Import Procedures for Vaccines, Antigens, Plasma & Other Special Items

 

 

 

 

I. Definition of Imported Special Items

This category encompasses human tissue (including blood), pathogenic microorganisms, and biological products that impact public health safety, excluding items regulated as pharmaceuticals, veterinary drugs, or medical devices.

 

 

 

 

II. What Defines Their Special Characteristics

In our globalized era of scientific and medical collaboration, these items play vital roles in disease research, drug development, organ transplantation, and clinical treatments. However, their importation demands strict adherence to biosafety regulations due to potential biological risks.

 

 

 

 

III. Enterprise Preparation Requirements

Enterprises must prepare detailed documentation related to the special items to be imported, including Chinese/English nomenclature, classification, composition, origin, intended use, and production processes.

For imported special items containing or potentially containing pathogenic microorganisms, documentation shall include the scientific names (in both Chinese and Latin), bilingual (Chinese-English) documentation of biological properties, and certification demonstrating the producer/operator/user's compliance with appropriate biosafety containment measures. Special items categorized under high-risk management must undergo mandatory risk assessment procedures in accordance with regulatory requirements.

 

 

 

 

IV. Import Approval and Inspection Declaration Procedures for Imported Special Items

1. Approval Procedure

Applicants shall submit applications through the Customs Entry/Exit Special Items Health Quarantine Supervision System to the destination's direct customs authority, completing all required information fields and uploading necessary documentation as specified. The direct customs authority shall conduct preliminary review upon receiving applications. For incomplete or non-compliant submissions, a comprehensive list of requiredsupplementary materials shall be provided either immediately or within 5 days from the date of document receipt. Applications shall be deemed formally accepted as of the initial receipt date if no deficiency notice is issued within the stipulated timeframe.

Customs authorities shall conduct documentary review of application materials that have passed the initial examination, which may involve expert document evaluation, on-site assessment, and laboratory testing for verification. Where regulatory standards are met, the Direct Customs Authority shall issue the Sanitary Quarantine Approval Certificate for Entry/Exit Special Items within 20 days from the acceptance date. Non-compliant cases will receive a written disapproval decision with stated reasons.

2. Declaration and Inspection Procedures

Enterprises shall prepare required documents including the Entry Approval Form for Special Items, contracts, invoices, packing lists, and bills of lading, then submit declarations through China International Trade Single Window system with accurate customs declaration information and attached documentation. Customs authorities shall review declared information and accompanying documents, conducting on-site inspections and laboratory testing based on inspection instructions.

On-site inspections include packaging verification and sensory evaluation, while laboratory testing focuses on microbiological examination, biosafety assessment, and bioactivity indicators analysis. Upon successful review of documents and inspection results, Customs shall authorize clearance for the imported special items.

V. Key Management Considerations for Post-Clearance Utilization of Special Imported Items

1. Upon receipt of imported special items after clearance, enterprises shall strictly use them for declared purposes as approved. Any alteration of intended use requires prior authorization.

For example, special items approved for scientific research must not be repurposed for clinical treatment applications.

2. All operational procedures and safety protocols must be strictly adhered to during handling processes to ensure personnel safety and environmental security. For high-risk special items, enterprises must establish detailed usage records documenting all handling activities.

3. Special items shall be stored in facilities meeting specified preservation conditions, including appropriate refrigeration or freezing environments. Storage facilities must maintain requisite equipment such as refrigerated warehouses or freezer units, with scheduled maintenance and regular inspections.

4. Implement a comprehensive inventory management system with detailed records of stock movements to ensure quantity accuracy and enhance traceability.

5. Waste generated from special items during usage shall be disposed of in strict compliance with relevant regulatory requirements. For example, waste containing pathogens must undergo decontamination treatment and shall not be improperly disposed of, to prevent environmental pollution and mitigate biosafety risks.

 

 

 

 

Importing special items requires strict compliance with all provisions, with meticulous attention to each stage from pre-import preparation and customs declaration to post-clearance usage management. This ensures the safe utilization of imported biological materials, thereby providing robust support for the advancement of China's scientific research and medical development initiatives.

Note: This article references the Frontier Health and Quarantine Law of the People's Republic of China, the Implementation Regulations of the Frontier Health and Quarantine Law of the People's Republic of China, and the Administrative Provisions for Health and Quarantine of Entry/Exit Special Items (AQSIQ Order No. 160, as amended by GACC Order No. 243).

 

 

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Disclaimer：The above content is translated from Chinese version of Alayongguan. The Alayongguan version shall prevail.