关于执行药品GMP认证办法有关事宜的通知
国家药监局
关于执行药品GMP认证办法有关事宜的通知
国药监安[2003]110号
各省、自治区、直辖市药品监督管理局：
为贯彻落实2003年全国药品安全监管工作会议精神，切实加强药品GMP认证管理，依法做好认证工作，现就执行《药品生产质量管理规范认证管理办法》（国药监安〔2002〕442号）有关事宜通知如下：
一、各级药品监管部门要认真做好开展药品GMP认证的各项准备工作，并在组织实施认证前，将药品GMP认证的工作方案等详细情况报我局。自各省、自治区、直辖市药品监督管理局正式开展药品GMP认证工作之日起，我局将不再受理该省（区、市）所辖企业提出的规定类别或剂型的GMP认证申请。
二、已开展药品GMP认证的省、自治区、直辖市药品监督管理局，应按月制订认证工作计划，并于每月的28日前将下月的认证工作计划（包括企业名称、受理编号、认证范围、现场检查时间、检查员名单等）以传真或电子邮件形式发送至我局安全监管司。传真号码：（010）88363227。电子邮件地址：Xiao@sda.gov.cn。
三、为保证药品GMP认证的科学性和公正性，增加透明度，同时便于社会监督，我局决定对药品GMP认证企业进行统一公告，并实行事前公告审查制度。凡经国家药品监督管理局或省、自治区、直辖市药品监督管理局认证通过的药品GMP认证企业，在向企业发放《药品GMP证书》前，均由我局预先在国家药品监督管理局网站（网址：WWW.sda.gov.cn）向社会发布“药品GMP认证审查公告”。公告发布10日后，对无异议的企业，由我局在国家药品监督管理局网站和《中国医药报》同时发布“药品GMP认证公告”，并由国家药品监督管理局或省、自治区、直辖市药品监督管理局颁发《药品GMP证书》；对有异议的企业，我局将组织调查，在调查期间暂缓发布公告和颁发《药品GMP证书》。
“药品GMP认证审查公告”定期发布，每月1日和15日发布两次（遇有节假日顺延）。请各省、自治区、直辖市药品监督管理局将已通过本省、自治区、直辖市GMP认证的企业情况（包括企业名称、证书编号、认证范围、现场检查时间、审批日期、检查员名单等）及时报我局安全监管司，以便统一发布公告。
四、根据《药品管理法》及《药品管理法实施条例》的规定，由国家药品监督管理局和由省、自治区、直辖市药品监督管理局颁发的《药品GMP证书》具有同等法律效力，各有关部门在药品价格、招标采购及监督管理等活动中应予以同等对待。
五、我局将组织对各省、自治区、直辖市药品监督管理局认证工作进行检查和指导，并将采取派遣观察员参加认证现场检查工作和对认证情况进行抽查等方式，随时发现和处理认证工作中存在的问题，以确保认证工作质量。
六、关于省、自治区、直辖市药品监督管理局药品GMP认证收费标准问题，我局已报国务院有关部门核定。为保证该项工作的正常开展，在国家收费标准出台前，各地可结合本地情况报经当地政府及有关部门同意后，参照《国家计委、财政部关于调整药品生产质量管理规范（GMP）认证收费标准的通知》（计价格〔2001〕904号）的规定收取认证费用。
国家药品监督管理局
二○○三年三月二十四日
开采海洋石油资源缴纳矿区使用费的规定(附英文)
财政部
开采海洋石油资源缴纳矿区使用费的规定(附英文)
(1988年12月5日国务院批准 1989年1月1日财政部令第1号发布)
第一条 为促进国民经济的发展，扩大国际经济技术合作，鼓励开发我国海洋石油资源，根据《中华人民共和国对外合作开采海洋石油资源条例》，制定本规定。
第二条 在中华人民共和国内海、领海、大陆架及其他属于中 华人民共和国行使管辖权的海域内依法从事开采海洋石油资源的中国企业和外国企业，应当依照本规定缴纳矿区使用费。
第三条 矿区使用费按照每个油、气田日历年度原油或者天然气总产量计征，矿区使用费费率如下：
（一）原油
年度原油总产量不超过100万吨的部分，免征矿区使用费；
年度原油总产量超过一百万吨至150万吨的部分，费率为4％；
年度原油总产量超过150万吨至200万吨的部分，费率为6％；
年度原油总产量超过200万吨至300万吨的部分，费率为8％；
年度原油总产量超过300万吨至400万吨的部分，费率为10％；
年度原油总产量超过400万吨的部分，费率为12．5％。
（二）天然气
年度天然气总产量不超过20亿立方米的部分，免征矿区使用费；
年度天然气总产量超过20亿立方米至35亿立方米的部分，费率为1％；
年度天然气总产量超过35亿立方米至50亿立方米的部分，费率为2％；
年度天然气总产量超过50亿立方米的部分，费率为3％。
第四条 原油和天然气的矿区使用费，均用实物缴纳。
第五条 原油和天然气的矿区用使用费，由税务机关负责征收管理。
中外合作油、气田的矿区使用费，由油、气田的作业者代扣，交由中国海洋石油总公司负责代缴。
第六条 矿区使用费按年计算，分次或分期预缴，年度终了后汇算清缴。预缴期限和汇算清缴期限，由税务机关确定。
第七条 油、气田的作业者应当在每一季度终了后10日内向税务机关报送油、气田的产量，以及税务机关所需要的其他有关资科。
第八条 矿区使用费的代扣义务人和代缴义务人，必须按照税务机关确定的期限缴纳矿区使用费。逾期缴纳的，税务机关从逾期之日起，按日加收滞纳矿区使用费的1‰的滞纳金。
第九条 油、气田的作业者违反第七条的规定，不按期向税务机关报送油、气田的实际产量和税务机关所需其他有关资科的，税务机关可酌情处以人民币5000元以下的罚款；隐匿产量的，除追缴应缴纳的矿区使用费外，可酌情处以应补缴矿区使用费5倍以下的罚款。
第十条 本规定下列用语的含义是：
（一）原油：指在自然状态下的固态和液态烃，也包括从天然气中提取的除甲烷（ＣＨ4）以外的任何液态烃。
（二）天然气：指在自然状态下的非伴生天然气及伴生天然气。
非伴生天然气：指从气藏中采出的所有气态烃包括湿气、干气，以及从湿气中提取液态烃后的剩余气体。
伴生天然气：指从油藏中与原油同时采出的所有气态烃，包括从中提取液态烃后的剩余气体。
（三）年度原油总产量：指合同区内每一个油、气田在每一日历年度内生产的原油量，扣除石油作业用油和损耗量之后的原油总量。
（四）年度天然气总产量：指合同区每一个油、气田在每一日历年度内生产的天然气量，扣除石油作业用气和损耗量之后的天然气总量。
第十一条 本规定自1989年1月1日起施行。(附英文)
PROVISIONS CONCERNING THE PAYMENT OF ROYALTIES FOR THE EXPLOITA-TION OF OFFSHORE PETROLEUM RESOURCES
(Approved by the State Council on December 5, 1988, promulgated byDecree No. 1 of the Minister of Finance on January 1, 1989)
Important Notice: (注意事项)
英文本源自中华人民共和国务院法制局编译, 中国法制出版社出版的《中华人民
共和国涉外法规汇编》(1991年7月版).
当发生歧意时, 应以法律法规颁布单位发布的中文原文为准.
This English document is coming from the "LAWS AND REGULATIONS OF THE
PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
which is compiled by the Brueau of Legislative Affairs of the State
Council of the People's Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.
Whole Document (法规全文)
PROVISIONS CONCERNING THE PAYMENT OF ROYALTIES FOR THE EXPLOITA-
TION OF OFFSHORE PETROLEUM RESOURCES
(Approved by the State Council on December 5, 1988, promulgated by
Decree No. 1 of the Minister of Finance on January 1, 1989)
Article 1
These Provisions are formulated in accordance with the "Regulations of the
People's Republic of China on the Exploitation of Offshore Petroleum
Resources in cooperation with Foreign Enterprises", in order to promote
the development of national economy, to expand international economic and
technological cooperation, and to encourage the exploitation of China's
offshore petroleum resources.
Article 2
All Chinese and foreign enterprises, which are engaged in the exploitation
of offshore petroleum resources pursuant to the law in the inland sea,
territorial sea and continental shelf of the People's Republic of China
and in any other sea areas under the jurisdiction of the People's Republic
of China, shall pay royalties in accordance with these Provisions.
Article 3
Royalties shall be computed and imposed on the basis of the gross output
of crude oil or natural gas produced every calendar year from each oil or
natural gas field. The rates of the royalties are as follows:
1. Crude oil
the portion of annual gross output of crude oil not exceeding 1 million
tons, shall not be subject to the payment of royalties;
for the portion of annual gross output of crude oil from 1 million to 1.5
million tons, the rate shall be 4%;
for the portion of annual gross output of crude oil from 1.5 million to 2
million tons, the rate shall be 6%;
for the portion of annual gross output of crude oil from 2 million to 3
million tons, the rate shall be 8%;
for the portion of annual gross output of crude oil from 3 million to 4
million tons, the rate shall be 10%;
for the portion of annual gross output of crude oil exceeding 4 million
tons, the rate shall be 12.5%.
2. Natural gas
the portion of annual gross output of natural gas not exceeding 2 billion
cubic meters, shall not be subject to the payment of royalties;
for the portion of annual gross output of natural gas from 2 billion to
3.5 billion cubic meters, the rate shall be 1%;
for the portion of annual gross output of natural gas from 3.5 billion to
5 billion cubic meters, the rate shall be 2%;
for the portion of annual gross output of natural gas exceeding 5 billion
cubic meters, the rate shall be 3%.
Article 4
The royalties for crude oil and natural gas shall be paid in kind.
Article 5
The royalties for crude oil and natural gas shall be levied and
administered by the tax authorities.
With respect to the royalties of Chinese-foreign Cooperative oil or gas
fields, the operators shall act as agents for withholding the royalties,
and shall hand over the royalties withheld to China National Offshore
Petroleum Corporation, which, in turn, shall act as an agent for making
the payment of the royalties.
Article 6
The royalties shall be computed annually and paid in advance in
installments either based on times or on terms; and the final settlement
shall be made after the end of the tax year. The time limits for advance
payment and final settlement shall be set by the tax authorities.
Article 7
The oil or gas fields operators shall, within 10 days after the end of
each quarter, submit to the tax authorities a report on the output of oil
or gas fields and any other related materials required by the tax
authorities.
Article 8
The withholding agents and paying agents with regard to the royalties
must, in accordance with the time limits set by the tax authorities, pay
the royalties. In case of failure to pay the royalties within the time
limits, the tax authorities shall impose a surcharge for overdue payment
equal to 1% of the overdue royalties for everyday in arrears, starting
from the first day the payment becomes overdue.
Article 9
In the case that the oil or gas fields operators, in violation of the
provisions in Article 7, fail to submit on time to the tax authorities the
reports on output of oil or gas fields and other related materials
required by the tax authorities, the tax authorities may impose a fine in
light of the circumstances up to but not exceeding RMB 5,000 yuan; in
dealing with those who conceal the actual output, the tax authorities, in
addition to pursuing the royalties payment, may impose a fine, in light of
the circumstances, up to but not exceeding five times of the amount of
royalties that shall be made up.
Article 10
The following terms, used in these Provisions, are defined below:
(1) Crude oil: refers to solid and liquid hydrocarbon in the natural state
as well as any liquid hydrocarbon extracted from natural gas, except for
methane (CH 4) (2) Natural gas: refers to non-associated natural gas and
associated natural gas in the natural state.
Non-associated natural gas: refers to all gaseous hydrocarbon extracted
from gas deposits, including wet gas, dry gas, and residual gas remaining
after the extraction of liquid hydrocarbon from wet gas.
Associated natural gas: refers to all gaseous hydrocarbon extracted from
oil deposits simultaneously with crude oil, including residual gas
remaining after the extraction of liquid hydrocarbon.
(3) Annual gross output of crude oil: refers to the total amount of crude
oil produced by each oil or gas field in the same contracted area, in one
calendar year, less the quantity of oil used for petroleum operations and
that of wasted.
(4) Annual gross output of natural gas: refers to the total amount of
natural gas produced by each oil or gas field in the same contracted area,
in one calendar year, less the quantity of natural gas used for petroleum
operations and that of wasted.
Article 11
These Provisions shall become effective as of January 1, 1989.
