关于重申地方药品标准和地方药品批准文号有关问题的函

作者:法律资料网 时间:2024-07-15 23:39:15   浏览:9019   来源:法律资料网
下载地址: 点击此处下载

关于重申地方药品标准和地方药品批准文号有关问题的函

国家食品药品监督管理局


关于重申地方药品标准和地方药品批准文号有关问题的函

食药监注函[2003]68号


各省、自治区、直辖市药品监督管理局:

  为加强药品监督管理,原国家药品监督管理局先后开展了地方药品标准整顿和统一换发药品批准文号等工作,并下发了相关的文件。为便于药品的生产、经营和监督管理,现将有关问题重申如下:

  一、正确理解地方药品标准和地方药品批准文号
  地方药品标准和地方药品批准文号是两个不同的概念。“地方药品标准”是指各省级药品监督管理部门批准颁布的药品质量标准。1985年施行的《药品管理法》允许有地方药品标准存在;2001年12月1日施行修订的《药品管理法》则取消了地方药品标准。“地方药品批准文号”是指各省级药品监督管理部门核发的药品批准文号(如“粤卫药准字(1994)第XXXXXX号”)。使用地方药品批准文号的药品,有的执行地方标准,也有的执行国家标准。

  二、按照地方标准生产药品的使用期限
  按照修订的《药品管理法》取消地方药品标准的要求,国家药品监督管理局开展了地方药品标准整顿工作。地方药品标准整顿是对执行地方标准的药品进行医学药学再评价,审核通过后颁布国家药品标准。按照地方标准生产药品的使用期限,根据《国务院办公厅关于施行〈药品管理法〉有关药品标准延期执行问题的复函》(国办函〔2001〕68号)的精神,原国家药品监督管理局2003年3月25日印发的《关于妥善处理地方标准品种问题的通知》(国药监注〔2003〕96号)作出了规定:

  (一)未纳入国家药品标准管理的地方药品标准品种应立即停止生产、销售和使用。

  (二)已纳入国家药品标准管理的原地方药品标准品种,有关药品生产企业应按我局颁布的国家药品标准组织生产;尚未换发批准文号的,可以使用原地方批准文号。按照国家药品标准生产的药品,可以在药品的有效期内流通和使用。

  (三)已纳入国家药品标准管理的原地方药品标准品种,按照原地方药品标准生产的药品,可流通和使用至2003年12月31日。

  三、地方药品批准文号的使用期限
  为加强药品管理,规范医药经济秩序,保证人民群众用药安全有效,促进医药产业健康发展,国家药品监督管理局开展了统一换发批准文号工作。该项工作是对国家标准药品和已纳入国家标准管理的原地方标准药品,统一换发“国药准字”批准文号。使用地方批准文号药品的使用期限,原国家药品监督管理局2002年4月29日印发的《关于药品包装标签和说明书使用期限的公告》(国药监注〔2002〕156号)规定:

  (一)药品生产企业应在批准文号换发通知后6个月内完成新旧包装标签和说明书的更换工作。在批准文号换发6个月后生产的药品不得再使用原包装标签和说明书,此前已进入流通领域的药品,可在其有效期内继续流通、使用。
  因此,国家药品批准文号和地方药品批准文号在今后的一段时间内将会并存。

  (二)尚未换发批准文号的药品,除不符合国家有关规定的品种外,可以使用原药品批准文号。

  四、近期,有企业反映,医院、药品经营企业盲目向生产企业退回地方标准药品和地方批准文号药品,希望医院、药品经营企业按照上述规定执行,避免盲目退货造成的不必要损失。


                     国家食品药品监督管理局药品注册司
                        二○○三年八月十四日

下载地址: 点击此处下载

文化部因公出国机票管理试行办法

文化部


文化部因公出国机票管理试行办法
1998年8月21日,文化部


一、为加强文化部因公出国(出境,含赴港澳台,下同)机票管理,根据财政部、中国民用航空总局《关于加强因公出国机票管理的通知》(财外字〔1998〕283号),制定本试行办法。
二、文化部组派的因公临时派出团组和个人出国,文化部及其所属部门提供机票的来华人员来华,以及文化部常驻国外人员赴任及其配偶初次出国探亲适用本试行办法。
三、文化部护照签证主管部门负责按照文化部因公派出任务批件的规定,审核出国路线和时限,并填写国际机票订购通知单送文化部机票订购部门。
文化部机票订购部门负责按国际机票订购通知单要求订购国际机票,出票后,送文化部护照签证主管部门审核。
因签证等问题需要改变因公临时出国团组和个人航班及日期,文化部护照签证主管部门应及时通知文化部机票订购部门更改航班和日期;因航班问题确需变更因公临时出国行程,文化部机票订购部门应及时通知文化部护照签证主管部门重新审核行程。
四、因公出国团组和个人,应按规定到文化部护照签证主管部门办理国际机票订购事宜。由文化部护照签证主管部门按照文化部因公派出任务批件规定的出国路线和时限,通知文化部机票订购部门到规定的航空公司统一订购国际机票。
因公临时出国团组人员较多的,可在“项目批复件”下达后,及时到文化部护照签证主管部门统一办理订票手续。
常驻国外人员赴任及其配偶初次出国探亲,须凭文化部人事管理部门开具的赴任、初次出国探亲通知,按外交部规定的出国路线到文化部护照签证主管部门办理订票手续。
五、因情况特殊,并经规定的航空公司核准确需购买外航国际机票的,须凭其开具的“因公出国人员购买外航机票证明”,由文化部机票订购部门按规定统一订购。
六、经文化部批准,由各省、自治区、直辖市组派的因公临时出国文化团组,按照所在地区制定的因公出国机票管理办法统一订购机票。
七、航空公司出票后,因公出国团组或个人因工作需要更改航班日期或退票时,由文化部机票订购部门在所订航班起飞前,到原售票地点办理更改日期或退票手续。
出国团组或个人在出访期间,因特殊原因没有使用所购机票,回国后须退票的,由文化部机票订购部门到原售票地点办理退票手续,并将退票支票交回组团单位财务部门。
出国团组或个人因个人原因没有在规定时间内办理退票手续,其退票费用由团组或个人自行负担。
八、出国团组或个人可对航空公司在办理国际机票手续和出访过程中,因服务质量引发的各类问题进行投诉,并将投诉情况通报文化部护照签证主管部门。
九、本试行办法由文化部对外文化联络局负责解释。
十、本试行办法自发布之日起试行。


国家税务总局关于境外团体或个人在我国从事文艺及体育演出有关税收问题的通知(附英文)

国家税务总局


国家税务总局关于境外团体或个人在我国从事文艺及体育演出有关税收问题的通知(附英文)
国家税务总局



各省、自治区、直辖市、计划单列市税务局、文化厅(局)、体委:
一九九三年九月二十日我局与文化部、国家体委联合下发了国税发〔1993〕089号《关于来我国从事文艺演出及体育表演收入应严格依照税法规定征税的通知》,现对外国及港、澳、台地区团体或个人在我国(大陆)从事文艺演出和体育表演所取得收入征税的具体政策业务问题
,明确如下:
一、外国或港、澳、台地区演员、运动员以团体名义在我国(大陆)从事文艺、体育演出,对该演出团体及其演员或运动员个人取得的收入,应按照以下规定征税:
(一)对演出团体应依照《中华人民共和国营业税暂行条例》(以下简称营业税暂行条例)的有关规定,以其全部票价收入或者包场收入减去付给提供演出场所的单位、演出公司或经纪人的费用后的余额为营业额,按3%的税率征收营业税。
(二)演出团体凡能够提供完整、准确费用支出凭证的,依照《中华人民共和国外商投资企业和外国企业所得税法》(以下简称企业所得税法)的有关规定,应对演出团体的收入总额减除实际支出的费用后的余额,按30%的税率征收企业所得税,并按3%的税率征收地方所得税;对
演出团体实际支付给演员或运动员个人的报酬部分,依照《中华人民共和国个人所得税法》(以下简称个人所得税法)的有关规定征收个人所得税。
(三)演出团体不能提供完整、准确的费用支出凭证,不能正确计算应纳税所得额的,在计算征收企业所得税时,根据企业所得税法实施细则第十六条规定的原则,应以其收入总额减除支付给演员、运动员个人的报酬部分和相当于收入总额30%的其他演出费用后的余额,依照企业所
得税法规定的税率征收企业所得税和地方所得税;对上述支付给演员、运动员个人的报酬部分,依照个人所得税法的规定,由演出团体支付报酬时代扣代缴个人所得税。对没有申报支付给演员、运动员个人报酬额的或未履行代扣代缴义务的,应以其收入总额减除上述相当于收入总额30%
的其他演出费用的余额视为该演出团体的应纳税所得额,依照企业所得税法计算征收企业所得税和地方所得税。对演员或运动员个人不再征收个人所得税。
(四)对本条第(二)、(三)款中所述演出团体支付给演员、运动员个人的报酬,凡是演员、运动员属于临时聘请,不是该演出团体雇员的,应依照个人所得税法的规定,按劳务报酬所得,减除规定费用后,征收个人所得税;凡是演员、运动员属该演出团体雇员的,应依照个人所得
税法的规定,按工资、薪金所得,减除规定费用后,征收个人所得税。
二、对外国或港、澳、台地区演员、运动员以个人名义在我国(大陆)从事演出、表演所取得的收入,应以其全部票价收入或者包场收入减去支付给提供演出场所的单位、演出公司或者经纪人的费用后的余额为营业额,依3%的税率征收营业税;依照个人所得税法的有关规定,按劳务
报酬所得征收个人所得税。
三、对演出团体或个人应向演出所在地主管税务机关申报缴纳应纳税款的,具体可区别以下情况处理:
(一)演出团体及个人应缴纳的营业税,应以其在一地的演出收入,依照营业税暂行条例的有关规定,向演出所在地主管税务机关申报缴纳。
(二)演出团体应缴纳的企业所得税和地方所得税,应以其在一地的演出收入,依照企业所得税法及其实施细则和本通知的有关规定,计算应纳税所得额及税款,并向演出所在地主管税务机关申报缴纳。按本通知第一条第二款所述依实际费用支出计算纳税的演出团体,在全部演出活动
结束后,可在与其签订演出合同的中方接待单位所在地主管税务机关,办理企业所得税结算手续。
(三)演员、运动员个人应缴纳的个人所得税,应以其在一地演出所得报酬,依照个人所得税法的有关规定,在演出所在地主管税务机关申报缴纳。属于劳务报酬所得的,在一地演出多场的,以在一地多场演出取得的总收入为一次收入,计算征收个人所得税。
(四)主管税务机关可以指定各承包外国、港、澳、台地区演出、表演活动的演出场、馆、院或中方接待单位,在其向演出团体、个人结算收入中代扣代缴该演出团体或个人的各项应纳税款。凡演出团体或个人未在演出所在地结清各项应纳税款的,其中方接待单位应在对外支付演出收
入时代扣代缴该演出团体或个人所欠应纳税款。对于未按本通知有关规定代扣代缴应纳税款的单位,应严格依照《中华人民共和国税收征收管理法》的规定予以处理。
四、各中方接待单位在对外签订演出或表演合同后的七日内,应将合同、资料报送各有关演出、表演活动所在地主管税务机关,对于逾期不提供合同资料的,可依照企业所得税法及有关法规予以处理。
本通知自文到之日起执行。

CIRCULAR ON THE QUESTION CONCERNING TAX ON ARTISTIC AND SPORT PER-FORMANCES GIVEN BY OVERSEAS TROUPES OR INDIVIDUALS IN CHINA

(State Administration of Taxation: 21 April 1994 Coded Guo Shui Fa[1994] No. 106)

Whole Doc.

To the tax bureaus of various provinces, autonomous regions and
municipalities and cities with independent planning, to cultural
departments (bureaus) and to State Commission for Physical Culture and
Sports:

The Circular Concerning the Levy of Tax Strictly in Accordance With
the Stipulations of the Tax Law on the Incomes Gained From Artistic and
Sports Performances Given in China, was issued on September 20, 1993
jointly by our Administration, the Ministry of Culture and the State
Commission for Sports and Physical Culture, a document Coded Guo Shui Fa
[1993] No. 089. The concrete policy-related business questions concerning
tax levied on the incomes gained from artistic and sports performances
staged in China (Chinese Mainland) by troupes or individuals coming from
abroad and from the regions of Hong Kong, Macao and Taiwan are hereby
clarified as follows:

I. For performers and athletes from abroad or from the regions of
Hong Kong, Macao and Taiwan who stage artistic and sports performances in
China (Chinese mainland) in the name of organization; tax shall be levied
on the incomes gained by art troupes and their performers or by individual
athletes in accordance with the following stipulations:
(1) In line with the related stipulations of the Provisional
Regulations of the People's Republic of China Concerning Business Tax
(hereinafter referred to as Provisional Regulations Concerning Business
Tax), after subtracting the expenses paid to the units, performing
companies or brokers who provide performing venus from all income gained
from ticket price or from booking the whole theatre or stadium, the
balance shall be regarded as the business volume on which business tax is
levied at a 3 percent rate.
(2) For performing troupes which can provide complete and accurate
certificates showing their outlay of expenses, according to the related
stipulations of the Income Tax Law of the People's Republic of China on
enterprise with foreign investment and Foreign Enterprises (hereinafter
referred to as Enterprise Income Tax Law), enterprise income tax shall be
levied at a 30 percent rate on the balance of the performing troupes'
total income amount after subtracting the expenses actually paid and local
income tax shall be levied at a 3 percent rate; individual income tax
shall be levied on the remuneration actually paid by the performing
troupes to individual performers or athletes in accordance with the
related stipulations of the Individual Income Tax Law of the People's
Republic of China (hereinafter referred to as Individual Income Tax Law).
(3) For performing troupes which cannot provide complete and accurate
certificates showing the outlay of expenses and cannot correctly calculate
the amount of taxable income, while calculating and levying enterprise
income tax, in accordance with the principle stipulated in Article 16 of
the Detailed Rules for the Implementation of the Enterprise Income Tax
Law, enterprise income tax and local income tax shall be levied at the tax
rate stipulated in the Enterprise Income Tax Law on the balance of their
total income amount after subtracting the remuneration paid to individual
performers and athletes and other performing expenses equivalent to 30
percent of the total income value; with regard to the remuneration paid to
individual performers and athletes as mentioned above, individual income
tax shall be withheld by the performing troupe when it pays the
remuneration in accordance with the stipulations as set in the Individual
Income Tax Law, with regard to performing troupes which have not declared
the amount of payments of remuneration to individual performers and
athletes or fail to fulfill the withholding obligations, the balance of
their total income value after subtracting other performing expenses
equivalent to 30 percent of the total value of income as mentioned above
should be regarded as the amount of payable income of that performing
troupe, enterprise income tax and local income tax shall be calculated and
levied in accordance with the Enterprise Income Tax Law. No more
individual income tax shall be levied on individual performer or athletes.

(4) In regard to the remunerations paid by the performing troupe as
mentioned in Clauses 2 and 3 of this Article to individual performers and
athletes, the performers and athletes who are invited temporarily and are
not employees of the performing troupe, individual income tax shall be
levied on the income from labor service remuneration after subtracting the
prescribed expenses in accordance with the stipulations of the Individual
Income Tax Law; for performers and athletes who belong to employees of the
performing troupe, individual income tax shall be levied on the wage and
salary incomes after subtracting the prescribed expenses in accordance
with the stipulations of the Individual Income Tax Law.

II. For the incomes gained from performances staged in China (Chinese
Mainland) by performers or athletes from abroad or from Hong Kong, Macao
and Taiwan in personal name, the balance of incomes from all ticket price
or from booking whole theatre or venues after subtracting the expenses
paid to units, performing companies or brokers who provide performing
venus is regarded as the business volume on which business tax shall be
levied at a 3 percent rate; in line with the related stipulations of the
Individual Income Tax Law, individual income tax shall be levied on the
income from labor service remunerations.

III. With regard to performing troupes or individuals who should
declared payments of payable tax to competent tax authorities in the
location where performances are staged, the matter shall be dealt with
concretely in accordance with the following different situations:
(1) Performing troupe and individuals shall pay business tax, they
shall declare payment of business tax to the competent tax authorities in
the location where performances are staged on the income from performances
staged at one locality in accordance with related stipulations of the
Provisional Regulations on Business Tax.
(2) For the enterprise income tax and local income tax which the
performing troupe should pay, the amount of taxable income and tax payment
are calculated on the basis of the income from performances staged in one
locality in accordance with the related stipulations of the Enterprise
Income Tax Law and the Detailed Rules for its Implementation and this
Circular, the performing troupe shall declare tax payment to competent tax
authorities at the location where performances are staged. The performing
troupe which calculates tax payment on the basis of the outlay of actual
expenses as mentioned in Clause 2 of Article 1 of this Circular shall,
after the end of all performing activities, perform the procedures for
settlement of enterprise income tax with the competent tax authorities at
the location of Chinese reception unit with whom it signs the performing
contract.
(3) For the individual income tax which performers and athletes
should pay, they shall declared tax payment with competent tax authorities
at the location where performances are staged in accordance with the
related stipulations of the Individual Income Tax Law for the
remunerations gained from performances given at one locality. For income
belonging to labor service remuneration and performances staged on several
occasions at one locality, the total income gained from performances given
on several occasions at one locality is regarded as a lump sum income on
which individual income tax is calculated and levied.

(4) Competent tax authorities can designate various venues, halls,
theatres or Chinese reception units to contract to provide spaces for the
performing activities staged by performing troupes or individuals from
abroad, or from Hong Kong, Macao and Taiwan, they should withhold various
payable taxes for the performing troupes or individuals from the incomes
settled with these troupes and individuals. If the performing troupes or
individuals who have not yet cleared off various payable taxes in the
locality where performances are staged, when paying for the income from
performances to other units, the Chinese reception units should withhold
the payable tax owed by the performing troupes or individuals. Units which
fail to withhold the payable tax in accordance with the related
stipulations of this Circular shall be dealt with strictly in accordance
with the stipulations of the Tax Collection and Management Law of the
People's Republic of China.

IV. Various Chinese reception units shall, within seven days after
signing performance contracts with units from outside, send the contracts
and materials to competent tax authorities at the location where
performing activities are staged, those who fail to provide contracts and
materials by exceeding the time limit shall be dealt with in accordance
with the Enterprise Income Tax Law and related regulations.
This Circular goes into effect from the day of receipt of the
document.



1994年4月21日