Free Movement of Medicines and Protection of Public Health.

Abstract

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.