Similarity of Medicinal Products and Free Movement of Goods: Is Parallel Distribution the Beginning of the end for Mutual Recognition?

Abstract

Marketing authorisation procedures should facilitate global access to the European Union market. Restrictions to free movement of goods are only compatible with the EC Treaty in very limited situations, and national authorities must not oppose the placing on the market of a medicinal product approved in another member state unless the protection of public health so requires. Generic medicines are products whose efficacy and safety are well known. Once approved in one member state it seems rather difficult to justify a restriction to free movement based on the need to protect public health. The jurisprudence on parallel trade of medicinal products may help to revisit the current mutual recognition system.