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3 B 67/14, 3 B 67/14 (3 C 18/15) ECLI:DE:BVerwG:2015:250815B3B67.14.0 AI generated

Classification of imported live leeches as medicinal products under German Medicines Act and distinction from raw precursors

Case Number 3 B 67/14, 3 B 67/14 (3 C 18/15)
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 allowed the plaintiff's appeal for leave to appeal, finding that the case possesses fundamental legal significance, thereby directing the matter to the court for substantive review. The dispute concerns the classification of imported live leeches under German pharmaceutical law, specifically whether they constitute a medicinal product requiring a licensing for import and marketing or merely a raw precursor used in pharmaceutical preparation. The decisive legal issues involve the precise definition of a "medicinal product" under Section 2 of the German Medicines Act (AMG) and the judicial distinction between a finished drug and a simple precursor substance.

Legislator headnote

AI generated

§ 132 Abs. 2 Nr. 1 VwGO, § 63 Abs. 1 Satz 1 GKG, § 47 Abs. 1, § 52 Abs. 1, § 63 Abs. 1 Satz 1 GKG; Classification of imported live leeches as medicinal products under German Medicines Act and distinction from raw precursors: The dispute concerns the classification of imported live leeches under German pharmaceutical law, specifically whether they constitute a medicinal product requiring a licensing for import and marketing or merely a raw precursor used in pharmaceutical preparation. The decisive legal issues involve the precise definition of a "medicinal product" under Section 2 of the German Medicines Act (AMG) and the judicial distinction between a finished drug and a simple precursor substance.

Keywords

AI generated
medicinal products judicial review matter in dispute classification, labelling and packaging food legislation anti-dumping legislation

Cited Legislation

AI generated
§ 132 Abs. 2 Nr. 1 VwGO
Legal basis for admitting the appeal due to the question of fundamental significance.
§ 63 Abs. 1 Satz 1 GKG
1, § 63 Abs. 1 Satz 1 GKG.
§ 47 Abs. 1, § 52 Abs. 1, § 63 Abs. 1 Satz 1 GKG
Provisions governing the calculation and provisional determination of the value in dispute for the appeal proceedings.
AI generated
3 C 18/15
Live medicinal leeches as import medicines: requirement of essential post-import processing to exclude status under § 2 AMG
5 C 3/22
Beihilfefähigkeit of imported pharmaceuticals: dynamic reference to AMG definitions and lawful marketing requirement for pharmacy-only status
5 C 4/22
Beihilfe eligibility for unapproved foreign supplements: requirement of lawful market placement in exporting state under AMG § 73
3 B 1/22
BVerwG: Consideration of post-administrative evidence in drug vs. supplement classification under § 21 AMG
3 B 9/18, 3 B 9/18 (3 C 19/18)
Delimitation of functional medicines from food supplements for purposes of leave to appeal

Key legal questions extracted by Legislator

AI generated
§ 132 Abs. 2 Nr. 1 VwGO

Legal basis for admitting the appeal due to the question of fundamental significance.

§ 47 Abs. 1, § 52 Abs. 1, § 63 Abs. 1 Satz 1 GKG

Provisions governing the calculation and provisional determination of the value in dispute for the appeal proceedings.

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Full text

Revisionszulassung; Präzisierung des Arzneimittelbegriffs und Abgrenzung zum Vorprodukt

[GRUENDE]

Die Beschwerde hat Erfolg. Der Rechtssache kommt die von der Klägerin geltend gemachte grundsätzliche Bedeutung zu (§ 132 Abs. 2 Nr. 1 VwGO).

Das Revisionsverfahren wird dem Senat voraussichtlich Gelegenheit geben, den Arzneimittelbegriff nach § 2 AMG und die Abgrenzung eines Arzneimittels von einem bloßen Vorprodukt bei der arzneilichen Aufbereitung von aus dem Ausland importierten Stoffen (hier: lebend gefangene Blutegel) weiter zu präzisieren.

Die vorläufige Streitwertfestsetzung für das Revisionsverfahren beruht auf § 47 Abs. 1, § 52 Abs. 1, § 63 Abs. 1 Satz 1 GKG. Im Unterschied zu den Vorinstanzen geht der Senat davon aus, dass die mit der Feststellungsklage zur Klärung gestellte arzneimittelrechtliche Erlaubnisbedürftigkeit der Einfuhr lebender Wildegel wirtschaftlich mit dem Geschäftszweig ihrer arzneilichen Vermarktung gleichzusetzen ist. Damit ist nach dem Streitwertkatalog für die Verwaltungsgerichtsbarkeit (Nr. 25.1) der Jahresbetrag der erwarteten wirtschaftlichen Auswirkungen maßgeblich; diesen schätzt der Senat vorläufig auf den festgesetzten Betrag.