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Legal Counselling IN HANOI, VIETNAM

Specific Prices for Drug Sample Testing Services, Pharmaceutical Raw Materials, and Drugs for Human Use in Vietnam

Recently, the Minister of Health of Vietnam has issued Circular 35/2017/TT-BYT stipulating specific prices for the service of testing drug samples, drug materials, and drugs for human use at public health establishments using the state budget (collectively referred to as service-providing organizations).

The specific prices for testing services of medicinal samples, raw materials for medicine, and medicine for human use at service provision organizations in Vietnam do not include value-added tax of service provision as regulated in the Appendix issued together with Circular 35/2017/TT-BYT.

gia DV kiem nghiem mau thuoc, nguyen lieu, thuoc dung cho nguoi, Thong tu 35/2017/TT-BYT

Illustration (source: internet)

No. CRITERIA Specific Price (VND)
    Samples submitted for testing Standards assessment samples
1 Checking upon receipt, sample storage, registration and response 20,000 40,000
2 External reviews by sensory (smell, color, shape, packaging, label...) 20,000 40,000
  - Size, sensory, smell, color, mold, worm of medicinal herbs, traditional medicine (calculated for each criterion) 20,000 40,000
3 Physical testing for initial materials and pharmaceutical preparations    
  - Volume 20,000 40,000
  - Sediment level 30,000 60,000
  - Residue after evaporation 200,000 400,000
  - Clarity observation for injectables 60,000 120,000
  - Particle size counting or measuring using particle counters 200,000 400,000
  - Clarity observation for liquid medicine 30,000 60,000
  - Clarity, turbidity, color of solution (calculated for each criterion) 60,000 120,000
4 Testing for tablets, granules, powders...    
  - Weight variation for powders, granules, tablets (excluding capsules) 30,000 60,000
  - Weight variation for capsules, lyophilized injectables 60,000 120,000
  - Solubility test for drugs, dispersion of granules 20,000 40,000
  - Measuring thickness, diameter, friability, hardness of tablets, granules (calculated for each criterion) 20,000 40,000
  - Disintegration test for tablets, capsules 40,000 80,000
  - Disintegration test for enteric-coated tablets 80,000 160,000
  - Disintegration test for suppositories, vaginal tablets 60,000 120,000
  - Fineness 40,000 80,000
  - Dissolution by spectrophotometry requires processing 500,000 1,000,000
  - Dissolution by spectrophotometry determined by E1% 300,000 600,000
  - Dissolution by spectrophotometry determined by standard 400,000 800,000
  - Dissolution for extended-release tablets Add 20% per each additional testing stage accordingly
  - Direct HPLC dissolution method 500,000 1,000,000
  - HPLC dissolution method requires processing 700,000 1,400,000
  - Uniformity of content Calculated by 150% corresponding quantitative tests
5 Ointment    
  - Uniformity of weight 60,000 120,000
  - Homogeneity 40,000 80,000
  - Measuring particle size for ophthalmic ointment 60,000 120,000
  - Metal particles in ophthalmic ointment 100,000 200,000
6 Qualitative analysis    
  - Simple, per reaction 20,000 40,000
  - Complex 100,000 200,000
  - UV spectrophotometric method 100,000 200,000
  - Infrared spectrophotometric method 200,000 400,000
  - Mixed powder microscopy 100,000 200,000
  - Microscopic analysis 200,000 400,000
  - Medicinal herbs powder microscopy 80,000 160,000
  - Chromatographic methods Charged at 50% corresponding quantitative tests
7 Purity, impurities testing    
  - Each simple ion 40,000 80,000
  - Organic substances 40,000 80,000
  - Heavy metals (each ion), arsenic without processing 60,000 120,000
  - Heavy metals (each ion), arsenic with processing 100,000 200,000
  - Determining aldehyde in essential oils 100,000 200,000
  - Identifying artificial sugar in honey 100,000 200,000
  - Compounds in medicinal herbs 20,000 40,000
  - Fragmentation of medicinal herbs 40,000 80,000
  - Impurity identification by chromatographic methods Calculated by corresponding quantitative tests
  - Identifying toxic elements, heavy metals in medicinal herbs and medicine by atomic absorption spectrophotometry (calculated per element) 600,000 1,600,000
8 Determining water content, weight loss on drying    
  - Drying method 120,000 240,000
  - Vacuum drying method 180,000 360,000
  - Karl Fischer method 300,000 600,000
  - Solvent distillation method 80,000 160,000
9 Residue ash    
  - Total ash 200,000 400,000
  - Sulfated ash 240,000 480,000
  - Acid-insoluble ash 200,000 400,000
  - Water-soluble ash 300,000 600,000
10 Indices    
  - Acid value 140,000 280,000
  - Saponification value 180,000 360,000
  - Acetyl value 200,000 400,000
  - Refractive index 100,000 200,000
  - Iodine value 180,000 360,000
  - Unsaponifiable matter 200,000 400,000
  - Hydroxyl value 200,000 200,000
  - Peroxide value 100,000 200,000
  - Swelling index 60,000 120,000
11 Melting point and drop melting point    
  - Known substance 40,000 80,000
  - Unknown substance 80,000 160,000
  - Ointment 40,000 80,000
12 Freezing point 40,000 80,000
13 Boiling point    
  - Simple capillary method 40,000 80,000
  - Complex distillation method 100,000 200,000
14 Sublimation 40,000 80,000
15 Density measurement    
  - Using a densitometer 30,000 60,000
  - Using a hydrostatic balance 50,000 100,000
  - Using a pycnometer 80,000 160,000
16 Viscosity measurement    
  - Using Hoppler or Ostwald apparatus 200,000 400,000
  - Using wide-range viscosity devices, no sample preparation 300,000 600,000
  - Using wide-range viscosity devices, sample preparation required 400,000 800,000
17 Polarimetric measurement 50,000 100,000
18 Drop weight 80,000 160,000
19 pH measurement    
  - Direct 40,000 80,000
  - After processing 60,000 120,000
20 Alcohol content measurement    
  - Simple 40,000 80,000
  - Complex 100,000 200,000
21 Biological and microbiological tests    
  - Pyrogen test 300,000 600,000
  - Bacterial endotoxins test 1,200,000 2,400,000
  - Acute toxicity test 2,000,000 4,000,000
  - Abnormal toxicity test 200,000 400,000
  - Skin irritation test 300,000 600,000
  - Hypotensive substance test 400,000 800,000
  - Sterility test by membrane filtration method 500,000 1,000,000
  - Sterility test by direct inoculation method 300,000 600,000
  - Isolation and identification of bacteria: calculated per criterion 100,000 200,000
  - Antibiotic susceptibility test 280,000 560,000
  - Microbial contamination limit test (simple processing) 240,000 480,000
  - Microbial contamination limit test (complex processing) 320,000 640,000
  - Antibiotic determination (raw material) 400,000 800,000
  - Antibiotic determination (finished product) without processing 500,000 1,000,000
  - Antibiotic determination (finished product) with processing 600,000 1,200,000
  - Vitamin B12 determination by microbiological method 800,000 1,600,000
22 Quantitative analysis    
  1. Volumetric method    
  - Acid-base titration method 160,000 320,000
  - Volumetric method requiring processing 260,000 520,000
  - Nitrite 220,000 440,000
  - Penicillin quantification 300,000 600,000
  - Silver determination 200,000 400,000
  - Complexon titration 200,000 400,000
  - Direct non-aqueous titration 240,000 480,000
  - Non-aqueous titration requiring processing 300,000 600,000
  - Potentiometric, amperometric titration (calculated per method) 400,000 800,000
  2. Gravimetric method 240,000 480,000
  3. Physical method    
  - Direct spectrophotometric method, calculated by E1% 200,000 400,000
  - Direct spectrophotometric method, calculated by standard 300,000 600,000
  - Spectrophotometric method requiring extraction, calculated by standard 400,000 800,000
  - Spectrophotometric method requiring extraction, calculated by E1% 300,000 600,000
  - Thin-layer chromatography (excluding other corresponding quantitative tests) 200,000 400,000
  - Thin-layer chromatography, scrapings extraction, spectrophotometry 500,000 1,000,000
  - Paper chromatography (excluding other corresponding quantitative tests) 150,000 300,000
  - Column chromatography 140,000 280,000
  - Quantitative densitometry on thin-layer chromatogram    
  + 2-4 spots 200,000 400,000
  + From 4 spots onwards, each additional spot 24,000 48,000
  - Ion-exchange chromatography (excluding the necessary supporting analyses) 120,000 240,000
    For multi-component drugs, each component adds 50,000 VND
  - Direct gas chromatography method 500,000 1,000,000
    For multi-component drugs, each component adds 50,000 VND
  - Gas chromatography method requiring processing 600,000 1,200,000
    For multi-component drugs, each component adds 50,000 VND
  - Direct liquid chromatography method (HPLC) 500,000 1,000,000
    For multi-component drugs, each component adds 50,000 VND
  - Liquid chromatography method (HPLC) requiring processing 600,000 1,200,000
    For multi-component drugs, each component adds 50,000 VND
  - Liquid chromatography mass spectrometry method (HPLC-MS) 1,000,000 2,000,000
    For multi-component drugs, each component adds 50,000 VND
  - Amino acid quantification 600,000 1,200,000
    For multi-component drugs, each component adds 50,000 VND
  - Quantification by infrared spectrophotometry 600,000 1,200,000
    For multi-component drugs, each component adds 50,000 VND
  - Quantification by capillary electrophoresis 600,000 1,200,000
    For multi-component drugs, each component adds 50,000 VND
  - Fluorescence spectrophotometry method 200,000 400,000
  4. Quantification of special objects    
  - Direct total nitrogen quantification 240,000 480,000
  - Total nitrogen quantification requiring processing 300,000 600,000
  - Rutin quantification in medicinal herbs 500,000 1,000,000
  - Total menthol quantification in peppermint oil 200,000 400,000
  - Methyl salicylate quantification by iodometric titration 300,000 600,000
  - Essential oil quantification in ointment by Cassia bottle 300,000 600,000
  - Essential oil quantification in medicinal herbs 120,000 240,000
  - Eugenol 300,000 600,000
  - Cineole 300,000 600,000
  - Cinnamaldehyde 300,000 600,000
  - Ascaridole 480,000 960,000
  - Camphor 360,000 720,000
  - Tannin 200,000 400,000
  - Carotene in Gac oil 700,000 1,400,000
  - Vitamin A in fish oil 400,000 800,000
  - Extractable substances in medicinal herbs 400,000 800,000
  - Other active ingredients in medicinal herbs (alkaloid, saponin, flavonoid...) Calculated by corresponding quantitative tests and sample processing methods
  - Fatty oil 600,000 1,200,000
  - Iodine in medicinal herbs 800,000 1,600,000
  - Melaleuca oil quantification 300,000 600,000
  - Sugar in honey by the Caussbonan method 300,000 600,000
  - Serratiopeptidase 400,000 800,000
  - Protease 400,000 800,000
  - Papain 400,000 800,000
  - Alpha-Chymotrypsin by spectrophotometry 300,000 600,000
  - Alpha-Chymotrypsin by potentiometry 400,000 800,000
  - Beta-Amylase 300,000 600,000
  - Alpha-Amylase 300,000 600,000
  - Cellulase 400,000 800,000
  - Lipase 400,000 800,000
  - Streptokinase 600,000 1,200,000
  - Heparine 460,000 920,000
  - Oxytoxine 500,000 1,000,000
  - Insuline 1,500,000 3,000,000
23 Empty Gelatin Capsules    
  - Hardness 100,000 200,000
  - Gelatin Melting Point 200,000 400,000
  - Other Criteria Applied as medication
24 IV Infusion Sets    
  - Physical Appearance 40,000 80,000
  - Transparency 40,000 80,000
  - Sealing, Force Resistance 100,000 200,000
  - Stretchability 40,000 80,000
  - Heat and Cold Resistance 100,000 200,000
  - Foreign Particles 100,000 200,000
  - Flow Rate 100,000 200,000
  - Solution Extraction 100,000 200,000
  - Other Physico-chemical Tests Applied as medication
25 Medical Containers, Latex Gloves    
  - Sealing 60,000 120,000
  - Flexibility 40,000 80,000
  - Clarity of Extract Solution 200,000 400,000
  - Container Clarity 60,000 120,000
  - Light Transmission 100,000 200,000
  - Durability of Eye Ointment Metal Tube 300,000 600,000
  - Water Vapor Permeability 100,000 200,000
  - Water Resistance of Internal Container 300,000 600,000
  - Other Physical, Chemical, Biological Criteria Applied as medication
  - Thickness of Latex Gloves 50,000 100,000
26 Testing Rubber Stoppers for Serum Bottles and Injection Vials    
  - Durability 200,000 400,000
  - Sealing 140,000 280,000
  - Size 40,000 80,000
  - Other Physical, Chemical, Biological Tests (priced per criterion) 100,000 200,000
27 Sample Processing Methods for Special Subjects 400,000 500,000
28 Toxicological Testing    
  - Sample Receipt Inspection, Dossier Review, and Related Documents 20,000
  - Qualitative and Quantitative Methods for Toxicological Analysis Priced according to corresponding medication categories
  - Sample Treatment Priced according to corresponding medication categories
  - Excavated Samples from 10 Days Onwards Additional 100,000

Note, in case the price is stipulated in foreign currency, convert the foreign currency into Vietnamese Dong according to the buying exchange rate via bank transfer method of the Head Office of the Joint Stock Commercial Bank for Foreign Trade of Vietnam at the time of service fee collection or the last working day before a holiday or day off.

More details can be found in: Circular 35/2017/TT-BYT effective from October 5, 2017.

Thu Ba

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  • - The legal regulations in this article are according to Vietnamese Law;
  • - This English translation is for reference purposes only and not a definitive translation of the original Vietnamese texts;
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