do-me/EUR-LEX huggingface dataset:
Case T-211/18: Action brought on 26 March 2018 — Vanda Pharmaceuticals v Commission
Date: 2018-03-26
Institutions: General Court
Subjects: drug surveillance, equal treatment, market approval, medicinal product








C_2018190EN.01003502.xml










4.6.2018   


EN


Official Journal of the European Union


C 190/35





Action brought on 26 March 2018 — Vanda Pharmaceuticals v Commission
(Case T-211/18)
(2018/C 190/59)
Language of the case: English

Parties


Applicant: Vanda Pharmaceuticals Ltd (London, United Kingdom) (represented by: M. Meulenbelt, B. Natens, A.-S. Melin, and C. Muttin, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:






—


annul Commission Implementing Decision C(2018) 252 final of 15 January 2018 refusing marketing authorisation under Regulation (EC) No 726/2004 for ‘Fanaptum — iloperidone’, a medicinal product for human use, together with the scientific conclusions and grounds for refusal of 9 November 2017 and the Assessment Report of the Committee for Medicinal Products for Human Use of 9 November 2017;










—


in the alternative, annul only the said Commission Implementing Decision C(2018) 252 final;










—


order the European Commission to pay the applicant’s costs.





Pleas in law and main arguments

In support of the action, the applicant relies on five pleas in law.






1.


First plea in law, alleging that the risk assessment of the arrhythmogenic potential of iloperidone is based on a failure to state reasons (and, in any event, is manifestly erroneous), and violates the principle of equal treatment.










2.


Second plea in law, alleging that the assessment of the risk minimisation measures proposed for iloperidone is based on a failure to state reasons (and, in any event, is manifestly erroneous), and violates Articles 5(1) and 5(4) of the Treaty on European Union (TEU) and the principle of equal treatment.










3.


Third plea in law, alleging that the assessment of the consequences of the delayed onset of iloperidone is based on a failure to state reasons and violates Articles 5(1) and 5(4) TEU.










4.


Fourth plea in law, alleging that the requirement to identify a population in which iloperidone would outperform other products violates Article 5(1), 5(2) and 5(3) TEU, Articles 12 and 81(2) of Regulation 726/2004, (1) and the principle of equal treatment.










5.


Fifth plea in law, alleging that the overall risk-benefit assessment of iloperidone is based on a failure to state reasons (and, in any event, is manifestly erroneous).






(1)  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 (OJ 2004 L 136, p. 1).
Information concerning the entry into force of the Agreement between the European Community and the Government of the Republic of India on certain aspects of air services
Date: 2018-03-26
Institutions: Council of the European Union
Subjects: India, agreement (EU), air transport








L_2018082EN.01000101.xml










26.3.2018   


EN


Official Journal of the European Union


L 82/1







Information concerning the entry into force of the Agreement between the European Community and the Government of the Republic of India on certain aspects of air services

The Agreement between the European Community and the Government of the Republic of India on certain aspects of air services, signed in Marseille on 28 September 2008, entered into force on 21 February 2018, in accordance with Article 7(1) of the Agreement, as the last notification was deposited on 21 February 2018.
Non-opposition to a notified concentration (Case M.8772 — Borealis/Nova Chemicals/Total/JV) (Text with EEA relevance. )
Date: 2018-03-26
Institutions: European Commission
Subjects: chemical industry, economic concentration, energy industry, fertiliser, gas industry, marketing, merger control, oil industry








C_2018111EN.01002101.xml










26.3.2018   


EN


Official Journal of the European Union


C 111/21





Non-opposition to a notified concentration
(Case M.8772 — Borealis/Nova Chemicals/Total/JV)
(Text with EEA relevance)
(2018/C 111/02)
On 20 March 2018, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:






—


in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,










—


in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32017M8772. EUR-Lex is the online access to European law.






(1)  OJ L 24, 29.1.2004, p. 1.
Corrigendum to Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award of concession contracts (OJ L 94, 28.3.2014)
Date: 2018-03-26
Institutions: Council of the European Union, European Parliament
Subjects: administrative transparency, award of contract, invitation to tender, principle of legal certainty, services contract, single market, works contract








L_2018082EN.01001702.xml










26.3.2018   


EN


Official Journal of the European Union


L 82/17







Corrigendum to Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award of concession contracts

(
Official Journal of the European Union L 94 of 28 March 2014
)


On page 56 and on page 57, Annex IV, table, first row (heading):
for:







‘Description


CPV Code’,





read:







‘CPV Code


Description’.
Non-opposition to a notified concentration (Case M.8806 — Richemont/Yoox Net-a-Porter Group) (Text with EEA relevance. )
Date: 2018-03-26
Institutions: European Commission
Subjects: economic concentration, electronic commerce, holding company, luxury products industry, merger control, retail trade








C_2018111EN.01002201.xml










26.3.2018   


EN


Official Journal of the European Union


C 111/22





Non-opposition to a notified concentration
(Case M.8806 — Richemont/Yoox Net-a-Porter Group)
(Text with EEA relevance)
(2018/C 111/04)
On 19 March 2018, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:






—


in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,










—


in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32018M8806. EUR-Lex is the online access to European law.






(1)  OJ L 24, 29.1.2004, p. 1.
Case C-215/18: Request for a preliminary ruling from the District Court for Prague 8 (Czech Republic) lodged on 26 March 2018 — Libuše Králová v Primera Air Scandinavia
Date: 2018-03-26
Institutions: Court of Justice
Subjects: air transport, carriage of passengers, consumer protection, contract, indemnification, private international law, travel agency








C_2018190EN.01001301.xml










4.6.2018   


EN


Official Journal of the European Union


C 190/13





Request for a preliminary ruling from the District Court for Prague 8 (Czech Republic) lodged on 26 March 2018 — Libuše Králová v Primera Air Scandinavia
(Case C-215/18)
(2018/C 190/17)
Language of the case: Czech

Referring court

District Court for Prague 8

Parties to the main proceedings


Applicant: Libuše Králová

Defendant: Primera Air Scandinavia

Questions referred







1.


Did a contractual relationship exist between the applicant and the defendant for the purposes of Article 5(1) of [Council] Regulation No 44/2001 (1) on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, even though no contract had been concluded between the applicant and the defendant and the flight was part of a package of services provided on the basis of a contract between the applicant and a third party (travel agency)?










2.


Can that relationship be qualified as a consumer relationship in accordance with Section 4, Article 15 to Article 17 of [Council] Regulation No 44/2001 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters?










3.


Does the defendant have legal capacity to be sued in an action seeking satisfaction of the claims arising from Regulation [(EC)] No 261/2004 [of the European Parliament and of the Council] of 11 February 2004, establishing common rules on compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights, and repealing Regulation (EEC) No 295/91?






(1)  OJ 2001 L 12, p. 1.
Euro exchange rates
Date: 2018-03-26
Institutions: European Commission
Subjects: euro, exchange rate, money








C_2018111EN.01002301.xml










26.3.2018   


EN


Official Journal of the European Union


C 111/23





Euro exchange rates (1)

23 March 2018
(2018/C 111/06)

1 euro =











 


Currency


Exchange rate




USD


US dollar


1,2346 




JPY


Japanese yen


129,74 




DKK


Danish krone


7,4478 




GBP


Pound sterling


0,87285 




SEK


Swedish krona


10,1943 




CHF


Swiss franc


1,1703 




ISK


Iceland króna


122,10 




NOK


Norwegian krone


9,5715 




BGN


Bulgarian lev


1,9558 




CZK


Czech koruna


25,405 




HUF


Hungarian forint


312,90 




PLN


Polish zloty


4,2262 




RON


Romanian leu


4,6630 




TRY


Turkish lira


4,8880 




AUD


Australian dollar


1,5978 




CAD


Canadian dollar


1,5868 




HKD


Hong Kong dollar


9,6889 




NZD


New Zealand dollar


1,7024 




SGD


Singapore dollar


1,6216 




KRW


South Korean won


1 330,30 




ZAR


South African rand


14,5204 




CNY


Chinese yuan renminbi


7,7975 




HRK


Croatian kuna


7,4398 




IDR


Indonesian rupiah


16 993,03 




MYR


Malaysian ringgit


4,8365 




PHP


Philippine peso


64,640 




RUB


Russian rouble


70,5388 




THB


Thai baht


38,495 




BRL


Brazilian real


4,0726 




MXN


Mexican peso


22,8804 




INR


Indian rupee


80,2550 






(1)  Source: reference exchange rate published by the ECB.
Corrigendum to public holidays 2018 (OJ C 8, 11.1.2018)
Date: 2018-03-26
Institutions: European Commission
Subjects: EU Member State, public holiday








C_2018111EN.01003601.xml










26.3.2018   


EN


Official Journal of the European Union


C 111/36





Corrigendum to public holidays 2018
(
Official Journal of the European Union C 8 of 11 January 2018
)
(2018/C 111/11)
On page 14, in the table, the entry for ‘Nederland’:

for:


‘1.1, 1.4, 2.4, 27.4, 10.5, 20.5, 21.5, 25.12, 26.12’,


read:


‘1.1, 1.4, 2.4, 27.4, 10.5, 11.5, 20.5, 21.5, 24.12, 25.12, 26.12, 31.12’.
Non-opposition to a notified concentration (Case M.8821 — Advent International/Circet Groupe) (Text with EEA relevance. )
Date: 2018-03-26
Institutions: European Commission
Subjects: distributor, economic concentration, investment company, merger control, telecommunications








C_2018111EN.01002202.xml










26.3.2018   


EN


Official Journal of the European Union


C 111/22





Non-opposition to a notified concentration
(Case M.8821 — Advent International/Circet Groupe)
(Text with EEA relevance)
(2018/C 111/05)
On 19 March 2018, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:






—


in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,










—


in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32018M8821. EUR-Lex is the online access to European law.






(1)  OJ L 24, 29.1.2004, p. 1.
Non-opposition to a notified concentration (Case M.8799 — Marubeni Itochu Steel/Sumitomo Corporation/JV) (Text with EEA relevance. )
Date: 2018-03-26
Institutions: European Commission
Subjects: economic concentration, investment company, iron and steel industry, merger control








C_2018111EN.01002102.xml










26.3.2018   


EN


Official Journal of the European Union


C 111/21





Non-opposition to a notified concentration
(Case M.8799 — Marubeni Itochu Steel/Sumitomo Corporation/JV)
(Text with EEA relevance)
(2018/C 111/03)
On 19 March 2018, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:






—


in the merger section of the Competition website of the Commission (http://ec.europa.eu/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,










—


in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32018M8799. EUR-Lex is the online access to European law.






(1)  OJ L 24, 29.1.2004, p. 1.
Corrigendum to Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory (OJ L 68, 13.3.2015)
Date: 2018-03-26
Institutions: Council of the European Union, European Parliament
Subjects: crop production, genetically modified organism, internal border of the EU, location of production, plant health control, transfrontier pollution








L_2018082EN.01001701.xml










26.3.2018   


EN


Official Journal of the European Union


L 82/17







Corrigendum to Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory

(
Official Journal of the European Union L 68 of 13 March 2015
)


On page 1, footnote 2:
for:







‘(2)



OJ C 102, 2.4.2011, p. 62.’,





read:







‘(2)



OJ C 104, 2.4.2011, p. 62.’.