22专利情况:专利权属声明:我们声明:本申请对他人专利不构成侵权。 Patent information: patent declaration: we declare that this application does not infringe any other’s patent.
23是否涉及特殊管理药品或成分: If the drug is subject to special administration or contains any ingredients subject to special administration:
否 No
立项批复文件号[4]: The number of the official approval document of the proposal:
24中药品种保护[5]: Drugs under application for TCM protection:
25同品种新药监测期[6]: Monitoring period of new drugs for products of the same drug by other enterprises:
无 None
26本次申请为:首次申请 This application is: initial application
[4]: If the drug is subject to special administration or contains any ingredients subject to special administration, the applicant should propose and get the official approval document of the proposal from SFDA before filling in this application form.
[5]: For those products under application for TCM protection, application for generic products of the same drug will be suspended from the date the protection application was accepted to the date an administration decision is made.
[6]: To ensure public health, SFDA may implement a monitoring period for the approved new drugs to monitor the safety. For new drugs under the monitoring period, SFDA shall not approve production, dosage change and importation of the drug by other enterprises.
经审查,本表填写符合形式审查要求。 审查机关 After examination, the format of this application form is considered to be in accordance with the requirements. The examining authority
审查机关: 审查人签名: 日期: 年 月 日 The examining authority: the signature of the examiner: date: year month date
本表必须使用SFDA制发的申请表填报软件填写、修改和打印。不得涂改。数据核对码:********** The application form must be filled in, amended or printed with the software provided by SFDA and shall not be altered. The bar code is **********.