Nội dung toàn văn 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
THE MINISTRY OF FINANCE | SOCIALIST REPUBLIC OF VIET NAM |
No. 103/2004/QD-BTC | Hanoi, December 28, 2004 |
DECISION
PROMULGATING THE REGULATION ON COLLECTION, REMITTANCE, MANAGEMENT AND USE OF CHARGES FOR ASSAYING MEDICINES, MEDICINE SAMPLES, RAW MATERIALS FOR MANUFACTURE OF MEDICINES AND COSMETICS
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:
Article 1.- To promulgate together with this Decision the Table of charge rates for assaying medicines, medicine samples, raw materials for manufacture of medicines and cosmetics.
Article 2.- Vietnamese organizations and individuals as well as foreign organizations and individuals that manufacture and/or trade in raw materials for manufacture of medicines, medicine samples, preventive and curative medicines for people and cosmetics, when having their medicines, medicine samples, raw materials for manufacture of medicines and cosmetics assayed by assaying establishments of the health service, shall have to pay the assaying charge at the rates specified in the table of charge rate promulgated together with this Decision.
Article 3.-
1. Assaying establishments of the health service which conduct the assay of medicines, medicine samples, raw materials for manufacture of medicines and cosmetics are tasked to organize the collection, remittance, management and use of charge according to the provisions of this Decision (hereinafter referred collectively to as collecting units).
2. The charge for assaying medicines, medicine samples, raw materials for manufacture of medicines and cosmetics specified in this Decision constitutes a revenue of the state budget and shall be managed and used as follows:
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.
b/ The remainder (10%) of the total of actually collected charge amount, after subtracting the amount appropriated at the rate specified in Point a, must be remitted by collecting units into the state budget at the corresponding chapter, category, clause, item and sub-item of the current state budget index.
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.
Article 4.-
1. This Decision takes effect 15 days after its publication in "CONG BAO," and replaces the following Circulars:
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.
FOR THE FINANCE MINISTER |
THE TABLE OF CHARGE RATES
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) | |
Samples sent for assaying | 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 |
- 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 | 20 | 40 | |
- Sedimentation | 30 | 60 | |
- Post-evaporation adhesion | 200 | 400 | |
- Transparency of injection infusions | 60 | 120 | |
- Counting and measurement of dimensions of fractions by fractometer | 200 | 400 | |
- Transparency of potion | 30 | 60 | |
- Transparency, opacity and color of solution (for each norm) | 60 | 120 | |
4 | Testing of tablet, granular, powder medicines: | ||
- 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 | 20 | 40 | |
- Measurement of thickness, diameter, abrasion, hardness of pills, size of pellets (for each norm) | 20 | 40 | |
- Sparsity of compacted tablets, capsules | 40 | 80 | |
- Sparsity of enclosed tablets which are soluble in intestines | 80 | 160 | |
- Sparsity of pellets, gelatin capsules, softgels | 60 | 120 | |
- Fineness | 40 | 80 | |
- Solubility by photometric method under treatment | 500 | 1,000 | |
- Solubility by photometric method calculated according to E1% | 300 | 600 | |
- 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 | 1,000 | |
- Solubility by HPLC method under treatment | 700 | 1,400 | |
- Content uniformity | Equal to 150% of corresponding quantitative test | ||
5 | Ointments: | ||
- Weight equality | 60 | 120 | |
- Homogeneity | 40 | 80 | |
- Measurement of size of fractions of eye ointment | 60 | 120 | |
- Metal molecules in eye ointments | 100 | 200 | |
6 | Qualification: | ||
- Simple, per reaction | 20 | 40 | |
- Complex | 100 | 200 | |
- Ultraviolet spectrographic method | 100 | 200 | |
- Infrared spectrographic method | 200 | 400 | |
- Double farinoscope | 100 | 200 | |
- Microtomy | 200 | 400 | |
- Farinoscope of materia medica | 80 | 160 | |
- Chromatographic methods | Equal to 50% of corresponding quantitative tests | ||
7 | Testing of purity, testing of impurity: | ||
- Per simple ion | 40 | 80 | |
- Organic substances | 40 | 80 | |
- Heavy metals (per ion), non-treated Arsenic | 60 | 120 | |
- Heavy metals (per ion), treated Arsenic | 100 | 200 | |
- Determination of aldehyde in essences | 100 | 200 | |
- Detection of artificial fructose in honey | 100 | 200 | |
- Impurities in materia medica | 20 | 40 | |
- Incoherency of materia medica | 40 | 80 | |
- Determination of impurities by chromatographic methods | 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 | ||
- Heat-drying method | 120 | 240 | |
- Vacuum heat-drying method | 180 | 360 | |
- Karlfischer method | 300 | 600 | |
- Solvent distilling method | 80 | 160 | |
9 | Ash adhesion: | ||
- Total ash | 200 | 400 | |
- Sulfate ash | 240 | 480 | |
- Ash insoluble in acids | 200 | 400 | |
- Ash soluble in water | 300 | 600 | |
10 | Indicators: | ||
- Acid indicator | 140 | 280 | |
- Saponification indicator | 180 | 360 | |
- Acetyl indicator | 200 | 400 | |
- Refraction indicator | 100 | 200 | |
- Iodine indicator | 180 | 360 | |
- Non-saponification substances | 200 | 400 | |
- Hydroxyl indicator | 200 | 400 | |
- Peroxide indicator | 100 | 200 | |
- Expansion indicator | 60 | 120 | |
11 | Melting point and dripping point: | ||
- Of known substances | 40 | 80 | |
- Of unknown substances | 80 | 160 | |
- Of balm | 40 | 80 | |
12 | Condensing point | 40 | 80 |
13 | Boiling point | ||
- Simple, by capillary | 40 | 80 | |
- Complex, with distillation | 100 | 200 | |
14 | Sublimation | 40 | 80 |
15 | Density measurement: | ||
- By densitometer | 30 | 60 | |
- By hydrostatic balance | 50 | 100 | |
- By Picnometer | 80 | 160 | |
16 | Viscosity measurement | ||
- By Hoppler or Ostwald machine | 200 | 400 | |
- By bandwidth viscosity-measuring device, without preparing samples | 300 | 600 | |
- By broadband viscosity-measuring device, with preparing samples | 400 | 800 | |
17 | Max rotation capacity: | 50 | 100 |
18 | Freezing point: | 80 | 160 |
19 | Measurement of pH: | ||
- Direct | 40 | 80 | |
- Under treatment | 60 | 120 | |
20 | Measurement of alcoholic volume | ||
- Simple | 40 | 80 | |
- Complex | 100 | 200 | |
21 | Biological and micro-biological tests | ||
+ Pyrogen | 300 | 600 | |
+ Testing of microbial endotoxin | 1,200 | 2,400 | |
+ Testing of acute toxicity | 2,000 | 4,000 | |
+ Testing of abnormal toxicity | 200 | 400 | |
+ Testing of skin irritation | 300 | 600 | |
+ Hypotensive agent | 400 | 800 | |
+ Testing of sterility by filter membrane method | 500 | 1,000 | |
+ Testing of sterility by direct culture method | 300 | 600 | |
+ Segregation and naming of microbes: for each norm | 100 | 200 | |
+ Antibiography | 280 | 560 | |
+ Testing of infection limit (simple treatment) | 240 | 480 | |
+ Testing of infection limit (complex treatment) | 320 | 640 | |
+ Antibiotic quantification (raw materials) | 400 | 800 | |
+ 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 | 800 | 1,600 | |
22 | Quantification: | ||
1. Volume method: | |||
- pH standardization method | 160 | 320 | |
- Treated volume method | 260 | 520 | |
- Nitrite | 220 | 440 | |
- Penicillin quantification | 300 | 600 | |
- Silver measure | 200 | 400 | |
- Complexion | 200 | 400 | |
- Direct anhydrous environment standardization | 240 | 480 | |
- Treated anhydrous environment standardization | 300 | 600 | |
- Voltage or ampere measure standardization (for each method) | 400 | 800 | |
2. Weighing method | 240 | 480 | |
3. Physical methods | |||
- Direct photometric method, calculated according to E1% | 200 | 400 | |
- Direct photometric method, calculated according to standards | 300 | 600 | |
- Extraction photometric method, calculated according to standards | 400 | 800 | |
- Extraction photometric method, calculated according to E1% | 300 | 600 | |
- 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) | 150 | 300 | |
- Column chromatography | 140 | 280 | |
- Quantification of densitometer on thin-layer chromatograms: | |||
+ 2 stains – 4 stains | 200 | 400 | |
+ More than 4 stains, an addition for each stain | 24 | 48 | |
- Ion exchange chromatography (exclusive of supporting analyses) | 120 | 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 | 600 | 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) | 600 | 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 | 600 | 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 | 600 | 1,200 | |
For multi-component medicines, VND 50,000 shall be added for each component | |||
- Fluorescent spectrography | 200 | 400 | |
4. Quantification of special objects | |||
- Direct total nitrogen quantification | 240 | 480 | |
- Treated total nitrogen quantification | 300 | 600 | |
- Quantification of rutin in materia medica | 500 | 1,000 | |
- Quantification of total menthol in menthol essence | 200 | 400 | |
- Quantification of methyl salicylate by iodine measuring method | 300 | 600 | |
- Quantification of essence in balm by Cassia pot | 300 | 600 | |
- Quantification of essence in materia medica | 120 | 240 | |
- Ogennol | 300 | 600 | |
- Xineol | 300 | 600 | |
- Aldehydcinnamic | 300 | 600 | |
- Ascaridol | 480 | 960 | |
- Camphor | 360 | 720 | |
- Tanin | 200 | 400 | |
- Caroten in monortica oil | 700 | 1,400 | |
- Vitamin A in fish oil | 400 | 800 | |
- 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 | 600 | 1,200 | |
- Iodine in materia medica | 800 | 1,600 | |
- Quantification of cajeput oil | 300 | 600 | |
- Fructose in honey by Caussbonan method | 300 | 600 | |
- Serratiopeptidase | 400 | 800 | |
- Protease | 400 | 800 | |
- Papain | 400 | 800 | |
- Alphachymotrypsin by photometric method | 300 | 600 | |
- Alphachymotrypsin by voltage measuring method | 400 | 800 | |
- Beta-Amylase | 300 | 600 | |
- Alpha-Amylase | 300 | 600 | |
- Cellulose | 400 | 800 | |
- Lipase | 400 | 800 | |
- Streptokinase | 600 | 1,200 | |
- Heparine | 460 | 920 | |
- Oxytoxine | 500 | 1,000 | |
- Insuline | 1,500 | 3,000 | |
23 | Empty capsule cases: | ||
- Porosity | 100 | 200 | |
- Gelatin concentrating point | 200 | 400 | |
- Other indicators | Applicable as those for medicines | ||
24 | Infusion hose sets: | ||
- Perceptible appearance | 40 | 80 | |
- Transparency | 40 | 80 | |
- Tightness, impact value | 100 | 200 | |
- Elongation | 40 | 80 | |
- Heat and cold resistance | 100 | 200 | |
- Foreign elements | 100 | 200 | |
- Current flow speed | 100 | 200 | |
- Trial solution extraction | 100 | 200 | |
- Other physio-chemical tests | Applicable as those for medicines | ||
25 | Containing vessels for medical use, rubber gloves | ||
- Tightness | 60 | 120 | |
- Bent | 40 | 80 | |
- Transparency of extracted solution | 200 | 400 | |
- Transparency of containing vessels | 60 | 120 | |
- Light passage | 100 | 200 | |
- Metal vessels containing eye ointment | 300 | 600 | |
- Vapor infiltration | 100 | 200 | |
- Water resistance of inner side of containing vessels | 300 | 600 | |
- Other physio-chemical and biological norms | Applicable as those for medicines | ||
- Thickness of rubber gloves | 50 | 100 | |
26 | Testing of rubber stoppers of serum bottles and injection infusion bottles | ||
- Durability | 200 | 400 | |
- Tightness | 140 | 280 | |
- Dimensions | 40 | 80 | |
- Other physio-chemical and biological tests (for each norm) | 100 | 200 | |
27 | Cosmetics: | ||
- Determination of actual state: | |||
+ Direct observation | 20 | 40 | |
+ Heat-drying method | 120 | 240 | |
- Determination of color | 20 | 40 | |
- Determination of smell | 20 | 40 | |
- Determination of fineness: | |||
+ Direct sensation | 20 | 40 | |
+ Screening method | 120 | 240 | |
- Determination of weight and volume by scaling and measurement | 30 | 60 | |
- Determination of hardness by devices and tools | 60 | 120 | |
- Determination of pH | 60 | 120 | |
- Checking of stability at temperature of 40o-50o C | 120 | 240 | |
- Determination of water and vapor | 120 | 240 | |
- Determination of weight loss after burning | 180 | 360 | |
- Determination of lead content: | |||
+ Simple method | 70 | 140 | |
+ Heat-drying method | 160 | 320 | |
- Determination of Arsenic content: | |||
+ Simple method | 70 | 140 | |
+ Heat-drying method | 200 | 400 | |
- Determination of volume of foam column | 75 | 150 | |
- Determination of stability of foam column | 20 | 40 | |
- Determination of original volume of foam column | 150 | 300 | |
- Determination of content of insoluble substances | 240 | 480 | |
- Determination of content of surfactant in anion or DBSA form | 340 | 680 | |
- Determination of content of surfactant | |||
+ Soluble in alcohol | 240 | 480 | |
+ Sodium carbonate | 200 | 400 | |
+ Chloride salt | 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 | 300 | |
- Determination of content of glycerin | 200 | 400 | |
- Determination of content of fatty acid | 200 | 400 | |
- Determination of content of sodium hydroxide | 200 | 400 | |
- Determination of content of sodium silicate, ZnPTO | 240 | 480 | |
- Determination of content of sodium chloride | 200 | 400 | |
- Determination of content of sulfate salts | 200 | 400 | |
- Determination of content of free ammonium | 200 | 400 | |
- Determination of content of sulfur | 200 | 400 | |
- Determination of content of non-saponification organic substances and unsaponified fats | 200 | 400 | |
- Determination of content of non-saponification organic substances | 200 | 400 | |
- Determination of content of unsaponified fats | 100 | 200 | |
- Determination of condensing point of fatty acids | 80 | 160 | |
- Determination of iodine indicator | 200 | 400 | |
28 | Method of treating samples for special objects | 400 | 500 |
29 | Essay by chemical methods | ||
- Checking upon delivery and receipt of samples, study of dossiers and related documents | 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 | 100 | ||
