Drugdu.com expert's response:

The requirements for documents in drug import customs clearance are complex and comprehensive, aiming to ensure the quality, safety, and legality of imported drugs in compliance with China's drug administration regulations.

Ⅰ. Key Documents

Import Drug Registration Certificate (or Pharmaceutical Product Registration Certificate)

Reason: Verifies that the drug has been registered in China and approved by relevant national departments, allowing for legal sale and use domestically.

Drug Business License or Drug Production License and Enterprise Legal Person Business License

Reason: Demonstrates that the enterprise importing drugs possesses the legal qualifications for drug operation or production, as well as the legitimacy and scope of business.

Certificate of Origin

Reason: Proves the origin of the imported drugs, serving as an important basis for customs import administration and tariff collection.

Purchase Contract

Reason: Verifies the authenticity and legality of the transaction for imported drugs, including information on buyer and seller, transaction quantity, price, etc.

Packing List, Bill of Lading, and Freight Invoice

Reason: Provides detailed information on the transportation of goods, including the quantity of drugs, mode of transport, and expenses.

Factory Inspection Report

Reason: Issued by the manufacturer in the exporting country or region, certifying that the drugs comply with relevant standards and requirements upon leaving the factory.

Chinese Version of Drug Instructions and Packaging, Label Samples

Reason: Provides information on drug usage and packaging appearance, ensuring compliance with domestic regulations upon domestic sale.

Import Drug Inspection Report and Import Drug Clearance Permit

Reason: Important documents issued by relevant inspection agencies and port drug administration departments, verifying that the imported drugs have passed inspection and are permitted for customs clearance.

Import Permit (for special drugs such as narcotics and psychotropic substances)

Reason: Issued by the National Medical Products Administration, certifying that the import of special drugs complies with relevant regulatory requirements.

Self-Declaration of Authenticity of Application Materials

Reason: A self-commitment by the importing entity regarding the authenticity of all submitted materials, ensuring the accuracy and completeness of customs declaration information.

Ⅱ. Other Possible Documents

Import Drug Approval (for first-time imported drugs or clinically urgent drugs, samples, or controls)

Import Approval for Medicinal Materials (for medicinal material imports)

Other relevant materials required by the Food and Drug Administration

III. Summary of Reasons

The requirements for these documents are primarily based on the following considerations:

Ensuring Drug Quality and Safety: Through rigorous registration, inspection, and approval processes, the quality and safety of imported drugs are ensured to meet national standards.

Maintaining Market Order: Preventing illegal drugs from entering the market, protecting the rights and interests of legitimate enterprises, and maintaining fair competition in the market.

Compliance with Laws and Regulations: Adhering to national laws and regulations related to drug imports, ensuring the legality and standardization of import activities.

In conclusion, the diversity and complexity of documents required for drug import customs clearance reflect the country's high degree of attention to the quality, safety, and legality of imported drugs. Importing entities should ensure that all relevant documents and materials are prepared in full before customs declaration to ensure the smooth progress of the customs clearance process.