Repackaging and rebranding parallel imports: the rules as they stand

What was decided

The Falsified Medicines Directive put an anti-tampering device on every prescription pack. Parallel importers must break it to relabel, and several national authorities (Denmark in particular) began requiring importers to put medicines into new boxes rather than relabel the original. Trade mark owners objected to the new boxes; importers objected to being made to use them. Five references reached the Court of Justice and were decided together on 17 November 2022.

The Court held that the pre-existing rules survive the Directive. A trade mark owner may oppose repackaging unless it is objectively necessary for the importer to reach the destination market. Relabelling the original pack and resealing it with a new anti-tampering device is the normal course. The visible traces that opening leaves do not by themselves make a new box necessary; a new box is justified only where relabelled packs would meet such strong resistance from a significant proportion of consumers that market access would be hindered, and that resistance must be shown case by case. A national rule requiring new boxes as a matter of course is not compatible with the Directive.

In the companion rebranding cases, the Court held that an importer may replace a generic’s own trade mark with the reference product’s brand, so as to sell it under the better-known name in the destination country, only where the two products are identical in every respect and the rebranding is objectively necessary to market the import there; it is not enough that the brand sells better.

Timeline

Date	Event
9 February 2019	Anti-tampering devices become mandatory under the Falsified Medicines Directive
2020	Danish, German and Belgian courts refer the repackaging and rebranding questions
17 November 2022	CJEU judgments in C-147/20, C-204/20, C-224/20, C-253/20 and C-254/20
2023–26	National courts apply the test to individual products and markets

What it means if you are…

A parallel trader. Relabel and reseal unless you can evidence, for that product in that market, that relabelled packs will be refused by a significant share of pharmacists or patients. Keep that evidence; the burden is yours. Do not rebrand a generic to the originator’s name unless the products are identical and you can show the generic name would not sell. Each pack design is a trade mark decision as well as a regulatory one.

A generics company. Your branded generic can be rebranded on import only in the narrow circumstances above, which protects the brand you built in the destination market more than many assumed before 2022.

A wholesaler or buyer. Repackaged imports that follow these rules are lawful product; those that do not can be withdrawn by injunction mid-contract. Ask importers how they repackage.

Status and what to watch

The rules are settled at EU level; the action is in national courts applying the “significant proportion” test product by product. The UK, after leaving the EU’s exhaustion regime, follows its own rules for imports from the EEA and is covered in a separate note.