Views: 1 Author: Shanghai custom Publish Time: 2022-08-19 Origin: 上海海关 12360热线
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Special items are no longer 'special'
Go to the front line of customs together
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Recently, many people and enterprises have inquired about the business issues of customs approval of special items. Combined with the launch of the new version of the customs clearance and analysis system for entry-exit special items, let us take a look at the relevant entry and exit procedures and the latest policies for special items. Yes.
What are special items?
Special items refer to the entry and exit of microorganisms, human tissues, biological products, blood and its products and other items.Therefore, such items are easy to spread infectious diseases, or have potential risks of spreading infectious diseases, cold chain transportation and high requirements for customs clearance speed. They are the objects of strict quarantine supervision by the customs.
What is an entry-exit special item unit?
Refers to legal persons or other organizations engaged in the production, use, sales, scientific research, medical treatment, inspection, and pharmaceutical R&D outsourcing of special items.
★ It belongs to the category of special items and is subject to customs entry and exit supervision★
| microorganism | Viruses, bacteria, fungi, actinomycetes, rickettsia, spirochetes, chlamydia, mycoplasma and other medical microbial bacteria (virus) species and samples, as well as parasites, environmentally friendly microbial agents |
| human tissue | Human cells, cell lines, embryos, organs, tissues, bone marrow, secretions, excretions, etc. |
| Biological product | Vaccines, antitoxins, diagnostic reagents, cytokines, enzymes and their preparations, as well as toxins, antigens, allergens, antibodies, antigen-antibody complexes, nucleic acids, immunomodulators, microecology derived from human medicine and life science related fields biologically active preparations |
| blood and its products | Human whole blood, plasma, serum, blood cells and plasma protein fractions or blood cell fraction preparations separated, purified or biotechnically produced from blood |
What are the procedures for the entry and exit of special items?
01
Quarantine approval
Before entering or leaving the country for all special items, the applicant unit needs to submit the administrative approval of health and quarantine to the customs directly under the customs. The customs directly under the customs will conduct a written review of the application materials in a timely manner, and take expert data review, on-site evaluation, laboratory testing and other methods to review the application materials according to the situation. The substantive content of the entry and exit special items will be reviewed, and if the statutory conditions and standards are met, the customs will issue the 'Entry and Exit Special Items Health and Quarantine Approval Form'.
What materials do I need to provide for quarantine approval?
(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, an 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 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.
Things to watch out for
#Processing time:
According to the requirements of the time limit for examination and approval in the 'Administrative Regulations on Health 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.
# Risk type and approval validity period：
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.Among them, 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; For 6 months, the approval form for grades C and D special items is valid for 1 year; special items for grades A and B must be subject to follow-up supervision; the quarantine approval for grade D special items can authorize branches to carry out administrative licensing approval.
02
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 of the export of special goods or his agent shall report to the local customs with the 'Special Goods Approval Form' and other materials before leaving the country.declare.Declaration materialsIf the materials are not complete or do not conform to the statutory form, 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 according to the requirements of the port customs, and can only be transported or used after passing the quarantine inspection.
Check the little details
# What to check:
The customs that accepts the declaration shall conduct on-site inspection of entry-exit special items in accordance with the following requirements, and fill in the On-site Inspection Record of Entry/Exit Health and Quarantine of Special Items:
(1) Check whether the name, composition, batch number, specification, quantity, validity period, transportation and storage conditions, exporting/importing country and manufacturer of entry-exit special items conform to the contents of the 'Special Items Approval Form';
(2) Check whether the packaging of entry-exit special items is safe and undamaged, not leaking or leaking, and whether there is a biosafety risk with a biohazardous product label that meets the relevant requirements.
If the inspection site at the port of entry does not have the safety protection conditions required for the inspection of special items, the special items shall be transported to a designated place that meets the requirements for biosafety levels for inspection.
# Special items for entry requiring laboratory testing：
For inbound special items that require laboratory testing, the owner or his agent shall store the special items in a qualified storage place according to the requirements of the port customs, and can only be transported or used after passing the quarantine inspection.If the customs at the port does not have the ability to test, it shall entrust a laboratory with corresponding qualifications to carry out the test.
For entry special items that contain or may contain pathogenic microorganisms, toxins and other biosafety hazard factors, the port customs shall electronically transfer the order to the destination customs in a timely manner after on-site inspection.The destination customs shall implement follow-up supervision.
# Entry-exit special items to be mailed and carried:
For the entry-exit special items that are mailed or carried, if the 'Special Items Approval Form' has not been obtained, the customs shall detain them and issue a retention certificate, and the retention period shall not exceed 7 days.
After the courier or carrier obtains the 'Special Items Approval Form' within the withholding period, the customs shall conduct inspections in accordance with Article 16 of the 'Regulations on the Administration of Sanitation and Quarantine of Entry-Exit Special Items', and those who pass the quarantine inspection will be released.
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 and quarantine, and you should present the relevant certificate of the hospital to the customs when you enter or leave the country. The course of treatment is limited.
# Return or destroy:
The port customs will release the entry-exit special items that meet the requirements of health quarantine.In any of the following circumstances, the port customs will issue a 'Notice of Inspection and Quarantine Disposal', which will be returned or destroyed:
(1) The name, batch number, specification, biologically active ingredient, etc. are inconsistent with the approval content of special items;
(2) Exceeding the scope of the quantity approved for health quarantine;
(3) The packaging does not meet the safety management requirements for special items;
(4) Those who fail to meet the requirements of health and quarantine after quarantine inspection;
(5) Those who have been detained by mailing or carrying special items have not obtained the 'Special Items Approval Form' within 7 days from the date of interception, or have failed the quarantine inspection after obtaining the 'Special Items Approval Form'.
The port customs shall keep records and archives of the processing results.
03
follow-up supervision
Entry-exit units of special items shall establish a special item safety management system, and produce, use or sell special items in strict accordance with the approved purposes of special items.Entry-exit special goods entities shall establish records of the production, use and sales of special goods.The records shall be authentic and shall be kept for a period of not less than 2 years.The customs implements risk management for entry-exit special items, divides special items with different risk levels into different risk levels according to the risk that entry-exit special items may transmit human diseases, and adopts different health and quarantine supervision methods.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.
Regulatory content
# Whether the laboratory of the user unit is consistent with the 'Special Items Approval Form'; whether the imported special items are consistent with the 'Special Items Approval Form' cargo certificate.
一
Policy on foreign trade export of in vitro diagnostic reagents
In order to implement the deployment requirements of the State Council to promote the steady growth of foreign trade, and to fully guarantee the resumption of work and production of enterprises, the relevant matters concerning the examination and approval of customs entry and exit special items for health and quarantine are hereby announced as follows (General Administration of Customs [2021] No. 52):
Article 9, item 5 of the 'Regulations on the Administration of Health and Quarantine of Entry-Exit Special Items' stipulates that 'biological products and human blood products that are used for the prevention, diagnosis and treatment of human diseases should beWhen providing the drug supervision and management department (the current function belongs to the market supervision department)The issued sales certificate ' refers to the 'sales certificate', including the drug supervision and management departmentThe issued 'Medical Device Export Record Form' and 'Medical Device Product Export Sales Certificate' can be used as the relevant application materials for enterprises to handle the health and quarantine approval of entry-exit special items.
01
How to apply for the 'Export Sales Certificate of Medical Device Products' for the export of in vitro diagnostic reagents?
According to the 'Administrative Regulations on the Export Sales Certificate of Medical Device Products', only those who have obtained medical device products in my countryOnly if the product registration certificate and production license have been obtained, or the medical device product filing and production filing have been completed, the market supervision department can issue the 'Medical Device Product Export Sales Certificate' for the relevant manufacturer.The provincial market supervision department where the enterprise is located shall be responsible for the management of the 'Medical Device Product Export Sales Certificate' within its administrative area.
02
How to handle the 'Medical Device Product Export Record Form' for exporting in vitro diagnostic reagents?
According to the 'Measures for the Supervision and Administration of the Production of Medical Devices', those who manufacture and export medical devices shall ensure that the medical devices they produce meet the requirements of the importing country (region), and the relevant product information shall be filed with the market supervision department of the city divided into districts where they are located.For specific procedures, you can consult the municipal market supervision department where the manufacturer is located.
Recently, due to new policies and other reasons, if the enterprise cannot obtain the 'Medical Device Export Record Form', the enterprise can provide materials such as the product obtaining foreign standard certification or registration certificate, and the commitment that the product meets the quality standards and safety requirements of the importing country (region) for health and quarantine approval. formalities
03
Both the 'Medical Device Product Export Sales Certificate' and the 'Medical Device Product Export Record Form' are recognized by the customs!
If the exported in vitro diagnostic reagents meet the requirements of the importing country (region), according to the latest announcement issued by the General Administration of Customs, the customs also recognizes the 'Medical Device Product Export Record Form' and 'Medical Device Product Export Sales Certificate' issued by the market supervision department. All of them can be used as the relevant application materials for enterprises to handle the health and quarantine approval of entry-exit special items.
Look for the correct format of the official certification when processing!
二
The new version of the customs entry and exit special items health quarantine approval and analysis system is online!
From December 15, 2021, the customs entry and exit special items health quarantine supervision and analysis system will be piloted in the national customs, and the new system will gradually replace the old system in April 2022.
Compared with the old system, the new system automatically cancels the approval form for special items with the customs declaration form during customs clearance, which speeds up the customs clearance efficiency and improves the intelligence of the customs clearance system.Customs brokers should pay attention to the changes in the new system when they declare customs on behalf of biopharmaceutical enterprises, and declare customs declaration forms in strict accordance with the specifications, so as to help enterprises successfully complete the automatic write-off of the approval forms of the new system.The new intelligent system can better optimize the health and quarantine supervision and management of special items and maintain the security of the country.
Login URL
Use Google Chrome to log in to the Customs Entry-Exit Special Items Health and Quarantine Approval and Analysis System.website:
https://customs.chinaport.gov.cn/tswpwebserver/tswp/view/homepage
In order to improve the pass rate of automatic verification and write-off of customs declaration forms for special items, enterprises should pay attention to the inspection and quarantine codes, English names, specifications and other filling matters of customs declaration forms.
The approval form reviewed by the new system does not need or cannot be applied for write-off of the approval form before customs declaration, otherwise it will result in repeated write-off and insufficient write-off (verification).
Enterprises can check the automatic write-off status of the approval form in the special item health and quarantine approval and analysis system -> view the details of the approval form -> item information.If there is abnormal write-off or abnormal write-off, please apply for manual write-off in time and contact the customs declaration port in the write-off application for audit to confirm that the number of approval documents has been deducted.
三
Administrative approval authority will be further liberalized!
In order to further deepen the reform of 'decentralization, regulation and service', the General Administration of Customs will delegate the authority to examine and approve the health and quarantine of D-level low-risk special items across the country.Each directly-affiliated customs can delegate the acceptance authority or all the approval authority of the entry-exit D-level special items health and quarantine approval to the qualified subordinate customs.However, due to the 'speciality' and 'risks' of special items, this work is being studied and implemented in an orderly manner. Once the conditions are met, the customs will also announce the scope, time limit and work requirements of the delegation to everyone in time. .Please also pay attention to the release of customs in time!!!
四
New Directory Released!
On March 15, 2022, the General Administration of Customs issued the 'Corresponding List of Customs Inspection and Quarantine Names and Commodity Numbers for Special Items' (General Administration of Customs Announcement No. 26 of 2022, hereinafter referred to as the 'List'), which aims to ensure my country's biosafety. Further strengthen the health and quarantine supervision of entry-exit special items.The 'Catalogue' includes the corresponding relationship among the inspection and quarantine names, inspection and quarantine codes, HS commodity names and HS commodity numbers of special items, including 63 commodity numbers, 195 Inspection and Quarantine Code.
The inspection and quarantine code is a refinement of the commodity number in order to meet the requirements of customs inspection and quarantine supervision; the inspection and quarantine name corresponding to the inspection and quarantine code is classified and expanded on the basis of the corresponding commodity name.When declaring entry-exit special items, it should be classified into the correct commodity number first, and then classified into the correct inspection and quarantine code according to the ingredients and uses.If the declaration is wrong, it may be suspected of violating laws and regulations or affecting the efficiency of customs clearance.
According to the relevant definitions in the 'Regulations on the Administration of Sanitation and Quarantine of Entry-Exit Special Items', all items that are special items shall undergo customs health quarantine.Some commodities are very special in terms of composition, characteristics, and uses. If the import and export declaration cannot be found in the 'Catalogue' to fully meet the inspection and quarantine names and codes, they should be in accordance with the requirements of the 'People's Republic of China Customs Import and Export Goods Declaration Form Filling Specifications' requirements. , declare according to the closest category.If there is any doubt during the declaration process, you can put forward opinions and suggestions to the customs through appropriate channels, so as to make overall consideration when adjusting the inspection and quarantine codes of special items in the next year.
Q1
Is it necessary to go through the approval of special items only for the commodities in the 'Correspondence Table of Customs Commodity Numbers and Inspection and Quarantine Names for Special Items'?
wrong.All items belonging to entry-exit special items shall be subject to special item approval.
According to the General Administration of Customs Announcement No. 26 of 2022 (announcement on the announcement of the 'Correspondence Table of Customs Commodity Numbers and Inspection and Quarantine Names for Special Items') implemented on March 15, 2022, 'Special entry-exit special items not listed in the corresponding table Items are classified and declared according to the classification principle', and Article 11 of the 'Implementation Rules of the Frontier Health and Quarantine Law of the People's Republic of China''The carrier, shipper or postal person of special items entering or leaving the country must report to the health and quarantine authority. To declare and accept health 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, entry and exit are not allowed, and the entry and exit of special items must go through health quarantine approval procedures.
Q2
How to apply for health and quarantine approval for individuals carrying or mailing special items into or out of the country?
For special items carried by individuals and mailed into and out of the country, they should 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.
Q3
Can schools, hospitals, scientific research institutions and other non-profit institutions be the main body of applicants for health and quarantine approval of entry-exit special items?
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 being applied for, they can be the applicants for the health and quarantine approval of entry-exit special items.
Q4
What materials are required for the first application?
When applying for the approval of special items for the first time, the electronic version of the following materials shall 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.
Q5
What are the violations of the relevant laws and regulations on import and export of special items?
According to the 'Implementation Rules of the Frontier Health and Quarantine Law of the People's Republic of China' and 'Regulations on the Administration of Health and Quarantine of Entry-Exit Special Items' (Order No. 243 of the General Administration of Customs), a fine of the corresponding amount will be imposed in the following circumstances:
(1) Refusing to accept quarantine or resisting the supervision and management of health quarantine;
(2) Forging or altering health and quarantine orders or certificates;
(3) concealing the carrying of prohibited microorganisms, human tissues, biological products, blood and its products, or other animals and articles that may cause the spread of infectious diseases;
(4) Obtaining approval for special items by deceit, bribery or other improper means;
(5) Moving, selling or using special items without the permission of the customs;
(6) Failing to declare to the customs or providing false materials to obtain inspection and quarantine certificates by fraud;
(7) Failing to operate special items in the corresponding biosafety level laboratory or the unit using the special item does not have the corresponding level of biosafety control capability, failing to establish records on the use and sale of special items or the records are inconsistent with the actual situation;
(8) Unauthorized use of special items for entry requiring follow-up supervision without the consent of the customs.
special notice
With the changes in the global COVID-19 situation, domestic and foreign policies and regulations involving the import and export of special items and prevention and control materials have been dynamically adjusted and updated rapidly. All enterprises are reminded to pay close attention to relevant changes. The relevant policies are based on the latest requirements of domestic and foreign official institutions. prevail.
