| Notice of the National Medical Products Administration on Issuing the Provisions on the Administration of the Drug Export Sales Certificates | | 国家药监局关于印发药品出口销售证明管理规定的通知 |
| (No. 43 [2018] of the National Medical Products Administration) | | （国药监药管〔2018〕43号） |
| The food and drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government; and the Food and Drug Administration of Xinjiang Production and Construction Corps: | | 各省、自治区、直辖市食品药品监督管理局，新疆生产建设兵团食品药品监督管理局： |
| For the purpose of further regulating the handling of the Drug Export Sales Certificates and facilitating and serving China's export of drugs, the National Medical Products Administration (hereinafter referred to as the “NMPA”) has developed the Provisions on the Administration of the Drug Export Sales Certificates, which are hereby issued for your compliance and implementation. You are hereby notified of the relevant matters as follows: | | 为进一步规范《药品出口销售证明》的办理，为我国药品出口提供便利和服务，国家药品监督管理局制定了《药品出口销售证明管理规定》，现予发布，请遵照执行。有关事项通知如下： |
| I. The medical product administrations of all provinces (autonomous regions, and municipalities directly under the Central Government) shall, according to the requirements of the Notice by the General Office of the State Council of Issuing the Implementation Plan for Further Deepening “Internet plus Government Services” and Promoting the Reform of “One-Stop Online Government Services by One Department at One time” (No. 45 [2018], State Council) and this Notice, improve the internal application and handling procedures, shorten the time limits for handling, and actively promote online acceptance and issuance of certificates, so as to facilitate export enterprises. Where the information-based conditions are ripe, paper photocopies may be replaced with electronic copies in submission as the case may be. | | 一、请各省（区、市）局按照《国务院办公厅关于印发进一步深化“互联网＋政务服务”推进政务服务“一网、一门、一次”改革实施方案的通知》（国办发〔2018〕45号）和本通知要求，完善内部申请办事流程，压缩办理时限，积极推行网上受理和出证，为出口企业提供便利。信息化条件成熟的，可视情况逐步以电子提交代替纸质复印件申报。 |
| II. The NMPA will establish a unified information management system for the drug export sales certificates. The medical product administrations of all provinces (autonomous regions, and municipalities directly under the Central Government) shall, before the system is officially launched, upload the data and information about issuance of certificates through the direct reporting system for drug manufacturing and supervision information, including the original copy of the certification documents (in PDF format); and shall, after the information management system is launched, transmit the data and information about issuance of certificates according to the system requirements. | | 二、国家局将建设统一的药品出口销售证明信息管理系统。在该系统正式上线运行前，各省（区、市）局通过药品生产和监管信息直报系统上传出证数据信息，包含证明文件原件（pdf文件格式）。信息管理系统上线后，按系统要求传送出证数据信息。 |
| III. Regarding “the original copy of the certification documents of the related varieties provided by international organizations that have relevant agreements with China” in Article 4 of these Provisions, the NMPA shall offer examination opinions. The medical product administrations of all provinces (autonomous regions, and municipalities directly under the Central Government) may handle the matter according to the examination opinions of the NMPA. | | 三、关于本规定第四条中“与我国有相关协议的国际组织提供的相关品种证明文件”，由国家局提出审核意见。各省（区、市）局可依据国家局审核意见予以办理。 |
| IV. All local authorities shall strengthen the supervision of manufacturers of exported drugs, strictly follow inspection standards in accordance with the Good Manufacturing Practice for Drugs, and pay close attention to enterprises' auditing of suppliers and implementation of the requirements for data reliability. While providing certification issuance services to enterprises, all local authorities shall urge enterprises to continue to engage in production in compliance with the laws and regulations; where they find that any enterprise fails to meet the requirements, they shall take measures in a timely manner. | | 四、请各地对出口药品生产企业加强监管，按照药品生产质量管理规范，严格把握检查标准和尺度，重点关注企业执行供应商审计和落实数据可靠性要求的情况。各地为企业提供出证服务的同时，督促企业持续合规生产；发现不符合要求的，及时采取措施。 |
| V. The Provisions shall come into force on the date of issuance, upon which the Notice of Issuing the Several Administrative Provisions on the Issuance of the Drug Sales Certificates (No. 225 [2001], CFDA) issued by the former National Medical Products Administration on shall be repealed. | | 五、本规定自发布之日起施行，原国家药品监督管理局《关于印发〈出具“药品销售证明书”若干管理规定〉的通知》（国药监安〔2001〕225号）同时废止。 |
| National Medical Products Administration | | 国家药监局 |
| November 9, 2018 | | 2018年11月9日 |
| Provisions on the Administration of the Drug Export Sales Certificates | | 药品出口销售证明管理规定 |
| Article 1 The Provisions are developed for the purposes of further regulating the handling of the Drug Export Sales Certificates and facilitating and serving China's export of drugs. | | 第一条 为进一步规范《药品出口销售证明》的办理，为我国药品出口提供便利和服务，制定本规定。 |
| Article 2 The Drug Export Sales Certificates shall apply to the export of drugs of drug marketing license holders or drug manufacturers within the territory of the People's Republic of China that have been approved for marketing, except for drugs that are restricted or prohibited from export by the relevant departments of the State Council. | | 第二条 《药品出口销售证明》适用于中华人民共和国境内的药品上市许可持有人、药品生产企业已批准上市药品的出口，国务院有关部门限制或者禁止出口的药品除外。 |
| These Provisions may also apply to unregistered specifications (unit doses) of drugs approved for marketing that are manufactured by drug marketing license holders or drug manufacturers according to the requirements of the Good Manufacturing Practice for Drugs. | | 对于与已批准上市药品的未注册规格（单位剂量），药品上市许可持有人、药品生产企业按照药品生产质量管理规范要求生产的，也可适用本规定。 |
| These Provisions may also apply to drugs that are not registered in China but manufactured by drug marketing license holders or drug manufacturers according to the requirements of the Good Manufacturing Practice for Drugs, and meet the requirements of international organizations that have relevant agreements with China. | | 对于未在我国注册的药品，药品上市许可持有人、药品生产企业按照药品生产质量管理规范要求生产的，且符合与我国有相关协议的国际组织要求的，也可适用本规定。 |
The issuance of the Drug Export Sales Certificates is a service item of facilitating the export of drugs by enterprises upon the application of enterprises.
．．．．．． | | 出具《药品出口销售证明》是根据企业申请，为其药品出口提供便利的服务事项。
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