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    題名: 歐洲聯盟內醫藥產品自由流通之研究
    其他題名: The study on the free movement of medicinal products in the European Union
    作者: 林毅璁;Lin, Yi-Tsung
    貢獻者: 淡江大學歐洲研究所碩士班
    陳麗娟
    關鍵詞: 歐洲聯盟;內部市場;商品自由流通;醫藥產品;原產國原則;相互承認原則;比例原則;European Union;Internal Market;Free Movement of Goods;Medicinal Products;Country of origin;Mutual Recognition;Proportionality
    日期: 2012
    上傳時間: 2013-04-13 10:36:09 (UTC+8)
    摘要: 歐洲聯盟內部市場的形成,促成了境內的商品自由流通,各會員國進出口的商品得以無課徵關稅與禁止採取限額措施在內部市場上市銷售,而醫藥產品不同於一般商品,須特別立法規定管理之,在符合歐盟法與各會員國國內法的規定下,始得於歐盟境內自由流通。

    歐盟為統一調和各會員國間不同的藥事法規,自1965年起制定了許多醫藥產品的規章、指令等相關法規,由各會員國直接或間接轉換立法,但會員國國內法仍存有差異,特別是界定醫藥產品定義的問題,將產生系爭產品適用法規的不同,而阻礙醫藥產品於內部市場的自由流通。

    本論文將說明歐盟商品自由流通原則的沿革,並以歐盟制定的醫藥產品法律架構作為本論文的法律基礎,進而探討歐盟醫藥產品市場行銷的運作模式。其次,歐洲聯盟法院歷年來對醫藥產品自由流通的法規適用爭議之釋義,因其確立的原則在各會員國間一致的適用,與歐盟醫藥產品市場的實務運作息息相關,故藉由相關判決分析醫藥產品定義界定之問題,以期排除系爭產品的定義規定不明確,所產生法規適用之疑慮,避免造成醫藥產品自由流通的障礙與維繫歐盟醫藥產品市場正常運作。
    The establishment of the European Internal Market contributes to the free movement of goods within the European Union, whose member states can import and export without tariff and quantitative restriction. Due to the distinction between medicinal products and normal products, it must be provided for medicinal products and complied with EU’s law and national laws.

    Since 1965, the EU has provided regulations and directives in order to harmonize the legal divergences, and eliminate obstacles for the medicinal products’transaction among the member states. The goal of the harmonization is to complete the internal market for the medicinal products in the EU.

    The thesis works on the development of the rules of free movement of goods, which are legal basis for the trade of the medicinal products in the EU. The Court of Justice of the European Union has established the unique rules for the application of the free movement of medicinal products in the EU. The case law of the ECJ plays an important role for the trade of medicinal products in the EU so that this thesis also focuses on the case law of the ECJ in order to learn the function of the free movement of medicinal products in the European Internal Market.
    顯示於類別:[歐洲研究所] 學位論文

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