do-me/EUR-LEX huggingface dataset:
Case C-118/24, Laboratoires Eurogenerics and Theramex France: Request for a preliminary ruling from the Conseil d’État (France) lodged on 14 February 2024 - EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS v Agence nationale de sécurité du médicament et des produits de santé (ANSM) and Biogaran SAS
Date: 2024-02-14
Institutions: Court of Justice
Subjects: drug surveillance, jurisdiction, legal action, market approval, medicinal product, national competent authority, public health








C_202403440EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/3440


10.6.2024






Request for a preliminary ruling from the Conseil d’État (France) lodged on 14 February 2024 – EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS v Agence nationale de sécurité du médicament et des produits de santé (ANSM) and Biogaran SAS


(Case C-118/24, Laboratoires Eurogenerics and Theramex France)

(C/2024/3440)
Language of the case: French

Referring court

Conseil d'État

Parties to the main proceedings


Applicants: EG Labo Laboratoires Eurogenerics SAS, Theramex France SAS

Defendant: Agence nationale de sécurité du médicament et des produits de santé (ANSM), Biogaran SAS

Other parties to the proceedings: Eli Lilly Nederland BV, Lilly France SAS

Questions referred







1.


Should Articles 28 and 29 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 (1) be interpreted as meaning that a court of a Member State involved in a decentralised marketing authorisation procedure without being the reference Member State, which has jurisdiction to hear an action brought against that decision granting marketing authorisation taken by the competent authority of that Member State in accordance with what the Court held in its judgment of 14 March 2018, Astellas Pharma (C-557/16), is competent, in such a case, to verify that the decentralised procedure was conducted in compliance with the provisions of Directive 2001/83/EC and that the placing of the medicinal product on the market does not present a potential serious risk to public health within the meaning of Article 29(1) of that directive?










2.


Should Article 10 of Directive 2001/83/EC be interpreted as meaning that it precludes a marketing authorisation from being granted to a chemical medicinal product in accordance with the simplified procedure laid down in Article 10(1) of that directive where the reference medicinal product is a biological medicinal product?






(1)  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 (OJ 2001 L 311, p. 67).


ELI: http://data.europa.eu/eli/C/2024/3440/oj
ISSN 1977-091X (electronic edition)
Information communicated by Member States regarding closure of fisheries
Date: 2024-02-14
Institutions: Directorate-General for Maritime Affairs and Fisheries, European Commission
Subjects: Atlantic Ocean, EU Member State, catch by species, catch quota, fishing area, fishing rights, international waters, sea fish, sea fishing








C_202401493EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2024/1493


14.2.2024






Information communicated by Member States regarding closure of fisheries
(C/2024/1493)

In accordance with Article 35(3) of Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy (1), a decision has been taken to close the fishery as set down in the following table:






Date and time of closure


22.12.2023




Duration


22.12.2023 - 31.12.2023




Member State


European Union (All Member States)




Stock or Group of stocks


COD/N3M.




Species


Cod (Gadus Morhua)




Zone


NAFO 3M




Type(s) of fishing vessels


—




Reference number


23/TQ194






(1)  
            OJ L 343, 22.12.2009, p. 1.


ELI: http://data.europa.eu/eli/C/2024/1493/oj
ISSN 1977-091X (electronic edition)
Political and Security Committee Decision (CFSP) 2024/644 of 14 February 2024 on the appointment of the EU Force Commander for the European Union maritime security operation to safeguard freedom of navigation in relation to the Red Sea crisis (EUNAVFOR ASPIDES/1/2024)
Date: 2024-02-14
Institutions: Political and Security Committee
Subjects: EU military mission, Red Sea, appointment of members, deterrent, freedom of navigation, maritime economy, maritime safety, maritime shipping, military personnel, piracy








L_202400644EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2024/644


19.2.2024







            POLITICAL AND SECURITY COMMITTEE DECISION (CFSP) 2024/644
of 14 February 2024
         
on the appointment of the EU Force Commander for the European Union maritime security operation to safeguard freedom of navigation in relation to the Red Sea crisis (EUNAVFOR ASPIDES/1/2024)


THE POLITICAL AND SECURITY COMMITTEE,

Having regard to the Treaty on European Union, and in particular Article 38 thereof,


Having regard to Council Decision (CFSP) 2024/583 of 8 February 2024 on a European Union maritime security operation to safeguard freedom of navigation in relation to the Red Sea crisis (EUNAVFOR ASPIDES) (1), and in particular Article 4(2) thereof,

Whereas:







(1)


On 8 February 2024, the Council adopted Decision (CFSP) 2024/583, which established a military European Union maritime security operation to safeguard freedom of navigation in relation to the Red Sea crisis (EUNAVFOR ASPIDES).












(2)


Pursuant to Decision (CFSP) 2024/583, the Council authorised the Political and Security Committee to take decisions on the appointment of the EU Force Commander for EUNAVFOR ASPIDES.












(3)


On 9 February 2024, the Italian military authorities proposed the appointment of Rear Admiral Stefano COSTANTINO as the EU Force Commander for EUNAVFOR ASPIDES (‘the proposed appointment’).












(4)


On 13 February 2024, the EU Military Committee supported the proposed appointment.












(5)


A decision on the appointment of the EU Force Commander for EUNAVFOR ASPIDES should be taken,





HAS ADOPTED THIS DECISION:



Article 1
Rear Admiral Stefano COSTANTINO is hereby appointed as EU Force Commander for the European Union maritime security operation to safeguard freedom of navigation in relation to the Red Sea crisis (EUNAVFOR ASPIDES).


Article 2
This Decision shall enter into force on the date of its adoption.




Done at Brussels, 14 February 2024.


For the Political and Security Committee


The Chairperson

D. PRONK
            





(1)  
            OJ L, 2024/583, 12.2.2024, ELI: http://data.europa.eu/eli/dec/2024/583/oj.


ELI: http://data.europa.eu/eli/dec/2024/644/oj
ISSN 1977-0677 (electronic edition)