Pari Pharma GmbH c European Medicines Agency

European Union – Information. Novartis Europharm Ltd, established in the UK, had been granted a conditional marketing authorisation (MA) for the tobramycin-based orphan medicinal product 'TOBI Podhaler'. The applicant pharmaceutical company (Pari Pharma) was subsequently granted MA for a competing medicinal product, Vantobra, on the basis that Vantobra was similar and clinically superior to TOBI Podhaler. The respondent European Medicines Agency granted Novartis access to the documents in the file relating to the MA application for Vantobra. In the present proceedings, Pari Pharma sought, pursuant to Regulation (EC) No 1049/2001, annulment of that decision. The General Court of the European Union dismissed Pari Pharma's action on the basis that the pleas relied on by Pari Pharma were not justified for the purposes of art 4 of that regulation.

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