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37 records in EU in 2024

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Record· CJCELEX 62022CJ0119_SUMdecided

Judgment of the Court (Third Chamber) of 19 December 2024.#Teva BV and Teva Finland Oy v Merck Sharp & Dohme LLC and Merck Sharp & Dohme LLC v Clonmel Healthcare Limited.#Reference for a preliminary ruling – Medicinal products for human use – Supplementary protection certificate (SPC) – Regulation (EC) No 469/2009 – Conditions for obtaining an SPC for medicinal products – Article 3(a) – Concept of ‘product protected by a basic patent in force’ – Article 3(c) – Concept of ‘product the subject of an SPC’ – Criteria for assessment.#Joined Cases C-119/22 and C-149/22.

European Union · Court of Justice of the European Union · 19 December 2024

Record· CJCELEX 62022CJ0119decided

Judgment of the Court (Third Chamber) of 19 December 2024.#Teva BV and Teva Finland Oy v Merck Sharp & Dohme LLC and Merck Sharp & Dohme LLC v Clonmel Healthcare Limited.#Requests for a preliminary ruling from the Markkinaoikeus and the Supreme Court (Ireland).#Reference for a preliminary ruling – Medicinal products for human use – Supplementary protection certificate (SPC) – Regulation (EC) No 469/2009 – Conditions for obtaining an SPC for medicinal products – Article 3(a) – Concept of ‘product protected by a basic patent in force’ – Article 3(c) – Concept of ‘product the subject of an SPC’ – Criteria for assessment.#Joined Cases C-119/22 and C-149/22.

European Union · Court of Justice of the European Union · 19 December 2024

Record· CJCELEX 62023CJ0016_RESdecided

Judgment of the Court (First Chamber) of 17 October 2024.#FA.RO. di YK & C. Sas v Agenzia delle Dogane e dei Monopoli.#Reference for a preliminary ruling – Services in the internal market – Directive 2006/123/EC – Authorisation scheme – Article 10 – Conditions for granting authorisation – Sale of tobacco products – National legislation making the grant of authorisation to establish a point of sale for tobacco products subject to compliance with conditions – Conditions relating to distance and population – Protection of public health against smoking.#Case C-16/23.

European Union · Court of Justice of the European Union · 17 October 2024

Record· CJCELEX 62023CJ0016decided

Judgment of the Court (First Chamber) of 17 October 2024.#FA.RO. di YK & C. Sas v Agenzia delle Dogane e dei Monopoli.#Request for a preliminary ruling from the Tribunale amministrativo regionale per la Liguria.#Reference for a preliminary ruling – Services in the internal market – Directive 2006/123/EC – Authorisation scheme – Article 10 – Conditions for the granting of authorisation – Sale of tobacco products – National legislation making the grant of authorisation to establish a point of sale for tobacco products subject to compliance with conditions – Conditions relating to distance and population – Protection of public health against smoking.#Case C-16/23.

European Union · Court of Justice of the European Union · 17 October 2024

Record· COCELEX 62024CO0599_INFdecided

Order of the Vice-President of the Court of 4 October 2024.#Accord Healthcare, SL v European Commission.#Appeal – Intervention – Public health – Medicinal product for human use – Decision granting marketing authorisation for the medicinal product Degarelix Accord – Action for annulment – Time limits – Force majeure or unforeseeable circumstances – Dismissal.#Case C-599/24 P(I).

European Union · Court of Justice of the European Union · 4 October 2024

Record· CJCELEX 62022CJ0237_SUMdecided

Judgment of the Court (Eighth Chamber) of 4 October 2024.#Mylan IRE Healthcare Ltd v European Commission.#Appeal – Regulation (EC) No 141/2000 – Orphan medicinal products – Articles 3 and 8 – Concept of ‘significant benefit’ – Concept of ‘clinical superiority’ – Regulation (EC) No 847/2000 – Article 3 – Marketing authorisation for the medicinal product for human use Tobramycin VVB – Period of market exclusivity of Tobi Podhaler, containing the active substance tobramycin – Derogation from that market exclusivity.#Case C-237/22 P.

European Union · Court of Justice of the European Union · 4 October 2024

Record· COCELEX 62024CO0599decided

Order of the Vice-President of the Court of 4 October 2024.#Accord Healthcare SL v Ferring Pharmaceuticals A/S and European Commission.#Appeal – Intervention – Public health – Medicinal product for human use – Decision granting marketing authorisation for the medicinal product Degarelix Accord – Action for annulment – Time limits – Force majeure or unforeseeable circumstances – Dismissal.#Case C-599/24 P(I).

European Union · Court of Justice of the European Union · 4 October 2024

Record· CJCELEX 62022CJ0237decided

Judgment of the Court (Eighth Chamber) of 4 October 2024.#Mylan IRE Healthcare Ltd v European Commission.#Appeal – Regulation (EC) No 141/2000 – Orphan medicinal products – Articles 3 and 8 – Concept of ‘significant benefit’ – Concept of ‘clinical superiority’ – Regulation (EC) No 847/2000 – Article 3 – Marketing authorisation for the medicinal product for human use Tobramycin VVB – Period of market exclusivity of Tobi Podhaler, containing the active substance tobramycin – Derogation from that market exclusivity.#Case C-237/22 P.

European Union · Court of Justice of the European Union · 4 October 2024

Record· TJCELEX 62022TJ0570_INFdecided

Judgment of the General Court (Second Chamber) of 25 September 2024.#Herbert Smith Freehills LLP v European Commission.#Access to documents – Regulation (EC) No 1049/2001 – Public health – Delegated Directive (EU) 2022/2100 – Withdrawal of certain exemptions for heated tobacco products – Preparatory documents – Databases – Article 2(3) of Regulation No 1049/2001 – Documents held by an institution – Declaration of non-existence – Presumption of lawfulness.#Case T-570/22.

European Union · Court of Justice of the European Union · 25 September 2024

Record· TJCELEX 62022TJ0570decided

Judgment of the General Court (Second Chamber) of 25 September 2024.#Herbert Smith Freehills LLP v European Commission.#Access to documents – Regulation (EC) No 1049/2001 – Public health – Delegated Directive (EU) 2022/2100 – Withdrawal of certain exemptions for heated tobacco products – Preparatory documents – Databases – Article 2(3) of Regulation No 1049/2001 – Documents held by an institution – Declaration of non-existence – Presumption of lawfulness.#Case T-570/22.

European Union · Court of Justice of the European Union · 25 September 2024

Record· TJCELEX 62023TJ0311decided

Judgment of the General Court (Second Chamber) of 25 September 2024.#British American Tobacco Polska Trading sp. z o.o. v European Commission.#Access to documents – Council Regulation (EC) No 1049/2001 – Public health – Delegated Directive (EU) 2022/2100 – Withdrawal of certain exemptions for heated tobacco products – Preparatory documents – Databases – Article 2(3) of Regulation No 1049/2001 – Documents held by an institution – Declaration of non-existence – Presumption of lawfulness.#Case T-311/23.

European Union · Court of Justice of the European Union · 25 September 2024

Record· TJCELEX 62023TJ0311_INFdecided

Judgment of the General Court (Second Chamber) of 25 September 2024.#British American Tobacco Polska Trading sp. z o.o. v European Commission.#Access to documents – Council Regulation (EC) No 1049/2001 – Public health – Delegated Directive (EU) 2022/2100 – Withdrawal of certain exemptions for heated tobacco products – Preparatory documents – Databases – Article 2(3) of Regulation No 1049/2001 – Documents held by an institution – Declaration of non-existence – Presumption of lawfulness.#Case T-311/23.

European Union · Court of Justice of the European Union · 25 September 2024

Record· CJCELEX 62023CJ0412_INFdecided

Judgment of the Court (Eighth Chamber) of 19 September 2024.#European Commission v Slovak Republic.#Failure of a Member State to fulfil obligations – Directive 2011/7/EU – Combating late payments 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-412/23.

European Union · Court of Justice of the European Union · 19 September 2024

Record· CJCELEX 62023CJ0412decided

Judgment of the Court (Eighth Chamber) of 19 September 2024.#European Commission v Slovak Republic.#Failure of a Member State to fulfil obligations – Directive 2011/7/EU – Combating late payments 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-412/23.

European Union · Court of Justice of the European Union · 19 September 2024

Record· CJCELEX 62023CJ0248_SUMdecided

Judgment of the Court (First Chamber) of 12 September 2024.#Novo Nordisk A/S v Nemzeti Adó- és Vámhivatal Fellebbviteli Igazgatósága.#Reference for a preliminary ruling – Common system of value added tax (VAT) – Directive 2006/112/EC – Article 90(1) – Reduction of the taxable amount consequent on a price reduction after the supply takes place – Contributions paid by a pharmaceutical company to the national health insurance agency – National tax legislation excluding contributions paid by a pharmaceutical company to the public health insurance agency pursuant to an ex lege obligation from the benefit of the reduction of the taxable amount.#Case C-248/23.

European Union · Court of Justice of the European Union · 12 September 2024

Record· CJCELEX 62023CJ0248decided

Judgment of the Court (First Chamber) of 12 September 2024.#Novo Nordisk A/S v Nemzeti Adó- és Vámhivatal Fellebbviteli Igazgatósága.#Request for a preliminary ruling from the Fővárosi Törvényszék.#Reference for a preliminary ruling – Common system of value added tax (VAT) – Directive 2006/112/EC – Article 90(1) – Reduction of the taxable amount consequent on a price reduction after the supply takes place – Contributions paid by a pharmaceutical company to the national health insurance agency – National tax legislation excluding contributions paid by a pharmaceutical company to the public health insurance agency pursuant to an ex lege obligation from the benefit of the reduction of the taxable amount.#Case C-248/23.

European Union · Court of Justice of the European Union · 12 September 2024

Report· CCCELEX 62022CC0237decided

Opinion of Advocate General Emiliou delivered on 11 July 2024.#Mylan IRE Healthcare Ltd v European Commission.#Appeal – Regulation (EC) No 141/2000 – Orphan medicinal products – Articles 3 and 8 – Concept of ‘significant benefit’ – Concept of ‘clinical superiority’ – Regulation (EC) No 847/2000 – Article 3 – Marketing authorisation for the medicinal product for human use Tobramycin VVB – Period of market exclusivity of Tobi Podhaler, containing the active substance tobramycin – Derogation from that market exclusivity.#Case C-237/22 P.

European Union · Court of Justice of the European Union · 11 July 2024

Record· CJCELEX 62023CJ0062_SUMdecided

Judgment of the Court (Tenth Chamber) of 13 June 2024.#Pedro Francisco v Subdelegación del Gobierno en Barcelona.#Reference for a preliminary ruling – Right of citizens of the Union and their family members to move and reside freely within the territory of the Member States – Directive 2004/38/EC – Article 27 – Restrictions on the right of entry and the right of residence on grounds of public policy, public security or public health – Conduct representing a genuine, present and sufficiently serious threat affecting one of the fundamental interests of society – Refusal to issue a temporary residence card of a family member of a Union citizen due to a police record – Unfavourable police report due to arrest.#Case C-62/23.

European Union · Court of Justice of the European Union · 13 June 2024

Report· CCCELEX 62022CC0119decided

Opinion of Advocate General Emiliou delivered on 6 June 2024.#Teva BV and Teva Finland Oy v Merck Sharp & Dohme LLC and Merck Sharp & Dohme LLC v Clonmel Healthcare Limited.#Requests for a preliminary ruling from the Markkinaoikeus and the Supreme Court (Ireland).#Reference for a preliminary ruling – Medicinal products for human use – Supplementary protection certificate (SPC) – Regulation (EC) No 469/2009 – Conditions for obtaining an SPC for medicinal products – Article 3(a) – Concept of ‘product protected by a basic patent in force’ – Article 3(c) – Concept of ‘product the subject of an SPC’ – Criteria for assessment.#Joined Cases C-119/22 and C-149/22.

European Union · Court of Justice of the European Union · 6 June 2024

Report· CCCELEX 62023CC0248decided

Opinion of Advocate General Ćapeta delivered on 6 June 2024.#Novo Nordisk A/S v Nemzeti Adó- és Vámhivatal Fellebbviteli Igazgatósága.#Request for a preliminary ruling from the Fővárosi Törvényszék.#Reference for a preliminary ruling – Common system of value added tax (VAT) – Directive 2006/112/EC – Article 90(1) – Reduction of the taxable amount consequent on a price reduction after the supply takes place – Contributions paid by a pharmaceutical company to the national health insurance agency – National tax legislation excluding contributions paid by a pharmaceutical company to the public health insurance agency pursuant to an ex lege obligation from the benefit of the reduction of the taxable amount.#Case C-248/23.

European Union · Court of Justice of the European Union · 6 June 2024

Record· CJCELEX 62022CJ0654_SUMdecided

Judgment of the Court (Fourth Chamber) of 11 April 2024.#FOD Volksgezondheid, Veiligheid van de voedselketen & Leefmilieu v Triferto Belgium NV.#Reference for a preliminary ruling – Registration, evaluation, authorisation and restriction of chemicals – Regulation (EC) No 1907/2006 (REACH Regulation) – Article 2(1)(b) – Scope – Article 3(10) and (11) – Concepts of ‘import’ and ‘importer’ – Article 6 – Obligation to register – Person assuming responsibility for registration – Regulation (EU) No 952/2013 – Union Customs Code – Customs warehousing.#Case C-654/22.

European Union · Court of Justice of the European Union · 11 April 2024

Record· CJCELEX 62022CJ0654decided

Judgment of the Court (Fourth Chamber) of 11 April 2024.#FOD Volksgezondheid, Veiligheid van de voedselketen & Leefmilieu v Triferto Belgium NV.#Request for a preliminary ruling from the rechtbank van eerste aanleg Oost-Vlaanderen Afdeling Gent.#Reference for a preliminary ruling – Registration, evaluation, authorisation and restriction of chemicals – Regulation (EC) No 1907/2006 (REACH Regulation) – Article 2(1)(b) – Scope – Article 3(10) and (11) – Concepts of ‘import’ and ‘importer’ – Article 6 – Obligation to register – Person assuming responsibility for registration – Regulation (EU) No 952/2013 – Union Customs Code – Customs warehousing.#Case C-654/22.

European Union · Court of Justice of the European Union · 11 April 2024

Report· CCCELEX 62023CC0016decided

Opinion of Advocate General Campos Sánchez-Bordona delivered on 14 March 2024.#FA.RO. di YK & C. Sas v Agenzia delle Dogane e dei Monopoli.#Request for a preliminary ruling from the Tribunale amministrativo regionale per la Liguria.#Reference for a preliminary ruling – Services in the internal market – Directive 2006/123/EC – Authorisation scheme – Article 10 – Conditions for the granting of authorisation – Sale of tobacco products – National legislation making the grant of authorisation to establish a point of sale for tobacco products subject to compliance with conditions – Conditions relating to distance and population – Protection of public health against smoking.#Case C-16/23.

European Union · Court of Justice of the European Union · 14 March 2024

Record· CJCELEX 62021CJ0606_RESdecided

Judgment of the Court (Second Chamber) of 29 February 2024.#Doctipharma SAS v Union des Groupements de pharmaciens d’officine (UDGPO) and Pictime Coreyre.#Reference for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Article 85c – Scope – Distance selling to the general public of medicinal products – Medicinal products for human use not subject to compulsory medical prescription – Persons authorised or entitled to engage in distance selling to the general public of medicinal products – Power of the Member States to impose conditions, justified by the protection of public health, on the retailing, on their territory, of medicinal products sold online – Information society services – Directive 98/34/EC – Directive (EU) 2015/1535 – Service connecting pharmacists and customers for the online sale of medicinal products.#Case C-606/21.

European Union · Court of Justice of the European Union · 29 February 2024

Record· CJCELEX 62021CJ0606decided

Judgment of the Court (Second Chamber) of 29 February 2024.#Doctipharma SAS v Union des Groupements de pharmaciens d’officine (UDGPO) and Pictime Coreyre.#Request for a preliminary ruling from the Cour d'appel de Paris.#Reference for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Article 85c – Scope – Distance selling to the general public of medicinal products – Medicinal products for human use not subject to compulsory medical prescription – Persons authorised or entitled to engage in distance selling to the general public of medicinal products – Power of the Member States to impose conditions, justified by the protection of public health, on the retailing, on their territory, of medicinal products sold online – Information society services – Directive 98/34/EC – Directive (EU) 2015/1535 – Service connecting pharmacists and customers for the online sale of medicinal products.#Case C-606/21.

European Union · Court of Justice of the European Union · 29 February 2024

Record· CJCELEX 62023CJ0085_SUMdecided

Judgment of the Court (Seventh Chamber) of 22 February 2024.#Landkreis Jerichower Land v A.#Reference for a preliminary ruling – Public health – Health rules applicable to animal by-products and derived products not intended for human consumption – Regulation (EC) No 1069/2009 – Approval – Article 24(1)(i) – Concept of ‘storage of animal by-products’ – Interruption of a transport operation for up to eight hours.#Case C-85/23.

European Union · Court of Justice of the European Union · 22 February 2024

Record· CJCELEX 62023CJ0085decided

Judgment of the Court (Seventh Chamber) of 22 February 2024.#Landkreis Jerichower Land v A.#Request for a preliminary ruling from the Oberverwaltungsgericht des Landes Sachsen-Anhalt.#Reference for a preliminary ruling – Public health – Health rules applicable to animal by-products and derived products not intended for human consumption – Regulation (EC) No 1069/2009 – Approval – Article 24(1)(i) – Concept of ‘storage of animal by-products’ – Interruption of a transport operation for up to eight hours.#Case C-85/23.

European Union · Court of Justice of the European Union · 22 February 2024