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What are the requirements for the chemical supply?
The specific requirements for the chemical supply include the following aspects:
Proof of Legal Source: A proof of legal source for chemical raw materials is required, and proof of excipients does not need to be provided. If the chemical raw materials are imported, a power of attorney from the overseas production enterprise and the domestic agent should be submitted.
Drug Production License: The applicant shall provide the original and duplicate copies of the Drug Production License of the chemical raw material production enterprise, and the chemical raw material shall be produced within the validity period of the Drug Production License.
Re registration approval and sales invoice: The applicant should provide the latest re registration approval for chemical raw materials or a screenshot of the information on the national bureau's original and auxiliary package registration platform (status should be A), and provide sales invoices from the past 1-2 years.
Quality inspection report: The applicant should provide a factory inspection report from the chemical raw material production enterprise or a self inspection report from a medical institution (issued within the past 1-2 years).
Drug Quality Standards: The applicant shall provide the current drug quality standards for chemical raw materials and affix the official seal of the drug production enterprise.
Procurement time requirement: The procurement time of chemical raw materials should be within the validity period of the drug production license and the latest re registration approval.
In addition, suppliers of chemical reagents and equipment need to meet the following requirements:
Qualification requirements: The supplier must be a production manufacturer or authorized agent with independent legal personality and hold a legal business license. At the same time, suppliers need to have a hazardous chemical business license and a non pharmaceutical precursor chemical business registration certificate.
Quality standards and service requirements: The chemical reagents provided by the supplier must be complete in variety, meet the quality requirements of national standards, be able to supply in small quantities, and be delivered to the door within 24 hours without special circumstances. Suppliers are required to provide detailed contact information to facilitate communication with purchasers.