| Order of the Ministry of Agriculture | | 农业部令 |
| (No. 4 [2015]) | | （2015年第4号） |
| The Administrative Measures for the Approval Documents of Veterinary Drug Products, as deliberated and adopted at the 11th executive meeting of the Ministry of Agriculture on November 17, 2015, are hereby issued, and shall come into force on May 1, 2016. | | 《兽药产品批准文号管理办法》已于2015年11月17日经农业部2015年第11次常务会议审议通过，现予发布，自2016年5月1日起施行。 |
| Minister, Han Changfu | | 部长 韩长赋 |
| December 3, 2015 | | 2015年12月3日 |
| Administrative Measures for the Approval Documents of Veterinary Drug Products | | 兽药产品批准文号管理办法 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 For the purpose of strengthening the administration of the approval documents of veterinary drug products, these Measures are developed in accordance with the Regulation on the Administration of Veterinary Drugs. | | 第一条 为加强兽药产品批准文号的管理，根据《兽药管理条例》，制定本办法。 |
| Article 2 These Measures shall apply to the application for, issuance of and supervision and administration of the approval documents of veterinary drug products. | | 第二条 兽药产品批准文号的申请、核发和监督管理适用本办法。 |
| Article 3 To produce veterinary drugs, a veterinary drug manufacturing enterprise shall obtain an approval document issued by the Ministry of Agriculture for veterinary drug products. | | 第三条 兽药生产企业生产兽药，应当取得农业部核发的兽药产品批准文号。 |
| The approval document of a veterinary drug product is a certificate of approval issued by the Ministry of Agriculture on the basis of the national standards, manufacturing techniques, and manufacturing conditions for veterinary drugs when approving a specific veterinary drug manufacturing enterprise's manufacturing of a specific veterinary drug product. | | 兽药产品批准文号是农业部根据兽药国家标准、生产工艺和生产条件批准特定兽药生产企业生产特定兽药产品时核发的兽药批准证明文件。 |
| Article 4 The Ministry of Agriculture shall be responsible for the issuance of approval documents of veterinary drug products throughout the country, and the supervision and administration thereof. | | 第四条 农业部负责全国兽药产品批准文号的核发和监督管理工作。 |
| The veterinary administrative departments of local people's governments at and above the county level shall be responsible for the supervision and administration of approval documents of veterinary drug products within their respective administrative regions. | | 县级以上地方人民政府兽医行政管理部门负责本行政区域内的兽药产品批准文号的监督管理工作。 |
| Chapter II Application for and Issuance of Approval Documents of Veterinary Drug Products | | 第二章 兽药产品批准文号的申请和核发 |
| Article 5 To apply for an approval document of a veterinary drug product, the following conditions shall be met: | | 第五条 申请兽药产品批准文号的兽药，应当符合以下条件： |
| (1) It falls with the scope of production indicated on the Veterinary Drug Manufacturing License. | | （一）在《兽药生产许可证》载明的生产范围内； |
| (2) There is no revocation of the approval document of the product in the three years prior to application. | | （二）申请前三年内无被撤销该产品批准文号的记录。 |
| Where the review and inspection result of the application for an approval document of the veterinary drug product fails to comply with relevant provisions for two consecutive times, the application for an approval document of the veterinary drug product shall not be accepted within one year. | | 申请兽药产品批准文号连续2次复核检验结果不符合规定的，1年内不再受理该兽药产品批准文号的申请。 |
| Article 6 The applicant shall, when applying for an approval document of a veterinary drug product developed by it, submit the following materials to the Ministry of Agriculture, if the Registration Certificate of New Veterinary Drugs has been obtained and the review samples submitted at the time of registration of the new veterinary drug are produced by the applicant itself: | | 第六条 申请本企业研制的已获得《新兽药注册证书》的兽药产品批准文号，且新兽药注册时的复核样品系申请人生产的，申请人应当向农业部提交下列资料： |
| (1) A copy of the Application Form for an Approval document of a Veterinary Drug Product. | | （一）《兽药产品批准文号申请表》一式一份； |
| (2) A photocopy of the Veterinary Drug Manufacturing License. | | （二）《兽药生产许可证》复印件一式一份； |
| (3) A photocopy of the GMP Certificate of Veterinary Drugs. | | （三）《兽药GMP证书》复印件一式一份； |
| (4) A photocopy of the Registration Certificate of New Veterinary Drugs. | | （四）《新兽药注册证书》复印件一式一份； |
| (5) A photocopy of the review and inspection report. | | （五）复核检验报告复印件一式一份； |
| (6) The samples of labels and instructions in duplicate. | | （六）标签和说明书样本一式二份； |
| (7) The manufacturing techniques, formulas and other materials of the product. | | （七）产品的生产工艺、配方等资料一式一份。 |
| The Ministry of Agriculture shall, within five working days of acceptance of the application, send application materials to the China Institute of Veterinary Drug Control for expert review, and make a decision of approval or disapproval within 15 working days of receipt of the review opinion. If the application complies with relevant provisions, it shall issue an approval document for the veterinary drug product, along with the approval label and instructions. If the application fails to comply with relevant provisions, it shall notify the applicant in writing, and explain the reason. | | 农业部自受理之日起5个工作日内将申请资料送中国兽医药品监察所进行专家评审，并自收到评审意见之日起15个工作日内作出审批决定。符合规定的，核发兽药产品批准文号，批准标签和说明书；不符合规定的，书面通知申请人，并说明理由。 |
| An application for an approval document for a veterinary drug product developed by an enterprise, for which the Registration Certificate of New Veterinary Drugs has been obtained, shall be handled in accordance with Articles 7 and 9 of these Measures respectively, if the review samples submitted at the time of registration of the new veterinary drug are not produced by the applicant, and the applicant is not required to submit a photocopy of the intellectual property right assignment contract or power of attorney. | | 申请本企业研制的已获得《新兽药注册证书》的兽药产品批准文号，但新兽药注册时的复核样品非申请人生产的，分别按照本办法第七条、第九条规定办理，申请人无需提交知识产权转让合同或授权书复印件。 |
| Article 7 To apply for an approval document for a veterinary biological product assigned by any other person, for which the Registration Certificate of New Veterinary Drugs or Registration Certificate of Import Veterinary Drugs has been obtained, the applicant shall submit samples of three consecutive batches produced by it and the following materials to the Ministry of Agriculture: | | 第七条 申请他人转让的已获得《新兽药注册证书》或《进口兽药注册证书》的生物制品类兽药产品批准文号的，申请人应当向农业部提交本企业生产的连续三个批次的样品和下列资料： |
| (1) An Application Form for Approval document of Veterinary Drug Products. | | （一）《兽药产品批准文号申请表》一式一份； |
| (2) A photocopy of the Veterinary Drug Manufacturing License. | | （二）《兽药生产许可证》复印件一式一份； |
| (3) A photocopy of the GMP Certificate of Veterinary Drugs. | | （三）《兽药GMP证书》复印件一式一份； |
| (4) A photocopy of the Registration Certificate of New Veterinary Drugs or the Registration Certificate of Import Veterinary Drugs. | | （四）《新兽药注册证书》或《进口兽药注册证书》复印件一式一份； |
| (5) The samples of labels and instructions in duplicate. | | （五）标签和说明书样本一式二份； |
| (6) A self-inspection report on the samples submitted. | | （六）所提交样品的自检报告一式一份； |
| (7) The manufacturing techniques, formulas and other materials of the product. | | （七）产品的生产工艺、配方等资料一式一份； |
| (8) The intellectual property right assignment contract or power of attorney (the original shall be provided in the case of the first application, and a photocopy to which the applicant's official seal is affixed shall be provided in the case of a renewal application). | | （八）知识产权转让合同或授权书一式一份（首次申请提供原件，换发申请提供复印件并加盖申请人公章）。 |
| The submitted samples shall be selected by the provincial veterinary drug inspection agency on site, and sealed and labeled. | | 提交的样品应当由省级兽药检验机构现场抽取，并加贴封签。 |
| The Ministry of Agriculture shall, within five working days of acceptance of the application, send the samples and application materials to the China Institute of Veterinary Drug Control for re-check and inspection and expert review as required, and make a decision of approval or disapproval within 15 working days as of receipt of the inspection conclusion and review opinion. If the application complies with relevant provisions, it shall issue an approval document for the veterinary drug product, along with the approval label and instructions. If the application fails to comply with relevant provisions, it shall notify the applicant in writing, and explain the reason. | | 农业部自受理之日起5个工作日内将样品及申请资料送中国兽医药品监察所按规定进行复核检验和专家评审，并自收到检验结论和评审意见之日起15个工作日内作出审批决定。符合规定的，核发兽药产品批准文号，批准标签和说明书；不符合规定的，书面通知申请人，并说明理由。 |
| Article 8 To apply for an approval document for a veterinary biological product other than those prescribed in Articles 6 and 7, the applicant shall submit samples of three consecutive batches produced by it and the following materials to the Ministry of Agriculture: | | 第八条 申请第六条、第七条规定之外的生物制品类兽药产品批准文号的，申请人应当向农业部提交本企业生产的连续三个批次的样品和下列资料： |
| (1) An Application Form for Approval document of Veterinary Drug Products. | | （一）《兽药产品批准文号申请表》一式一份； |
| (2) A photocopy of the Veterinary Drug Manufacturing License. | | （二）《兽药生产许可证》复印件一式一份； |
| (3) A photocopy of the GMP Certificate of Veterinary Drugs. | | （三）《兽药GMP证书》复印件一式一份； |
| (4) The samples of labels and instructions in duplicate. | | （四）标签和说明书样本一式二份； |
| (5) A self-inspection report on the samples submitted. | | （五）所提交样品的自检报告一式一份； |
| (6) The manufacturing techniques, formulas and other materials of the product. | | （六）产品的生产工艺、配方等资料一式一份； |
| (7) A photocopy of the certificate on the legal source of bacteria (viruses, worms) (to which the official seal of the applicant is affixed). | | （七）菌（毒、虫）种合法来源证明复印件（加盖申请人公章）一式一份。 |
| The submitted samples shall be selected by the provincial veterinary drug inspection agency on site, and sealed and labeled. | | 提交的样品应当由省级兽药检验机构现场抽取，并加贴封签。 |
| The Ministry of Agriculture shall, within five working days as of acceptance of the application, send the samples and application materials to the China Institute of Veterinary Drug Control for re-check and inspection and expert review as required, and make a decision of approval or disapproval within 15 working days as of receipt of the inspection conclusion and review opinion. If the application complies with relevant provisions, it shall issue an approval document for the veterinary drug product, along with the approval label and instructions. If the application fails to comply with relevant provisions, it shall notify the applicant in writing, and explain the reason. | | 农业部自受理之日起5个工作日内将样品及申请资料送中国兽医药品监察所按规定进行复核检验和专家评审，并自收到检验结论和评审意见之日起15个工作日内作出审批决定。符合规定的，核发兽药产品批准文号，批准标签和说明书；不符合规定的，书面通知申请人，并说明理由。 |
| Article 9 To apply for an approval document for a veterinary non-biological product assigned by others, for which the Registration Certificate of New Veterinary Drugs or Registration Certificate of Import Veterinary Drugs has been obtained, the applicant shall submit samples of three consecutive batches produced by it and the following materials to the veterinary administrative department of the local provincial people's government: | | 第九条 申请他人转让的已获得《新兽药注册证书》或《进口兽药注册证书》的非生物制品类的兽药产品批准文号的，申请人应当向所在地省级人民政府兽医行政管理部门提交本企业生产的连续三个批次的样品和下列资料： |
| (1) An Application Form for Approval document of Veterinary Drug Products in duplicate. | | （一）《兽药产品批准文号申请表》一式二份； |
| (2) A photocopy of the Veterinary Drug Manufacturing License in duplicate. | | （二）《兽药生产许可证》复印件一式二份； |
| (3) A photocopy of the GMP Certificate of Veterinary Drugs in duplicate. | | （三）《兽药GMP证书》复印件一式二份； |
| (4) A photocopy of the Registration Certificate of New Veterinary Drugs or the Registration Certificate of Import Veterinary Drugs in duplicate. | | （四）《新兽药注册证书》或《进口兽药注册证书》复印件一式二份； |
| (5) The samples of labels and instructions in duplicate. | | （五）标签和说明书样本一式二份； |
| (6) The photocopies of the original manufacturing and inspection records of each batch of the submitted samples and a self-inspection report in duplicate. | | （六）所提交样品的批生产、批检验原始记录复印件及自检报告一式二份； |
| (7) The manufacturing techniques, formulas and other materials of the product in duplicate. | | （七）产品的生产工艺、配方等资料一式二份； |
| (8) The intellectual property right assignment contract or power of attorney (the original shall be provided in the case of of the first application, and a photocopy to which the applicant's official seal is affixed shall be provided in the case of a renewal application). | | （八）知识产权转让合同或授权书一式二份（首次申请提供原件，换发申请提供复印件并加盖申请人公章）。 |
| The veterinary administrative department of the provincial people's government shall, within five working days as of receipt of the relevant materials and samples, send samples to the provincial veterinary drug inspection agency for re-check and inspection, complete preliminary examination within 10 working days as of receipt of the re-check and inspection conclusion, and submit a copy of the examination opinion, the re-check and inspection report and all application materials to the Ministry of Agriculture. | | 省级人民政府兽医行政管理部门自收到有关资料和样品之日起5个工作日内将样品送省级兽药检验机构进行复核检验，并自收到复核检验结论之日起10个工作日内完成初步审查，将审查意见和复核检验报告及全部申请材料一式一份报送农业部。 |
| The Ministry of Agriculture shall, within five working days as of receipt of the review opinion of the veterinary administrative department of the provincial people's government, send the opinion to the China Institute of Veterinary Drug Control for expert review, and make a decision of approval or disapproval within 10 working days as of receipt of the review opinion. If the application complies with relevant provisions, it shall issue an approval document for the veterinary drug product, along with the approval label and instructions. If the application fails to comply with relevant provisions, it shall notify the applicant in writing, and explain the reason. | | 农业部自收到省级人民政府兽医行政管理部门审查意见之日起5个工作日内送中国兽医药品监察所进行专家评审，并自收到评审意见之日起10个工作日内作出审批决定。符合规定的，核发兽药产品批准文号，批准标签和说明书；不符合规定的，书面通知申请人，并说明理由。 |
Article 10 Where an application is filed for an approval document for a veterinary non-biological product other than those prescribed in Articles 6 and 9, the Ministry of Agriculture shall conduct comparison test administration in a step by step manner.
．．．．．． | | 第十条 申请第六条、第九条规定之外的非生物制品类兽药产品批准文号的，农业部逐步实行比对试验管理。
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