Things You Want to Know When Import & Export of Special Articles/Goods in China
What are special articles£¿
Provisions on the Administration of Sanitary Quarantine of Entry and Exit Special Articles, Order # 243 of the General Administration of Customs of China, specifies that special articles include microorganisms, human tissues, biological products, blood and blood products, totally 4 categories, 43 sub-categories, 58 hs codes, and 165 CIQ codes.
Microorganisms include viruses, bacteria, fungi, actinomycetes, Rickettsia, spirochetes, chlamydia, Mycoplasma and other medical microorganisms (virus) species and samples as well as parasites, environmental protection microbial agents;
Human tissues includes human cells, cell lines, embryos, organs, tissues, bone marrow, secretions, excretions, etc.
Biological products include vaccines, antitoxins, diagnostic reagents, cytokines, enzymes and their preparations used in the fields related to human medicine and life sciences, as well as bioactive agents such as toxins, antigens, antibodies, antigen-antibody complexes, allergens, nucleic acids, immunomodulators and microecological agents;
Blood and blood products include human whole blood, plasma components, special blood components, and various human plasma protein products.
Special articles are easy to spread infectious diseases or have hidden risks of spreading infectious diseases. They shall be transported via cold chain and have very high requirements on the speed of customs clearance. They are thus subject to strict quarantine supervision of customs ans shall not entry or exit without permissions.
Customs classify entry & exit special articles into different risk grades based on their risks that might spread human diseases and adopts different sanitary quarantine methods accordingly.
Based on special articles¡¯ pathogenicities, pathogenic pathways, using methods and controllabilities and other risk elements, Customs divide special articles to A,B, C and D, four grades. Therein, A has highest risk, D lowest.
The Approval Sheet for A grade special articles, with a validity of three months, can only be used once and can not be canceled after verification by batches. Approval Sheet for Grade B, C and D can be canceled after verification by batches. Therein, approval sheet for Grade B is valid for 6 months, while those for Grade C and D have a validity of 1 year. Grade A and B special articles shall accept follow-up super supper visions. And the quarantine approval of Grade D special articles can be authorized to branched organizations.
Whether only commodities listed in the Corresponding Table For Tariff Codes and Inspection and Quarantine Names of Special Articles need to obtain Quarantine Approval for Special Articles?
No. Entry & Exit goods that are special articles all shall obtain Quarantine Approval for Special Articles. In accordance with the Announcement on the Publication of the Corresponding Table For Tariff Codes and Inspection and Quarantine Names of Special Articles, announcement #46 of the General Administration of Customs OF China which was enforced on April 1, 2020, the entry & exit special articles unlisted in the Corresponding Table shall be classified and declared pursuant to classification principles. Article #11 of the People¡¯s Republic of China Enforcement Regulations for Border Sanitary Quarantine Laws stipulates that carrier, consignor/consignee, shipper/receiver of entry & exit special articles shall declare to sanitary quarantine organization and accept sanitary quarantine, and shall handle customs clearance procedures with the Approval Sheet for Special Articles issued by Sanitary Quarantine Organization. Without Approval from Sanitary Quarantine Organization, special articles shall not be exported or imported. The entry and exit of special goods shall both handle sanitary quarantine approval procedures.
But there is one exception. Blood products or biological products carried for personal use and only use for preventing or treat diseases do not need to handle sanitary quarantine approval procedures. When carried for entry or exit, the carrier shall declare to port customs and present the relevant certificates by the hospital. The carry quantity allowed is subject to a course of treatment.
To which customs the application of sanitary quarantine approval for special articles shall be made?
In accordance with Article 6 of Provisions on the Administration of Sanitary Quarantine of Entry and Exit Special Articles, Order # 243 of the General Administration of Customs of China, the consignee of imported special articles or its agent shall apply for sanitary quarantine approval at the regional customs of the destination before the special articles are shipper, and the shipper of exported special articles or its agent shall apply for sanitary quarantine approval at the regional customs where its company is located.
To facilitate enterprises to handle the relevant procedures, Guangzhou customs has took a lead in the pilot project that delegating of approval authority for grade special articles. Within customs district of Guangzhou customs, grade D special articles, biological products or blood products that has obtain import registration certificate for imported medicines from CFDA or export sales certificate
To facilitate enterprises, Guangzhou customs has took a lead in the pilot project that delegating approval authorities for grade D special articles. Within customs district of Guangzhou customs, the sanitary quarantine approval of grade D special articles , biological products and blood products used in preventing, diagnosing and treating that have obtained registration certificate for imported medicine from CFDA or export sales certificate shall be applied at Guangzhou airport customs, Haizhu customs and Nansha customs that subordinated to Guang zhou customs based on territorial jurisdiction.
How to obtain approval for exit & entry special articles £¿
Application conditions.
1.Those shall obtain approval documents from relevant department in accordance with laws and regulations shall obtain the relevant documents.
2.The applicant shall have the matching bio-safety control abilities over the special articles to be imported or exported.
3.The applicant for pathogenic microorganism or special articles that may contain pathogenic microorganism shall not be natural person.
Application Materials
1.application form.
2.descriptive materials that indicate English name, Chinese name, categories, ingredients, sources, usages, mainly sales channels, exporting/importing country/region, manufacturer, etc.
3.Imported biological products and blood products used in preventing, diagnosing and treating shall obtain registration certificate for imported medicine from CFDA
4.imported/exported special articles that contain or might contain pathogenic microorganism shall provide Chinese name and Latin name of the pathogenic microorganism, the Chinese vs English illustrative document of biological characteristics, the supporting document that proves the manufacturer or user has the matching bio-safety prevention and control abilities.
5.Exported biological products and blood products used in preventing, diagnosing and treating shall obtain sales certificate from CFDA.
6.exported special articles that involves the management of human genetic resources shall obtain approval document issued by Human Genetic Resource Administration of China. Custom will do system automatic comparison and verification on the electronic data of the approval document.
7.Enterprises that use imported/exported special articles that contain or might contain pathogenic microorganism shall provide bio-safety laboratory qualification certificate that matches the bio-safety risk level of the subject special articles. Laboratories above BSL-3 shall obtain recognition of the relevant institutions that have achieved national accreditation.
8.Imported/exported Pathogenic microorganism Bacteria/virus or samples with high pathogenicity shall provide approval documents from Human Genetic Resource Administration of provincial level or above.
¡ùApplicants that apply for approval of special articles shall also provide electronic version of below documents.
Enterprise applicant shall provide: £¨1£© basic info of enterprise, for example, management system accreditation, address, production place, laboratory setup, storage facility and equipment, product processing conditions, production process or flow, etc., £¨2£©Laboratory bio-safety qualification certificates.
Natural person applicant shall provide photocopy of identity card.
How to declare customs after obtaining Approval Sheet for Special Articles?
Customs Declaration
1.After imported special articles arrive at the port, the consignee or its China customs broker shall declare to customs of entry port with the Approval sheet and other declaration documents
2.Before outbound, the shipper or its China customs broker shall declare to local customs with with the Approval sheet and other declaration documents.
3.Custom will not grant entry or exit when the declaration documents are not complete or not in legal formats.
Customs Inspection
Port customs will release the entry/exit special articles that pass sanitary quarantine and will not grant entry or exit for the special articles when the declaration documents are not complete or not in legal format or names, or when ingredients, batch numbers and other inspection items are not consistent with the contents of approval sheet, or when the packages are broken or leaking.
Consignee or its agent of imported special articles that need laboratory tests shall put the special articles to storage place that meets relevant conditions. Only after pass the quarantine, shall the special articles be moved or used.
Follow -Up inspection
Imported special articles that needs to accept follow up (please refer to the remark of the Quarantine Approval Sheet), the using enterprises shall declare to destination customs with 30 days from the date of entry and let destination customs implement the follow-up inspection.
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