国务院法制办公室对宁夏回族自治区政府法制办《关于对〈中华人民共和国药品管理法〉第四十八条有关法律适用问题的请示》的复函

作者:法律资料网 时间:2024-05-02 17:04:20   浏览:9620   来源:法律资料网
下载地址: 点击此处下载

国务院法制办公室对宁夏回族自治区政府法制办《关于对〈中华人民共和国药品管理法〉第四十八条有关法律适用问题的请示》的复函

国务院法制办公室


国务院法制办公室对宁夏回族自治区政府法制办《关于对〈中华人民共和国药品管理法〉第四十八条有关法律适用问题的请示》的复函

(2003年3月6日中华人民共和国国务院法制办公室文件国法函〔2003〕20号公布 自公布之日起施行)



宁夏回族自治区政府法制办:

你办《关于对〈中华人民共和国药品管理法〉第四十八条有关法律适用问题的请示》(宁府法函[2003]第1号)收悉。经研究,函复如下:

一、《药品管理法》第二十三条第一款规定:“医疗机构配制制剂,须经所在地省、自治区、直辖市人民政府卫生行政部门审核同意,由省、自治区、直辖市人民政府药品监督管理部门批准,发给《医疗机构制剂许可证》。无《医疗机构制剂许可证》的,不得配制制剂。”第二十四条规定:“医疗机构配制制剂,必须具有能够保证制剂质量的设施、管理制度、检验仪器和卫生条件。”因此,《医疗机构制剂许可证》是医疗机构制剂室符合配制制剂条件的合法证明文件,非经药品监督管理部门批准,医疗机构不得擅自决定或者变更配制场所。

二、《药品管理法》第二十五条规定,医疗机构须经药品监督管理部门批准后方可配制制剂。据此,医疗机构必须按照批准的标准配制制剂,并须按规定进行质量检验。如果在原经批准配制标准中添加新的成份,配制新的制剂品种,应当报经药品监督管理部门批准后方可配制。《药品管理法》第四十八条第一款规定,药品的生产包括制剂的配制。未经药品监督管理部门批准的配制行为,属于《药品管理法》第四十八条第三款规定的应当按生产假药论处的情形,即“依照本法必须批准而未经批准生产”的情形。



附:宁夏回族自治区人民政府法制办公室关于对《中华人民共和国药品管理法》第四十八条有关法律适用问题的请示

(2003年1月10日宁府法函[2003]第1号)

国务院法制办公室:

2002年10月22日,我办受理了申请人宁夏秦杨风湿病医院不服被申请人宁夏回族自治区药品监督管理局(宁)药行罚字(2002)第048号行政处罚决定申请行政复议一案。(宁)药行罚字(2002)第048号行政处罚决定认定申请人:1.在没有经过批准、没有保证制剂质量设施、卫生条件的民宅配制制剂,价值1128760元;2.在配制的制剂中抽取13种制剂的15个批次检出化学药制剂“感冒通”成份;3.未经批准自行配制“五虎搜风”Ⅱ、Ⅲ号;4.将制剂销往区外。违反了《药品管理法》第二十四条、第二十五条、第四十八条之规定,依据《药品管理法》第七十四条、第七十六条、第八十四条之规定,给予以下行政处罚:1.没收剩余假药31869瓶;2.没收违法所得561546元;3.处以三倍罚款3386280元;4.没收原辅材料、包装材料、生产设备;5.吊销医院《医疗机构制剂许可证》。我办于2002年12月25日公开举行了听证会,现就听证会争议的定性和法律适用问题请示如下:

一、关于定性问题。被申请人根据《药品管理法》第四十八条第一款和第三款第二项将申请人在批准配制的制剂中擅自加入“感冒通”的行为定性为假药。通过对《中华人民共和国药品管理法学习辅导》(郑筱萸、徐玉麟主编)第四十八条第一款是禁止性条款,第三款第二项针对“新药的开发研制”,而不针对制剂,学习《药品管理法》第四十八条第二款假药的概念,其中第一项“药品所含成份与国家药品标准规定的成份不符的”,为假药,而该制剂是自治区卫生行政部门批准的,不存在国家标准。而第二项“以非药品冒充药品或以他种药品冒充此种药品”似乎与本案情况也不相符,而未按照省级卫生行政部门或药品监督管理部门的标准配制制剂的行为在《药品管理法》第四十八条中未找到相对应的条款,将在经批准的制剂中擅自加入“感冒通”的行为是否可以定性为假药或以假药论处。

二、法律依据的适用问题,本案中被申请人于2002年6月19日在监督检查中发现申请人的违法事实并开始查处。于2002年10月9日作出处罚决定。国务院于2002年8月4日颁布、9月15日起实施的《中华人民共和国药品管理法实施条例》第七十一条中规定:“医疗机构不按照省、自治区、直辖市人民政府药品监督管理部门批准的标准配制制剂的,依照《药品管理法》第七十五条的规定给予处罚”,即按生产、销售劣药给予处罚。本案是否可以适用该条例对申请人进行处罚。

三、申请人已取得《医疗机构制剂许可证》,但在没有经过批准,没有保证制剂质量设施、卫生条件的民宅配制制剂。所配制的制剂是否可以认定为假药。

特此请示,请予答复。


下载地址: 点击此处下载

国家安全监管总局关于下达2011年安全生产行业标准制修订项目计划的通知

国家安全生产监督管理总局


国家安全监管总局关于下达2011年安全生产行业标准制修订项目计划的通知

安监总政法〔2011〕63号


各有关单位:

经研究,现将2011年安全生产行业标准制修订项目计划下达给你们,并就有关事项通知如下:

一、各项目承担单位要高度重视,切实加强领导,落实责任。要按照《安全生产标准制修订工作细则》(国家安全监管总局令第9号,以下简称《细则》)的要求,制订标准制修订工作计划,成立标准起草小组,并明确专人负责。

二、全国安标委及各分标委秘书处要加强标准起草工作的管理,及时督促检查项目进展情况。各专业技术委员会要按照《细则》要求,对完成的标准项目抓紧组织审查。

三、要确保标准项目在规定的时间内完成。确因特殊原因不能如期完成的,项目承担单位要及时向全国安标委秘书处或国家安全监管总局政策法规司报告并说明理由。对于未完成的2010年度标准项目计划,各承担单位要抓紧完成。

附件:2011年安全生产行业标准项目计划表
http://www.chinasafety.gov.cn/newpage/Contents/Channel_5330/2011/0506/130288/files_founder_525027311/95171434.xls

国家安全生产监督管理总局

二○一一年五月五日

中华人民共和国海关对保税仓库及所存货物的管理办法(附英文)

海关总署


中华人民共和国海关对保税仓库及所存货物的管理办法(附英文)

1988年4月14日,海关总署

第一条 为了适应对外经济贸易的发展,便利生产、仓储、运输,促进社会主义现代化建设,根据《中华人民共和国海关法》,特制定本办法。
第二条 保税仓库限于存放供来料加工、进料加工复出口的货物,或者暂时存放后再复运出口的货物以及经海关批准缓办纳税手续进境的货物。一般贸易进口货物不允许存入保税仓库。
第三条 保税仓库应具有专门储存、堆放进口货物的安全设施;建立健全的仓储管理制度和详细的仓库帐册;配备经海关培训认可的专职管理人员。保税仓库的经理人应具备向海关缴纳税款的能力。
建立保税仓库应由其经理人持工商行政管理部门颁发的营业执照,填写《保税仓库申请书》,并按规定交验经贸主管部门批准经营有关业务的批件,向海关提出申请,经海关审核并派员实地调查后颁发《保税仓库登记证书》。
第四条 保税仓库对所存的货物,应有专人负责,并于每月的前五天内将上月转存货物的收、付、存等情况列表报送当地海关核查。
保税仓库中不得对所存货物进行加工。如需改变包装、加刷唛码,必须在海关监管下进行。
海关认为必要时,可以会同保税仓库经理人双方共同加锁。海关可以随时派员进入仓库检查货物的储存情况和有关帐册,必要时可派员驻库监管。保税仓库经理人应当为海关提供办公场所和必要的方便条件。
保税仓库经理人应按章交纳监管手续费。
第五条 保税货物在保税仓库所在地海关入境时,货主或其代理人应当填写进口货物报关单一式三份,加盖“保税仓库货物”印章并注明此货物系存入某保税仓库,向海关申报,经海关查验放行后,一份由海关留存、二份随货带交保税仓库。保税仓库经理人应于货物入库后即在上述报关单上签收,一份留存、一份交回海关存查。
货主在保税仓库所在地以外的其他口岸进口货物,应按海关对转关运输货物的规定办理转关运输手续。货物运抵后再按本条第一款的规定办理入库手续。
第六条 保税货物经海关核准转为进入国内市场销售时,由货主或其代理人向海关递交进口货物许可证件、进口货物报关单和海关需要的其他单证并交纳关税和产品(增值)税或工商统一税后,由海关签印放行,将原进口货物报关单注销。
对用于中、外国际航行船舶的保税油料和零备件,以及用于在保修期限内免费维修有关外国产品的保税零备件,免征关税和产品(增值)税或工商统一税。
第七条 对从来料加工、进料加工备料保税仓库提取的货物,货主应事先持批准文件、合同等有关单证向海关办理备案登记手续,并填写来料加工、进料加工专用报关单和《保税仓库领料核准单》一式三份,一份由批准海关备存,一份由领料人留存,一份由海关签盖放行章后交货主。
仓库经理人凭海关签印的领料核准单交付有关货物并凭以向海关办理核销手续。
对提取用于来料加工、进料加工的进口货物,海关按来料加工、进料加工的规定进行管理并按实际加工出口情况确定免税或补税。
第八条 保税货物复运出口时,货主或其代理人应当填写出口货物报关单一式三份并交验进口时由海关签印的报关单,向当地海关办理复运出口手续。经海关核查与实货相符合签印,一份留存,一份发还,一份随货带交出境地海关凭以放行货物出境。
第九条 保税仓库进口供自己使用的货架、办公用品、管理用具、运输车辆,搬动、起重和包装设备以及改装用的机器等,不论是价购的或外商无价提供的,应按规定交纳关税和产品(增值)税或工商统一税。
第十条 保税仓库所存货物储存期限为一年。如因特殊情况可向海关申请延期,但延期最长不得超过一年。保税货物储存期满仍未转为进口也不复运出境的,由海关将货物变卖,所得价款比照《中华人民共和国海关法》第二十一条的规定处理。
第十一条 保税仓库所存货物在储存期间发生短少,除由于不可抗力的原因者外,其短少部分应当由保税仓库经理人承担交纳税款的责任,并由海关按有关规定进行处理。
第十二条 保税仓库经理人如有违反本办法规定的行为或走私行为,由海关按《中华人民共和国海关法》和有关规定进行处理。
第十三条 本办法自一九八八年五月一日起实施。

Administrative Rules of the Customs of the People's Republic ofChina Concerning the Bonded Warehouse and Goods

(Promulgated by the General Administration of Customs of thePeople's Republic of China on April 16, 1988)

Whole Doc.
Article 1
The present rules are hereby formulated in order to meet the
development of foreign economic relations and trade, and facilitate
production, storage and transportation and promote the construction of
socialist modernization in accordance with the Customs Law of the People's
Republic of China.
Article 2
The bonded warehouse is confined to store goods of processing
imported materials and buyer-supplied materials for re-export, or goods of
temporary storage for re-export, and goods permitted by the Customs to
enter the territory and suspend the formality of import duty. Other
imported goods for general trade shall not be allowed to be stored in the
bonded warehouse.
Article 3
The bonded warehouse shall have special security facilities for
storing and piling up the imported goods; shall establish complete
warehouse management system and detailed warehouse account books; shall
provide full-time management personnel trained and approved by the
Customs. The operator of the warehouse shall have ability to pay tax to
the Customs.
When setting up a bonded warehouse, the operator shall fill in the
"Application for Bonded Warehouse Form" with the business license issued
by the administrative bureau for industry and commerce, and shall submit
the document of approval permitting to conduct the relevant businesses
issued by the competent authority of foreign economic relations and trade,
and apply to the Customs. After the on-the-spot investigation and
examination by the Customs, the "Registration Certificate of Bonded
Warehouse" shall be issued.
Article 4
The bonded warehouse shall have full-time personnel in charge of the
storage of the goods, and shall list receipt, delivery and storage of the
stored goods of last month into forms and report them within the first 5
days of each month to the Customs for verification.
The stored goods shall not be processed in the bonded warehouse. If
it is necessary to change the packages or print shipping marks, it shall
be conducted under the Custom's supervision and control.
Considering necessary, the Customs may add locks jointly with the
operator of the bonded warehouse. The Customs may at any time send its
officer into the warehouse to check the storage and relevant account books
of the goods, if necessary, the Customs may send its officer to station in
the warehouse for supervision and control. The operator of the bonded
warehouse shall offer office and necessary convenience for the Customs.
The operator of the bonded warehouse shall pay the fees of the
supervision and control in according to regulations.
Article 5
When the bonded goods enter into the territory through the Customs at
which the bonded warehouse is located, the owner or his agent shall fill
in declaration for imported goods intriplicate, and affix "Goods of Bonded
Warehouse and state the goods will be stored in the specific bonded
warehouse and declare to the Customs. After examination and release by the
Customs, one copy shall be kept for the Customs' record, and other two
copies shall be handed over to the bonded warehouse with the goods. The
operator of the bonded warehouse shall at once sign the declaration after
the receipt of the goods. One copy of the declaration shall be kept for
record, and another copy shall be handed back to the Customs for record.
If the owner imports goods at a port at which the warehouse is not
locate, the owner shall go through the formalities of transportation
between deferent Customs according to the provisions of the Customs. When
the goods arrive at the destination, the owner shall go through the
formality of storage according to the provisions stipulated in Paragraph
One of this Article.
Article 6
When the bonded goods enter the domestic market for sale upon
verification and permission by the Customs, the owner of the goods or his
agent shall submit the licenses of imported goods, the declaration for
imported goods and other necessary documents to the Customs and pay the
customs duty, product (value added) tax and consolidated industrial and
commercial tax, and then the Customs shall release the goods with stamps
on the documents, and shall nullify the original declaration for imported
goods.
The bonded fuel and spare parts used by Chinese or foreign vessels on
international routes and the bonded spare parts used for maintaining
relevant foreign products free of charge relevant foreign products during
the garantee period shall be exempted from the Customs duty, the product
(value added) tax and the consolidated industrial and commercial tax.
Article 7
When the owner wants to take delivery of the goods from the bonded
warehouse of processing import materials and buyer-supplied materials, the
owner shall beforehand go through the Customs formalities of registration
on file with the document of approval contract and relevant documents and
fill in the special declaration for processing imported materials and
buyer-supplied materials the "Release Certificate of the Materials of
Bonded Warehouse" in triplicate. One copy of the release certificate shall
be kept by the approving Customs on file, one copy shall be kept by the
person who draws the materials for records, and one copy shall be sent
over to the owner of the goods with the Customs' stamp of release. The
operator of the warehouse shall deliver the relevant goods based on the
Release Certificate of the Materials with the Customs' stamp on it, and by
it go through the procedure of conciliation to the Customs.
For drawing the imported materials used for processing imported
materials and buyer-supplied materials, the Customs shall administrate
them according to the regulations concerning processing imported materials
and buyer-supplied materials, and decide tax exemption or collection
according to actuarial facts of processing and export.
Article 8
When bonded goods are re-exported, the owner of the goods or his
agent shall fill in the declaration for exported goods in triplicate and
submit the declaration with the Customs' stamp obtained when the goods
were imported for examination, and then go through the Customs formalities
of re-export. After the documents have been examined by the Customs to
tally with the goods, the Customs shall affix on the declaration for
exported goods. One copy of the declaration shall be kept on file, one
copy shall be handed back, and one copy shall be brought with the goods to
the Customs where the goods leave the territory. By it the Customs will
release the goods out of the territory.
Article 9
The goods shelves, office stationery, equipment for management,
transport vehicles, equipment for moving, lifting and packaging and
machines for refitting imported for self-use of the bonded warehouse shall
be collected the Customs duties, the product (value added) tax and the
consolidated industrial and commercial tax according to the regulations,
no matter the equipment were purchased at price or offered free of charge
by foreign businessmen.
Article 10
The duration of the goods stored in the bonded warehouse is one year.
The extension of duration may be applied to the Customs because of special
situations, but the extension shall not exceed one year. The bonded goods
which have not been imported nor re-transported out of the territory after
the duration, shall be sold off by the Customs. The earnings gained from
the sale shall be handled according to the provisions of Article 21 of the
Customs Law of the People's Republic of China.
Article 11
If the goods stored in the bonded warehouse happen to be missing in
the duration, the operator of the bonded warehouse shall take the
liability to pay the taxes for the shortage unless it is due to force
majeure. And the matter shall be dealt with by the Customs according to
relevant regulations.
Article 12
If the operator of the bonded warehouse violates the present rules or
undertakes smuggling, the Customs shall handle the case in accordance with
the Customs Law of the People's Republic of China and the relevant
regulations.
Article 13
These present Rules shall enter into force on May 1, 1988.