Entrance Rules of Pharmaceutical Industry
1.Introduction
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 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 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 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 Only after the user submits the corresponding documents can the online shop be authenticated on www.echemi.com and upload the products.
2. Entrance requirements
2.1 Drug
2.1.1 Entrance requirements for suppliers
Factory |
Trading company |
Business license |
Business license |
Drug Manufacturing Certificate |
Wholesale Drug License or the Drug Manufacturing Certificate of the supplier factory |
Drug Registration Certificate or Certificate of Pharmaceutical Product |
Drug Registration Certificate or Certificate of Pharmaceutical Product of the supplier factory |
|
Supply Certificate or Purchase Certificate (or Purchase Contract) |
2.2 APIs, Pharmaceutical packaging materials, Pharmaceutical excipients
2.2.1 Entrance requirements for Chinese suppliers
Factory |
Trading company |
Business license |
Business license |
Register screenshot of Center for Drug Evaluation of National Medical Products Administration |
The supply factory of register screenshot of Center for Drug Evaluation of National Medical Products Administration |
|
Supply certificate or purchase certificate (or purchase contract) |
2.2.2 Entrance requirements for overseas suppliers
Factory |
Trading company |
Business license |
Business license |
Register screenshot of local National Medical Products Administration (If any) |
Supply certificate or purchase certificate (or purchase contract) |
Register screenshot sample
3. Why is this rule made?
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. What are the penalties for breaking the rules?
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. Supplementary provisions
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 can adjust this management specification at any time according to the operation of the platform and publicize it to users.
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.