People's Republic of China promulgated by Decree No. 404 of the regulations on the administration of the State Council on March 24, 2004 veterinary drugs at the 45th Executive Council, are hereby promulgated and come into force on November 1, 2004.
Premier Wen Jiabao on April 9, 2004, chapter I General provisions article in order to strengthen the management of veterinary drugs, ensure the quality of veterinary drugs, prevention and control of veterinary diseases, promoting the development of farming, safeguard human health, this Ordinance is enacted.
Article in the People's Republic of China territory of veterinary medicine research, production and management, import and export, use, supervision and administration, shall comply with this regulation.
Article veterinary administrative departments under the State Council is responsible for supervision and administration of veterinary drugs throughout the country.
Veterinary Administrative Department under the people's Governments at and above the county level shall be responsible for supervision and administration of veterinary drugs within their respective administrative areas. Beast in fourth country use prescription and non-prescription drug classification system.
Animal use prescription and non-prescription drugs classification management approaches and concrete steps by the veterinary administrative departments under the State Council.
The fifth State practices veterinary medicine reserve system.
When major animal epidemics, disasters or other emergencies, veterinary administrative departments under the State Council can call the national emergency reserves of veterinary drugs, if necessary, can also be called veterinary drugs beyond the national reserve.
Chapter new developing the sixth the State encourages the development of new veterinary drugs veterinary drugs, development shall protect the lawful rights and interests.
Seventh development of new veterinary drugs, should be commensurate with the development of the premises, equipment, professional and technical personnel, security practices and measures. Development of new veterinary drugs, safety evaluation should be carried out.
Units engaged in safety assessment of veterinary drugs should be determined by the veterinary administrative departments under the State Council and comply with the non-clinical research and the quality control of veterinary drugs and animal drugs in clinical trials quality control standard.
Eighth development of new veterinary drugs should be in clinical trials prior to provinces, autonomous regions and municipalities apply veterinary administrative departments, and affix the new laboratory safety assessment of veterinary drugs reports and other preclinical studies; the provinces, autonomous regions and municipalities veterinary administrative departments shall, from the date of receipt of the application will review the results within 60 business days written notice to the applicant.
The development of new veterinary drugs belonging to biological products, shall, before clinical trial application to the veterinary administrative departments under the State Council, veterinary administrative departments under the State Council shall, within 60 working days of receipt of the application will review the results of written notice to the applicant.
The development of new veterinary drugs need to use a class of pathogenic microorganisms, shall satisfy the conditions of veterinary administrative departments under the State Council, and the laboratory report before veterinary administrative departments under the State Council for approval.
Nineth article clinical test completed Hou, new veterinary drugs development who to State Veterinary Administration sector proposed new veterinary drugs registered application Shi, should submitted the new veterinary drugs of samples and following information: (a) name, and main components, and physico-chemical nature; (ii) development method, and production process, and quality standard and detection method; (three) pharmacological and HIV acting test results, and clinical test report and stability test report; (four) environment effect report and pollution control measures. The development of new veterinary drugs belonging to biological products, should also provide bacteria (virus, insect) species, cells and other relevant materials and information.
Bacterial (viral, insect) species, cell preservation institutions designated by the veterinary administrative departments under the State Council.
Development of new veterinary drugs for food animals should also be in accordance with the provisions of the veterinary administrative departments under the State Council for veterinary drug residue testing and to provide withdrawal period, maximum residue limits, residues and make based on such information. Veterinary administrative departments under the State Council shall, within 10 working days of receipt of the application, decided to accept the information sent through the establishment of new veterinary drugs veterinary drugs review bodies review, new animal drug samples to send their designated Inspection Agency verification and receipt of review and verification completed within 60 working days of the conclusion of the review.
Examination and issue new veterinary drug registration certificates, and publish the quality standards of veterinary drugs; not qualified, shall notify the applicant in writing.
Tenth State shall be registered according to law, veterinary drug submission containing new compounds its what I have achieved and protect undisclosed test data, and other data.
6 years from the date of registration, to other applicants without the consent of applicants who qualify for registration of veterinary drugs, using the data provided for in the preceding paragraph apply for registration of veterinary drugs, veterinary drug registration authorities refuse to register, however, except for applicants to submit their own data.
Except for the following cases, the veterinary drug registration authority shall not disclose any data specified in the first paragraph of this article: (a) the public interest, (ii) has taken measures to ensure that such information is not improperly for commercial use.
Third chapter veterinary drugs production 11th article established veterinary drugs production enterprise, should meet national veterinary drugs industry development planning and industry policy, and has following conditions: (a) and by production of veterinary drugs phase adapted of veterinary learn, and pharmacy or related professional of technicians; (ii) and by production of veterinary drugs phase adapted of plant, and facilities; (three) and by production of veterinary drugs phase adapted of veterinary drugs quality management and quality test of institutions, and personnel, and instrument equipment; (four) meet security, and health requirements of production environment;
(E) the veterinary drug manufacturing practices under other conditions of production.
Comply with the conditions prescribed in the preceding paragraph, the applicant party may apply to the provinces, autonomous regions and municipalities apply veterinary administrative departments, and attached in accordance with the conditions prescribed in the preceding paragraph prove that materials of provinces, autonomous regions and municipalities veterinary administrative departments shall, within 20 working days of receipt of the application, will review comments and related materials submitted to the veterinary administrative departments under the State Council. Veterinary administrative departments under the State Council, shall receive comments and related material completed within 40 working days from the date of the review. Upon examination, veterinary drug production licenses to; not qualified, shall notify the applicant in writing.
Applying for registration by the veterinary drug manufacturing license.
12th veterinary drug production licenses shall set forth the scope of production, production locations, expiration date and name of the legal representative and address issues. Veterinary medicine production license is valid for 5 years.
Has expired, the need to continue production of veterinary drugs should be 6 months before the expiry date of the permit to the original certificate authority for the renewal of the veterinary drug production licenses.
13th veterinary drug manufacturers change the range, production locations, shall, in accordance with the provisions of this section 11th applied for renewal of the veterinary drug production licenses, applicant renewal veterinary drug production licenses for industrial and commercial register the change; change of company name, legal representative shall, within 15 working days of registration procedures for business change, to the original certificate authority for the renewal of the veterinary drug production licenses.
14th veterinary drug production enterprises shall, in accordance with veterinary administrative departments under the State Council's veterinary drug manufacturing practices to organize production.
Veterinary administrative departments under the State Council, veterinary drug manufacturers should meet the requirements of veterinary drug manufacturing practices conducting supervision and inspection, and to publish the results of inspection. 15th veterinary drug manufacturers in the production of veterinary drugs, shall obtain product approval number issued by the veterinary administrative departments under the State Council, product approval number is valid for 5 years.
Veterinary drug product approval number issued by the State Council of veterinary administrative departments. 16th veterinary drug production enterprises shall, in accordance with veterinary standards and veterinary Administrative Department under the State Council approved production for production.
Veterinary drug manufacturers to change affecting the quality of veterinary drugs in the production process, shall be submitted to the original authority for examination and approval.
Veterinary drug manufacturers shall establish production records, production records should be complete and accurate.
17th veterinary drugs required for the production of raw materials, auxiliary materials, shall conform to the national standards and quality requirements for the production of veterinary drugs.
Direct contact packaging materials and containers shall meet the requirements for medicinal use of veterinary drugs.
18th veterinary drugs should be subject to quality inspection before delivery, do not meet the quality standards shall not be manufactured. Veterinary medicine factory product quality certificate shall be attached.
Prohibition of the production of false and inferior veterinary drugs.
19th veterinary drug manufacturers in the production of each batch of veterinary Biologics, in front of the factory inspection bodies designated by the veterinary administrative departments under the State Council should be reviewed to check, and random testing if necessary; without a review to check or fail to pass the test, may not be sold.
Compulsory vaccination required veterinary biological products, produced by enterprises designated by the veterinary administrative departments under the State Council.
20th veterinary drug packaging shall be in accordance with the regulations or tagged, attached with the manual, and prominently marked "animal".
Labeling and use instruction of veterinary drugs veterinary administrative departments under the State Council for approval and publication, may be used. Veterinary drugs of label or manual, should to Chinese indicate veterinary drugs of general name, and components and content, and specifications, and production enterprise, and products approved paper, (imports veterinary drugs registered card,), and products batch, and production date, and validity, and indications or function attending, and usage, and dosage, and Hugh drug period, and taboo, and bad reaction, and note matters, and transport storage custody conditions and the other should description of content.
Trade names shall also indicate the trade name.
Except Qian paragraph provides of content outside, beast with prescription drug of label or manual also should printing has State Veterinary Administration sector provides of warning content, which beast with anesthesia drug, and spirit drug, and toxicity drug and radioactive drug also should printing has State Veterinary Administration sector provides of special logo; beast with non-prescription drug of label or manual also should printing has State Veterinary Administration sector provides of non-prescription drug logo. 21st veterinary administrative departments under the State Council, according to guarantee the quality and safety of animal products and the needs of human health, could be established for new veterinary drugs are not more than 5-year monitoring period; during the monitoring period, shall not be approved for production or import the new veterinary drugs.
Production enterprises should be collected during the monitoring period the new veterinary drug efficacy and adverse reaction data, and timely submitted to the veterinary administrative departments under the State Council.
Fourth chapter veterinary drugs business 22nd article business veterinary drugs of enterprise, should has following conditions: (a) and by business of veterinary drugs phase adapted of veterinary drugs technicians; (ii) and by business of veterinary drugs phase adapted of business places, and equipment, and warehouse facilities; (three) and by business of veterinary drugs phase adapted of quality management institutions or personnel; (four) veterinary drugs business quality management specification provides of other business conditions.
Comply with the conditions prescribed in the preceding paragraph, the applicant may apply to a municipal or county administrative departments, and attached in accordance with the conditions prescribed in the preceding paragraph prove that materials management of biological products for animal uses shall be made to the veterinary Administrative Department under the people's Governments of provinces, autonomous regions and municipalities to apply, and evidence of sufficient attached in accordance with the conditions prescribed in the preceding paragraph. Local veterinary Administrative Department under the people's Governments at or above the county level, shall be completed within 30 working days from the date of receipt of the application for review. Examination, to veterinary drugs operating permits; failed, it shall notify the applicant in writing.
Applying for registration by the veterinary drugs business license.
23rd veterinary drugs operating permit shall set forth the scope of business, business location, expiration date and name of the legal representative and address issues. Veterinary drugs operating license is valid for 5 years.
Has expired, the need to continue operating veterinary drugs should be 6 months before the expiry date of the permit to the original certificate authority for the renewal of the veterinary drug license.
Article 24th of veterinary drug enterprises change business, place of business, this 22nd of the Ordinance shall be in accordance with the provisions of articles applying for renewal of the veterinary drug business license, the applicant renewed change of business licenses for industrial and commercial registration of veterinary drugs; change of company name, legal representative shall, within 15 working days of registration procedures for business change, to the original certificate authority for the renewal of the veterinary drug license.
25th of veterinary drug enterprises shall comply with the specification for quality control of veterinary drugs for veterinary administrative departments under the State Council.
Local veterinary Administrative Department under the people's Governments at or above the county level, veterinary drug enterprises should meet the requirements of specification for quality control of veterinary drugs carry out supervision and inspection, and to publish the results of inspection.
26th of veterinary drug enterprises purchasing veterinary drugs, veterinary products and product labels or instructions, product certificate of quality check. 27th of veterinary drug enterprises, should explain to the purchaser veterinary drug indications, usage, dosage and precautions.
Sales of veterinary prescription drugs shall comply with veterinary use prescription management. Business sales of veterinary drugs, veterinary Chinese herbal medicine, you should indicate the origin.
Banned veterinary drug distribution business and the false and inferior veterinary drugs pharmaceuticals for human use. The 28th business purchase and sale of veterinary drugs veterinary drugs, records should be established.
Records shall contain the veterinary drug product name, generic name, dosage form, specifications, batch number, expiry date, manufacturers, buying and selling units, the number of purchases and sales, purchase and sale dates and other matters of veterinary administrative departments under the State Council.
Article 29th of veterinary drug enterprises, veterinary drugs-keeping system should be established, to take the necessary refrigeration, freezing, moisture-proof, pest control, prevention measures such as keeping the operating quality of veterinary drugs.
Veterinary medicine storage, a library, shall perform inspection and acceptance system, and an accurate record.
Article 30th compulsory immunization required veterinary Biologics business, shall conform to the veterinary administrative departments under the State Council. 31st veterinary drug advertising content shall be consistent with the specification of veterinary drugs, veterinary drug advertising in key national media shall be subject to veterinary administrative departments under the State Council for examination and approval, obtain advertising review approval of veterinary drugs.
Of veterinary drug advertising in the local media, shall be subject to veterinary Administrative Department under the people's Governments of provinces, autonomous regions and municipalities approved access to veterinary drug advertising review approval number; without approval, shall not be published. Fifth chapter veterinary drugs import and export 32nd article first to China export of veterinary drugs, by export party standing China territory of do institutions or its delegate of China territory agent institutions to State Veterinary Administration sector application registered, and submitted following information and items: (a) production enterprise where national (area) veterinary drugs management sector approved production, and sales of proved file; (ii) production enterprise where national (area) veterinary drugs management sector issued of meet veterinary drugs production quality management specification of proved file; (three) veterinary drugs of manufacturing method
, And production process, and quality standard, and detection method, and pharmacological and HIV acting test results, and clinical test report, and stability test report and the other related information; for edible animal of veterinary drugs of Hugh drug period, and highest residues limited standard, and residues detection method and developed according to, information; (four) veterinary drugs of label and manual sample; (five) veterinary drugs of samples, and control products, and standard products; (six) environment effect report and pollution control measures; (seven) involved veterinary drugs security of other information.
Veterinary Biologics applications for exports to China, should also provide bacteria (virus, insect) species, cells and other relevant materials and information. Article 33rd veterinary administrative departments under the State Council shall, within 10 working days of receipt of the application organized preliminary review. Following a preliminary examination, decision of admissibility should be send information through the establishment of veterinary medicine veterinary medicine accreditation agencies review the veterinary drug samples to send their designated Inspection Agency verification and receipt of review and verification completed within 60 working days of the conclusion of the review.
Examination and issue the certificate of registration of veterinary drugs imported, and publish the quality standards of veterinary drugs; not qualified, shall notify the applicant in writing.
In the process of reviewing, and veterinary Administrative Department under the State Council can export to China of veterinary drug enterprises to meet the requirements of veterinary drug manufacturing practices examined and veterinary Administrative Department under the State Council may require the enterprise designated bodies for the veterinary drug safety and efficacy tests.
Urgent need of veterinary drugs, a small amount of domestic scientific research veterinary medicine or registered veterinary drug samples, controls, and standards, import, shall be handled in accordance with veterinary administrative departments under the State Council. Article 34th imported veterinary drug registration certificate is valid for 5 years.
Has expired, the need to continue to export to China of veterinary drugs, shall, before the expiry of 6 months to the original certificate, apply for registration. 35th foreign enterprises in China direct sales of veterinary drugs.
Foreign companies in China, sales of veterinary drugs, should be set up according to law in China sales offices within China or entrust a qualified agency. Imports in China has made imports veterinary drugs registered certificate of beast with biological products of, China territory agent institutions should to State Veterinary Administration sector application allows imports beast with biological products proved file, by allows imports beast with biological products proved file to port location Government veterinary administration sector handle imports veterinary drugs clearance single; imports in China has made imports veterinary drugs registered certificate of other veterinary drugs of, by imports veterinary drugs registered certificate to port location Government veterinary administration sector handle imports veterinary drugs clearance single. Customs customs clearance of imported veterinary drugs release.
Veterinary import management approach developed by the veterinary administrative departments under the State Council in conjunction with the General Administration of customs. Veterinary biological products after importation, this 19th of the Ordinance shall be in accordance with the provisions of article review check and inspection.
Other veterinary drugs imported by the local veterinary administrative departments shall notify the veterinary drug inspection institutions to conduct random testing.
36th article ban imports following veterinary drugs: (a) efficacy not determine, and bad reaction big and may on aquaculture, and human health caused against or exists potential risk of; (ii) from area may caused blight in China territory spread of beast with biological products; (three) by test production conditions not meet provides of; (four) State Veterinary Administration sector ban production, and business and using of.
The 37th to export veterinary medicine outside China, provide veterinary drug export documentation requirements of the importing party, and veterinary Administrative Department under the State Council, or seat of the enterprise of the province, autonomous region, municipality directly under the veterinary Administrative Department under the people's Government may issue export certificates of veterinary drugs.
Domestic prevention of urgently needed vaccines and veterinary Administrative Department under the State Council may restrict or prohibit the export.
Sixth chapter article 38th of veterinary drugs veterinary drugs the use of units shall comply with veterinary administrative departments under the State Council for safe use of veterinary drugs regulations, and establish a record of drug use. 39th prohibits the use of false and inferior veterinary drugs and veterinary Administrative Department under the State Council prohibiting the use of drugs and other compounds.
The prohibition of the use of medicines and other compounds directory published by the veterinary administrative departments under the State Council.
The 40th when the withdrawal period for veterinary drugs used in food animals, breeders should be to the purchaser or Slayer provides accurate, real-world use of drugs recorded buyers or slaughter shall ensure that animals and their products in the use of drugs, the withdrawal period is not used for food consumption.
41st veterinary administrative departments under the State Council, is responsible for the development of published drug feed additives in feed allows you to add list of varieties.
Ban added hormones in drinking water in feed and animal drugs and veterinary Administrative Department under the State Council of other banned drugs. Approved to add veterinary drugs in animal feed should be made of a veterinary drug manufacturers drug feed additives before they can add.
Banned APIs directly added to the feed and animal drinking water or direct-fed animals.
For pharmaceuticals for human use of animals is prohibited.
42nd veterinary administrative departments under the State Council, should develop and implement national animals and animal products veterinary drug residue control plan. Veterinary Administrative Department under the people's Governments above the county level, and is responsible for organizing the detection of veterinary drug residues in animal products.
Veterinary drug residue, veterinary administrative departments under the State Council or provincial, autonomous region or municipality veterinary administrative departments in accordance with the permissions to the public.
Animal disagrees with the producer or seller of the product on the test results, since receiving the test results within 7 working days from the date of implementation of veterinary drug residues of veterinary administrative departments or the superior administrative departments to apply, inspection agencies specified by the Administrative Department for accepting applications for review.
Residues and residue limits for veterinary drugs, issued by the veterinary administrative departments under the State Council.
43rd article banning the sale of illegal drugs or eating animal products veterinary drugs residues exceeded the standard.
Seventh chapter of veterinary drugs regulatory 44th veterinary Administrative Department under the people's Governments above the county level shall exercise the right of supervision and management of veterinary drugs. Veterinary inspection veterinary administrative departments under the State Council and provinces, autonomous regions and municipalities established by the Veterinary Administration of veterinary drug inspection institutions.
Veterinary administrative departments under the State Council, based on the need to identify the other testing agencies testing of veterinary drugs.
Party disagrees with the veterinary drug test results, since receiving the test results within 7 working days of the date the inspection agencies or by the Veterinary Administration established by the inspection body for review.
Article 45th shall conform to the national standards for veterinary drugs veterinary drugs.
National veterinary Pharmacopoeia Committee, veterinary administrative departments under the State Council published the People's Republic of China veterinary code and other veterinary drugs veterinary administrative departments under the State Council issued national standards quality standards for veterinary drugs.
National standards of veterinary drugs standard and standard demarcation established by the veterinary administrative departments under the State Council of veterinary drug inspection bodies. 46th article veterinary administration sector law for supervision check Shi, on has evidence proved may is fake, and bad veterinary drugs of, should take seized, and seized of administrative forced measures, and since take administrative forced measures of day up 7 a days within made whether filed of decided; need test of, should since test report book issued of day up 15 a days within made whether filed of decided; not meet filed conditions of, should lifted administrative forced measures; need suspended production, and business and using of,
Veterinary administrative departments under the State Council or provincial, autonomous region or municipality veterinary administrative departments in accordance with permission to make a decision.
Without the decision of compulsory administrative measures or by a superior authority, are not allowed to transfer, use, destruction, sale or seizure related to veterinary drugs and seized materials.
47th under any of the following circumstances, as fake veterinary drugs: (a) non-veterinary drug posed as veterinary drugs or other veterinary drugs to imitate such veterinary drugs, (ii) type of veterinary drug ingredients, names are incompatible with national standards for veterinary drugs.
Has following case one of of, according to fake veterinary drugs processing: (a) State Veterinary Administration sector provides ban using of; (ii) in accordance with this Ordinance provides should by review approved and without review approved that production, and imports of, or in accordance with this Ordinance provides should by checks test, and review check and without checks test, and review check that sales, and imports of; (three) metamorphic of; (four) was pollution of; (five) by marked of indications or function attending beyond provides range of.
48th under any of the following circumstances, for inferior veterinary drugs: (a) the content does not meet state standards or does not identify a valid component of veterinary drugs, (ii) that do not specify or change your valid or expired, (iii) does not indicate or change the product lot number; (d) does not meet the standards of veterinary drugs, but not fake veterinary drugs.
49th prohibited veterinary drug standardizes sales or sales to entities and individuals outside of the veterinary drug manufacturers.
Prohibited without veterinary prescription sales, purchase or use of prescription drug management of veterinary administrative departments under the State Council of veterinary drugs.
50th State practices of veterinary drug adverse reaction reporting system.
Veterinary drug manufacturers, drug distributors and veterinary drug use and prescribing of veterinary staff found that may be related to serious adverse reactions related to the use of veterinary drugs, shall immediately report to the local veterinary Administrative Department under the people's Government.
51st veterinary drug manufacturers, drug distributors to stop production, shut down or operated for more than 6 months, by the original issuing authorities shall order him to return it to veterinary drug production licenses, veterinary medicine license, and industrial and commercial administrative departments to change or cancellation of their registration.
52nd veterinary drug production prohibits the sale, rental, lending licenses, license for veterinary drugs and veterinary drug approval document.
53rd review test items and standards of veterinary drugs, developed by the financial departments of the State Council Department in charge of price under the State Council, and shall be published.
54th levels of veterinary administrative departments, veterinary inspection body and its staff shall not participate in veterinary drugs production and business activities, not to recommend or supervise, supervision of sales of veterinary drugs on their behalf.
Eighth chapter legal liability article 55th veterinary administrative departments and functionary convenience charge on other people's property, or seeking other interests, does not meet the statutory conditions of unit and individual licensing approval, signature, does not carry out its oversight responsibilities or that the violation is not investigated, resulting in serious consequences, constitute a crime, criminal responsibility shall be investigated according to law; do not constitute a crime, administrative sanctions according to law. 56th article violation this Ordinance provides, no veterinary drugs production license, and veterinary drugs business license production, and business veterinary drugs of, or is has veterinary drugs production license, and veterinary drugs business license, production, and business fake, and bad veterinary drugs of, or veterinary drugs business enterprise business people with drug of, ordered its stop production, and business, confiscated for illegal production of raw materials, and accessories, and packaging material and the production, and business of veterinary drugs and illegal proceeds, and at illegal production, and business of veterinary drugs (including has sold of and not sold of veterinary drugs, With) goods value amount twice times above 5 times times following fine, goods value amount cannot check verified of, at 100,000 yuan above 200,000 yuan following fine; no veterinary drugs production license production veterinary drugs, plot serious of, confiscated its production equipment; production, and business fake, and bad veterinary drugs, plot serious of, revoked veterinary drugs production license, and veterinary drugs business license; constitute crime of, law held criminal; to others caused loss of, law bear compensation responsibility.
Production and management enterprises of main head and persons directly in charge of life shall not be engaged in the production and marketing of veterinary drugs.
Compulsory vaccination required for the production of biological products for animal uses without authorization, in accordance with the production of veterinary drugs veterinary drugs production license-free punishments. 57th in violation of the provisions of this Ordinance, to provide false information, samples or other fraudulent means to obtain veterinary drug production licenses business licenses or veterinary drug approval document, veterinary medicine, veterinary drug production licenses revoked, veterinary license or revocation of veterinary drug approval document, and fines of between 50,000 yuan and 100,000 yuan and cause damage to others shall bear liability.
Its principals and staff life engaged in veterinary drugs directly in charge of production, management and import and export activities.
58th sold, leased, lent veterinary drugs production permits, business licenses and veterinary drugs veterinary drugs approval documents, confiscate the illegal income, and fined a maximum of between 100,000 yuan and 10,000 yuan in serious cases, veterinary drug production licenses revoked business licenses or revocation of approval of veterinary drugs, veterinary medicine documents constitute a crime, criminal responsibility shall be investigated according to law; cause damage to others shall bear liability.
59th article violation this Ordinance provides, veterinary drugs security evaluation units, and clinical test units, and production and business enterprise not according to provides implementation veterinary drugs research test, and production, and business quality management specification of, give warning, ordered its deadline corrected; late not corrected of, ordered stop veterinary drugs research test, and production, and business activities, and at 50,000 yuan following fine; plot serious of, revoked veterinary drugs production license, and veterinary drugs business license; to others caused loss of, law bear compensation responsibility.
Violation of these regulations, does not meet the prescribed conditions of development of new veterinary drugs used for a class of pathogenic microorganisms or the laboratory prior to approval, ordered to stop the experiment, and fines of between 50,000 yuan and 100,000 yuan constitutes a crime, criminal responsibility shall be investigated according to law; cause damage to others shall bear liability.
60th in violation of the provisions of this Ordinance, labeling and use instruction of veterinary drugs without approval, shall be ordered to correct within; it fails, in accordance with production, management of fake veterinary drugs penalty veterinary drug product approval number, revocation of veterinary drug product approval number and cause damage to others shall bear liability.
Veterinary medicine does not bear a label on the packaging and manuals, or labels and not consistent with the approved content, ordered to rectify serious cases, in accordance with the provisions of the preceding paragraph.
61st in violation of these regulations, foreign companies in China, direct sales of veterinary drugs, ordered to rectify, confiscation of direct sales of veterinary drugs and the illegal gains and fines of between 50,000 yuan and 100,000 yuan in serious cases, suspension of importing veterinary drug registration certificate; cause damage to others shall bear liability.
62nd article violation this Ordinance provides, not according to national about veterinary drugs security using provides using veterinary drugs of, and not established medication records or records not full real of, or using ban using of drug and other compounds of, or will people with drug for animal of, ordered its immediately corrected, and on feeding has prohibited drug and the other compounds of animal and products for harmless of processing; on illegal units at 10,000 yuan above 50,000 yuan following fine; to others caused loss of, law bear compensation responsibility.
63rd article violation this Ordinance provides, sales is in medication period, and Hugh drug period within of animal and products for food consumption of, or sales contains prohibited drug and veterinary drugs residues exceeded of animal products for food consumption of, ordered its on contains prohibited drug and veterinary drugs residues exceeded of animal products for harmless of processing, confiscated illegal proceeds, and at 30,000 yuan above 100,000 yuan following fine; constitute crime of, law held criminal; to others caused loss of, law bear compensation responsibility.
64th in violation of the provisions of this Ordinance, without authorization, transfer, use, destruction, sale of seized or seizure related to veterinary drugs and materials, ordered to stop the illegal practice, given a warning and a fine below 50,000 yuan and 100,000 yuan.
The 65th in violation of the provisions of this Ordinance, producing enterprises, trading enterprises and use of veterinary drugs veterinary drugs and prescription veterinary staff found that may be related to serious adverse reactions related to the use of veterinary drugs, do not report to the local veterinary Administrative Department under the people's Governments, given a warning and fined a maximum of 5000 Yuan and 10,000 yuan.
Production enterprises in the monitored period of new veterinary drugs is not collected or not submitted in a timely manner the new veterinary drugs the efficacy and adverse reaction data, ordered to rectify, and fined a maximum of between 50,000 yuan and 10,000 yuan in serious cases, revocation of the new animal drug product approval number.
66th in violation of the provisions of this Ordinance, without a veterinary prescription sales, purchase and use of veterinary prescription drugs, ordered to rectify, confiscate the illegal gains and fines of between 50,000 yuan and cause damage to others shall bear liability. 67th article violation this Ordinance provides, veterinary drugs production, and business enterprise put raw materials drug sales to veterinary drugs production enterprise yiwai of units and personal of, or veterinary drugs business enterprise standardizes sales raw materials drug of, ordered its immediately corrected, give warning, confiscated illegal proceeds, and at 20,000 yuan above 50,000 yuan following fine; plot serious of, revoked veterinary drugs production license, and veterinary drugs business license; to others caused loss of, law bear compensation responsibility.
68th article violation this Ordinance provides, in feed and animal drinking water in the added hormone class drug and State Veterinary Administration sector provides of other disabled drug, in accordance with feed and feed additives Management Ordinance of about provides punishment; directly will raw materials drug added to feed and the animal drinking water in the, or feeding animal of, ordered its immediately corrected, and at 10,000 yuan above 30,000 yuan following fine; to others caused loss of, law bear compensation responsibility.
69th under any of the following circumstances to remove imported veterinary drugs veterinary drug product approval number or revoked certificate of registration: (a) failed to pass the test 2 times in a row; (b) the efficacy, adverse reactions, and possible uncertainty of farming, human health risk, or potential risk, (iii) the veterinary administrative departments under the State Council banned production, marketing and use of veterinary drugs. Revoked approval numbers imported or been revoked certificate of registration of veterinary drugs veterinary drugs, may not continue production, import, marketing and use.
Have been produced, imported, the local veterinary administrative departments supervise the destruction, the costs borne by the violation and cause damage to others shall bear liability.
70th administrative penalties stipulated in these regulations are decided by the veterinary Administrative Department under the people's Governments above the county level; veterinary drug production licenses revoked, veterinary medicine license, revoke veterinary drug approval document or to order the suspension of veterinary studies, by the original certification, approval decision.
Superior veterinary administrative departments at lower levels of the Administration the administrative acts in contravention of this Ordinance, shall be ordered to correct; it fails to have the power to alter or annul.
The 71st article of the regulations amount to an offence in the value of production, management of veterinary drugs the price calculation; no price, in accordance with the market prices of similar veterinary drugs.
Nineth chapter schedule 72nd article this Ordinance following terms of meaning is: (a) veterinary drugs, is refers to for prevention, and treatment, and diagnosis animal disease or has destination regulation animal physiological function of material (containing drug feed additives), main including: serum products, and vaccine, and diagnosis products, and micro-ecological products, and Chinese herbal medicines, and proprietary Chinese medicines, and chemical drug, and antibiotics, and biochemical drug, and radioactive drug and the topical pesticides, and disinfectant,.
(B) veterinary prescription drugs refers to veterinary medicine prescriptions may purchase and use of drugs.
(C) veterinary non-prescription medicine, refers to the veterinary administrative departments under the State Council and published by, does not need a veterinary prescription veterinary drugs can be used to purchase and follow the instructions.
(D) veterinary drug manufacturers, refers to the enterprise and specializes in the production of veterinary drugs and animal drugs production enterprise, including enterprise engaged in the packaging of veterinary drugs.
(E) the veterinary drugs business, refers to enterprises exclusively or partly engaged in veterinary medicine business enterprise.
(F) a new veterinary drug, refers to has not been listed in China sales of veterinary medicines.
(VII) veterinary drug approval document, refers to the approval number, imported veterinary drugs veterinary drug product registration certificate, allowing import of biological products for animal uses documents, export certificates of veterinary drugs, new veterinary drug registration certificates and other documents.
73rd veterinary narcotic drugs, psychotropic drugs, toxic drugs and radioactive drugs, special drugs, in accordance with the relevant provisions of the State administration.
The 74th bar use of veterinary drugs in aquaculture, veterinary drug residues and supervising administrative penalties and the illegal use of drugs in aquaculture, fisheries authorities above the county level people's Governments and their respective fishery management agencies. 75th these regulations come into force on November 1, 2004.