Regulations on Administration of Veterinary Drugs
(Adopted at the 45th Executive Meeting of the State Council on March 24, 2004, promulgated by Decree No. 404 of the State Council of the People’s Republic of China on April 9, 2004, and effective as of November 1, 2004)
Chapter I General Provisions
Article 1 These Regulations are formulated for the purpose of strengthening the administration of veterinary drugs, ensuring the quality of such drugs, preventing and controlling animal diseases, promoting the development of breeding industry, and safeguarding human health.
Article 2 Any entity engaged in research and development, manufacture, distribution, import and export, use, supervision and administration of veterinary drugs within the territory of the People’s Republic of China shall comply with these Regulations.
Article 3 The administrative department for veterinary medicine of the State Council is responsible for the supervision and administration of veterinary drugs nationwide.
The administrative departments for veterinary medicine of the local people’s governments at or above the county level are responsible for the supervision and administration of veterinary drugs within their respective administrative areas.
Article 4 The State adopts an administration system for classifying veterinary drugs into prescription and non-prescription ones. The measures and the specific implementation procedures of the administration system for classifying veterinary drugs into prescription and non-prescription ones shall be formulated by the administrative department for veterinary medicine of the State Council.
Article 5 The State adopts a system for reserve of veterinary drugs.
In the event of a serious epizootic disease, calamity or other emergency, the administrative department for veterinary medicine of the State Council may, for purposes of first aid, transfer veterinary drugs from the national reserve and, when necessary, may also transfer veterinary drugs from the reserve of other quarters.
Chapter II Research and Development of New Veterinary Drugs
Article 6 The State encourages research and development of new veterinary drugs and protects the legitimate rights and interests of researchers and developers according to law.
Article 7 For research and development of a new veterinary drug, there shall be premises, instruments and equipment, professional technicians, standards and measures for safety control commensurate with the research and development work.
For research and development of a new veterinary drug, safety evaluation shall be conducted. Any institution to be engaged in safety evaluation of veterinary drugs shall be subject to accreditation by the administrative department for veterinary medicine of the State Council, and shall comply with the Good Laboratory Practice for Non-clinical Laboratory Studies and the Good Clinical Practice in respect of veterinary drugs.
Article 8 For research and development of a new veterinary drug, an application attached with a report of safety evaluation made at the laboratory stage and other pre-clinical study data on the drug shall, before clinical trials are conducted, be submitted to the administrative department for veterinary medicine of the people’s government of the province, autonomous region or municipality directly under the Central Government, which shall notify the applicant of the result of examination in writing within 60 working days from the date it receives the application.
Where the new veterinary drug being researched and developed is a biological product, an application shall, before clinical trials are conducted, be submitted to the administrative department for veterinary medicine of the State Council, which shall notify the applicant of the result of examination in writing within 60 working days from the date it receives the application.
Where pathogenic microorganisms of Class I are necessary to be used in the research and development of a new veterinary drug, conditions laid down by the administrative department for veterinary medicine of the State Council are, in addition, required to be met, and the matter shall, prior to the laboratory stage, be reported to the administrative department for veterinary medicine of the State Council for approval.
Article 9 When applying to the administrative department for veterinary medicine of the State Council for registration of a new veterinary drug after clinical trials are concluded, the researcher and developer of the drug shall submit a sample of the drug and the following data:
(1) the name, principal ingredients and physicochemical characteristics;
(2) the method and process of manufacturing, quality standards and analytical method;
(3) results of pharmacological and toxicological tests, the clinical trial report and stability test report; and
(4) the environmental impact report and measures for prevention and control of pollution.
Where the new veterinary drug being researched and developed is a biological product, the master seed bacteria (viruses or insects), cell lines and other relevant materials and data shall, in addition, be provided. The master seed bacteria (viruses or insects) and cell lines shall be preserved by an institution designated by the administrative department for veterinary medicine of the State Council.
Where the new veterinary drug being researched and developed is to be used in food animals, a residue depletion test of the drug shall, in addition, be conducted and the data relating to the withdrawal period, maximum residue limits, residue analytical method and their basis provided, as is required by the administrative department for veterinary medicine of the State Council.
The administrative department for veterinary medicine of the State Council shall, within 10 working days from the date it receives the application, send the data of the new veterinary drug, which it decides to accept, to the veterinary drug evaluation institution established by itself for evaluation, and send the sample of the new veterinary drug to the test institution designated by itself for quality retrial, and shall complete the examination within 60 working days from the date it receives the results of evaluation and quality retrial. If the drug passes the examination, the said department shall issue a Registration Certificate of New Veterinary Drugs and publish the quality standards of the drug; if the drug fails to pass the examination, the department shall notify the applicant thereof in writing.
Article 10 The State offers protection to the undisclosed test data and other data, accumulated by the applicant itself and submitted by it, which concern the veterinary drug that has been registered according to law and contains a new compound.
Where another entity, without consent of the applicant of the veterinary drug already registered, applies for registration of a veterinary drug by using the data specified in the preceding paragraph, the veterinary drug registration department shall, within six years from the date the drug is registered, refuse to have it registered, unless the data submitted by that entity are accumulated by itself.
The veterinary drug registration department shall not disclose the data specified in the first paragraph of this Article, except under the following circumstances:
(1) for the need of public interest; or
(2) where measures have been taken to ensure that the data are protected against illegitimate commercial use.
Chapter III Manufacture of Veterinary Drugs
Article 11 A veterinary drug manufacturer shall be established in conformity with the national development programme and policy for the veterinary drug industry and shall meet the following requirements:
(1) having technical workers in the field of veterinary science, pharmacy or other relevant sciences commensurate with manufacture of veterinary drugs;
(2) having premises and facilities commensurate with manufacture of veterinary drugs;
(3) having the quality control and test institutions, personnel, instruments and equipment commensurate with manufacture of veterinary drugs;
(4) having a manufacturing environment required for safety and hygiene; and
(5) other requirements for manufacture specified in the Good Manufacturing Practice for Veterinary Drugs.
Only when meeting the requirements specified in the preceding paragraph may an applicant submit an application, which is attached with the documents certifying that the requirements specified in the preceding paragraph are met, to the administrative department for veterinary medicine of the people’s government of the province, autonomous region or municipality directly under the Central Government, which shall, within 20 working days from the date it receives the application, submit its opinions of verification and relevant materials to the administrative department for veterinary medicine of the State Council.
The administrative department for veterinary medicine of the State Council shall complete the examination within 40 working days from the date it receives the opinions of verification and relevant materials. If the application passes the examination, the said department shall issue a Veterinary Drug Manufacturing Licence; if the application fails to pass the examination, the department shall notify the applicant thereof in writing. The applicant shall complete the formalities for business registration on the basis of the Veterinary Drug Manufacturing Licence.
Article 12 In the Veterinary Drug Manufacturing Licence shall be clearly stated the scope and place of manufacturing, expiry date, the name and address of the legal representative, etc.
A Veterinary Drug Manufacturing Licence is valid for five years. A manufacturer that needs to continue the production of veterinary drugs after the expiry date shall, six months before the expiration of the licence, apply to the original department that issued the licence for renewal of the Veterinary Drug Manufacturing Licence.
Article 13 Where intending to change its scope or place of manufacturing, a veterinary drug manufacturer shall apply for renewal of the Veterinary Drug Manufacturing Licence in accordance with the provisions of Article 11 of these Regulations, and the applicant shall, on the basis of the renewed Veterinary Drug Manufacturing Licence, complete the formalities for change of business registration; where intending to change the name of the enterprise or its legal representative, it shall, within 15 working days after it completes the formalities for change of business registration, apply to the original department that issued the licence for renewal of the Veterinary Drug Manufacturing Licence.
Article 14 A veterinary drug manufacturer shall conduct production in accordance with the Good Manufacturing Practice for Veterinary Drugs laid down by the administrative department for veterinary medicine of the State Council.
The administrative department for veterinary medicine of the State Council shall supervise and inspect veterinary drug manufacturers to see whether they meet the requirements of the Good Manufacturing Practice for Veterinary Drugs and publish the results of inspection.
Article 15 To produce a veterinary drug, a veterinary drug manufacturer shall acquire an approval number for the product verified and issued by the administrative department for veterinary medicine of the State Council, and such approval number of the product is valid for five years. The measures for verifying and issuing such an approval number for the product shall be formulated by the administrative department for veterinary medicine of the State Council.
Article 16 A veterinary drug manufacturer shall conduct production in accordance with the national standards for veterinary drugs and the manufacturing process approved by the administrative department for veterinary medicine of the State Council. When intending to alter the manufacturing process that affects the quality of a veterinary drug, a veterinary drug manufacturer shall report the matter to the original approval department for verification and approval.
A veterinary drug manufacturer shall keep records of production, which shall be complete and accurate.
Article 17 The substances and excipients used for the production of veterinary drugs shall be up to the national standards or the quality required for the veterinary drugs produced.
The immediate packaging materials and containers of veterinary drugs shall meet the requirements for medicinal use.
Article 18 A veterinary drug shall be subject to quality test before it leaves the manufacturing plant, and it shall not be released if it does not conform to the quality standards.
A veterinary drug that leaves the manufacturing plant shall bear a certificate of quality.
Manufacturing of counterfeit or substandard veterinary drugs is prohibited.
Article 19 Before being released from the manufacturing plant, every batch of veterinary biologics manufactured by a veterinary drug manufacturer shall be subject to verification by a test institution designated by the administrative department for veterinary medicine of the State Council, which may conduct sampling tests, when necessary; those drugs that have not undergone verification or that have failed to pass the sampling tests shall not be marketed.
Veterinary biologics needed for compulsory vaccination shall be produced by enterprises designated by the administrative department for veterinary medicine of the State Council.
Article 20 A label shall be printed on or stuck to every package of veterinary drugs, together with a package leaflet, and with the words “for animal use only” indicated at a conspicuous place, as is required by the provisions.
No label and package leaflet of a veterinary drug may be used unless they are approved and published by the administrative department for veterinary medicine of the State Council.
In the label and package leaflet of a veterinary drug shall be indicated in Chinese the common name, ingredients and content, presentation, manufacturer, approval number of the product (number of the Registration Certificate of an Imported Veterinary Drug), product batch number, manufacturing date, expiry date, indications or functions, usage, dosage, withdrawal period, contraindications, adverse reactions, precautions, conditions for transportation, storage and preservation of the drug, and other necessary explanations. The trade name, if any, shall also be indicated.
In addition to the information specified in the preceding paragraph, precautions prescribed by the administrative department for veterinary medicine of the State Council shall also be printed in the labels or package leaflets attached to veterinary prescription drugs, and for narcotic drugs, psychotropic substances, toxic drugs and radioactive pharmaceuticals used for animals, a special sign prescribed by the administrative department for veterinary medicine of the State Council shall also be printed; moreover, in the labels or package leaflets attached to veterinary non-prescription drugs shall be printed the sign for non-prescription drugs prescribed by the administrative department for veterinary medicine of the State Council.
Article 21 In the light of the need to ensure the quality and safety of animal products and human health, the administrative department for veterinary medicine of the State Council may fix a period of not more than five years for surveillance of a new veterinary drug, and shall not give approval to another enterprise for producing or importing the same drug during this period. During the surveillance period, the manufacturer shall collect data regarding the therapeutic efficacy and adverse reactions of the new veterinary drug, and submit them to the administrative department for veterinary medicine of the State Council without delay.
Chapter IV Distribution of Veterinary Drugs
Article 22 A veterinary drug distributor shall meet the following requirements:
(1) having veterinary drug technical workers commensurate with distribution of veterinary drugs;
(2) having the business operation premises, equipment and storage facilities commensurate with distribution of veterinary drugs;
(3) having the quality control institution or personnel commensurate with distribution of veterinary drugs; and
(4) other distribution conditions laid down in the Good Sale Practice for Veterinary Drugs.
Only when meeting the requirements specified in the preceding paragraph may an applicant submit an application, which is attached with the documents certifying that the requirements specified in the preceding paragraph are met, to the administrative department for veterinary medicine of the people’s government of the city or county; an entity that intends to distribute veterinary biologics shall submit an application, which is attached with the documents certifying that the requirements specified in the preceding paragraph are met, to the administrative department for veterinary medicine of the people’s government of the province, autonomous region or municipality directly under the Central Government.
The administrative department for veterinary medicine of the local people’s government at or above the county level shall complete the examination within 30 working days from the date it receives the application. If the application passes the examination, the said department shall issue a Veterinary Drug Distribution Licence; if the application fails to pass the examination, the department shall notify the applicant thereof in writing. The applicant shall complete the formalities for business registration on the basis of the Veterinary Drug Distribution Licence.
Article 23 In the Veterinary Drug Distribution Licence shall be clearly stated the scope of distribution, place of business, expiry date, the name and address of the legal representative, etc.
A Veterinary Drug Distribution Licence is valid for five years. A distributor that needs to continue the distribution of veterinary drugs after the expiry date shall, six months before the expiration of the licence, apply to the original department that issued the licence for renewal of the Veterinary Drug Distribution Licence.
Article 24 Where intending to change its scope of distribution or place of business, a veterinary drug distributor shall apply for renewal of the Veterinary Drug Distribution Licence in accordance with the provisions of Article 22 of these Regulations, and the applicant shall, on the basis of the renewed Veterinary Drug Distribution Licence, complete the formalities for change of business registration; where intending to change the name of the enterprise or its legal representative, it shall, within 15 working days after it completes the formalities for change of business registration, apply to the original department that issued the licence for renewal of the Veterinary Drug Distribution Licence.
Article 25 A veterinary drug distributor shall comply with the Good Sale Practice for Veterinary Drugs laid down by the administrative department for veterinary medicine of the State Council.
The administrative department for veterinary medicine of the local people’s government at or above the county level shall supervise and inspect veterinary drug distributors to see whether they meet the requirements of the Good Sale Practice for Veterinary Drugs and publish the results of inspection.
Article 26 When purchasing a veterinary drug, a veterinary drug distributor shall have the product checked against its label, package leaflet and certificate of quality.
Article 27 A veterinary drug distributor shall provide its customers with information about the indications and functions, usage, dosage and precautions of the veterinary drug. When selling a veterinary prescription drug, it shall comply with the measures for administration of veterinary prescription drugs.
When selling crude Chinese medicines to be used for animals, a veterinary drug distributor shall indicate their origin.
A veterinary drug distributor is prohibited from distributing drugs for human use, as well as counterfeit and substandard veterinary drugs.
Article 28 When purchasing and selling veterinary drugs, a veterinary drug distributor shall keep purchase and sale records. In such records shall be indicated the trade name, common name, formulation, presentation, batch number, expiry date, manufacturer, purchaser or seller, quantity of the drug purchased or sold, date of purchase or sale, and other information specified by the administrative department for veterinary medicine of the State Council.
Article 29 A veterinary drug distributor shall establish a system for preservation of veterinary drugs and take all necessary measures including cold storage, protection against freeze and humidity, and avoidance of insects and rodents, in order to preserve the quality of veterinary drugs it distributes.
An inspection and acceptance system shall be implemented for placing veterinary drugs in and releasing them from the storehouse, and accurate records shall be kept in this regard.
Article 30 Veterinary biologics needed for compulsory vaccination shall be distributed in compliance with the provisions laid down by the administrative department for veterinary medicine of the State Council.
Article 31 The content of an advertisement for a veterinary drug shall be consistent with that of the package leaflet. Where such an advertisement is to be published in the principal national media, the matter shall be subject to examination and approval by the administrative department for veterinary medicine of the State Council, and an approval number shall be obtained for the advertisement of the drug. Where the advertisement of a veterinary drug is to be published in the local media, the matter shall be subject to examination and approval by the administrative department for veterinary medicine of the people’s government of the province, autonomous region or municipality directly under the Central Government, and an approval number shall be obtained for the advertisement of the drug; no advertisement may be published without approval.
Chapter V Import and Export of Veterinary Drugs
Article 32 Where a veterinary drug is to be exported to China for the first time, the representative office established by the exporter within the territory of China or the agency within the territory of China authorized by it shall apply to the administrative department for veterinary medicine of the State Council for registration, and submit the following data and articles:
(1) the document certifying that the veterinary drug regulatory department of the country (region) where the manufacturer is located has approved the production or marketing of such drug;
(2) the document issued by the veterinary drug regulatory department of the country (region) where the manufacturer is located, certifying that the drug conforms to the Good Manufacturing Practice for Veterinary Drugs;
(3) the method and process of manufacturing, quality standards, analytical method, results of pharmacological and toxicological tests, clinical trial report, stability test report, and other data relevant to the veterinary drug; the data relating to the withdrawal period, maximum residue limits, residue analytical method and their basis for a veterinary drug used for food animals;
(4) a sample copy of the label and package leaflet of the veterinary drug;
(5) a sample, reference substance and standard substance of the veterinary drug;
(6) the environmental impact report and measures for prevention and control of pollution; and
(7) other data concerning safety of the veterinary drug.
Where applying for exporting veterinary biologics to China, the applicant shall, in addition, provide the master seed bacteria (viruses or insects), cell lines and other relevant materials and data.
Article 33 The administrative department for veterinary medicine of the State Council shall arrange for preliminary examination within 10 working days from the date it receives the application. If the application passes the preliminary examination, the said department shall send the data of the veterinary drug, which it decides to accept, to the veterinary drug evaluation institution established by itself for evaluation, send the sample of the drug to the test institution designated by itself for quality retrial, and shall complete the examination within 60 working days from the date it receives the results of evaluation and quality retrial. If the drug passes the examination, the department shall issue a Registration Certificate of Imported Veterinary Drugs and publish the quality standards of the drug; if the drug fails to pass the examination, the department shall notify the applicant thereof in writing.
In the course of examination, the administrative department for veterinary medicine of the State Council may carry out an on-the-spot inspection to see whether the enterprise that intends to export a veterinary drug to China meets the requirements of the Good Manufacturing Practice for Veterinary Drugs, and shall have the right to require the enterprise to conduct tests on safety and efficacy of the drug at an institution designated by the administrative department for veterinary medicine of the State Council.
As for the importation of a veterinary drug urgently needed by a domestic user, a small amount of a veterinary drug to be used for scientific research, or the sample, reference substance or standard substance of a registered veterinary drug, the matter shall be handled in accordance with the provisions laid down by the administrative department for veterinary medicine of the State Council.
Article 34 A Registration Certificate of Imported Veterinary Drugs is valid for five years. An exporter that needs to continue the exportation of veterinary drugs to China after the expiry date shall, six months before the expiry date, apply to the original department that issued the certificate for renewed registration.
Article 35 No enterprises from abroad may directly sell veterinary drugs in China. An enterprise from abroad that intends to sell veterinary drugs in China shall, in accordance with the law, establish a sales office within the territory of China or authorize an agency within the territory of China that meets the requirements.
To import a veterinary biologic that has obtained the Registration Certificate of Imported Veterinary Drugs in China, the agency within the territory of China shall apply to the administrative department for veterinary medicine of the State Council for an import permission certificate for veterinary biologics, and shall, on the basis of the import permission certificate, complete the formalities for obtaining a veterinary drug import note from the administrative department for veterinary medicine of the people’s government in the place where the port of entry is located; to import other veterinary drugs that have obtained the Registration Certificate of Imported Veterinary Drugs in China, the agency shall, on the basis of the Registration Certificate of Imported Veterinary Drugs, complete the formalities for obtaining the veterinary drug import note from the administrative department for veterinary medicine of the people’s government in the place where the port of entry is located. The Customs shall release the drugs on the basis of the veterinary drug import note. The measures for administration of importation of veterinary drugs shall be formulated by the administrative department for veterinary medicine of the State Council jointly with the General Administration of Customs.
After it is imported, a veterinary biologic shall undergo verification and sampling tests in accordance with the provisions of Article 19 of these Regulations. After other veterinary drugs are imported, the local administrative department for veterinary medicine shall notify the veterinary drug test institution to conduct sampling tests.
Article 36 Importing any of the following veterinary drugs is prohibited:
(1) drugs with uncertain therapeutic efficacy or serious adverse reactions, or drugs that may be harmful to the breeding industry or to human health or harbour potential risks;
(2) veterinary biologics that come from an epidemic area and may cause the spread of the epidemic disease within the territory of China;
(3) drugs manufactured in conditions where an on-the-spot inspection proves to be not in conformity with the provisions; or
(4) drugs the production, distribution or use of which is prohibited by the administrative department for veterinary medicine of the State Council.
Article 37 Where a veterinary drug is to be exported abroad and the importer requires the provision of a document certifying exportation of the veterinary drug, the administrative department for veterinary medicine of the State Council or the administrative department for veterinary medicine of the people’s government of the province, autonomous region or municipality directly under the Central Government where the exporter is located may issue such a document.
The administrative department for veterinary medicine of the State Council may restrict or prohibit the exportation of the vaccines that are urgently needed for epidemic prevention within the country.
Chapter VI Use of Veterinary Drugs
Article 38 Any unit using veterinary drugs shall comply with the provisions on the safe use of veterinary drugs laid down by the administrative department for veterinary medicine of the State Council and keep a record of the use of such drugs.
Article 39 It is prohibited to use counterfeit and substandard veterinary drugs, as well as drugs and other compounds the use of which is prohibited according to the provisions of the administrative department for veterinary medicine of the State Council. The catalogue of the drugs and other compounds the use of which is prohibited shall be compiled and published by the administrative department for veterinary medicine of the State Council.
Article 40 Where a veterinary drug requiring a withdrawal period is used in food animals, the raiser of the animals shall provide the purchaser or slaughter with an accurate and truthful record of use of the drug; the purchaser or slaughter shall ensure that during the period of drug taking or withdrawal the animals and their products are not used as food for human consumption.
Article 41 The administrative department for veterinary medicine of the State Council shall be responsible for compiling and publishing a catalogue of the varieties of medicated feed additives permitted to be added in animal feed.
It is prohibited to add in animal feed or drinking water any hormonal drug or other prohibited drugs specified by the administrative department for veterinary medicine of the State Council.
No veterinary drugs that may be added in animal feed with approval may be added therein before being made into medicated feed additives by a veterinary drug manufacturer. Directly adding a bulk drug in animal feed or drinking water or directly administering such a drug to animals is prohibited.
Using drugs for human beings to animals is prohibited.
Article 42 The administrative department for veterinary medicine of the State Council shall formulate and arrange for the implementation of national programmes for monitoring the residue of veterinary drugs in animals and their products.
The administrative department for veterinary medicine of the people’s government at or above the county level shall be responsible for the detection of the residual amount of veterinary drugs in animal products. The results of the detected residue of veterinary drugs shall be published by the administrative department for veterinary medicine of the State Council or the administrative department for veterinary medicine of the people’s government of the province, autonomous region or municipality directly under the Central Government within their respective limits of power.
Any producer or seller of animal products that objects to the detection results may, within seven working days from the date it receives the results, submit an application to the administrative department for veterinary medicine that arranges for the detection of the residue of veterinary drugs or the administrative department for veterinary medicine at the next higher level, and the administrative department for veterinary medicine that accepts the application shall designate a test institution for a retest.
The residue limits and the residue analytical methods of veterinary drugs shall be formulated and published by the administrative department for veterinary medicine of the State Council.
Article 43 It is prohibited to sell food animal products that contain illicit drugs or in which the residual amount of veterinary drugs exceeds the limits.
Chapter VII Supervision and Administration of Veterinary Drugs
Article 44 The administrative department for veterinary medicine of the people’s government at or above the county level shall exercise the power of supervision and administration of veterinary drugs.
Testing of veterinary drugs shall be conducted by the veterinary drug test institutions established by the administrative department for veterinary medicine of the State Council or by the administrative department for veterinary medicine of the people’s government of the province, autonomous region or municipality directly under the Central Government. The administrative department for veterinary medicine of the State Council may, when necessary, accredit other test institutions to conduct testing of veterinary drugs.
Any party that objects to the testing result of a veterinary drug may, within seven working days from the date it receives the testing result, apply for a retest to the institution that did the testing or a test institution established by the administrative department for veterinary medicine at a higher level.
Article 45 Veterinary drugs shall measure up to the national standards of such drugs.
The Chinese Veterinary Pharmacopoeia drafted by the National Veterinary Pharmacopoeia Commission and promulgated by the administrative department for veterinary medicine of the State Council, and other quality standards of veterinary drugs issued by the administrative department for veterinary medicine of the State Council constitute the national standards of veterinary drugs.
The standardization of standard and reference substances for the national standards of veterinary drugs shall be the responsibility of the veterinary drug test institution established by the administrative department for veterinary medicine of the State Council.
Article 46 When carrying out supervision and inspection in accordance with the law, the administrative department for veterinary medicine shall take compulsory administrative measures to seal up or distrain the veterinary drugs that are proved to be potentially counterfeit or substandard and shall, within seven working days from the date it takes the compulsory administrative measures, decide on whether or not to place the case on file; where test is needed, it shall, within 15 working days from the date the test report is issued, decide on whether or not to place the case on file; where the conditions for placing the case on file are not satisfied, it shall discontinue the compulsory administrative measures; where the manufacturing, distribution or use of the drug needs to be suspended, the administrative department for veterinary medicine of the State Council or the administrative department for veterinary medicine of the people’s government of the province, autonomous region or municipality directly under the Central Government shall make a decision thereon within their respective limits of power.
Without approval by the department that makes the decision on taking compulsory administrative measures or the department at the next higher level, no veterinary drugs or relevant materials that are sealed up or distrained may be transferred, used, destroyed or sold.
Article 47 A veterinary drug is a counterfeit one in any of the following cases:
(1) a non-veterinary drug substance is passed off as a veterinary drug or one veterinary drug is passed off as another; or
(2) the types or names of the ingredients contained in a veterinary drug are not in conformity with the national standards of veterinary drugs.
A veterinary drug shall be treated as counterfeit in any of the following cases:
(1) its use is prohibited according to the provisions of the administrative department for veterinary medicine of the State Council;
(2) it is manufactured or imported without examination and approval as is required by these Regulations, or it is marketed or imported without sampling tests or verification as is required by these Regulations;
(3) it is deteriorated;
(4) it is contaminated; or
(5) the indications or functions indicated are beyond the specified scope.
Article 48 A veterinary drug is a substandard one in any of the following cases:
(1) the content of the ingredients is not up to the national standards of veterinary drugs, or the active ingredients are not indicated;
(2) the expiry date is not indicated or is altered, or the drug is beyond the expiry date;
(3) the batch number is not indicated or is altered; or
(4) other veterinary drugs that are not up to the national standards of veterinary drugs but are not counterfeit.
Article 49 It is prohibited to sell a bulk veterinary drug piecemeal or sell such a drug to other units or individuals than veterinary drug manufacturers.
It is prohibited to sell, purchase or use, without the prescription of a veterinarian, any veterinary drugs specified as prescription drugs by the administrative department for veterinary medicine of the State Council.
Article 50 The State practises a report system for adverse reactions of veterinary drugs.
When discovering serious adverse reactions that are possibly induced by the use of a veterinary drug, the veterinary drug manufacturer, distributor or user, or the veterinarian who prescribes the drug shall promptly report the matter to the administrative department for veterinary medicine of the local people’s government.
Article 51 Where a veterinary drug manufacturer or distributor has suspended production or distribution for at least six months or is closed down, the original department that issued the licence shall order it to return the Veterinary Drug Manufacturing Licence or the Veterinary Drug Distribution Licence, and the administrative department for industry and commerce shall change or cancel its business registration.
Article 52 Trading in, renting out or lending the Veterinary Drug Manufacturing Licence, Veterinary Drug Distribution Licence or veterinary drug approval documents is prohibited.
Article 53 The items and rates of fees charged for evaluation and testing of veterinary drugs shall be decided on and published by the finance department of the State Council jointly with the competent pricing department of the State Council.
Article 54 No administrative departments for veterinary medicine or veterinary drug test institutions at various levels, nor their staff members may be involved in the manufacturing or distribution of veterinary drugs, nor may they recommend veterinary drugs in their names or have the supervisors for drug manufacturing or sale named after them.
Chapter VIII Legal Liability
Article 55 Any administrative department for veterinary medicine or any of its staff members that, taking advantage of its position, accepts another person’s money or things of value or seeks other benefits, issues licences or, after examination, grants approval with its signature to the unit or individual that does not meet the statutory requirements, fails to fulfill its duties of supervision, or fails to investigate and punish violations of law it discovers, which causes serious consequences and constitutes a crime, shall be investigated for criminal liability in accordance with the law; if no crime is constituted, it shall be given administrative sanctions in accordance with the law.
Article 56 In violation of the provisions of these Regulations, any entity that produces or distributes veterinary drugs without a Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence, or produces or distributes counterfeit or substandard veterinary drugs even if it has a Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence, or any veterinary drug distributor that distributes drugs for human use, shall be ordered to desist from producing or distributing the drugs, the drug substances, excipients and packaging materials used for illegal production, as well as the veterinary drugs produced or distributed and the unlawful gains therefrom shall be confiscated and, in addition, a fine of not less than two times but not more than five times the value of the veterinary drugs illegally produced or distributed (including the veterinary drugs sold and not sold, the same below) shall be imposed; if the amount of the value cannot be investigated and verified, a fine of not less than 100,000 yuan but not more than 200,000 yuan shall be imposed; if veterinary drugs are produced without a Veterinary Drug Manufacturing Licence and the circumstances are serious, the manufacturing equipment shall be confiscated; if counterfeit or substandard veterinary drugs are produced or distributed and the circumstances are serious, its Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence shall be revoked; if a crime is constituted, criminal liability shall be investigated in accordance with the law; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law. The principal leading members of the manufacturer or distributor and the persons in charge who are directly responsible shall not be allowed to engage in production or distribution of veterinary drugs for their lifetime.
Manufacturing, without approval, of veterinary biologics needed for compulsory vaccination shall be punished the same as for manufacturing of veterinary drugs without a Veterinary Drug Manufacturing Licence.
Article 57 Where an entity, in violation of the provisions of these Regulations, obtains the Veterinary Drug Manufacturing Licence, the Veterinary Drug Distribution Licence, or veterinary drug approval document by providing false data, samples or by other fraudulent means, its Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence shall be revoked, or the veterinary drug approval document shall be withdrawn and, in addition, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law. The principal leading members of the entity and the persons in charge who are directly responsible shall not be allowed to engage in production, distribution, or importation and exportation of veterinary drugs for their lifetime.
Article 58 Where an entity trades in, rents out or lends the Veterinary Drug Manufacturing Licence, Veterinary Drug Distribution Licence or veterinary drug approval document, its unlawful gains therefrom shall be confiscated and, in addition, a fine of not less than 10,000 yuan but not more than 100,000 yuan shall be imposed; if the circumstances are serious, its Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence shall be revoked, or the veterinary drug approval document shall be withdrawn; if a crime is constituted, criminal liability shall be investigated in accordance with the law; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
Article 59 Any institution for veterinary drug safety evaluation or clinical trial or any manufacturer or distributor that, in violation of the provisions of these Regulations, fails to implement the Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice or Good Sale Practice for Veterinary Drugs in accordance with the provisions shall be given a warning and shall be ordered to rectify within a time limit; if it fails to comply at the expiration of the time limit, it shall be ordered to desist from research and trial, production, or distribution of veterinary drugs and shall, in addition, be fined not more than 50,000 yuan; if the circumstances are serious, its Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence shall be revoked; if losses are caused to another person, it shall bear the liability for compensation in accordance with the law.
Any entity that, in violation of the provisions of these Regulations, uses pathogenic microorganisms of Class I in the research and development of a new veterinary drug with no conditions required, or does so with no approval obtained prior to the laboratory stage shall be ordered to desist from the experimentation and shall, in addition, be fined not less than 50,000 yuan but not more than 100,000 yuan; if a crime is constituted, it shall be investigated for criminal liability in accordance with the law; if losses are caused to another person, it shall bear the liability for compensation in accordance with the law.
Article 60 Any entity that, in violation of the provisions of these Regulations, fails to have the label and package leaflet of a veterinary drug approved shall be ordered to rectify within a time limit; if it fails to comply at the expiration of the time limit, it shall be punished the same as for the manufacturing or distribution of counterfeit veterinary drugs; the approval number of the veterinary drug product, if any, shall be cancelled; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
Where no label and package leaflet are attached to the package of a veterinary drug or the label and package leaflet are different from what is approved in content, an order shall be given to rectify the situation within a time limit; if the circumstances are serious, a penalty shall be imposed in accordance with the provisions of the preceding paragraph.
Article 61 Any enterprise from abroad that, in violation of the provisions of these Regulations, directly sells veterinary drugs in China shall be ordered to rectify within a time limit, the veterinary drugs for direct sale and its unlawful gains shall be confiscated and, in addition, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if the circumstances are serious, its Registration Certificate of Imported Veterinary Drugs shall be revoked; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
Article 62 Any entity that, in violation of the provisions of these Regulations, fails to use veterinary drugs in accordance with the provisions of the State on the safe use of veterinary drugs, or fails to keep a record of the use of the drugs or keeps an incomplete or untruthful record, or uses the drugs or other compounds the use of which is prohibited, or uses drugs for human use in animals, shall be ordered to rectify promptly and to give innocuous treatment to the animals that are administered with the illicit drugs or other compounds as well as to their products; the unit violating the provisions shall be fined not less than 10,000 yuan but not more than 50,000 yuan; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
Article 63 Any entity that, in violation of the provisions of these Regulations, sells animals being in the period of drug taking or withdrawal or their products as food for human consumption, or sells animal products, which contain any illicit drug or in which the residual amount of a veterinary drug exceeds the limits, as food for human consumption, shall be ordered to give innocuous treatment to the said animal products, its unlawful gains shall be confiscated and, in addition, a fine of not less than 30,000 yuan but not more than 100,000 yuan shall be imposed; if a crime is constituted, criminal liability shall be investigated in accordance with the law; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
Article 64 Any entity that, in violation of the provisions of these Regulations, transfers, uses, destroys or sells without approval the veterinary drugs or relevant materials which are sealed up or distrained shall be ordered to desist from the violation, shall be given a warning and shall, in addition, be fined not less than 50,000 yuan but not more than 100,000 yuan.
Article 65 Any veterinary drug manufacturer, distributor or user, or veterinarian who prescribes drugs that discovers serious adverse reactions that are possibly induced by the use of a veterinary drug but, in violation of the provisions of these Regulations, fails to report the matter to the administrative department for veterinary medicine of the local people’s government, shall be given a warning and shall, in addition, be fined not less than 5,000 yuan but not more than 10,000 yuan.
Any manufacturer that, during the period of surveillance of a new veterinary drug, fails to collect or to promptly submit the data concerning the therapeutic efficacy and adverse reactions of the drug shall be ordered to rectify within a time limit and shall, in addition, be fined not less than 10,000 yuan but not more than 50,000 yuan; if the circumstances are serious, the approval number of the product for the drug shall be revoked.
Article 66 Any entity that, in violation of the provisions of these Regulations, sells, purchases or uses veterinary prescription drugs without the prescription of a veterinarian shall be ordered to rectify within a time limit, its unlawful gains shall be confiscated and, in addition, a fine of not more than 50,000 yuan shall be imposed; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
Article 67 In violation of the provisions of these Regulations, any veterinary drug manufacturer or distributor that sells a bulk veterinary drug to other units or individuals than veterinary drug manufacturers, or any veterinary drug distributor that sells such a drug piecemeal, shall be ordered to rectify promptly and shall be given a warning, its unlawful gains shall be confiscated and, in addition, a fine of not less than 20,000 yuan but not more than 50,000 yuan shall be imposed; if the circumstances are serious, its Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence shall be revoked; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
Article 68 Any entity that, in violation of the provisions of these Regulations, adds in animal feed or drinking water any hormonal drug or other prohibited drugs specified by the administrative department for veterinary medicine of the State Council shall be punished in accordance with the relevant provisions of the Regulations on Administration of Animal Feed and Feed Additives; any entity that directly adds a bulk drug in animal feed or drinking water or administers such a drug to animals shall be ordered to rectify promptly and shall, in addition, be fined not less than 10,000 yuan but not more than 30,000 yuan; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
Article 69 In any of the following cases the approval number of a product for a veterinary drug shall be cancelled or the Registration Certificate of Imported Veterinary Drugs be revoked:
(1) the drug fails to pass two consecutive sampling tests;
(2) the therapeutic efficacy of the drug is uncertain, its adverse reactions are serious, it may be harmful to the breeding industry or to human health, or it harbours potential risks; or
(3) the production, distribution or use of the drug is prohibited by the administrative department for veterinary medicine of the State Council.
Where their approval numbers of the products are cancelled or Registration Certificates of Imported Veterinary Drugs are revoked, the veterinary drugs shall not be produced, imported, distributed or used any longer. Such drugs already produced or imported shall be destroyed under the supervision of the local administrative department for veterinary medicine, and the expenses thus entailed shall be paid by the violator; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
Article 70 The administrative penalties provided for by these Regulations shall be decided on by the administrative department for veterinary medicine of the people’s government at or above the county level; among such penalties, the decision on revocation of the Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence, on withdrawal of the veterinary drug approval document or on an order for desisting from the research and trial of veterinary drugs shall be made by the original department that issues the licence or document or the approval department.
The administrative department for veterinary medicine at a higher level shall order the one at a lower level that performs administrative acts in violation of these Regulations to rectify within a time limit; if the latter does not comply at the expiration of the time limit, the former shall have the power to alter or annul such acts.
Article 71 The value of a veterinary drug mentioned in these Regulations shall be calculated on the basis of the marked price of the veterinary drug illegally produced or distributed; if there is no price marked, it shall be calculated on the basis of the market price of the veterinary drug of the same kind.
Chapter IX Supplementary Provisions
Article 72 The meanings of the following terms used in these Regulations are:
(1) “Veterinary drugs” means substances (including medicated feed additives) used for prevention, treatment and diagnosis of animal diseases, or intended for regulation of the physiological functions of animals, mainly including sera, vaccines, diagnostic kits, probiotics, crude Chinese medicines, traditional Chinese medicine preparations, chemical pharmaceuticals, antibiotics, biochemical drugs, radioactive pharmaceuticals, ectoparasiticides and disinfectants.
(2) “Veterinary prescription drugs” means veterinary drugs purchased and used only by the prescription of a veterinarian.
(3) “Veterinary non-prescription drugs” means veterinary drugs that are published as such by the administrative department for veterinary medicine of the State Council and can be freely purchased without the prescription of a veterinarian and used in accordance with the package leaflet.
(4) “Veterinary drug manufacturers” means enterprises exclusively or partly engaged in production of veterinary drugs, including the ones engaged in repacking of veterinary drugs.
(5) “Veterinary drug distributors” means enterprises exclusively or partly engaged in distribution of veterinary drugs.
(6) “New veterinary drugs” means veterinary drugs that have not yet been placed on the market within the territory of China.
(7) “Veterinary drug approval documents” includes the documents such as the approval number of a veterinary drug product, the Registration Certificate of Imported Veterinary Drugs, the import permission certificate for veterinary biologics, the document certifying exportation of a veterinary drug, and the Registration Certificate of New Veterinary Drugs.
Article 73 Special drugs including narcotic drugs, psychotropic substances, toxic drugs and radioactive pharmaceuticals used for animals shall be administered in accordance with the relevant provisions of the State.
Article 74 The use, detection of residues, supervision and administration of veterinary drugs in aquaculture, and the imposition of administrative penalties for unlawful use of drugs in the course of breeding aquatics shall be the responsibility of the competent department for fisheries of the people’s government at or above the county level and the fisheries authorities affiliated to the department.
Article 75 These Regulations shall be effective as of November 1, 2004.