Decree 35/2016/nd-Cp: Detailing A Number Of Articles Of The Law On Animal Health

Original Language Title: Nghị định 35/2016/NĐ-CP: Quy định chi tiết một số điều của Luật thú y

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The DECREE detailing a number of articles of the law on animal health Act the Government base on June 19, 2015;
Pursuant to the law of animal health on June 19, 2015;
Pursuant to the law on investment on November 26, 2014;
According to the recommendation of the Minister of agriculture and rural development; The Government issued a decree detailing a number of articles of the law on animal health. Chapter I GENERAL PROVISIONS article 1. Scope of this Decree, detailing and guiding the implementation of some articles of the law on animal health, in particular the following: 1. system management agency specialized in animal health and policy regime for veterinary staff communes, wards and towns.
2. Cost of animal disease prevention.
3. Suspend the export, import and export; export, import of animals, animal products.
4. conditions of production, trade, import, testing, veterinary assay; regulations on good manufacturing practice GMP for veterinary drugs.
5. veterinary practice conditions. 2. The object of this Decree apply apply to agencies, organizations, individuals and organizations, foreign individuals are related to animal health activities in Vietnam.
Article 3. Explanation of terms In this Decree, the terms below are understood as follows;
1. Practice good medicine production (GMP: Good Manufacturing Practice) are the rules, regulations, instructions on drug production conditions to ensure drug product quality standards.
2. The WHO GMP-good manufacturing practice is led by the World Health Organization (WHO) issued, including good manufacturing practice of drugs (Good Manufacturing Practice-GMP), good laboratory practices (GLP-Good Laboratory Practice), good storage practice (Good Practice Store-GSP).
3. GMP-ASEAN good manufacturing practice of drugs is due to the Association of South-East Asian countries (ASEAN).
Chapter II SPECIFIC PROVISIONS 1. AGENCY MANAGEMENT SYSTEM of veterinary and policy REGIME for veterinary STAFF communes, wards and TOWNS of article 4. Agency management system specialized in animal health 1. At Central: Department of animal health under the Ministry of agriculture and rural development has a staff function, help the Minister of agriculture and rural development, governance and law enforcement organization in the field of prevention, cure, disease-resistant animals; quarantine of animals, animal products; control animal slaughtering, processing, processing of animals, animal products; veterinary hygiene inspection; management of veterinary drugs; veterinary practitioners across the country.
2. In the local: a) the Agency has the function of specialized veterinary management directly under the Department of agriculture and rural development, the central cities (hereafter referred to as the specialized agency provincial animal health), help the Director advised provincial people's Committee to implement state management functions and law enforcement organization in the field of prevention , healing, disease-resistant animals; quarantine of animals, animal products; control animal slaughtering, processing, processing of animals, animal products; veterinary hygiene inspection; management of veterinary drugs; veterinary practice in the province, central cities and take the direction of professional expertise of the Department of animal health;
b) Bureau functions in Station management of animal health in the district, the County, a town, a city in the province and equivalent administrative unit (hereafter referred to as the specialized agency-level veterinary) perform tasks on the district level and in collaboration with agriculture and rural development or economic help to the Management Committee at district level the State management in the field of prevention, cure, disease-resistant animals; quarantine of animals, animal products; control animal slaughtering, processing, processing of animals, animal products; veterinary hygiene inspection; management of veterinary drugs; veterinary practice on the district level.
Article 5. Mode, the policy for veterinary staff in the communes, wards, town of 1. Based on the operational requirements on animal health and the ability to balance the resources of the local people's Committee, the city in Central People's Councils of the same level of consideration, decided to arrange a veterinary staff communes, wards and towns (hereafter referred to as veterinary staff) as defined in item 2 article 6 of the law on animal health. 2. Veterinary social workers be entitled to extra mode level and health insurance as defined in paragraph 3 article 1 of Decree No. 29/2013/ND-CP of July 8, 2013 the Government's amendments and supplements to some articles of Decree No. 92/2009/ND-CP of September 22, 2009 by the Government on the title the number of modes, internal policy, public servants in the communes, wards and towns and the people who operate the specialised and not made the insurance regime prescribed in the law on social insurance by 2014.
3. veterinary staff trained Township, fostered under the provisions of paragraph 1 article 15 of Decree No. 92/2009/ND-CP of September 22, 2009 by the Government about the title, the number of modes, internal policy, public servants in the communes, wards and towns and those not dedicated to the.
Section 2. COST of ANIMAL DISEASE prevention article 6. Cost of animal disease prevention 1. Funding animal disease prevention be made as specified in paragraph 2 to article 23 of the law on animal health. 2. Use the funds for disease prevention: a) State budget: the central budget arranged funding for the departments of the central authorities, in accordance with the law on the State budget.
Local budget expense layout for disease prevention in local animals. The case cost of animal epidemic prevention beyond the ability to balance the budget of the local people's Committee issued the report in writing, send the Ministry of agriculture and rural development, the Ministry of finance to the prime consideration, the decision prescribed in article 27 paragraph 3 d of Veterinary Law. b) the expense of pet owners , home base of livestock, aquaculture products The cost of prevention in addition to funding support from the State budget, funding the funding of organizations and individuals in and outside the country.
c) funding contributions, funding of organizations and individuals in and outside the country to follow regulations of the law on the State budget, the guidance documents state budget Law and the provisions of other relevant laws.
3. Content of the spending from the State budget: a) advocacy, dissemination, training, organization of animal epidemic prevention;
b) shopping facilities, equipment, veterinary drugs (vaccines, antiseptics) and costs for the participants of animal epidemic prevention;
c) activity monitoring, sampling, tests; monitoring, alerting farming environment; reviews of animal disease risk;
d) forecasts, warns of disease in animals; The investigation, animal disease research;
DD) support to build the safe of animal disease;
e) support the damage caused by the animal disease caused or because of the application of measures of compulsory disposal on request of the competent State organs and the costs of handling;
g) support to restore the environment of livestock and aquaculture;
4. Level of support from the State budget: a) the support level of damage caused by the animal disease caused by damage to support, adopt measures for the handling of animals at the request of the competent State agencies comply with the current regulations.
For those not content to have rules about the level of support, the Ministry of finance, in cooperation with the Ministry of agriculture and rural development, the Prime Minister decides according to the provisions of point b item 2 article 27 paragraph 3 and article 30 of the law on animal health; The provincial people's Committee in the same people's Council decision to grant the support level consistent with the ability of the local budget.

b) environmental recovery support level of husbandry, aquaculture based on the ability to balance the budget, the instructions of the Ministry of agriculture and rural development and the actual requirements in the local people's Committee of the provincial people's Council decision to supply the same level of support consistent with the ability of the local budget.
Category 3. TO TEMPORARILY STOP EXPORTING, IMPORTING; EXPORT, IMPORT of animals, ANIMAL PRODUCTS article 7. Suspension of exports, imports of animals, animal products 1. To temporarily stop exporting animals, animal products in the following cases: a) animals, animal products are at risk of carrying the object to quarantine the animal, animal product or object of veterinary hygiene inspection according to the regulations of the importing country and not take measures to handle veterinary hygiene thoroughly;
b) animals, animal products exported in violation of regulations on the import, importing countries were warned that not yet have permanent remedy to cause offense and risk losing export markets of Vietnam.
2. To temporarily stop the importation of animals, animal products in the following cases: a) animals, animal products originating from countries, territories animal diseases are in the category of animal diseases must be announced by Vietnam or sexually transmitted disease Category between animals and people or new infectious pathogens;
b) animals, animal products originating from countries, territories are detected infected object to quarantine the animal, animal product or object of veterinary hygiene inspection of the Vietnam Veterinary Department has been warning that does not comply with the regulations of Vietnam;
c) animals, animal products originating from the territories, countries at high risk of carrying the object to quarantine the animal, animal product or object of veterinary hygiene inspection of Vietnam that have yet to take measures to handle thoroughly.
Article 8. Conditions continue to export, the importing of animals, animal products 1. Conditions continue exporting animals, animal products: a) animals, animal products without the risk of carrying objects quarantined animals, animal products or objects of veterinary hygiene inspection and has applied measures to ensure the required hygiene and animal health at the request of the importing country;
b) animals, animal products have been tested, monitored, endorsed the implementation of effective measures to rectify the cause of the breach at the request of the importing country.
2. The conditions to continue the import of animals, animal products: a) animals, animal products halted imports specified in point a of Paragraph 2 article 7 of this Decree are allowed to import into Vietnam when the competent authority of the exporting country certifying control disease or infectious pathogens and have applied security measures make sure no longer risk do spread the disease at the request of Vietnam;
b) animals, animal products are specified in point b of Paragraph 2 article 7 of this Decree are allowed to import into Vietnam when the competent authority of the exporting country has reported identifying causes infected objects quarantined animals, animal products or test subjects of veterinary hygiene and applied the radical remedy;
c) animals, animal products are specified in point c of Paragraph 2 article 7 of this Decree are allowed to import into Vietnam when the competent authority of the country of export inspection, monitoring, remediation and validation ensure no longer high risk.
Article 9. Export, import of animals, animal products 1. Prohibition of the export of animals, animal products infected objects quarantined animals, animal products or test subjects without veterinary hygiene measures to handle or take measures to treat but do not meet the regulations of the importing country.
2. Prohibit the importation of animals, animal products in the following cases: a) animals, animal products originating from countries, territories carry pathogens in animal disease Category is announced by Vietnam or sexually transmitted disease Category between animals and people or new infectious pathogens; risk spreading the disease to farmed animals in the country, affecting human health;
b) animals, imported animal products have been suspended import but still not applied the remedy or applied the remedy but still does not meet the regulations of Vietnam.
Article 10. The provisions for the suspension or prohibition of exports, imports of animals, animal products in quarantine area 1. Pursuant to the provisions of article 7 and article 9 of this Decree, the Department of animal health determines the specific type of animals, animal products must suspend or prohibit export, importation; the cause to suspend or prohibit exports, imports for a country or certain territories and report to the Minister of agriculture and rural development.
2. The Minister of agriculture and rural development based reporting of animal health to consider before you decide to suspend or prohibit export, importation of animals, animal products.
3. the decision to suspend or prohibit export, importation of animals, animal products must be specified the following: a) the names of animals, animal products (including scientific name);
b) name of the country or territory from which animals, animal products are exported to Vietnam or imported from Vietnam;
c) cause to suspend or prohibit exports, imports (including the legal basis and the scientific basis).
4. The suspension or banning of exports, imports of animals, animal products from the date of the decision in effect; published right on the mass media and to inform the relevant authorities of Vietnam, the competent authorities of the country or territory of export.
Article 11. The provisions for the continuation of the export and import of animals, animal products 1. Pursuant to the provisions of article 8 of this Decree, the Bureau of animal health inspection and supervision, to confirm the effective implementation of corrective measures and to report to the Minister of agriculture and rural development.
2. The Minister of agriculture and rural development based reporting of health consideration, decided to allow continued export, import of animals, animal products; immediate decision on the mass media and to inform the relevant authorities of Vietnam, the competent authorities of the country or territory of export, import.
Item 4. CONDITIONS of production, TRADE, import, testing, veterinary ASSAY article 12. General conditions for the production of veterinary organizations, individuals produce veterinary drugs must comply with the provisions of article 90 of the law on animal health; the law on fire, fire; the law on the protection of the environment; the law on safety, hygiene and labour and meet the following conditions: 1. Location: a) To the difference with residential, public buildings, hospitals, veterinary clinics, animal disease diagnostic facility, other polluting sources;
b) Not contaminated from the external environment;
c) do not influence the environment around them.
2. Factory: a) must be consistent with the scale and type of drug production, to avoid flooding, impervious to moisture and the penetration of insects and other animals; position separates the sources of infection from outside;
b) using materials of solid structure, accordingly, ensure safety and production;

c) Background of tall, smooth floor, no cracking, no slippery, not stagnant water or sanitation, sterilization, ease detoxification;
d) wall and the ceiling is made of durable, hygienic, easy to make;
DD) Have appropriate lighting system;
the e-level system) and clean water guaranteed for production; the drainage system, sewage treatment, waste ensuring sanitary and veterinary requirements according to the provisions of the law on the protection of the environment;
g) has a fire alarm system, fire; escape to the prescribed person.
3. Warehouse containing raw materials, accessories, smoking has an area of products consistent with the scale of production and ensure the following conditions: a) Has a private repository to preserve raw materials, finished products, drug material;
b) Have a separate external repository to preserve solvents and explosive materials;
c) avoided flooding, impervious to moisture and the penetration of insects and other animals;
d) high floor drain, not infuse or stagnant water;
DD) Have appropriate lighting system;
e) has a fire alarm system, fire; escape to the person under the provisions of the law on fire, fire;
g) Have the raw material to the shelves, accessories, packaging, drug product; have the equipment, means to ensure conditions of preservation.
4. Equipment and instruments must be deployed, installed in accordance with the scale and type of drug production; operating instructions; maintenance plans; hygienic process and ensure satisfactory sanitation, do not cause infection or opportunistic crossover between the products.
5. Quality control of veterinary medicine: a) check the quality area is separate from the manufacturing areas; be arranged accordingly to avoid cross-contamination; the regions conducted biological tests, microbiology;
b) form, standard substances must be stored in a separate area, ensuring the preservation conditions;
c) Must have sufficient appropriate equipment.
Article 13. Conditions for production facilities pharmaceutical form veterinary, vaccine in addition to the conditions prescribed in article 12 of this Decree, the basis of the production of veterinary vaccines, pharmaceutical form should apply good manufacturing practices of the Association of South-East Asian countries (GMP-ASEAN) or good manufacturing practice of drugs of the World Health Organization (WHO-GMP) or practice good medicine production GMP equivalence but not lower (GMP-ASEAN).
Article 14. Order and procedure for certification of good manufacturing practices GMP for veterinary drugs 1. Registration certificate of good manufacturing practice GMP for veterinary medicines (hereinafter the certificate GMP), including: a) GMP inspection application;
b) business registration certificate;
c) Organization and personnel of the facility;
d) program, training materials, evaluate the results of training of GMP in the facility;
DD) Navigation equipment for the production, maintenance and quality control equipment;
e) directory of standard operation procedures;
g) Category the items are produced, or slated for production;
h) report reviews the environmental impact management agency is the State of the environment;
I) GMP inspection order thereon;
k) new facility, GMP inspection registration must submit more professional person in charge of production engineering and the person in charge of laboratory veterinary medicine. the registration records must be GMP inspection cover and contents, are arranged in the correct sequence of contents, there are separate between sections.
2. The time limit for solving: a) within 10 days of receiving the registration records, animal health appraisal records, require additional amendments if the profile is not satisfactory;
b) within 30 days of receipt of a valid application, the Department of animal health decision established GMP inspection, the Group simultaneously announced the test schedule for the base and inspect;
c) within 10 days of the end of the test, if the basis of satisfactory animal health certificate of GMP, if the facility does not meet the requirements to respond in writing and stating the reason unsatisfactory.
3. test process: a) the base when GMP inspections are conducted the report with diagrams, charts and a brief on the State of data operations, deployments apply GMP;
b) When checking the GMP, the operation is being conducted;
c) check the operation of the whole production base veterinary drugs according to GMP, the registration records of the base and the current professional rules.
4. Processing test results: a) on the basis of the minutes of the test, the test Crew Chief suggested the Chief animal health certification for GMP facility meets the condition of GMP;
b) establishments meet the requirements of GMP but also some exist and can be overcome in a short time, the delegation examined require repair, fix base. Within a period of 2 (two) months from the date of the check, the base must fix, fix, and report the results in writing about animal health. Protagonist check to review, recommend the Chief Veterinary GMP certification for the facility meet the requirements;
c) for basis do not meet the condition of GMP should conduct remedy, repair the existence. After the self test reviews, if it meets the condition of GMP facility to conduct registration again according to the regulations.
5. Validity period of the certificate value within 5 years. Before 3 months as of the expiry date of the certificate of GMP, organization or individual wishing to continue the production of veterinary medicines apply to renew the certificate. The facility has been granted a certificate of GMP is not doing the procedure of certification of eligible production of veterinary drugs. Article 15. Order and procedure of renewal of certificate 1. Renewed registration documents GMP certification, include: a) re-examining application of GMP;
b) activity reports, changes in the base's 12 years of GMP;
c) reports the fix exists in check times before;
d) report on the training, of training facilities;
DD) Category of existing equipment;
e) Category the items are produced;
g) directory of standard operation procedures;
h) report reviews the environmental impact management agency is the State of the environment;
I) minutes of self inspection and assessment of the base of the nearest inspection order (within 3 months) on the implementation of GMP.
2. The time limit for solving, process checks, handle the test results, the validity of the certificates of GMP as defined in paragraph 2, paragraph 3, clause 4 and Clause 5 article 14 of this Protocol.
Article 16. Order and procedure for granting, revoking the certificates of GMP 1. Profile, sequence, procedure of reissuing certificate in case of loss, damage, errors; change the information related to the registered organization: a) records reissued certificate includes: registration form again; documents proving the content change in case of change of information related to the registered organization; GMP certificate has been issued, except in the case of missing;
b) organizations, individuals filing certificate re-issuance of GMP for animal health; within 5 working days from the date of receipt of a valid application, the animal health certificate re-issuance of GMP; no case level must have text answers and stating the reason.
2. the animal health certificate revocation of the Organization, the individual production of veterinary medicines in the following cases: a) cGMP were erased, corrected the content;
b) violates the law that sanctioned administrative offense from 3 times or more in a year or sanctioned administrative offense 3 times in a row about a violation in the field of the production of veterinary drugs;
c) no longer active production of veterinary drugs;
DD) Have other violations which the law must revoke the certificate.
The Minister of agriculture and rural development-level record guidelines renewed, revoke, alter, Supplement GMP certificate.
Article 17. Conditions of trade in veterinary medicine

Individual organizations trafficking in veterinary medicine must follow the provisions of article 92 of the law on veterinary medicine and meet the following conditions: 1. There is no fixed business location and signage.
2. Have the cabinets, shelves, prices to contain the appropriate drugs.
3. Have the equipment ensure storage conditions as prescribed.
4. Have the books, invoices, tracking documents.
5. for establishments vaccines, biological preparations must have fridge, mini fridge cooler or cold storage to preserve under the preservation conditions indicated on the label; There's a thermometer to check the conditions of preservation. Have backup generators, supplies, transportation, vaccine delivery.
Article 18. Conditions for import of veterinary organizations and individuals to import veterinary drugs are prescribed in article 94 of the veterinary Act, article 17 of this Decree and satisfy the following conditions: 1. Has secured the conditions prescribed in paragraph 3 article 12 of this Decree.
2. Have the appropriate equipment such as exhaust fans, air-conditioning system, thermometers, humidity to ensure the conditions for preservation.
3. Must have the book system, the standard operation procedures for the preservation, control, monitor the veterinary import export. 4. For the basis of imported vaccines, biological preparations must have separate repositories for preservation, have backup generators, have the equipment, transportation, ensuring the preservation conditions indicated on the product label in the shipping process, distribution.
Article 19. Condition testing establishments veterinary drugs veterinary drugs testing facility is prescribed in paragraph 3 to article 101 of the law on veterinary medicine and meet the following conditions: 1. place the difference of residential, public works.
2. The facilities meet Biosafety, guaranteed to test the indicators microorganisms; clean room to analyze physical-chemical indicators.
3. Be equipped with machines, tools for ensuring for the sampling, analysis, edit and process the data correctly. The analytical equipment to ensure the correct test method, meet quality control standards, the current standards.
4. captive animal experiments; There are separate toxic intensity test area for vaccines, microorganisms; for the testing of the vaccine have pathogens have highly pathogenic animal breeding room to ensure biosafety.
5. waste treatment system, waste water ensures hygiene and animal health, environmental hygiene; There are separate areas for handling animal experiments tested vaccines use, microorganisms.
6. Have the equipment used to keep the same microorganism to test the service.
Article 20. Condition assay establishments veterinary drugs veterinary drugs assay basis under the provisions of article 88 of the law on veterinary medicine and meet the following conditions: 1. Where livestock, aquaculture products that meet the following conditions: a) Location consistent with planned local land use or the competent authority;
b) Have the fence or wall surrounding the guarantees to prevent the animal from outside, on the basis of;
c) has its clean water;
d) has sufficient area of the barn, pond, Aquarium animal layouts to ensure assay results;
DD) offers a variety of animals, sufficient in number to meet the assay; have a separate place to feed the animal experiments, the systematic treatment of waste, waste water, animals, diseases of veterinary hygiene guarantee products, environmental hygiene;
e) Where manufacturing, processing and feed store to the difference with where to the toxic chemicals and to take measures against insects, harmful animals;
g) kennels, ponds area, Aquarium there where containing the food gap and is designed to meet the requirements of preserving.
2. veterinary testing facility or contract testing facility rental; test establishments must meet the conditions prescribed in article 19 of this Decree.
Section 5. Veterinary PRACTICE CONDITIONS article 21. Veterinary practice conditions, organization of veterinary practitioners must be eligible under the provisions of article 108 of the law of animal health and must meet the professional requirements are as follows: 1. The practice of diagnosis, healing, animal surgery, consultation activities related to the veterinary field must have the minimum level of veterinary specialisation , breeding or aquaculture, aquatic pathology for veterinary practice. The practice of vaccination for animals must have the certificate of technical training classes by the State Agency has the authority to grant the province level.
2. The person in charge of the technical basis of animal surgery, examinations, diagnosis, tests of animal diseases must have college degree major animal health, breeding or aquaculture, aquatic pathology for veterinary practice.
3. The trafficking in veterinary medicine must have intermediate major animal health, breeding or aquaculture, aquatic pathology for veterinary practice.
4. The person in charge of the technical basis of the assay, export, import of veterinary drugs are prescribed as follows: a) the basis of assay, export, import of the drug used in veterinary medicine for animals on land must have college degree major animal health, husbandry, pharmacist, Bachelor of medicinal chemistry , chemistry, biology;
b) assay basis, export, import of drugs used in veterinary medicine for aquatic animals must have college degree major aquaculture, aquatic pathology, pharmacology, pharmaceutical chemistry, chemistry b.SC., biology.
5. The person in charge of technical production facilities, veterinary testing are specified as follows: a) production facilities, drug testing is used in veterinary medicine for animals on land must have college degree major veterinary, pharmacist, pharmaceutical chemistry; used in veterinary medicine for aquatic animals must have college degree major aquaculture, aquatic pathology, pharmacy, pharmaceutical chemistry;
b) establishments manufacturing, testing the drug as vaccines, probiotics, microorganisms, chemicals used in veterinary medicine for animals on land must have college degree major animal health, husbandry, pharmacist, pharmaceutical chemistry, chemistry b.SC., biology; used in veterinary medicine for aquatic animals must have college degree major aquaculture, Aquatic Biology, pathology, pharmacology, pharmaceutical chemistry, Bachelor in chemistry.
Article 22. Veterinary practice 1. Veterinary practice certificates issued to organizations and individuals who are qualified to practise under the provisions of article 108 of the law on veterinary medicine, article 21 of this Decree and the records prescribed in clause 2 and Clause 5 Article 109 of Veterinary Law. 2. The content of the certificate of practice veterinary medicine include: a) the full name, date of birth;
b) residence address;
c) qualified;
d) type of practice;
DD) Location.
Attached to this Decree, annex on veterinary practice certificate templates and certificate application of veterinary practice. 3. The use of the practice of veterinary medicine is prescribed as follows: a) the veterinary practice certificate of vaccination, diagnosis, healing, animal surgery, consultation activities related to the field of veterinary medicine is used within the country. The Agency issued a certificate of practice is not to write to the Directory location of practice;
b) practice of veterinary technical supervisor at the facility animal surgery, examinations, diagnosis, tests of animal disease, the veterinary drug trafficking was used within the province, central cities;
c) veterinary practitioners certified by the person in charge of engineering at production facilities, testing, assay, export, import of veterinary drugs are used within the country.
Chapter III the TERMS of the IMPLEMENTATION of Article 23. Enforceable

1. This Decree shall be effective from July 1, 2016.
2. This Decree replaces Decree No. 32/2005/ND-CP dated 15 March 2005 from the Government detailing the implementation of a number of articles of the Ordinance on veterinary medicine; Decree No. 119/2008/ND-CP on November 28, 2008 the Government's amendments and supplements to some articles of the Decree No. 32/2005/ND-CP; Article 4 of Decree 98/2010/ND-CP on January 26, 2011 the Government's amendments and supplements to some articles of the Decree on agriculture.
Article 24. Responsibility of Ministers, heads of ministerial agencies, heads of government agencies, the Chairman of the provincial people's Committee, central cities and other agencies responsible for the implementation of this Decree.
 

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