Circular No. 10/2018/TT-BNNPTNT dated August 14, 2018 of the Ministry of Agriculture and Rural Development on promulgation of national technical regulation on veterinary drug - general requirements

THEMINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT

CircularNo. 10/2018/TT-BNNPTNT dated August 14, 2018 of the Ministry of Agriculture and Rural Development onpromulgationof national technical regulation on veterinary drug - general requirements

Pursuant to the Law on Technical regulations and standards dated June 29, 2006;

Pursuant to the Law on veterinary medicine dated June 19, 2015;

Pursuant to the Government s Decree No. 15/2017/NĐ-CP on functions, tasks, entitlements and organizational structure of the Ministry of Agriculture and Rural Development;

At the request of the Director of the Department of Science, Technology, and Environment and Director of Department of Animal Health,

The Minister of Agriculture and Rural development promulgates a National Technical Regulation on veterinary medicines.

Article 1. The National Technical Regulation on veterinary drug - General requirements (QCVN01-187:2018/BNNPTNT) is promulgated together with this Circular.

Article 2. Effect

This Circulartakes effect onFebruary 14, 2019.

Article 3. Implementation

Chief of the Ministry Office, Director of Science, Technology and Environment Department, Director of Department of Animal Health heads of relevant organizations and relevant individuals are responsible for the implementation of this Circular./. 

For theMinister

Deputy Minister

Vu Van Tam 

QCVN 01-187: 2018/BNNPTNT

NATIONAL TECHNICAL REGULATION ON VETERINARY DRUG - GENERAL REQUIREMENT

Preamble:

QCVN 01-187:2018/BNNPTNT is drafted by Department of Animal Health, submitted by Department of Science, Technology and Environment and promulgated by the Ministry of Agriculture and Rural Development under Circular No. 10/2018/TT-BNNPTNT dated August 14, 2018.

NATIONAL TECHNICAL REGULATION ON VETERINARY DRUG - GENERAL REQUIREMENT

1.GENERAL PROVISIONS

1.1. Scope of regulation

This document provides for veterinary drug qualitative specifications.

1.2. Subjects of application

This document applies to organizations and individuals involved in manufacture, trade and/or import of veterinary drugs.

1.3. Definition

For the purpose of this document, the terms below are construed as follows:

1.3.1. Injectable drugs: sterile preparation in the form of solution or suspension or emulsion, administered through various injection routes.

1.3.2. Powder for injectable reconstitution (including freeze-dried preparations): sterile preparation that contains one or several active ingredients and excipients, can be mixed with a sterile solution before use for injection.

1.3.3. Eye drops: sterile preparation that contains one or several active ingredients, in the form of solution, suspension or dried medication (powder, freeze-dried powder, tablet) and that can be dissolved in a suitable sterile solution for use as eye drops for animals.

1.3.3. Ear drops: preparation that contains one or several active ingredients, in the form of solution, suspension or emulsion for use ad ear drops for animal without applying harmful pressure on the ear drum.

1.3.4. Nose drops, nasal spray: preparation that contains one or several active ingredients, in the form of solution, suspension or emulsion for dropping or spraying into the animal s nose.

1.3.5. Powder for oral administration: preparation in the form of small grains with certain smoothness, contains one or several active ingredients and excipients, for oral use.

1.3.6. Granules: preparation in the form of small soft granules or pellets for oral use.

1.3.7. Solution for oral administration: preparation in the form of liquid that contains one or several active ingredients in a solvent or a mixture of solvents, for oral use.

1.3.8. Suspension for oral administration: preparation in the form of liquid that contains insoluble active ingredients uniformly dispersed in the form of very small particles in water or oil, for oral use.

1.3.9. Emulsion for oral administration: a liquid or semisolid, prepared by using emulsifier to mix 2 insoluble liquids.

1.3.10. Semisolid drugs for topical administration: preparations in the form of ointment, paste, cream, gel for application to the skin and mucous membrane.

1.3.11. Tablets: preparations in the form of tablets that contain one or several active ingredients, may include excipients, in many shapes and sizes; each tablet is a dosage unit, administered in various ways according to treatment purposes.

1.3.12. Capsules: preparations in the form of a capsule that contain one or several active ingredients, may include excipients, in many shapes and sizes; each tablet is a dosage unit, for oral administration.

1.3.13. Veterinary chemicals: chemically obtained products used for prevention, treatment or diagnosis of diseases, sterilization in husbandry, aquaculture, slaughtering, preparation and processing of animals and animal products.

1.4. References

1.4.1. QCVN 01-03:2009/BNNPTNT on veterinary drug sampling.

1.4.2. TCVN 8684:2011 - Veterinary vaccines and biological products – Purity test.

1.4.3. ASEAN Standards for Animal Vaccines.

2.TECHNICAL PROVISIONS

A. VETERINARY PHARMACEUTICALS

I. INJECTABLE DRUGS

1. Appearance

1.1. Color: No color or color of the active ingredient.

1.2. Dispersion:

1.2.1. For injectable suspension: the suspension may sediment but has to uniformly disperse on shaking and the dispersion is maintained long enough to obtain the dose.

1.2.2. For injectable emulsion: no sign of layering.

1.3. Transparency: the injectable solution must be transparent without insoluble particles during visual inspection.

2. Volume:

2.1. Tolerance for bottles under 50 ml: +10% of declared volume.

2.2. Tolerance for bottles over 50 ml: +5% of declared volume.

3.Sterility:

No bacteria or molds and fungi in the culture environment for 14 days of monitoring.

4.Active ingredient content

4.1. Qualitative requirement:contains theactive ingredient(s) written on the label.

4.2. Quantitative requirement:90% - 110% of declared content.

II. POWDER FOR RECONSTITUTION

1. Appearance:the powder must be dry, moisture-free, and has uniform color.

2.Weight:

2.1. Tolerance for a packaging unit not exceeding 0,5 g: ±10% of declared weight.

2.2. Tolerance for a packaging unit exceeding 0,5 g but not exceeding 1,5 g: ±7% of declared weight;

2.3. Tolerance for a packaging unit exceeding 1,5 g but not exceeding 6 g: ±5% of declared weight;

2.4. Tolerance for a packaging unit exceeding 6 g: ±3% of declared weight;

3.Sterility:

No bacteria or molds and fungi in the culture environment for 14 days of monitoring.

4.Active ingredient content:

4.1. Qualitative requirement:contains the active ingredient(s) written on the label

4.2. Quantitative requirement:90% - 110% of declared content.

5.The reconstituted drug shall meet the quality requirements for injectable drugs specified in this document.

III.EYE DROPS

1.Appearance:

1.1. For eye drop solution: the solution must be transparent without observable particles.

1.2. For suspension: the suspension may sediment but has to uniformly disperse on shaking.

2. Volume tolerance:± 10% of declared volume.

3. Sterility:No bacteria or molds and fungi in the culture environment for 14 days of monitoring.

4.Active ingredient content:

4.1. Quantitative requirement:contains the active ingredient(s) written on the label

4.2. Quantitative requirement:90% - 110% of declared content.

IV.EAR DROPS, NOSE DROPS (SPRAYS)

1.Appearance:

1.1 For emulsion: the suspension may be layered but has to uniformly disperse on shaking.

1.2. For suspension: the suspension may sediment but has to uniformly disperse on shaking to ensure accurate dosing.

2. Volume tolerance:± 10% of declared volume

3.Bacterial contamination limit:

Total aerobic revivable bacteria does not exceed 100 in 1 g (ml) of drug.

Does not contain Enterobacteria, Pseudomonas aeruginosa, Staphylococcus aureus, mold and fungi in 1 g(ml) or drug.

4.Active ingredient content:

4.1. Quantitative requirement:contains the active ingredient(s) written on the label

4.2. Quantitative requirement:90% - 110% of declared content.

V. POWDER FOR ORAL ADMINISTRATION

1. Appearance:the powder must be dry, moisture-free, and has uniform color.

2. Humidity: water content in the powder does not exceed 9,0% (except drugs that containhydratedactive ingredient)

3.Weight:

3.1. Tolerance for a packaging unit smaller than 100 g: ±10% of declared weight;

3.2. Tolerance for a packaging unit exceeding 100 g but not exceeding 1000 g: ±5% of declared weight;

3.3. Tolerance for a packaging unit exceeding 1000 g: ±3% of declared weight.

4.Active ingredient content:

4.1. Qualitative requirement:contains the active ingredient(s) written on the label.

4.2.Quantitative requirement:Active ingredient content is 90% - 110% of declared content. For drugs that contain probiotics, the probiotics contents must be equal to or greater than 90% of declared content.

VI.GRANULES FOR ORAL ADMINISTRATION

1. Appearance:The granules must be dry, has uniform size, does not absorb moist, soften or changes in color.

2. Humidity:water content in the granules does not exceed 5,0%

3.Weight:

3.1. Tolerance for a packaging unit smaller than 100 g: ±10% of declared weight;

3.2. Tolerance for a packaging unit exceeding 100 g but not exceeding 1000 g: ±5% of declared weight;

3.3. Tolerance for a packaging unit exceeding 1000 g: ±3% of declared weight;

4.Active ingredient content:

4.1. Qualitative requirement:contains the active ingredient(s) written on the label.

4.2. Quantitative requirement:90% - 110% of declared content.

VII.SOLUTIONS, SUSPENSIONS AND EMULSIONS FOR ORAL ADMINISTRATION

1.Appearance:

1.1. For solutions: transparent, with or without color.

1.2. For suspension: the solid may be layered while remaining still but has to uniformly disperse on shaking for 1 – 2 minutes and remain so for a few minutes.

1.3. For emulsion: the condense emulsion must be as smooth and uniform as cream; the liquid emulsion must be opaque, white and uniform as milk.

2.Volume:

2.1. Tolerance for a bottle smaller than 50 ml: +8% of declared volume.

2.2. Tolerance for a bottle exceeding 50 ml but not exceeding 150 ml: +6% of declared volume.

2.3. Tolerance for a bottle exceeding 150 ml: +4% of declared volume.

3.Bacterial contamination:

Total aerobic revivable bacteria does not exceed 10⁴in 1 g (ml) of drug.

Total Enterobacteria does not exceed 500 in 1 g (ml) of drug.

Total mold and fungi do not exceed 100 in 1 g (ml) of drug.

Does not contain Salmonella in 10 g of drug.

Does not contain Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus in 1 g(ml) or drug.

4.Active ingredient content:

4.1. Quantitative requirement:contains the active ingredient(s) written on the label

4.2. Quantitative requirement:90% - 110% of declared content.

VIII.SEMISOLID DRUGS FOR TOPICAL ADMINISTRATION

1.Weight:

1.1. Tolerance for a packaging unit not exceeding 50 g: ±10% of declared weight.

1.2. Tolerance for a packaging unit exceeding 50 g: ±5% of declared weight.

2.Bacterial contamination:

Total aerobic revivable bacteria does not exceed 500 in 1g (ml) of drug.

Does not contain Enterobacteria, Pseudomonas aeruginosa, Staphylococcus aureus, mold and fungi in 1 g(ml) or drug.

3.Active ingredient content:

3.1. Quantitative requirement:contains the active ingredient(s) written on the label

3.2. Quantitative requirement:90% - 110% of declared content.

IX.TABLETS

1. Appearance:solid, both sides are smooth; surface may have an indentation, text or symbol; sides and edges are intact.

2. Disintegration:Disintegrates in water within 15 minutes for uncoated tablets, 30 minutes for film-coated tablets, 60 minutes for otherwise coated tablets.

3.Weight:

3.1. Tolerance for a packaging unit not exceeding 80 mg: ±10% of declared weight;

3.2. Tolerance for a packaging unit exceeding 80 mg but smaller than 250 mg: ±7,5% of declared weight;

3.3. Tolerance for a packaging unit exceeding 250 mg: ±5% of declared weight.

4.Active ingredient content:

4.1. Quantitative requirement:contains the active ingredient(s) written on the label

4.2. Quantitative requirement:90% - 110% of declared content.

X. CAPSULES

1. Disintegration:Disintegrates within 30 minutes in water or HCI 0,1 N or simulated gastric fluid.

2.Weight:

2.1. Tolerance for a packaging unit smaller than 300 mg: ±10% of declared weight;

2.2. Tolerance for a packaging unit exceeding 300 mg: ±7,5% of declared weight.

3.Active ingredient content:

3.1. Qualitative requirement:contains the active ingredient(s) written on the label.

3.2. Quantitative requirement:90% - 110% of declared content.

B. VETERINARY CHEMICALS

1.Permissible limits:

1.1. Volume:

1.1.1. Tolerance for a bottle smaller than 100 ml: +10% of declared volume.

1.1.2.Tolerance for a bottle exceeding 100 ml but not exceeding 1000 ml: +5% of declared volume.

1.1.3.Tolerance for a bottle exceeding 1000 ml: +3% of declared volume.

1.2. Weight:

1.2.1. Tolerance for a packaging unit exceeding 100 g but not exceeding 1000 g: ±5% of declared weight;

1.2.2. Tolerance for a packaging unit exceeding 1000 g: ±3% of declared weight.

2.Active ingredient content:

2.1. Quantitative requirement:contains the active ingredient(s) written on the label

2.2. Quantitative requirement:90% - 110% of declared content.

C. VETERINARY VACCINES

1.Purity or sterility.

- For inactivated vaccines: does not contain bacteria or molds and fungi in the culture environment according to TCVN 8684:2011 - Veterinary vaccines and biological products – Purity test.

- For injectable bacterial vaccines and attenuated vaccines: satisfies purity requirements specified TCVN 8684:2011 - Veterinary vaccines and biological products – Purity test.

- For attenuated vaccines for oral administration, topical administration or spray: not more than 01 aerobic colony in 01 dose according to ASEAN standards for Animal vaccines.

2.Safety for vaccinated animals

No local or systemic effect on the youngest animal for 14 – 21 days after injection of 02 doses for inactivated vaccines and 10 doses for attenuated vaccines according to the manufacturer’s instructions on the label.

3.Efficacy.

Efficacy of the vaccine shall be determined using one of the following methods: serology-based method and virulent challenge.

3.1. A vaccine for terrestrial animals passes when it satisfies the efficacy requirements specified in national, regional or international vaccine testing standards depending on the disease.

3.2. Vaccines for aquatic animals:

3.2.1. Serology-based method: the vaccine passes when the antibody titer of at least 60% of the serum samples taken from the vaccinated animals reaches 80% and that of the serum samples taken from the unvaccinated animals is negative.

3.2.2. Virulent challenge: The vaccine passes when the vaccinated animals that are administered the challenged is ≥ 60% and at least 80% of animals that are not administered the challenge vaccine die or shows typical symptoms of the disease.

3.SAMPLING AND TEST METHODS

3.1. Sampling

Vaccine samples shall be taken for testing in accordance with QCVN 01-03:2009/BNNPTNT.

3.2. Test methods

The specifications mentioned in this document shall be tested using the following methods (or those with equivalent accuracy):

3.2.1. Vaccine purity shall be tested in accordance with TCVN 8684:2011 - Veterinary vaccines and biological products – Purity test.

3.2.2. Safety and efficacy of FMD vaccine shall be tested in accordance with TCVN 8685-10:2014 - Vaccine testing procedure - Part 10: Foot and mouth disease vaccine, inactivated.

3.2.2. Safety and efficacy of swine fever vaccine shall be tested in accordance with TCVN 8685-8:2011 - Vaccine testing procedure – Part 8: Swine fever vaccine, live.

3.2.4. Safety and efficacy of porcine salmonella vaccine shall be tested in accordance with TCVN 8685-1:2011- Vaccine testing procedure – Part 1: Porcine salmonella vaccine, attenuated.

3.2.5. Safety and efficacy of duck hepatitis virus vaccine shall be tested in accordance with TCVN 8685-2:2011 - Vaccine testing procedure – Part 2: Duck hepatitis virus vaccine.

3.2.6. Safety and efficacy of porcine E.Coli vaccine shall be tested in accordance with TCVN 8685-3:2011- Vaccine testing procedure – Part 3: porcine E.Coli vaccine.

3.2.7. Safety and efficacy of egg drop syndrome vaccine shall be tested in accordance with TCVN 8685-4:2011- Vaccine testing procedures – Part 4: Egg drop syndrome vaccine, inactivated.

3.2.8. Safety and efficacy of blackleg vaccine shall be tested in accordance with TCVN 8685-5:2011- Vaccine testing procedure – Part 5: Blackleg vaccine.

3.2.9. Safety and efficacy of infectious bursal disease vaccine, live shall be tested in accordance with TCVN 8685-6:2011- Vaccine testing procedure – Part 6: Infectious bursal disease vaccine, live.

3.2.10. Safety and efficacy of Anthrax Spore Vaccine, 34 F2 strain shall be tested in accordance with TCVN 8685-7:2011- Vaccine testing procedure – Part 7: Anthrax Spore Vaccine, 34 F2 strain.

3.2.11. Safety and efficacy of avian influenza A/H5N1 vaccine shall be tested in accordance with TCVN 8685-9:2014- Vaccine testing procedures: Avian influenza A/H5N1 vaccine.

3.2.12. Safety and efficacy of inactivated haemophilus paragallinarum (coryza) vaccine shall be tested in accordance with TCVN 8685-11:2014 - Vaccine testing procedures: Haemophilus paragallinarum vaccine.

3.2.13. Safety and efficacy of porcine reproductive and respiratory syndrome (PRRS) vaccine, living shall be tested in accordance with TCVN 8685- 12:2014 - Vaccine testing procedure: Porcine reproductive and respiratory syndrome vaccine, living.

3.2.14. Safety and efficacy of PRRS vaccine, inactivated shall be tested in accordance with TCVN 8685-13:2014 - Vaccine testing procedure: Porcine reproductive and respiratory syndrome vaccine, inactivated.

3.2.15. Safety and efficacy of haemophillusparasuis vaccine, inactivated shall be tested in accordance with TCVN 8685-14:2017- Vaccine testing procedures: Haemophillusparasuis vaccine, inactivated.

3.2.16. Safety and efficacy of pasteurella multociada type D vaccine, inactivated shall be tested in accordance with TCVN 8685-15:2017- Vaccine testing procedures: Pasteurella multociada type D vaccine, inactivated.

3.2.17. Safety and efficacy of bordetella bronchiseptica vaccine, inactivated shall be tested in accordance with TCVN 8685-16:2017- Vaccine testing procedures - Bordetella bronchiseptica vaccine, inactivated.

3.2.18. Safety and efficacy of actinobacillus pleuropneumoniae vaccine, inactivated shall be tested in accordance with TCVN 8685-17:2017 - Vaccine testing procedures - Actinobacillus pleuropneumoniae vaccine, inactivated.

3.2.19. Safety and efficacy of newcastle disease vaccine, inactivated shall be tested in accordance with TCVN 8685-18:2017 - Vaccine testing procedures - Newcastle disease vaccine, inactivated.

3.2.20. Safety and efficacy of infectious bursal disease vaccine, inactivated shall be tested in accordance with TCVN 8685-19:2017 - Vaccine testing procedures - Infectious bursal disease vaccine, inactivated.

3.2.21. Safety and efficacy of duck plague vaccine, live shall be tested in accordance with TCVN 3298:2010 - Duck plague vaccine, live - Technical requirements.

3.2.22. Safety and efficacy of vaccines shall be tested under the applicable Vietnam’s Standard on vaccine testing procedures.

3.2.23. Safety and efficacy of vaccines shall be tested under ASEAN Standards for Animal Vaccines.

3.2.24. Veterinary drugs shall undergo quality inspection in accordance with TCVN 8686-3:2011: Veterinary drugs - Part 3: Injectable enrofloxacin 10%.

3.2.25. Veterinary drugs shall undergo quality inspection in accordance with TCVN 8686-4:2011: Veterinary drugs - Part 4: Injectable lincomycin 10%.

3.2.26. Veterinary drugs shall undergo quality inspection in accordance with TCVN 8686-5:2011: Veterinary drugs - Part 5: Injectable nofloxacin 10%.

3.2.27. Veterinary drugs shall undergo quality inspection in accordance with TCVN 8686-6:2011: Veterinary drugs - Part 6: Powder paracetamol and acid ascorbic.

3.2.28. Veterinary drugs shall undergo quality inspection in accordance with TCVN 86860-7:2011: Veterinary drugs - Part 7: Injectable tiamulin 10%.

3.2.29. Safety and efficacy of vaccines shall be tested under OIE’s Manual of Diagnostic Test and Vaccines for Terrestrial Animals.

3.2.30. Humidity, sterility, bacterial contamination, volume, weight, quantity, active ingredient content and decay of veterinary drugs shall be tested in accordance with Vietnam’s pharmacopoeia.

3.2.31. Quality specifications of veterinary drugs shall be tested under other methods approved by competent authorities.

4.MANAGEMENT

4.1. Manufacturers and importers of veterinary drugs shall submit the declaration of conformity of the veterinary drugs they produce or import in accordance with this document.

4.2. Preparation of declarations of conformity of veterinary drugs:

4.2.1. For veterinary drugs that are domestically produced pharmaceuticals and chemicals: the manufacturer shall prepare the declaration of conformity based on either:

4.2.1.1. Result of conformity assessment by the manufacturer that has been granted the GMP for veterinary drugs by Department of Animal Health.

4.2.1.2. The certification result given by a registered or recognized certification body as prescribed by law.

4.2.1.3. The certification result given by an appointed certification body as prescribed by law.

4.2.2. For veterinary drugs that are imported pharmaceuticals and chemicals: the importer shall prepare the declaration of conformity based on either:

4.2.2.1. The result given by a registered or recognized certification body as prescribed by law.

4.2.2.2. The certification result given by an appointed certification body as prescribed by law.

4.2.3. Domestic manufacturers and importers of veterinary vaccines shall prepare their declaration of conformity based on the certification result given by appointed certification bodies as prescribed by law.

4.3. Procedures for registration of the declaration of conformity are specified in Clause 3 and Clause 4 Article 1 of Circular No. 02/2017/TT-BKHCN, which amends Circular No. 28/2012/TT-BKHCN.

4.4. Veterinary drugs shall be labeled in accordance with the Government s Decree No. 43/2017/NĐ-CP on goods labeling.

5.RESPONSIBILITY OF ORGANIZATIONS AND INDIVIDUALS

5.1. The organizations and individuals mentioned in 1.2 of this document shall comply with provisions of this document, prepare and register declarations of conformity in accordance with regulations of Department of Animal Health.

5.2. Department of Animal Health, Provincial Departments of Agriculture and Rural development shall inspect implementation of this document as authorized by the Ministry of Agriculture and Rural Development.

6.IMPLEMENTATION

6.1. Department of Animal Health has the responsibility to disseminate, provide instructions, carry out inspections, and cooperate with relevant authorities in organizing the implementation of this document.

6.2. In cases where any of the regulations of this document is amended or superseded, the newest document shall apply.