ECHEMI医药类目供应商入驻要求 ECHEMI Entrance Requirements of Suppliers in Pharmaceutical Category

1.1药品指用于预防、治疗、诊断人的疾病，有目的地调节人的生理机能并规定有适应症或者功能主治、用法和用量的物质，包括中药、化学药和生物制品等。

1.1 Drug refers to the articles intended for use in the prevention, treatment or diagnosis of human diseases, or intended to effect the purposive regulation of human physiological functions, for which indications or major functions, usage and dosage are prescribed. They include traditional Chinese medicines, chemical medicines and biological products, etc.

1.2 原料药指用于生产各类制剂的原料药物，是制剂中的有效成份，由化学合成、植物提取或者生物技术所制备的各种用来作为药用的粉末、结晶、浸膏等，但病人无法直接服用的物质。

1.2 APIs refer to the raw materials used in the production of various pharmaceutical preparations, which are the effective ingredients in the preparations, powders, crystals, extracts, etc., prepared by chemical synthesis, plant extraction or biotechnology, which are used as medicinal substances, but cannot be taken directly by patients.

1.3药包材是指药品生产企业生产的药品和医疗机构配制的制剂所使用的直接接触药品的包装材料和容器。

1.3 Pharmaceutical packaging materials refer to the packaging materials and containers that directly contact drugs used in the drugs produced by drug manufacturers and the preparations prepared by medical institutions.

1.4 药用辅料指生产药品和调配处方时使用的赋形剂和附加剂；是除活性成分以外，在安全性方面已进行了合理的评估，且包含在药物制剂中的物质。

1.4 Pharmaceutical excipients refer to the excipients and additives intended for manufacturing drug dosage forms and prescription dispensing, which are the substances other than the active ingredient that have been reasonably assessed for safety and are included in the pharmaceutical product.

1.5 用户提交相应的文件后才可在www.echemi.com上认证店铺成功并上传商品。

1.5 Only after the user submits the corresponding documents can the online shop be authenticated on www.echemi.com and upload the products.

2. 入驻要求

2. Entrance requirements

2.1 药品

2.1 Drug

2.1.1供应商入驻要求

2.1.1 Entrance requirements for suppliers

2.2 原料药、药包材、药用辅料

2.2 APIs, Pharmaceutical packaging materials, Pharmaceutical excipients

2.2.1国内供应商入驻要求

2.2.1 Entrance requirements for Chinese suppliers

2.2.2海外供应商入驻要求

2.2.2 Entrance requirements for overseas suppliers

药监局注册证明示例

Register screenshot sample 

3. 为什么制定这个规则？ 

3. Why is this rule made?

为了加强药品管理，保证药品质量，保障公众用药安全和合法权益，保护和促进公众健康，遵守国家的相关法律法规，只有取得药品、药包材相关资质的客户才能在www.echemi.com发布此类产品。

In order to strengthen pharmaceuticals management, ensure pharmaceuticals quality, guarantee the public to use medicine safety and their rights and interests, protect and promote public health, and comply with the relevant laws and regulations of our state, only customers who have obtained the qualification related to drugs and pharmaceutical packaging materials can publish such products on www.echemi.com.

4. 违反规定会有怎么样的处罚措施？

4. What are the penalties for breaking the rules?

若不遵守我网发布规则，可能会导致一系列的处罚，比如违规信息直接被删除、相关类目商品被限制发布、公司帐号使用权暂定以及永久关闭帐号不再合作等等。

If you do not comply with our network publishing rules, it may lead to a series of penalties, such as the illegal information directly deleted, related categories of products are restricted to release, the right to use your account is temporary, permanently closed account no longer cooperation and so on.

5. 附则

5. Supplementary provisions

5.1  供应商的违规行为，发生在本管理规范生效之日以前的，适用当时的规范。发生在本管理规范生效之日以后的，适用本规范。 

5.1 Any violation of the supplier that occurred before the effective date of this management specification shall be applicable to the specifications at that time.

Any violation of the supplier that occur after the effective date of this management specification shall be applicable to this specifications.

5.2 ECHEMI可根据平台运营情况随时调整本管理规范并向用户公示。

5.2 ECHEMI can adjust this management specification at any time according to the operation of the platform and publicize it to users.

5.3  供应商应遵守国家法律、行政法规、部门规章等规范性文件。对任何涉嫌违反国家法律、行政法规、部门规章等规范性文件的行为，本规范已有规定的，适用于本规范，本规范尚无规定的，依照法律法规处理。供应商依据相关规则承担的相关责任并不免除其应承担的法律责任。供应商在www.echemi.com的任何行为，应同时遵守与ECHEMI及其关联公司签订的各项协议。

5.3 Suppliers shall comply with national laws, administrative regulations, departmental rules and other normative documents. Any act suspected of violating the national laws, administrative regulations, departmental rules and other normative documents, if there are provisions in this specification, they shall apply to this specification. If there is no provision in this specification, it shall be dealt with in accordance with laws and regulations. The relevant liability undertaken by the supplier in accordance with the relevant rules shall not exempt him from the legal liability. Any action of the supplier at www.echemi.com shall simultaneously comply with all agreements with ECHEMI and its affiliates.

www.echemi.com

Feb 6, 2023

2023年2月6日