药品行政保护条例 REGULATIONS ON ADMINISTRATIVE PROTECTION OF
文章来源: 文章作者: 发布时间:2007-05-04 01:48 字体: [ ]  进入论坛
(单词翻译:双击或拖选)
 

(Approved by the State Council on December 12, 1992 and promulgated1 by Decree No. 12 of the State Pharmaceutical2 Administration on December 19, 1992)
颁布日期:19921219  实施日期:19930101  颁布单位:国务院批准、 国家医药管理局发布

  Chapter I General Provisions

  Article 1 These Regulations are formulated3 with a view to expanding economic and technological4 cooperation and exchange with foreign countries and providing administrative5 protection for the lawful6 rights and interests of the owners of the exclusive right of foreign pharmaceuticals7.

  Article 2 The pharmaceuticals as mentioned in these Regulations refer to medicines for human beings.

  Article 3 Enterprises and other organizations or individuals from any country or region which has concluded bilateral8 treaty or agreement with the People's Republic of China on administrative protection of pharmaceuticals may apply for administrative protection of pharmaceuticals in accordance with these Regulations.

  Article 4 The competent administrative department for the production and distribution of pharmaceuticals under the State Council shall accept and examine applications for administrative protection of pharmaceuticals, grant administrative protection to the pharmaceuticals which conform with the provisions of these Regulations, and issue to the applicants10 the certificates for administrative protection.

  Chapter II Application for Administrative Protection

  Article 5 A pharmaceutical to be applied11 for administrative protection shall meet the following requirements:

  (1) Its exclusive right was not subject to protection in accordance with the provisions of the China's Patent Law prior to January 1, 1993;

  (2) Its exclusive right to prohibit others from making, using or selling it in the country to which the applicant9 belongs was granted after January 1, 1986 and before January 1, 1993;

  (3) It has not been marketed in China prior to the date of filing the application for administrative protection.

  Article 6 The right of applying for administrative protection of a pharmaceutical belongs to the owner of the exclusive right of the pharmaceutical.

  Article 7 Where an owner of the exclusive right of a foreign pharmaceutical applies for administrative protection, he shall appoint an agency designated by the competent administrative department for the production and distribution of pharmaceuticals under the State Council to undertake the matter.

  Article 8 An applicant shall submit the Chinese and foreign language bilingual versions of following documents:

  (1) an application for administrative protection of the pharmaceutical;

  (2) a copy of the certificate issued by the competent authorities of the country to which the applicant belongs granting such exclusive right;

  (3) a copy of the document issued by the competent authorities of the country to which the applicant belongs approving the manufacture or marketing12 of the pharmaceutical;

  (4) a copy of the contract for the manufacture or marketing of the pharmaceutical in China formally entered into between the applicant and a Chinese enterprise as legal person (including foreign capital enterprises, Chinese-foreign joint13 ventures, or Chinese-foreign equity14 contractual joint ventures) which has been permitted to manufacture or market pharmaceuticals in accordance with the relevant Chinese laws and regulations.

  Article 9 Before or after applying for the administrative protection, the owner of the exclusive right of a foreign pharmaceutical shall apply to the administrative department of health under the State Council for going through the procedures for permitting the manufacture or marketing of the pharmaceutical in China, in accordance with the provisions of the Pharmaceutical Administration Law of the People's Republic of China.

  Chapter III Examination and Approval of Administrative Protection

  Article 10 Within 15 days from the date of receipt of the application documents for administrative protection, the competent administrative department for the production and distribution of pharmaceuticals under the State Council, upon preliminary examination, shall handle the case in either of following measures according to different conditions:

  (1) Where the application documents are in conformity15 with the provisions of Article 8 of these Regulations, issue the notice of acceptance and announce it;

  (2) Where the application documents are not in conformity with the provisions of Article 8 of these Regulations, require the applicant to complete them within a definite time limit; if on the expiry of the time limit the requirement is not met, the application shall be deemed as not having been filed.

  Article 11 The competent administrative department for the production and distribution of pharmaceuticals under the State Council shall finish the examination within six months from the date of receipt of the application documents, or from the date of receipt of the complementary documents stipulated16 in Article 10, Item (2) of these Regulations. If, under special circumstances, the examination cannot be finished within six months, the competent administrative department for the production and distribution of pharmaceuticals under the State Council shall promptly17 notify the applicant, give the reason and properly prolong the examination time.

  After examination, where the application is in conformity with the provisions of these Regulations, the administrative protection shall be granted; where the application is not in conformity with the provisions of these Regulations, no administrative protection shall be granted and the reason shall be given.

  Article 12 Where a pharmaceutical is granted with administrative protection, the competent administrative department for the production and distribution of pharmaceuticals under the State Council shall issue the certificate of administrative protection and make an announcement.

  Chapter IV Duration, Cessation, Revocation18 and Effect of Administrative Protection

  Article 13 The duration of administrative protection of a pharmaceutical is seven years and six months beginning from the date on which the certificate of administrative protection is issued.

  Article 14 The owner of the exclusive right of a foreign pharmaceutical shall pay an annual fee beginning with the year in which the certificate of administrative protection of the pharmaceutical is issued.

  Article 15 In any of the following cases, the administrative protection shall cease before the expiration19 of its duration:

  (1) where the exclusive right of a pharmaceutical is ineffective or becomes invalid20 in the country to which the applicant belongs;

  (2) where the owner of the exclusive right of a pharmaceutical does not pay the annual fee as prescribed;

  (3) where the owner of the exclusive right of a pharmaceutical waives21 the administrative protection by a written declaration;

  (4) where the owner of the exclusive right of a pharmaceutical does not apply to the administrative department of health under the State Council for going through the procedures for permitting the manufacture or marketing of this pharmaceutical in China within a year from the date on which the certificate of administrative protection of the pharmaceutical is issued.

  Article 16 After the certificate for administrative protection of a pharmaceutical has been issued, any organization or individual that thinks that the grant of administrative protection to the pharmaceutical is not in conformity with the provisions of these Regulations may request the competent administrative department for the production and distribution of pharmaceuticals under the State Council to revoke22 the administrative protection of the pharmaceutical. Where the owner of the exclusive right of the pharmaceutical is not satisfied with the revocation decision made by the competent administrative department for the production and distribution of pharmaceuticals under the State Council, may institute legal proceedings23 in a people's court.

  Article 17 The cessation or revocation of the administrative protection of a pharmaceutical shall be announced by the competent administrative department for the production and distribution of pharmaceuticals under the State Council.

  Article 18 For the pharmaceuticals which have obtained administrative protection, without the authorization24 of the owners of the exclusive right of the pharmaceuticals, the administrative department of health under the State Council or the administrative departments of health of provinces, autonomous25 regions or municipalities directly under the Central Government may not permit others to manufacture or sell them.

  Article 19 Where there is any manufacture or marketing of a pharmaceutical without authorization of the owner of the exclusive right of the pharmaceutical who has obtained administrative protection, the owner of the exclusive right of the pharmaceutical may request the competent administrative department for the production and distribution of pharmaceuticals under the State Council to check the infringing26 act; if the owner of the exclusive right of the pharmaceutical claims for economic compensation, he may institute a legal proceedings in a people's court.

  Chapter V Supplementary27 Provisions

  Article 20 The competent administrative department for the production and distribution of pharmaceuticals under the State Council shall take measures to keep secret all the materials provided by applicants which require to be kept secret.

  Article 21 Fees shall be paid as prescribed for filing the application for administrative protection of pharmaceuticals and fulfilling any other relevant procedures with the competent administrative department for the production and distribution of pharmaceuticals under the State Council.

  Article 22 The rules for the implementation28 of these Regulations shall be formulated by the competent administrative department for the production and distribution of pharmaceuticals under the State Council.

  Article 23 The competent administrative department for the production and distribution of pharmaceuticals under the State Council shall be responsible for the interpretation29 of these Regulations.

  Article 24 These Regulations shall enter into force as of January 1, 1993.



点击收听单词发音收听单词发音  

1 promulgated a4e9ce715ee72e022795b8072a6e618f     
v.宣扬(某事物)( promulgate的过去式和过去分词 );传播;公布;颁布(法令、新法律等)
参考例句:
  • Hence China has promulgated more than 30 relevant laws, statutes and regulations. 中国为此颁布的法律、法规和规章多达30余项。 来自汉英非文学 - 白皮书
  • The shipping industry promulgated a voluntary code. 航运业对自律守则进行了宣传。 来自辞典例句
2 pharmaceutical f30zR     
adj.药学的,药物的;药用的,药剂师的
参考例句:
  • She has donated money to establish a pharmaceutical laboratory.她捐款成立了一个药剂实验室。
  • We are engaged in a legal tussle with a large pharmaceutical company.我们正同一家大制药公司闹法律纠纷。
3 formulated cfc86c2c7185ae3f93c4d8a44e3cea3c     
v.构想出( formulate的过去式和过去分词 );规划;确切地阐述;用公式表示
参考例句:
  • He claims that the writer never consciously formulated his own theoretical position. 他声称该作家从未有意识地阐明他自己的理论见解。 来自《简明英汉词典》
  • This idea can be formulated in two different ways. 这个意思可以有两种说法。 来自《现代汉英综合大词典》
4 technological gqiwY     
adj.技术的;工艺的
参考例句:
  • A successful company must keep up with the pace of technological change.一家成功的公司必须得跟上技术变革的步伐。
  • Today,the pace of life is increasing with technological advancements.当今, 随着科技进步,生活节奏不断增快。
5 administrative fzDzkc     
adj.行政的,管理的
参考例句:
  • The administrative burden must be lifted from local government.必须解除地方政府的行政负担。
  • He regarded all these administrative details as beneath his notice.他认为行政管理上的这些琐事都不值一顾。
6 lawful ipKzCt     
adj.法律许可的,守法的,合法的
参考例句:
  • It is not lawful to park in front of a hydrant.在消火栓前停车是不合法的。
  • We don't recognised him to be the lawful heir.我们不承认他为合法继承人。
7 pharmaceuticals be065c8a4af3a2d925d11969faac34cf     
n.医药品;药物( pharmaceutical的名词复数 )
参考例句:
  • the development of new pharmaceuticals 新药的开发
  • The companies are pouring trillions of yen into biotechnology research,especially for pharmaceuticals and new seeds. 这些公司将大量资金投入生物工艺学研究,尤其是药品和新种子方面。 来自《简明英汉词典》
8 bilateral dQGyW     
adj.双方的,两边的,两侧的
参考例句:
  • They have been negotiating a bilateral trade deal.他们一直在商谈一项双边贸易协定。
  • There was a wide gap between the views of the two statesmen on the bilateral cooperation.对双方合作的问题,两位政治家各自所持的看法差距甚大。
9 applicant 1MlyX     
n.申请人,求职者,请求者
参考例句:
  • He was the hundredth applicant for the job. 他是第100个申请这项工作的人。
  • In my estimation, the applicant is well qualified for this job. 据我看, 这位应征者完全具备这项工作的条件。
10 applicants aaea8e805a118b90e86f7044ecfb6d59     
申请人,求职人( applicant的名词复数 )
参考例句:
  • There were over 500 applicants for the job. 有500多人申请这份工作。
  • He was impressed by the high calibre of applicants for the job. 求职人员出色的能力给他留下了深刻印象。
11 applied Tz2zXA     
adj.应用的;v.应用,适用
参考例句:
  • She plans to take a course in applied linguistics.她打算学习应用语言学课程。
  • This cream is best applied to the face at night.这种乳霜最好晚上擦脸用。
12 marketing Boez7e     
n.行销,在市场的买卖,买东西
参考例句:
  • They are developing marketing network.他们正在发展销售网络。
  • He often goes marketing.他经常去市场做生意。
13 joint m3lx4     
adj.联合的,共同的;n.关节,接合处;v.连接,贴合
参考例句:
  • I had a bad fall,which put my shoulder out of joint.我重重地摔了一跤,肩膀脫臼了。
  • We wrote a letter in joint names.我们联名写了封信。
14 equity ji8zp     
n.公正,公平,(无固定利息的)股票
参考例句:
  • They shared the work of the house with equity.他们公平地分担家务。
  • To capture his equity,Murphy must either sell or refinance.要获得资产净值,墨菲必须出售或者重新融资。
15 conformity Hpuz9     
n.一致,遵从,顺从
参考例句:
  • Was his action in conformity with the law?他的行动是否合法?
  • The plan was made in conformity with his views.计划仍按他的意见制定。
16 stipulated 5203a115be4ee8baf068f04729d1e207     
vt.& vi.规定;约定adj.[法]合同规定的
参考例句:
  • A delivery date is stipulated in the contract. 合同中规定了交货日期。
  • Yes, I think that's what we stipulated. 对呀,我想那是我们所订定的。 来自辞典例句
17 promptly LRMxm     
adv.及时地,敏捷地
参考例句:
  • He paid the money back promptly.他立即还了钱。
  • She promptly seized the opportunity his absence gave her.她立即抓住了因他不在场给她创造的机会。
18 revocation eWZxW     
n.废止,撤回
参考例句:
  • the revocation of planning permission 建筑许可的撤销
  • The revocation of the Edict of Nantes was signed here in 1685. 1685年南特敕令的废除是在这里宣布的。 来自互联网
19 expiration bmSxA     
n.终结,期满,呼气,呼出物
参考例句:
  • Can I have your credit card number followed by the expiration date?能告诉我你的信用卡号码和它的到期日吗?
  • This contract shall be terminated on the expiration date.劳动合同期满,即行终止。
20 invalid V4Oxh     
n.病人,伤残人;adj.有病的,伤残的;无效的
参考例句:
  • He will visit an invalid.他将要去看望一个病人。
  • A passport that is out of date is invalid.护照过期是无效的。
21 waives 3dc42ba6619cb696796fac2e888582eb     
v.宣布放弃( waive的第三人称单数 );搁置;推迟;放弃(权利、要求等)
参考例句:
  • The surety waives in writing the right provided in the preceding paragraph. (三)保证人以书面形式放弃前款规定的权利的。 来自互联网
  • In exchange, the tribe waives claim to similar water rights on non federal and private lands. 作为交换,部落放弃非联邦河私人土地上的类似水权。 来自互联网
22 revoke aWYxX     
v.废除,取消,撤回
参考例句:
  • The university may revoke my diploma.大学可能吊销我的毕业证书。
  • The government revoked her husband's license to operate migrant labor crews.政府撤销了她丈夫管理外来打工人群的许可证。
23 proceedings Wk2zvX     
n.进程,过程,议程;诉讼(程序);公报
参考例句:
  • He was released on bail pending committal proceedings. 他交保获释正在候审。
  • to initiate legal proceedings against sb 对某人提起诉讼
24 authorization wOxyV     
n.授权,委任状
参考例句:
  • Anglers are required to obtain prior authorization from the park keeper.垂钓者必须事先得到公园管理者的许可。
  • You cannot take a day off without authorization.未经批准你不得休假。
25 autonomous DPyyv     
adj.自治的;独立的
参考例句:
  • They proudly declared themselves part of a new autonomous province.他们自豪地宣布成为新自治省的一部分。
  • This is a matter that comes within the jurisdiction of the autonomous region.这件事是属于自治区权限以内的事务。
26 infringing 9830a3397dcc37350ee4c468f7bfe45a     
v.违反(规章等)( infringe的现在分词 );侵犯(某人的权利);侵害(某人的自由、权益等)
参考例句:
  • The material can be copied without infringing copyright. 这份材料可以复制,不会侵犯版权。
  • The media is accused of infringing on people's privacy. 人们指责媒体侵犯了大家的隐私。 来自《简明英汉词典》
27 supplementary 0r6ws     
adj.补充的,附加的
参考例句:
  • There is a supplementary water supply in case the rain supply fails.万一主水源断了,我们另外有供水的地方。
  • A supplementary volume has been published containing the index.附有索引的增补卷已经出版。
28 implementation 2awxV     
n.实施,贯彻
参考例句:
  • Implementation of the program is now well underway.这一项目的实施现在行情看好。
29 interpretation P5jxQ     
n.解释,说明,描述;艺术处理
参考例句:
  • His statement admits of one interpretation only.他的话只有一种解释。
  • Analysis and interpretation is a very personal thing.分析与说明是个很主观的事情。
TAG标签:
发表评论
请自觉遵守互联网相关的政策法规,严禁发布色情、暴力、反动的言论。
评价:
表情:
验证码:点击我更换图片