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| THE MINISTRY OF FINANCE | SOCIALIST REPUBLIC OF VIET NAM |
| No. 103/2004/QD-BTC | Hanoi, December 28, 2004 |
THE FINANCE MINISTER
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 Finance Ministry;
Pursuant to the Government's Decree No. 57/2002/ND-CP of June 3, 2002, detailing the implementation of the Charge and Fee Ordinance;
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 Political Bureau's Resolution No. 07-NQ/TW of November 27, 2001 on international economic integration;
After consulting the Health Ministry (in Official Dispatch No. 8797/YT-KH-TC of November 17, 2004);
At the proposal of the director of the Tax Policy Department,
DECIDES:
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a/ Collecting units are entitled to withhold 90% of the total collected charge amount to cover expenses for the assay and charge collection according to the following specified spending contents:
- Payment of salaries or wages, allowances, salary- or wage-based contributions and overtime pays according to current regulations;
- Expenses in direct service of the charge collection, covering stationery and office supplies, telephone, electricity, water and environmental sanitation (including industrial sanitation) charges, working mission allowance, public-duty allowance, expenses for conferences, attire, footwear, labor safety helmets for laborers, etc., according to current standards and norms;
- Expenses for regular repairs, overhauls and maintenance of assets, machinery and equipment in direct service of the assay and charge collection;
- Expenses for procurement of supplies, raw materials, chemicals, spare parts and management devices in direct service of the assay and charge collection;
- Expenses for hiring domestic and foreign experts, conducting international cooperation, and renting means and material foundations in service of the assay and charge collection;
- Other expenses directly related to the assay and charge collection;
- For setting up a reward fund and a welfare fund for officials and staff members personally engaged in the charge of collection in their units. The level for the said two funds per year per head must not exceed 3 (three) months' actually paid salary in cases where the collected charge amount in a year is higher than that in the preceding year, or be equal to 2 (two) months' actually paid salary in cases where the collected charge amount in a year is equal to or lower than that in the preceding year.
The whole charge amount appropriated at the above rate must be incorporated by collecting units in their annual financial plans. Throughout the course of management, such appropriated amount must be used for spending contents in strict compliance with the current financial expenditure regulations and have lawful invoices and vouchers. In annual settlement, if the appropriated amount is not spent up, the remainder shall be carried forward to the next year for continued spending according to regulations.
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c/ Annually, basing themselves on the charge rates, spending contents specified in this Decision and the current financial expenditure regulations, charge-collecting units shall make the charge revenue-expenditure estimates, detailed according to the current state budget index, then send them to their managing agencies for consideration and approval, and summing up and submission to competent finance agencies of the same level for approval. Charge-collecting units shall make the settlement with tax authorities of charge collection receipts already used; collected charge amounts; amounts left to them, amounts remittable, amounts already remitted and amounts to be remitted into the state budget with tax authorities; and make settlement of the use of appropriated amounts with financial agencies of the same level according to regulations.
a/ Joint Circular No. 17-TT/LB of March 7, 1995 of the Finance Ministry and the Health Ministry, promulgating the Regulation on collection, remittance, management and use of the charge for assaying medicine samples, raw materials for manufacture of medicines, and medical instruments and equipment;
b/ Joint Circular No. 32/1999/TTLT/BTC-BYT of March 25, 1999 of the Finance Ministry and the Health Ministry, guiding the amendments and supplements to Circular No. 17-TT/LB of March 7, 1995 on the regulation on collection, remittance, management and use of the charge for assaying medicine samples, raw materials for manufacture of medicines, and medical instruments and equipment.
2. Other matters related to the collection, remittance, management, use of the charge, charge receipts and publicization of charge collection regulations, etc., not mentioned in this Decision shall comply with the guidance of the Finance Ministry's Circular No. 63/2002/TT-BTC of July 24, 2002 guiding the implementation of law provisions on charges and fees.
3. All previously promulgated regulations on the charges for assaying medicines, medicine samples, materials for manufacture of medicines and cosmetics, which are contrary to this Decision, shall cease to be effective.
4. Any problems arising in the course of implementation should be promptly reported by agencies, organizations and individuals to the Finance Ministry for study and additional guidance.
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FOR ASSAYING MEDICINES, MEDICINE SAMPLES, RAW MATERIALS FOR MANUFACTURE OF MEDICINES AND COSMETICS
(Promulgated together with the Finance Minister's Decision No. 103/2004/TT-BTC of December 28, 2004)
No.
Norms
Charge rates (VND 1,000)
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Standard samples for evaluation
1
Checking upon delivery, receipt and custody of samples, registration and notification of results
20
40
2
Assessment of perceptible appearance (smell, color, figure, package, label, etc.)
20
40
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- Size, perceptible features, smell, color, mold or moth of materia medica, oriental medicines (for each norm)
20
40
3
Physical test of initial raw materials and medical preparations:
- Volume
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40
- Sedimentation
30
60
- Post-evaporation adhesion
200
400
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- Transparency of injection infusions
60
120
- Counting and measurement of dimensions of fractions by fractometer
200
400
- Transparency of potion
...
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60
- Transparency, opacity and color of solution (for each norm)
60
120
4
Testing of tablet, granular, powder medicines:
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- Weight difference of powder, granular and tablet medicines (except for capsules)
30
60
- Weight difference of capsules, injection powder
60
120
- Test of solubility of medicines, diffusion of granular medicines
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40
- Measurement of thickness, diameter, abrasion, hardness of pills, size of pellets (for each norm)
20
40
- Sparsity of compacted tablets, capsules
40
80
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- Sparsity of enclosed tablets which are soluble in intestines
80
160
- Sparsity of pellets, gelatin capsules, softgels
60
120
- Fineness
...
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80
- Solubility by photometric method under treatment
500
1,000
- Solubility by photometric method calculated according to E1%
300
600
...
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...
- Solubility by photometric method calculated according to standards
400
800
- Solubility of tablets releasing retarded active substances
20% added to each testing stage of corresponding solubility test
- Solubility by direct high pressure liquid chromatography (HPLC) method
500
...
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- Solubility by HPLC method under treatment
700
1,400
- Content uniformity
Equal to 150% of corresponding quantitative test
5
Ointments:
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- Weight equality
60
120
- Homogeneity
40
80
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- Measurement of size of fractions of eye ointment
60
120
- Metal molecules in eye ointments
100
200
6
Qualification:
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- Simple, per reaction
20
40
- Complex
100
200
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- Ultraviolet spectrographic method
100
200
- Infrared spectrographic method
200
400
- Double farinoscope
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200
- Microtomy
200
400
- Farinoscope of materia medica
80
160
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- Chromatographic methods
Equal to 50% of corresponding quantitative tests
7
Testing of purity, testing of impurity:
- Per simple ion
40
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- Organic substances
40
80
- Heavy metals (per ion), non-treated Arsenic
60
120
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100
200
- Determination of aldehyde in essences
100
200
- Detection of artificial fructose in honey
100
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- Impurities in materia medica
20
40
- Incoherency of materia medica
40
80
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Calculated by corresponding quantitative tests
- Identification of toxic elements and heavy metals in materia medica and medicines by atomic absorption spectrographic method (per element)
600
1,600
8
Determination of water content, weight loss due to dehydration
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- Heat-drying method
120
240
- Vacuum heat-drying method
180
360
- Karlfischer method
...
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600
- Solvent distilling method
80
160
9
Ash adhesion:
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- Total ash
200
400
- Sulfate ash
240
480
- Ash insoluble in acids
...
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...
400
- Ash soluble in water
300
600
10
Indicators:
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- Acid indicator
140
280
- Saponification indicator
180
360
- Acetyl indicator
...
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400
- Refraction indicator
100
200
- Iodine indicator
180
360
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- Non-saponification substances
200
400
- Hydroxyl indicator
200
400
- Peroxide indicator
...
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200
- Expansion indicator
60
120
11
Melting point and dripping point:
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- Of known substances
40
80
- Of unknown substances
80
160
- Of balm
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80
12
Condensing point
40
80
13
Boiling point
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- Simple, by capillary
40
80
- Complex, with distillation
100
200
14
Sublimation
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80
15
Density measurement:
- By densitometer
30
60
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- By hydrostatic balance
50
100
- By Picnometer
80
160
16
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- By Hoppler or Ostwald machine
200
400
- By bandwidth viscosity-measuring device, without preparing samples
300
600
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400
800
17
Max rotation capacity:
50
100
18
Freezing point:
80
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19
Measurement of pH:
- Direct
40
80
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60
120
20
Measurement of alcoholic volume
- Simple
40
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- Complex
100
200
21
+ Pyrogen
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600
+ Testing of microbial endotoxin
1,200
2,400
+ Testing of acute toxicity
2,000
4,000
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+ Testing of abnormal toxicity
200
400
+ Testing of skin irritation
300
600
+ Hypotensive agent
...
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800
+ Testing of sterility by filter membrane method
500
1,000
+ Testing of sterility by direct culture method
300
600
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+ Segregation and naming of microbes: for each norm
100
200
+ Antibiography
280
560
+ Testing of infection limit (simple treatment)
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480
+ Testing of infection limit (complex treatment)
320
640
+ Antibiotic quantification (raw materials)
400
800
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+ Antibiotic quantification (finished product) not under treatment
500
1,000
+ Antibiotic quantification (finished product) under treatment
600
1,200
+ Quantification of Vitamin B12 by microbiological method
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1,600
22
Quantification:
1. Volume method:
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- pH standardization method
160
320
- Treated volume method
260
520
- Nitrite
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440
- Penicillin quantification
300
600
- Silver measure
200
400
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- Complexion
200
400
- Direct anhydrous environment standardization
240
480
- Treated anhydrous environment standardization
...
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600
- Voltage or ampere measure standardization (for each method)
400
800
2. Weighing method
240
480
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3. Physical methods
- Direct photometric method, calculated according to E1%
200
400
- Direct photometric method, calculated according to standards
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600
- Extraction photometric method, calculated according to standards
400
800
- Extraction photometric method, calculated according to E1%
300
600
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- Thin-layer chromatography (exclusive of other corresponding quantitative tests)
200
400
- Thin-layer chromatograms of scrapped extraction photometric stains
500
1,000
- Paper chromatography (exclusive of other corresponding quantitative tests)
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300
- Column chromatography
140
280
- Quantification of densitometer on thin-layer chromatograms:
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+ 2 stains – 4 stains
200
400
+ More than 4 stains, an addition for each stain
24
48
- Ion exchange chromatography (exclusive of supporting analyses)
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240
For multi-component medicines, VND 50,000 shall be added for each component
- Direct gas chromatography
500
1,000
For multi-component medicines, VND 50,000 shall be added for each component
- Treated gas chromatography
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1,200
For multi-component medicines, VND 50,000 shall be added for each component
- Direct high pressure liquid chromatography (HPLC)
500
1,000
For multi-component medicines, VND 50,000 shall be added for each component
- Treated high pressure liquid chromatography (HPLC)
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1,200
For multi-component medicines, VND 50,000 shall be added for each component
- Spectral mass liquid chromatography
1,000
2,000
For multi-component medicines, VND 50,000 shall be added for each component
- Amino acid quantification
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1,200
For multi-component medicines, VND 50,000 shall be added for each component
- Quantification by infrared spectrography
600
1,200
For multi-component medicines, VND 50,000 shall be added for each component
- Quantification by capillary electrophoresis
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1,200
For multi-component medicines, VND 50,000 shall be added for each component
- Fluorescent spectrography
200
400
4. Quantification of special objects
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- Direct total nitrogen quantification
240
480
- Treated total nitrogen quantification
300
600
...
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500
1,000
- Quantification of total menthol in menthol essence
200
400
- Quantification of methyl salicylate by iodine measuring method
300
...
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- Quantification of essence in balm by Cassia pot
300
600
- Quantification of essence in materia medica
120
240
...
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300
600
- Xineol
300
600
- Aldehydcinnamic
300
...
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- Ascaridol
480
960
- Camphor
360
720
...
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200
400
- Caroten in monortica oil
700
1,400
- Vitamin A in fish oil
400
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- Extracts from materia medica
400
800
- Other active substances in materia medica (alkaloid, saponin, flavonoid, etc.)
Calculated by quantitative tests and corresponding sample-treating methods
- Fatty oil
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1,200
- Iodine in materia medica
800
1,600
- Quantification of cajeput oil
300
600
...
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- Fructose in honey by Caussbonan method
300
600
- Serratiopeptidase
400
800
- Protease
...
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...
800
- Papain
400
800
- Alphachymotrypsin by photometric method
300
600
...
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...
- Alphachymotrypsin by voltage measuring method
400
800
- Beta-Amylase
300
600
- Alpha-Amylase
...
...
...
600
- Cellulose
400
800
- Lipase
400
800
...
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...
- Streptokinase
600
1,200
- Heparine
460
920
- Oxytoxine
...
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...
1,000
- Insuline
1,500
3,000
23
Empty capsule cases:
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- Porosity
100
200
- Gelatin concentrating point
200
400
- Other indicators
...
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24
Infusion hose sets:
- Perceptible appearance
40
80
...
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40
80
- Tightness, impact value
100
200
- Elongation
40
...
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- Heat and cold resistance
100
200
- Foreign elements
100
200
...
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...
100
200
- Trial solution extraction
100
200
- Other physio-chemical tests
Applicable as those for medicines
...
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Containing vessels for medical use, rubber gloves
- Tightness
60
120
- Bent
...
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80
- Transparency of extracted solution
200
400
- Transparency of containing vessels
60
120
...
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- Light passage
100
200
- Metal vessels containing eye ointment
300
600
- Vapor infiltration
...
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...
200
- Water resistance of inner side of containing vessels
300
600
- Other physio-chemical and biological norms
Applicable as those for medicines
...
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50
100
26
Testing of rubber stoppers of serum bottles and injection infusion bottles
- Durability
200
...
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- Tightness
140
280
- Dimensions
40
80
...
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...
100
200
27
Cosmetics:
- Determination of actual state:
...
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+ Direct observation
20
40
+ Heat-drying method
120
240
...
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...
20
40
- Determination of smell
20
40
- Determination of fineness:
...
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+ Direct sensation
20
40
+ Screening method
120
240
...
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...
30
60
- Determination of hardness by devices and tools
60
120
- Determination of pH
60
...
...
...
- Checking of stability at temperature of 40o-50o C
120
240
- Determination of water and vapor
120
240
...
...
...
180
360
- Determination of lead content:
+ Simple method
70
...
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...
+ Heat-drying method
160
320
- Determination of Arsenic content:
...
...
...
70
140
+ Heat-drying method
200
400
- Determination of volume of foam column
75
...
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- Determination of stability of foam column
20
40
- Determination of original volume of foam column
150
300
...
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...
240
480
- Determination of content of surfactant in anion or DBSA form
340
680
- Determination of content of surfactant
...
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+ Soluble in alcohol
240
480
+ Sodium carbonate
200
400
...
...
...
200
400
- Determination of content of phosphorus oxide by weight or volume method
200
400
- Determination of content of calcium carbonate and sodium carbonate
150
...
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...
- Determination of content of glycerin
200
400
- Determination of content of fatty acid
200
400
...
...
...
200
400
- Determination of content of sodium silicate, ZnPTO
240
480
- Determination of content of sodium chloride
200
...
...
...
- Determination of content of sulfate salts
200
400
- Determination of content of free ammonium
200
400
...
...
...
200
400
- Determination of content of non-saponification organic substances and unsaponified fats
200
400
- Determination of content of non-saponification organic substances
200
...
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...
- Determination of content of unsaponified fats
100
200
- Determination of condensing point of fatty acids
80
160
...
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...
200
400
28
Method of treating samples for special objects
400
500
29
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20
- Qualitative and quantitative methods of analyzing toxic substances, chemical methods
Charge shall be calculated according to corresponding items of medicines and cosmetics
- Treatment of samples
Charge shall be calculated according to corresponding items of medicines and cosmetics
- Samples excavated after 10 days or more shall be subject to an additional fee
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- 1Decree No. 77/2003/ND-CP of July 01st, 2003, defining the functions, tasks, powers and organizational structure of the Finance Ministry.
- 2Circular No. 63/2002/TT-BTC of July 24, 2002 guiding the implementation of the law provisions on charges and fees
- 3Decree No. 57/2002/ND-CP of June 3, 2002, of detailing the implementation of the ordinance on charges and fees
Decision No. 103/2004/QD-BTC of December 28, 2004 promulgating the regulation on collection, remittance, management and use of charges for assaying medicines, medicine samples, raw materials for manufacture of medicines and cosmetics
- Số hiệu: 103/2004/QD-BTC
- Loại văn bản: Quyết định
- Ngày ban hành: 28/12/2004
- Nơi ban hành: Bộ Tài chính
- Người ký: Trương Chí Trung
- Ngày công báo: Đang cập nhật
- Số công báo: Đang cập nhật
- Ngày hiệu lực: Kiểm tra
- Tình trạng hiệu lực: Kiểm tra