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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II REGISTRATION OF NEW VETERINARY DRUGS CHAPTER III REGISTRATION OF IMPORTED VETERINARY DRUGS CHAPTER IV ALTERATION REGISTRATION OF VETERINARY DRUGS CHAPTER V RE-REGISTRATION OF IMPORTED VETERINARY DRUGS CHAPTER VI CHECKING AND INSPECTION ON VETERINARY DRUGS CHAPTER VII ADMINISTRATION ON STANDARD SUBSTANCES OF VETERINARY DRUGS CHAPTER VIII PENALTIES CHAPTER IX SUPPLEMENTARY PROVISIONS CHAPTER I GENERAL PROVISIONS Article 1. The present Measures are formulated in accordance with the Regulation on the Administration of Veterinary Drugs for the purpose of ensuring the safety, effectiveness and quality control of veterinary drugs and regulating the acts of veterinary drug registration. Article 2. The present Measures shall be abided by for the undertaking of registration of new veterinary drugs and registration of imported drugs within the territory of the People's Republic of China. Article 3. The Ministry of Agriculture shall be responsible for the work of veterinary drug registration. The veterinary drug appraisal committee under the Ministry of Agriculture shall be responsible for the appraisal of the registration materials of new veterinary drugs and imported veterinary drugs. The China Institute of Veterinary Drug Control and other veterinary drug inspection institutions designated by the Ministry of Agriculture shall undertake the work of checking and inspecting the registration of veterinary drugs. CHAPTER II REGISTRATION OF NEW VETERINARY DRUGS Article 4. An applicant for the registration of any new veterinary drug shall, after completing clinical tests, file an application to the Ministry of Agriculture, and submit the relevant materials in accordance with the Requirements for the Registration Materials of Veterinary Drugs. Article 5. For any new veterinary drug jointly developed, the registration may be applied for by any of the entities or applied for jointly, but no repetitive registration is allowed; where the entities apply jointly for registration, they shall sign their names together with the applicants of the new veterinary drug. Article 6. When applying for the registration of any new veterinary drug, the materials submitted shall be complete and standard, and the data shall be authentic and reliable. In case any literature and materials are cited, the name of the works or periodicals and the volume, period, and page shall be indicated; for the literature and materials that have not been published to the general public, the certificate documents for allowing the owners of the materials to use shall be provided; for foreign language materials, a Chinese version shall be provided as required. When applying for the registration of any new veterinary drug, an applicant shall submit a guaranty, promising that no intellectual property right of any other person is infringed upon and that it shall be held liable for the consequences of the infringement, if any, and shall ensure the authenticity of the testing data it has obtained by itself. In case any overseas veterinary drug testing research materials are included in the application materials, the statements on the items and pages of the materials provided by the overseas research institution and the lawful registration certificate documents that have been notarized shall be attached. Article 7. In any of the following circumstances, the application for the registration of any new veterinary drug shall be rejected: (1) The veterinary drug is in the monitoring period announced by the Ministry of Agriculture, but the applicant is unable to prove that the data are obtained by itself; (2) The veterinary drug outside the inactivated vaccine and the diagnosis products, which are obtained through genetic engineering technology, but fail to pass through the biological safety appraisal; (3) The application materials do not meet the requirements and fail to be made up within a prescribed time limit; or (4) Other circumstances under which it shall not be accepted. Article 8. The Ministry of Agriculture shall, within 10 workdays from the date when the application is accepted, submit the application materials for the registration of new veterinary drugs it decides to accept to the veterinary drug appraisal committee under the Ministry of Agriculture to make technical appraisal, notify the applicant to submit samples in three consecutive production batches and the relevant materials required for checking and inspection, and send them to the designated veterinary drug inspection institute for checking and inspection. Where any new veterinary drug applied for falls within a biological product, inspections shall be made on the relevant seed virus, if necessary. Article 9. The veterinary drug appraisal committee under the Ministry of Agriculture shall put forward appraisal opinions within 120 workdays after receiving the materials and submit them to the Ministry of Agriculture. Where there is necessity to make up materials in the appraisal, an applicant shall make up all the relevant data within 6 months from the date of receiving the notice; if it fails to make up exceeding the time limit, it shall be regarded as withdrawing the registration application. Article 10. A veterinary drug inspection institution shall complete the checking and inspection within a prescribed time limit, and serve a inspection report and checking opinions to the applicant, and meanwhile send them to the Ministry of Agriculture and the veterinary drug appraisal committee under the Ministry of Agriculture. In case the samples are found not to meet the standard after the first inspection, an applicant may send another sample for checking and inspection again. Article 11. The Ministry of Agriculture shall complete the examination within 60 workdays from the date when it receives the conclusions of technical appraisal, checking and inspection; and may appoint personnel to make on-site checking if necessary. If they are found to meet the standard after examination, it shall issue a New Veterinary Drug Registration Certificate and make a public notice, and meanwhile issue the standard, label and instructions for the new veterinary drug. If they are found not to meet the standard, it shall notify the applicant in writing. Article 12. During the period of examination and approval of registration on any new veterinary drug, if there is any alteration on the technical requirements for the new veterinary drug because the same variety of veterinary drug is approved to be listed overseas, the examination and approval shall be made according to the original technical requirements. CHAPTER III REGISTRATION OF IMPORTED VETERINARY DRUGS Article 13. When exporting any veterinary drug to China for the first time, the office of the export party within the territory of China or the agency entrusted by it within the territory of China shall file an application to the Ministry of Agriculture, fill in the Application Form for Veterinary Drug Registration, and submit the relevant materials in light of the Requirements for Registration Materials of Veterinary Drugs. When applying for exporting biological products for animal use to China, an applicant shall also provide relevant materials and documents such as bacterium (virus or insect) seeds or cells, etc.. Article 14. When applying for the registration on the import of any veterinary drug preparation, an applicant shall provide the certification documents of raw material drugs and supplementary materials used for the production of the preparation, and the packaging materials directly contacting with the veterinary drug and the lawful sources of the containers. If the raw material drug has not obtained the approval of the Ministry of Agriculture, the applicant shall apply for the registration of the raw material drug at the same time, and shall submit the relevant production techniques, quality indexes, inspection methods and other research materials. Article 15. When applying for the registration of any imported veterinary drug, the materials submitted shall be complete and standard, and the data thereof shall be authentic and reliable. In case any literature and materials are cited, the name of the works and periodicals as well as the volume, period and page shall be indicated; for foreign language materials, a Chinese version shall be provided as required. Article 16. The Ministry of Agriculture shall organize the preliminary examination within ten workdays from the date of receiving the application, and accept the application if it is found to meet the standard after the preliminary examination, and notify the applicant in writing. In case an application is accepted, the Ministry of Agriculture shall submit the materials of application for veterinary drug registration to the veterinary drug appraisal committee under the Ministry of Agriculture for technical appraisal, notify the applicant to submit samples in three consecutive production batches and the relevant materials required for checking and inspection, and send them to the designated veterinary drug inspection institution for checking and inspection. Article 17. In any of the following circumstances, the application for the registration of any imported veterinary drug shall be rejected: (1) The veterinary drug is in the monitoring period announced by the Ministry of Agriculture, but the applicant cannot prove that the data are obtained by itself; (2) The veterinary drug is outside the inactivated bacteria or diagnosis products, which is obtained through genetic engineering technology and fails to pass the biological safety appraisal; (3) The Class A epidemic diseases prescribed by our country and the live bacteria through which no epidemic disease is occurred in our country; (4) Biological products for animal use, which come from epidemic areas and my result in the spread of any epidemic disease within the territory of China; (5) The application documents do not comply with the requirements but fail to be supplemented within a prescribed time limit; or (6) Other circumstances under which the application is not accepted. Article 18. The provisions of Articles 9 and 10 of the present Measures shall apply to the procedures for the appraisal and inspection of the registration of imported veterinary drugs. Article 19. To apply for the import registration of any chemical medicine for animal use, one shall make relevant clinical tests and test the remains for proof at designated institutions within the territory of the People's Republic of China; the Ministry of Agriculture may require it to make tests on the elimination of remains if it is necessary to determine the withdrawal period. In the case of applying for import registration on any veterinary drug, which falls within the category of biological product, the Ministry of Agriculture may require it to make tests on its safety and effectiveness at a designated institution within the territory of the People's Republic of China. Article 20. The Ministry of Agriculture shall complete the examination within 60 workdays from the date of receiving the technical appraisal and checking and inspection conclusions; and may appoint personnel to make on-site checking, if necessary. If they are found to meet the standard after examination, a Registration Certificate of Imported Veterinary Drugs shall be issued with public announcement; the production enterprises in China Hong Kong, Macao, and Taiwan regions shall be issued a Veterinary Drug Registration Certificate when they apply for the registration of any veterinary drug. If they are found not to meet the standard after examination, the applicant shall be notified in writing. The Ministry of Agriculture shall issue the standard for an import veterinary drug and the labels and instructions of the product that has been approved when approving the registration of the imported veterinary drug. Article 21. The Ministry of Agriculture shall make a risk analysis on the veterinary drugs under application for import registration, and shall not register those that are found to have safety risks after risk analysis. CHAPTER IV ALTERATION REGISTRATION OF VETERINARY DRUGS Article 22. In case any former approval matter of any registered veterinary drug is altered, the applicant shall apply to the Ministry of Agriculture for alteration registration of the veterinary drug. Article 23. When applying for alteration registration, an applicant shall fill in the Application From for Alteration of Veterinary Drug Registration and submit the relevant materials and statements. In case the alteration concerns the change of the ownership of the veterinary drug product, it shall also provide effective certificate documents. For the alteration registration of any imported veterinary drug, an applicant shall also submit the documents for approving the alteration of the veterinary drug administration organ of the country or district at the locality of the production enterprise. Article 24. The Ministry of Agriculture shall complete the examination on the application for registration alteration of the veterinary drugs that are not subject to technical appraisal within 30 workdays from the date of receiving the application, and approve the alteration registration on those that are found to meet the standard after examination. Where there is necessity to make technical appraisal on any application for the alteration registration of any veterinary drug, the Ministry of Agriculture shall submit the materials it accepts to the veterinary drug appraisal committee under the Ministry of Agriculture for appraisal, and notify the applicant to submit the samples in three consecutive production batches and the relevant materials needed for checking and inspection, and send them to the designated veterinary drug inspection institution for checking and inspection. Article 25. The provisions on the registration of new veterinary drugs and imported veterinary drugs of the present Measures shall be applicable to the appraisal and inspection procedures, time limit and requirements for the application for veterinary drug alteration registration. When applying for alteration registration on revising the standard for any veterinary drug, the veterinary drug inspection institution shall verify the standard. Article 26. The Ministry of Agriculture shall complete the examination within 30 workdays from the date of receiving the conclusions of technical appraisal and checking and inspection, and approve the alteration registration on those that are found to meet the standard after examination, and notify the applicant in writing for those that found not to meet the standard after examination. CHAPTER V RE-REGISTRATION OF IMPORTED VETERINARY DRUGS Article 27. The period of validity of the Registration Certificate of Imported Veterinary Drugs and the Veterinary Drug Registration Certificate shall be five years. Where it is necessary to continue the import after the period of validity expires, the applicant shall file an application for re-registration to the Ministry of Agriculture six months before the expiration of the period of validity. Article 28. When applying for re-registration of any imported veterinary drug, an applicant shall fill in the Application Form for Re-registration of Veterinary Drugs and submit the relevant materials according to the Requirement for Registration Materials of Veterinary Drugs. Article 29. The Ministry of Agriculture shall complete the examination within 20 workdays after accepting the application for re-registration of any imported veterinary drug, and re-register those complying with the requirements; or notify the applicant in writing for those not complying with the requirements. Article 30. In any of the following circumstances, re-registration shall not be granted: (1) Failing to file an application for re-registration 6 months before the expiry of the period of validity; (2) Failing to submit a monitoring report on bad effect of any veterinary drug as required; (3) The veterinary drug is listed as a drug prohibited by the Ministry of Agriculture after reappraisal of safety; (4) The production conditions do not comply with the requirements after examination; (5) It is found to possess any safety risk after risk analysis; (6) The class A epidemic disease prescribed by our country and the live bacteria through which no epidemic disease occurs in our country; (7) Biological products for animal use coming from epidemic areas, which may result in the spread of any epidemic disease within the territory of China; or (8) Other circumstances under which re-registration shall not be granted according to law. Article 31. In case no re-registration is granted, the Ministry of Agriculture shall revoke its Registration Certificate of Imported Veterinary Drugs or the Veterinary Drug Registration Certificate and make a public announcement. CHAPTER VI CHECKING AND INSPECTION ON VETERINARY DRUGS Article 32. Veterinary drug checking and inspection shall be made when applying for the registration of any veterinary drug, including inspection on samples and checking on the quality standard of the veterinary drug. Article 33. Any veterinary drug inspection institution which undertakes the checking and inspection of veterinary drugs shall comply with the criterions for quality control of veterinary drug inspection. Article 34. An applicant shall provide the relevant materials and samples needed for the checking and inspection of a veterinary drug to a veterinary drug inspection institution, and provide standard substances for the use of inspection and necessary materials. When applying for the registration of any veterinary drug registration, the three batches of samples needed shall be produced at the workshop that has obtained the GMP Certificate of Veterinary Drugs. Each batch of samples shall be three minimum packages to be marketed, and shall be the 3 to 5 times the dosages of inspection. Article 35. When checking the quality standard of any veterinary drug, a veterinary drug inspection institution shall, in addition to making inspection on the samples, put forward its checking opinions on the quality standards, inspection items and methods of the veterinary drug on the basis of the research data of the veterinary drug, quality standard of the same kind of veterinary drugs home and abroad and the relevant requirements of the state. Article 36. A veterinary drug inspection institution shall, after receiving the inspection notice and samples, complete the inspection on the samples within 90 workdays and issue an inspection report; for the veterinary drugs that need to be inspected in any special method, it shall complete the inspection within 120 workdays. Where it is necessary to make inspection on samples and check the quality standard of any veterinary drug, a veterinary drug inspection institution shall complete them within 120 workdays; and shall compete the inspection within 150 workdays on the veterinary drug that need to be inspected in any special method. CHAPTER VII ADMINISTRATION ON STANDARD SUBSTANCES OF VETERINARY DRUGS Article 37. The China Institute of Veterinary Drug Control shall be responsible for demarcating and supplying the standard substance of state veterinary drugs. The China Institute of Veterinary Drug Control may organize veterinary drug control offices, veterinary drug research institutions or veterinary drug production enterprises of the relevant provinces, autonomous regions, and municipalities directly under the Central Government to demarcate the standard substances of state veterinary drugs through cooperation. Article 38. An applicant shall, when applying for the registration of any new veterinary drug and imported veterinary drug, provide the materials of the standard substances for the manufacture of the veterinary drugs to the China Institute of Veterinary Drug Control and submit the research materials of the relevant standard substances. Article 39. The China Institute of Veterinary Drug Control shall make overall technical examination on materials concerning the standard substances of veterinary drugs such as the selection of materials, preparation methods, demarcation method, demarcation result, veracity of the fixed value, affiliation of the quantity value, stability and conditions of sub-packaging and packaging, etc; and shall make demarcation or organize to make demarcation, if necessary, and draw a recommendation conclusion on whether it may be regarded as national quality standard substances of veterinary drugs and send it to the state veterinary drug codex committee for examination. Article 40. The Ministry of Agriculture shall approve the national quality standard substances of veterinary drugs according to the examination opinions of the state veterinary drug codex committee and issue the lists of standard substances of veterinary drugs and quality standards. CHAPTER VIII PENALTIES Article 41. In case any applicant applies for registration by providing false materials, samples or taking other fraudulent means, the Ministry of Agriculture shall not grant approval to the application, and give warnings to the applicant, and the applicant shall be prohibited from reapplying for registration of the veterinary drug within one year. In case any applicant obtains any certification documents of registration on any veterinary drug by providing false materials, samples or taking other fraudulent means, he shall be subject to the punishment prescribed in Article 57 of the Regulation on the Administration of Veterinary Drugs, and the applicant shall be prohibited from reapplying for the registration of the veterinary drug within three years. Article 42. Other acts in violation of the provisions of the present Measures shall be punished according to the relevant provisions of the Regulation on the Administration of Veterinary Drugs. CHAPTER IX SUPPLEMENTARY PROVISIONS Article 43. The application for the registration of new veterinary drugs and imported veterinary drugs such as the stupefacient for animal use, psychotropic drugs for animal use, toxic drugs for medical treatment of veterinarians and radioactive drugs shall also comply with other relevant state provisions in addition to following the present Measures. Article 44. The Ministry of Agriculture shall apply the recording system on the alteration of the bacteria or virus seeds used for the production of bacteria used for mandatory immunity recommended by the state veterinarian consulting laboratory upon the need of animal epidemic prevention, and it is not required to make alteration registration. Article 45. The present Measures shall come into force as of January 1, 2005. |
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