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.