Registered Veterinary Measures
(November 24, 2004 the Ministry of Agriculture issued Decree No. 44, since January 1, 2005 shall come into force)

Chapter I General Provisions
The first veterinary drug to ensure the safety, efficacy and quality control, regulate veterinary registration act, according to the "Veterinary Regulations", to develop this approach.
Article in the PRC engaged in registration of new veterinary drug registration and import of veterinary drugs shall comply with these measures.
Ministry of Agriculture is responsible for third country veterinary drug registration.
Ministry of Agriculture, Veterinary Review Committee is responsible for registration of new veterinary drugs and import of veterinary assessment data.
China Institute of Veterinary Drug Control and the Ministry of Agriculture and other veterinary inspection agencies designated to bear the review of registered veterinary inspection.
Chapter II Registration of new veterinary drug
Article in new veterinary drug registration applicant shall complete the clinical trial, apply to the Ministry of Agriculture, according to "veterinary registration request" to submit relevant information.
Article joint development of new veterinary drug, can apply for registration by one unit or a joint application for registration, but shall not repeat the application for registration; joint application for registration shall be co-signed as the new veterinary applicants.
Article submitted registration applications for new veterinary drug information should be complete, standardized, data must be truthful and reliable. Works of literature cited should indicate the name, publication name and volume number, issue, page, etc.; unpublished literature should provide information on the owner's permission to use documents; foreign materials shall request a Chinese translation.
Apply for a new veterinary drug registration, the applicant shall submit an undertaking that the intellectual property of others does not constitute an infringement and may be responsible for the consequences of infringement, to obtain the test data to ensure their own authenticity.
Test for disclosure of information with foreign veterinary research data, shall be attached to information provided by research institutions outside the project, note the page number and the agency's legal registration notarized documents.
Article one of the following circumstances of the new veterinary drug registration application shall be rejected:
(A) the Ministry of Agriculture has announced in the monitoring period, the applicant can not prove that the data obtained for his veterinary medicine;
(B) obtained by genetic engineering techniques, is not inactivated by biological safety evaluation of vaccines, diagnostic products outside of the veterinary drugs;
(C) the application materials do not meet the requirements within the required period, no correction of;
(D) not be accepted in other cases.
Article VIII of the Ministry of Agriculture since the date of receipt of the application within 10 working days, will determine the admissibility of applications for registration of new veterinary information sent to the Ministry of Agriculture Veterinary Technical Review Committee review and notify the applicant to submit the required continuous review of test three production batches of samples and relevant information, to send the designated inspection agency for review veterinary inspection.
Application of new biological products, veterinary drugs are necessary to deal with the kinds of drug testing.
Article IX Department of Agriculture Veterinary Committee shall review the information received from the date of 120 working days to review comments submitted to the Ministry of Agriculture.
Review additional information is required, the applicant shall receive notification within 6 months from the date of the relevant data filled; overdue correction, and as to withdraw the application for registration.
Article veterinary inspection agency shall complete the review within the specified time test, and review the inspection report and the views served on the applicant, while the Ministry of Agriculture reported that the Ministry of Agriculture and Veterinary Medicine Committee for the Review.
Initial sample test failed, the applicant can test sending a sample for review.
Ministry of Agriculture, Article XI of receipt of technical evaluation and review of inspection findings within 60 working days from the date of completion of the review; if necessary, can be sent on-site verification. Review of qualified, be given a "certificate of registration of new veterinary drugs", and make an announcement, also released the new veterinary drug standards, labels and instructions. Failed, notify the applicant in writing.
Article XII of the new veterinary drug registration and approval period, the technical requirements for new animal drugs for the same species in the offshore market and allowed changes, according to the original technical requirements for approval.
Chapter III Registration of veterinary drugs imports
Article XIII of the first veterinary drug exports to China should be decided by the exporter in the territory of China or its offices within the agency commissioned by the Chinese Ministry of Agriculture to apply, fill out the "Application Form for registration of veterinary drugs", and press "Veterinary registration request "to submit relevant information.
Application to China's export of veterinary biological products, should also provide bacteria (viruses, worms) species, cells and other relevant materials and information.
Article 14 When applying import registered veterinary preparation, the preparation must be provided for the production of bulk drugs and excipients, direct contact with the veterinary drug packaging materials and containers legitimate source documents. API has not yet obtained approval from the Ministry of Agriculture, the API must also apply for registration, and shall be submitted to the production process, quality indicators and testing methods and other research materials.
Article XV of the submitted registration application for imported veterinary drug information should be complete, standardized, data must be truthful and reliable. Works of literature cited should indicate the name, publication name and volume number, issue, page, etc.; foreign materials shall request a Chinese translation.
Article XVI of the Ministry of Agriculture from the receipt of the application within 10 working days from the date of initial review organization, qualified by the preliminary examination, to be admissible, a written notice to the applicant.
Be accepted, the Ministry of Agriculture to import veterinary drug registration information sent to the Ministry of Agriculture Veterinary Technical Review Committee review and notify the applicant to submit the required review of testing three consecutive production batches of samples and relevant information, to send a specified veterinary inspection and testing agency for review.
Article 17 of the following cases imported veterinary drug registration application shall be rejected:
(A) the Ministry of Agriculture has announced in the monitoring period, the applicant can not prove that the data obtained for his veterinary medicine;
(B) obtained by genetic engineering techniques, is not inactivated by biological safety evaluation of vaccines, diagnostic products outside of the veterinary drugs;
(C) provides a class of diseases in China and domestic disease live vaccine did not occur;
(D) of the disease from infected areas in China may cause the spread of veterinary biological products;
(E) The application does not meet the requirements of data, no correction is made within the required period of;
(F) shall not accept in other circumstances.
Article 18 The import of veterinary drug registration procedures for the assessment and testing methods applicable to the provisions of Articles 9 and 10.
Article 19 The registration application for imported veterinary chemicals, should be specified in the People's Republic of clinical trials and related institutions residue method validation; if necessary, may request the Ministry of Agriculture to eliminate residue test to determine the withdrawal period.
Application for registration of veterinary drugs are imported biological products, the Ministry of Agriculture may request the designated agency in the PRC for the safety and efficacy trials.
Diershitiao received from the Ministry of Agriculture technical assessment and review of inspection findings within 60 working days from the date of completion of the review; if necessary, can be sent on-site verification. Review of qualified, be given a "import veterinary certificate of registration", and make an announcement; China, Hong Kong, Macao and Taiwan manufacturers to apply for registration of veterinary drugs, issued "certificate of registration of veterinary drugs." Review failed, notify the applicant in writing.
Ministry of Agriculture approved the import of veterinary drugs registered at the same time, release the import veterinary drugs approved standards and product labeling, instructions.
Twenty-one application for the Ministry of Agriculture veterinary drugs registered for import risk analysis, risk analysis after a security risk, not registered.
Chapter IV Registration of veterinary drugs change
Article 22 has been registered veterinary matters to be to change the original approval, it shall apply to the Ministry of Agriculture to change registration of veterinary drugs.
Article 23 The registration of applicants for change, should fill out the "Change veterinary drug registration application form", submitted to the relevant information and instructions. Involves changes in ownership of veterinary products, should provide valid documents.
Changes in import veterinary drugs registered, the applicant shall also submit the manufacturer country (region) Veterinary approval to change the file.
Article 24 The Ministry of Agriculture decided to accept the need for changes in the technical review of applications for registration of veterinary drugs, from the date of receipt of the application within 30 working days to complete the review. Review of qualified, approved changes to registration.
The need for changes in the technical review of applications for registration of veterinary drugs, the Ministry of Agriculture will accept materials sent to the Ministry of Agriculture Veterinary Review Committee review and notify the applicant to submit the required review of testing three consecutive production batches of samples and relevant information, sent to the designated inspection agency for review veterinary inspection.
Article 25 The application for registration of veterinary drugs to change the assessment, inspection procedures, time limits and requirements apply to the way the new veterinary drug registration and import of veterinary drugs registration.
Change application to modify the standard registration of veterinary drugs, veterinary inspection agency should be the standard review.
Article 26 The Ministry of Agriculture of receipt of technical evaluation and review of inspection findings within 30 working days to complete the review, review of qualified, approved changes to registration. Review failed, inform the applicant in writing.
Chapter imports for re-registration of veterinary drugs
Article 27 "import veterinary certificate of registration" and "veterinary registration certificate" is valid for 5 years. Expiry of the need to continue to import, the applicant shall be six months before the expiry of the Ministry of Agriculture in the re-registration.
Article 28 re-registration application for imported veterinary drugs should fill out the "Application Form for Re-registration of veterinary drugs," according to "veterinary drug registration request" to submit relevant information.
Article 29 The Ministry of Agriculture and then accepting the application for registration of imported veterinary medicine, shall be completed within 20 working days to review. Compliance, to be re-registered. Non-compliance, notify the applicant in writing.
Article 30 of the following circumstances, shall not be registered:
(A) is not in the six months before the expiry of the re-registration application;
(B) failing to submit monitoring reports of adverse reactions of veterinary drugs;
(C) the safety re-evaluation by the Ministry of Agriculture is listed as prohibited species;
(D) examine the conditions of production by non-compliance;
(E) The risk analysis of security risks;
(F) provides a class of diseases in China and domestic disease live vaccine did not occur;
(G) from infected areas in China may cause the spread of the disease veterinary biological products;
(H) Other law not re-registered.
Article 31 not re-registered by the Ministry of Agriculture canceled its "import veterinary certificate of registration" or "veterinary certificate of registration", and announce it.
Veterinary inspection and review of Chapter VI
Article 32 shall apply for registration of veterinary drugs for veterinary inspection and review, including sample tests and veterinary quality standards review.
Article 33 review of inspection of veterinary drugs in veterinary inspection agencies, veterinary inspection shall comply with quality management standards.
Article 34 The applicant shall provide veterinary inspection agencies to veterinary inspection and the need to review the relevant information and samples, with standard material and provide the necessary test materials.
Veterinary drug registration application required three batches of samples, should be made "Certificate of GMP," the workshop production. Each batch of samples should be marketed to the three smallest packaging, and to test the amount of 3 to 5 times.
Article 35 veterinary veterinary inspection agency for quality standards review, in addition to the samples tested, but also veterinary drugs should be based on the research data, domestic and foreign similar products, veterinary drug quality standards and national requirements, the veterinary quality standards of veterinary drugs, and methods of test items for review comments.
Article 36 veterinary inspection agency receiving notification and sample inspection, shall be completed within 90 working days to sample test, issue an inspection report; require special methods of veterinary inspection shall be completed within 120 working days.
The need for sample testing and review of quality standards of veterinary drugs, veterinary inspection agency shall be completed within 120 working days; require special methods of veterinary inspection shall be completed in 150 working days.
Chapter VII of the management of veterinary reference material
Article 37 Chinese Veterinary Drug Control is responsible for calibration and supply of national veterinary reference material.
China Institute of Veterinary Drug Control can organize the relevant provinces, autonomous regions and municipalities to monitor the veterinary, veterinary research institute or national veterinary veterinary medicine production enterprise collaboration calibration standard material.
Article 38 The applicant in the registration applications for new veterinary drug registration and import of veterinary drugs, veterinary drugs should be monitored to provide Chinese preparation of the standard veterinary raw material and material submitted to the standards of research data.
Article 39 of the China Institute of Veterinary Drug Control standard veterinary raw material selection, preparation methods, calibration methods, calibration results, valuation accuracy, traceability, stability and conditions of packing and packaging materials to conduct a comprehensive technical audit ; necessary, for calibration or calibration organizations, and could make as a matter of national quality standards for veterinary drugs recommended conclusion, the State Veterinary Pharmacopoeia Commission for review.
Article 40 The Ministry of Agriculture's National Veterinary Pharmacopoeia Committee review comments approved national quality standards for veterinary drug substances and publish the list of substances veterinary standards and quality standards.
Chapter VIII Penalties
Article 41 applicant provides false information, samples or by other fraudulent means to apply for registration, the Ministry of Agriculture does not approve the application, the applicant be given a warning, the applicant shall not re-apply within one year of the veterinary drug registration.
The applicant provided false information, samples or by other fraudulent means to obtain documentary proof of registration of veterinary drugs, according to the "Veterinary Regulations" provisions of Article 57 be punished, the applicant may not apply again within three years of the veterinary drug registration .
Article 42 other violation of the provisions of the act, in accordance with the "Veterinary Regulations" of the relevant provisions of punishment.
Chapter IX Supplementary Provisions
Article 43 belongs to veterinary narcotic drugs, psychotropic substances veterinary, veterinary medicinal toxic drugs, radioactive drugs, veterinary drugs and import of new veterinary drug registration, except in accordance with the Measures for, should also comply with other relevant provisions.
Article 44 Based on animal epidemic prevention needs, the Ministry of Agriculture National Veterinary Reference Laboratory for compulsory vaccination with the recommended vaccine used in bacteria (viruses) changes in registration and recording system without the need to change the registration.
Article 45 These Measures January 1, 2005 shall come into force.

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