How much do you know about the import and export declaration of special items--biological products as an example

The 'Detailed Rules for the Implementation of the Frontier Health and Quarantine Law of the People's Republic of China' stipulates that: Special items refer to microorganisms, human tissues, biological products, blood, etc. and its products.Such items have the characteristics of high value, high risk, cold chain transportation, and high requirements for customs clearance speed.The specific categories are as follows:

The entry and exit process of special items can be divided into three steps

Quarantine approval

The owner or his agent of inbound/outbound special items shall apply to the customs directly under the destination/location for approval of special items before the delivery of the special items.Log in to the 'Internet + Customs' integrated online service platform (website: http//online.customs.gov.cn), and enter the 'Administrative Approval' section--'Entry-exit Special Items Health and Quarantine Approval' module , fill in the declaration form online as required.

1. The materials that should be provided by the owner or agent to apply for approval include:

(1) 'Application Form for Health and Quarantine Examination and Approval of Entry/Exit Special Items';

(2) Descriptive materials for entry-exit special items, including Chinese and English names, categories, ingredients, sources, uses, main sales channels, exporting and importing countries or regions, manufacturers, etc. of special items;

(3) For biological products and human blood products used for the prevention, diagnosis and treatment of human diseases, the import drug registration certificate issued by the drug regulatory department of the State Council shall be provided;

(4) If the entry or exit special articles contain or may contain pathogenic microorganisms, the scientific name of the pathogenic microorganism (in Chinese and Latin), the descriptive documents on the biological characteristics (in both Chinese and English), and the manufacturer, operator or user shall be provided. Proof of the corresponding biosafety prevention and control level;

(5) For biological products and human blood products that are used for the prevention, diagnosis and treatment of human diseases, the sales certificate issued by the drug supervision and administration department shall be provided;

(6) If the exit special items involve the management of human genetic resources, the approval document issued by the human genetic resources management department shall be provided;

(7) Units that use entry-exit special items that contain or may contain pathogenic microorganisms shall provide biosafety laboratory qualification certificates that are compatible with the biosafety risk level, and laboratories above BSL-3 must be accredited by national accreditation agencies;

(8) For the entry or exit of highly pathogenic pathogenic microbial strains (viruses) or samples, approval documents from the competent health department of the people's government at or above the provincial level shall be provided.

If the applicant's application meets the statutory conditions and standards, the customs will issue the 'Entry/Exit Special Items Health and Quarantine Approval Form'; if the applicant's application does not meet the statutory conditions and standards, the customs will make a written decision not to approve it.

2. Pre-verification of special items

You can apply for a pre-verification form after the application form has passed the review

1. List of verification forms

(1) Approval form 'quasi font size'

(2) Pre-write off serial number

(3) Applicant's name

(4) The write-off status includes 'not write-off', ' write-off passed', ' write-off failed', 'unit (individual) revocation', 'return at the central office'.The applicant can retrieve the verification form information in the system through the above content.

2. Verification form declaration

Click the 'Verification Form Fill in' button to apply for a verification form.

(1) Basic interest of the applicant unit

(2) Information on special items

(3) Schedule of pre-verification single product merchants

quarantine inspection

After the inbound special goods arrive at the port, the owner or his agent shall declare to the customs at the port of entry with the 'Special Items Approval Form' and other materials.

The owner or his agent of outbound special items shall declare to the local customs with the 'Special Items Approval Form' and other materials before leaving the country.

If the declaration materials are incomplete or do not conform to the statutory form, the customs will not allow entry or exit.

The port customs will release the entry-exit special items that meet the requirements of health quarantine.

For inbound special items that require laboratory testing, the owner or his agent shall store the special items in a qualified storage place in accordance with the requirements of the port customs, and can only be transported or used after passing the quarantine inspection.

Supervision and management

The customs implements risk management for entry-exit special items. According to the risk that the entry-exit special items may transmit human diseases, special items with different risk levels are classified into different risk levels, and different health and quarantine supervision methods are adopted.

For inbound special items that need to be subject to follow-up supervision, the user unit shall declare to the destination customs within 30 days after the entry of the special items, and the destination customs will implement follow-up supervision.

※The validity period of the 'Special Items Approval Form'

(1) Special articles that contain or may contain highly pathogenic pathogenic microorganisms are valid for 3 months.

(2) Special articles that contain or may contain other pathogenic microorganisms are valid for 6 months.

(3) Other special items other than those specified above are valid for 12 months.

The 'Approval Form for Special Items' can be written off and used in batches within the validity period.If the validity period has expired, a new application shall be applied.