projetos

Revision admitted on refusal to renew drug authorization

BVerwG 3 B 27/14, 3 B 27/14 (3 C 15/15)Bverwg / Divisão 36 de jul. de 2015Granted

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Extraído pela Omnilex

Resumo Omnilex

The Federal Administrative Court upheld the complaint against non-admission of revision. It found the matter of fundamental significance because it is likely to clarify when renewal of a medicinal product authorization may be refused under Section 31(3) AMG in conjunction with Section 25(2) sentence 1 no. 5 AMG, namely where the benefit-risk balance is unfavorable. The decision only concerned admission of revision and did not decide the merits.

Sumário Omnilex

§ 132 Abs. 2 Nr. 1 VwGO; admission of revision for fundamental significance in a dispute over refusal to renew a medicinal product authorization under § 31 Abs. 3 in conjunction with § 25 Abs. 2 sentence 1 no. 5 AMG. Fundamental significance exists where the dispute raises an unresolved legal question of general importance that is suitable to be clarified in revision proceedings (consid. 1). The court need not itself resolve the substantive question; it suffices that the case is likely to provide occasion for clarifying the legal requirements of the contested administrative refusal.

Texto completo

BVerwG — 3 B 27/14, 3 B 27/14 (3 C 15/15), Beschluss

Entscheidungsdatum: 2015-07-06

Aktenzeichen: 3 B 27/14, 3 B 27/14 (3 C 15/15)

ECLI: ECLI:DE:BVerwG:2015:060715B3B27.14.0

Dokumenttyp: Beschluss

Normen: § 132 Abs 2 Nr 1 VwGO, § 31 Abs 3 AMG 1976, § 25 Abs 2 S 1 Nr 5 AMG 1976

Vorinstanz: vorgehend Oberverwaltungsgericht für das Land Nordrhein-Westfalen, 29. Januar 2014, Az: 13 A 2755/12, Urteilvorgehend VG Köln, 23. Oktober 2012, Az: 7 K 211/11, Urteil

Spruchkörper: 3. Senat

Titelzeile

Revisionszulassung; Voraussetzungen für eine Versagung der Verlängerung einer Arzneimittelzulassung

Gründe

1 Die Beschwerde hat Erfolg. Der Rechtssache kommt die geltend gemachte grundsätzliche Bedeutung (§ 132 Abs. 2 Nr. 1 VwGO) zu. Sie wird dem Bundesverwaltungsgericht voraussichtlich Gelegenheit zur Klärung der Voraussetzungen für die Versagung der Verlängerung einer Arzneimittelzulassung nach § 31 Abs. 3 i.V.m. § 25 Abs. 2 Satz 1 Nr. 5 AMG (ungünstiges Nutzen-Risiko-Verhältnis) geben.

2 Die vorläufige Streitwertfestsetzung für das Revisionsverfahren beruht auf § 47 Abs. 1, § 52 Abs. 1 und § 63 Abs. 1 Satz 1 GKG.

Palavras-chave

revision admissionfundamental significancedrug authorizationbenefit-risk balanceadministrative law

Extraído pela Omnilex

Questões jurídicas principais extraídas pela Omnilex

Questão jurídica principal

Whether revision should be admitted for fundamental significance regarding refusal to extend a medicinal product authorization.

Decisão extraída

Yes. The case raises a question of fundamental significance, because the Federal Administrative Court is likely to clarify the requirements for refusing renewal under Section 31(3) in conjunction with Section 25(2) sentence 1 no. 5 AMG.

Fundamentação extraída

The legal question whether an unfavorable benefit-risk balance justifies refusal of renewal under the cited provisions was not yet clarified and is suitable for review in revision proceedings.

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