|
THE
MINISTRY OF FINANCE
-------
|
SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
---------
|
|
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;
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
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.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
FOR
THE MINISTER OF FINANCE
VICE MINISTER
Do Hoang Anh Tuan
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)
No.
Charges
Unit of
calculation
Charge rate
(VND 1,000)
I
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
1
Evaluation of information on and advertisement of
medicines and cosmetics
Dossier
1,000
2
Evaluation of advertisement of medical equipment and
instruments
Dossier
1,000
3
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Dossier
700
4
Evaluation for the grant of circulation registration
numbers for medicines (new medicines and pharmaceutical medicines), vaccines
and medical biologicals
Dossier
1,500
- In case of supplements to or changes in medicines, vaccines
or medical biologicals for which circulation registration numbers have been
granted
Dossier
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
5
Publication of cosmetics quality (including inspection of
production conditions and quality control)
Dossier
500
6
Evaluation for the grant of circulation registration
numbers for medical equipment and instruments
Dossier
300
7
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Dossier
4,000
- In case of re-registration or additional registration
of the use scope
Dossier
500
8
Evaluation of the eligibility for assay of chemicals and insecticidal
and germicidal preparations for household and medical use
Dossier
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
II
CHARGES FOR EVALUATING MEDICINE AND PHARMACY PRACTICE
CRITERIA AND CONDITIONS
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
2
Evaluation of criteria and conditions for the manufacture
of oriental medicines and pharmaceutical medicines according to the GMP
implementation roadmap:
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
a
On enterprises
Per evaluation
6,000
b
On cooperatives and business households
Per evaluation
3,000
3
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Per evaluation
14,000
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
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
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
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
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
8
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Per evaluation
14,000
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
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
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
11
Evaluation of criteria and conditions for the manufacture
of medical equipment and instruments
Per evaluation
3,000
12
Evaluation of criteria and conditions of establishments
wholesaling medicines, vaccines and medical biologicals:
a
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Per evaluation
3,000
b
Agents
Per evaluation
500
13
Evaluation of dossiers of application for pharmacy
practice certificates
Per evaluation
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
No.
Charges
Unit of
calculation
Charge rate (VND
1,000)
Centrally run
cities
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Mountainous, deep-lying
and remote provinces
14
Evaluation of medicine trading criteria and conditions
of:
a
Pharmacies; oriental and pharmaceutical medicine
cooperatives and business households
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
300
240
180
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
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Evaluation of practice criteria and conditions of private
medical establishments:
a
Hospitals:
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
- General hospitals
Establishment
2,000
1,500
900
- Specialized hospitals
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
1,500
1,200
900
- Traditional medicine hospitals
Establishment
1,000
900
600
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Maternity hospitals
Establishment
500
400
300
c
Clinics:
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
- General clinics
Establishment
400
300
180
- Specialized clinics
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
350
240
180
- Traditional medicine therapy clinics
Establishment
300
200
150
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Traditional medicine and pharmacy application centers
Center
500
400
300
e
Medical service establishments:
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
- Establishments providing injection, bandage change,
pulse check, temperature taking and blood pressure measuring services
Establishment
100
80
60
- Establishments providing convalescence and functional
rehabilitation services; testing and functional exploration laboratories; and
family planning service establishments
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
300
240
180
- Plastic surgery establishments
Establishment
1,500
1,200
900
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
- Dental and denture clinics; establishments providing
the service of transporting patients at home and overseas and other medical
services
Establishment
500
400
300
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
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
60
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
LIST
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
No.
Fees
Unit of
calculation
Fee rate (VND
1,000)
1
Grant of licenses for the import of medical equipment and
instruments:
a
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Commodity per evaluation
500
b
Imported medical equipment valued at between VND 1 and 3
billion
Commodity per evaluation
1,000
c
Imported medical equipment valued at over VND 3 billion
Commodity per evaluation
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
d
Imported medical instruments
Commodity per evaluation
200
2
Grant of licenses for the import and export of medicines
without registration numbers
License
500