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Revision allowed due to fundamental question in post-authorization procedure

BVerwG 3 B 64/11, 3 B 64/11 (3 C 10/12)Bverwg / 3a divisione7 feb 2012Granted

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Sintesi Omnilex

The Federal Administrative Court upheld the plaintiff’s complaint against the refusal of leave to appeal. It held that the case raises a question of fundamental importance under § 132(2) No. 1 VwGO: when a post-authorization change in a medicinal product’s indications is impermissible and what legal consequences follow. The decision therefore opens revision proceedings for further clarification.

Massima Omnilex

§ 132 Abs. 2 Nr. 1 VwGO; post-authorization procedure under the AMG; leave to appeal for fundamental importance: A complaint against the denial of leave to appeal is well founded where the case presents a legally unresolved and generally clarifiable question, here concerning when a change of a medicinal product’s indications in post-authorization proceedings is impermissible and which consequences attach to such a change. Fundamental importance exists if the revision may contribute to clarifying a question of abstract legal significance requiring further appellate development (consid. 1).

Testo completo

BVerwG — 3 B 64/11, 3 B 64/11 (3 C 10/12), Beschluss

Entscheidungsdatum: 2012-02-07

Aktenzeichen: 3 B 64/11, 3 B 64/11 (3 C 10/12)

Dokumenttyp: Beschluss

Normen: § 132 Abs 2 Nr 1 VwGO, AMG 1976

Vorinstanz: vorgehend Oberverwaltungsgericht für das Land Nordrhein-Westfalen, 13. April 2011, Az: 13 A 58/09, Urteil

Spruchkörper: 3. Senat

Titelzeile

Nachzulassungsverfahren; unzulässige Änderung der Anwendungsgebiete; Revisionszulassung

Gründe

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 Frage bieten, wann eine im Nachzulassungsverfahren unzulässige Änderung der Anwendungsgebiete eines Arzneimittels anzunehmen ist und welche Konsequenzen sich aus einer solchen Änderung ergeben.

Parole chiave

post-authorization proceduremedicinal productsindicationsleave to appealfundamental importancerevision admission

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Questioni giuridiche chiave estratte da Omnilex

Questione giuridica chiave

Whether the complaint against denial of leave to appeal should be upheld because the case raises a question of fundamental importance under § 132(2) No. 1 VwGO.

Decisione estratta

Yes. The case may clarify when a post-authorization change to a medicinal product's indications is impermissible and what consequences follow.

Motivazione estratta

The legal question is unresolved and suitable for clarification in revision proceedings, so the statutory ground for leave to appeal is met.

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