Drugdu.com expert's response:

To successfully export proprietary Chinese medicines, the following processes are required:

I. Preliminary Preparations

Understanding Target Market Regulations: Prior to exporting traditional Chinese medicines (TCMs), enterprises must conduct thorough research on the relevant regulations of the target market, including import registration requirements, quality standards, and certification systems. This information is crucial for ensuring the smooth entry of TCMs into the target market.

Product Preparation:

a. Ensure that the exported TCMs comply with relevant quality standards and possess valid drug production licenses and drug registration certificates issued by the national drug regulatory authority.

b. Prepare product specifications, labels, packaging, etc., ensuring they comply with the regulatory requirements of the target market.

Finding Partners: Identify suitable partners, such as importers, agents, or distributors. Selecting the right partners can help enterprises better understand the target market and reduce export risks.

II. Preparation of Application Materials

Basic Information of Medicines: Detailed information on the TCMs to be exported, including their names, ingredients, manufacturers, production dates, expiration dates, etc.

Quality Inspection and Safety Assessment: Provide quality inspection reports and safety assessment reports of the medicines to demonstrate their quality and safety.

Relevant Licenses and Certificates: Production and sales licenses of the medicines, as well as export-related licenses or documents issued by the national drug regulatory authority.

Contracts or Letters of Intent: Provide contracts or letters of intent signed with importers in the target market to prove the cooperation intention and transaction content.

III. Submission of Application and Review

Submission of Application: Submit the application materials for exporting TCMs to the national drug regulatory authority (such as the National Medical Products Administration). This typically involves filling out an online application form and uploading all relevant supporting documents.

Review and Evaluation: The regulatory agency will review and evaluate the application materials to ensure that the TCMs for export comply with relevant quality and safety standards, as well as the regulations and requirements of the importing country. During the review process, the agency may request additional information or conduct on-site inspections.

IV. Obtaining Export License

If the application passes the review and evaluation, the regulatory agency will issue an export license. This license is a necessary document for exporting TCMs, serving as proof that the medicines have passed relevant quality and safety inspections and meet the requirements of the importing country.

V. Handling Export Procedures

Preparation of Customs Documents: Enterprises must prepare customs documents for exporting TCMs, including export cargo declaration forms, invoices, packing lists, bills of lading, etc. These documents serve as the basis for customs inspection and release of goods.

Customs Inspection: Customs will verify the customs documents submitted by enterprises, confirming that the information such as the name, quantity, and value of the goods matches the contract. During the inspection process, customs may request additional materials or conduct on-site inspections.

Payment of Taxes and Fees: Enterprises must pay the corresponding export taxes and fees according to customs regulations. After payment, customs will process the release of the exported goods.

Arranging Transportation: Enterprises must select appropriate transportation modes and companies to transport the TCMs to the target market. During transportation, enterprises must ensure the safety and timely arrival of the goods.

Insurance: To reduce transportation risks, enterprises can purchase cargo transportation insurance. In case of loss or damage to the goods, enterprises can obtain corresponding compensation.

Settlement of Payment: Enterprises must settle payments with importers or agents. During the settlement process, both parties must follow the contract terms and international trade practices to ensure timely payment.

VI. Compliance with Target Market Regulations

In the target market, enterprises must comply with local relevant regulations to ensure the compliant sale and use of TCMs. In case of regulatory changes or market fluctuations, enterprises must promptly adjust their business strategies.

Please note that the specific procedures for exporting TCMs may vary depending on the target market. Therefore, in actual operations, enterprises should thoroughly understand and comply with the relevant regulations and requirements of both the target market and China.