What are special items? What is its inbound and outbound business process? What regulatory provisions and facilitation measures does the customs have for the entry of special items? Let's find out together~

1. What is a "special item"?

Answer: Order No. 243 of the General Administration of Customs "Regulations on the Administration of Sanitation and Quarantine of Entry-Exit Special Items" clarifies that special items include microorganisms, human tissues, biological products, blood and their products. A total of 4 categories, 43 subcategories, 58 commodity codes, and 165 inspection and quarantine codes.

Microorganisms: including viruses, bacteria, fungi, actinomycetes, rickettsia, spirochetes, chlamydia, mycoplasma and other medical microbial strains and samples, as well as parasites and environmentally friendly microbial agents;

Human tissue: including human cells, cell lines, embryos, organs, tissues, bone marrow, secretions, excretions, etc.;

Biological products: including vaccines, antitoxins, diagnostic reagents, cytokines, enzymes and their preparations, as well as toxins, antigens, antibodies, antigen-antibody complexes, allergens, nucleic acids, immunomodulatory products used in human medicine and life science related fields biologically active preparations such as pharmaceuticals, probiotics, etc.;

Blood and its products: including human whole blood, plasma components, special blood components, and various human plasma protein products.

Such items have the characteristics of easy transmission of infectious diseases, or potential risks of transmission of infectious diseases, cold chain transportation, and high requirements for customs clearance speed.

The customs classifies entry-exit special items into different risk levels according to the risk of spreading human diseases, and adopts different health and quarantine supervision methods.

Customs classifies special items into four levels: A, B, C, and D according to risk factors such as pathogenicity, pathogenic route, usage and purpose, and controllability. Class A is the highest risk and class D the lowest risk.

The A-level special item approval form is valid for one time and cannot be written off in batches, and the validity period is 3 months; the B, C, D grade special item approval form can be written off in batches, and the B-level special item approval form is valid for 6 months, the C and D grade special items approval form is valid for 1 year; A and B grade special items must be subject to follow-up supervision; D grade special items quarantine approval can authorize branches to carry out administrative licensing approval.

Customs officers preached the knowledge of national biosafety on Guangzhou International Biological Island

2. Is the approval of special items only required for the products listed in the "Correspondence Table of Customs Commodity Numbers and Inspection and Quarantine Names for Special Items"?

Answer: No. All items belonging to entry-exit special items shall be subject to special item approval.

According to the General Administration of Customs No. 46 of 2020 (announcement on the publication of the "Correspondence Table of Customs Commodity Numbers and Inspection and Quarantine Names for Special Items") implemented on April 1, 2020, "entry-exit special items not listed in the corresponding table shall be According to Article 11 of the Rules for the Implementation of the Frontier Health and Quarantine Law of the People's Republic of China: "The carrier, shipper or postal carrier of special items entering or leaving the country must declare to the health and quarantine authority and accept the For quarantine, go through customs clearance procedures with the approval form for special items issued by the health and quarantine authority. Without the permission of the health and quarantine authority, no entry or exit is allowed.” The entry and exit of special items must go through health quarantine approval procedures.

However, those who carry blood products or biological products for personal use and only for the prevention or treatment of diseases do not need to go through the examination and approval procedures for health quarantine. When carrying it into and out of the country, you should declare it to the port customs and show the relevant certificate of the hospital. The allowable amount is limited to one course of treatment.

Customs officers preached the recent customs clearance facilitation measures to enterprises on Guangzhou International Bio-island

3. Which customs to apply for the approval of health and quarantine of special items?

Answer: According to Article 6 of "Regulations on the Administration of Sanitation and Quarantine of Entry-Exit Special Items" (Order No. 243 of the General Administration of Customs), "The customs directly under the jurisdiction is responsible for the examination and approval of entry-exit special items for health and quarantine". The agent shall apply to the customs directly under the destination for the examination and approval of health and quarantine before the delivery of special items; the consignor of the outbound special items or his agent shall apply to the customs directly under the locality for the examination and approval of health and quarantine before the delivery of the special items.

In order to facilitate enterprises to handle business, Guangzhou Customs took the lead in piloting the decentralization of the approval authority for D-level special items. In the Guangzhou Customs area, the health and quarantine approval of D-level special items (that is, biological products or blood products used for prevention, diagnosis, and treatment that have obtained the import drug registration certificate or export sales certificate from the drug regulatory authority) can be approved according to the territory. In principle, the application should be processed at Guangzhou Baiyun Airport Customs, Haizhu Customs, and Nansha Customs under Guangzhou Customs.

4. How to handle the approval of entry-exit special items?

(1) Application conditions

1. If the laws and regulations stipulate that approval documents from relevant departments must be obtained, corresponding approval documents shall be obtained;

2. The applicant should have the ability to control the biosecurity suitable for entry and exit special items;

3. For entry-exit pathogenic microorganisms or special articles that may contain pathogenic microorganisms, the applicant must not be a natural person.

(2) Application materials

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 that are used to prevent, diagnose and treat 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), descriptive documents on biological characteristics (in both Chinese and English), and the manufacturer, operator or user shall be provided with the corresponding documents. Documents certifying the level of biosecurity prevention and control;

5. For biological products and human blood products that are used for the prevention, diagnosis and treatment of human diseases, a 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 obtained, and the customs shall automatically compare and verify the electronic data of the relevant approval document;

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

8. For 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.

※For the first application for approval of special items, the electronic version of the following materials should also be provided.

If the applicant is a unit, you need to provide: (1) Basic information of the unit, such as: unit management system certification, unit address, production site, laboratory settings, storage facilities and equipment, product processing, production process or technological process, floor plan, etc.; ( 2) Laboratory biosafety qualification certificate.

Applicants who are natural persons need to provide: a copy of the ID card.

(3) How to provide materials

[Online application] The applicant logs in to the "Internet + Customs" integrated online service platform (copy and open the website through a browser: http://online.customs.gov.cn), enter the "Administrative Examination and Approval" section, and select "Special Entry and Exit" Article health quarantine approval" function, fill in the declaration form online as required.

At the same time, it can also be submitted to the administrative examination and approval window of the customs directly under the Customs.

(4) Procedure

1. Submit your application.

2. Customs acceptance: If the application does not require approval for special items, or does not fall within the scope of the unit’s authority, the customs shall immediately inform the applicant that it will not accept the application.

If the materials are incomplete or the materials have errors or do not conform to the legal form, the customs will inform the applicant of all the contents that need to be supplemented and corrected at one time within 5 working days.

If the application items are special items, and the application materials are complete and conform to the legal form, the customs will issue an acceptance decision within 5 working days.

3. Customs approval: The accepting customs will conduct a written review of the application materials in a timely manner, and verify the substance of the application materials by means of expert data review, on-site assessment, laboratory testing, etc. according to the situation.

4. Make a decision: 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 of disapproval .

(5) The latest policy

According to the Announcement on Matters Concerning the Health and Quarantine Examination and Approval of Entry-Exit Special Items (Announcement No. 52 [2021] of the General Administration of Customs), “Biological products and human blood products that are used for the prevention, diagnosis, and treatment of human diseases shall be provided for drug supervision and management. The "sales certificate" referred to in the "sales certificate issued by the department" includes the "Medical Device Export Record Form" and the "Medical Device Product Export Sales Certificate" issued by the drug regulatory department, both of which can be used as special items for enterprises to handle entry and exit. Application materials for health and quarantine approval.

5. How to declare after obtaining the "Approval Form for Special Items"?

(1) Enterprise customs declaration

1. After the entry of special items arrives at the port, the owner or his agent declares to the customs at the port of entry with the "Entry/Exit Special Items Health and Quarantine Approval Form" and other customs declaration materials;

2. The owner or his agent of outbound special items shall declare to the local customs with the "Entry/Exit Special Items Health and Quarantine Approval Form" and other customs declaration materials before leaving the country;

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

(2) Customs inspection

The port customs will release the entry-exit special items that meet the requirements of health quarantine. If the declaration materials are incomplete or do not conform to the legal form, the inspection items such as the name, composition, batch number and other inspection items of special items are inconsistent with the contents of the “Approval Form for Special Items”, and the packaging of special items is damaged or leaked, the customs will not allow entry or exit. .

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.

Customs officers are inspecting a batch of imported reagents

Unqualified Special Items Intercepted by Customs

3) Follow-up supervision

Entry special items that need to be subject to follow-up supervision (see the remarks on the "Entry/Exit Special Items Health and Quarantine Approval Form"), the user unit should declare to the destination customs within 30 days after the entry of the special items, and the destination customs will implement follow-up Supervision.

Customs officers conduct follow-up supervision on a batch of imported special items

6. How to apply for health and quarantine approval when individuals carry or mail special items into and out of the country?

Answer: Special items carried by individuals or sent by mail to and from the country shall apply for health and quarantine approval procedures according to the normal process. If you carry blood products or biological products for personal use and only for the prevention or treatment of diseases, you do not need to go through the examination and approval procedures for health quarantine, but you should declare to the port customs and show the relevant certificate of the hospital when you enter or leave the country. The allowed amount is one course of treatment. limited.

7. Can non-profit institutions such as schools, hospitals, and scientific research institutions be the main body of applicants for health and quarantine approval of entry-exit special items?

A: For non-profit institutions such as schools, hospitals, and scientific research institutions, if their biosafety control capabilities match the potential microbial danger of the entry-exit special items applied for, they can be the applicant for the health and quarantine approval of entry-exit special items.

8. How long does it take for the approval of health and quarantine for special items?

Answer: According to the requirements of the time limit for approval and completion in the "Regulations on the Administration of Sanitation and Quarantine of Entry-Exit Special Items", the customs directly under the Customs shall make a decision on whether to approve or not within 20 working days from the date of accepting the application. If a decision cannot be made within 20 working days, with the approval of the person in charge of the administrative organ, it can be extended for 10 working days.

In order to improve the customs clearance efficiency of the bio-industry and promote the development of the bio-pharmaceutical industry in Guangzhou, Guangzhou Customs has tried to reduce the time limit for approval of special items used in the Guangdong-Hong Kong-Macao Greater Bay Area to 10 working days; A decision will be made within 3 working days after acceptance; the time limit for approval of special items for Advanced Certification (AEO) enterprises is reduced to 5 working days.

9. What are the specific procedures for quick customs clearance via the South China Biomaterials Entry and Exit Public Service Platform?

The South China Biomaterials Entry and Exit Public Service Platform is set up in Phase 1, Unit 101, First Floor, No. 7, Helix 4th Road, International Bio Island, Guangzhou. It is registered by Guangzhou Customs and is a supervisory workplace for the entry and exit of biomedical goods. It has a multi-temperature zone cold storage. Wait.

Haizhu Customs, a subsidiary of Guangzhou Customs, implements on-site supervision on this platform, providing one-stop customs clearance services such as customs declaration acceptance, inspection, tax collection, policy consultation, etc. Currently, two “Baiyun Airport-Bio Island” and “Guangzhou East Station-Bio Island” have been opened. A fast customs clearance mode for biopharmaceutical goods, which facilitates the safe and fast customs clearance of biopharmaceutical goods, effectively compresses the customs clearance time for biopharmaceutical goods, and reduces the logistics and warehousing costs of enterprises.

▼Long press the QR code below to get more information on the "Entry and Exit of Biological Materials" service