Legislator Case Law & Legislation
DE FR IT EN
Analyze in Legislator
3 B 63/12, 3 B 63/12 (3 C 10/13) AI generated

Pharmaceutical authorization denial: Clarifying prerequisites for rejecting combination product justification under § 25 AMG

Case Number 3 B 63/12, 3 B 63/12 (3 C 10/13)
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 (BVerwG) granted the plaintiff's leave to appeal, finding the complaint well-founded and ruling that the case holds fundamental significance, thereby permitting a revision proceeding to further clarify the legal standards for denying pharmaceutical approval. The dispute concerned the refusal of a drug marketing authorization due to alleged insufficient justification for a combination product, challenging the administrative agency's decision under the German Medicines Act. The decisive legal basis for the admission of the appeal was § 132 Abs. 2 Nr. 1 VwGO, citing the need for judicial clarification of the prerequisites for denying authorization under § 25 Abs. 2 Satz 1 Nr. 5a AMG, with the interim matter worth in revision calculated pursuant to §§ 47, 52, and 63 GKG.

Legislator headnote

AI generated

§ 132 Abs. 2 Nr. 1 VwGO, § 63 Abs. 1 Satz 1 GKG, § 25 Abs. 2 Satz 1 Nr. 5a AMG, § 47 Abs. 1 i.V.m. § 52 Abs. 1 und § 63 Abs. 1 Satz 1 GKG; Pharmaceutical authorization denial: Clarifying prerequisites for rejecting combination product justification under § 25 AMG: The dispute concerned the refusal of a drug marketing authorization due to alleged insufficient justification for a combination product, challenging the administrative agency's decision under the German Medicines Act. The decisive legal basis for the admission of the appeal was § 132 Abs. 2 Nr. 1 VwGO, citing the need for judicial clarification of the prerequisites for denying authorization under § 25 Abs. 2 Satz 1 Nr. 5a AMG, with the interim matter worth in revision calculated pursuant to §§ 47, 52, and 63 GKG.

Keywords

AI generated
products concerned grounds for revision matter in dispute administrative complaint procedural objections authorization to sue

Cited Legislation

AI generated
§ 132 Abs. 2 Nr. 1 VwGO
Grounds for admitting the appeal due to fundamental significance.
§ 63 Abs. 1 Satz 1 GKG
1 und § 63 Abs. 1 Satz 1 GKG.
§ 25 Abs. 2 Satz 1 Nr. 5a AMG
Substantive legal provision for the denial of pharmaceutical authorization, identified as the key issue for clarification in the revision.
§ 47 Abs. 1 i.V.m. § 52 Abs. 1 und § 63 Abs. 1 Satz 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 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 B 40/13
Pharmaceutical re-marketing authorization: constitutional validity of preclusion bar on deficiency-curing documents and evidentiary standards for therapeutic efficacy
3 C 3/18
Administrative-law standing to challenge prescription status of a registered medicinal product: admissibility of declaratory action against norm-giver and limits of discretion under § 48 AMG
3 C 9/16, 3 C 9/16 (3 C 18/14)
Pharmaceutical data protection: Admissibility of objection for lack of due process against refusal to refer preliminary questions on second marketing authorization applications

Key legal questions extracted by Legislator

AI generated
§ 132 Abs. 2 Nr. 1 VwGO

Grounds for admitting the appeal due to fundamental significance.

§ 25 Abs. 2 Satz 1 Nr. 5a AMG

Substantive legal provision for the denial of pharmaceutical authorization, identified as the key issue for clarification in the revision.

§ 47 Abs. 1 i.V.m. § 52 Abs. 1 und § 63 Abs. 1 Satz 1 GKG

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

Need to analyze how this precedent applies to your matter?

Cross-reference this judgment against statutes, commentaries, and subsequent citing case law inside Legislator AI.

Open in Legislator →

Full text

Arzneimittelzulassung; Versagung wegen unzureichender Kombinationsbegründung; Revisionszulassung

[GRUENDE]

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 Voraussetzungen für die Versagung einer Arzneimittelzulassung nach § 25 Abs. 2 Satz 1 Nr. 5a AMG bieten.

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