To better carry out the Cross-border E-commerce Sales Pilot for Medical Products of Beijing Municipality, and in accordance with the Reply of the State Council to the General Plan for the Comprehensive Pilot of Further Opening Up the Service Sector in the Beijing Municipality (Guo Han [2019] No. 16) and the Reply Letter from the Department of Comprehensive Affairs, Planning, and Finance Affairs of the National Medical Products Administration on Carrying out Cross-border E-commerce Sales of Pharmaceutical Products (Yao Jian Zong Yao Guan Han [2019] No. 518), Beijing Medical Products Administration, together with the Beijing Municipal Commerce Bureau, Beijing Customs, the Administrative Committee of Beijing Tianzhu Comprehensive Bonded Zone, formulated the Implementation Plan of Cross-border E-commerce Sales Pilot for Medical Products of Beijing Municipality, and now is hereby issued.

It is hereby notified the above.

Beijing Municipal Commerce Bureau

Beijing Customs

Tianzhu Comprehensive Bonded Zone

Administrative Committee of Beijing Beijing Medical Products Administration

December 30, 2019

Implementation Plan of Cross-border E-commerce Sales Pilot for Medical Products of Beijing Municipality

To better carry out the Cross-border E-commerce Sales Pilot for Medical Products of Beijing (hereinafter referred to as the Pilot), this plan is formulated in accordance with the Reply of the State Council to the General Plan for the Comprehensive Pilot of Further Opening Up the Service Sector in the Beijing Municipality (Guo Han [2019] No. 16) and the Reply Letter from the Department of Comprehensive Affairs, Planning, and Finance Affairs of the National Medical Products Administration on Carrying out Cross-border E-commerce Sales of Pharmaceutical Products (Yao Jian Zong Yao Guan Han [2019] No. 518).

I. General Requirements

(1). Guiding Ideology

Guided by Xi Jinping 's Thought on Socialism with Chinese Characteristics for a New Era, this plan fully follows the instructions of the 19th CPC National Congress, adopts a new vision for development, fully implements the innovation-driven development strategy, take the supply-side structural reform as the main line, deepens market-oriented reforms and expands high-level opening up, with the aim of facilitating a new pattern for comprehensive opening-up. This plan strictly sticks to the strategic positioning of the capital, gives full play to its technological innovation and talent advantages, takes rule of law, internationalization, and convenient services as the guide, focuses on differentiated development, achieve breakthroughs in key areas, and strive to create an operation and supervision service system of medical cross-border e-commerce characterized by collaboration among authorities, cooperation between the government and enterprises, support from the market.

(2). Objectives

With the fundamental goal of fully implementing the requirements of the CPC Central Committee concerning the "four most stringent" drug safety measures, and "allowing citizens of the capital to enjoy a higher level of drug safety ", this plan is formulated to adapt to the current trend of "new industry, new business, and new model" of pharmaceutical retailing, deepen the exploration of smart Internet supervision, studies the access conditions, operating standards, and supervision methods of the pilot enterprises, establish and improve a long-term mechanism to ensure the safety of cross-border e-commerce sales of medical products, so as to promote the coordinated development of the pharmaceutical e-commerce industry.

II. Organizational guarantee and Responsibility Division

We will establish a Leading Group for the Promotion of the Cross-border E-commerce Sales Pilot for Medical Products (hereinafter referred to as the Pilot Leading Group),which consists of Beijing Medical Products Administration, Beijing Municipal Commerce Bureau, Beijing Customs, and the Administrative Committee of Beijing TianzhuComprehensive Bonded Zone. We will also set up a joint work mechanism of the member units accordingly.

Each member unit and the respective responsibilities are as follows:

Beijing Medical Products Administration: Responsible for taking the lead in drafting the pilot work plan, organizing joint meetings among the member units on a regular basis, organizing and coordinating departments concerned to research and formulate standards for the selection, traceability, storage and distribution of cross-border medical products, and organizing the implementation of monitoring of cross-border medical products within the scope of the pilot, and organizing and coordinating the departments concerned to earnestly conduct the evaluation of pilot effects, summary of experience and information reporting.

Beijing Municipal Commerce Bureau: Responsible for organizing and guiding the pilot enterprises to improve the marketing service mechanism for cross-border e-commerce sales of medical products, coordinating the departments concerned to promote consumption of cross-border medical products, and reporting the progress of relevant work to the pilot leading group on a regular basis.

Beijing Customs: Responsible for organizing and implementing the operation and management of the pilot product variety customs clearance, assisting in the filing and review of the list of qualification of the pilot enterprises and the list of pilot pharmaceutical products, and supervising the customs clearance declaration of the pilot enterprises and the pilot products in accordance with their responsibilities, and reporting the progress of related work to the pilot leading group on a regular basis.

Administrative Committee of Beijing Tianzhu Comprehensive Bonded Zone: Responsible for the publicity of the pilot enterprises, organizing the regulatory authorities concerned in the zone to carry out the supervision and management of the tracing, storage, and distribution of cross-border medical products, as well as the emergency treatment and risk assessment of the pilot work, and reporting the progress of the relevant work to the pilot leading group on a regular basis.

III. Application for Pilot Enterprises

The pilot enterprises are comprehensive and overall management organs for the pilot work. They can provide services including online trading, customs clearance, warehousing, and distribution for cross-border medical products through other related companies, but they are not allowed to directly participate in the cross-border sales of medical product.

(1) Basic conditions and responsibilities of pilot enterprises

A pilot enterprise shall be an enterprise registered in the administrative area of Beijing and qualified as an enterprise legal person and a third-party online trading service platform for medical devices. The relevant cross-border medical products shall be cleared at Beijing port and have the storage capacity in Beijing Tianzhu Comprehensive Bonded Zone that meets the storage requirements of cross-border medical products (can entrust the eligible logistics warehousing enterprises). The pilot enterprise shall has the trading service system of the e-commerce platform in line with the pilot requirements (it can be the system of affiliated companies),and be able to achieve quality control and traceability management of cross-border medical products, and to establish a sound cross-border pharmaceutical product risk prevention and control system, pre-sales and after-sales service system and quality assurance system.

The Pilot enterprises shall strengthen the quality management of cross-border medical products, be responsible for the safety and authenticity information released on cross-border pharmaceutical products, ensure the legitimacy and traceability of the products, and perform the following responsibilities:

1. Be responsible for the organizing of the formulation of quality management system, the guiding and supervising the implementation of the system, and the inspecting, correcting and continuously improving the implementation of the quality management system;

2. Be responsible for the examination of the settled enterprises and cross-border medical products on their platforms;

3.Be responsible for the management of purchasing and selling process and traceability of cross-border medical products;

4. Be responsible for the investigation, handling and reporting of quality complaints and accidents of cross-border medical products;

5. Be responsible for the implementation of cross-border medical product recall management;

6. Other responsibilities that shall be performed by the pilot enterprises.

(2) Access management of pilot enterprises

The pilot enterprises shall meet the requirements of this plan and submit the pilot work plan and the following application materials to the pilot leading group:

1. Profile of the pilot enterprise;

2. Organization and personnel engaged in the pilot work;

3. A brief introduction of the current situation of the cross-border e-commerce trading service platform construction as well as the information management;

4. Summary sheet of the facilities and equipment;

5. List of settled enterprises, cross-border medical products and product introduction;

6. Management system related to the assurance of the quality and safety of the cross-border medical product trading.

The pilot leading group shall organize a joint meeting to conduct comprehensive analysis and research on the materials submitted by the enterprises to participate in the pilot project, the operation mode and the previous operation status, organize the implementation of on-site verification, confirm the enterprises that meet the requirements and have pilot significance, and make relevant information available to the public.

IV. Management of settled enterprises

(1). Definition of settled enterprises

The settled enterprise refers to an overseas medical enterprise that sells cross-border medical products to the domestic market through a pilot enterprise. Except for domestic individual consumers, it shall not be allowed to sell overseas pharmaceutical products to any domestic enterprises or other institutions.

(2). Obligations

The settled enterprises shall ensure that the cross-border medical products sold to the domestic market meet the requirements of laws and regulations of their county, sign the platform settlement agreement with the pilot enterprises, and provide the pilot enterprises with Chinese versions of product introductions and quality control requirements for each cross-border medical product.

(3). Management of settled enterprises

The settled enterprise shall comply with other relevant requirements of cross-border e-commerce in China. The pilot enterprise shall monitor the cross-border medical product sales behaviors and information of the settled enterprises, and shall immediately stop providing pilot services to the settled enterprises if they are found to have the following behaviors, and shall keep relevant records and report to the pilot leading group:

1. Selling cross-border medical products beyond the scope of pilot product varieties;

2. Publishing false information or exaggerating propaganda;

3. Being ordered to suspend business by overseas regulatory authorities, Voluntarily cancelling or losing the qualification of overseas operation;

4. Where there are other serious security risks.

V. Tracing management

The pilot enterprises have the obligation of traceability and shall establish a cross-border medical product traceability system based on the principle of "one object with one code, and traceability for both the code and the object", and give full play to the main role of enterprises, and achieve the traceability and verification of the minimum packaging unit of cross-border medical products in China.. The Pilot enterprises will be encouraged to bring the production and circulation of the cross-border products abroad into the traceability system.

The cross-border medical product traceability system established by the pilot enterprises through IT means shall timely and accurately record and keep the traceability data of cross-border medical products, so as to form a cross-border medical product traceability data chain, and ensure that the source and the whereabouts of the medical products are traceable throughout their circulation within China; The system shall effectively prevent illegal drugs and medical devices from entering the market circulation, and ensure that the cross-border medical products with quality and safety risks can be recalled and held accountable.

VI. Storage and Transportation Management

The Pilot enterprises shall have warehouses in Tianzhu Comprehensive Bonded Zone that meet the storage conditions for cross-border medical products. The warehouse area shall not be less than 500 square meters, and shall be equipped with storage facilities and equipment appropriate to the scale of the pilot, product quantity, and quality characteristics, so as to meet the rational and safe storage and distribution of the products.

The pilot enterprises shall have more than two warehouse management personnel to perform duties of rational storage, regular maintenance, and regular inventory of cross-border medical products. The established cross-border medical product warehouse management system shall have the functions of warehouse control such as early warning of near effective period and automatic locking after expiration.

The Pilot enterprises shall formulate corresponding cross-border medical product distribution management system and operating process according to the actual business model, and take effective measures to ensure product quality and safety in the process of the distribution. Where another distribution enterprise is entrusted to provide distribution services, the quality assurance capabilities of the distribution enterprises shall be assessed and evaluated, and the quality responsibilities shall be clarified. The Pilot enterprises are encouraged to track, monitor, and record the delivery trajectory, temperature and humidity, and delivery time of cross-border medical products by means of information technology.

VII. Sales Management

The pilot enterprises shall examine and verify the business qualification of the settled enterprises in their countries and the names, model, specifications, indications or scope of application of the cross-border medical products, the number of the overseas registration qualifications, the production enterprises, contraindication and other information, establish registration files, and make regular verification and updates to ensure the authenticity of the published cross-border medical products. The pilot enterprises shall also record and keep the cross-border products' information and trading information released by the settled companies, and ensure that information integrity, confidentiality and availability. The retention period of the cross-border medical product information shall not be less than 3 years, and the trading records shall be kept until 2 years after the expiry date of the products, but not less than 5 years, and the relevant records shall be true, complete and traceable.

The pilot enterprises are encouraged to establish an advance compensation system for cross-border medical products, and have the obligation to assist consumers in safeguarding their rights in case of disputes caused by product quality problems.

VIII. Regulatory Measures

(1) The pilot leading group shall organize member units concerned to supervise and inspect the pilot enterprises on a regular basis, and the pilot enterprises shall promptly rectify the problems and potential quality and safety risks found.

(2) The technical monitoring records and traceability data of the pilot operation activities of the pilot leading group can be retained as the basis for subsequent disposal.

(3) When the pilot leading group exercises the supervisory functions and powers prescribed in the preceding paragraph of this plan, the pilot enterprises shall assist and cooperate with it, and shall not refuse or obstruct it. The pilot enterprises shall provide necessary technical support in the aspects of information inquiry, data extraction, illegal information shielding, and discontinuation of services.

(4) If any of the following situations is found, the pilot leading group shall order the pilot enterprises to immediately stop providing pilot services and hold them accountable in accordance with the law; those who refuse to make corrections within the limited time limit or whose circumstances are serious, the pilot qualification shall be cancelled.

1. Providing services to enterprises that do not meet the settlement conditions;

2. Disseminating information on narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, Rehabilitation medicines, and precursor chemicals that are controlled in accordance with laws and regulations of the country;

3. The settled enterprises sell cross-border medical products beyond the designated scope;

4. Releasing untrue information about medical products in violation of the requirements for the release of cross-border medical product information;

5. Expanding the pilot scope and contents without authorization;

6. Failing to cooperate with the supervision and inspection organized by the pilot leading group;

7. Failing to perform proper management of the settled enterprise or meet the requirements of this plan.

(Publicity attribute: positive disclosure)