European Union · Record · CJ
CELEX 62006CJ0452
Judgment of the Court (First Chamber) of 16 October 2008.#The Queen, on the application of Synthon BV v Licensing Authority of the Department of Health.#Reference for a preliminary ruling: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - United Kingdom.#Community code relating to medicinal products for human use - Marketing authorisation - Essentially similar medicinal products - Abridged procedure - Procedure for mutual recognition - Grounds for refusal - Liability of a Member State - Serious breach of Community law.#Case C-452/06.
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16 October 2008
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16 October 2008
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Official record CELEX 62006CJ0452 from European Union at Court of Justice of the European Union. Dated 16 October 2008. Status: decided.
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Judgment of the Court (First Chamber) of 16 October 2008.#The Queen, on the application of Synthon BV v Licensing Authority of the Department of Health.#Reference for a preliminary ruling: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - United Kingdom.#Community code relating to medicinal products for human use - Marketing authorisation - Essentially similar medicinal products - Abridged procedure - Procedure for mutual recognition - Grounds for refusal - Liability of a Member State - Serious breach of Community law.#Case C-452/06.
judgment · EN · 16 October 2008
Presuda Suda (prvo vijeće) od 16. listopada 2008.#The Queen, na zahtjev Synthon BV protiv Licensing Authority of the Department of Health.#Zahtjev za prethodnu odluku: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Ujedinjena Kraljevina.#Predmet C-452/06.
judgment · HR · 16 October 2008
Rozsudok Súdneho dvora (prvá komora) zo 16. októbra 2008.#The Queen, na návrh Synthon BV proti Licensing Authority of the Department of Health.#Návrh na začatie prejudiciálneho konania: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Spojené kráľovstvo.#Zákonník Spoločenstva o humánnych liekoch - Povolenie na uvedenie na trh - V podstate podobné lieky - Skrátené konanie - Konanie o vzájomnom uznaní - Dôvody zamietnutia - Zodpovednosť členského štátu - Závažné porušenie práva Spoločenstva.#Vec C-452/06.
judgment · SK · 16 October 2008
Domstolens Dom (Første Afdeling) af 16. oktober 2008.#The Queen, på vegne af Synthon BV mod Licensing Authority of the Department of Health.#Anmodning om præjudiciel afgørelse: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Forenede Kongerige.#Fællesskabskodeks for humanmedicinske lægemidler - markedsføringstilladelse - lægemidler, der i det væsentlige svarer til hinanden - forkortet procedure - procedure for gensidig anerkendelse - grunde til nægtelse heraf - en medlemsstats ansvar- kvalificeret tilsidesættelse af fællesskabsretten.#Sag C-452/06.
judgment · DA · 16 October 2008
Sentencia del Tribunal de Justicia (Sala Primera) de 16 de octubre de 2008.#The Queen, a instancia de Synthon BV contra Licensing Authority of the Department of Health.#Petición de decisión prejudicial: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Reino Unido.#Código comunitario sobre medicamentos para uso humano - Autorización de comercialización - Medicamentos esencialmente similares - Procedimiento simplificado - Procedimiento de reconocimiento mutuo - Motivos de denegación - Responsabilidad de un Estado miembro - Violación caracterizada del Derecho comunitario.#Asunto C-452/06.
judgment · ES · 16 October 2008
Sentenza della Corte (Prima Sezione) del 16 ottobre 2008.#The Queen, su istanza di Synthon BV contro Licensing Authority of the Department of Health.#Domanda di pronuncia pregiudiziale: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Regno Unito.#Codice comunitario relativo ai medicinali per uso umano - Autorizzazione all’immissione in commercio - Medicinali essenzialmente analoghi - Procedura abbreviata - Procedura di mutuo riconoscimento - Motivi di rifiuto - Responsabilità di uno Stato membro - Violazione qualificata del diritto comunitario.#Causa C-452/06.
judgment · IT · 16 October 2008
Hotărârea Curții (camera întâi) din data de 16 octombrie 2008.#The Queen, la cererea formulată de Synthon BV împotriva Licensing Authority of the Department of Health.#Cerere având ca obiect pronunțarea unei hotărâri preliminare: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Regatul Unit.#Cod comunitar cu privire la medicamentele de uz uman - Autorizație de introducere pe piață - Medicamente similare în fond - Procedura simplificată - Procedură de recunoaștere reciprocă - Motive de refuz - Responsabilitate a unui stat membru - Încălcare gravă a dreptului comunitar.#Cauza C-452/06.
judgment · RO · 16 October 2008
Arrest van het Hof (Eerste kamer) van 16 oktober 2008.#The Queen, op verzoek van Synthon BV tegen Licensing Authority of the Department of Health.#Verzoek om een prejudiciële beslissing: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Verenigd Koninkrijk.#Communautair wetboek betreffende geneesmiddelen voor menselijk gebruik - Vergunning voor in handel brengen - In wezen gelijkwaardige geneesmiddelen - Verkorte procedure - Procedure van wederzijdse erkenning - Gronden voor weigering - Aansprakelijkheid van lidstaat - Gekwalificeerde schending van gemeenschapsrecht.#Zaak C-452/06.
judgment · NL · 16 October 2008
Acórdão do Tribunal de Justiça (Primeira Secção) de 16 de Outubro de 2008.#The Queen, a pedido de Synthon BV contra Licensing Authority of the Department of Health.#Pedido de decisão prejudicial: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Reino Unido.#Código comunitário relativo aos medicamentos para uso humano - Autorização de introdução no mercado - Medicamentos essencialmente similares - Procedimento abreviado - Procedimento de reconhecimento mútuo - Motivos de recusa - Responsabilidade de um Estado-Membro - Violação caracterizada do direito comunitário.#Processo C-452/06.
judgment · PT · 16 October 2008
Решение на Съда (първи състав) от 16 октомври 2008 г.#The Queen, по искане на Synthon BV срещу Licensing Authority of the Department of Health.#Искане за преюдициално заключение: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Обединеното кралство.#Кодекс на Общността относно лекарствени продукти за хуманна употреба - Разрешение за търговия - Лекарствени продукти, които по същество са аналози - Съкратена процедура - Процедура по взаимно признаване - Основания за отказ - Отговорност на държава-членка - Съществено нарушение на общностното право.#Дело C-452/06.
judgment · BG · 16 October 2008
Rozsudek Soudního dvora (prvního senátu) ze dne 16. října 2008.#The Queen, na žádost Synthon BV proti Licensing Authority of the Department of Health.#Žádost o rozhodnutí o předběžné otázce: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Spojené království.#Kodex Společenství týkající se humánních léčivých přípravků - Registrace - V zásadě podobné léčivé přípravky - Zkrácený postup - Postup vzájemného uznávání - Důvody pro zamítnutí - Odpovědnost členského státu - Závažné porušení práva Společenství.#Věc C-452/06.
judgment · CS · 16 October 2008
Sentenza tal-Qorti tal-Ġustizzja (l-Ewwel Awla) tas-16 ta' Ottubru 2008.#The Queen, fuq talba ta' Synthon BV vs Licensing Authority of the Department of Health.#Talba għal deċiżjoni preliminari: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - ir-Renju Unit.#Kodiċi Komunitarju li għandu x’jaqsam ma’ prodotti mediċinali għall-użu mill-bniedem - Awtorizzazzjoni għat-tqegħid fis-suq - Prodotti mediċinali essenzjalment simili - Proċedura mqassra - Prinċipju għar-rikonoxximent reċiproku - Motivi għar-rifjut - Responsabbiltà ta’ Stat Membru - Ksur serju tad-dritt Komunitarju.#Kawża C-452/06.
judgment · MT · 16 October 2008
Yhteisöjen tuomioistuimen tuomio (ensimmäinen jaosto) 16 päivänä lokakuuta 2008.#The Queen, seuraavien hakemuksesta Synthon BV vastaan Licensing Authority of the Department of Health.#Ennakkoratkaisupyyntö: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Yhdistynyt kuningaskunta.#Ihmisille tarkoitettuja lääkkeitä koskevat yhteisön säännöt - Markkinoille saattamista koskeva lupa - Olennaisilta osiltaan samanlaiset lääkkeet - Lyhennetty menettely - Vastavuoroisen tunnustamisen menettely - Hylkäysperusteet - Jäsenvaltion vastuu - Yhteisön oikeuden ilmeinen rikkominen.#Asia C-452/06.
judgment · FI · 16 October 2008
A Bíróság (első tanács) 2008. október 16-i ítélete.#The Queen, kérelme alapján Synthon BV kontra Licensing Authority of the Department of Health.#Előzetes döntéshozatal iránti kérelem: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Egyesült Királyság.#Az emberi felhasználásra szánt gyógyszerek közösségi kódexe - Forgalomba hozatali engedély - Alapvetően hasonló gyógyszerek - Rövidített eljárás - Kölcsönös elismerési eljárás - Kizáró okok - Tagállami felelősség - A közösségi jog súlyos megsértése.#C-452/06. sz. ügy.
judgment · HU · 16 October 2008
Domstolens dom (första avdelningen) den 16 oktober 2008.#The Queen, på begäran av Synthon BV mot Licensing Authority of the Department of Health.#Begäran om förhandsavgörande: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Förenade kungariket.#Gemenskapsregler för humanläkemedel - Godkännande för försäljning - Läkemedel som i allt väsentligt överensstämmer med varandra - Förenklat förfarande - Förfarande för ömsesidigt erkännande - Skäl för avslag - Medlemsstaternas skadeståndsansvar - Klar överträdelse av gemenskapsrätten.#Mål C-452/06.
judgment · SV · 16 October 2008
Arrêt de la Cour (première chambre) du 16 octobre 2008.#The Queen, à la demande de Synthon BV contre Licensing Authority of the Department of Health.#Demande de décision préjudicielle: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Royaume-Uni.#Code communautaire relatif aux médicaments à usage humain - Autorisation de mise sur le marché - Médicaments essentiellement similaires - Procédure abrégée - Procédure de reconnaissance mutuelle - Motifs de refus - Responsabilité d’un État membre - Violation caractérisée du droit communautaire.#Affaire C-452/06.
judgment · FR · 16 October 2008
2008 m. spalio 16 d. Teisingumo Teismo (pirmoji kolegija) sprendimas.#The Queen, prašoma Synthon BV prieš Licensing Authority of the Department of Health.#Prašymas priimti prejudicinį sprendimą: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Jungtinė Karalystė.#Bendrijos kodeksas, reglamentuojantis žmonėms skirtus vaistus -Leidimas pateikti į rinką - Iš esmės panašūs vaistai - Sutrumpinta procedūra - Abipusio pripažinimo procedūra - Atsisakymo pagrindai - Valstybės narės atsakomybė - Akivaizdus Bendrijos teisės pažeidimas.#Byla C-452/06.
judgment · LT · 16 October 2008
Wyrok Trybunału (pierwsza izba) z dnia 16 października 2008 r.#The Queen, na wniosek Synthon BV przeciwko Licensing Authority of the Department of Health.#Wniosek o wydanie orzeczenia w trybie prejudycjalnym: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Zjednoczone Królestwo.#Wspólnotowy kodeks odnoszący się do produktów leczniczych stosowanych u ludzi - Pozwolenie na dopuszczenie do obrotu - Produkty lecznicze zasadniczo podobne - Procedura skrócona - Procedura wzajemnego uznawania - Podstawy odmowy - Odpowiedzialność państwa członkowskiego - Istotne naruszenie prawa wspólnotowego.#Sprawa C-452/06.
judgment · PL · 16 October 2008
Απόφαση του Δικαστηρίου (πρώτο τμήμα) της 16ης Οκτωβρίου 2008.#The Queen, κατόπιν αιτήσεως των Synthon BV κατά Licensing Authority of the Department of Health.#Αίτηση για την έκδοση προδικαστικής αποφάσεως: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Ηνωμένο Βασίλειο.#Κοινοτικός κώδικας για τα φάρμακα που προορίζονται για ανθρώπινη χρήση - Άδεια κυκλοφορίας - Oυσιωδώς παρεμφερή φάρμακα - Συνοπτική διαδικασία - Διαδικασία αμοιβαίας αναγνωρίσεως - Λόγοι αρνήσεως - Ευθύνη κράτους μέλους - Κατάφωρη παραβίαση του κοινοτικού δικαίου.#Υπόθεση C-452/06.
judgment · EL · 16 October 2008
Euroopa Kohtu otsus (esimene koda), 16. oktoober 2008.#The Queen, taotluse alusel, mille esitasid Synthon BV versus Licensing Authority of the Department of Health.#Eelotsusetaotlus: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Ühendkuningriik.#Inimtervishoius kasutatavaid ravimeid käsitlevad ühenduse eeskirjad - Müügiluba - Olemuselt sarnased ravimid - Lihtsustatud kord - Vastastikuse tunnustamise menetlus - Keeldumise alused - Liikmesriigi vastutus - Ühenduse õiguse selge rikkumine.#Kohtuasi C-452/06.
judgment · ET · 16 October 2008
Sodba Sodišča (prvi senat) z dne 16. oktobra 2008.#The Queen, na predlog Synthon BV proti Licensing Authority of the Department of Health.#Predlog za sprejetje predhodne odločbe: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Združeno kraljestvo.#Zakonik Skupnosti o zdravilih za uporabo v humani medicini - Dovoljenje za promet - Bistveno podobna zdravila - Skrajšani postopek - Postopek medsebojnega priznanja - Razlogi za zavrnitev - Odgovornost države članice - Resna kršitev prava Skupnosti.#Zadeva C-452/06.
judgment · SL · 16 October 2008
Urteil des Gerichtshofes (Erste Kammer) vom 16. Oktober 2008.#The Queen, auf Antrag von/der Synthon BV gegen Licensing Authority of the Department of Health.#Ersuchen um Vorabentscheidung: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Vereinigtes Königreich.#Gemeinschaftskodex für Humanarzneimittel - Genehmigung für das Inverkehrbringen - Im Wesentlichen gleiche Arzneimittel - Abgekürztes Verfahren - Verfahren der gegenseitigen Anerkennung - Versagungsgründe - Haftung eines Mitgliedstaats - Qualifizierter Verstoß gegen das Gemeinschaftsrecht.#Rechtssache C-452/06.
judgment · DE · 16 October 2008
Tiesas spriedums (pirmā palāta) 2008. gada 16.oktobrī.#The Queen, ko lūdza Synthon BV pret Licensing Authority of the Department of Health.#Lūgums sniegt prejudiciālu nolēmumu: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Apvienotā Karaliste.#Kopienas kodekss, kas attiecas uz cilvēkiem paredzētām zālēm - Tirdzniecības atļauja - Pēc būtības līdzīgas zāles - Saīsinātā procedūra - Savstarpējās atzīšanas procedūra - Atteikuma pamatojums - Dalībvalsts atbildība - Būtisks Kopienu tiesību pārkāpums.#Lieta C-452/06.
judgment · LV · 16 October 2008
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