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3 B 17/17, 3 B 17/17 (3 C 3/18) ECLI:DE:BVerwG:2018:080218B3B17.17.0 AI generated

Admissibility of declaratory action against lifting of pharmaceutical prescription requirement under § 48 AMG

Case Number 3 B 17/17, 3 B 17/17 (3 C 3/18)
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 granted the plaintiff's complaint and permitted an appeal to the highest administrative court, effectively allowing the plaintiff to proceed in challenging the regulatory change. The dispute arose from a declaratory action against the state authority that enacted the Pharmaceutical Prescribing Regulation, specifically contesting the withdrawal of the prescription requirement for a medicinal product originally licensed nationally. The decisive legal basis for permitting the revision was the fundamental significance of the question under § 132 Abs. 2 Nr. 1 VwGO: whether the holder of a national marketing authorization can legally pursue the lifting of the mandatory prescription status (governed by § 48 Abs. 2 Satz 1 Nr. 3 AMG) through a declaratory claim against the issuing authority of the applicable prescription regulation.

Legislator headnote

AI generated

§ 132 Abs. 2 Nr. 1 VwGO, § 52 Abs. 1 GKG, § 63 Abs. 1 Satz 1 GKG, § 47 Abs. 1 Satz 1 und Abs. 3 i.V.m. § 52 Abs. 1 GKG; Admissibility of declaratory action against lifting of pharmaceutical prescription requirement under § 48 AMG: The dispute arose from a declaratory action against the state authority that enacted the Pharmaceutical Prescribing Regulation, specifically contesting the withdrawal of the prescription requirement for a medicinal product originally licensed nationally. The decisive legal basis for permitting the revision was the fundamental significance of the question under § 132 Abs. 2 Nr. 1 VwGO: whether the holder of a national marketing authorization can legally pursue the lifting of the mandatory prescription status (governed by § 48 Abs. 2 Satz 1 Nr. 3 AMG) through a declaratory claim against the issuing authority of the applicable prescription regulation.

Keywords

AI generated
prescription withdrawal of action declaratory decision status action administrative authority legal status

Cited Legislation

AI generated
§ 132 Abs. 2 Nr. 1 VwGO
Basis for permitting the revision due to the fundamental significance of the legal issue.
§ 52 Abs. 1 GKG
§ 52 Abs. 1 GKG; die vorläufige Festsetzung des Streitwerts für das Revisionsverfahren beruht auf § 63 Abs.
§ 63 Abs. 1 Satz 1 GKG
Legal basis for the provisional determination of the amount in dispute for the revision proceedings.
§ 47 Abs. 1 Satz 1 und Abs. 3 i.V.m. § 52 Abs. 1 GKG
Legal basis for the determination of the amount in dispute for the complaint proceedings.
AI generated
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 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 63/12, 3 B 63/12 (3 C 10/13)
Pharmaceutical authorization denial: Clarifying prerequisites for rejecting combination product justification under § 25 AMG
3 B 64/11, 3 B 64/11 (3 C 10/12)
Permissibility of changing a drug's applicable areas in post-approval proceedings and the legal consequences of such changes
1 BvR 2424/20
Constitutional complaint against ban on commercial prescription brokering dismissed for failure to exhaust administrative declaratory action

Key legal questions extracted by Legislator

AI generated
§ 132 Abs. 2 Nr. 1 VwGO

Basis for permitting the revision due to the fundamental significance of the legal issue.

§ 47 Abs. 1 Satz 1 und Abs. 3 i.V.m. § 52 Abs. 1 GKG

Legal basis for the determination of the amount in dispute for the complaint proceedings.

§ 63 Abs. 1 Satz 1 GKG

Legal basis for the provisional determination of the amount in dispute for the revision proceedings.

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Full text

Revisionszulassung; Klage gegen die Aufhebung der Verschreibungspflicht für ein Arzneimittel

[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 Klärung der Frage bieten, ob der Inhaber einer nationalen Arzneimittelzulassung die Aufhebung der Verschreibungspflicht (§ 48 Abs. 2 Satz 1 Nr. 3 AMG) durch eine gegen den Normgeber der Arzneimittelverschreibungsverordnung gerichtete Feststellungsklage verfolgen kann (vgl. Fuhrmann, MedR 2017, 653).

Die Streitwertfestsetzung für das Beschwerdeverfahren folgt aus § 47 Abs. 1 Satz 1 und Abs. 3 i.V.m. § 52 Abs. 1 GKG; die vorläufige Festsetzung des Streitwerts für das Revisionsverfahren beruht auf § 63 Abs. 1 Satz 1 GKG.