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Case T-672/14: Judgment of the General Court of 20 October 2016 — August Wolff and Remedia v Commission (Medicinal products for human use — Article 31 of Directive 2001/83/EC — Article 116 of Directive 2001/83 — Active substance estradiol — Commission decision ordering the Member States to withdraw or amend national marketing authorisations for medicinal products with 0,01 % estradiol by weight for topical use — Burden of proof — Proportionality — Equal treatment)
ECLI:EU:UNKNOWN:62014TA0672
62014TA0672
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5.12.2016
Official Journal of the European Union
C 454/22
(Case T-672/14) (*)
((Medicinal products for human use - Article 31 of Directive 2001/83/EC - Article 116 of Directive 2001/83 - Active substance estradiol - Commission decision ordering the Member States to withdraw or amend national marketing authorisations for medicinal products with 0,01 % estradiol by weight for topical use - Burden of proof - Proportionality - Equal treatment))
(2016/C 454/40)
Language of the case: German
Parties
Applicants: Dr. August Wolff GmbH & Co. KG Arzneimittel (Bielefeld, Germany) and Remedia d.o.o (Zagreb, Croatia) (represented by: P. Klappich, C. Schmidt and P. Arbeiter, lawyers)
Defendant: European Commission (represented by: B.-R. Killmann and A. Sipos, acting as Agents)
Re:
Application based on Article 263 TFEU and seeking the annulment of Commission Decision C(2014) 6030 final of 19 August 2014 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for high concentration of estradiol containing human medicinal products for topical use in so far as it requires Member States to comply with the obligations imposed in the implementing decision for the medicinal products listed in Annex I to the implementing decision and those not listed with 0,01 % estradiol by weight for topical use, with the exception of the restriction that the medicinal products named in Annex I to the implementing decision with 0,01 % estradiol by weight for topical use may be administered only intravaginally.
Operative part of the judgment
The Court:
1.Dismisses the action;
2.Orders Dr. August Wolff GmbH & Co. KG Arzneimittel and Remedia d.o.o. to pay the costs of the proceedings and of those relating to the application for interim measures.
(*)
Language of the case: German.
* * *
(1) OJ C 439, 8.12.2014.