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Labelling of parallel imported medicinal products a potential alternative to repackaging

27.4.2023

The Finnish Medicines Agency Fimea has previously required the repackaging of parallel imported medicinal products as a precondition for introducing them on the market. According to a new policy, labelling the original outer packaging will now be accepted in addition to repackaging.

Parallel importing is the import of a medicine with an existing Finnish marketing authorisation from another EU member state by a pharmaceutical company independent of the Finnish marketing authorisation holder.

The new policy is based on a decision of the Court of Justice of the European Union (CJEU). In its decision on trademark law, the CJEU confirmed that the Directive on human medicines prevents a Member State from requiring a new outer packaging from the parallel importer.

The parallel imported packaging must still contain the package leaflet in Finnish and Swedish. This means that if the product is not repackaged but labelled, the tamper evidence mechanism (anti-tampering device, ATD) must be opened to replace the package leaflet and then sealed again.

The unique identifier of the medicinal product must be replaced in connection with repackaging or labelling. The correctness of a medicinal product can be verified at a pharmacy with the unique identifier.

Fimea has informed parallel importers of the new policy. Fimea has also informed pharmacies and instructed them to take this change into consideration in medication counselling.

For more information, please contact

Tarja Kankkunen, Head of Division, tel. +358 (0)29 522 3345 (Contact for media on the new policy)

The e-mail takes the form [email protected]

Operators’ questions

Fimea’s service e-mails:

Parallel importers operating in Finland (Questions related to parallel imported medicines or parallel imports)

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