EU Pharmaceutical Package: No Reset For Parallel Imports

The EU Pharmaceutical Package will reshape major parts of EU pharmaceutical law. For parallel imports, however, the central message is continuity. The current draft Directive no longer contains the proposed rule that would have allowed Member States to require new outer packaging for parallel imported medicines. The CJEU’s established case law on repackaging therefore remains the key framework.

This article provides a practical overview of the expected impact of the EU Pharmaceutical Package on parallel imports of medicines.

Parallel imports in the EU pharmaceutical market

Parallel imports of medicines have long been a recurring issue in the EU internal market. Parallel importers use differences in price, supply and reimbursement conditions between Member States. They buy medicines that have lawfully entered the market in one Member State and sell them in another Member State, without a commercial mandate from the marketing authorisation holder or the trademark owner.