BVerwG 3 B 63/12, 3 B 63/12 (3 C 10/13)•Revision allowed in pharmaceutical authorization dispute
BVerwG 3 B 63/12, 3 B 63/12 (3 C 10/13)Bverwg / Divisão 317 de mai. de 2013Granted
Extraído pela Omnilex
The Federal Administrative Court upheld the plaintiff’s complaint and admitted revision. It found that the case had fundamental importance because the revision could clarify when refusal of a medicinal product authorization is permissible under § 25(2) sentence 1 no. 5a AMG 1976. The court also provisionally fixed the amount in dispute for the revision proceedings.
§ 132 Abs. 2 Nr. 1 VwGO; admission of revision for fundamental importance in medicinal product authorization cases; revision may be admitted where the dispute raises a clarifiable legal question concerning the conditions for refusing authorization under § 25 Abs. 2 sentence 1 no. 5a AMG 1976. The requirement of fundamental importance is satisfied when the appeal court identifies a need for further clarification of the abstract legal standard by the revising court. The provisional determination of the amount in dispute follows § 47 Abs. 1, § 52 Abs. 1, § 63 Abs. 1 sentence 1 GKG.
Entscheidungsdatum: 2013-05-17
Aktenzeichen: 3 B 63/12, 3 B 63/12 (3 C 10/13)
Dokumenttyp: Beschluss
Normen: § 132 Abs 2 Nr 1 VwGO, § 25 Abs 2 S 1 Nr 5a AMG 1976
Vorinstanz: vorgehend Oberverwaltungsgericht für das Land Nordrhein-Westfalen, 5. Juli 2012, Az: 13 A 1638/10, Urteil
Spruchkörper: 3. Senat
Arzneimittelzulassung; Versagung wegen unzureichender Kombinationsbegründung; Revisionszulassung
1 Die Beschwerde der Klägerin ist begründet. Die Rechtssache hat grundsätzliche Bedeutung im Sinne des § 132 Abs. 2 Nr. 1 VwGO. Das Revisionsverfahren kann Gelegenheit zur weiteren Klärung der Voraussetzungen für die Versagung einer Arzneimittelzulassung nach § 25 Abs. 2 Satz 1 Nr. 5a AMG bieten.
2 Die vorläufige Streitwertfestsetzung für das Revisionsverfahren beruht auf § 47 Abs. 1 i.V.m. § 52 Abs. 1 und § 63 Abs. 1 Satz 1 GKG.
Extraído pela Omnilex
Whether the complaint justified admission of revision for fundamental importance in a medicinal product authorization dispute.
Yes. The case had fundamental importance because the revision could clarify the requirements for refusing a medicinal product authorization under § 25(2) sentence 1 no. 5a AMG 1976.
The legal question remained in need of further clarification, so the matter was suitable for revision.
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