Parallel import: import of a nationally authorised product from another Member State

Parallel import rests on the free movement of goods in Articles 34 to 36 of the Treaty on the Functioning of the European Union. A trader buys a medicine in a Member State where it is cheaper and sells it in a Member State where the same product, or one that is essentially the same, is already authorised. The importing authority grants a parallel import licence in a simplified procedure that does not require the full dossier, as set out in the Commission Communication on parallel imports of proprietary medicinal products of 2003 and in the Court of Justice case law that preceded it. The national licence confirms that the imported product has no therapeutic difference from the product authorised domestically.

Article 76(3) of Directive 2001/83/EC requires a distributor who is not the marketing authorisation holder to notify the holder and the competent authority of the intention to import. The importer usually has to relabel or repackage the product to meet the language and labelling rules of the destination market. The Court's conditions for repackaging a trademarked product, set in the Bristol-Myers Squibb v Paranova line of cases, are that repackaging is necessary for market access, does not affect the product's condition, states who repackaged and who manufactured it, does not damage the brand's reputation, and that the trademark owner gets prior notice and, on request, a sample.

Since the Falsified Medicines Directive, a parallel importer who repackages must decommission the original unique identifier and apply an equivalent new one, which requires a manufacturing authorisation and makes the importer responsible for the safety features. The holder's own obligations continue: variations to the original product flow through to the parallel-imported presentation only when the importer updates its licence, so leaflets in the market can lag behind the latest approved text.

What goes wrong for holders: pack designs that make repackaging unnecessary or necessary in ways that invite disputes, failure to answer repackaging notices within the time the courts expect, and supply allocation systems that breach the public service obligation in the exporting market. Importers fail on licence maintenance, relabelling that hides mandatory information, and out-of-date leaflets.