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3 B 27/14, 3 B 27/14 (3 C 15/15) ECLI:DE:BVerwG:2015:060715B3B27.14.0 Generato dall'IA

Preconditions for refusing extension of pharmaceutical marketing authorization based on unfavorable benefit-risk profile

Numero d'incarto 3 B 27/14, 3 B 27/14 (3 C 15/15)
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 (BVerwG) granted the appellant's complaint and allowed the appeal for reasons of fundamental significance, thereby remitting the case for further review. The dispute concerns the prerequisites for the refusal to extend a pharmaceutical marketing authorization on the basis of an unfavorable benefit-risk profile. The decisive legal basis involves the interpretation and application of § 31 Abs. 3 in conjunction with § 25 Abs. 2 Satz 1 Nr. 5 of the German Pharmaceutical Act (AMG), which governs the conditions under which a medicine's authorization can be denied extension due to safety or efficacy concerns.

Regesto Legislator

Generato dall'IA

§ 132 Abs. 2 Nr. 1 VwGO, § 63 Abs. 1 Satz 1 GKG, § 47 Abs. 1 GKG, § 52 Abs. 1 GKG; Preconditions for refusing extension of pharmaceutical marketing authorization based on unfavorable benefit-risk profile: The dispute concerns the prerequisites for the refusal to extend a pharmaceutical marketing authorization on the basis of an unfavorable benefit-risk profile. The decisive legal basis involves the interpretation and application of § 31 Abs. 3 in conjunction with § 25 Abs. 2 Satz 1 Nr. 5 of the German Pharmaceutical Act (AMG), which governs the conditions under which a medicine's authorization can be denied extension due to safety or efficacy concerns.

Parole chiave

Generato dall'IA
utili e rischi reclamo amministrativo motivi di sicurezza motivo di revisione giustificato motivo per il mancato uso medicinali

Disposizioni normative citate

Generato dall'IA
§ 132 Abs. 2 Nr. 1 VwGO
Cited as the legal basis for granting leave to appeal on grounds of fundamental significance in the operative order.
§ 63 Abs. 1 Satz 1 GKG
Cited in the dispositive for the preliminary determination of the amount in dispute for costs.
§ 47 Abs. 1 GKG
Cited in the dispositive for the preliminary determination of the amount in dispute for costs.
§ 52 Abs. 1 GKG
Cited in the dispositive for the preliminary determination of the amount in dispute for costs.
Generato dall'IA
3 B 26/14, 3 B 26/14 (3 C 14/15)
Conditions for refusing renewal of pharmaceutical license based on unfavorable benefit-risk ratio under German Medicines Act
3 B 63/12, 3 B 63/12 (3 C 10/13)
Pharmaceutical authorization denial: Clarifying prerequisites for rejecting combination product justification under § 25 AMG
3 B 69/16, 3 B 69/16 (3 C 4/18)
Standing to challenge exemption of pharmacist-manufactured drug from marketing authorization under § 42(2) VwGO and § 21 AMG
3 C 19/09
Medicinal product license: Impossibility of imposing substantive contraindications via information-text conditions under § 28 AMG
3 C 15/15
Extension of marketing authorization for homeopathic drug: burden of proof for lack of efficacy and benefit-risk assessment in renewal proceedings

Questioni giuridiche chiave estratte da Legislator

Generato dall'IA
§ 132 Abs. 2 Nr. 1 VwGO

Cited as the legal basis for granting leave to appeal on grounds of fundamental significance in the operative order.

§ 47 Abs. 1 GKG

Cited in the dispositive for the preliminary determination of the amount in dispute for costs.

§ 52 Abs. 1 GKG

Cited in the dispositive for the preliminary determination of the amount in dispute for costs.

§ 63 Abs. 1 Satz 1 GKG

Cited in the dispositive for the preliminary determination of the amount in dispute for costs.

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Testo completo

Revisionszulassung; Voraussetzungen für eine Versagung der Verlängerung einer Arzneimittelzulassung

[GRUENDE]

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.

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