药品盲文标签和说明书法律问题研究
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华东政法大学

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Research on Legal Issues of Braille Labels and Package Inserts for Drugs
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    摘要:

    《中华人民共和国无障碍环境建设法》的颁布并施行体现我国注重对残障人士合法权益的保护。在该法第三十七条对药品盲文的标签和说明书的提供主体以及监管主体进行了规定,以法律的形式为残障人士的用药安全进一步提供法律保障。但是目前相关规定之间的衔接存在空白,仍存在诸如责任主体的义务和职能不清晰、缺乏药品盲文标签和说明书统一的书写规范、法律责任以及配套制度和措施有待完善的问题。对此,需要进一步做好规定之间的衔接和解决法律适用问题,明确责任主体各自的义务和权限范围,完善我国在药品盲文标签和说明书方面的管理规范、书写规范以及国家标准,补充法律责任的规定以及国家和社会需要提供一定的政策和经济上的支持。本文基于当前存在的问题提出相关的建议和措施,以期更好地推动无障碍格式版本的药品标签和说明书规定的落实。

    Abstract:

    China Accessibility Construction Law promulgation and implementation reflects our country pay more attention to the protection of the legitimate rights and interests of the disabled. The Article 37 of China Accessibility Construction Law stipulates the providers and regulators of labels and package insert in braille for drugs, providing further legal protection for drug safety of persons with disabilities in the form of law. However, there is a gap in the connection between relevant regulations, and there are still some problems, such as unclear obligations and functions of the subject of relevant liability, lack of uniform writing norms for braille labels and package insert of drugs, provisions on legal liability, and supporting systems and measures need to be improved. In this regard, it is necessary to improve the convergence between regulations and solve the problem of the application of law, further clarify the respective obligations and scope of authority of the responsible parties, improve the management norms, writing norms and national standards of drug braille labels and package insert in China, supplement the provisions of legal liability, and provide certain policy and economic support from the State and society. Based on the existing problems, this essay puts forward relevant suggestions and measures, in order to better promote the implementation of the accessibility format version of drug labels and package insert.

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  • 收稿日期:2023-08-25
  • 最后修改日期:2023-09-02
  • 录用日期:2023-09-06
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