AQSIQ Decree No. 160 (on Inbound/Outbound Special Articles Quarantine Regulations)

[2015-02-15 13:22:30]

The Regulations Of China On Quarantine Of Inbound/Outbound Special Articles, approved by China's General Administration of Quality Supervision, Inspection & Quarantine (AQSIQ) on 4 December 2014, are hereby promulgated and shall enter into force on 1 March 2015.


AQSIQ Minister
January 21, 2015

Regulations of China On Quarantine Of Inbound/Outbound Special Articles

Chapter 1 General Rules

Article 1. These Regulations are formulated in accordance with P. R. China's Law on Frontier Health Quarantine and its implementation rules, AIDS Prevention Regulations, pathogenic microbiology laboratory biosafety regulations, Human Genetic Resources Management Interim Measures, etc.

Article 2. These Regulations apply to quarantine matters concerning inbound/outbound micro-organisms, human tissues, biological products, blood and blood products and other special articles.

Article 3. The AQSIQ has the authority to supervise and manage the entry-exit inspection and quarantine matters all over China, while local entry-exit inspection and quarantine agencies are in charge of local matters as such under AQSIQ leadership.

Article 4. The management of the inbound/outbound special articles quarantine is in the principle of risk control, which includes quarantine approval, inspection and supervision as per risk levels upon assessment.

Article 5. The special articles owners or agents shall import, export, produce, and operate the special articles in accordance with relevant laws, regulations and standards.

Chapter 2 Quarantine Approval

Article 6. Local inspection-quarantine bureaus under AQSIQ leadership are in charge of approval of local quarantine for the inbound/outbound special articles.

Article 7. Conditions for application for the approval:
(1) Where necessary, relevant approval documents shall be acquired from government agencies;
(2) Biosafety control capacity shall be available to the inbound/outbound special articles;

Article 8. The owners/agents of inbound special articles shall, before delivery of the articles, apply for the quarantine approval to the destination-based inspection-quarantine bureaus under AQSIQ leadership; the owners/agents of outbound special articles shall, before delivery of the articles, apply for the quarantine approval to locally-based inspection-quarantine bureaus under AQSIQ leadership;

Article 9. For the quarantine approval, the owners/agents shall submit documents as required below:
(1) The completed form of the Application For Quarantine Of Inbound/Outbound Special Articles;
(2) Specific descriptions of the inbound/outbound special articles, including Chinese and English names, classification, composition, origin, purpose, sale channel, export/import destination, manufacturer information, etc.
(3) Regarding inbound human blood, plasma, tissue, organs, cells, bone marrow, etc., the approval documents from health authorities shall be provided;
(4) Regarding the special articles for medical transplantation, the approval documents from medical authorities shall be provided;
(5) Regarding the inbound special articles for disease prevention and treatment, the Import Drug Registration Certificate from State Council's drug regulatory agency shall be provided;
(6) Regarding the special articles risking any pathogenic microorganisms, they shall provide pathogenic microorganisms' names, biological descriptions (in Chinese and English) and Biosafety Capacity Certificates;
(7) Regarding the outbound special articles for disease prevention and treatment, they shall provide the sale certificate issued by drug regulatory agency.
(8) Regarding the outbound special articles involving human genetic resources, they shall provide the approval document issued by the regulatory agency for human genetic resources;
(9) The users of the special articles involving pathogenic microorganisms shall provide corresponding biosafety lab qualification proof; BSL-3 and grade-higher labs must have state accreditation;
(10) Regarding serious pathogenic microorganism strains or samples, they shall provide the approval documents issued by provincial-level and higher Health Administrations.

Article 10. A firm in its first application shall also provide other documents as required below:
(1) Business License, Organization Code Certificate (copied);
(2) Firm information including management system certification status, address, place of production, laboratory setup, storage facilities, processing conditions, production processes, floor plan, etc.;
(3) Biosafety documents including storage management rules, use management rules, waste disposal rules, professional management rules, emergency handling procedures, etc.

Regarding the special articles involving pathogenic microorganisms, the applicant may not be a natural person.

Article 11. Local inspection-quarantine bureaus shall deal with the quarantine approval as per their jurisdiction and AQSIQ regulations.

Article 12. Local inspection-quarantine bureaus shall timely examine the application materials in such manners as expert review, on-site assessment, laboratory testing, etc.

Article 13. Where the applications are compliant, local inspection-quarantine bureaus shall, within 20 days upon acceptance, issue Inbound/Outbound Special Articles Quarantine Approval Sheet to the applicant.

Where the applications are not compliant, local inspection-quarantine bureaus shall, within 20 days upon acceptance, issue a disapproval notice with reasons and suggestions to the applicant.

Article 14. The Inbound/Outbound Special Articles Quarantine Approval Sheet has the following forms of validity period:
(1) Where involving serious pathogenic microorganisms, the Approval validity may last for 3 months;
(2) Where involving other pathogenic microorganisms, the Approval validity may last for 6 months;
(3) Regarding other special articles except the aforesaid, the Approval validity may last for 12 months.

The Approval Sheet within validity may be used by batch; when it expires, re-application shall apply.

Chapter 3 Quarantine Inspection

Article 15. Upon the entry of the inbound special articles, the owner/agents shall declare to local port-based inspection-quarantine agencies on the strength of the Approval Sheet.
Regarding the outbound special articles, the owners/agents shall, before exit, declare to local inspection-quarantine agencies on the strength of the Approval Sheet.

Article 16. Local inspection-quarantine agencies shall conduct onsite inspection of the special articles and make onsite inspection records.

Article 17. Regarding the special articles to be lab-tested, the owners/agents shall store them in qualified warehouses and move or use them only after they are quarantined compliant.

Article 18. Regarding the special articles by post or along with passengers, where the Approval Sheet is not available, the inspection-quarantine agencies shall detain the articles for not more than 7 days base on issue of detention proof; where the Approval Sheet is available, the inspection-quarantine agencies shall conduct inspection, quarantine and release processes.

Article 19. Where a passenger carries self-use blood products or biological products, he may be free from the quarantine approval and shall present corresponding hospital-issued proof to the inspection-quarantine agencies; the permitted carrying volume shall be within one course of treatment as per prescription or specification.

Article 20. Regarding the human tissues for transplantation, where the Approval Sheet is not available, the inspection-quarantine agencies may release in advance after quarantine, but the owners/agents shall provide the Approval Sheet within 10 days after the release.

Article 21. In any of the following cases, the inspection-quarantine agencies shall conduct return or destruction of the articles based on issue of corresponding notices:
(1) Incompliance with Approval Sheet in terms of name, batch, specification, bioactive components, etc.;
(2) Exceeding the approved quantity or scope of the articles;
(3) Incompliance in package of the articles;
(4) Incompliance of the articles with health quarantine requirements;
(5) Failure to provide the Approval Sheet within 7 days upon detention of the postal or passenger-carried articles, or failed in quarantine results based on the Approval Sheet.


Chapter 4 Quarantine Supervision

Article 22. The firms of the special articles shall maintain relevant safety management system and relevant production, use and sale records with a shelf life of two years or longer.

Article 23. The inspection-quarantine agencies shall maintain risk control over the inbound/outbound special articles by conducting different quarantine models as per different levels of disease transmission risk.

Article 24. Regarding the inbound special articles subjected to follow-up supervision, the user shall, within 30 days upon the entry, declare to the destination-based inspection-quarantine agency for the follow-up supervision and shall not use the articles without permission by that inspection-quarantine agency.

Article 25. The follow-up supervision aforesaid contains the following matters:
(1) Whether the user's lab is consistent with its specification in the Approval Sheet;
(2) Whether the inbound special articles are consistent with their specification in the Approval Sheet

Article 26. In any of the following cases of the follow-up supervision, the destination-based inspection-quarantine agency shall withdraw the Approval Sheet and issue the order for return or destruction of the special articles:
(1) The user's lab is not consistent with its specification in the Approval Sheet;
(2) The inbound special articles are not consistent with their specification in the Approval Sheet

Article 27. The inspection-quarantine agency personnel shall act by law and keep confidential any business secret learned by them from work.

Chapter 5 Legal Liabilities

Article 28. In breach of these Regulations in any of the following cases, the inspection-quarantine agencies shall impose punishment of warning or penalty of RMB 100-5000:
(1) Refusal to receive the quarantine or rejection to the supervision;
(2) Counterfeiting or alteration of quarantine proofs;
(3) Concealment of any inbound special articles that are banned from entry

Article 29. In breach of these Regulations in any of the following cases with illegal gains, the inspection-quarantine agencies shall impose penalty of RMB 30,000 at most:
(1) The approval is obtained in an improper way as fraud and bribery;
(2) The special articles are moved, sold and used without prior permission by the inspection-quarantine agencies;
(3) The special articles are not declared to the inspection-quarantine agencies or an inspection-quarantine proof is obtained by means of fake documents/materials;
(4) The special articles are not processed in appropriate biosafety labs, or the user does not have appropriate biosafety capacity; the special articles are not provided with use and sale records that are truthful;
(5) The special articles subject to the follow-up supervision are put into use without prior permission by the inspection-quarantine agencies;
(6) Regarding the pre-released human tissues used for medical transplantation, the applicant fails to provide the Approval Sheet within 10 days upon the pre-release.

Article 30. The special articles owners/agents hindering the quarantine supervision shall be punished by authorities.

Article 31. The inspection-quarantine agency personnel in misconduct or violating laws/regulations shall be punished for administrative or criminal liability.

Article 32. Where any quarantinable disease is led to transmission or is put at risk of transmission owing to violation of these Regulations, the criminal liability shall be prosecuted in accordance with China law.

Chapter 6 Supplementary Provisions

Article 33. Meanings of Some Terms herein:

Microorganisms refer to viruses, bacteria, fungi, actinomycetes, rickettsia, spirochetes, chlamydia, mycoplasma and other medical microbiological strains and samples and parasites, environment-friendly microbial agents.

Human tissues refer to human cells, cell lines, embryos, organs, tissues, bone marrow, secretions, excretions, etc.

Human genetic resources refer to genetic materials including organs, tissue, cells, blood, preparations, and recombined deoxyribonucleic acid (DNA) constructs that contain human genome, genes and their products.

Biological products refer to vaccine, antitoxin, diagnostic reagents, cytokines, enzymes and their preparations as well as toxins, antigens, allergens, antibodies, antigen-antibody complex, nucleic acid, immunomodulator agents, probiotics and other bioactive agents.

Blood means human whole blood, blood plasma components and special blood ingredients.

Blood products refer to various human plasma protein products.

Firms of the special articles refer to legal persons or other organizations engaging in the special articles production, use, sale, research, medical treatment, testing, pharmaceutical R&D outsourcing, etc.

Article 34. Regarding import/export environment-oriented microbial agents, their quarantine shall be subjected to corresponding Environmental Safety Management Measures (by Ministry of Environmental Protection-AQSIQ Decree No. 10).

Article 35. Any necessary quarantine of inbound/outbound animals and plants shall be subjected to corresponding quarantine law/regulations.

Article 36. The interpretation of these Regulations shall remain with the AQSIQ hereto.

Article 37. These Regulations shall enter into force on March 1, 2015 along with simultaneous repeal of the corresponding edition of October 17, 2005 (in AQSIQ Decree No.83).

Source: ETCN