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3 B 11/22, 3 B 11/22 (3 C 9/23) ECLI:DE:BVerwG:2023:160523B3B11.22.0 Generato dall'IA

Parallel import authorization violating original holder's rights due to non-compliant labeling under the Medicines Act

Numero d'incarto 3 B 11/22, 3 B 11/22 (3 C 9/23)
Autorità giudiziaria
Giurisdizione Germania (DE)
Data della decisione
Esito del giudizio Accolto (Allowed)
Apri la fonte ufficiale Versione Markdown leggibile dalle macchine (.md)

Sintesi Legislator

Generato dall'IA

The Federal Administrative Court overturned the Higher Administrative Court of North Rhine-Westphalia's decision refusing to admit an appeal and granted the plaintiff leave to appeal to the Federal Administrative Court. The case concerns a pharmaceutical marketing authorization holder challenging the approval of a parallel import of the same medicinal product from another EU/EEA member state, specifically alleging that the import violates the original holder's rights due to non-compliant labeling. The Court found the complaint well-founded and admitted the revision under § 132 Abs. 2 Nr. 1 VwGO due to the general significance of the legal question regarding whether and to what extent the grant of a parallel import authorization violates the rights of the original German marketing authorization holder when the imported product's labeling does not meet the requirements of § 10 Abs. 8 Satz 3 of the German Medicines Act (AMG).

Regesto Legislator

Generato dall'IA

§ 132 Abs. 2 Nr. 1 VwGO, § 52 Abs. 1 GKG, § 63 Abs. 1 Satz 1 i. V. m. § 47 Abs. 1 und 3 und § 52 Abs. 1 GKG; Parallel import authorization violating original holder's rights due to non-compliant labeling under the Medicines Act: The case concerns a pharmaceutical marketing authorization holder challenging the approval of a parallel import of the same medicinal product from another EU/EEA member state, specifically alleging that the import violates the original holder's rights due to non-compliant labeling. The Court found the complaint well-founded and admitted the revision under § 132 Abs. 2 Nr. 1 VwGO due to the general significance of the legal question regarding whether and to what extent the grant of a parallel import authorization violates the rights of the original German marketing authorization holder when the imported product's labeling does not meet the requirements of § 10 Abs. 8 Satz 3 of the German Medicines Act (AMG).

Parole chiave

Generato dall'IA
medicinali reclamo amministrativo esenzioni all'importazione e all'esportazione ricorso per inadempienza restrizioni e diritti di proprietà intellettuale licenza d'importazione

Disposizioni normative citate

Generato dall'IA
§ 132 Abs. 2 Nr. 1 VwGO
Die Revision ist gemäß § 132 Abs. 2 Nr. 1 VwGO wegen grundsätzlicher Bedeutung der Rechtssache zuzulassen.
§ 52 Abs. 1 GKG
1 und 3 und § 52 Abs. 1 GKG.
§ 63 Abs. 1 Satz 1 i. V. m. § 47 Abs. 1 und 3 und § 52 Abs. 1 GKG
Cited in the dispositive as the basis for the preliminary determination of the amount in dispute (Streitwert) for the revision proceedings.
Generato dall'IA
3 C 9/23
Parallel import of pharmaceuticals: applicability of EU labeling directives and direct effect of exemption clauses for primary packaging stability issues.
I ZR 239/14
Trademark exhaustion in parallel import: Binding effect of regulatory authority's authorization on civil court assessment of labeling compliance
I ZR 99/12
Markenrecht: Zulässigkeit des Umpackens parallelimportierter Arzneimittel zur Beseitigung künstlicher Marktabschottung
I ZR 152/13
Parallel import of CE-marked medical products: obligation to conduct new conformity assessment for translated labels and instructions
3 C 30/13
Permissibility of cross-border pharmaceutical supply via EU pharmacy invoice under German pharmacy management and import restrictions

Questioni giuridiche chiave estratte da Legislator

Generato dall'IA
§ 63 Abs. 1 Satz 1 i. V. m. § 47 Abs. 1 und 3 und § 52 Abs. 1 GKG

Cited in the dispositive as the basis for the preliminary determination of the amount in dispute (Streitwert) for the revision proceedings.

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Testo completo

Revisionszulassung; Inverkehrbringen eines Arzneimittels

[TENOR]

Die Entscheidung des Oberverwaltungsgerichts für das Land Nordrhein-Westfalen über die Nichtzulassung der Revision im Urteil vom 14. Dezember 2021 wird aufgehoben.

Die Revision wird zugelassen.

Die Entscheidung über die Kosten des Beschwerdeverfahrens folgt der Kostenentscheidung in der Hauptsache.

Der Wert des Streitgegenstandes wird für das Revisionsverfahren vorläufig auf 50 000 € festgesetzt.

[GRUENDE]

Die zulässige Beschwerde der Klägerin ist begründet. Die Revision ist gemäß § 132 Abs. 2 Nr. 1 VwGO wegen grundsätzlicher Bedeutung der Rechtssache zuzulassen. Sie wird voraussichtlich zur Klärung der Frage beitragen, ob und inwieweit der Inhaber einer arzneimittelrechtlichen Zulassung zum Inverkehrbringen eines Arzneimittels in Deutschland durch die Erteilung einer Zulassung des Parallelimports des Arzneimittels aus einem EU-/EWR-Mitgliedstaat in eigenen Rechten verletzt wird, wenn die Kennzeichnung des zu importierenden Arzneimittels nicht den Anforderungen des § 10 Abs. 8 Satz 3 AMG entspricht.

Die vorläufige Festsetzung des Streitwerts für das Revisionsverfahren beruht auf § 63 Abs. 1 Satz 1 i. V. m. § 47 Abs. 1 und 3 und § 52 Abs. 1 GKG.