Veterinary Regulations (April 9, 2004 release)

PRC State Council Order (No. 404)

"Veterinary Regulations" has been March 24, 2004 the 45th executive meeting of the State Council, is hereby promulgated, November 1, 2004 shall come into force.

Premier Wen Jiabao, April 9, 2004

Veterinary Regulations

Chapter I General Provisions

In order to strengthen veterinary management to ensure the quality of veterinary drugs, animal disease prevention, promotion of aquaculture development, and safeguard human health, the enactment of this Ordinance.

Article in the PRC engaged in veterinary research and development, production, operation, import and export, use and supervision shall comply with these regulations.

Veterinary under the State Council administrative department responsible for the national veterinary supervision and management.

Local people's governments above the county level and veterinary administrative department responsible for the administrative area of ​​veterinary supervision and management.

The state shall implement veterinary prescription and non prescription drugs category management system. Veterinary prescription and non prescription drugs category management approach and the specific implementation steps, by the veterinary administrative department under the State Council.

The state shall practice veterinary reserve system.

Major animal epidemics, disasters or other emergencies, the State veterinary administration can call the national emergency reserves of veterinary drugs; necessary, you can also call the national reserves outside of veterinary medicine.

Chapter development of new animal drugs

The State encourages the development of new veterinary drug, developer of the law to protect the legitimate rights and interests.

Article development of new veterinary drug, and development should be compatible with the place, equipment, professional and technical personnel, security management practices and measures.

Development of new veterinary drugs, safety evaluation should be conducted. Safety evaluation of veterinary drugs in the unit, shall be subject to veterinary administrative department believes that the State Council, and to comply with non-clinical studies of veterinary drugs and veterinary clinical quality management standard quality control tests.

Article VIII of the development of new veterinary drug, should be in clinical trials prior to the provinces, autonomous regions and municipalities apply for veterinary administration, and attach the new veterinary laboratory stage of safety evaluation report and other pre-clinical research data; Province, autonomous regions and municipalities and veterinary administrative department shall, from the date of receipt of the application will be reviewed within 60 working days written notice to the applicant the results.

Development of new veterinary drugs are biological products, should be in clinical trials before the State Council administrative department for veterinary application, and veterinary administrative department of the State Council shall from the date of receipt of the application will be reviewed within 60 working days written notice to the applicant the results.

Development of new veterinary drug to use a class of pathogenic microorganisms, but also should have the administrative department under the State Council's veterinary conditions and veterinary laboratory stage before the State Council administrative department for approval.

Article IX of clinical trials completed, the developer of new animal drugs and veterinary administrative department under the State Council put forward a new application for registration of veterinary drugs, veterinary drugs should be submitted to the new samples and the following information:

(A) the name, main ingredients, physical and chemical properties;

(B) development of methods, production processes, quality standards and testing methods;

(C) the results of pharmacological and toxicological testing, clinical trial reports and stability test report;

(D) environmental impact report and pollution prevention measures.

Development of new veterinary drugs are biological products, should also provide bacteria (viruses, worms) species, cells and other relevant materials and information. Bacteria (viruses, worms) species, cells from the State Council administrative department for veterinary institutions designated preservation.

Development of new veterinary drugs for food animals, veterinarians should also be in accordance with the State Council administrative department for veterinary drug residue testing requirements and provide the withdrawal period, the maximum residue limits, residue detection method and its development based on such information.

State veterinary administrative department shall, from the date of receipt of the application within 10 working days, will determine the admissibility of the new data to send its veterinary veterinary accrediting bodies set up to review, send samples of the new veterinary inspection agency designated by the review inspection and assessment and review of the receipt date of inspection findings within 60 working days to complete the review. Review of qualified, issue a new certificate of registration of veterinary drugs, veterinary drugs and publish the quality standards; failure, it shall notify the applicant in writing.

The state of registration according to law, veterinary medicines containing new compounds submitted by the applicant to obtain their own undisclosed test and other data protection implementation.

Since the six years from the date of registration of other applicants have been registered without the consent of the applicant veterinary drugs, the use of the data preceding paragraph apply for registration of veterinary drugs, veterinary registration authorities refuse to register; However, other applicants to submit its own, except the data obtained.

In addition to the following conditions, the veterinary drug registration authority shall not disclose data from the first paragraph of this Article:

(A) the public interest so requires;

(B) has taken measures to ensure that such information will not be improper for commercial use.

Chapter III production of veterinary drugs

Article 11 The establishment of veterinary drugs manufacturers, veterinary drug industry should be in line with national development plans and industrial policies, and meet the following conditions:

(A) and to adapt the production of veterinary drugs veterinary science, pharmacy or related professional and technical personnel;

(B) the production of veterinary drugs and to adapt the plant and facilities;

(C) the production of veterinary drugs and veterinary drugs suited to quality control and quality inspection institutions, personnel, equipment;

(D) compliance with safety and health requirements of the production environment;

(E) veterinary drug manufacturing practices of the other production conditions.

Meet the conditions of the preceding paragraph, the applicant only to the provinces, autonomous regions and municipalities apply for veterinary administration, and attach proof of the conditions in line with the provisions of the preceding material; provinces, autonomous regions and municipalities should government veterinary administration Since the date of receipt of the application within 20 working days, will review comments and related material submitted to the State veterinary administration.

State veterinary administration, shall receive an audit opinion and related materials from the date of 40 working days to complete the review. Passes the examination, the veterinary drug production license issued; failure, it shall notify the applicant in writing. Applicants with veterinary drug production license apply for business registration.

Article XII of veterinary drug production license shall specify the scope of production, production sites, valid and legal representative of the name, address and other matters.

Veterinary drug production license is valid for 5 years. Expired, the need to continue production of veterinary drugs, and should permit six months before the expiry of the original issuing authority for veterinary drug production license renewal.

Article XIII of the scope of veterinary drug manufacturers to change production, production sites, in accordance with the provisions of Article 11 shall apply for renewal of the veterinary drug production license, an applicant with the veterinary drug production license renewal for change of business registration; change the corporate name, legal representative, it should be in the process of change of business registration within 15 working days to the original issuing authority for veterinary drug production license renewal.

Article XIV veterinary drug manufacturers in accordance with the State Council shall be formulated by the administrative department for veterinary veterinary drug manufacturing practices for production.

State veterinary administration, veterinary drug manufacturers should be compliance with veterinary requirements of good manufacturing practices for supervision and inspection, and publish the test results.

Article XV production of veterinary drugs veterinary drug manufacturer shall obtain the State Council issued the administrative department for veterinary approval number of products, product approval number is valid for 5 years. Veterinary Product Approval Number issued by the State Council administrative department of veterinary.

Article XVI veterinary drug manufacturer shall, in accordance with national standards and veterinary medicine and veterinary administrative department of the State Council approved the production process for production. Impact of veterinary drugs veterinary manufacturers to change the quality of the production process, should be reported to the original approval department for approval.

Veterinary drug manufacturer shall establish production records, production records should be complete and accurate.

Article XVII of raw materials required for production of veterinary drugs, materials, shall comply with national standards or quality requirements of the production of veterinary drugs.

Direct contact with the veterinary drug packaging materials and containers shall meet the medical requirements.

Article 18 of the veterinary drug factory shall be subject to quality inspection, does not meet the quality standards shall not be manufactured.

Veterinary drug factory shall be accompanied by product quality certification.

Ban on the production fake, inferior veterinary drugs.

Article 19 The production of each batch of veterinary drug manufacturers of veterinary biological products, the factory should be by the State Council administrative department for veterinary inspection agencies to review the specified check and random testing when necessary; not been reviewed or random inspection check failed , and may not be sold.

Veterinary biological products required compulsory vaccination, veterinary administration by the State Council designated production.

Diershitiao veterinary drugs shall be subject to packaging or printed on a label, accompanied by instructions, and in a prominent position marked "animal" words.

Veterinary medicine labels and instructions by the State Council administrative department for veterinary approved and published, before use.

Veterinary medicine label or instructions, shall be marked in Chinese veterinary medicine generic name, composition and content, specifications, manufacturers, product approval number (import veterinary drug registration number), product batch number, production date, expiry date, indications or functions, usage, dosage, withdrawal period, contraindications, adverse reactions, precautions, transportation, storage and other storage conditions should be clarification. There is a product name, product name should also be noted.

Notwithstanding the foregoing, the content, or veterinary prescription drug label instructions should also be printed with the provisions of the State Council administrative department for veterinary warning content, including veterinary narcotic drugs, psychotropic substances, toxic drugs and radioactive drugs should also be printed with the State Veterinary Administration administration department under the special mark; veterinary non-prescription drug label instructions should also be printed or veterinary administration department under the State Council, a non-prescription drugs signs.

Twenty-one State veterinary administration, according to the quality of animal products to ensure the safety and health needs, you can set up new veterinary drugs not more than five years monitoring period; the monitoring period, other companies may not approve of the new production or import veterinary medicine. Manufacturers should be collected during the monitoring of the new veterinary drug efficacy, adverse reactions, etc., and timely submitted to the State veterinary administration.

Chapter veterinary drug

Article 22 of the veterinary business enterprises shall meet the following conditions:

(A) and operated by veterinary technicians veterinary compatible;

(B) operated by veterinary and adapt to business premises, equipment, storage facilities;

(C) operated by veterinary and adapt quality management agencies or personnel;

(D) veterinary drug quality control of the other operating conditions.

Meet the conditions of the preceding paragraph, the applicant only to the city and county people's government veterinary administration to apply, and attach the conditions of the preceding paragraph, in line with evidence; management of veterinary biological products, should be to the provinces, autonomous regions and municipalities people's government veterinary administration to apply, and attach the conditions of the preceding paragraph, in line with evidence.

Local people's governments above the county level and veterinary administrative department, shall from the date of receipt of the application within 30 working days to complete the review. Review of qualified veterinary drug license issued; failure, it shall notify the applicant in writing. Applicants with veterinary license apply for business registration.

Article 23 of the veterinary drug license shall specify the scope of business, place of business, valid and legal representative of the name, address and other matters.

Veterinary license is valid for 5 years. Expired, the need to continue to operate veterinary drugs, and should permit six months before the expiry of the original issuing authority for veterinary license renewal.

Article 24 The enterprises change the scope of veterinary medicine, business locations, it should be in accordance with the provisions of this Article 22 apply for renewal of veterinary drug license, the applicant's veterinary license renewal with the change of business registration for procedures; to change corporate name, legal representative, it should be in the process of change of business registration within 15 working days to the original issuing authority for veterinary license renewal.

Article 25 veterinary enterprises shall abide by the State Council administrative department of veterinary veterinary quality management specification.

Local people's governments above the county level veterinary administration, veterinary enterprises should be whether the quality management standard veterinary drug supervision and inspection requirements, and publish the test results.

Article 26 veterinary drug companies to purchase veterinary drugs, veterinary products should be with the product label or instructions, product quality certification verification.

Article 27 veterinary drug companies should explain to the buyers veterinary functions, usage, dosage and precautions. Sales of veterinary prescription drugs, shall comply with veterinary prescription drug management.

Sales of veterinary medicines veterinary enterprises, it shall indicate the place of origin.

Prohibited veterinary drug business people use drugs and fake, inferior veterinary drugs.

Article 28 The purchase and sale of veterinary drugs veterinary enterprises, purchase and sale records should be established. Purchase and sale records should contain veterinary drugs trade names, generic name, dosage form, size, batch number, expiry date, manufacturer, purchase and sale of units, the number of purchase and sale, purchase and sale dates and veterinary administrative department under the State Council and other matters.

Article 29 A veterinary drug companies, veterinary care system should be established to take the necessary refrigeration, freezing, moisture, insects, rodents and other measures to maintain the quality of the veterinary business.

Veterinary medicine storage, a library, should perform inspection and acceptance system, and have accurate records.

Article 30 required for mandatory immunization of veterinary biological products business, shall conform to the State Council administrative department for veterinary requirements.

Article 31 veterinary advertising content should be consistent with the contents of veterinary manual, published in the national media focus on veterinary drug advertising, should be approved by the State Council administrative department for veterinary examination and approval, to obtain veterinary drug advertising review approval. Release veterinary drug advertising in the local media, it should be by the provinces, autonomous regions and municipalities and veterinary administrative department for examination and approval, to obtain veterinary drug advertising review approval number; without approval, and shall publish.

Chapter veterinary import and export

Article 32 of the first veterinary drug exports to China by the exporter in the territory of China or its offices within the agency entrusted to the Chinese State Council administrative department for veterinary registration and submit the following information and items:

(A) the manufacturer country (region) regulatory approval of veterinary drugs production and sales documents;

(B) the manufacturer country (region) issued by the veterinary authorities in line with good manufacturing practices for veterinary certificates;

(C) the veterinary drug manufacturing methods, production processes, quality standards, testing methods, pharmacological and toxicological test results, clinical trial reports, stability test reports and other relevant information; used in food animal veterinary medicine withdrawal period, maximum residue limits, residue detection methods and to develop based on such information;

(D) veterinary samples of labels and instructions;

(E) veterinary samples, reference standards, standard;

(Vi) environmental impact report and pollution prevention measures;

(Vii) safety of veterinary drugs and other related information.

Application to China's export of veterinary biological products, should also provide bacteria (viruses, worms) species, cells and other relevant materials and information.

Article 33 The State veterinary administration, shall receive the application within 10 working days from the date of initial review organization. After initial review of qualified, shall determine the admissibility of veterinary information sent to its accrediting bodies set up by the assessment of veterinary drugs, veterinary samples sent to the designated inspection agency review of its inspection and assessment and review of the receipt of the date of inspection findings within 60 working days to complete the review. Passes the examination, the issue of import veterinary certificate of registration, and publish the quality standards of the veterinary drug; failure, it shall notify the applicant in writing.

During the review process, the State Council administrative department of veterinary can export to China's enterprises are in line with veterinary veterinary requirements of good manufacturing practices are examined, and the right to require the enterprises in the State veterinary administration bodies of the animals designated drug safety and efficacy trials.

Badly needed veterinary medicine, veterinary medicine or registered with a small amount of research and veterinary samples, reference standards, standard import, and veterinary administrative department under the State Council's regulations.

Article 34 The import of veterinary drugs registration certificate is valid for 5 years. Expired, the need to continue to export to China of veterinary drugs, it should be six months before the expiry of the original issuing authority for re-registration.

Article 35 Foreign enterprises shall direct sales of veterinary drugs in China. Foreign enterprises in China, sales of veterinary drugs, shall set up sales offices in China or entrust qualified agencies in China.

Import of veterinary drugs in China has gained a certificate of registration of imported veterinary biological products, the agency in China shall apply for the State Council administrative department for veterinary import of veterinary biological products allow documents to allow the import of veterinary biological products with supporting documents to the port location people's government veterinary administration Customs Clearance for import veterinary drugs; imported veterinary drugs in China has gained a certificate of registration of imports of other veterinary drugs, veterinary import registration certificate with the seat of government to the port administrative department for veterinary Customs Clearance of Imported Veterinary Drugs . Import Customs Clearance Customs shall release veterinary drug. Veterinary import controls by the State Council administrative department in conjunction with the Veterinary Administration of Customs.

After importation of veterinary biological products shall be in accordance with the provisions of Article 19 of the Ordinance to review and random inspection check. Other veterinary drugs, imported by the local administrative department for veterinary inspection agency to conduct random checks to inform veterinary inspection.

Article 36 banned the import of the following veterinary drugs:

(A) the uncertain efficacy, adverse reactions and possible aquaculture, human health hazards or potential risks;

(B) may result from the epidemic spread of the disease in China veterinary biological products;

(C) examine the conditions of production by non-compliance;

(D) of the State Council banned production of veterinary administration, operation and use.

Article 37 The export to the overseas Chinese veterinary medicine, veterinary medicine importer required export documents, the State Council administrative department for veterinary or business location of the provinces, autonomous regions and municipalities can issue the administrative department for veterinary veterinary export certificate.

Much-needed domestic vaccine immunization, the State Council administrative department for veterinary can restrict or prohibit the export.

Chapter VI Use of Veterinary Drugs

Article 38 The use of veterinary drugs unit, shall comply with the State Council administrative department of veterinary safe use of veterinary regulations, and the establishment of medication records.

Article 39 prohibiting the use of fake or inferior veterinary drugs and veterinary administrative department under the State Council banned the use of drugs and other compounds. Prohibit the use of drugs and other compounds catalog by the State Council announced the development of veterinary administration.

Article 40 Withdrawal period for veterinary drugs used in food animals, breeders should be to the purchaser or slaughter to provide accurate, real medication records; purchaser or slaughter shall ensure that the animals and their products in the medication period, withdrawal period is not used for food consumption.

Veterinary administrative department under the State Council, responsible for the publication allows you to add the feed medicated feed additives that directory.

Prohibit drinking water in the feed and animal drugs and hormones added to the State Council administrative department under the veterinary and other disabling drugs.

Upon approval of veterinary drugs in feed, veterinary drug manufacturers should be made by the feed additive before adding drugs. Prohibited drug substance added directly to animal feed and drinking water or direct-fed animals.

Prohibition for animal medicines for human use.

Article 42 The State Council administrative department for veterinary, should formulate and implement national animal and animal product veterinary drug residue monitoring plan.

Above the county level people's government veterinary administration, responsible for the organization for animal products in the detection of veterinary drug residues. Veterinary drug residue test results, and veterinary administrative department by the State Council or provincial, autonomous regional and municipal people's government veterinary administration in accordance with permissions to the public.

Animal producers, sellers on the test results have objections from the receipt of the test result within 7 working days from the date of the organization of veterinary drug residues of veterinary administration or veterinary administration of its parent application, the application is accepted by the veterinary administration designated inspection agency conduct a review.

Veterinary drug residue limits and residue detection methods, veterinary administration by the State Council formulated and promulgated.

Article 43 prohibit the sale of prohibited drugs or veterinary drug residues in edible animal products than the standard.

Chapter VII Supervision and Administration of veterinary drugs

Article 44 The people's governments above the county level administrative departments of veterinary drugs veterinary supervision and management.

Veterinary veterinary inspection by the State Council administrative department and provincial, autonomous regional and municipal people's government veterinary administration established veterinary inspection agencies. State veterinary administration, can bear the need to identify other veterinary inspection agencies inspection.

Veterinary inspection of the parties disagrees with the results, from the receipt of test results within seven working days from the date of the inspection body or the establishment of superior administrative department of veterinary inspection to apply for re-examination.

Article 45 veterinary drug shall meet the national standards for veterinary drugs.

National Veterinary Pharmacopoeia Commission proposed, the State Council administrative department for veterinary release of "People's Republic of Veterinary Pharmacopoeia" and the State Council administrative department for veterinary veterinary medicine quality standards issued by other national standards for the veterinary drugs.

Veterinary standards and national standards for the calibration of the reference substance by the State Council set up by the administrative department for veterinary veterinary inspection agencies.

Article 46 The administrative department for veterinary supervision and inspection, there is evidence that may be fake, inferior veterinary drugs shall be taken to attachment, seizure of administrative enforcement measures, and from compulsory administrative measures taken to seven working days from the date of make a decision whether to file within; need to be inspected, the inspection report should be issued since the date of 15 working days to decide whether to file a case; do not meet the conditions placed on file, should lift the administrative compulsory measures; need to suspend production, operation and use of by the State Council administrative department for veterinary or provinces, autonomous regions and municipalities and veterinary administrative department under authority to make decisions.

Administrative compulsory measures decided without their superior authorities or organs are not allowed to transfer, use, destruction, sale or seizure of veterinary drugs were seized and related materials.

Article 47 of the following circumstances, in order to fake veterinary drugs:

(A) posing as a non-veterinary or veterinary drugs in his posing of such veterinary drugs veterinary drugs;

(B) the type of veterinary medicine ingredients, name and does not meet national standards for veterinary drugs.

One of the following circumstances, in accordance with fake veterinary treatment:

(A) of the State Council administrative department for veterinary use prohibited;

(B) in accordance with these Regulations shall be subject to examination and approval and without examination and approval that is manufactured, imported, or in accordance with provisions of this Ordinance shall be subject to random testing, random testing without the review and verification, review of verification that is sold or imported;

(C) deterioration;

(D) was contaminated;

(E) indicated the indications or functions beyond the scope of the provisions.

Article 48 of the following circumstances, for the inferior veterinary drugs:

(A) the ingredients do not meet national standards for veterinary drugs or active ingredients are not labeled;

(B) does not indicate or change the period of validity or over;

(C) does not indicate or change the production lot;

(D) Other veterinary drugs do not meet national standards, but not fake veterinary drugs.

Article 49 prohibits unbundling veterinary bulk drugs to veterinary drug manufacturer or sold to other establishments and individuals.

Prohibited without veterinary prescription sales, purchase, and veterinary administrative department under the State Council provides for veterinary prescription drug management.

Article 50 National implementation of veterinary adverse reaction reporting system.

Veterinary drug manufacturers, enterprises, units and use of veterinary drugs veterinary prescription use of veterinary drugs found may be related to serious adverse reactions should be immediately to the local people's government veterinary administration department.

Article 51 veterinary drug manufacturers, enterprises stop production, operation or shut down more than 6 months, the original issuing authority shall order the return of veterinary drug production license, veterinary license by the administrative department for industry and commerce Change or cancellation of their business registration.

Article 52 prohibit the sale, lease, lend, license production of veterinary drugs, veterinary drugs and veterinary license approval documents.

Article 53 of the veterinary inspection fees and accreditation standards, the financial sector by the State Council department of the State Council in charge of prices, and announce it.

Article 54 The administrative departments at all levels of veterinary, veterinary inspection agencies and their staff shall not participate in veterinary medicine production and business activities, not recommended in its own name or supervising sales of veterinary drugs.

Chapter VIII liability

Article 55 veterinary administrative departments and their staff to use their jobs to receive property or seek other interests that do not meet the statutory requirements of the units and individuals issued permits, review of consent signed by not fulfilling its oversight responsibilities, or that illegal behavior are not investigated, resulting in serious consequences, constitute a crime shall be investigated for criminal responsibility; not constitute a crime, shall be given administrative sanctions.

Article 56 violation of these regulations, no veterinary drug production license, veterinary drug production license, operating veterinary drugs, or veterinary drug production license, although, veterinary drug license, production, management leave, bad beast medicine, or veterinary drug business people use drugs, and ordered to stop production, operation, confiscated for illegal production of raw materials, auxiliary materials, packaging materials and production, management of veterinary drugs and illegal income, impose illegal production, management veterinary drugs (including the sale and the sale of veterinary drugs are not the same below) value of 2 to 5 times the amount of a fine, not subject to verification of the value of the amount, 100,000 yuan to 200,000 yuan fine; no beast production of veterinary drug production licenses in serious cases, confiscation of their production equipment; production, management leave, inferior veterinary drugs, in serious cases, revocation of veterinary drug production license, veterinary license; constitutes a crime shall be prosecuted for criminal responsibility; damage caused to others, shall be liable for compensation. Production and business enterprises and is mainly responsible for life directly in charge shall not engage in veterinary medicine production and business activities.

Unauthorized production of veterinary biological products required compulsory vaccination, and veterinary drug production license in accordance with the production of veterinary drugs without punishment.

Article 57 violation of these regulations, to provide false information, samples or by other fraudulent means to obtain veterinary drug production license, veterinary license or veterinary drug approval documents, the suspension of veterinary drug production license, veterinary drug revocation of license or veterinary drug approval documents, and impose more than 5 million 10 million fine; damage caused to others, shall bear the compensation responsibility. The main leaders and executives directly responsible for the production of veterinary drugs shall not engage in life, business and import and export activities.

Article 58 The sale, lease, lend, license production of veterinary drugs, veterinary drugs and veterinary drugs approved business license documents, confiscate the illegal income and impose a 10,000 yuan 10 million fine; serious cases, suspension of animal drug production licenses, business license or revocation of veterinary veterinary drug approval document; constitute a crime shall be investigated for criminal responsibility; causes losses to others, shall be liable for compensation.

Article 59 violation of these regulations, safety evaluation of veterinary drugs unit, clinical trials unit, production and management company is not in accordance with the provisions of the implementation of veterinary research testing, production, quality management specification, and given a warning, ordered to make corrections; overdue correction, ordered to stop veterinary research testing, production, business activities, and impose a fine of 50,000 yuan; serious cases, suspension of veterinary drug production license, veterinary license; damage caused to others, shall bear the compensation responsibility.

Violation of these regulations, the development of new veterinary drugs do not have the required conditions for the unauthorized use of a class of pathogenic microorganisms in the laboratory stage or before the unauthorized, and ordered to stop it, and impose more than 5 million 10 million fine; a crime shall be prosecuted for criminal responsibility; causes losses to others, shall be liable for compensation.

Article 60 in violation of the regulations, veterinary medicine labels and instructions unauthorized, and ordered to make corrections; it fails to do, according to production, management punished fake veterinary drugs; the approval number of veterinary products, veterinary drugs withdrawn product approval number; damage caused to others, shall bear the compensation responsibility.

Veterinary medicine is not labeled on the packaging and instructions, labels and instructions or inconsistent with the approved, and ordered to make corrections; the circumstances are serious, shall be punished in accordance with the preceding paragraph.

Article 61 violation of these regulations, foreign enterprises in China, direct sales of veterinary drugs shall be ordered to make corrections, direct sales of veterinary drugs and the confiscation of illegal income, impose more than 5 million 10 million fine; the circumstances are serious, import veterinary certificate of registration revoked; damage caused to others, shall bear the compensation responsibility.

Article 62 violation of these regulations, not in accordance with relevant provisions of the safe use of veterinary drugs veterinary drugs, the drug has not been established record or records are incomplete, the real, or prohibit the use of drugs and other compounds, or medicines for human use for animals, and ordered its immediate correction, and the feeding of prohibited drugs and other compounds of the animals and their products sound processing; of illegal units at 10,000 and 50,000 million fine; damage caused to others shall bear the compensation responsibility.

Violation of Article 63 regulations, medication is still selling period, off-drug period of the animals and their products for food consumption, or sale of prohibited drugs and excessive veterinary drug residues in animal products for food consumption, and ordered prohibited drugs and their excessive veterinary drug residues in animal products, sound processing, confiscate the illegal income and impose a more than 3 million 10 million fine; constitute a crime shall be investigated for criminal responsibility; damage caused to others, shall bear the compensation responsibility.

Article 64 violation of these regulations, unauthorized transfer, use, destruction, sale or seizure of veterinary drugs were seized and related materials shall be ordered to stop illegal activities, give a warning, and impose more than 5 million 10 million fine.

Article 65 in violation of the regulations, veterinary medicine production enterprises, enterprises, units and use of veterinary drugs veterinary prescription use of veterinary drugs found may be related serious adverse events, not to the seat of government veterinary administration report given a warning, and impose more than 5,000 yuan 10,000 yuan.

Production enterprises in the new veterinary drug monitoring period does not collect or do not timely submit the new veterinary drug efficacy, adverse reactions, etc., shall be ordered to make corrections and impose a 1 million to 5 million fine; the circumstances are serious, revocation of the new veterinary product approval.

Article 66 in violation of the regulations, without veterinary prescription sales, purchase and use veterinary prescription drugs, and ordered to make corrections, confiscate the illegal income, impose a fine of 50,000 yuan; damage caused to others, shall bear the compensation responsibility.

Article 67 in violation of the regulations, veterinary medicine production and business enterprises to raw materials, veterinary drug manufacturers to sell to other units and individuals, or enterprises unbundling veterinary bulk drugs, and ordered its immediate correction, given a warning, confiscate the illegal income, impose more than 20,000 yuan 50,000 yuan; serious cases, revocation of veterinary drug production license, veterinary license; causes losses to others, shall be liable for compensation.

Article 68 in violation of the regulations, animal feed and drinking water in the added hormone drugs and veterinary administrative department under the State Council and other disabling drugs, according to "feed and feed additives regulations" the relevant provisions of punishment; directly to the API added to animal feed and drinking water, or feeding animals, and ordered its immediate correction, and impose more than 10,000 yuan to 30,000 yuan fine; causes losses to others, shall be liable for compensation.

Article 69 of the following circumstances, the revocation of veterinary approval number of the product or revoke the registration certificate import veterinary drugs:

(A) random testing 2 consecutive unqualified;

(B) the uncertain efficacy, adverse reactions and possible aquaculture, human health hazards or potential risks;

(C) the State veterinary administration ban on the production, operation and use of veterinary drugs.

Product approval number has been revoked or suspended certificate of registration of veterinary drugs imported veterinary drugs shall not continue to produce, import, management and use. Have been produced, imported, the local veterinary administration to supervise the destruction, the cost borne by the offense; damage caused to others, shall bear the compensation responsibility.

Article 70 of the Regulations of the administrative penalty by the people's governments above the county level veterinary administration decisions; which revoked the production license veterinary, veterinary license, revocation of veterinary drug approval documents or order them to stop veterinary research trials, original certification, approval departments.

The higher administration of lower levels of veterinary and veterinary administrative department in violation of the regulations of administrative action, shall order rectification; overdue correction, the right to be changed or revoked.

Article 71 the Regulations of the value of the amount to illegal production, management calculated the price of veterinary drugs; no price, in accordance with similar market prices of veterinary drugs.

Chapter IX Supplementary Provisions

Article 72 of the Ordinance the following terms mean:

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