# C_2019187EN.01000501.xml

| 3.6.2019 | EN | Official Journal of the European Union | C 187/5 |
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3.6.2019

EN

Official Journal of the European Union

C 187/5

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Judgment of the Court (Fourth Chamber) of 27 March 2019 — Dr. August Wolff GmbH & Co. KG Arzneimittel, Remedia d.o.o. v European Commission

(Case C-680/16 P) (1)

(Appeal - Medicinal products for human use - Directive 2001/83/EC - Article 30(1) - Committee for Medicinal Products for Human Use - Referral of a matter to the committee subject to the absence of a previous national decision - Active substance estradiol - Decision of the European Commission ordering the Member States to revoke or vary marketing authorisations for medicinal products with 0.01% estradiol by weight for topical use)

(2019/C 187/06)

Language of the case: German

Parties

Appellants: Dr. August Wolff GmbH & Co. KG Arzneimittel, Remedia d.o.o. (represented by: P. Klappich and C. Schmidt, Rechtsanwälte)

Other party to the proceedings: European Commission (represented by: B.-R. Killmann and A. Sipos and by M. Šimerdová, Agents)

Operative part of the judgment

The Court:

| 1. | Sets aside the judgment of the General Court of the European Union of 20 October 2016, August Wolff and Remedia v Commission (T-672/14, not published, EU:T:2016:623); |
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1.

Sets aside the judgment of the General Court of the European Union of 20 October 2016, August Wolff and Remedia v Commission (T-672/14, not published, EU:T:2016:623);

| 2. | Annuls Commission Implementing Decision C(2014) 6030 final of 19 August 2014 concerning the marketing authorisations for high concentration of estradiol containing human medicinal products for topical use in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council in so far as that decision directs the Member States to comply with the requirements which it stipulated for the medicinal products, for which Dr. August Wolff GmbH & Co. KG Arzneimittel and Remedia d.o.o. hold marketing authorisation, with 0.01% estradiol by weight for topical use referenced and non-referenced in Annex I thereto, excluding the restriction that the medicinal products with 0.01% estradiol by weight for topical use; |
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2.

Annuls Commission Implementing Decision C(2014) 6030 final of 19 August 2014 concerning the marketing authorisations for high concentration of estradiol containing human medicinal products for topical use in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council in so far as that decision directs the Member States to comply with the requirements which it stipulated for the medicinal products, for which Dr. August Wolff GmbH & Co. KG Arzneimittel and Remedia d.o.o. hold marketing authorisation, with 0.01% estradiol by weight for topical use referenced and non-referenced in Annex I thereto, excluding the restriction that the medicinal products with 0.01% estradiol by weight for topical use;

| 3. | Orders the European Commission to pay the costs of the proceedings at first instance and on appeal, with the exception of the proceedings for interim measures, which are to be borne by Dr. August Wolff GmbH & Co. KG Arzneimittel and Remedia d.o.o. |
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3.

Orders the European Commission to pay the costs of the proceedings at first instance and on appeal, with the exception of the proceedings for interim measures, which are to be borne by Dr. August Wolff GmbH & Co. KG Arzneimittel and Remedia d.o.o.

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(1)  OJ C 78, 13.3.2017.

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