CSL Behring GmbH v European Commission and European Medicines Agency (EMA) (T-264/07)

Judgment of 9 Sept 2010

law://eu/cjeu/2007/t-264-07/para_117@2026-11-12

117The Court observes that any trader with regard to whom an institution has given rise to justified hopes may rely on the principle of protection of legitimate expectations (Case T-489/93 Unifruit Hellas v Commission [1994] ECR II-1201, paragraph 51, and Case T-70/99 Alpharma v Council [2002] ECR II-3495, paragraph 374; see, to that effect, Case 78/77 Lührs [1978] ECR 169, paragraph 6). However, a person may not plead a breach of that principle unless he has been given precise assurances (Case T-290/97 Mehibas Dordtselaan v Commission [2000] ECR II-15, paragraph 59). Likewise, where a prudent and discriminating trader could have foreseen the adoption of a measure at European Union level likely to affect his interests, he cannot plead that principle if the measure is adopted (Joined Cases T-481/93 and T-484/93 Exporteurs in Levende Varkens and Others v Commission [1995] ECR II-2941, paragraph 148, and Alpharma v Council, paragraph 374; see, to that effect, Lührs, paragraph 6).

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History · 1 version

9 Sept 2010Reading

Key facts

Court: General Court · Fifth Chamber
Case: T-264/07 · ECLI:EU:T:2010:371
Decided: 9 Sept 2010
Procedure: Action for annulment
Applicant: CSL Behring GmbH
Defendants: European Commission; and; European Medicines Agency (EMA)
Rapporteur: M. Prek
Bench: 3 judges
M. Vilaras, M. Prek, V.M. Ciucă
Language: German
Official: CURIA · EUR-Lex 62007TJ0264

Topics

Approximation of laws

Judgment of 9 Sept 2010

117The Court observes that any trader with regard to whom an institution has given rise to justified hopes may rely on the principle of protection of legitimate expectations (Case T-489/93 Unifruit Hellas v Commission [1994] ECR II-1201, paragraph 51, and Case T-70/99 Alpharma v Council [2002] ECR II-3495, paragraph 374; see, to that effect, Case 78/77 Lührs [1978] ECR 169, paragraph 6). However, a person may not plead a breach of that principle unless he has been given precise assurances (Case T-290/97 Mehibas Dordtselaan v Commission [2000] ECR II-15, paragraph 59). Likewise, where a prudent and discriminating trader could have foreseen the adoption of a measure at European Union level likely to affect his interests, he cannot plead that principle if the measure is adopted (Joined Cases T-481/93 and T-484/93 Exporteurs in Levende Varkens and Others v Commission [1995] ECR II-2941, paragraph 148, and Alpharma v Council, paragraph 374; see, to that effect, Lührs, paragraph 6).

Connections

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Cited by 4: Vanda Pharmaceuticals Ltd v European Commission (T-211/18); Shire Pharmaceuticals Ireland Ltd v European Medicines Agency (T-80/16); Teva Pharma BV and Teva Pharmaceuticals Europe BV v European Medicines Agency (EMA) (T-140/12)2 provisions; Arch Chemicals, Inc. and Arch Timber Protection Ltd, Rhodia UK Ltd, Sumitomo Chemical (UK) plc and Troy Chemical Co. BV v European Commission (T-400/04)
Cites 20: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use; Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance); Vereniging van Exporteurs in Levende Varkens and others and Nederlandse Bond van Waaghouders van Levend Vee and others v Commission of the European Communities (T-481/93, T-484/93); Alpharma Inc. v Council of the European Union (T-70/99); LR AF 1998 A/S, formerly Løgstør Rør A/S v Commission of the European Communities (T-23/99); Federal Republic of Germany v Council of the European Union (C-280/93); The Queen v The Competition Commission, Secretary of State for Trade and Industry and The Director General of Fair Trading, ex parte Milk Marque Ltd and National Farmers' Union (C-137/00); Affish BV v Rijksdienst voor de keuring van Vee en Vlees (C-183/95); Mehibas Dordtselaan BV v Commission of the European Communities (T-290/97); Edouard Dubois et Fils SA v Council of the European Union and Commission of the European Communities (T-113/96); Sermide SpA v Cassa Conguaglio Zucchero and others (106/83); Unifruit Hellas EPE v Commission of the European Communities (T-489/93); SCA Holding Ltd v Commission of the European Communities (T-327/94); Johann Lührs v Hauptzollamt Hamburg-Jonas (78/77); Streamserve Inc. v European Union Intellectual Property Office (T-106/00); Council of the European Union v Boehringer Ingelheim Vetmedica GmbH and C. H. Boehringer Sohn (C-23/00 P); The Queen v Minister of Agriculture, Fisheries and Food and Secretary of State for Health, ex parte: Fedesa and others (C-331/88); Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products; Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products; Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts 'similar medicinal product' and 'clinical superiority'