国家食品药品监督管理局关于施行行政许可项目的公告

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国家食品药品监督管理局关于施行行政许可项目的公告

国家食品药品监督管理局


国家食品药品监督管理局关于施行行政许可项目的公告

国食药监法[2004]504号


  为贯彻实施《中华人民共和国行政许可法》,现将国家食品药品监督管理局负责组织施行的行政许可项目公告如下:

  一、根据《中华人民共和国药品管理法》、《中华人民共和国食品卫生法》、《中华人民共和国招投标法》等法律的设定,共实施下列18项行政许可:
  1.新药证书核发
  2.药品临床试验批准
  3.进口药品(含进口药材)注册证书核发
  4.直接接触药品的包装材料和容器审批
  5.《进口药品通关单》核发
  6.药品委托生产批准
  7.刊登处方药专业刊物审批
  8.保健食品审批
  9.医疗机构配制、调剂制剂批准
  10.药品经营质量管理规范(GSP)认证
  11.药品生产、经营许可证核发
  12.医疗机构制剂许可证核发
  13.新药或者已有国家标准的药品生产批准
  14.药品生产质量管理规范(GMP)认证
  15.药物临床试验机构资格认定
  16.药品招标代理机构资格认定
  17.药品广告审查
  18.保健食品检验机构资格认定

  二、根据《中华人民共和国药品管理法实施条例》、《中华人民共和国医疗器械监督管理条例》、《反兴奋剂条例》、《麻醉药品管理办法》、《精神药品管理办法》、《医疗用毒性药品管理办法》、《放射性药品管理办法》、《中药品种保护条例》、《药品行政保护条例》、《中华人民共和国互联网信息服务管理办法》等行政法规的设定,共实施下列37项行政许可:
  1.医疗器械临床试验机构资格认定
  2.新药试行标准转正审查
  3.(港澳台)医药产品注册
  4.药品补充申请审核
  5.国家规定的生物制品销售前或进口时检验或审核
  6.药品(含进口药品、港澳台医药产品)再注册
  7.首次进口医疗器械产品注册
  8.医疗器械新产品证书核发
  9.医疗器械检测机构资格认可
  10.部分第三类医疗器械强制性安全认证
  11.麻醉药品研制立项批准
  12.麻醉药品(含药用植物、复方制剂)种植、生产、收购计划核准
  13.麻醉药品(含第一类精神药品)制剂经营企业审批
  14.放射性药品研制立项备案
  15.放射性药品生产、经营企业许可证核发
  16.精神药品原料药经营企业批准
  17.麻醉药品和精神药品生产定点单位批准
  18.麻醉药品和精神药品进出口审批
  19.国产医疗器械注册
  20.第二、三类医疗器械产品临床试用(验证)批准
  21.第二、三类医疗器械生产、经营企业许可证核发
  22.麻醉药品、第一类精神药品购用证明核发
  23.放射性药品使用许可证核发
  24.第二类精神药品制剂经营企业批准
  25.药用罂粟壳经营企业批准
  26.药用罂粟壳购进计划审核
  27.医疗用毒性药品的收购、经营单位批准
  28.癌症病人麻醉药品专用卡核发单位审批
  29.中药保护品种证书核发
  30.医疗器械广告审查
  31.互联网药品、医疗器械信息服务审核
  32.蛋白同化制剂、肽类激素境外委托生产备案
  33.蛋白同化制剂、肽类激素出口许可证审批
  34.蛋白同化制剂、肽类激素批发企业审批
  35.蛋白同化制剂、肽类激素进口许可证审批
  36.药品行政保护
  37.科研和教学所需毒性药品购用审批

  三、根据《国务院对确需保留的行政审批项目设定行政许可的决定》(国务院令第412号)的设定,共实施下列12项行政许可:
  1.精神药品研制立项审批
  2.麻黄素类产品和单方制剂生产计划核准
  3.麻黄素类产品和单方制剂购用凭证核发
  4.生产、经营麻黄素审批
  5.麻黄素出口购用证明核发
  6.咖啡因和氯胺酮原料药购用证明核发
  7.中药材生产质量管理规范(GAP)认证
  8.药物非临床研究质量管理规范(GLP)认证
  9.互联网药品交易服务企业审批
  10.执业药师注册
  11.药用辅料注册
  12.保健食品广告审查


                         国家食品药品监督管理局
                          二○○四年十月十四日



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国家林业局关于做好灾区重建征占用林地服务工作的紧急通知

国家林业局


国家林业局文件

林资发[2008]34号


国家林业局关于做好灾区重建征占用林地服务工作的紧急通知

江苏、浙江、安徽、福建、江西、河南、湖北、湖南、广东、广西、海南、重庆、四川、贵州、云南、陕西、甘肃、青海、新疆省、自治区、直辖市林业厅(局):
为贯彻落实国务院关于认真做好灾区重建工作的要求,切实发挥林业部门在灾区重建涉及征占用林地过程中的服务作用,现就有关灾区重建征占用林地服务工作通知如下:
一、对修建抢险救灾急需或灾毁的输电设施、交通设施等征占用林地项目(含临时占用林地,下同),可以先行使用林地;重建灾毁民房确需征占用林地的,根据有关规划、宅基地建房标准和当地政府的统一安排,可以先行使用林地。对修筑救灾或灾毁的直接为林业生产服务的森林防火、森林病虫害防治、野生动植物保护、种苗生产及林区供水、供电等工程设施,确需使用林地的,可以先行使用。
二、对于灾情特别严重的省(含自治区、直辖市),省级林业主管部门要合理分配2008年度征占用林地定额指标,对抢险救灾工程征占用林地的,要优先保证使用林地。因灾害原因确需增加2008年度征占用林地定额指标的,省级林业主管部门要组织对增加的定额指标进行认真测算、论证,及时提出申请,经我局派驻森林资源监督机构审核同意后,报我局审定。
三、建设单位应在灾毁设施建成后6个月内申请补办征占用林地审核(批)手续。地方各级林业行政主管部门,要积极主动地做好征占用林地审核(批)的服务、指导和监督等相关工作,保障抗灾重建及时使用林地,同时,对先行使用林地的救灾工程项目要严格把关,严防发生非救灾工程借机搭车先行使用林地的现象。
我局各有关派驻森林资源监督机构要同省级林业主管部门密切配合,加强对救灾重建工程使用林地的实施情况进行服务、指导和监督。
特此通知。

                                国家林业局
                             二OO八年二月二十六日

国家税务总局关于境外所得征收个人所得税若干问题的通知(附英文)

国家税务总局


国家税务总局关于境外所得征收个人所得税若干问题的通知(附英文)
国家税务总局



各省、自治区、直辖市税务局,各计划单列市税务局,海洋石油税务管理局各分局:
为维护国家税收权益,根据《中华人民共和国个人所得税法》及其实施条例的有关规定,现对境外所得征收个人所得税若干问题通知如下:
一、关于纳税申报期限问题
纳税人来源于中国境外的应税所得,在境外以纳税年度计算缴纳个人所得税的,应在所得来源国的纳税年度终了、结清税款后的三十日内,向中国税务机关申报缴纳个人所得税;在取得境外所得时结算税款的,或者在境外按来源国税法规定免予缴纳个人所得税的,应在次年一月一日起
三十日内向中国税务机关申报缴纳个人所得税。纳税人兼有来源于中国境内、境外所得的,应分别申报计算纳税。
二、关于境外代扣代缴税款问题
纳税人任取或受雇于中国的公司、企业和其他经济组织或单位派驻境外的机构的,可由境外该任职、受雇机构集中申报纳税,并代扣代缴税款。
三、关于纳税申报方式问题
纳税人在规定的申报期限内不能到主管税务机关申报纳税的,应委托他人申报纳税或者邮寄申报纳税。邮寄申报纳税的,以寄出地的邮戳日期为实际申报日期。
四、境外所得税款抵扣举例
某纳税人1994年1月至12月在A国取得工薪收入60000元(人民币,下同),特许权使用费收入7000元;同时,又在B国取得利息收入1000元。该纳税人已分别按A国和B国税法规定,缴纳了个人所得税1150元和250元。其抵扣计算方法如下:
(一)在A国所得缴纳税款的抵扣
1.工资、薪金所得按我国税法规定计算的应纳税额:
60000
{(───────── -4000)×税率-速算扣除数}×12(月份数)
12
=(1000×10%-25)×12=900元

2.特许权使用费所得按我国税法规定计算的应纳税额:
7000×(1-20%)×20%(税率)=1120元
3.抵扣限额:
900+1120=2020元

4.该纳税人在A国所得税缴纳个人所得税1150元,低于抵扣限额,因此,可全额抵扣,并需在中国补缴税款870元(2020-1150)。
(二)在B国所得缴纳税款的抵扣
其在B国取得的利息所得按我国税法规定计算的应纳税额,即抵扣限额:1000×20%(税率)=200元该纳税人在B国实际缴纳的税款超出了抵扣限额,因此,只能在限额内抵扣200元,不用补缴税款。
(三)在A、B两国所得缴纳税款抵扣结果
根据上述计算结果,该纳税人当年度的境外所得应在中国补缴个人所得税870元,B国缴纳税款未抵扣完的50元,可在以后五年内该纳税人从B国取得的所得中的征收抵扣限额有余额时补扣。
五、本通知自一九九四年一月一日起施行。

CIRCULAR ON SOME QUESTIONS CONCERNING THE LEVY OF INDIVIDUAL IN-COME TAX ON INCOME EARNED FROM ABROAD

(State Administration of Taxation: 8 March 1994 Coded Guo Shui Fa[1994] No. 044)

Whole Doc.

To the tax bureaus of various provinces, autonomous regions and
municipalities, to the tax bureaus of various cities with independent
planning, and to various sub-bureaus of the Offshore Oil Tax
Administration:
In order to safeguard the state's taxation rights and interests, and
in accordance with the related stipulations of the Law of the People's
Republic of China on Individual Income Tax and the Regulations for Its
Implementation, the Circular on Some Questions Concerning the Levy of
Individual Income Tax on Income Earned From Abroad is hereby given as
follows:

I. Question concerning the declaration time limit for tax payment
For the taxable income earned from outside China and the individual
income tax is calculated and paid on the tax-paying year abroad, the tax
payer shall, within 30 days after the end of the tax-paying year and the
clearing of taxes in the country where the income is earned, declare to
China's tax authorities and pay individual income tax; those who settle
the account of tax when income is earned from abroad, or the individual
income tax is exempt abroad in accordance with the stipulations of the tax
law of the country where the income is earned shall, with in 30 days from
January 1 of the following year, declare to China's tax authorities and
pay individual income tax. A tax payer who has income earned from both
inside and outside China shall respectively declare, calculate and pay
tax.

II. Question concerning withholding taxes abroad
For a tax payer who holds a post in or is hired by a Chinese company,
or enterprise, another economic organization or unit which sends him to an
overseas organization, the overseas organization where he holds a post or
is hired shall declare tax payment together and withhold the tax.

III. The question concerning declaration method for tax payment
A tax payer who is unable to declare tax payment at the competent tax
authorities within the specified declaration time limit shall entrust
someone with declaration on tax payment or mail the declaration on tax
payment. For a mailed declaration on tax payment, the local postmark day
on which the mail is sent out is taken as the actual day of declaration.

IV. Examples for the deduction of overseas income tax
A tax payer who earned salary income of 60000 yuan (the same below)
in A country from January to December 1994, and income from royalties of
7000 yuan; at the same time he earned 1000 yuan income from interest in B
country. In accordance with the stipulations of the tax laws of A country
and B country, the tax payer has paid 1150 yuan and 250 yuan in individual
income tax, the method for calculating deduction follows:
(1) Deduction of tax paid for the income earned in A country
The amount of payable tax calculated in accordance with the
stipulations of China's Tax Laws on the income earned from wages and
salaries:

60000 quick calculation
{(-------- - 4000) X tax rate - deducted amount } X 12 (months)
12

= (1000 X 10% - 25) X 12 = 900 yuan

2. The payable amount of tax calculated in accordance with the
stipulations of China's Tax Laws on the income earned from royalties:

7000 X (1 - 20%) X 20% (tax rate) = 1120 yuan

3. Deducted quota:

900 + 1120 = 2020 yuan

4. The tax payer pays 1150 yuan of individual income tax on the
income earned in A country, which is lower than the deducted quota,
therefore, it can be fully deducted and the tax payer shall repay 870 yuan
of tax in China (2020 - 1150).
(2) Deduction of tax paid for the income earned from B country
The payable amount of tax calculated according to the
stipulations of China's Tax Laws on the income gained from interest
in B country, that is the deduction quota:

1000 x 20% (tax rate) = 200 yuan

The actual tax paid by the tax payer in B country exceeds the
deduction quota, therefore, only 200 yuan can be deducted from within the
quota, and no more back duty is required.
(3) Deduction result of tax payment for the income earned from
A and B countries In accordance with the above-mentioned calculation
result, the tax payer shall repay 870 yuan of individual income tax in
China on the income he earns from abroad in the current year, the 50 yuan
which has not been deducted from the tax paid in B country can be
re-deducted from the balance of the deduction quota of the tax levied on
the income gained by the tax payer from the B country within the
subsequent five years.

V. This Circular goes into effect on January 1, 1994.



1994年3月8日