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3 B 26/14, 3 B 26/14 (3 C 14/15) ECLI:DE:BVerwG:2015:060715B3B26.14.0 AI generated

Conditions for refusing renewal of pharmaceutical license based on unfavorable benefit-risk ratio under German Medicines Act

Case Number 3 B 26/14, 3 B 26/14 (3 C 14/15)
Court / Authority
Jurisdiction Germany (DE)
Decision Date
Outcome Allowed / Granted
Open official source Machine-readable Markdown (.md)

Legislator summary

AI generated

The Federal Administrative Court granted the complainant's appeal, admitting the revision and finding the case to have fundamental significance, thereby requiring the matter to proceed to the full court for clarification of the legal standards governing the refusal to renew a drug license. The dispute centered on the conditions under which the renewal of a pharmaceutical marketing authorization can be denied specifically due to an unfavorable benefit-risk ratio. The decision rests on the procedural requirement for fundamental significance under Section 132(2)(1) of the Administrative Court Procedure Act, in conjunction with the substantive grounds for refusing renewal under Section 31(3) in conjunction with Section 25(2) Sentence 1 Number 5 of the German Medicines Act.

Legislator headnote

AI generated

§ 132 Abs. 2 Nr. 1 VwGO, § 63 Abs. 1 Satz 1 GKG, § 47 Abs. 1 GKG, § 52 Abs. 1 GKG; Conditions for refusing renewal of pharmaceutical license based on unfavorable benefit-risk ratio under German Medicines Act: The dispute centered on the conditions under which the renewal of a pharmaceutical marketing authorization can be denied specifically due to an unfavorable benefit-risk ratio. The decision rests on the procedural requirement for fundamental significance under Section 132(2)(1) of the Administrative Court Procedure Act, in conjunction with the substantive grounds for refusing renewal under Section 31(3) in conjunction with Section 25(2) Sentence 1 Number 5 of the German Medicines Act.

Keywords

AI generated
renewal of authorization benefits and risks matter in dispute non-renewal of contract administrative complaint grounds for revision

Cited Legislation

AI generated
§ 132 Abs. 2 Nr. 1 VwGO
Ground for admitting the revision because the case has fundamental significance.
§ 63 Abs. 1 Satz 1 GKG
Basis for the provisional determination of the amount in dispute for the revision proceedings.
§ 47 Abs. 1 GKG
Basis for the provisional determination of the amount in dispute for the revision proceedings.
§ 52 Abs. 1 GKG
Basis for the provisional determination of the amount in dispute for the revision proceedings.
AI generated
3 B 27/14, 3 B 27/14 (3 C 15/15)
Preconditions for refusing extension of pharmaceutical marketing authorization based on unfavorable benefit-risk profile
3 C 2/11
Renewal of legacy drug authorization: strict interpretation of "public health danger" and tolerance of deviations from EU reference authorization
3 C 19/09
Medicinal product license: Impossibility of imposing substantive contraindications via information-text conditions under § 28 AMG
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 VR 1/17, 3 VR 1/17 (3 B 69/16)
Suspensive effect of third-party challenge to pharmaceutical license exemption: restoration not justified despite pending revision on standing

Key legal questions extracted by Legislator

AI generated
§ 132 Abs. 2 Nr. 1 VwGO

Ground for admitting the revision because the case has fundamental significance.

§ 47 Abs. 1 GKG

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

§ 52 Abs. 1 GKG

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

§ 63 Abs. 1 Satz 1 GKG

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

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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.