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3 B 63/12, 3 B 63/12 (3 C 10/13) KI-generiert

Pharmaceutical authorization denial: Clarifying prerequisites for rejecting combination product justification under § 25 AMG

Geschäftsnummer 3 B 63/12, 3 B 63/12 (3 C 10/13)
Gericht / Behörde
Rechtsordnung Deutschland (DE)
Entscheiddatum
Ausgang Gutgeheissen (Allowed)
Originalquelle öffnen Maschinenlesbares Markdown (.md)

Legislator-Zusammenfassung

KI-generiert

The Federal Administrative Court (BVerwG) granted the plaintiff's leave to appeal, finding the complaint well-founded and ruling that the case holds fundamental significance, thereby permitting a revision proceeding to further clarify the legal standards for denying pharmaceutical approval. The dispute concerned the refusal of a drug marketing authorization due to alleged insufficient justification for a combination product, challenging the administrative agency's decision under the German Medicines Act. The decisive legal basis for the admission of the appeal was § 132 Abs. 2 Nr. 1 VwGO, citing the need for judicial clarification of the prerequisites for denying authorization under § 25 Abs. 2 Satz 1 Nr. 5a AMG, with the interim matter worth in revision calculated pursuant to §§ 47, 52, and 63 GKG.

Legislator-Regeste

KI-generiert

§ 132 Abs. 2 Nr. 1 VwGO, § 63 Abs. 1 Satz 1 GKG, § 25 Abs. 2 Satz 1 Nr. 5a AMG, § 47 Abs. 1 i.V.m. § 52 Abs. 1 und § 63 Abs. 1 Satz 1 GKG; Pharmaceutical authorization denial: Clarifying prerequisites for rejecting combination product justification under § 25 AMG: The dispute concerned the refusal of a drug marketing authorization due to alleged insufficient justification for a combination product, challenging the administrative agency's decision under the German Medicines Act. The decisive legal basis for the admission of the appeal was § 132 Abs. 2 Nr. 1 VwGO, citing the need for judicial clarification of the prerequisites for denying authorization under § 25 Abs. 2 Satz 1 Nr. 5a AMG, with the interim matter worth in revision calculated pursuant to §§ 47, 52, and 63 GKG.

Schlagwörter

KI-generiert
Erfasste Erzeugnisse Revisionsgründe Streitgegenstand Verwaltungsbeschwerde Verfahrensrügen Klagebewilligung
KI-generiert
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Standing to challenge exemption of pharmacist-manufactured drug from marketing authorization under § 42(2) VwGO and § 21 AMG
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WBRE201900874
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WBRE201700003
Pharmaceutical data protection: Admissibility of objection for lack of due process against refusal to refer preliminary questions on second marketing authorization applications

Zentrale Rechtsfragen, extrahiert von Legislator

KI-generiert
§ 132 Abs. 2 Nr. 1 VwGO

Grounds for admitting the appeal due to fundamental significance.

§ 25 Abs. 2 Satz 1 Nr. 5a AMG

Substantive legal provision for the denial of pharmaceutical authorization, identified as the key issue for clarification in the revision.

§ 47 Abs. 1 i.V.m. § 52 Abs. 1 und § 63 Abs. 1 Satz 1 GKG

Basis for the provisional determination of the amount in dispute for the revision proceedings.

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Volltext

Arzneimittelzulassung; Versagung wegen unzureichender Kombinationsbegründung; Revisionszulassung

[GRUENDE]

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.

Die vorläufige Streitwertfestsetzung für das Revisionsverfahren beruht auf § 47 Abs. 1 i.V.m. § 52 Abs. 1 und § 63 Abs. 1 Satz 1 GKG.