Court of Justice of the European Union · EU
Judgment of the General Court (Fifth Chamber) of 23 September 2026 (Extracts).#Advanz Pharma Ltd v European Commission.#Public health – Medicinal products for human use – Orphan medicinal product for human use Ocaliva – obeticholic acid – Revocation of the conditional marketing authorisation – Procedure for review – Procedure initiated without awaiting the outcome of the renewal procedure – Consultation of an ad-hoc expert group by the EMA’s Committee for Medicinal Products for Human Use – Impartiality of the experts consulted – Declaration of a conflict of interest – Procedural defect – Principle of sound administration – Article 116 of Directive 2001/83/EC, as amended by Directive 2004/27/EC – Manifest errors of assessment – Legitimate expectations – Proportionality – Article 57 of Regulation (EC) No 726/2004 as amended by Regulation (EU) 2019/5.#Case T-455/24.
- Identifier
- CELEX 62024TJ0455_EXT
- Status
- decided
- Decided
- 23 September 2026
- Official source
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:62024TJ0455_EXT
- Source provider
- eurlex
- Retrieved
- 2026-09-23T08:46:29.504Z
Identifier
- CELEX: 62024TJ0455_EXT
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