Amendments to certain clauses in Regulations for Administration of Entry and Exit Health Quarantine on Special Goods and their interpretations
1. Q: Which ports are entitled to entry and exit business on special goods?
A: At present, all the ports nationwide are entitled to it. Any changes will be publicly announced on the website of AQSIQ.
2. Q: How are theareas of responsibility of the Entry-Exit Inspection and Quarantine Bureaus Directly under AQSIQ divided?
A: Entry Inspection and Quarantine on special goods is in the charge of Inspection and Quarantine Bureaus Directly under AQSIQ which are located in the port of entry, whereas the exit Inspection and Quarantine on special goods is in the charge of Inspection and Quarantine Bureaus Directly under AQSIQ which are located in the places of production.
3. Q: Shall the owner or the agent of the entry and exit special goods submit the application to Department of Inspection and Quarantine Clearance before shipment?
A: According to the existing provisions, the Department of Inspection and Quarantine Clearance shall not accept and conduct the application for inspection without Health Quarantine Approval Form at entry and exit. No submitting the application to the Department of Inspection and Quarantine Clearance before shipment but getting the approval may result in the following consequences: (1) The goods may be sustained，which will delay the shipment due to the handling of the approval procedures; (2) Being impossible to get the permit from the Department of Inspection and Quarantine Clearance leads to the goods not getting through the port, which will cause unnecessary losses to the owners. Thus, this regulation is to protect and maximize the benefits of the owners of the goods.
4. Q: What do the entry special goods carrying or probably carrying pathogenic microorganism refer to?
A: The entry special goods carrying or probably carrying pathogenic microorganism mainly refer to the microorganism, human organism and blood involved in article nine.
5. Q: What are the entry-prohibited microorganism, human organism, biological products, blood and its products?
A: At present, the entry-prohibited special goods are subject to the Entry-prohibited Blood Products Lists worked out in 1986 by Ministry of Health. For the details, please refer to the website of AQSIQ.
6. Q: Do the products originated from animals belong to the scope of inspection on special goods (including animal serum, animal albumen)?
A: The products originated from animals don’t belong to the scope of inspection on special goods except those from mouse (which require permit from related departments).
7. Q: Are the products, such as antibiotics, drug-trial reagent/paper disc, amino acid, inorganic salts listed in the scope of inspection on special goods?
A: No, they are not.
8. Q: What are the specific requirements for the enterprises when they submit the application materials?
A: Things such as application form, product description, letter of guarantee are required to submit according to regulation no.83.As to the product description, besides the contents, like raw materials, manufacturing process, all the ingredients and so on, the existing or potential risks, infectious substances and its preventing and controlling measures, and matters need attention when transporting, storing and using shall be added.
9. Q: Is it ok for us not to present the contract, invoices and packing lists?
A: Invoices and packing lists are not necessary. However, it is necessary to present the contract .
10. Q: As to the high risk products without importing permit temporally, is it necessary to have the importing permit approval department offer the introduction letter and the inspection and quarantine department examine the information like the name and quantity of the products in the introduction letter and then approve the import?
11. Q: Can the quantity of the actual arrival special goods and their types be short of or equal to those data stated in the application?
A: Yes, they can.
12. Q: Are some microecologics and nucleic acid products, whose components are inorganic salt, amino acid and vitamin included in the scope of inspection?
A: No, they are not included in the scope and shall be given the Not Accepting Decision.
13. Q:Are some nucleic acid products such as cDNA, DNA pieces, primer or mRNAi included in the scope of inspection?
A: They are low risk special goods. Their carrier shall be analyzed, evaluated or examined in order to see whether it belongs to high risk list.
14. Q: Are nutrilit, surface active agent and nonsurfactant included in thescope of inspection?
A: They are low risk special goods.
15. Q: If certain reagents contain microorganism, human organism, blood and its products and cell component, shall we categorize them into high risk goods to apply for inspection?
A: Yes, you are right.
16. Q: If certain reagents contain interferon, hormone, enzyme and its preparation, antigen, allergen, monoclonal antibody, recombining DNA products, antigen-antibody complex, immunoregulator components,shall we categorize them into high risk goods or low risk goods to apply for inspection?
A: They belong to low risk goods. (Note: toxin is high risk special goods)
17. Q: Are the goods without product description and components on the ground of maintaining commercial secrets not accepted to check and examine?