In the Pharma Expressz judgment (case C-178/20) the Court of Justice clarified which conditions a Member State can impose to the import of a medicinal product not having a marketing authorisation in the national territory. The Court pointed out that a medicine not authorised in a Member State can entry in that Member State only in accordance with Article 5(1) of Directive 2001/83/EC on medicinal products for human use. Moreover, according to the Court a national measure requiring a medical prescription and a declaration from the competent national health authority is justified to protect public health although the product can be dispensed in another Member State without a medical prescription. After an overview on the development of pharmaceutical law in the EU, the contribution analyses this judgment in which the Court balanced the Treaty rules on the free movement of goods with the need to protect human health.

在Pharma Expressz判决（C-178/20 案）中，法院澄清了成员国可以对在本国境内没有上市许可的药品的进口施加哪些条件。法院指出，未经成员国授权的药物只能根据指令 2001/83/ EC第 5(1) 条进入该成员国关于人类使用的医药产品。此外，根据法院的说法，一项需要医疗处方和国家卫生主管部门声明的国家措施有理由保护公众健康，尽管该产品可以在没有医疗处方的情况下在另一个成员国分发。在概述了欧盟药品法的发展之后，该文稿分析了法院在该判决中平衡了关于货物自由流动的条约规则与保护人类健康的必要性。