Preconditions for refusing extension of pharmaceutical marketing authorization based on unfavorable benefit-risk profile
Germany (DE)
Legislator summary
AI generatedThe 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.
Legislator headnote
AI generated§ 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.
Keywords
AI generatedCited Legislation
AI generatedRelated Decisions
AI generatedKey legal questions extracted by Legislator
AI generatedCited as the legal basis for granting leave to appeal on grounds of fundamental significance in the operative order.
Cited in the dispositive for the preliminary determination of the amount in dispute for costs.
Cited in the dispositive for the preliminary determination of the amount in dispute for costs.
Cited in the dispositive for the preliminary determination of the amount in dispute for costs.
Full text
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.