Report by ProxyNo.34 [2002] of the General Administration of Quality Supervision, Inspection and Quarantine

Chapter 1 General Principles

Article 1 For the purposes of regulating the administration of entry and exit health quarantine on special goods, these regulations are formulated in accordance with relative provisions of Health Quarantine Law of the People's Republic of China and their detailed implementation rules.

Article 2 These regulations apply to the supervision and administration of entry and exit health quarantine on microorganism, human body tissue, biological products, blood and its products and other special goods.

Article 3 General Administration of Quality Supervision, Inspection and Quarantine of China （AQSIQ） uniformly manages national supervision and administration of entry and exit health quarantine on special goods. The entry and exit inspection and quarantine organs established by AQSIQ in all local areas （inspection and quarantine organs in short below） carry out the supervision and administration of entry and exit health quarantine on special goods within the areas under their jurisdiction.

Article 4 Rules for health quarantine approval, examination on the spot and follow-up supervision and administration are carried out in the administration of entry and exit health quarantine on special goods.

Article 5 Entry and exit Special goods could enter or leave the country only when obtaining the Approval Certificate for Entry and Exit Health Quarantine on Special Goods （Health Quarantine Approval Certificate） and pass the health quarantine.

Article 6 Entry and exit special goods should enter and leave the country from the ports appointed and published by AQSIQ.

Chapter 2 Examination and Approval of Health Quarantine

Article 7 Directly affiliated Inspection and Quarantine Bureaus are responsible for the examination and approval of entry and exit health quarantine on special goods in the areas under their jurisdiction.

Article 8 The owners of entry and exit special goods or their agent should submit Application Form for Examination and Approval of Entry and Exit Health Quarantine on Special Goods （Application Form for Approval）.

The owners or their agent should fill in Application Form for Approval according to the classifications of entry and exit special goods, one form for one classification.

Article 9 Whoever applies for approval of entry and exit health quarantine on microorganism, human body tissues, biological products, blood should provide following materials:

1. Approval certificate for entry and exit issued by corresponding competent authority （original one and a copy）;
2. Directions of special goods, including scientific name of disease-causing microorganism （both in Chinese and Latin） and biology characteristic （bilingual Chinese-English version） contained in the special goods.
3. For the entry and exit special goods containing or may containing Grade 3 to 4 disease-causing microorganism, and containing or may containing disease-causing microorganism that has not been divided into grades, the unit using the goods should have Grade BSL-3 （Grade P3） Laboratory and provide corresponding qualification certificate.
4. For the special goods for scientific research, the original document for approving the scientific research or the agreement between the applicant for the scientific research project and internal or external cooperation organs （original one and copy in bilingual Chinese-English version） should be provided;
5. For the tissue used for transplanting, health certificate of the supplier and corresponding examination report issued by a hospital with qualifications should be provided.

Article 10 To apply for going through health quarantine approval formalities for biological products and blood products, the owner of the goods or his agent should submit following materials:

1. To the entry biological products and blood products used for treatment, prevention and diagnosis, import registration certificate issued by national pharmaceutical supervision and management departments should be provided;
2. To the exit biological products and blood products used for treatment, prevention and diagnosis, Certificate of Pharmacy Sales issued by pharmaceutical supervision and administration department should be provided;
3. To the entry and exit biological products and blood products used in other field, the certificate for approval of import issued by corresponding competent department should be provided.

Article 11 Directly affiliated inspection and quarantine bureau should accept and handle the application that the materials are completed and being up to the legal form.

Article 12 Directly affiliated inspection and quarantine bureau accepting and handling the application should make substantive review on the application materials and make the decision whether or not to grant the permission within 20 working days. If they could not make the decision within 20 working days, they may prolong 10 working days with the approval of the person in charge of it, and inform the applicants of the reason why to prolong the term.

To the special goods getting the permission, the Approval Paper for Health Quarantine should be issued, and to the special goods failing to the permission, reasons should be given in writing.

The direct affiliated inspection and quarantine bureau should report the special goods that have not been known to AQSIQ for technical analysis. The time needed for technical analysis should not be included into the approval term but the owner of the goods or his agent should be informed of it in writing.

Article 13 The approval paper for entry and exit health quarantine on special goods can be used only once, and valid for 90 days.

Article 14 If the tissue used for transplanting has not gone through the formalities of health quarantine approval because of special reasons, the inspection and quarantine organ may let it pass first, then the owner or his agent should apply for health quarantine approval within 10 days after the tissue got the clearance.

Chapter 3 Health Quarantine

Article 15 After the entry and exit special goods arrive at the port or before leaving the port, the owner or his agent should report to the inspection and quarantine organ of the port in accordance with laws. The inspection and quarantine organ should not accept and handle the quarantine in one of following circumstances:

1. can not provide Approval Paper for Health Quarantine;
2. approval Paper for Health Quarantine has lost efficacy;
3. forge or alter relative documents or papers;
4. other circumstances that do not meet the requirements of the inspection and quarantine.

Article 16 The inspection and quarantine organ of the port handling the quarantine report should make examination on the spot to the entry and exit special goods according to the requirements, and fill in On-the-spot Examination Record for Entry / Exit Health Quarantine on Special Goods:

1. Examine whether the name, batch number, specification, quantity, entry / exit country and production factory of the entry and exit special goods conform with the content listed in the approval paper;
2. Examine whether the pack of entry and exit special goods is safety without damage, leaking and oozing;
3. Examine whether the ex-factory quality inspection report, production record, origin of the raw materials and production process of exit special goods meet the requirements of health.

Article 17 To the entry special goods that need to be examined by selecting samples, the owner or his agent may transport the goods to a place meeting the requirements of storing with the permission of the inspection and quarantine organ of the port, and transfer or use them after passing the examination. If the inspection and quarantine organ have no ability to make the examination, it should authorize the laboratory appointed by AQSIQ to make the examination.

Article 18 If the entry and exit special goods that are posted or brought with do not go through health quarantine approval formalities because of special reasons, the inspection and quarantine organ should hold them back and ask to handle health quarantine approval formalities according to the rules, and examine them in accordance with Article 16. The goods can get clearance only when they pass the quarantine.

Article 19 The inspection and quarantine organ of the port should let the entry and exit special goods that meet the requirements of health quarantine leave the port. Notice on Inspection and Quarantine Treatment should be issued and the goods should be sealed up, returned back or destroyed if one of following cases is found:

1. name, batch number, specification, quantity and etc. do not conform with the approved content;
2. pack or storage condition do not meet the requirements;
3. pass the expiry date;
4. do not pass the health quarantine examination;
5. the goods that have been hold back do not obtain the approval within 60 days at the date of holding back.

To the treatment result, the inspection and quarantine organ of the port should take notes, put into files and report to AQSIQ.

Chapter 4 Follow-up Supervision and Administration

Article 20 Inspection and quarantine organ should carry out follow-up supervision and administration on the entry special goods that contain or may contain disease-causing microorganism in the area under its jurisdiction.

The entry special goods that need follow-up supervision and administration should not be used without the permission of inspection and quarantine organ.

Article 21 To the entry special goods that need follow-up supervision in alien land, inspection and quarantine organ of the port should issue Transferring Paper for Entry Goods, and send the electronic paper to the destination inspection and quarantine organ. The unit that use the goods should declare the goods to the destination inspection and quarantine organ with the Transferring Paper for Entry Goods and accept follow-up supervision and administration within 30 days after the entry of the special goods.

Article 22 The content that Inspection and quarantine organ carry out follow-up administration on entry and exit special goods includes:

1. Whether the unit using entry special goods including or may including disease-causing microorganism has corresponding grade of biological safety laboratory, the laboratory higher than Grade P3 must obtain the approval of national approval organ.
2. whether the operators in the laboratory of the unit using the special goods have corresponding qualifications;
3. whether the record how to use the entry special goods is used according to the approved uses;

The unit of using the special goods should tell the inspection and quarantine organ how they use the goods.

Article 23 If the inspection and quarantine organ find any circumstances that does not meet the requirements during follow-up supervision and administration, they should order them to make correction and seal up the special goods that have already entered the country until they meets the requirements. If the goods do not meet the requirements after the correction, they should be returned back or destroyed.

Article 24 Inspection and quarantine organ should report AQSIQ immediately the problems found in the follow-up supervision and administration, and circulate a notice to the affiliated inspection and quarantine bureau that made the original approval.

Chapter 5 Supplementary Articles

Article 25 Inspection and quarantine organ may give a warming or fine less than 5000 yuan to one of following behaviors violating these regulations:

1. cancel or fail to report the microorganism, human body tissues, biological products, blood and its products and other special goods that are forbidden to be imported;
2. move, sell and use special goods without the permission of the inspection and quarantine organs;
3. do not report to the inspection and quarantine organ within the time limited or refuse to accept follow-up supervision and administration of health quarantine on special goods;
4. forge or alter quarantine paper or certificate.

Article 26 Whoever violates these regulations, causes the spread of infectious disease relating to quarantine or serious danger of spread of infectious disease relating to quarantine should be ascertained criminal responsibility in accordance with relative provisions of Criminal Law of the People's Republic of China.

Article 27 The meaning of the words in terms of theses regulations:

1. microorganism means virus, bacterium, cumycete, actinomyees, reckttsia, spirochaeta, Chlamydia, mycoplasma and other microorganism;
2. human body tissues means human embryo, organs, tissues, cell, human secretion, excrement;
3. biological products means bacterial vaccine, viral vaccine, antitoxin, all kinds of reagents for diagnosis, interferon, hormone, enzyme and its preparation and other active preparation （toxin, antigen, allegy, single clone antibody, reorganized DNA products, antigen-antibody Composites, immunologic regulator, microecology preparation, nucleic acid preparation and etc）, and relative products made of biological materials;
4. blood and its products means blood, plasma, serum, blood cell and the products of plasma protein component or blood cell component that are separated or purified from blood or made by application biotechnology.

Article 28 Health quarantine on entry and exit special goods that enter and leave the bonded area and export processing area should be administered in accordance with these regulations.

Article 29 The interpretation of these regulations is vested in AQSIQ.

Article 30 These regulations shall come into effect as of January 1, 2006.

注意事项：

在本英文翻译版本同汉语原版本出现任何不符时，以汉语版本为准。

Important Notice:

In case of this English version has any discrepancy with the original version in Chinese, the Chinese version shall prevail.