# C_2021391EN.01001201.xml

| 27.9.2021 | EN | Official Journal of the European Union | C 391/12 |
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27.9.2021

EN

Official Journal of the European Union

C 391/12

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Appeal brought on 14 July 2021 by the European Commission against the judgment of the General Court (Seventh Chamber, Extended Composition) delivered on 5 May 2021 in Case T-611/18, Pharmaceutical Works Polpharma v EMA

(Case C-438/21 P)

(2021/C 391/18)

Language of the case: English

Parties

Appellant: European Commission (represented by: L. Haasbeek, S. Bourgois, A. Sipos, Agents)

Other parties to the proceedings: Pharmaceutical Works Polpharma S.A., European Medicines Agency, Biogen Netherlands BV

Form of order sought

The Appellant claims that the Court should:

| — | set aside the judgment under the appeal; |
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set aside the judgment under the appeal;

| — | reject the application at first instance; and |
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reject the application at first instance; and

| — | order the Pharmaceutical Works Polpharma S.A. to pay the costs. |
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order the Pharmaceutical Works Polpharma S.A. to pay the costs.

Pleas in law and main arguments

The present appeal is directed against paragraphs 181-218, paragraphs 224-238, 248-265, 273-275, 280-282, 288, 289 and 292 of the judgment under appeal, as well as its conclusions in paragraphs 295, 296 and the operative part.

The Commission raises four grounds of appeal:

| 1. | The General Court manifestly distorted the facts, leading it to manifestly flawed legal conclusions, when basing its reasoning in the judgment under appeal on the incorrect premise that Fumaderm was assessed by the German Bundesinstitut für Arzneimittel und Mediczinprodukte (‘BfArM’) for the first and only time in 1994. |
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1.

The General Court manifestly distorted the facts, leading it to manifestly flawed legal conclusions, when basing its reasoning in the judgment under appeal on the incorrect premise that Fumaderm was assessed by the German Bundesinstitut für Arzneimittel und Mediczinprodukte (‘BfArM’) for the first and only time in 1994.

| 2. | The General Court violated Article 6(1) of Directive 2001/83 (1), as interpreted by the case-law of the Court, by requiring — as part of the assessment by the EMA and the Commission of whether two medicinal products belong to the same global marketing authorisation (‘GMA’) — a (re-)assessment of the qualitative composition in terms of active substances of the initial medicinal product.
  First, the General Court unlawfully imported into the GMA assessment an assessment that forms part of the procedure granting the marketing authorisation for the initial medicinal product. Second, the General Court unlawfully created two diverging GMA concepts, depending on whether the GMA assessment is carried out by the Commission and the EMA or by a national competent authority. |
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2.

The General Court violated Article 6(1) of Directive 2001/83 (1), as interpreted by the case-law of the Court, by requiring — as part of the assessment by the EMA and the Commission of whether two medicinal products belong to the same global marketing authorisation (‘GMA’) — a (re-)assessment of the qualitative composition in terms of active substances of the initial medicinal product.

First, the General Court unlawfully imported into the GMA assessment an assessment that forms part of the procedure granting the marketing authorisation for the initial medicinal product. Second, the General Court unlawfully created two diverging GMA concepts, depending on whether the GMA assessment is carried out by the Commission and the EMA or by a national competent authority.

| 3. | The General Court violated the system of decentralised application of Union pharmaceuticals legislation as established by Regulation 726/2004 (2) and Directive 2001/83, the principles of conferral of powers and subsidiarity as laid down in Article 5 TEU, the principle of mutual trust, as well as Articles 6(1), 30 and 31 of Directive 2001/83, and Articles 57(1) and 60 of Regulation 726/2004 by concluding the Commission and the EMA have the competence and the obligation — within the framework of the assessment of whether two medicinal products belong to the same GMA — to carry out a re-assessment or verification of the previous assessment by a national competent authority of the qualitative composition in terms of active substances of one of those medicinal products. |
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3.

The General Court violated the system of decentralised application of Union pharmaceuticals legislation as established by Regulation 726/2004 (2) and Directive 2001/83, the principles of conferral of powers and subsidiarity as laid down in Article 5 TEU, the principle of mutual trust, as well as Articles 6(1), 30 and 31 of Directive 2001/83, and Articles 57(1) and 60 of Regulation 726/2004 by concluding the Commission and the EMA have the competence and the obligation — within the framework of the assessment of whether two medicinal products belong to the same GMA — to carry out a re-assessment or verification of the previous assessment by a national competent authority of the qualitative composition in terms of active substances of one of those medicinal products.

| 4. | The General Court exceeded the limits of judicial review by substituting its own scientific assessment for that of the competent regulatory authorities. |
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4.

The General Court exceeded the limits of judicial review by substituting its own scientific assessment for that of the competent regulatory authorities.

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(1)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001, L 311, p. 67).

(2)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004, L 136, p. 1).

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