Laws of the People's Republic of China

General Administration of Quality Supervision, Inspection and Quarantine

Announcement of the General Administration of Quality Supervision, Inspection and Quarantine

No.83

The Provisions for the Administration on the Sanitation Quarantine of Entry/Exit Special Articles, which were adopted through discussion at the executive meeting of the General Administration of Quality Supervision, Inspection and Quarantine on May 16, 2005, are hereby promulgated, and shall come into force as of January 1st, 2006.

Director General Li Changjiang

October 17, 2005

The Provisions for the Administration on the Sanitation Quarantine of Entry/Exit Special Articles

Chapter I General Provisions

Article 1

The present Provisions are formulated in accordance with the Frontier Sanitation and Quarantine Law of the People's Republic of China and the relevant provisions of its detailed implementation rules for the purpose of regulating the supervision and administration of sanitation and quarantine on entry/exit special articles.

Article 2

The present Provisions shall be applicable to the supervision and administration of sanitation and quarantine on entry/exit microorganism, human tissue, biological products, blood and its products, and other special articles.

Article 3

The General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as the GAQSIQ) shall administer uniformly the work for the supervision and administration of sanitation and quarantine of entry/exit special articles countrywide; and the entry/exit inspection and quarantine organ established by the GAQSIQ at each locality (hereinafter referred to as the inspection and quarantine organ) shall conduct supervision and administration of heath quarantine on entry/exit special articles within its own jurisdiction.

Article 4

The systems for the administration of heath quarantine on entry/exit special articles shall adopt on examination and approval for health quarantine, on-site checking, and follow-up supervision and administration. .

Article 5

No entry/exit special articles may be allowed to enter and exit the territory until they have obtained the Approval of Entry/Exit Special Articles for Verification of Health Quarantine (hereinafter referred to as the Approval for Verification of Health Quarantine), and are eligible after the heath quarantine inspection.

Article 6

The ports for entering and exiting the territory of entry/exit special articles shall be designated and announced by the GAQSIQ.

Chapter II Examine and Approve for Health Quarantine

Article 7

The inspection and quarantine bureau directly under the GAQSIQ shall be responsible for the examine and approve of the health quarantine on entry/exit special articles within its own jurisdiction..

Article 8

The consigners of the entry/exit special articles or their agents shall submit the Application for Verification of Health Quarantine of Entry/Exit Special Articles (hereinafter referred to as the Application for Verification) to the inspection and quarantine bureaus directly under the GAQSIQ at the entry/exit ports before delivering the special articles for shipment.

The consigners or their agents shall fill in the Application for Verification according to the classification of entry/exit special articles, with one copy for each category.

Article 9

The following materials shall be provided when applying for going through the formalities for the verification of heath quarantine on entry/exit micro-organism, human tissue, and blood:

1.

The certificate of entry and exit license (the original and photocopy) issued by the relevant competent departments;

2.

The descriptive documents on the scientific name of the pathogenic microbes contained in the special articles (both in Chinese and in Latin) and the biological characters (with Chinese and English comparison versions);

3.

With regard to the entry special articles that contain or are likely to contain the pathogenic microbes of Grades Three to Four, and the entry special articles that contain or are likely to contain the pathogenic microbes that have not been graded, the entity using them shall have the BSL- Grade Three (Grade P3) laboratories, and shall provide the certificate of corresponding qualification;

4.

With regard to the special articles for the use of scientific research, the original of the document of approval for the scientific research project or the agreement between the applicant of the scientific research project and the cooperative institutions both home and abroad (the originals and photocopies, with Chinese and English comparison version) shall be provided; and

5.

With regard to the organs for the use of transplanting, the health certificate of the provider and the relevant inspection report that are issued by the hospital that has the qualification shall be provided.

Article 10

The consigners or their agents shall provide the following materials when they apply for going through the formalities for the verification of health quarantine on biological products and blood products:

1.

For the entry biological products and blood products for treatment, prevention, and diagnosis, the import registration certificate issued by the department for drug supervision and administration of state shall be provided;

2.

For the exit biological products and blood products for treatment, prevention, and diagnosis, the Certificate of Drug Sale issued by the department of drug supervision and administration shall be provided; and

3.

For the entry/exit biological products and blood products for the use in other fields, the import documents of approval issued by the relevant competent departments shall be provided.

Article 11

The inspection and quarantine bureaus directly under the GAQSIQ shall accept the application with complete application materials and complies with the legal form.

Article 12

The inspection and quarantine bureau directly under the GAQSIQ that accepts an application shall make substantive examination to the application materials, and make a decision of approve or disapprove within 20 workdays. If it is impossible to make a decision within 20 workdays, another 10 workdays may be extended upon the approval of the person-in-charge, and the applicant shall be notified of the reasons for the extension.

If approved, the Approval for Verification of Health Quarantine shall be issued; if disapproved, the said bureau shall explain the reasons for it in written forms.

The inspection and quarantine bureau directly under the GAQSIQ shall report to and request the GAQSIQ to carry out technical analysis on the special articles whose epidemic nature has not been known. The time needed for technical analysis shall not be computed into the time limit for verification, but the consigners or their agents shall be informed in written forms.

Article 13

The Approval for Verification of Health Quarantine on entry/exit special articles may only be used for once, and its valid period shall be 90 days.

Article 14

In case the formalities for the verification of health quarantine on any organ for the use of transplanting have not been gone through, the inspection and quarantine organ may discharge it in advance when it enters and exits the territory, and the consigner or its agent shall apply for making up the formalities of verification for health quarantine within 10 days after it is discharged.

Chapter III Health Quarantine

Article 15

After any entry/exit special articles reach a port or before they leave a port, the consigner or its agent shall apply to the port inspection and quarantine organ for inspection according to law. Under any of the following circumstances, the inspection and quarantine organ shall not accept the application for inspection:

1.

The consigner or its agent fails to provide the Approval for Verification of Health Quarantine;

2.

The Approval for Verification of Health Quarantine exceeds the valid period;

3.

The consigner or its agent forges or alters the relevant documents or documentations; or

4.

Other circumstances that do not comply with the requirements of inspection and quarantine.

Article 16

The port inspection and quarantine organ that accepts the application for inspection shall conduct on-site checking on the entry/exit special articles in light of the following requirements, and fill in the Records of On-site Checking of Health Quarantine on Entry/Exit Special Articles:

1.

Inspecting whether the name, batch number, specification, quantity, export/import country, and manufacturer of the entry/exit special articles, and other items thereof comply with the contents listed in the approval for verification;

2.

Inspecting whether the package of the entry/exit special articles is safe and without damage, and does not leak; and

3.

Verifying the inspection eligibility report of leave factory on the exit special articles, inspecting the production records and sources of the raw materials, and whether the production flow complies with the health requirements.

Article 17

For the entry special articles that need to be inspected by sampling, the consigners or their agents may transport them to the place that have storage conditions upon the approval of the port inspection and quarantine organs, and may not move or use them until they are checked to be eligible. If a port inspection and quarantine organ has no inspection capacity, it shall entrust the laboratories designated by the GAQSIQ for inspection.

Article 18

In case the entry/exit special articles that are mailed or carried have not gone through the formalities for verification of health quarantine due to special circumstances, the inspection and quarantine organs shall detain them, request them to go through the formalities for verification of health quarantine according to the provisions, conduct the inspection in accordance with Article 16 of the present Measures , and discharge the articles after they have been eligible .

Article 19

The port inspection and quarantine organs shall discharge the entry/exit special articles that comply with the requirements after health quarantine. In case the port inspection and quarantine organs discover any of the following circumstances, they shall issue the Notice on Inspection and Quarantine Disposal, and seal, return, or destroy the entry/exit special articles:

1.

The name, batch number, specification, and quantity, and etc. do not comply with those verified;

2.

The conditions for packaging or preservation do not comply with the requirements;

3.

They exceed the valid period for utilization;

4.

They do not comply with the requirements of health quarantine after inspection; or

5.

The detained articles fail to obtain the license within 60 days from the day of detention.

The port inspection and quarantine organs shall make a good record for the handling result, place on file, and report them to the GAQSIQ.

Chapter IV Follow-up Supervision

Article 20

The inspection and quarantine organs shall conduct follow-up supervision on the entry special articles that contain or are likely to contain the pathogenic microbes within their jurisdictions.

The entry special articles that need follow-up supervision may not be used without the consent of the inspection and quarantine organs.

Article 21

For the entry special articles over which follow-up supervision shall be conducted at other places, the port inspection and quarantine organs shall issue the Transferring Notice on Entry Goods, and forwarding the Notice by electronic ways to the inspection and quarantine organ at the place of destination in a timely manner. The entity using the articles shall, within 30 days after the special articles enter the territory, declare at the inspection and quarantine organ at the place of destination upon the strength of the Notice on Transferring Entry Goods, and accept the follow-up supervision.

Article 22

The contents of follow-up supervision over entry special articles by an inspection and quarantine organ shall include:

1.

Whether the entity using the entry special articles that contain or are likely to contain pathogenic microbes has the corresponding level of bio-safety laboratory, the laboratory of Grade P3 or above shall be certified by the state certification organs;

2.

Whether the operators in the laboratories of the using entity have the corresponding qualification;

3.

As to the records on the use of the entry special articles, whether they are used in light of the usage having been verified.

The using entities shall provide specifications on their use to the inspection and quarantine organs timely.

Article 23

In case an inspection and quarantine organ discovers any incompliance during follow-up supervision, it shall order that the incompliance be rectified within a prescribed time limit, and seal the special articles that have entered the territory, until they comply with the requirements after rectification. If they still do not comply with the requirements after rectification, the inspection and quarantine organ shall order to return or destroy them.

Article 24

An inspection and quarantine organ shall, for the problem discovered in the follow-up supervision, immediately report to the GAQSIQ, and circulate a report to the inspection and quarantine bureau directly under the GAQSIQ that approves the verification.

Chapter V Supplementary Provisions

Article 25

In case anyone violates the present Provisions, and has any of the following acts, the inspection and quarantine organ may give it/him a warning or impose a fine of less than RMB 5,000 Yuan:

1.

Disguising or missing the report of microorganism, human tissue, biological products, flood and its products whose import is prohibited, and other special articles;

2.

Moving, selling, or using the special articles without the approval of the inspection and quarantine organ;

3.

Failing to apply for inspection to the inspection and quarantine organ within the prescribed time limit or refusing to accept the follow-up supervision of health quarantine on special articles; or

4.

Forging or altering the quarantine documentations.

Article 26

Anyone that violates the present Provisions and results in the spread of quarantine epidemic diseases or brings about grave danger of the spread of quarantine epidemic diseases, he/it shall be subject to criminal liabilities according to the relevant provisions of the Criminal Law of the People's Republic of China.

Article 27

The following terms in the present Provisions shall have the following meanings:

1.

Microorganisms shall refer to the viruses, bacteriums, epiphytes, actinomycetes, rickettsia, leptospira, chalmydiae, and mycoplasma, and other medical microorganism;

2.

Human Tissue shall refer to the human embryos, organs, tissue, cells, human secreta and human excrement;

3.

Biological Products shall refer to: bacterium vaccine, virus vaccine, antitoxin, various reagents for diagnosis, interferon (IFN), hormone, enzyme and its preparations, and other active preparations (toxin, antigen, allergen, single cloning antibody, recombinant DNA products, antigen-antibody complex, immune modulators, microeclogial modulators, and nucleic acid preparations, and etc.), and the relevant products produced with other biological materials; and

4.

Blood and Its Products shall refer to the whole blood, plasma, amylase, blood cell, and plasma protein composition or the blood cell composition products, which are separated, purified from blood or made by applying biological technology.

Article 28

The present Provisions shall be followed for the administration of health quarantine of entry/exit special articles that are transported in and out of the bonded zones and export processing zones.

Article 29

The power to interpret the present Provisions shall remain with the GAQSIQ.

Article 30

The present Provisions shall be implemented as of January 1, 2006.