Judgment of the Court (Third Chamber) of 1 October 2015.#Agenzia Italiana del Farmaco (AIFA) and Ministero della Salute v Doc Generici srl.#Request for a preliminary ruling from the Consiglio di Stato.#Reference for a preliminary ruling — Article 267 TFEU — Obligation to bring the matter before the Court of Justice — Approximation of laws — Proprietary medicinal products — Medicinal products for human use — Marketing authorisation — Variation — Fees — Regulation (EC) No 297/95 — Regulation (EC) No 1234/2008 — Scope.#Case C-452/14.

decidedEuropean Union· Court of Justice of the European Union· EN

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1 October 2015

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1 October 2015 · Decided

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Official record CELEX 62014CJ0452 from European Union at Court of Justice of the European Union. Dated 1 October 2015. Status: decided.

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1 October 2015
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Judgment of the Court - 1 October 2015#Doc Generici#Case C-452/14

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Judgment of the Court - 1 October 2015#Doc Generici#Case C-452/14
judgment · GA · 1 October 2015
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Rozsudek Soudního dvora (třetího senátu) ze dne 1. října 2015.#Agenzia Italiana del Farmaco (AIFA) a Ministero della Salute v. Doc Generici srl.#Žádost o rozhodnutí o předběžné otázce podaná Consiglio di Stato.#Řízení o předběžné otázce – Článek 267 SFEU – Povinnost obrátit se na Soudní dvůr – Sbližování právních předpisů – Hromadně vyráběné léčivé přípravky – Humánní léčivé přípravky – Registrace – Změna – Poplatky – Nařízení (ES) č. 297/95 – Nařízení (ES) č. 1234/2008 – Působnost.#Věc C-452/14.
judgment · CS · 1 October 2015
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Sentencia del Tribunal de Justicia (Sala Tercera) de 1 de octubre de 2015.#Agenzia Italiana del Farmaco (AIFA) y Ministero della Salute contra Doc Generici srl.#Petición de decisión prejudicial planteada por el Consiglio di Stato.#Procedimiento prejudicial — Artículo 267 TFUE — Obligación de someter una cuestión al Tribunal de Justicia — Aproximación de las legislaciones — Especialidades farmacéuticas — Medicamentos para uso humano — Autorización de comercialización — Modificación — Tasas — Reglamento (CE) nº 297/95 — Reglamento (CE) nº 1234/2008 — Ámbito de aplicación.#Asunto C-452/14.
judgment · ES · 1 October 2015
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Wyrok Trybunału (trzecia izba) z dnia 1 października 2015 r.#Agenzia Italiana del Farmaco (AIFA) i Ministero della Salute przeciwko Doc Generici srl.#Wniosek o wydanie orzeczenia w trybie prejudycjalnym złożony przez Consiglio di Stato.#Odesłanie prejudycjalne – Artykuł 267 TFUE – Obowiązek wystąpienia do Trybunału z pytaniem prejudycjalnym – Zbliżanie ustawodawstw – Leki gotowe – Produkty lecznicze stosowane u ludzi – Pozwolenie na dopuszczenie do obrotu – Dostosowanie – Opłaty – Rozporządzenie (WE) nr 297/95 – Rozporządzenie (WE) nr 1234/2008 – Zakres stosowania.#Sprawa C-452/14.
judgment · PL · 1 October 2015
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Hotărârea Curții (Camera a treia) din 1 octombrie 2015.#Agenzia Italiana del Farmaco (AIFA) și Ministero della Salute împotriva Doc Generici srl.#Cerere de decizie preliminară formulată de Consiglio di Stato.#Trimitere preliminară – Articolul 267 TFUE – Obligația de a sesiza Curtea – Apropierea legislațiilor – Medicamente brevetate – Medicamente de uz uman – Autorizație de introducere pe piață – Modificare – Taxe – Regulamentul (CE) nr. 297/95 – Regulamentul (CE) nr. 1234/2008 – Domeniu de aplicare.#Cauza C-452/14.
judgment · RO · 1 October 2015
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Решение на Съда (трети състав) от 1 октомври 2015 г.#Agenzia Italiana del Farmaco (AIFA) и Ministero della Salute срещу Doc Generici srl.#Преюдициално запитване, отправено от Consiglio di Stato.#Преюдициално запитване — Член 267 ДФЕС — Задължение за сезиране на Съда — Сближаване на законодателствата — Лекарствени продукти — Лекарствени продукти за хуманна употреба — Разрешение за търговия — Промяна — Такси — Регламент (ЕО) № 297/95 — Регламент (ЕО) № 1234/2008 — Приложно поле.#Дело C-452/14.
judgment · BG · 1 October 2015
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Urteil des Gerichtshofs (Dritte Kammer) vom 1. Oktober 2015.#Agenzia Italiana del Farmaco (AIFA) und Ministero della Salute gegen Doc Generici srl.#Vorabentscheidungsersuchen des Consiglio di Stato.#Vorlage zur Vorabentscheidung – Art. 267 AEUV – Pflicht zur Anrufung des Gerichtshofs – Rechtsangleichung – Arzneispezialitäten – Humanarzneimittel – Genehmigung für das Inverkehrbringen – Änderung – Gebühren – Verordnung (EG) Nr. 297/95 – Verordnung (EG) Nr. 1234/2008 – Anwendungsbereich.#Rechtssache C-452/14.
judgment · DE · 1 October 2015
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Sentenza tal-Qorti tal-Ġustizzja (It-Tielet Awla) tal-1 ta’ Ottubru 2015.#Agenzia Italiana del Farmaco (AIFA) u Ministero della Salute vs Doc Generici srl.#Talba għal deċiżjoni preliminari mressqa minn Consiglio di Stato.#Rinviju għal deċiżjoni preliminari – Artikolu 267 TFUE – Obbligu li tiġi adita l-Qorti tal-Ġustizzja – Approssimazzjoni tal-leġiżlazzjonijiet – Speċjalità mediċinali – Prodotti mediċinali għall-użu mill-bniedem – Awtorizzazzjoni ta’ tqegħid fis-suq – Varjazzjoni – Miżati – Regolament (KE) Nru 297/95 – Regolament (KE) Nru 1234/2008 – Kamp ta’ applikazzjoni.#Kawża C-452/14.
judgment · MT · 1 October 2015
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Unionin tuomioistuimen tuomio (kolmas jaosto) 1.10.2015.#Agenzia Italiana del Farmaco (AIFA) ja Ministero della Salute vastaan Doc Generici srl.#Consiglio di Staton esittämä ennakkoratkaisupyyntö.#Ennakkoratkaisupyyntö – SEUT 267 artikla – Velvollisuus saattaa asia unionin tuomioistuimen käsiteltäväksi – Jäsenvaltioiden lainsäädännön lähentäminen – Lääkevalmisteet – Ihmisille tarkoitetut lääkkeet – Myyntilupa – Muuttaminen – Maksut – Asetus (EY) N:o 297/95 – Asetus (EY) N:o 1234/2008 – Soveltamisala.#Asia C-452/14.
judgment · FI · 1 October 2015
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Acórdão do Tribunal de Justiça (Terceira Secção) de 1 de outubro de 2015.#Agenzia Italiana del Farmaco (AIFA) e Ministero della Salute contra Doc Generici Srl.#Pedido de decisão prejudicial apresentado pelo Consiglio di Stato.#Reenvio prejudicial — Artigo 267.° TFUE — Obrigação de submeter uma questão ao Tribunal de Justiça — Aproximação das legislações — Especialidades farmacêuticas — Medicamentos para uso humano — Autorização de introdução no mercado — Alteração — Taxas — Regulamento (CE) n.° 297/95 — Regulamento (CE) n.° 1234/2008 — Âmbito de aplicação.#Processo C-452/14.
judgment · PT · 1 October 2015
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Presuda Suda (treće vijeće) od 1. listopada 2015.#Agenzia Italiana del Farmaco (AIFA) i Ministero della Salute protiv Doc Generici srl.#Zahtjev za prethodnu odluku koji je uputio Consiglio di Stato.#Zahtjev za prethodnu odluku – Članak 267. UFEU‑a – Obveza upućivanja prethodnog pitanja Sudu – Usklađivanje zakonodavstava – Farmaceutski proizvodi – Lijekovi za humanu primjenu – Odobrenje za stavljanje na tržište – Izmjena – Naknade – Uredba (EZ) br. 297/95 – Uredba (EZ) br. 1234/2008 – Područje primjene.#Predmet C-452/14.
judgment · HR · 1 October 2015
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Απόφαση του Δικαστηρίου (τρίτο τμήμα) της 1ης Οκτωβρίου 2015.#Agenzia Italiana del Farmaco (AIFA) και Ministero della Salute κατά Doc Generici srl.#Αίτηση του Consiglio di Stato για την έκδοση προδικαστικής αποφάσεως.#Προδικαστική παραπομπή — Άρθρο 267 ΣΛΕΕ — Υποχρέωση υποβολής προδικαστικού ερωτήματος στο Δικαστήριο — Προσέγγιση των νομοθεσιών — Φαρμακευτικά ιδιοσκευάσματα — Φάρμακα που προορίζονται για ανθρώπινη χρήση — Άδεια κυκλοφορίας — Τροποποίηση — Τέλη — Κανονισμός (ΕΚ) 297/95 — Κανονισμός (ΕΚ) 1234/2008 — Πεδίο εφαρμογής.#Υπόθεση C-452/14.
judgment · EL · 1 October 2015
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Sodba Sodišča (tretji senat) z dne 1. oktobra 2015.#Agenzia Italiana del Farmaco (AIFA) in Ministero della Salute proti Doc Generici srl.#Predlog za sprejetje predhodne odločbe, ki ga je vložilo Consiglio di Stato.#Predhodno odločanje – Člen 267 PDEU – Obveznost predložitve zadeve Sodišču – Približevanje zakonodaj – Lastniška zdravila – Zdravila za uporabo v humani medicini – Dovoljenje za promet – Sprememba – Pristojbine – Uredba (ES) št. 297/95 – Uredba (ES) št. 1234/2008 – Področje uporabe.#Zadeva C-452/14.
judgment · SL · 1 October 2015
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Arrêt de la Cour (troisième chambre) du 1er octobre 2015.#Agenzia Italiana del Farmaco (AIFA) et Ministero della Salute contre Doc Generici Srl.#Demande de décision préjudicielle, introduite par le Consiglio di Stato.#Renvoi préjudiciel – Article 267 TFUE – Obligation de saisine de la Cour – Rapprochement des législations – Spécialités pharmaceutiques – Médicaments à usage humain – Autorisation de mise sur le marché – Modification – Redevances – Règlement (CE) no 297/95 – Règlement (CE) no 1234/2008 – Champ d’application.#Affaire C-452/14.
judgment · FR · 1 October 2015
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Domstolens dom (Tredje Afdeling) af 1. oktober 2015.#Agenzia Italiana del Farmaco (AIFA) og Ministero della Salute mod Doc Generici srl.#Anmodning om præjudiciel afgørelse indgivet af Consiglio di Stato.#Præjudiciel forelæggelse – artikel 267 TEUF – forelæggelsespligt – tilnærmelse af lovgivningerne – farmaceutiske specialiteter – humanmedicinske lægemidler – tilladelse til markedsføring – ændring – gebyrer – forordning (EF) nr. 297/95 – forordning (EF) nr. 1234/2008 – anvendelsesområde.#Sag C-452/14.
judgment · DA · 1 October 2015
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Domstolens dom (tredje avdelningen) av den 1 oktober 2015.#Agenzia Italiana del Farmaco (AIFA) och Ministero della Salute mot Doc Generici srl.#Begäran om förhandsavgörande från Consiglio di Stato.#Begäran om förhandsavgörande – Artikel 267 FEUF – Skyldighet att hänskjuta frågor till domstolen – Tillnärmning av lagstiftning – Farmaceutiska specialiteter – Humanläkemedel – Godkännande för försäljning – Ändring – Avgifter – Förordning (EG) nr 297/95 – Förordning (EG) nr 1234/2008 – Tillämpningsområde.#Mål C-452/14.
judgment · SV · 1 October 2015
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Arrest van het Hof (Derde kamer) van 1 oktober 2015.#Agenzia Italiana del Farmaco (AIFA) en Ministero della Salute tegen Doc Generici srl.#Verzoek van de Consiglio di Stato om een prejudiciële beslissing.#Prejudiciële verwijzing – Artikel 267 VWEU – Verplichting tot voorlegging aan het Hof – Harmonisatie van de wetgevingen – Farmaceutische specialiteiten – Geneesmiddelen voor menselijk gebruik – Vergunning voor het in de handel brengen – Wijziging – Vergoedingen – Verordening (EG) nr. 297/95 – Verordening (EG) nr. 1234/2008 – Werkingssfeer.#Zaak C-452/14.
judgment · NL · 1 October 2015
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2015 m. spalio 1 d. Teisingumo Teismo (trečioji kolegija) sprendimas.#Agenzia Italiana del Farmaco (AIFA) ir Ministero della Salute prieš Doc Generici Srl.#Consiglio di Stato prašymas priimti prejudicinį sprendimą.#Prašymas priimti prejudicinį sprendimą – SESV 267 straipsnis – Pareiga kreiptis į Teisingumo Teismą – Teisės aktų derinimas – Vaistai – Žmonėms skirti vaistai – Leidimas prekiauti – Pakeitimas – Mokesčiai – Reglamentas (EB) Nr. 297/95 – Reglamentas (EB) Nr. 1234/2008 – Taikymo sritis.#Byla C-452/14.
judgment · LT · 1 October 2015
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Euroopa Kohtu otsus (kolmas koda), 1.10.2015.#Agenzia Italiana del Farmaco (AIFA) ja Ministero della Salute versus Doc Generici srl.#Eelotsusetaotlus, mille on esitanud Consiglio di Stato.#Eelotsusetaotlus – ELTL artikkel 267 – Kohustus saata asi Euroopa Kohtusse – Õigusaktide ühtlustamine – Ravimpreparaadid – Inimtervishoius kasutatavad ravimid – Müügiluba – Muutmine – Lõivud – Määrus (EÜ) nr 297/95 – Määrus (EÜ) nr 1234/2008 – Kohaldamisala.#Kohtuasi C-452/14.
judgment · ET · 1 October 2015
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Rozsudok Súdneho dvora (tretia komora) z 1. októbra 2015.#Agenzia Italiana del Farmaco (AIFA) a Ministero della Salute proti Doc Generici Srl.#Návrh na začatie prejudiciálneho konania, ktorý podala Consiglio di Stato.#Návrh na začatie prejudiciálneho konania – Článok 267 ZFEÚ – Povinnosť obrátiť sa na Súdny dvor – Aproximácia právnych predpisov – Zvláštne liečivá – Humánne lieky – Povolenie na uvedenie na trh – Zmena – Poplatky – Nariadenie (ES) č. 297/95 – Nariadenie (ES) č. 1234/2008 – Pôsobnosť.#Vec C-452/14.
judgment · SK · 1 October 2015
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A Bíróság ítélete (harmadik tanács), 2015. október 1‑je.#Agenzia Italiana del Farmaco (AIFA) és Ministero della Salute kontra Doc Generici srl.#A Consiglio di Stato (Olaszország) által benyújtott előzetes döntéshozatal iránti kérelem.#Előzetes döntéshozatal iránti kérelem – EUMSZ 267. cikk – A Bírósághoz fordulásra vonatkozó kötelezettség – Jogszabályok közelítése – Törzskönyvezett gyógyszerkészítmények – Emberi felhasználásra szánt gyógyszerek – Forgalombahozatali engedély – Módosítás – Díjak – 297/95/EK rendelet – 1234/2008/EK rendelet – Hatály.#C-452/14. sz. ügy.
judgment · HU · 1 October 2015
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Sentenza della Corte (Terza Sezione) del 1° ottobre 2015.#Agenzia Italiana del Farmaco (AIFA) e Ministero della Salute contro Doc Generici srl.#Domanda di pronuncia pregiudiziale proposta dal Consiglio di Stato.#Rinvio pregiudiziale – Articolo 267 TFUE – Obbligo di rinvio alla Corte – Ravvicinamento delle legislazioni – Specialità farmaceutiche – Medicinali per uso umano – Autorizzazione all’immissione in commercio – Modifica – Diritti – Regolamento (CE) n. 297/95 – Regolamento (CE) n. 1234/2008 – Ambito di applicazione.#Causa C-452/14.
judgment · IT · 1 October 2015
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Tiesas spriedums (trešā palāta) 2015. gada 1. oktobrī.#Agenzia Italiana del Farmaco (AIFA) un Ministero della Salute pret Doc Generici Srl.#Consiglio di Stato lūgums sniegt prejudiciālu nolēmumu.#Lūgums sniegt prejudiciālu nolēmumu – LESD 267. pants – Tiesas kompetences neesamība – Tiesību aktu tuvināšana – Patentētas zāles – Cilvēkiem paredzētas zāles – Tirdzniecības atļauja – Grozījumi – Maksas – Regula (EK) Nr. 297/95 – Regula (EK) Nr. 1234/2008 – Piemērošanas joma.#Lieta C-452/14.
judgment · LV · 1 October 2015
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Judgment of the Court (Third Chamber) of 1 October 2015.#Agenzia Italiana del Farmaco (AIFA) and Ministero della Salute v Doc Generici srl.#Request for a preliminary ruling from the Consiglio di Stato.#Reference for a preliminary ruling — Article 267 TFEU — Obligation to bring the matter before the Court of Justice — Approximation of laws — Proprietary medicinal products — Medicinal products for human use — Marketing authorisation — Variation — Fees — Regulation (EC) No 297/95 — Regulation (EC) No 1234/2008 — Scope.#Case C-452/14.
judgment · EN · 1 October 2015
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Official source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:62014CJ0452
Open data entity: http://publications.europa.eu/resource/cellar/d1132770-6825-11e5-9317-01aa75ed71a1
eurlex · 62014CJ0452 · source updated 1 October 2015