Legislator Case Law & Legislation
DE FR IT EN
Analyze in Legislator
3 B 69/16, 3 B 69/16 (3 C 4/18) ECLI:DE:BVerwG:2018:220218B3B69.16.0 AI generated

Standing to challenge exemption of pharmacist-manufactured drug from marketing authorization under § 42(2) VwGO and § 21 AMG

Case Number 3 B 69/16, 3 B 69/16 (3 C 4/18)
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 appeal and referred the case for revision, finding that the matter possesses fundamental legal significance. The dispute concerns the standing of an authorized medicinal product holder under § 42(2) VwGO to challenge a determination by the Federal Institute for Drugs and Medical Devices (BfArM) that a comparable, pharmacist-manufactured drug is exempt from the marketing authorization requirement. The decisive legal questions involve the interpretation of the standing provision in administrative court proceedings and the extent of fundamental rights protection for entrepreneurial professional activity in the pharmaceutical market regarding participation in competition, specifically under the Pharmaceuticals Act (AMG) §§ 21(2) No. 1 and 21(4).

Legislator headnote

AI generated

§ 132 Abs. 2 Nr. 1 VwGO, § 42 Abs. 2 VwGO, § 63 Abs. 1 Satz 1 GKG, § 47 Abs. 1 GKG, § 52 Abs. 1 GKG; Standing to challenge exemption of pharmacist-manufactured drug from marketing authorization under § 42(2) VwGO and § 21 AMG: The dispute concerns the standing of an authorized medicinal product holder under § 42(2) VwGO to challenge a determination by the Federal Institute for Drugs and Medical Devices (BfArM) that a comparable, pharmacist-manufactured drug is exempt from the marketing authorization requirement. The decisive legal questions involve the interpretation of the standing provision in administrative court proceedings and the extent of fundamental rights protection for entrepreneurial professional activity in the pharmaceutical market regarding participation in competition, specifically under the Pharmaceuticals Act (AMG) §§ 21(2) No. 1 and 21(4).

Keywords

AI generated
standing to appeal medicinal products legal protection grounds of challenge matter in dispute exemption from the prohibition

Cited Legislation

AI generated
§ 132 Abs. 2 Nr. 1 VwGO
Ground for granting leave to appeal on appeal on grounds of fundamental legal significance.
§ 42 Abs. 2 VwGO
§ 63 Abs. 1 Satz 1 GKG
Provision cited for the provisional determination of the amount in dispute for the revision proceedings.
§ 47 Abs. 1 GKG
Provision cited for the provisional determination of the amount in dispute for the revision proceedings.
§ 52 Abs. 1 GKG
Provision cited for the provisional determination of the amount in dispute for the revision proceedings.
AI generated
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 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 17/17, 3 B 17/17 (3 C 3/18)
Admissibility of declaratory action against lifting of pharmaceutical prescription requirement under § 48 AMG
3 C 41/10
Competitor action against mail-order pharmacy license: lack of standing due to absent third-protective effect of statutory requirements and non-planned market
3 C 4/18
Third-party challenge to drug licensing exemption: protective effect of AMG § 21 for competing license holders.

Key legal questions extracted by Legislator

AI generated
§ 132 Abs. 2 Nr. 1 VwGO

Ground for granting leave to appeal on appeal on grounds of fundamental legal significance.

§ 47 Abs. 1 GKG

Provision cited for the provisional determination of the amount in dispute for the revision proceedings.

§ 52 Abs. 1 GKG

Provision cited for the provisional determination of the amount in dispute for the revision proceedings.

§ 63 Abs. 1 Satz 1 GKG

Provision cited 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

Revisionszulassung; Klagebefugnis des Inhabers einer Arzneimittelzulassung gegen eine Feststellung des BfArM; Arzneimittelmarkt und Wettbewerb

[GRUENDE]

Die Beschwerde der Klägerin hat Erfolg. Der Rechtssache kommt die geltend gemachte grundsätzliche Bedeutung im Sinne von § 132 Abs. 2 Nr. 1 VwGO zu. Das Revisionsverfahren wird dem Bundesverwaltungsgericht voraussichtlich Gelegenheit zur Klärung der Frage geben, ob der Inhaber einer Arzneimittelzulassung gemäß § 42 Abs. 2 VwGO befugt ist, die einem wettbewerbsrechtlichen Unterlassungsanspruch entgegenstehende Feststellung des Bundesinstituts für Arzneimittel und Medizinprodukte anzufechten, dass ein vergleichbares Arzneimittel, das von einem Apotheker hergestellt wird, nicht der Zulassungspflicht unterliegt (§ 21 Abs. 2 Nr. 1, Abs. 4 AMG). Zudem bietet das Revisionsverfahren voraussichtlich Gelegenheit zu einer weitergehenden Klärung von Inhalt und Reichweite des Grundrechtsschutzes der unternehmerischen Berufstätigkeit am Arzneimittelmarkt unter dem Gesichtspunkt der Teilhabe am Wettbewerb.

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