Promulgation Date: 2020-2-15 Title: Ten Items to Support the Return to Work issued by the State Administration for Market Regulation, State Drug Administration, and State Intellectual Property Office Document Number:国市监综〔2020〕30号 Expiration date: Promulgating Entities:State Administration for Market Regulation, State Drug Administration, State Intellectual Property Office Source of text: http://gkml.samr.gov.cn/nsjg/zhghs/202002/t20200215_311667.html
To the departments (offices, commissions) for market regulation, drug administration bureaus, and intellectual property bureaus of each province, autonomous regions, municipalities directly under the central government and cities specifically designated in the state plan, sub-provincial cities, and those for the Xinjiang Production and Construction Corps.
为贯彻落实习近平总书记重要讲话和指示批示精神,按照党中央、国务院关于切实加强疫情科学防控、有序做好企业复工复产工作的部署,现就充分发挥职能作用,解决企业复工复产中面临的实际问题,提出十条政策措施。
I. Online Handling of Registration
Fully rely on the effective tactics of "online handling, mobile handling, handling by delivery, and meetings by appointment" to further reduce steps, time, and cost of registration, and implement special handling for the registration of enterprises making goods for epidemic prevention. For new industries and business formats that emerge during the epidemic, the standards for scope of business are to be promptly adjusted.
II. Implement Notice Pledges
Facilitate handling and reduce approval times for production permits and mandatory certifications involving resumption of product or conversion for production. Carry out information pledges for enterprises that have production capacity but are temporarily unable to provide relevant materials because due to time constraints, having the enterprise promise to provide supplemental materials then finishing handling onsite.
So long as food safety can be guaranteed, simplify the permitting processes for food production and sales, promoting online handling and expanding the issuance of electronic certifications. For enterprises applying for new permits and enterprises applying to modify permits, that need on-site verifications, the provincial-level market regulatory departments are to pilot the use of information pledges for low-risk foods based on the local food safety risk level, and to carry out 'permitting before inspections' for eligible enterprises.
The qualifications of inspection and testing institutions are to be determined through online and mail processing and using implementation methods such as deferred review, information pledges, remote monitoring and review, expert document review, and so forth.
To facilitate mergers and acquisitions of enterprises, online declarations are to be used for the centralized anti-monopoly examination of business operators to improve the efficiency of review in simple cases, and to ensure that mergers and acquisitions are carried out smoothly. Optimize work mechanisms for centralized anti-trust reviews, increasing guidance and services for enterprise compliance in competition.
III. Establish Emergency Green Channels for Administrative Permits
对生产企业转产生产口罩、防护服等应急物资的,简化生产资质审批程序,合并产品注册及生产许可证检查流程,启动加急检验检测程序,同时认可企业的部分自检报告。 对符合许可条件的企业现场确认后,立即办理产品注册和发给生产许可证。 对于转产生产医疗器械的企业,实行应急审批,依法办理医疗器械注册证和生产许可证。
对疫情防控所需药品的注册申请,在确保安全性和有效性的基础上,加快审评审批。 对疫情防控所需的药品,各省级药品监管部门要指导企业合理安排生产,充分释放产能,全力保障临床供应。 对医用口罩、防护服等医疗器械产品注册、生产许可和检验检测等实施特别措施,合并审批流程。
As requested, give priority to handling applications for patents and trademark registrations involving the prevention and treatment of Covid-19. Support enterprises in carrying out pledge financing for intellectual property rights, establishing green channels for registering IPR pledges, and supporting enterprises to quicky finance and renew loans.
IV. Extend the Period of Administrative Permits
对在疫情防控期间营业执照登记事项发生变化又不能及时办理变更登记的,延期至疫情解除之后一个月内办理。
对因疫情影响未能按时办理工业产品生产许可证换证导致许可证书过期的生产企业,可办理许可证延期,待疫情解除后再行提交延期申请。
Where permits for the production and trade in food products expire, the effective period may be extended until the epidemic in the relevant area.
对因疫情影响不能按时完成换证的特种设备生产单位及检验检测机构,可办理许可证延期。 鼓励符合条件的特种设备生产单位,采用自我声明承诺的方式免评审换证。
对受疫情影响无法按期申请办理检验检测机构复查换证的,可以延期至疫情解除后办理,证书有效期延长至疫情解除后三个月。
对复工复产企业办理专利、商标、集成电路布图设计等事务,因受疫情影响超出相关期限的,依法给予期限中止、顺延,以及请求恢复权利等便利化救济政策措施。
Quicken the converted application of standards
支持外贸出口企业复产,加快国际标准与国内标准的转换,推动出口产品依据标准和国内标准的衔接。 对依据国际标准生产,且相关国际标准主要技术指标达到强制性国家标准安全要求的,允许在国内生产销售。 鼓励社会团体组织制定相关团体标准,增加企业复工复产所需标准的有效供给。 对于生产国外标准口罩用于出口、有能力生产国内标准口罩未取得相关资质的企业,加快办理。
VI. Cautiously Administer the Irregulatory List
对生产、经营疫情防控相关物资的企业,已被列入经营异常名录的,经企业申请,可以简化流程、尽快移出。 对因受疫情影响暂时失联的企业,可以暂不列入经营异常名录。
VII. Strictly Investigate Arbitrary Fees and Price Increases
加强价格监管,严查各类涉及企业的乱收费行为,减轻企业复工复产负担。 支持企业增加产能,严厉打击口罩等防控物资生产领域哄抬价格等违法行为,维护防控物资生产所需机器设备、原辅材料市场价格秩序稳定。
VIII. Increase the Quality of Technological Service Support
实行计量型式评价专人受理,缩短试验时间。 对到期的有关计量标准器具,经所在单位自行核查满足相关技术要求,可适当延长有效期。
鼓励标准化技术组织和机构,围绕企业复工复产提供标准化咨询等标准技术服务。 帮助企业尽快建立可操作的防疫质量控制流程和规范,实现防疫控制与企业复工的精细化管理。 启动物品编码业务24小时快速响应机制。
引导认证机构加强对复工复产企业的技术服务,开辟线上咨询、受理、评价等综合服务通道,采取线上认证申请受理、延期现场审核检查、优先安排3C认证等方式进行办理。
IX. Reduce or Waive Technological Service Fees
疫情防控期间,市场监管总局所属的计量检定机构、产品质量检验检测机构、特种设备检验检测机构,对复工复产企业计量器具的检定校准收费、产品质量检验检测项目收费、特种设备检验项目收费减少50%,对湖北省企业免除各类检定校准和检验检测费用。 市场监管总局所属的标准化技术机构,对中外标准信息咨询服务、标准时效性确认和标准翻译费用予以免收。
X. Encourage Enterprises to Participate in the "three guarantees" action
持续深入开展“保价格、保质量、保供应”行动,不断提升活动覆盖面,为企业搭建与民生期望互通互信的平台。 鼓励引导更多企业参加“三保”行动,承诺加快恢复产能,保证产品质量,保持价格稳定,保障市场供应,凝聚疫情防控合力。
各级市场监管、药监、知识产权部门要加强组织领导,强化责任担当,紧密结合各地实际,把十条政策措施进一步细化,落实落细落到位,更好服务于企业复工复产工作,坚决打赢疫情防控阻击战。
市场监管总局 国家药监局 国家知识产权局
February 15, 2020
Be First to Comment