(Promulgated by Decree No. 325 of the State Council of the People's Republic of China on November 29, 2001, and effective as of the date of promulgation)

The State Council decides to make the following amendments to the Regulations on Administration of Veterinary Drugs:

1. One article is added as Article 27: "The State offers protection to undisclosed test or other data acquired and submitted by the applicant of a veterinary drug that has been approved or registered according to law and contains new chemical entities.

"For a period of six years from the date of approval or registration, if any second applicant applies for approval or registration of a veterinary drug by relying on the data provided in the preceding paragraph without the permission of the applicant who has been granted approval or registration, the approval or registration department shall grant no approval or registration, unless the second applicant has submitted his own data."

"Except for the following circumstances, the approval or registration department shall not disclose the data provided in the first paragraph:

(1) the disclosure of such data is necessary to protect the public;

(2) steps have been taken to ensure that the data are protected against unfair commercial use."

2. One article is added as Article 37: "Any unit or individual using veterinary drugs shall comply with the provisions on safe use formulated by the administrative department for animal husbandry and veterinary work of the State Council. It is prohibited to use fake veterinary drugs, veterinary drugs of inferior quality, veterinary drugs the production and marketing of which are prohibited by the second paragraph of Article 29 of these Regulations, and veterinary drugs imported without approval.

The administrative departments for animal husbandry and veterinary work of the people's governments at or above the county level shall strengthen the test of the residual amount of veterinary drugs in animal products and publicize the results. The standards for the residual amount of veterinary drugs shall be set forth and the testing measures therefor formulated by the administrative department for animal husbandry and veterinary work of the State Council."

3. Article 40 is changed to be Article 42: "Anyone who produces or markets fake veterinary drugs, or violates the provisions of the second paragraph of Article 29 of these Regulations, shall be investigated for criminal liability in accordance with the provisions of the Criminal Law on crimes of producing or selling fake or substandard products or crimes of producing or selling fake veterinary drugs or veterinary drugs of inferior quality. If the case is not serious enough for criminal punishment, he shall be ordered to suspend the production or marketing of the veterinary drugs, have the drugs and the illegal income confiscated and be fined not less than one time nor more than five times the illegal income. Concurrently, an enterprise offender may be ordered to suspend its production or business for rectification or have its Veterinary Drug Producing License, Veterinary Drug Marketing License or Veterinary Drug Dispensing License Revoked."

4. Article 41 is changed to be Article 43: "Anyone who produces or markets veterinary drugs of inferior quality shall be investigated for criminal liability in accordance with the provisions of the Criminal Law on crimes of producing or selling fake or substandard products or crimes of producing or selling fake veterinary drugs or veterinary drugs of inferior quality. If the case is not serious enough for criminal punishment, he shall be ordered to suspend the production or marketing of the veterinary drugs, have the drugs and the illegal income confiscated and be fined not less than one time nor more than five times the illegal income. If the circumstances or results are serious, he may concurrently be ordered to suspend his production or business for rectification or have his Veterinary drug Producing License, Veterinary drug Marketing License or Veterinary Drug Dispensing License revoked. "

5. Article 42 is changed to Article 44: "Anyone who, in absence of Veterinary Drug Producing License, Veterinary Drug Marketing License or Veterinary Drug Dispensing License, produces, markets veterinary drugs or dispenses veterinary drug preparations shall be investigated for criminal responsibility in accordance with the provisions of the Criminal Law on the crime of illegal business operation. If the case is not serious enough for criminal punishment, he shall be ordered to suspend his production, business or dispensing of veterinary drug preparations, have all the veterinary drugs and illegal income confiscated, and may concurrently be fined not less than one time nor more than five times the illegal income."

6. Article 43 is changed to be Article 45: "Anyone who violates the relevant provisions of these Regulations on importing veterinary drugs shall be investigated for criminal responsibility in accordance with the provisions of the Criminal Law on the crime of illegal business operation. If the cases are not serious enough for criminal punishment, he shall, in accordance with the seriousness of the circumstances, be given a warning or have the veterinary drugs confiscated. Where the veterinary drugs are sold without authorization, the illegal income shall be confiscated and a fine of not less than one time nor more than five times the illegal income shall be imposed concurrently."

7. One article is added as Article 46: "Anyone who fails to use veterinary drugs in accordance with the relevant provisions of the State on safe use of veterinary drugs shall be given a warning and may be concurrently fined not more than 30000 yuan".

"Anyone who uses fake veterinary drugs, veterinary drugs of inferior quality or other veterinary drugs prohibited from being used shall be ordered to stop using them, have the drugs confiscated, and may be concurrently fined not less than 10000 yuan nor more than 50000 yuan."

8. In Article 3, the first paragraph of Article 6, the first paragraph of Article 12, the first paragraph of Article 18, the second paragraph of Article 21, the second paragraph of Article 22, Article 23, Article 24, Article 25, Article 26, the second paragraph of Article 28, Article 30, Article 31, the first paragraph of Article 32, the second paragraph of Article 33, Article 37, the first paragraph of Article 38, Article 39, Article 45, Article 46 and the first paragraph of Article 47, "administrative organ(s) for agriculture and animal husbandry" is amended as "administrative department(s) for animal husbandry and veterinary work".

9. The provisions of Article 44: "Any person responsible for the production or marketing of fake veterinary drugs or veterinary drugs of inferior quality, or for the violation of the second paragraph of Article 28 of these Regulations, shall be give an administrative sanction by the unit he works for or the superior competent department. If the circumstances and results are so serious that a crime is constituted in accordance with the Criminal Law of the People's Republic of China, the judicial organs shall conduct an investigation for his criminal liability." are deleted. The provisions of Article 49: "The implementing rules of these Regulations shall be formulated by the administrative department for agriculture and animal husbandry of the State Council jointly with the State administration departments for industry and commerce." are deleted. The provisions of Article 50: "The administrative department for agriculture and animal husbandry of the State Council is responsible for the interpretation of these Regulations." are deleted.

In addition, some words in relevant articles and paragraphs are correspondingly alternated in accordance with the above amendments and the order of articles correspondingly adjusted. In Article 40, "Article 28" is changed to be "Article 29"; in Article 45, "Article 43" is changed to be "Article 45".

This decision shall be effective as of the date of promulgation.

The Regulations on Administration of Veterinary Drugs shall be amended correspondingly according to this Decision and re-promulgated.

Regulations on Administration of Veterinary Drugs

(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 Administration of Veterinary Drugs on November 29, 2001)

Chapter I General Provisions

Article 1These Regulations are formulated to strengthen the supervision over and administration of veterinary drugs, ensure the quality of veterinary drugs, effectively prevent and control the diseases of domestic animals, poultry and other animals, so as to promote the development of animal husbandry and safeguard human health.

Article 2Quality, safety and efficacy shall be ensured in the production, marketing and use of veterinary drugs.

Article 3The administrative department for animal husbandry and veterinary work of the State Council shall take charge of the administration of veterinary drugs throughout the country, and the administrative departments for animal husbandry and veterinary work of local people's governments at or above the county level shall take charge of the administration of veterinary drugs within the regions under their jurisdiction.

Article 4Anyone engaged in the production, marketing or use of veterinary drugs shall comply with the provisions of these Regulations.

Chapter II Administration of Veterinary Drug Producing Enterprises

Article 5A veterinary drug producing enterprise shall meet the following requirements:

(1) being staffed with technical personnel with a technical title equivalent to or higher than engineer or veterinarian and skilled workers commensurate with the veterinary drugs to be produced;

(2) having premises, facilities and a hygienic environment commensurate with the veterinary drugs to be produced;

(3) having facilities and conditions in conformity with the Standards of the State for labour safety and hygiene;

(4) having quality inspection institutions, full-time inspection staff, and necessary apparatus and equipments;

(5) if an enterprise not specially for producing veterinary drugs concurrently engages in the production of veterinary drugs, it must have separated areas for such production.

Article 6The establishment of a veterinary drug producing enterprise shall be subject to the examination and consent of the administrative department for animal husbandry and veterinary work of the people's government at the county level in the place where it will be located, then upon the examination and approval of the administrative department for animal husbandry and veterinary work of the people's governments of the province, autonomous region and municipality directly under the Central Government, a Veterinary drug Producing License shall be granted. On the basis of this License, the veterinary drug producing enterprise shall apply to the local administrative department for industry and commerce for registration and, upon approval, be issued a Business License.

Each Veterinary drug Producing License shall have a term of validity. After the expiry of the term, the License may be renewed, upon reexamination, for those up to standards.

Article 7A veterinary drug producing enterprise shall conduct its production in accordance with the technological procedures, and the data of production shall be recorded completely and accurately. The needed raw and supplementary materials and the containers and package materials in direct contact with veterinary drugs shall meet the requirements for medical use.

Article 8The package of veterinary drugs shall be labeled, inscribing the words "For Animals" and the directions for use attached. The label or directions for use of a veterinary drug shall inscribe the trade mark, name of the veterinary drug, specification, name of the producing enterprise, the lot number, the serial number of the approval document, as well as the principal ingredients, contents, indications, action, usage, dosage, period of efficacy and precautions, etc.

Article 9The repackaging of veterinary drugs shall be recorded completely and accurately. The name of the repacked veterinary drug, specification, name of the producing enterprise, the lot number, the serial number of the approval document, name of the repackaging unit and the lot number of the repackaging shall be inscribed on the package and the directions for use shall be attached. If the veterinary drug has a period of efficacy, it shall be inscribed on the new package.

Article 10A veterinary drug shall be subject to quality inspection before it is dispatched from the factory; those not up to quality standards shall not be dispatched.

A veterinary drug shall bear a qualify inspection certificate when it is dispatched from the factory. A veterinary drug marketing enterprise shall not market drugs without such certificates.

Chapter III Administration of Veterinary Drug Marketing Enterprises

Article 11A veterinary drug marketing enterprise shall meet the following requirements:

(1) having veterinary drug technicians commensurate with the veterinary drugs to be marketed;

(2) having premises, equipment and storage facilities commensurate with the veterinary drugs to be marketed.

Article 12The establishment of a veterinary drug marketing enterprise shall be subject to the approval of the administrative department for animal husbandry and veterinary work of the local people's government at or above the county level and a Veterinary Drug Marketing License shall be issued upon approval. On the basis of this license, the veterinary drug marketing enterprise shall apply to the local administrative department for industry and commerce for registration and, upon approval, be issued a Business License.

Each Veterinary Drug Marketing License shall have a term of validity. After the expiry of the term, the License may be renewed, upon reexamination, for those up to standards.

Article 13The quality of veterinary drugs shall be inspected on purchasing and those substandard ones shall not be purchased.

Article 14A Warehousing and deposit system shall be established and implemented in the storage of veterinary drugs to ensure the quality and safety of veterinary drugs.

Article 15In the sale of veterinary drugs, care shall be taken to ensure quality and avoid mistakes, and the indication, action, usage, dosage and precaution shall be correctly stated.

Article 16Anyone marketing veterinary drugs in urban or rural fair trade fairs shall hold veterinary drug marketing license and business license.

Chapter IV Administration of the Veterinary Drugs in Veterinary Units

Article 17A veterinary unit shall be staffed with veterinary drug technicians and veterinarians commensurate with their medical work, and shall establish and improve a control system of veterinary drugs to strength the control of veterinary drugs.

Article 18A veterinary unit shall, in dispensing veterinary drug preparations, be equipped with facilities and inspection apparatus capable of ensuring the quality of the preparations, and be subject to the examination and approval of the administrative department for animal husbandry and veterinary work of the people's government of the province, autonomous region and municipality directly under the Central Government. A Veterinary Drug Dispensing License shall be issued upon approval.

Each Veterinary Drug Dispensing License shall have a term of validity. After the expiry of the term, the License may be renewed, upon reexamination, for those up to standards.

Article 19Any veterinary drug preparation dispensed by a veterinary unit shall not be used clinically by itself or in its responsible medical areas until it is up to the standards. No veterinary drug preparation dispensed by a veterinary unit may be sold on the market.

Article 20In purchasing veterinary drugs, a veterinary unit shall exercise a quality inspection system, and those not up to standards shall not be used.

To make it easy for farmers and ranchers to buy veterinary drugs, veterinary units may concurrently retail veterinary drugs.

Chapter V Examination and Approval of New Veterinary Drugs and Administration of the Import and Export of Veterinary Drugs

Article 21Standards for veterinary drugs are categorized as the national standard, trade standard and local standard.

The production of a veterinary drug for which the national, trade or local standard has been established shall be subject to the examination and approval of the administrative department for animal husbandry and veterinary work of the people's government of the province, autonomous region and municipality directly under the Central Government and a serial number of the approval document shall be issued upon approval.

Article 22The State encourages the research into and the development of new veterinary drugs.

For the development of a new veterinary drug, the relevant materials such as the method of development, the technology of production, the standards of quality, pharmacodynamics and toxicodynamics, the clinical trial report, the report on the impact on the environment, the pollution control measures and a sample of the new drug shall be submitted to the administrative department for animal husbandry and veterinary work of the State Council. The new veterinary drug shall be reexamined and evaluated by the veterinary drug supervision institution of the State. If it is proved safe and effective, it shall be recognized as national standard or trade standard upon the examination and approval of the administrative department for animal husbandry and veterinary work of the State Council, and be issued a new Veterinary Drug Certificate. Without a new Veterinary Drug Certificate, no veterinary drug may be classified as a formal research achievement or be eligible for technology transfer.

Article 23For the development of a new preparation of a veterinary drug, the materials such as the dispensations, the dispensing technology, the standards of quality, and the clinical trial report shall be submitted to the administrative department for animal husbandry and veterinary work of the people's government of the province, autonomous region and municipality directly under the Central Government where the developing unit is located. The new preparation shall be reexamined and evaluated by the supervision institution of the province, autonomous region and municipality directly under the central government. If it is proved safe and effective it shall be recognized as local standard upon the examination and approval of the administrative department for animal husbandry and veterinary work of the province, autonomous region and municipality directly under the Central Government.

Article 24Any newly produced new veterinary drug or preparation of a veterinary drug shall pass the inspection of the veterinary drug supervision institute of the province, autonomous region and municipality directly under the Central Government, and a number of the approval document shall be issued upon the approval of the administrative department for animal husbandry and veterinary work of the province, autonomous region and municipality directly under the Central Government.

Article 25The import of any veterinary drug shall be subject to the examination and approval of the administrative department for animal husbandry and veterinary work of the Stated Council or of the province, autonomous region and municipality directly under the Central Government and a veterinary drug import license shall be issued upon approval. No veterinary drug may be imported unless it has passed the inspection of the administrative department for animal husbandry and veterinary work of the province, autonomous region and municipality directly under the Central Government or of the veterinary drug supervision institution designated by the administrative department for animal husbandry and veterinary work of the Stated Council.

Article 26For any veterinary drug that is produced or marketed by a foreign enterprise and is to be imported into China for the first time, the foreign enterprise selling it shall apply to the administrative department for animal husbandry and veterinary work of the Stated Council for inspection and registration, and shall present the materials such as the quality standard of the veterinary drug, the method of inspection, the results of pharmacological and toxicological tests and the clinical trial report, as well as the exporting country's (region's) documents certifying the approval of its production or sale. If it proved safe and effective after the inspection and examination, a Registration License for Imported Veterinary Drugs shall be issued.

Article 27The State offers protection to undisclosed test or other data acquired and submitted by the applicant of a veterinary drug that has been approved or registered according to law and contains new chemical entities.

For a period of six years from the date of approval or registration, if any second applicant applies for approval or registration of a veterinary drug by relying on the data provided in the preceding paragraph without the permission of the applicant who has been granted approval or registration, the approval or registration department shall grant no approval or registration, unless the second applicant has submitted his own data.

Except for the following circumstances, the approval or registration department shall not disclose the data provided in the first paragraph:

(1) the disclosure of such data is necessary to protect the public;

(2) steps have been taken to ensure that the data are protected against unfair commercial use.

Article 28The Import Licenses or Export Licenses issued by the administrative department of health of the State Council shall be required for the import or export of narcotics and psychotropic substances for animals.

Chapter VI Supervision over Veterinary Drugs

Article 29The production or marketing of fake veterinary drugs shall be prohibited. A veterinary drug under any of the following circumstances shall be deemed as a fake one.

(1) a non-veterinary drug is passed off as a veterinary drug;

(2) the types or names of the ingredients contained in a veterinary drug are inconformity with the national standard, trade standard of local standard.

The production or marketing of a veterinary drug under one of the following circumstances shall be prohibited.

(1) failing to obtain a number of the approval document;

(2) the use of which is explicitly prohibited by the administrative department for animal husbandry and veterinary work of the Stated Council.

Article 30The production or marketing of veterinary drugs of inferior quality shall be prohibited. A veterinary drug falling under any of the following circumstances shall be deemed inferior in quality.

(1) the contents of the ingredients thereof are inconformity with the national standard, trade standard of local standard;

(2) the period of efficacy is exceeded;

(3) it can not be used as a veterinary drug any longer due to deterioration;

(4) it can not be used as a veterinary drug any longer due to being contaminated;

(5) other veterinary drugs that are inconformity with the standards for veterinary drugs but are not classified as fake veterinary drugs.

Article 31The administrative departments for animal husbandry and veterinary work of the people's governments at or above the county level exercise the power of supervision over and administration of veterinary drugs.

In assisting the administrative departments for animal husbandry and veterinary work, the veterinary drug supervision institution of the State and the veterinary drug supervision institutions of the provinces, autonomous regions and municipalities directly under the Central Government, as well as the city veterinary drug supervision institutions established upon the approval of the provinces, autonomous regions and municipalities directly under the Central Government shall be respectively responsible for the supervision over and inspection of the quality of veterinary drugs throughout the country and in the regions under their own jurisdiction.

Article 32The administrative departments for animal husbandry and veterinary work at various levels shall regularly conduct investigations, verifications and assessments with respect to the veterinary drugs the production of which has been approved, and revoke, in accordance with their functions and powers, the numbers of the approval documents of the veterinary drugs the medical efficacy of which is uncertain or the safe use of which is not ensured. The veterinary drugs the numbers of the approval documents of which are revoked shall not be produced and marketed any longer.

Article 33The administrative departments for animal husbandry and veterinary work at or above the county level shall appoint veterinary drug supervisors through selection. The office of veterinary drug supervisors must be assumed by veterinary drug technicians or veterinarians, and they shall carry out their work on the basis of the Identification for Veterinary drug Supervisor issued by the people's governments they belong to.

Veterinary drug supervisors are empower to, in accordance with the provisions of these Regulations, supervise and inspect the quality of the veterinary drugs of the units producing, marketing or using veterinary drugs within their jurisdiction, and may, when necessary, pick samples at random and ask for essential materials in accordance with the provisions. The relevant units shall not refuse such request or conceal anything from them. For the technical materials presented by veterinary drug producers or researchers, veterinary drug supervisors are obliged to maintain them in confidence.

Article 34Drug producing enterprises, drug marketing enterprises and veterinary units shall regularly inspect the quality, medical efficacy and safety of the veterinary drugs produced, marketed or used by them.

Units using veterinary drugs shall, upon detection of veterinary drug poisoning, promptly report to the local administrative departments for animal husbandry and veterinary work.

Article 35The veterinary drug inspection institutions or personnel in drug producing enterprises and drug marketing enterprises shall be subject to the professional guidance of the local veterinary drug supervision institutes.

Article 36The administration of special drugs for animals such as narcotics, psychotropic substances, toxic or radioactive drugs shall be conducted in accordance with the relevant regulations of the State.

Article 37Any unit and individual using veterinary drugs shall comply with the provisions on safe use formulated by the administrative department for animal husbandry and veterinary work of the State Council. The use of fake veterinary drugs, veterinary drugs of inferior quality, veterinary drugs the production and marketing of which is prohibited in the second paragraph of Article 29 of these Regulations, and veterinary drugs imported without approval shall be prohibited.

The administrative departments for animal husbandry and veterinary work of the people's governments at or above the county level shall strengthen the test of the residual amount of veterinary drugs in animal products and publicize the results. The standards for the residual amount of veterinary drugs shall be set forth and the testing measures therefor formulated by the administrative department for animal husbandry and veterinary work of the State Council.

Chapter VII Administration of Trademarks and Advertisements of Veterinary Drugs

Article 38Trademarks of veterinary drugs shall be registered in accordance with the provisions of the trademark laws and regulations of the State.

Registered trademarks accompanied by the words "Registered Trademark" or other registration marks shall be inscribed on packages, labels and in directions for use of veterinary drugs.

Article 39Advertisements of veterinary drugs shall be subject to the examination and approval of the administrative department for animal husbandry and veterinary work of the State Council or the administrative departments for animal husbandry and veterinary work of the provinces, autonomous regions or municipalities directly under the Central Government. No advertisement of veterinary drugs may be published, placed, printed, broadcasted, disseminated or posted without approval.

Article 40Advertisements of veterinary drugs shall be based on the directions for use approved by the administrative department for animal husbandry and veterinary work of the State Council or the administrative departments for animal husbandry and veterinary work of the provinces, autonomous regions or municipalities directly under the Central Government.

Narcotics and psychotropic substances for animals shall not be advertised.

Article 41In applying for advertising a veterinary drug, a foreign enterprise shall hold the Registration License for Imported Veterinary Drugs issued by the administrative department for animal husbandry and veterinary work of the State Council and present the directions for use of the veterinary drug.

Chapter VIII Penalty Provisions

Article 42Anyone who produces or markets fake veterinary drugs, or violates the provisions of the second paragraph of Article 29 of these Regulations, shall be investigated for criminal liability in accordance with the provisions of the Criminal Law on crimes of producing or selling fake or substandard products or crimes of producing or selling fake veterinary drugs or veterinary drugs of inferior quality. If the case is not serious enough for criminal punishment, he shall be ordered to suspend the production or marketing of the veterinary drugs, have the drugs and the illegal income confiscated and be fined not less than one time nor more than five times the illegal income. Concurrently, an enterprise offender may be ordered to suspend its production or business for rectification or have its Veterinary Drug Producing License, Veterinary Drug Marketing License or Veterinary Drug Dispensing License revoked.

Article 43Anyone who produces or markets veterinary drugs of inferior quality shall be investigated for criminal liability in accordance with the provisions of the Criminal Law on crimes of producing or selling fake or substandard products or crimes of producing or selling fake veterinary drugs or veterinary drugs of inferior quality. If the case is not serious enough for criminal punishment, he shall be ordered to suspend the production or marketing of the veterinary drugs, have the drugs and the illegal income confiscated and be fined not less than one time nor more than five times the illegal income. If the circumstances or results are serious, he may concurrently be ordered to suspend his production or business for rectification or have his Veterinary Drug Producing License, Veterinary Drug Marketing License or Veterinary Drug Dispensing License revoked.

Article 44Anyone who, in absence of Veterinary Drug Producing License, Veterinary Drug Marketing License or Veterinary Drug Dispensing License, produces, markets veterinary drugs or dispenses veterinary drug preparations shall be investigated for criminal responsibility in accordance with the provisions of the Criminal Law on the crime of illegal business operation. If the case is not serious enough for criminal punishment, he shall be ordered to suspend his production, business or dispensing of veterinary drug preparations, have all the veterinary drugs and illegal income confiscated, and may concurrently be fined not less than one time nor more than five times the illegal income.

Article 45Anyone who violates the relevant provisions of these Regulations on importing veterinary drugs shall be investigated for criminal responsibility in accordance with the provisions of the Criminal Law on the crime of illegal business operation. If the cases are not serious enough for criminal punishment, he shall, in accordance with the seriousness of the circumstances, be imposed a warning or have the veterinary drugs confiscated. The illegal income of an unauthorized veterinary drug seller shall be confiscated and a fine of not less than one time nor more than five times the illegal income shall concurrently be imposed.

Article 46Anyone who fails to use veterinary drugs in accordance with the relevant provisions of the State on safe use of veterinary drugs shall be imposed a warning and may concurrently be fined not more than 30000 yuan.

Anyone who uses fake veterinary drugs, veterinary drugs of inferior quality or other veterinary drugs the use of which is prohibited shall be ordered to stop using, have the drugs confiscated, and may concurrently be fined not less than 10000 yuan nor more than 50000 yuan.

Article 47The administrative penalties provided for in these Regulations shall be determined by the administrative departments for animal husbandry and veterinary work of the people's governments at or above the county level. However, the administrative penalties to be imposed according to Article 16 and Chapter VII of these Regulations, the confiscation and fine to be imposed according to Article 45 of these Regulations and the confiscation and fine to be imposed on those who violate the relevant provisions of the Regulations on Responsibilities for Quality of Industrial Products in producing or marketing veterinary drugs shall be determined by the administrative departments for industry and commerce, the administrative departments for animal husbandry and veterinary work shall render assistance in investigation and disposition.

All fines and illegal income confiscated shall be turned over to the State Treasury. Confiscated fake drugs, drugs of inferior quality and other confiscated drugs the use of which is explicitly prohibited by the State shall be destroyed by the administrative departments for animal husbandry and veterinary work.

Article 48If a party concerned disagrees with the administrative penalty imposed on him, he may institute an action to a people's court within 15 days from the date of receipt of the notice. However, he shall implement the decisions on veterinary drug control made by the administrative departments for animal husbandry and veterinary work. Where the party concerned neither implements the administrative penalty decisions nor institutes an action upon the expiry of the specified time limit, the department imposing the administrative penalty shall apply to a people's court for compulsory enforcement.

Article 49Any unit or individual who, in violation of these Regulations, causes a veterinary drug poisoning accident or cause other damage to domestic animals, poultry or other animals shall assume the liability for compensation. The party suffering from damage may request the administrative departments for animal husbandry and veterinary work of the people's governments at or above the county level for disposition. If the party concerned disagrees with the disposition decision, he may institute an action to a people's court within 15 days from the date of receipt of the notice.

The party suffering from damage may also directly institute an action to a people's court.

The claims for compensation shall be submitted within one year after the party suffering from damage was aware or ought to have been aware of that his rights are infringed upon. No claims may be accepted if they are not submitted in such a time limit.

Chapter VIIII Supplementary Provisions

Article 50For the purpose of these Regulations:

(1) the term of "Domestic animals, poultry and other animals" means domestic animals, poultry, fishes, bees, silkworms and other man-raised animals.

(2) the term of " Veterinary drugs" means those substances (including medicated feed additives) used for the prevention, treatment and diagnosis of the diseases of domestic animals, poultry and other animals, and for the intentional regulation of their physiological functions, for which indications, action, usage, and dosage are specified. The veterinary drugs referred to here include:

i) Biological products such as sera, vaccines (bacterial and viral) and diagnostic aid;

ii) Traditional Chinese medicinal materials, prepared Chinese medicines, raw chemical drugs and their preparations used for animals;

iii) Antibiotics, biochemical drugs and radioactive drugs.

(3) the term of "New veterinary drugs" means raw veterinary drugs newly developed in China.

(4) the term of "New preparations of veterinary drugs" means preparations of veterinary drugs newly developed and processed form raw veterinary drugs.

Article 51These Regulations shall be effective as of January 1, 1988. The Interim Regulations on Administration of Veterinary Drugs approved and transmitted by the State Council on August 26, 1980 shall be repealed simultaneously.