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51 records in EU in 2025

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Record· CJCELEX 62023CJ0731_SUMdecided

Judgment of the Court (Second Chamber) of 18 December 2025.#Nicoventures Trading Ltd and Others v European Commission.#Appeal – Public health – Heated tobacco products – Withdrawal of certain exemptions – Delegated Directive EU 2022/2100 – Action for annulment – Standing – Fourth paragraph of Article 263 TFEU – Condition that the applicant must be individually concerned by the contested act – Limited class of economic operators – Reporting and notification obligations – Marketing authorisation.#Case C-731/23 P.

European Union · Court of Justice of the European Union · 18 December 2025

Record· CJCELEX 62023CJ0731decided

Judgment of the Court (Second Chamber) of 18 December 2025.#Nicoventures Trading Ltd and Others v European Commission.#Appeal – Public health – Heated tobacco products – Withdrawal of certain exemptions – Delegated Directive (EU) 2022/2100 – Action for annulment – Standing – Fourth paragraph of Article 263 TFEU – Condition that the applicant must be individually concerned by the contested act – Limited class of economic operators – Reporting and notification obligations – Marketing authorisation.#Case C-731/23 P.

European Union · Court of Justice of the European Union · 18 December 2025

Record· TJCELEX 62023TJ0536_RESdecided

Judgment of the General Court (Sixth Chamber) of 3 December 2025.#AlzChem Trostberg GmbH v European Commission.#Public health – Biocidal products – Decision not approving cyanamide as an existing active substance for use in biocidal products of product-types 3 and 18 – Regulation (EU) No 528/2012 – Transitional measures – Manifest error of assessment – Proportionality.#Case T-536/23.

European Union · Court of Justice of the European Union · 3 December 2025

Record· TJCELEX 62023TJ0536decided

Judgment of the General Court (Sixth Chamber) of 3 December 2025.#AlzChem Trostberg GmbH v European Commission.#Public health – Biocidal products – Decision not approving cyanamide as an existing active substance for use in biocidal products of product-types 3 and 18 – Regulation (EU) No 528/2012 – Transitional measures – Manifest error of assessment – Proportionality.#Case T-536/23.

European Union · Court of Justice of the European Union · 3 December 2025

Report· CCCELEX 62024CC0118decided

Opinion of Advocate General Emiliou delivered on 23 October 2025.#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.#Request for a preliminary ruling from the Conseil d'État.#Reference for a preliminary ruling – Directive 2001/83/EC – Medicinal products for human use – Articles 28 and 29 – Decentralised procedure for marketing authorisation for a medicinal product – Article 10 – Generic medicinal product – Abridged procedure for granting a marketing authorisation – Biological medicinal product serving as reference medicinal product for a chemical medicinal product – Jurisdiction of the courts of the Member States concerned to determine whether there is a potential serious risk for public health – Jurisdiction of those courts to review the conditions for granting a marketing authorisation for a generic medicinal product.#Case C-118/24.

European Union · Court of Justice of the European Union · 23 October 2025

Record· TJCELEX 62022TJ0483_RESdecided

Judgment of the General Court (Fifth Chamber, Extended Composition) of 24 September 2025.#Sanofi BV, anciennement Genzyme Europe BV v European Commission.#Public health – Medicinal products for human use – Marketing authorisation for the medicinal product Nexviadyme (avalglucosidase alfa) – Non-recognition of avalglucosidase alfa as a new active substance – Directive 2001/83/EC – Regulation (EC) No 726/2004 – Commission document ‘Notice to Applicants, Volume 2A, Procedures for marketing authorisation, Chapter 1, Marketing Authorisation’ – Standard of proof – Obligation to state reasons – Principle of good administration – Right to be heard – Decision to remove the medicinal product from the European Union Register of Orphan Medicinal Products – Regulation (EC) No 141/2000 – Regulation (EC) No 847/2000 – Significant benefit – Standard of proof – Obligation to state reasons.#Case T-483/22.

European Union · Court of Justice of the European Union · 24 September 2025

Record· TJCELEX 62024TJ0354_RESdecided

Judgment of the General Court (Sixth Chamber) of 24 September 2025.#Mowi Poland S.A. v European Commission.#Public health – Specific hygiene rules for food of animal origin – Regulation (EC) No 853/2004 – Point 3(e) of the Annex to Delegated Regulation (EU) 2024/1141 – Action for annulment – Locus standi – Interest in bringing proceedings – Admissibility – Concept of ‘frozen product’ – Lack of consultation with EFSA – Article 13 of Regulation No 853/2004.#Case T-354/24.

European Union · Court of Justice of the European Union · 24 September 2025

Record· TJCELEX 62024TJ0354decided

Judgment of the General Court (Sixth Chamber) of 24 September 2025.#Mowi Poland S.A. v European Commission.#Public health – Specific hygiene rules for food of animal origin – Regulation (EC) No 853/2004 – Point 3(e) of the Annex to Delegated Regulation (EU) 2024/1141 – Action for annulment – Locus standi – Interest in bringing proceedings – Admissibility – Concept of ‘frozen product’ – Lack of consultation with EFSA – Article 13 of Regulation No 853/2004.#Case T-354/24.

European Union · Court of Justice of the European Union · 24 September 2025

Record· TJCELEX 62022TJ0483decided

Judgment of the General Court (Fifth Chamber, Extended Composition) of 24 September 2025.#Sanofi BV, anciennement Genzyme Europe BV v European Commission.#Public health – Medicinal products for human use – Marketing authorisation for the medicinal product Nexviadyme (avalglucosidase alfa) – Non-recognition of avalglucosidase alfa as a new active substance – Directive 2001/83/EC – Regulation (EC) No 726/2004 – Commission document ‘Notice to Applicants, Volume 2A, Procedures for marketing authorisation, Chapter 1, Marketing Authorisation’ – Standard of proof – Obligation to state reasons – Principle of good administration – Right to be heard – Decision to remove the medicinal product from the European Union Register of Orphan Medicinal Products – Regulation (EC) No 141/2000 – Regulation (EC) No 847/2000 – Significant benefit – Standard of proof – Obligation to state reasons.#Case T-483/22.

European Union · Court of Justice of the European Union · 24 September 2025

Record· CJCELEX 62024CJ0115decided

Judgment of the Court (Fourth Chamber) of 11 September 2025.#UJ v Österreichische Zahnärztekammer.#Request for a preliminary ruling from the Oberster Gerichtshof.#Reference for a preliminary ruling – Public health – Cross-border healthcare – Directive 2011/24/EU – Article 3(d) and (e) – Provision of healthcare through telemedicine – Concept of ‘telemedicine’ – Cross-border healthcare provided through telemedicine – Complex medical treatment that includes healthcare provided in person and through telemedicine – Member State of treatment – Directive 2000/31/EC – Information society service – Directive 2005/36/EC – Professional qualifications – Freedom to provide services – Scope – Article 56 TFEU.#Case C-115/24.

European Union · Court of Justice of the European Union · 11 September 2025

Record· CJCELEX 62024CJ0115_RESdecided

Judgment of the Court (Fourth Chamber) of 11 September 2025.#UJ v Österreichische Zahnärztekammer.#Reference for a preliminary ruling – Public health – Cross-border healthcare – Directive 2011/24/EU – Article 3(d) and (e) – Provision of healthcare through telemedicine – Concept of ‘telemedicine’ – Cross-border healthcare provided through telemedicine – Complex medical treatment that includes healthcare provided in person and through telemedicine – Member State of treatment – Directive 2000/31/EC – Information society service – Directive 2005/36/EC – Professional qualifications – Freedom to provide services – Scope – Article 56 TFEU.#Case C-115/24.

European Union · Court of Justice of the European Union · 11 September 2025

Record· CJCELEX 62023CJ0489_RESdecided

Judgment of the Court (Fourth Chamber) of 4 September 2025.#AF v Guvernul României and Others.#Reference for a preliminary ruling – Social security – Health insurance – Article 56 TFEU – Freedom to provide services – Regulation (EC) No 883/2004 – Article 20(1) and (2) – Medical treatment received in a Member State other than the insured person’s Member State of residence – Directive 2011/24/EU – Article 7(7) – Assumption of the costs of treatment incurred by the insured person – Reimbursement – National legislation making reimbursement of those costs conditional upon the completion of a medical assessment, carried out exclusively by a health professional belonging to the public health insurance system of the insured person’s Member State of residence, which has given rise to the issuing, by that health professional, of a document authorising the hospitalisation of that insured person – Significant limitation of the reimbursement of the costs of cross-border healthcare.#Case C-489/23.

European Union · Court of Justice of the European Union · 4 September 2025

Record· CJCELEX 62023CJ0489decided

Judgment of the Court (Fourth Chamber) of 4 September 2025.#AF v Guvernul României and Others.#Request for a preliminary ruling from the Înalta Curte de Casaţie şi Justiţie.#Reference for a preliminary ruling – Social security – Health insurance – Article 56 TFEU – Freedom to provide services – Regulation (EC) No 883/2004 – Article 20(1) and (2) – Medical treatment received in a Member State other than the insured person’s Member State of residence – Directive 2011/24/EU – Article 7(7) – Assumption of the costs of treatment incurred by the insured person – Reimbursement – National legislation making reimbursement of those costs conditional upon the completion of a medical assessment, carried out exclusively by a health professional belonging to the public health insurance system of the insured person’s Member State of residence, which has given rise to the issuing, by that health professional, of a document authorising the hospitalisation of that insured person – Significant limitation of the reimbursement of the costs of cross-border healthcare.#Case C-489/23.

European Union · Court of Justice of the European Union · 4 September 2025

Record· TOCELEX 62024TO0223decided

Order of the General Court (Fourth Chamber) of 14 July 2025.#Pinpoint Innovations Ltd v European Commission.#Research and technological development – Horizon 2020 Framework Programme for Research and Innovation (2014-2020) – Development of a data analysis system to reduce delays in healthcare – Grant agreement – Actual recovery of a debt by the mutual insurance mechanism – Manifest lack of jurisdiction in part – Action in part manifestly inadmissible and in part manifestly lacking any foundation in law.#Case T-223/24.

European Union · Court of Justice of the European Union · 14 July 2025

Record· COCELEX 62024CO0139_INFdecided

Order of the Court (Seventh Chamber) of 3 July 2025.#UY v European Commission.#Appeal – Article 181 of the Rules of Procedure of the Court of Justice – Public health – Medicinal products for human use – Marketing authorisation – Comirnaty – COVID-19 vaccine – Action for annulment – Independence and impartiality of the Courts of the European Union – Interest in bringing proceedings – Locus standi – Fourth paragraph of Article 263 TFEU – Appeal in part manifestly inadmissible and in part manifestly unfounded.#Case C-139/24 P.

European Union · Court of Justice of the European Union · 3 July 2025

Record· COCELEX 62024CO0148_INFdecided

Order of the Court (Seventh Chamber) of 3 July 2025.#UY v European Commission.#Appeal – Article 181 of the Rules of Procedure of the Court of Justice – Public health – Medicinal products for human use – Marketing authorisation – Spikevax – COVID-19 vaccine – Action for annulment – Independence and impartiality of the Courts of the European Union – Interest in bringing proceedings – Locus standi – Fourth paragraph of Article 263 TFEU – Appeal in part manifestly inadmissible and in part manifestly unfounded.#Case C-148/24 P.

European Union · Court of Justice of the European Union · 3 July 2025

Record· COCELEX 62024CO0148decided

Order of the Court (Seventh Chamber) of 3 July 2025.#UY v European Commission.#Appeal – Article 181 of the Rules of Procedure of the Court of Justice – Public health – Medicinal products for human use – Marketing authorisation – Spikevax – COVID-19 vaccine – Action for annulment – Independence and impartiality of the Courts of the European Union – Interest in bringing proceedings – Locus standi – Fourth paragraph of Article 263 TFEU – Appeal in part manifestly inadmissible and in part manifestly unfounded.#Case C-148/24 P.

European Union · Court of Justice of the European Union · 3 July 2025

Record· COCELEX 62024CO0139decided

Order of the Court (Seventh Chamber) of 3 July 2025.#UY v European Commission.#Appeal – Article 181 of the Rules of Procedure of the Court of Justice – Public health – Medicinal products for human use – Marketing authorisation – Comirnaty – COVID-19 vaccine – Action for annulment – Independence and impartiality of the Courts of the European Union – Interest in bringing proceedings – Locus standi – Fourth paragraph of Article 263 TFEU – Appeal in part manifestly inadmissible and in part manifestly unfounded.#Case C-139/24 P.

European Union · Court of Justice of the European Union · 3 July 2025

Record· CJCELEX 62023CJ0759_SUMdecided

Judgment of the Court (Second Chamber) of 26 June 2025.#PJ Carroll & Company Ltd and Nicoventures Trading Ltd v The Minister for Health and Others.#Reference for a preliminary ruling – Public health – Directive 2014/40/EU – Article 7(12) – Article 11(6) – Delegated Directive (EU) 2022/2100 – Validity – Manufacture, presentation and sale of tobacco products – Delegation of power to the European Commission – Novel tobacco products – Heated tobacco products – Power to withdraw exemptions from prohibitions of flavourings and labelling requirements – Substantial change of circumstances.#Case C-759/23.

European Union · Court of Justice of the European Union · 26 June 2025

Record· CJCELEX 62023CJ0759decided

Judgment of the Court (Second Chamber) of 26 June 2025.#PJ Carroll & Company Ltd and Nicoventures Trading Ltd v The Minister for Health and Others.#Request for a preliminary ruling from the High Court (Irlande).#Reference for a preliminary ruling – Public health – Directive 2014/40/EU – Article 7(12) – Article 11(6) – Delegated Directive (EU) 2022/2100 – Validity – Manufacture, presentation and sale of tobacco products – Delegation of power to the European Commission – Novel tobacco products – Heated tobacco products – Power to withdraw exemptions from prohibitions of flavourings and labelling requirements – Substantial change of circumstances.#Case C-759/23.

European Union · Court of Justice of the European Union · 26 June 2025

Record· CJCELEX 62024CJ0317_INFdecided

Judgment of the Court (Eighth Chamber) of 19 June 2025.#European Commission v Hellenic Republic.#Failure of a Member State to fulfil obligations – Directive 2011/7/EU – Combating late payment in commercial transactions – Article 4(4)(b) – Commercial transactions between undertakings and public authorities – Power conferred on Member States to extend up to a maximum of 60 calendar days the time limit for payment for public entities providing healthcare – Duty of Member States to ensure that those public entities do not in practice exceed that time limit.#Case C-317/24.

European Union · Court of Justice of the European Union · 19 June 2025

Record· CJCELEX 62024CJ0200_SUMdecided

Judgment of the Court (Ninth Chamber) of 19 June 2025.#European Commission v Republic of Poland.#Failure of a Member State to fulfil obligations – Article 49 TFEU – Freedom of establishment – Article 56 TFEU – Freedom to provide services – Directive 2000/31/EC – Electronic commerce – Article 8(1) – Commercial communications service provided by a member of a regulated profession – National legislation prohibiting advertising for pharmacies and pharmaceutical outlets as well as for the activities thereof – Restriction – Whether justified – Protection of public health.#Case C-200/24.

European Union · Court of Justice of the European Union · 19 June 2025

Record· CJCELEX 62024CJ0200decided

Judgment of the Court (Ninth Chamber) of 19 June 2025.#European Commission v Republic of Poland.#Failure of a Member State to fulfil obligations – Article 49 TFEU – Freedom of establishment – Article 56 TFEU – Freedom to provide services – Directive 2000/31/EC – Electronic commerce – Article 8(1) – Commercial communications service provided by a member of a regulated profession – National legislation prohibiting advertising for pharmacies and pharmaceutical outlets as well as for the activities thereof – Restriction – Whether justified – Protection of public health.#Case C-200/24.

European Union · Court of Justice of the European Union · 19 June 2025

Report· CCCELEX 62023CC0489decided

Opinion of Advocate General Spielmann delivered on 15 May 2025.#AF v Guvernul României and Others.#Request for a preliminary ruling from the Înalta Curte de Casaţie şi Justiţie.#Reference for a preliminary ruling – Social security – Health insurance – Article 56 TFEU – Freedom to provide services – Regulation (EC) No 883/2004 – Article 20(1) and (2) – Medical treatment received in a Member State other than the insured person’s Member State of residence – Directive 2011/24/EU – Article 7(7) – Assumption of the costs of treatment incurred by the insured person – Reimbursement – National legislation making reimbursement of those costs conditional upon the completion of a medical assessment, carried out exclusively by a health professional belonging to the public health insurance system of the insured person’s Member State of residence, which has given rise to the issuing, by that health professional, of a document authorising the hospitalisation of that insured person – Significant limitation of the reimbursement of the costs of cross-border healthcare.#Case C-489/23.

European Union · Court of Justice of the European Union · 15 May 2025

Report· CCCELEX 62024CC0115decided

Opinion of Advocate General Rantos delivered on 8 May 2025.#UJ v Österreichische Zahnärztekammer.#Request for a preliminary ruling from the Oberster Gerichtshof.#Reference for a preliminary ruling – Public health – Cross-border healthcare – Directive 2011/24/EU – Article 3(d) and (e) – Provision of healthcare through telemedicine – Concept of ‘telemedicine’ – Cross-border healthcare provided through telemedicine – Complex medical treatment that includes healthcare provided in person and through telemedicine – Member State of treatment – Directive 2000/31/EC – Information society service – Directive 2005/36/EC – Professional qualifications – Freedom to provide services – Scope – Article 56 TFEU.#Case C-115/24.

European Union · Court of Justice of the European Union · 8 May 2025

Record· TJCELEX 62023TJ0009_INFdecided

Judgment of the General Court (Eighth Chamber) of 9 April 2025.#Koppers Denmark ApS and Others v European Commission.#Action for annulment – Public health – Biocidal products – Regulation (EU) No 528/2012 – Renewal of the approval of creosote as an active substance for use in biocidal products of product-type 8 – Restrictions on the placing on the market of treated articles – Application for partial annulment of Implementing Regulation (EU) 2022/1950 – Contested provisions not severable from the rest of the act – Inadmissibility.#Case T-9/23.

European Union · Court of Justice of the European Union · 9 April 2025

Record· TJCELEX 62023TJ0009decided

Judgment of the General Court (Eighth Chamber) of 9 April 2025.#Koppers Denmark ApS and Others v European Commission.#Action for annulment – Public health – Biocidal products – Regulation (EU) No 528/2012 – Renewal of the approval of creosote as an active substance for use in biocidal products of product-type 8 – Restrictions on the placing on the market of treated articles – Application for partial annulment of Implementing Regulation (EU) 2022/1950 – Contested provisions not severable from the rest of the act – Inadmissibility.#Case T-9/23.

European Union · Court of Justice of the European Union · 9 April 2025

Record· TJCELEX 62023TJ0394decided

Judgment of the General Court (Eighth Chamber) of 12 February 2025.#Christoph Klein v European Commission.#Public health – EU regulatory framework governing medical devices – Safeguard clause – Article 8(1) and (2) of Directive 93/42/EEC – Notification by a Member State of a decision prohibiting the placing on the market of a medical device – Medical device Inhaler Broncho-Air® – Repeal of Directive 93/42 – Articles 94 to 97 of Regulation (EU) 2017/745 – Infringement of essential procedural requirements.#Case T-394/23.

European Union · Court of Justice of the European Union · 12 February 2025

Record· TJCELEX 62023TJ0394_INFdecided

Judgment of the General Court (Eighth Chamber) of 12 February 2025.#Christoph Klein v European Commission.#Public health – EU regulatory framework governing medical devices – Safeguard clause – Article 8(1) and (2) of Directive 93/42/EEC – Notification by a Member State of a decision prohibiting the placing on the market of a medical device – Medical device Inhaler Broncho-Air® – Repeal of Directive 93/42 – Articles 94 to 97 of Regulation (EU) 2017/745 – Infringement of essential procedural requirements.#Case T-394/23.

European Union · Court of Justice of the European Union · 12 February 2025

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