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科技法律透析

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篇名 從日本2013年藥事法修正看我國網路販售藥物之限制
卷期 26:3
並列篇名 Review the Restrictions on the Online Sale of Pharmaceutical Products and Medical Devices from Provisions of the 2013 Amended Japanese Pharmaceutical Affairs Law
作者 郭俊仁
頁次 053-068
關鍵字 藥事法網路賣藥電子商務Medicine for sale on internetElectronic commercePharmaceutical Affairs LawSelling medical product on internet
出刊日期 201403

中文摘要

網路販售藥物究竟應予開放或禁止,涉及到國民健康、國民生活便利性的保障、以及業者職業活動自由的限制,日本從早期未明文規定,歷經2006年藥事法課與藥品資訊提供義務、2009年藥事法施行細則限制網路販售第一類及第二類藥品、2013年1月東京最高法院判決厚生勞動省敗訴確定、一直到2013年12月再度修正藥事法,正式確立了網路販售藥品的開放與限制措施。而我國對於網路販售藥品之問題,一向採取嚴格禁止之作法,然而禁止理由及法規依據為何?則仍有待釐清。

英文摘要

Whether to allow or to prohibit selling pharmaceutical products and medical devices online is difficult to be balanced among the interests related to the protection of public health, convenience and the restrictions on business activities. The issue was not addressed in the Japanese Pharmaceutical Affairs Law in the past; however, the later legislative history shows the importance in the revolution. Undergone the Japanese Pharmaceutical Affairs Law required the information disclosure obligation of medical products in 2006, the Enforcement Rules of the Pharmaceutical Affairs Law prohibit the online sale of category 1 and 2 pharmaceutical products in 2009, and the Ministry of Health, Labour and Welfare lost its case in the Tokyo Supreme Court in January 2013, the issues was finally settled. The Amendment of the Pharmaceutical Affairs Law in December 2013 officially confirmed the issue. On the contrary, our government has enforce strict prohibition on the online sale of pharmaceutical products and medical devices, the reasons and the legal basis still need to be further clarified.

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