Regulations of the People's Republic of China on the Administration of Veterinary Drugs

2010/05/0414:50:00አስተያየቶች የማይሰጥባቸው በ 中华人民共和国兽药管理条例4,463阅读模式

(Promulgated by the State Council on May 21, 1987, and revised in accordance with the Decision of the State Council on Amending the Regulations on the Administration of Veterinary Drugs on November 29, 2001)文章源自FOFCC-http://fofcc.org.cn/am/11220/

Chapter I General Provisions文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 1 These Regulations are formulated to strengthen the supervision and administration of veterinary drugs, ensure the quality of veterinary drugs, effectively prevent and treat diseases of livestock, poultry, and other animals, promote the development of the animal husbandry industry, and safeguard human health.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 2 The production, operation, and use of veterinary drugs must ensure quality and safety and efficacy.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 3 The animal husbandry and veterinary administrative department of the State Council shall be responsible for the administration of veterinary drugs nationwide, and the animal husbandry and veterinary administrative departments of local people's governments at or above the county level shall be responsible for the administration of veterinary drugs within their respective jurisdictions.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 4 All persons engaged in the production, operation, and use of veterinary drugs shall comply with the provisions of these Regulations.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Chapter II Administration of Veterinary Drug Manufacturing Enterprises文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 5 Veterinary drug manufacturing enterprises must meet the following conditions:文章源自FOFCC-http://fofcc.org.cn/am/11220/

(1) Having technical personnel and skilled workers with technical positions of engineer, veterinarian, or above commensurate with the veterinary drugs to be produced;文章源自FOFCC-http://fofcc.org.cn/am/11220/

(2) Having factory buildings, facilities, and sanitary conditions commensurate with the veterinary drugs to be produced;文章源自FOFCC-http://fofcc.org.cn/am/11220/

(3) Having facilities and conditions conforming to national labor safety and sanitary standards;文章源自FOFCC-http://fofcc.org.cn/am/11220/

(4) Having a quality inspection institution, full-time inspection personnel, and necessary instruments and equipment;文章源自FOFCC-http://fofcc.org.cn/am/11220/

(5) Enterprises not specializing in the production of veterinary drugs but concurrently producing veterinary drugs must have a separate veterinary drug production area.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 6 To establish a veterinary drug manufacturing enterprise, the enterprise must be examined and approved by the animal husbandry and veterinary administrative department of the county-level people's government where the enterprise is located, and upon examination and approval by the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government, be issued a Veterinary Drug Manufacturing License. The veterinary drug manufacturing enterprise shall, with the Veterinary Drug Manufacturing License, apply to the local administrative department for industry and commerce for registration, and upon approval, obtain a Business License.文章源自FOFCC-http://fofcc.org.cn/am/11220/

The Veterinary Drug Manufacturing License shall specify a period of validity, and upon expiration, a new license shall be issued after re-examination and qualification.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 7 Veterinary drug manufacturing enterprises must conduct production in accordance with technical procedures, production records must be complete and accurate, and the required raw materials, auxiliary materials, and containers and packaging materials directly contacting veterinary drugs must meet pharmaceutical requirements.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 8 Veterinary drug packaging must bear a label indicating the words “For Veterinary Use” and be accompanied by instructions. The label or instructions must indicate the trademark, veterinary drug name, specifications, enterprise name, product batch number, and approval number, and clearly state the main ingredients, content, action, indications, usage, dosage, period of validity, and precautions of the veterinary drug.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 9 The subpackaging of veterinary drugs must have complete and accurate subpackaging records, and the packaging must indicate the veterinary drug name, specifications, enterprise name, product batch number, approval number, subpackaging unit, and subpackaging batch number, and be accompanied by instructions. For veterinary drugs with a specified period of validity, the period of validity must be indicated after subpackaging.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 10 Veterinary drugs must undergo quality inspection before leaving the factory, and those not conforming to quality standards shall not leave the factory.文章源自FOFCC-http://fofcc.org.cn/am/11220/

When veterinary drugs leave the factory, a product quality inspection certificate must be attached; if there is no certificate, veterinary drug operating enterprises shall not deal in them.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Chapter III Administration of Veterinary Drug Operating Enterprises文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 11 Veterinary drug operating enterprises must meet the following conditions:文章源自FOFCC-http://fofcc.org.cn/am/11220/

(1) Having veterinary drug technical personnel commensurate with the veterinary drugs to be operated;文章源自FOFCC-http://fofcc.org.cn/am/11220/

(2) Having business premises, equipment, and warehouse facilities commensurate with the veterinary drugs to be operated.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 12 To establish a veterinary drug operating enterprise, upon approval by the animal husbandry and veterinary administrative department of the local people's government at or above the county level, a Veterinary Drug Operating License shall be issued. The veterinary drug operating enterprise shall, with the Veterinary Drug Operating License, apply to the local administrative department for industry and commerce for registration, and upon approval, obtain a Business License.文章源自FOFCC-http://fofcc.org.cn/am/11220/

The Veterinary Drug Operating License shall specify a period of validity, and upon expiration, a new license shall be issued after re-examination and qualification.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 13 The purchase of veterinary drugs must undergo quality acceptance inspection. Those with unqualified quality shall not be purchased.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 14 The storage of veterinary drugs must establish and implement a warehousing and preservation system to ensure the quality and safety of veterinary drugs.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 15 The sale of veterinary drugs must ensure quality, verify accuracy, and correctly explain the action, indications, usage, dosage, and precautions of the veterinary drugs.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 16 Those operating veterinary drugs in urban and rural fair trade markets must hold a Veterinary Drug Operating License and a Business License.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Chapter IV Pharmaceutical Administration of Veterinary Medical Units文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 17 Veterinary medical units must be equipped with veterinary drugs and veterinary technical personnel commensurate with their medical tasks, establish and improve a veterinary drug management system, and strengthen pharmaceutical administration.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 18 To prepare veterinary drug preparations, veterinary medical units must have facilities and inspection instruments that ensure the quality of the preparations, and upon examination and approval by the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located, be issued a Veterinary Drug Preparation License.文章源自FOFCC-http://fofcc.org.cn/am/11220/

The Veterinary Drug Preparation License shall specify a period of validity, and upon expiration, a new license shall be issued after re-examination and qualification.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 19 Veterinary drug preparations prepared by veterinary medical units must meet qualified standards before they may be used for clinical use by the unit and in the medical area under its responsibility, but they shall not be sold on the market.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 20 Veterinary medical units purchasing veterinary drugs must implement a quality acceptance inspection system, and unqualified ones shall not be used.文章源自FOFCC-http://fofcc.org.cn/am/11220/

To facilitate the purchase of veterinary drugs by farmers and herdsmen, veterinary medical units may concurrently engage in retail business of veterinary drugs.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Chapter V Approval of New Veterinary Drugs and Administration of Import and Export Veterinary Drugs文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 21 Veterinary drug standards are divided into national standards, industry standards, and local standards.文章源自FOFCC-http://fofcc.org.cn/am/11220/

To produce veterinary drugs for which national standards, industry standards, or local standards already exist, examination and approval by the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government is required, and an approval number shall be issued.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 22 The State encourages the research and creation of new veterinary drugs.文章源自FOFCC-http://fofcc.org.cn/am/11220/

To develop new veterinary drugs, the research and development methods, production process, quality standards, pharmacology, toxicology, clinical trial reports, environmental impact reports, pollution prevention and control measures, and other relevant materials and samples of the new veterinary drugs must be submitted to the animal husbandry and veterinary administrative department of the State Council. After the new veterinary drugs are reviewed and appraised by the national veterinary drug supervisory institution and proven safe and effective, they shall be examined and approved by the animal husbandry and veterinary administrative department of the State Council, listed as national standards or industry standards, and a New Veterinary Drug Certificate shall be issued. Without a New Veterinary Drug Certificate, they shall not be listed as formal scientific research achievements or be subject to technology transfer.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 23 To develop new veterinary drug preparations, the formulation and preparation process, quality standards, clinical trial reports, and other materials of the new preparations must be submitted to the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located. After review and appraisal by the veterinary drug supervisory institute of the province, autonomous region, or municipality directly under the Central Government and proof of safety and efficacy, they shall be examined and approved by the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government and listed as local standards.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 24 To produce new veterinary drugs and new veterinary drug preparations, they must pass inspection by the veterinary drug supervisory institute of the province, autonomous region, or municipality directly under the Central Government, and upon approval by the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government, an approval number shall be issued.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 25 For the import of veterinary drugs, examination and approval by the animal husbandry and veterinary administrative department of the State Council or the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government is required, and an Import Veterinary Drug License shall be issued. Import may be carried out only after passing inspection by the veterinary drug supervisory institute designated by the animal husbandry and veterinary administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government or by the animal husbandry and veterinary administrative department of the State Council.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 26 When China first imports a certain veterinary drug produced or operated by a foreign enterprise, the foreign enterprise selling the veterinary drug must also apply to the animal husbandry and veterinary administrative department of the State Council for inspection and registration, and provide the quality standards, inspection methods, pharmacological and toxicological test results, clinical trial reports, instructions, and other materials of the veterinary drug, as well as documentary proof that the exporting country (region) has approved its production or sale. After inspection and review and proof of safety and efficacy, an Import Veterinary Drug Registration License shall be issued.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 27 The State shall protect the undisclosed test data and other data submitted by applicants for veterinary drugs containing new compounds that have been approved or registered in accordance with law and that were obtained by the applicants themselves.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Within 6 years from the date of approval or registration, if other applicants apply for veterinary drug approval or registration using the data specified in the preceding paragraph without the consent of the applicant that has obtained approval or registration, the approval or registration authority shall not approve or register; except where other applicants submit data obtained by themselves.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Except under the following circumstances, the approval or registration authority shall not disclose the data specified in the first paragraph:文章源自FOFCC-http://fofcc.org.cn/am/11220/

(1) where required by the public interest;文章源自FOFCC-http://fofcc.org.cn/am/11220/

(2) where measures have been taken to ensure that such information will not be improperly used for commercial purposes.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 28 For the import and export of veterinary narcotic drugs and psychotropic drugs, an Import Permit or Export Permit issued by the health administrative department of the State Council must be held.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Chapter VI Veterinary Drug Supervision文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 29 It is prohibited to produce or deal in counterfeit veterinary drugs. Any of the following constitutes a counterfeit veterinary drug:文章源自FOFCC-http://fofcc.org.cn/am/11220/

(1) Passing off a non-veterinary drug as a veterinary drug;文章源自FOFCC-http://fofcc.org.cn/am/11220/

(2) The types and names of the ingredients contained in the veterinary drug do not conform to the national standards, industry standards, or local standards.文章源自FOFCC-http://fofcc.org.cn/am/11220/

It is prohibited to produce or deal in any veterinary drug under any of the following circumstances:文章源自FOFCC-http://fofcc.org.cn/am/11220/

(1) It has not obtained an approval number;文章源自FOFCC-http://fofcc.org.cn/am/11220/

(2) It is explicitly prohibited from use by the administrative department of animal husbandry and veterinary medicine under the State Council.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 30 It is prohibited to produce or deal in inferior veterinary drugs. Any veterinary drug under any of the following circumstances is an inferior veterinary drug:文章源自FOFCC-http://fofcc.org.cn/am/11220/

(1) The content of the ingredients of the veterinary drug does not conform to the provisions of the national standards, industry standards, or local standards;文章源自FOFCC-http://fofcc.org.cn/am/11220/

(2) It has exceeded its expiration date;文章源自FOFCC-http://fofcc.org.cn/am/11220/

(3) It can no longer be used as medicine due to deterioration;文章源自FOFCC-http://fofcc.org.cn/am/11220/

(4) It can no longer be used as medicine due to contamination;文章源自FOFCC-http://fofcc.org.cn/am/11220/

(5) Other cases that do not conform to the provisions of veterinary drug standards but do not constitute counterfeit veterinary drugs.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 31 The administrative departments of animal husbandry and veterinary medicine of the people's governments at or above the county level shall exercise the authority of veterinary drug supervision and administration.文章源自FOFCC-http://fofcc.org.cn/am/11220/

The veterinary drug supervisory institutions of the State and of the provinces, autonomous regions, and municipalities directly under the Central Government, as well as the urban veterinary drug supervisory institutions established with the approval of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government, shall assist the administrative departments of animal husbandry and veterinary medicine and shall be respectively responsible for the supervision and inspection of veterinary drug quality nationwide and within their respective jurisdictions.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 32 The administrative departments of animal husbandry and veterinary medicine at all levels shall regularly organize investigations, verification, and review of veterinary drugs that have already been approved for production, and shall, in accordance with their functions and powers, revoke the approval numbers of those with uncertain efficacy or that cannot ensure medication safety. Veterinary drugs whose approval numbers have been revoked shall not continue to be produced or dealt in.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 33 The administrative departments of animal husbandry and veterinary medicine of the people's governments at or above the county level shall appoint veterinary drug supervisors. Veterinary drug supervisors must be held by veterinary drug or veterinary technical personnel and shall carry out their work on the strength of the Veterinary Drug Supervisor Certificate issued by the people's government to which they belong.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Veterinary drug supervisors shall have the right, in accordance with the provisions of these Regulations, to supervise and inspect the quality of veterinary drugs of units producing, dealing in, and using veterinary drugs within their jurisdictions, and when necessary may, in accordance with regulations, take samples and request necessary materials, and the units concerned shall not refuse or conceal such information. Veterinary drug supervisors shall be obligated to keep confidential the technical materials provided by veterinary drug production and scientific research units.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 34 Veterinary drug production enterprises, veterinary drug dealing enterprises, and veterinary medical units shall frequently inspect the quality, efficacy, and safety of the veterinary drugs they produce, deal in, and use.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Units using veterinary drugs that discover veterinary drug poisoning accidents must promptly report them to the local administrative department of animal husbandry and veterinary medicine.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 35 The veterinary drug inspection institutions or personnel of veterinary drug production enterprises and veterinary drug dealing enterprises shall be under the professional guidance of the local veterinary drug supervisory institute.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 36 Special drugs such as veterinary narcotic drugs, psychotropic drugs, toxic drugs, and radioactive drugs shall be managed in accordance with relevant state provisions.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 37 Units and individuals using veterinary drugs shall comply with the veterinary drug safe use provisions formulated by the administrative department of animal husbandry and veterinary medicine under the State Council. It is prohibited to use counterfeit veterinary drugs, inferior veterinary drugs, veterinary drugs whose production or dealing in is prohibited under paragraph 2 of Article 29 of these Regulations, and veterinary drugs imported without approval.文章源自FOFCC-http://fofcc.org.cn/am/11220/

The administrative departments of animal husbandry and veterinary medicine of the people's governments at or above the county level shall strengthen the detection of veterinary drug residues in animal products and shall publish the detection results. The limits standards and detection methods for veterinary drug residues shall be formulated by the administrative department of animal husbandry and veterinary medicine under the State Council.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Chapter VII Administration of Trademarks and Advertisements of Veterinary Drugs文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 38 Veterinary drug trademarks shall be registered in accordance with the provisions of the state's trademark laws and regulations.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Registered trademarks must be indicated on the packaging, labels, and instructions of veterinary drugs, and the words “registered trademark” or a registration mark shall be indicated.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 39 Veterinary drug advertisements must be examined and approved by the administrative department of animal husbandry and veterinary medicine under the State Council or the administrative department of animal husbandry and veterinary medicine of the people's government of a province, autonomous region, or municipality directly under the Central Government. Those not approved shall not be published, installed, printed, broadcast, distributed, or posted.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 40 The content of veterinary drug advertisements must be based on the instructions approved by the administrative department of animal husbandry and veterinary medicine under the State Council or the administrative department of animal husbandry and veterinary medicine of the people's government of a province, autonomous region, or municipality directly under the Central Government.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Veterinary narcotic drugs and psychotropic drugs shall not be advertised.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 41 Foreign enterprises applying in our country to handle veterinary drug advertisements must hold the Import Veterinary Drug Registration License issued by the administrative department of animal husbandry and veterinary medicine under the State Council and shall provide the veterinary drug instructions.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Chapter VIII Penalty Provisions文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 42 For producing or dealing in counterfeit veterinary drugs or violating the provisions of paragraph 2 of Article 29 of these Regulations, criminal liability shall be pursued in accordance with the provisions of the Criminal Law on the crime of producing or selling fake or inferior products or the crime of producing or selling fake or inferior veterinary drugs; if the case is not serious enough for criminal punishment, the party shall be ordered to stop producing or dealing in the veterinary drug, the drugs and illegal gains shall be confiscated, and a fine of not less than 1 time but not more than 5 times the illegal gains shall be imposed; and the enterprise may be ordered to suspend production, suspend business for rectification, or have its Veterinary Drug Production License, Veterinary Drug Dealing License, or Veterinary Drug Preparation License revoked.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 43 For producing or dealing in inferior veterinary drugs, criminal liability shall be pursued in accordance with the provisions of the Criminal Law on the crime of producing or selling fake or inferior products or the crime of producing or selling fake or inferior veterinary drugs; if the case is not serious enough for criminal punishment, the party shall be ordered to stop producing or dealing in the veterinary drug, the drugs and illegal gains shall be confiscated, and a fine of not less than 1 time but not more than 5 times the illegal gains shall be imposed; if the circumstances and consequences are serious, the enterprise may also be ordered to suspend production, suspend business for rectification, or have its Veterinary Drug Production License, Veterinary Drug Dealing License, or Veterinary Drug Preparation License revoked.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 44 For producing or dealing in veterinary drugs or preparing veterinary drug preparations without obtaining the Veterinary Drug Production License, Veterinary Drug Dealing License, or Veterinary Drug Preparation License, criminal liability shall be pursued in accordance with the provisions of the Criminal Law on the crime of illegal business operations; if the case is not serious enough for criminal punishment, the party shall be ordered to stop production, suspend business, or stop preparing veterinary drug preparations, all veterinary drugs and illegal gains shall be confiscated, and a fine of not less than 1 time but not more than 5 times the illegal gains may also be imposed.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 45 For violating the relevant provisions of these Regulations on the import of veterinary drugs, criminal liability shall be pursued in accordance with the provisions of the Criminal Law on the crime of illegal business operations; if the case is not serious enough for criminal punishment, a warning shall be given or the veterinary drugs shall be confiscated according to the seriousness of the circumstances; if they are sold without authorization, the illegal gains shall be confiscated, and a fine of not less than 1 time but not more than 5 times the illegal gains shall be imposed.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 46 For using veterinary drugs in violation of the state's relevant provisions on the safe use of veterinary drugs, a warning shall be given, and a fine of not more than 30,000 yuan may also be imposed.文章源自FOFCC-http://fofcc.org.cn/am/11220/

For using counterfeit veterinary drugs, inferior veterinary drugs, and other veterinary drugs prohibited from use, the party shall be ordered to stop using them, the drugs shall be confiscated, and a fine of not less than 10,000 yuan but not more than 50,000 yuan may also be imposed.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 47 The administrative penalties provided for in these Regulations shall be decided by the administrative departments of animal husbandry and veterinary medicine of the people's governments at or above the county level. However, where administrative penalties should be imposed for violating Article 16 and Chapter VII of these Regulations; where illegal gains should be confiscated and fines should be imposed in accordance with Article 45 of these Regulations; and where, in the production or dealing of veterinary drugs, the relevant provisions of the Regulations on the Quality Responsibility of Industrial Products are violated and illegal gains should be confiscated and fines should be imposed, the administrative organs for industry and commerce shall make the decision, and the administrative departments of animal husbandry and veterinary medicine shall assist in the investigation and handling.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Fines and confiscated illegal gains shall all be turned over to the state treasury. Confiscated counterfeit and inferior drugs and other drugs explicitly prohibited from use by the state shall be destroyed by the administrative departments of animal husbandry and veterinary medicine.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 48 If a party is dissatisfied with a decision on administrative penalty, it may bring a suit in a people's court within 15 days from the date of receiving notice of the penalty decision. However, with respect to decisions made by the administrative departments of animal husbandry and veterinary medicine on veterinary drug control, the party must execute them. If the party neither performs the penalty decision nor brings a suit upon expiration of the time limit, the organ that made the administrative penalty decision shall apply to a people's court for compulsory execution.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 49 If a violation of these Regulations causes a poisoning accident or other harmful consequences to livestock, poultry, or other animals, the unit or individual causing the harm shall bear liability for compensation. The injured party may request the administrative department of animal husbandry and veterinary medicine of the people's government at or above the county level to handle the matter. If a party is dissatisfied with the handling decision, it may bring a suit in a people's court within 15 days from the date of receiving notice.文章源自FOFCC-http://fofcc.org.cn/am/11220/

The injured party may also bring a suit directly in a people's court.文章源自FOFCC-http://fofcc.org.cn/am/11220/

A claim for compensation shall be raised within 1 year from the date on which the injured party knew or should have known that its rights were infringed; if the time limit is exceeded, it shall not be accepted.文章源自FOFCC-http://fofcc.org.cn/am/11220/

  Chapter IX Supplementary Provisions文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 50 The meanings of the following terms in these Regulations are:文章源自FOFCC-http://fofcc.org.cn/am/11220/

(1) Livestock, poultry, and other animals: refers to domestic animals, poultry, fish, bees, silkworms, and other artificially raised animals.文章源自FOFCC-http://fofcc.org.cn/am/11220/

(2) Veterinary drugs: refers to substances used for the prevention, treatment, and diagnosis of diseases of livestock, poultry, and other animals, and for purposefully regulating their physiological functions, with stipulated actions, uses, methods of use, and dosages (including feed drug additives). They include:文章源自FOFCC-http://fofcc.org.cn/am/11220/

1. Biological products such as sera, bacterial (vaccine) vaccines, and diagnostic fluids;文章源自FOFCC-http://fofcc.org.cn/am/11220/

2. Traditional Chinese medicinal materials, traditional Chinese patent medicines, chemical raw material drugs, and their preparations for veterinary use;文章源自FOFCC-http://fofcc.org.cn/am/11220/

3. Antibiotics, biochemical drugs, and radioactive drugs.文章源自FOFCC-http://fofcc.org.cn/am/11220/

(3) New veterinary drugs: refers to newly developed raw material veterinary drugs in our country.文章源自FOFCC-http://fofcc.org.cn/am/11220/

(4) New veterinary drug preparations: refer to veterinary drug preparations newly developed and processed from veterinary drug raw materials.文章源自FOFCC-http://fofcc.org.cn/am/11220/

Article 51 These Regulations shall come into force on January 1, 1988, and the Interim Regulations on the Administration of Veterinary Drugs approved and transmitted by the State Council on August 26, 1980 shall be repealed simultaneously.文章源自FOFCC-http://fofcc.org.cn/am/11220/

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