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Baza informacij za delovanje Partnerjev Mreže Modro Poslovanje

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CELEX:62022TJ0483: 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 141/200

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CELEX:62022TJ0483_RES: 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

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CELEX:62022TJ0484:           Arrêt du Tribunal (dixième chambre) du 22 novembre 2023 (Extraits).#QN contre Agence de l'Union européenne pour la gestion opérationnelle des systèmes d’information à grande échelle au sein de l’espace de liberté, de sécurité et de justice.#Fonction publique – Agents temporaires – Reclassement – Exercice de reclassement 2021 – Décision de non-reclassement – Taux multiplicateurs de référence – Dispositions générales d’exécution de l’article 54 du RAA – Exception d’illégalité – Égalité de traitement – Responsabilité.#Affaire T-484/22.

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CELEX:62022TJ0484_RES: Judgment of the General Court (Tenth Chamber) of 22 November 2023 (Extracts).#QN v European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice.#Civil service – Temporary staff – Reclassification – 2021 reclassification exercise – Decision not to reclassify – Guiding multiplication rates – General provisions for the implementation of Article 54 of the CEOS – Plea of illegality – Equal treatment – Liability.#Case T-484/22.

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