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出入境特殊物品衛(wèi)生檢疫管理規(guī)定-中英對(duì)照法律英語(yǔ)
青島希尼爾翻譯公司 2016年8月3日整理發(fā)布
《出入境特殊物品衛(wèi)生檢疫管理規(guī)定》已經(jīng)2005年5月16日國(guó)家質(zhì)量監(jiān)督檢驗(yàn)檢疫總局局務(wù)會(huì)議審議通過(guò),現(xiàn)予公布,自2006年1月1日起施行。
局 長(zhǎng)
二〇〇五年十月十七日
出入境特殊物品衛(wèi)生檢疫管理規(guī)定
第一章 總則
第一條 為規(guī)范出入境特殊物品的衛(wèi)生檢疫監(jiān)督管理,根據(jù)《中華人民共和國(guó)國(guó)境衛(wèi)生檢疫法》及其實(shí)施細(xì)則的有關(guān)規(guī)定,制定本規(guī)定。
第二條 本規(guī)定適用于入境、出境的微生物、人體組織、生物制品、血液及其制品等特殊物品的衛(wèi)生檢疫監(jiān)督管理。
第三條 國(guó)家質(zhì)量監(jiān)督檢驗(yàn)檢疫總局(以下簡(jiǎn)稱國(guó)家質(zhì)檢總局)統(tǒng)一管理全國(guó)出入境特殊物品的衛(wèi)生檢疫監(jiān)督管理工作;國(guó)家質(zhì)檢總局設(shè)在各地的出入境檢驗(yàn)檢疫機(jī)構(gòu)(以下簡(jiǎn)稱檢驗(yàn)檢疫機(jī)構(gòu))對(duì)轄區(qū)內(nèi)出入境特殊物品實(shí)施衛(wèi)生檢疫監(jiān)督管理。
第四條 出入境特殊物品的衛(wèi)生檢疫管理實(shí)行衛(wèi)生檢疫審批、現(xiàn)場(chǎng)查驗(yàn)和后續(xù)監(jiān)督管理制度。
第五條 取得《入/出境特殊物品衛(wèi)生檢疫審批單》(以下簡(jiǎn)稱《衛(wèi)生檢疫審批單》),并經(jīng)衛(wèi)生檢疫合格的出入境特殊物品,方準(zhǔn)入境、出境。
第六條 出入境特殊物品由國(guó)家質(zhì)檢總局指定并公布的口岸入境、出境。
第二章 衛(wèi)生檢疫審批
第七條 直屬檢驗(yàn)檢疫局負(fù)責(zé)所轄區(qū)域內(nèi)出入境特殊物品的衛(wèi)生檢疫審批。
第八條 入境、出境特殊物品的貨主或者其代理人應(yīng)當(dāng)在交運(yùn)前向入出境口岸直屬檢驗(yàn)檢疫局提交《入/出境特殊物品衛(wèi)生檢疫審批申請(qǐng)單》(下簡(jiǎn)稱《審批申請(qǐng)單》)。
貨主或者其代理人應(yīng)當(dāng)根據(jù)出入境特殊物品的分類填寫(xiě)《審批申請(qǐng)單》,每一類別填寫(xiě)一份。
第九條 申請(qǐng)辦理出入境微生物、人體組織、血液的衛(wèi)生檢疫審批手續(xù)的,應(yīng)當(dāng)提供以下材料:
?。ㄒ唬┫嚓P(guān)主管部門(mén)出具的準(zhǔn)許出入境證明(原件和復(fù)印件);
?。ǘ┨厥馕锲匪≡⑸锏膶W(xué)名(中文和拉丁文)和生物學(xué)特性(中英文對(duì)照件)的說(shuō)明性文件;
(三)含有或者可能含有3至4級(jí)病原微生物的入境特殊物品,及含有或者可能含有尚未分級(jí)病原微生物的入境特殊物品,使用單位應(yīng)當(dāng)具備BSL-3級(jí)(p3級(jí))實(shí)驗(yàn)室,并提供相應(yīng)資質(zhì)的證明;
(四)科研用特殊物品應(yīng)當(dāng)提供科研項(xiàng)目批準(zhǔn)文件原件或者科研項(xiàng)目申請(qǐng)人與國(guó)內(nèi)外合作機(jī)構(gòu)協(xié)議(原件和復(fù)印件,中、英文對(duì)照件);
?。ㄎ澹┕┮浦灿闷鞴賾?yīng)當(dāng)提供有資質(zhì)醫(yī)院出具的供體健康證明和相關(guān)檢驗(yàn)報(bào)告。
第十條 申請(qǐng)辦理生物制品、血液制品的衛(wèi)生檢疫審批手續(xù)的,貨主或者其代理人應(yīng)當(dāng)提供以下材料:
?。ㄒ唬┯糜谥委煛㈩A(yù)防、診斷的入境生物制品、血液制品,應(yīng)當(dāng)提供國(guó)家藥品監(jiān)督管理部門(mén)出具的進(jìn)口注冊(cè)證明;
(二)用于治療、預(yù)防、診斷的出境生物制品、血液制品,應(yīng)當(dāng)提供藥品監(jiān)督管理部門(mén)出具的《藥品銷售證明》;
?。ㄈ┯糜谄渌I(lǐng)域的出入境生物制品、血液制品,應(yīng)當(dāng)提供相關(guān)主管部門(mén)出具的進(jìn)口批件。
第十一條 直屬檢驗(yàn)檢疫局對(duì)申請(qǐng)材料齊全,符合法定形式的申請(qǐng),應(yīng)當(dāng)予以受理。
第十二條 受理申請(qǐng)的直屬檢驗(yàn)檢疫局對(duì)申請(qǐng)材料進(jìn)行實(shí)質(zhì)性審查,并在20個(gè)工作日內(nèi)作出準(zhǔn)予許可或者不準(zhǔn)予許可的決定,20個(gè)工作日內(nèi)不能作出決定的,經(jīng)負(fù)責(zé)人批準(zhǔn)可以延長(zhǎng)10個(gè)工作日,并應(yīng)當(dāng)將延長(zhǎng)期限的理由告知申請(qǐng)人。
準(zhǔn)予許可的,應(yīng)當(dāng)簽發(fā)《衛(wèi)生檢疫審批單》,不準(zhǔn)予許可的,應(yīng)當(dāng)書(shū)面說(shuō)明理由。
對(duì)于尚未認(rèn)知其傳染性的特殊物品,直屬檢驗(yàn)檢疫局應(yīng)當(dāng)報(bào)請(qǐng)國(guó)家質(zhì)檢總局開(kāi)展技術(shù)分析。技術(shù)分析所需時(shí)間不計(jì)入審批期限,但應(yīng)當(dāng)書(shū)面告知貨主或者其代理人。
第十三條 出入境的特殊物品衛(wèi)生檢疫審批單只能使用一次,有效期限為90天。
第十四條 供移植用器官因特殊原因未辦理衛(wèi)生檢疫審批手續(xù)的,入境、出境時(shí)檢驗(yàn)檢疫機(jī)構(gòu)可以先予放行,貨主或者其代理人應(yīng)當(dāng)在放行后10日內(nèi)申請(qǐng)補(bǔ)辦衛(wèi)生檢疫審批手續(xù)。
第三章 衛(wèi)生檢疫
第十五條 入境、出境特殊物品到達(dá)口岸后或者離開(kāi)口岸前,貨主或者其代理人應(yīng)當(dāng)依法向口岸檢驗(yàn)檢疫機(jī)構(gòu)報(bào)檢。有下列情形之一的,檢驗(yàn)檢疫機(jī)構(gòu)不予受理報(bào)檢:
?。ㄒ唬┎荒芴峁缎l(wèi)生檢疫審批單》的;
?。ǘ缎l(wèi)生檢疫審批單》超過(guò)有效期的;
?。ㄈ﹤卧?、涂改有關(guān)文件或單證的;
?。ㄋ模┢渌环蠙z驗(yàn)檢疫要求的。
第十六條 受理報(bào)檢的口岸檢驗(yàn)檢疫機(jī)構(gòu)按照下列要求對(duì)出入境特殊物品實(shí)施現(xiàn)場(chǎng)查驗(yàn),并填寫(xiě)《入/出境特殊物品衛(wèi)生檢疫現(xiàn)場(chǎng)查驗(yàn)記錄》:
(一)檢查出入境特殊物品名稱、批號(hào)、規(guī)格、數(shù)量、輸出/輸入國(guó)和生產(chǎn)廠家等項(xiàng)目是否與審批單列明的內(nèi)容相符;
?。ǘz查出入境特殊物品包裝是否安全無(wú)破損,不滲、不漏;
?。ㄈ?duì)出境的特殊物品應(yīng)核查出廠檢驗(yàn)合格報(bào)告,檢查生產(chǎn)記錄、原材料來(lái)源,以及生產(chǎn)流程是否符合衛(wèi)生要求。
第十七條 對(duì)需抽樣檢驗(yàn)的入境特殊物品,經(jīng)口岸檢驗(yàn)檢疫機(jī)構(gòu)許可,貨主或者其代理人可先運(yùn)至有儲(chǔ)存條件的場(chǎng)所,待檢驗(yàn)合格后方可移運(yùn)或使用??诎稒z驗(yàn)檢疫機(jī)構(gòu)不具有檢驗(yàn)?zāi)芰Φ?,?yīng)當(dāng)委托國(guó)家質(zhì)檢總局指定的實(shí)驗(yàn)室進(jìn)行檢驗(yàn)。
第十八條 郵寄、攜帶的出入境特殊物品,因特殊情況未辦理衛(wèi)生檢疫審批手續(xù)的,檢驗(yàn)檢疫機(jī)構(gòu)應(yīng)當(dāng)予以截留,要求按照規(guī)定辦理衛(wèi)生檢疫審批手續(xù),并按照第十六條進(jìn)行查驗(yàn),經(jīng)檢疫合格后方可放行。
第十九條 口岸檢驗(yàn)檢疫機(jī)構(gòu)對(duì)經(jīng)衛(wèi)生檢疫符合要求的出入境特殊物品予以放行。發(fā)現(xiàn)有下列情況之一的,簽發(fā)《檢驗(yàn)檢疫處理通知書(shū)》,并予以封存、退回或者銷毀:
(一)名稱、批號(hào)、規(guī)格、數(shù)量等與審批內(nèi)容不相符的;
?。ǘ┌b或者保存條件不符合要求的;
(三)超過(guò)有效使用期限的;
(四)經(jīng)檢驗(yàn)不符合衛(wèi)生檢疫要求的;
(五)被截留物品自截留之日起60日內(nèi)未獲準(zhǔn)許可的。
口岸檢驗(yàn)檢疫機(jī)構(gòu)對(duì)處理結(jié)果應(yīng)當(dāng)做好記錄、歸檔,并上報(bào)國(guó)家質(zhì)檢總局。
第四章 后續(xù)監(jiān)管
第二十條 檢驗(yàn)檢疫機(jī)構(gòu)對(duì)轄區(qū)內(nèi)含有或可能含有病原微生物的入境特殊物品實(shí)施后續(xù)監(jiān)管。
需要后續(xù)監(jiān)管的入境特殊物品,未經(jīng)檢驗(yàn)檢疫機(jī)構(gòu)的同意,不得擅自使用。
第二十一條 對(duì)需要實(shí)施異地后續(xù)監(jiān)管的入境特殊物品,口岸檢驗(yàn)檢疫機(jī)構(gòu)應(yīng)當(dāng)出具《入境貨物調(diào)離單》,并及時(shí)電子轉(zhuǎn)單給目的地檢驗(yàn)檢疫機(jī)構(gòu)。使用單位應(yīng)當(dāng)在特殊物品入境后30日內(nèi),持《入境貨物調(diào)離單》到目的地檢驗(yàn)檢疫機(jī)構(gòu)申報(bào),并接受后續(xù)監(jiān)管。
第二十二條 檢驗(yàn)檢疫機(jī)構(gòu)對(duì)入境特殊物品實(shí)施后續(xù)監(jiān)管的內(nèi)容包括:
(一)含有或者可能含有病原微生物入境特殊物品的使用單位是否具有相應(yīng)等級(jí)的生物安全實(shí)驗(yàn)室,P3級(jí)以上實(shí)驗(yàn)室必須獲得國(guó)家認(rèn)可機(jī)構(gòu)的認(rèn)可;
?。ǘ┦褂脝挝粚?shí)驗(yàn)室操作人員是否具備相應(yīng)的資質(zhì);
?。ㄈ┤刖程厥馕锲肥褂们闆r記錄,是否按照審批用途使用。
使用單位應(yīng)當(dāng)及時(shí)向檢驗(yàn)檢疫機(jī)構(gòu)提供使用情況說(shuō)明。
第二十三條 檢驗(yàn)檢疫機(jī)構(gòu)在后續(xù)監(jiān)管過(guò)程中發(fā)現(xiàn)有不符合要求的,應(yīng)當(dāng)責(zé)令限期整改,并對(duì)已入境的特殊物品進(jìn)行封存,直至整改符合要求。如經(jīng)整改仍不符合要求的,責(zé)令其退運(yùn)或者銷毀。
第二十四條 檢驗(yàn)檢疫機(jī)構(gòu)對(duì)后續(xù)監(jiān)管過(guò)程中發(fā)現(xiàn)的問(wèn)題,應(yīng)當(dāng)立即報(bào)告國(guó)家質(zhì)檢總局,并通報(bào)原審批的直屬檢驗(yàn)檢疫局。
第五章 附則
第二十五條 違反本規(guī)定,有下列行為之一的,檢驗(yàn)檢疫機(jī)構(gòu)可以給予警告或者處以5000元以下的罰款:
?。ㄒ唬┎m報(bào)或者漏報(bào)禁止進(jìn)口的微生物、人體組織、生物制品、血液及其制品等特殊物品的;
(二)未經(jīng)檢驗(yàn)檢疫機(jī)構(gòu)許可,擅自移運(yùn)、銷售和使用特殊物品的;
?。ㄈ┰谝?guī)定時(shí)限內(nèi)未向檢驗(yàn)檢疫機(jī)構(gòu)申報(bào)或者拒絕接受特殊物品衛(wèi)生檢疫后續(xù)監(jiān)管的;
?。ㄋ模﹤卧旎蛘咄扛臋z疫單、證的。
第二十六條 對(duì)違反本規(guī)定,引起檢疫傳染病傳播或者有引起檢疫傳染病傳播嚴(yán)重危險(xiǎn)的,依照《中華人民共和國(guó)刑法》的有關(guān)規(guī)定追究刑事責(zé)任。
第二十七條 本規(guī)定下列用語(yǔ)的含義:
?。ㄒ唬┪⑸锸侵覆《?、細(xì)菌、真菌、放線菌、立克次氏體、螺旋體、衣原體、支原體等醫(yī)學(xué)微生物;
?。ǘ┤梭w組織是指人體胚胎、器官、組織、細(xì)胞、人體分泌物、排泄物;
?。ㄈ┥镏破肥侵福杭?xì)菌類疫苗、病毒類疫苗、抗毒素、各種診斷用試劑、干擾素、激素、酶及其制劑以及其他活性制劑(毒素、抗原、變態(tài)反應(yīng)原、單克隆抗體、重組DNA產(chǎn)品、抗原-抗體復(fù)合物、免疫調(diào)節(jié)劑、微生態(tài)制劑、核酸制劑等),以及其他生物材料制備的有關(guān)制品;
?。ㄋ模┭杭捌渲破肥侵溉⒀獫{、血清、血細(xì)胞以及由血液分離、提純或者應(yīng)用生物技術(shù)制成的血漿蛋白組分或者血細(xì)胞組分制品。
第二十八條 進(jìn)出保稅區(qū)、出口加工區(qū)的出入境特殊物品的衛(wèi)生檢疫管理,按照本規(guī)定執(zhí)行。
第二十九條 本規(guī)定由國(guó)家質(zhì)檢總局負(fù)責(zé)解釋。
第三十條 本規(guī)定自2006年1月1日起施行。
Regulations for Administration of Entry and Exit Health Quarantine on Special
Goods
October 17,2005
Regulations for Administration of Entry and Exit Health Quarantine on Special
Goods
Chapter I 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 II 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 III 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 IV 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 V 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.
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