>>>welcome visitor, haven't logged in. Login
Subscribe Now Contact us  
Font Size:  A A A Search “Fabao” Window English 中文 = 简体  繁体
  Favorite   DownLoad   Print
 
Decision of the State Council to Provisionally Adjust the Implementation of the Relevant Provisions of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China in Hainan Bo'ao Lecheng International Medical Tourism Pilot Zone [Effective]
国务院关于在海南博鳌乐城国际医疗旅游先行区暂时调整实施《中华人民共和国药品管理法实施条例》有关规定的决定 [现行有效]
【法宝引证码】

Decision of the State Council to Provisionally Adjust the Implementation of the Relevant Provisions of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China in Hainan Bo'ao Lecheng International Medical Tourism Pilot Zone 

国务院关于在海南博鳌乐城国际医疗旅游先行区暂时调整实施《中华人民共和国药品管理法实施条例》有关规定的决定

(No. 43 [2018] of the State Council) (国发〔2018〕43号)

People's governments of all provinces, autonomous regions and municipalities directly under the Central Government, all ministries and commissions of the State Council and all institutions directly under the State Council: 各省、自治区、直辖市人民政府,国务院各部委、各直属机构:
In order to further support Hainan Province in the pilot program of developing international medical tourism-related industries, the State Council has decided to provisionally adjust the implementation of the provisions of Article 36 of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China in Hainan Bo'ao Lecheng International Medical Tourism Pilot Zone, and the application for importing a small amount of drugs (excluding vaccines) by medical institutions in the pilot zone due to urgent clinical needs shall be approved by the people's government of Hainan Province. The approved drug imports shall be used for specific medical purposes in designated medical institutions. The people's government of Hainan Province shall clarify approval conditions and procedures, scrutinize the applications from medical institutions, implement a strict drug traceability management system for approved drug imports, strengthen supervision and administration of medical institutions in drug use, and effectively monitor and handle adverse drug reactions so as to ensure the safety and reliability of imported drug sources and channels and the safety of drug use and effectively safeguard the people's health and safety. The specific administrative measures shall be developed by the people's government of Hainan Province, and be implemented with the approval of the drug administrative department of the State Council and the competent health department of the State Council. 为进一步支持海南省试点发展国际医疗旅游相关产业,国务院决定在海南博鳌乐城国际医疗旅游先行区暂时调整实施《中华人民共和国药品管理法实施条例》第三十六条的规定,对先行区内医疗机构因临床急需进口少量药品(不含疫苗)的申请,由海南省人民政府实施审批。经批准进口的药品应当在指定医疗机构内用于特定医疗目的。海南省人民政府要明确审批的条件和程序,严格审查医疗机构提出的申请,对经批准进口的药品实施严格的药品追溯管理制度,加强对医疗机构使用药品的监督管理,做好药品不良反应的监测和处理,确保所进口的药品来源渠道安全可靠,确保药品使用安全,切实维护人民群众身体健康和生命安全。具体管理办法由海南省人民政府制定,报国务院药品监督管理部门和国务院卫生主管部门同意后实施。
...... ......

Dear visitor, you are attempting to view a subscription-based section of lawinfochina.com. If you are already a subscriber, please login to enjoy access to our databases. If you are not a subscriber, you can pay for a document through Online Pay and read it immediately after payment.
An entity user can apply for a trial account or contact us for your purchase.
Tel: +86 (10) 82689699, +86 (10) 82668266 ext. 153
Mobile: +86 13311570712
Fax: +86 (10) 82668268
E-mail: database@chinalawinfo.com

 
您好:您现在要进入的是北大法律英文网会员专区。
如您是我们英文用户可直接 登录,进入会员专区查询您所需要的信息;如您还不是我们 的英文用户;您可通过网上支付进行单篇购买,支付成功后即可立即查看本篇内容;
单位用户可申请试用或者来电咨询购买。
Tel: +86 (10) 82689699, +86 (10) 82668266 ext. 153
Mobile: +86 13311570712
Fax: +86 (10) 82668268
E-mail:database@chinalawinfo.com
     
     
【法宝引证码】        北大法宝en.pkulaw.cn
Message: Please kindly comment on the present translation.
 
Confirmation Code:
Click image to reset code
 
  Translations are by lawinfochina.com, and we retain exclusive copyright over content found on our website except for content we publish as authorized by respective copyright owners or content that is publicly available from government sources.

Due to differences in language, legal systems, and culture, English translations of Chinese law are for reference purposes only. Please use the official Chinese-language versions as the final authority. Lawinfochina.com and its staff will not be directly or indirectly liable for use of materials found on this website.

We welcome your comments and suggestions, which assist us in continuing to improve the quality of our materials as we dynamically expand content.
 
Home | About us | Disclaimer | Chinese