Language of document :

Judgment of the General Court of 11 December 2014 — PP Nature-Balance Lizenz v Commission

(Case T-189/13) 1

(Medicinal products for human use — Active substance tolperisone — Article 116 of Directive 2001/83/EC — Commission decision ordering the Member States to vary the national marketing authorisations for medicinal products for human use containing the active substance at issue — Burden of proof — Proportionality)

Language of the case: German

Parties

Applicant: PP Nature-Balance Lizenz GmbH (Hamburg, Germany) (represented by: M. Ambrosius, lawyer)

Defendant: European Commission (represented by: initially B. R. Killmann and M. Šimerdová, then B. R. Killmann and A. Sipos, acting as Agents)

Re:

Application for partial annulment of Commission Implementing Decision C(2013) 369 (final) of 21 January 2013 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for the medicinal products for human use which contain the active substance ‘tolperisone’

Operative part of the judgment

The Court:

Dismisses the action;

Orders PP Nature-Balance Lizenz GmbH to bear its own costs and those incurred by the European Commission.

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1 OJ C 164, 8.6.2103.