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3 B 64/11, 3 B 64/11 (3 C 10/12) AI generated

Permissibility of changing a drug's applicable areas in post-approval proceedings and the legal consequences of such changes

Case Number 3 B 64/11, 3 B 64/11 (3 C 10/12)
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 and found the legal matter to have fundamental significance under § 132 Abs. 2 Nr. 1 VwGO, thereby permitting further proceedings to clarify the definition and consequences of an impermissible change in a drug's applicable areas during post-approval procedures. The dispute concerned the validity of modifications to the designated areas of application for a pharmaceutical product within the post-authorization regulatory framework. The decisive legal basis is the threshold for fundamental significance in administrative appeals, which triggers a review of when changes to a medicinal product's approved indications are deemed impermissible and what legal repercussions such changes entail.

Legislator headnote

AI generated

§ 132 Abs. 2 Nr. 1 VwGO; Permissibility of changing a drug's applicable areas in post-approval proceedings and the legal consequences of such changes: 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 Frage bieten, wann eine im Nachzulassungsverfahren unzulässige Änderung der Anwendungsgebiete eines Arzneimittels anzunehmen ist und welche Konsequenzen sich aus einer solchen Änderung ergeben.

Keywords

AI generated
administrative compliance medicinal products review procedures matter in dispute amendment of authorisation effects of a preliminary ruling

Cited Legislation

AI generated
§ 132 Abs. 2 Nr. 1 VwGO
Die Rechtssache hat grundsätzliche Bedeutung im Sinne des § 132 Abs. 2 Nr. 1 VwGO.
AI generated
3 C 10/12
Unlawful change from curative to adjuvant indication during pharmaceutical post-authorization procedure
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 25/09
Scope of post-approval dosing conditions versus mandatory refusal grounds for homeopathic medicines
3 C 11/10
Whether preclusion of defect correction bars asserting alternative drug marketing authorization based on approval in another EU member state

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Full text

Nachzulassungsverfahren; unzulässige Änderung der Anwendungsgebiete; 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 Frage bieten, wann eine im Nachzulassungsverfahren unzulässige Änderung der Anwendungsgebiete eines Arzneimittels anzunehmen ist und welche Konsequenzen sich aus einer solchen Änderung ergeben.