12, 2005, WHICH STIPULATES THE COLLECTION, REMITTANCE, MANAGEMENT AND USE OF CHARGES FOR EVALUATING CONDITIONAL COMMERCIAL BUSINESS IN THE HEALTH SECTOR, CHARGES FOR EVALUATING MEDICINE AND PHARMACY PRACTICE CRITERIA AND CONDITIONS, AND FEES FOR GRANTING IMPORT AND EXPORT LICENSES AND MEDICINE AND PHARMACY PRACTICE CERTIFICATES
THE MINISTER OF FINANCE
Pursuant to the June 14, 2005 Pharmacy Law and the Government’s Decree No. 79/2006/ND-CP of August 9, 2006, detailing the implementation of a number of the Pharmacy Law;
Pursuant to the Government’s Decree No. 57/2002/ND-CP of June 3, 2002, detailing the implementation of the Ordinance and Charges and Fees, and Decree No. 24/2006/ND-CP of March 6, 2006, amending and supplementing a number of articles of the Government’s Decree No. 57/2002/ND-CP of June 3, 2002;
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 Medicine and Pharmacy 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;
After obtaining the Health Ministry’s opinions in Official Letter No. 3296/BYT-QLD of May 14, 2008, on amending and supplementing items and levels of charges and fees for evaluating medicine registration dossiers and granting medicine import licenses;
At the proposal of the director of the Tax Policy Department,
DECIDES:
Article 1.- To promulgate together with this Decision a list of charge rates for evaluating conditional commercial business in the health sector and evaluating medicine and pharmacy practice criteria and conditions, and a list of fee rates for granting import and export licenses in replacement of the lists promulgated together with the Finance Minister’s Decision No. 44/2005/QD-BTC of July 12, 2005, stipulating the collection, remittance, management and use of charges for evaluating conditional commercial business in the health sector, charges for evaluating medicine and pharmacy practice criteria and conditions, and fees for granting import and export licenses and medicine and pharmacy practice certificates (below referred to as Decision No. 44/2005/QD-BTC).
Article 2.- To amend and supplement Clause 1, Article 4 of Decision No. 44/2005/QD-BTC as follows:
“1. Charge and fee collecting agencies may deduct 80% (eighty per cent) of the total collected charge and fee amounts to cover charge and fee collection expenses specified in Clause 8 of Circular No. 45/2006/TT-BTC of May 25, 2006, amending and supplementing the Finance Ministry’s Circular No. 63/2002/TT-BTC of July 24, 2002, which guides the implementation of legal provisions on charges and fees, and the following specific expenses:
a/ Expense for sending local experts to foreign countries and inviting foreign experts into Vietnam for inspection and mutual recognition of production conditions and product quality in service of evaluation and charge and fee collection;
b/ Expense for procuring office machinery and equipment for evaluation and charge and fee collection activities.”
Article 3.- This Decision takes effect 15 days after its publication in “CONG BAO.”
Article 4.- Any problems arising in the course of implementation should be promptly reported to the Ministry of Finance for study and additional guidance.
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FOR THE MINISTER OF FINANCE |
LIST
OF CHARGE RATES FOR EVALUATING CONDITIONAL COMMERCIAL BUSINESS IN THE HEALTH SECTOR AND EVALUATING MEDICINE AND PHARMACY PRACTICE CRITERIA AND CONDITIONS
(Promulgated together with the Finance Minister’s Decision No. 59/2008/QD-BTC of July 21, 2008)
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No. |
Charges |
Unit of calculation |
Charge rate |
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I |
CHARGES FOR EVALUATING CONDITIONAL COMMERCIAL BUSINESS IN THE HEALTH SECTOR |
CHARGES FOR EVALUATING CONDITIONAL COMMERCIAL BUSINESS IN THE HEALTH SECTOR |
CHARGES FOR EVALUATING CONDITIONAL COMMERCIAL BUSINESS IN THE HEALTH SECTOR |
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1 |
Evaluation of information on and advertisement of medicines and cosmetics |
Dossier |
1,000 |
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2 |
Evaluation of advertisement of medical equipment and instruments |
Dossier |
1,000 |
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3 |
Evaluation of advertisement of vaccines, biologicals, chemicals and insecticidal and germicidal preparations for household and medical use |
Dossier |
700 |
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4 |
Evaluation for the grant of circulation registration numbers for medicines (new medicines and pharmaceutical medicines), vaccines and medical biologicals |
Dossier |
1,500 |
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- In case of supplements to or changes in medicines, vaccines or medical biologicals for which circulation registration numbers have been granted |
Dossier |
500 |
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5 |
Publication of cosmetics quality (including inspection of production conditions and quality control) |
Dossier |
500 |
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6 |
Evaluation for the grant of circulation registration numbers for medical equipment and instruments |
Dossier |
300 |
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7 |
Evaluation for the grant of circulation registration certificates for chemicals and insecticidal and germicidal preparations for household and medical use |
Dossier |
4,000 |
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- In case of re-registration or additional registration of the use scope |
Dossier |
500 |
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8 |
Evaluation of the eligibility for assay of chemicals and insecticidal and germicidal preparations for household and medical use |
Dossier |
1,000 |
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II |
CHARGES FOR EVALUATING MEDICINE AND PHARMACY PRACTICE CRITERIA AND CONDITIONS |
CHARGES FOR EVALUATING MEDICINE AND PHARMACY PRACTICE CRITERIA AND CONDITIONS |
CHARGES FOR EVALUATING MEDICINE AND PHARMACY PRACTICE CRITERIA AND CONDITIONS |
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1 |
Evaluation of criteria and conditions of establishments manufacturing medicines, vaccines and medical biologicals (referred to as Good Manufacture Practice (GMP) registration establishments) |
Per evaluation |
20,000 |
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2 |
Evaluation of criteria and conditions for the manufacture of oriental medicines and pharmaceutical medicines according to the GMP implementation roadmap: |
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a |
On enterprises |
Per evaluation |
6,000 |
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b |
On cooperatives and business households |
Per evaluation |
3,000 |
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3 |
Evaluation of criteria and conditions of establishments testing medicines, vaccines and medical biologicals (referred to as Good Laboratory Practice (GLP) registration establishments) |
Per evaluation |
14,000 |
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4 |
Evaluation of criteria and conditions of establishments storing medicines, vaccines and medical biologicals (referred to as Good Storage Practice (GSP) registration establishments) |
Per evaluation |
14,000 |
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5 |
Evaluation of criteria and conditions of establishments concurrently manufacturing, testing and storing medicines, vaccines and medical biologicals (establishments concurrently registering GMP, GLP and GSP) |
Per evaluation |
20,000 |
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6 |
Evaluation of criteria and conditions of establishments concurrently manufacturing and testing medicines, vaccines and medical biologicals (establishments concurrently registering GMP and GLP) |
Per evaluation |
19,000 |
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7 |
Evaluation of criteria and conditions of establishments concurrently manufacturing and storing medicines, vaccines and medical biologicals (establishments concurrently registering GMP and GSP) |
Per evaluation |
19,000 |
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8 |
Evaluation of criteria and conditions of establishments concurrently testing and storing medicines, vaccines and medical biologicals (establishments concurrently registering GLP and GSP) |
Per evaluation |
14,000 |
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9 |
Evaluation of criteria and conditions of foreign enterprises trading in medicines, medicine materials, vaccines, medical biologicals and materials for the manufacture of vaccines and medical biologicals in Vietnam |
Per evaluation |
15,000 |
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10 |
Evaluation of criteria and conditions of Vietnam-based foreign individuals practicing medicine or traditional medicine and pharmacy or trading in medical equipment |
Per evaluation |
3,000 |
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11 |
Evaluation of criteria and conditions for the manufacture of medical equipment and instruments |
Per evaluation |
3,000 |
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12 |
Evaluation of criteria and conditions of establishments wholesaling medicines, vaccines and medical biologicals: |
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a |
Enterprises |
Per evaluation |
3,000 |
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b |
Agents |
Per evaluation |
500 |
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13 |
Evaluation of dossiers of application for pharmacy practice certificates |
Per evaluation |
300 |
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No. |
Charges |
Unit of calculation |
Charge rate (VND 1,000) |
Charge rate (VND 1,000) |
Charge rate (VND 1,000) |
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Centrally run cities |
Midland delta provinces |
Mountainous, deep-lying and remote provinces |
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14 |
Evaluation of medicine trading criteria and conditions of: |
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a |
Pharmacies; oriental and pharmaceutical medicine cooperatives and business households |
Establishment |
300 |
240 |
180 |
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b |
Medicine sale agents for medicine trading enterprises; drugstores; medicine chests of health stations (except those of commune-level health stations funded with state budget and operating for public purposes) |
Establishment |
150 |
120 |
90 |
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15 |
Evaluation of practice criteria and conditions of private medical establishments: |
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a |
Hospitals: |
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- General hospitals |
Establishment |
2,000 |
1,500 |
900 |
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- Specialized hospitals |
Establishment |
1,500 |
1,200 |
900 |
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- Traditional medicine hospitals |
Establishment |
1,000 |
900 |
600 |
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b |
Maternity hospitals |
Establishment |
500 |
400 |
300 |
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c |
Clinics: |
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- General clinics |
Establishment |
400 |
300 |
180 |
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- Specialized clinics |
Establishment |
350 |
240 |
180 |
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- Traditional medicine therapy clinics |
Establishment |
300 |
200 |
150 |
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d |
Traditional medicine and pharmacy application centers |
Center |
500 |
400 |
300 |
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e |
Medical service establishments: |
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- Establishments providing injection, bandage change, pulse check, temperature taking and blood pressure measuring services |
Establishment |
100 |
80 |
60 |
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- Establishments providing convalescence and functional rehabilitation services; testing and functional exploration laboratories; and family planning service establishments |
Establishment |
300 |
240 |
180 |
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- Plastic surgery establishments |
Establishment |
1,500 |
1,200 |
900 |
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- Dental and denture clinics; establishments providing the service of transporting patients at home and overseas and other medical services |
Establishment |
500 |
400 |
300 |
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f |
Establishments providing treatment, convalescence and functional rehabilitation services by traditional methods of acupuncture, massage and shiatsu, physical training for health and longevity, Qi Gong and medicine sauna |
Establishment |
100 |
80 |
60 |
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16 |
Evaluation of practice criteria and conditions of establishments trading in traditional finished medicines; traditional medicines in slices or pieces or non-prepared pharmaceuticals; and agents selling traditional finished medicines |
Establishment |
300 |
240 |
180 |
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LIST
OF FEE RATES FOR GRANTING IMPORT AND EXPORT LICENSES
(Promulgated together with the Finance Minister’s Decision No. 59/2008/TT-BTC of July 21, 2008)
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No. |
Fees |
Unit of calculation |
Fee rate (VND 1,000) |
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1 |
Grant of licenses for the import of medical equipment and instruments: |
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a |
Imported medical equipment valued at under VND 1 billion |
Commodity per evaluation |
500 |
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b |
Imported medical equipment valued at between VND 1 and 3 billion |
Commodity per evaluation |
1,000 |
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c |
Imported medical equipment valued at over VND 3 billion |
Commodity per evaluation |
3,000 |
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d |
Imported medical instruments |
Commodity per evaluation |
200 |
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2 |
Grant of licenses for the import and export of medicines without registration numbers |
License |
500 |