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Valentina R., lawyer
EN
(2016/C 038/100)
Language of the case: English
Applicant: Drugsrus Ltd (London, United Kingdom) (represented by: M. Howe and S. Ford, Barristers, and R. Sanghvi, Solicitor)
Defendant: European Medicines Agency
The applicant claims that the Court should:
—annul the decision contained in the EMA’s email dated 8 October 2015, that Drugsrus is not permitted to rebrand as Eklira Genuair, a product imported as Bretaris Genuair; and
—order EMA to pay the applicant’s costs.
In support of the action, the applicant relies on a single plea in law.
The applicant contends that the EMA has erred in law in concluding that it is impermissible to rebrand centrally authorised medicinal products. It submits that under the rules of the TFUE on the free movement of goods, a parallel importer is permitted to repackage and/or rebrand a product for parallel distribution provided that such repackaging or rebranding is objectively necessary in order that the imported product can gain effective access to the market of the importing Member State.