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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II APPLICATION FOR AND ISSUING OF APPROVAL DOCUMENT NUMBER OF VETERINARY DRUG PRODUCTS CHAPTER III SUPERVISION AND INSPECTION CHAPTER IV SUPPLEMENTARY PROVISIONS CHAPTER I GENERAL PROVISIONS Article 1. The present Measures are formulated in accordance with the Regulation on Veterinary Drug Administration for the purpose of strengthening the administration on the approval document number of veterinary drug products. Article 2. The present Measures shall be applicable to the application for, issue of and supervision over the approval document number of veterinary drug products. Article 3. A veterinary drug production enterprise shall obtain the product approval document number as is issued by the Ministry of Agriculture for the production of veterinary drugs. The approval document number of veterinary drug products is the certificate document of approval for veterinary drugs, which is issued by the Ministry of Agriculture on the basis of the national standards for veterinary drugs, production techniques, and production conditions when approving any special veterinary drug production enterprise to produce any special veterinary drug product. Article 4. The Ministry of Agriculture shall be responsible for the work of issuing and supervising the approval document number of veterinary drug products of the whole country. The administrative departments of veterinary of the local people's governments at or above the county level shall be responsible for the supervision over and administration of approval document number of veterinary drug products within their own administrative regions. CHAPTER II APPLICATION FOR AND ISSUING OF APPROVAL DOCUMENT NUMBER OF VETERINARY DRUG PRODUCTS Article 5. When applying for the approval document number of any veterinary drug product, which has had the national standard for veterinary drugs except the biological products, an applicant shall submit the samples in three consecutive batches produced by itself and the following materials to the administrative department of veterinary of the people's government at the level of the province at its locality: (1) A duplicate of the Application Form for Approval Document Number of Veterinary Drug Products; (2) A duplicate of the photocopy of the License for Veterinary Drug Production; (3) A duplicate of the photocopy of the GMP Certificate of Veterinary Drugs; (4) A duplicate of the stylebook of labels and instructions; and (5) A duplicate of the self-inspection report on the samples submitted. The administrative department of veterinary of the people's government at the provincial level shall, within 5 workdays from the date of acceptance, send the samples to a veterinary drug inspection institution for inspection, and shall complete the examination within 15 workdays from the date of accepting the inspection conclusions, and send a copy of the examination opinions and the inspection report issued by the inspection institution and all the application documents to the Ministry of Agriculture. The Ministry of Agriculture shall complete the examination within 20 workdays from the date when it receives the examination opinions of the administrative department of veterinary of the people's government at the provincial level. If the veterinary drug product passes the examination, the Ministry of Agriculture shall issue the approval document number of this product and publicize the labels and instructions. If it fails to pass the examination, the applicant shall be notified in writing and the reasons shall be explained. Article 6. When applying for the approval document number of biological products that have already had the national standards for veterinary drugs, an applicant shall submit the samples in three consecutive batches produced by itself and the following materials to the Ministry of Agriculture: (1) A copy of the Application Form for Approval Document Number of Veterinary Drug Products; (2) A copy of the photocopy of the License for Veterinary Drug Production; (3) A copy of the photocopy of the GMP Certificate of Veterinary Drugs; (4) A copy of the stylebook of labels and instructions; and (5) A duplicate of the self-inspection report on the samples submitted. The Ministry of Agriculture shall send the samples to a veterinary drug inspection institution for inspection within 5 workdays from the date of acceptance, and shall complete the examination within 15 workdays from the date of receiving the inspection conclusions. If the product passes examination, the Ministry of Agriculture shall issue the approval document number of this product and publicize the labels and instructions. If it fails to pass the examination, the applicant shall be notified in writing and the reasons shall be explained. Article 7. When applying for the approval document number of any self-developed veterinary drug product that has obtained the Registration Certificate of New Veterinary Drugs, and the samples of the product are produced by the applicant itself, the applicant shall submit the following materials to the Ministry of Agriculture: (1) A copy of the Application Form for Approval Document Number of Veterinary Drug Products; (2) A copy of the photocopy of the License for Veterinary Drug Production; (3) A copy of the photocopy of the GMP Certificate of Veterinary Drugs; (4) A copy of the photocopy of Registration Certificate of New Veterinary Drugs; and (5) A copy of the stylebook of labels and instructions. The Ministry of Agriculture shall complete the examination within 20 workdays from the date of acceptance. If the product passes the examination, the Ministry of Agriculture shall issue the approval document number of this product and publicize the labels and instructions. If it fails to pass the examination, the applicant shall be notified in writing and the reasons shall be explained. When applying for the approval document number of any self-developed veterinary drug that has obtained the Registration Certificate of New Veterinary Drugs, but the samples of the products are not produced by the applicant itself, it shall be handled in light of the provisions of Article 8 of the present Measures. Article 8. When applying for the approval document number of any veterinary drug product that has obtained the Registration Certificate of New Veterinary Drugs, which is transferred by other people, an applicant shall submit the samples in three consecutive batches produced by itself and the following materials to the Ministry of Agriculture: (1) A copy of the Application Form for Approval Document Number of Veterinary Drug Products; (2) A copy of the photocopy of the License for Veterinary Drug Production; (3) A copy of the photocopy of the GMP Certificate of Veterinary Drugs; (4) A copy of the photocopy of Registration Certificate of New Veterinary Drugs; (5) A copy of the stylebook of labels and instructions; (6) A duplicate of self-inspection report of the samples submitted; and (7) A copy of the original of the transfer contract. The Ministry of Agriculture shall send the samples to the veterinary drug inspection institution for inspection within 5 workdays from the date of acceptance, and complete the examination within 15 workdays from the date of receiving the inspection conclusions. If the product passes the examination, the Ministry of Agriculture shall issue the approval document number of this product and publicize the labels and instructions. If it fails to pass the examination, the applicant shall be notified in writing and the reasons shall be explained. Article 9. Where a Sino-foreign joint venture enterprise applies for the approval document number of any veterinary drug product whose Registration Certificate of Import Veterinary Drugs has been obtained by the foreign party, it shall submit the samples in three consecutive batches produced by itself and the following materials to the Ministry of Agriculture: (1) A copy of the Application Form for Approval Document Number of Veterinary Drug Products; (2) A copy of the photocopy of the License for Veterinary Drug Production; (3) A copy of the photocopy of the GMP Certificate of Veterinary Drugs; (4) A copy of the photocopy of Registration Certificate of New Veterinary Drugs; (5) A copy of the stylebook of labels and instructions; (6) A duplicate of self-inspection report of the samples submitted; and (7) The power of attorney of the overseas enterprise for approving the production. The Ministry of Agriculture shall send the samples to a veterinary drug inspection institution for inspection within 5 workdays from the date of acceptance, and complete the examination within 15 workdays from the date of receiving the inspection conclusions. If the product passes the examination, the Ministry of Agriculture shall issue the approval document number of this product and publicize the labels and instructions. If it fails to pass the examination, the applicant shall be notified in writing and the reasons shall be explained. Article 10. When applying for the approval document number of a product, an applicant shall ensure that the samples it submits meet the requirements for the inspection work. If the samples submitted at the first time are not up to the standard, it may send another batch of samples for reexamination. If the samples are still not up to the standard after the reexamination, the applicant shall not be issued the approval document number and shall be prohibited from filing an application again within one year. Article 11. A veterinary drug inspection institution shall complete the inspection within 90 workdays from the date of receiving the samples, and keep the samples for observation as required. In case the samples sent for inspection are biological products, the time limit for the inspection shall not exceed 120 workdays. Article 12. The Ministry of Agriculture may, when issuing the approval document number for any new veterinary drug product, determine a monitoring period of not exceeding 5 years, within which no other enterprise may be approved to produce or import the new veterinary drug. After the end of the monitoring period for the veterinary drug, other veterinary drug production enterprises may apply for the approval document number of products in accordance with the provisions of Articles 5 and 6 of the present Measures, for those veterinary drugs that are subject to the protection of intellectual property rights, the transfer contract shall also be submitted in application. Article 13. Where there is necessity to continue the production after the expiration of the period of validity of the approval document number of any veterinary drug product, the veterinary drug production enterprise shall file an application for renewing the approval document number of the product to the original department of examination and approval 6 months before the expiry of the period of validity. No sample may be provided any more when applying for renewing the approval document number of biological products. Except the biological products, if any veterinary drug whose monitoring period is ended, the veterinary drug production enterprise may apply for renewing the approval document number of the product in light of the provisions of Article 5 of the present Measures. CHAPTER III SUPERVISION AND INSPECTION Article 14. The administrative departments of veterinary of the local people's governments at or above the county level shall make on-site inspection on the veterinary drug production enterprises within their own jurisdictions, but shall not disturb the ordinary production activities of the enterprises, and may not ask for or take property or seek for other interests. In case any veterinary drug production enterprise is discovered to have any of the following circumstances in the on-site inspection, the administrative department of veterinary of the people's governments at or above the county level shall make decisions for handling according to law or propose handling opinions, and report to the administrative department of veterinary at the upper level people's government: (1) The production conditions alter greatly; (2) Failing to organize the production in light of the requirements of the Criterions for the Quality Control of Veterinary Drug Production; (3) There is any hidden trouble in the quality of the product; or (4) Other circumstances in violation of the Regulation on Veterinary Drug Administration and the provisions of the present Measures. Article 15. The administrative departments of veterinary of the local people's governments at or above the county level shall make supervision over and inspection on the listing veterinary drug products and make handling decisions according to law in case it discovers any circumstance in violation of the provisions on the administration of the approval document number of veterinary drug products, and shall report to the administrative departments of veterinary of the upper level people's governments. Article 16. In case any veterinary drug production enterprise produces any veterinary drug by establishing new workshops at a different place or altering production site, it shall apply for another approval document number of veterinary drug products. Article 17. In case anyone sells, leases or lends the approval document number of any veterinary drug product, it shall be subject to the punishment as prescribed in Article 58 of the Regulation on Veterinary Drug Administration. Article 18. Under any of the following circumstances, the Ministry of Agriculture shall take back or revoke the approval document number of any veterinary drug product, and make a public notice: (1) The period of validity of any approval document number expires but no extension is applied for; (2) The period of validity of the license for veterinary drug production expires or fails to be approved after application for extension; (3) There occur changes in the enterprise and it no longer has the corresponding production conditions; (4) The veterinary drug production enterprise goes bankrupt; (5) The approval document number of the product is altered without permission; or (6) Other circumstances under which the approval document number shall be revoked. Article 19. In case anyone violates the provisions on the approval document number of veterinary drug products, the Ministry of Agriculture shall make a decision on withdrawing the approval document number of veterinary drug products according to law and make a public notice. Article 20. In case any applicant applies for any approval document number of veterinary drug products by disguising the relevant conditions or providing false materials or samples, the Ministry of Agriculture shall not accept it or shall not grant the approval document number of veterinary drug products and shall give it warnings. And the applicant shall not reapply for the approval document number of the veterinary drug products within one year. Article 21. In case any applicant obtains any approval document number of any veterinary drug product by providing false materials or samples or taking other fraudulent means, it shall be subject to the punishment as prescribed in Article 57 of the Regulation on Veterinary Drug Administration, and the applicant shall not reapply for the approval document number within three years. CHAPTER IV SUPPLEMENTARY PROVISIONS Article 22. The format of compiling the approval document number of veterinary drug products shall be: the shortened form of the type of veterinary drugs + the year + the serial number of the province (autonomous region or municipality) where the enterprise is located + the sequence number of the enterprise + the serial number of the variety of veterinary drugs. The format shall be made as follows: VDA (xxxx) xx xxx xxxx BVD ©¤©¤©¤©Ð©¤ ©¤©Ð©¤ ©¤©Ð©¤ ©¤©¤©Ð©¤ VD ¡¡ ¡¡ ©¦ ©¦ ©¦ ©¦ ¡¡ ¡¡ ¡¡ ©¦ ©¦ ©¦ ©¦ ©¦ ©¦ ©¦ ©¦ ©¦ ©¦ ©¦ ©¦ ©¦ ©¦ ©¦ Serial number of the varieties ©¦ ©¦ ©¦ ©¦ ©¦ ©¸©¤©¤©¤Serial number of the enterprise ©¦ ©¦ ©¦ ©¸©¤©¤©¤©¤©¤©¤©¤Serial number of the province (autonomous region or municipality) ©¦ Year 1.The shortened form of the type of veterinary drugs: The type of drug additives shall be called for short as "VDA"; the types of blood serum products, bacterins, diagnosis products, micro-zoology products shall be called for short as "BVD"; the types of traditional Chinese medicinal materials, Chinese traditional patent medicines, chemical drugs, antibiotics, biological and chemical drugs, radioactive drugs, pesticides for external use and disinfectors shall be called for short as the "VD". 2. The "year" shall be expressed in a four digits numbers, that is, the year when the approval document number of the product is issued. 3. The "serial number of the province where the enterprise is located" shall be expressed in two digits Arabic numbers, which shall be prescribed and announced by the Ministry of Agriculture. 4. The order of the serial numbers of the enterprise shall be arranged by provinces, expressed in a three digits Arabic numbers, which shall be announced by the Ministry of Agriculture. 5. The serial numbers of the variety of veterinary drugs shall be expressed in four digits Arabic numbers, which shall be prescribed and announced by the Ministry of Agriculture. Article 23. The Application Form for Approval Document Number of Veterinary Drug Products may be received freely at the administrative department of veterinary of the people's government of the province at one's locality or downloaded from the China Veterinary Drug Information Network (The website address is: http£º//www.ivdc.gov.cn) Article 24. The present Measures shall come into force as of January 1, 2005. The Provisions on the Administration of Approval Document Number of Veterinary Drugs (No.4 [1998] of the Ministry of Agriculture) as promulgated by the Ministry of Agriculture on March 10, 1998 shall be repealed simultaneously. |
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