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3 B 9/18, 3 B 9/18 (3 C 19/18) ECLI:DE:BVerwG:2018:121218B3B9.18.0 AI generated

Delimitation of functional medicines from food supplements for purposes of leave to appeal

Case Number 3 B 9/18, 3 B 9/18 (3 C 19/18)
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) allowed the plaintiff's complaint and granted leave to appeal for the revision proceeding, ruling that the plaintiff prevailed in the procedural stage by establishing the fundamental significance of the legal issue. The dispute concerned the regulatory classification of a product, specifically the legal distinction between a functional medicine and a food supplement, challenging the administrative authority's determination of its legal nature as a medicine. The decisive legal basis for the admission of the revision was § 132 Abs. 2 Nr. 1 VwGO, invoked to enable the court to further refine the standards for differentiating functional medicines from food supplements.

Legislator headnote

AI generated

§ 132 Abs. 2 Nr. 1 VwGO, § 63 Abs. 1 Satz 1 GKG, § 47 Abs. 1 Satz 1 GKG, § 52 Abs. 1 GKG; Delimitation of functional medicines from food supplements for purposes of leave to appeal: The dispute concerned the regulatory classification of a product, specifically the legal distinction between a functional medicine and a food supplement, challenging the administrative authority's determination of its legal nature as a medicine. The decisive legal basis for the admission of the revision was § 132 Abs. 2 Nr. 1 VwGO, invoked to enable the court to further refine the standards for differentiating functional medicines from food supplements.

Keywords

AI generated
food supplements procedural revision products concerned proceeds administrative complaint decisions on medical matters

Cited Legislation

AI generated
§ 132 Abs. 2 Nr. 1 VwGO
Serves as the main ground for granting leave to appeal the revision due to the fundamental significance of the legal issue.
§ 63 Abs. 1 Satz 1 GKG
Procedural basis cited for the preliminary determination of the amount in dispute in the revision proceeding.
§ 47 Abs. 1 Satz 1 GKG
Procedural basis cited for the preliminary determination of the amount in dispute in the revision proceeding.
§ 52 Abs. 1 GKG
Procedural basis cited for the preliminary determination of the amount in dispute in the revision proceeding.
AI generated
3 B 1/22
BVerwG: Consideration of post-administrative evidence in drug vs. supplement classification under § 21 AMG
3 B 14/20, 3 B 14/20 (3 C 20/20)
Health-related mandatory labels on special medical foods: sufficiency to preclude classification as presentation medicines regardless of balanced diet compliance
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
I ZR 19/08
Ginkgo extract beverage classified as functional pharmaceutical where vague consumption recommendation permits reaching pharmacological threshold under normal use
VII R 10/11
Tax classification of medical formula as beverage versus food preparation; insufficient revision grounds for challenging lower court’s EU tariff and VAT analysis

Key legal questions extracted by Legislator

AI generated
§ 132 Abs. 2 Nr. 1 VwGO

Serves as the main ground for granting leave to appeal the revision due to the fundamental significance of the legal issue.

§ 47 Abs. 1 Satz 1 GKG

Procedural basis cited for the preliminary determination of the amount in dispute in the revision proceeding.

§ 52 Abs. 1 GKG

Procedural basis cited for the preliminary determination of the amount in dispute in the revision proceeding.

§ 63 Abs. 1 Satz 1 GKG

Procedural basis cited for the preliminary determination of the amount in dispute in the revision proceeding.

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Full text

Revisionszulassung; Arzneimitteleigenschaft; Abgrenzung Funktionsarzneimittel von Nahrungsergänzungsmittel

[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 kann dem Bundesverwaltungsgericht Gelegenheit zur weiteren Präzisierung der Maßstäbe bieten, nach denen Funktionsarzneimittel von Nahrungsergänzungsmitteln abzugrenzen sind.

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