Opinion of Mr Advocate General Mazák delivered on 26 March 2009.#The Queen, on the application of Generics (UK) Ltd v Licensing Authority.#Reference for a preliminary ruling: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - United Kingdom.#Reference for a preliminary ruling - Directive 2001/83/EC - Medicinal products for human use - Marketing authorisation - Grounds of refusal - Generic medicinal products - Concept of ‘reference medicinal product’.#Case C-527/07.

Record

Official report CELEX 62007CC0527 from European Union at Court of Justice of the European Union. Dated 26 March 2009. Status: decided.

Timeline

1. 26 March 2009

   Decided

   Source: work_date_document

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Documents

23 official files

• Opinion of Mr Advocate General Mazák delivered on 26 March 2009.#The Queen, on the application of Generics (UK) Ltd v Licensing Authority.#Reference for a preliminary ruling: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - United Kingdom.#Reference for a preliminary ruling - Directive 2001/83/EC - Medicinal products for human use - Marketing authorisation - Grounds of refusal - Generic medicinal products - Concept of ‘reference medicinal product’.#Case C-527/07.

  judgment · EN · 26 March 2009

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• Mišljenje nezavisnog odvjetnika Mazák iznesen26. ožujka 2009.#The Queen, na zahtjev Generics (UK) Ltd protiv Licensing Authority.#Zahtjev za prethodnu odluku: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Ujedinjena Kraljevina.#Zahtjev za prethodnu odluku - Direktiva 2001/83/EZ.#Predmet C-527/07.

  judgment · HR · 26 March 2009

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• Concluziile avocatului general Mazák prezentate la data de 26 martie 2009.#The Queen, la cererea formulată de Generics (UK) Ltd împotriva Licensing Authority.#Cerere având ca obiect pronunțarea unei hotărâri preliminare: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Regatul Unit.#Cerere de pronunțare a unei hotărâri preliminare - Directiva 2001/83/CE - Medicamente de uz uman - Autorizație de introducere pe piață - Motive de refuz - Medicamente generice - Noțiunea «medicament de referință».#Cauza C-527/07.

  judgment · RO · 26 March 2009

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• Conclusiones del Abogado General Mazák presentadas el 26 de marzo de 2009.#The Queen, a instancia de Generics (UK) Ltd contra Licensing Authority.#Petición de decisión prejudicial: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Reino Unido.#Petición de decisión prejudicial - Directiva 2001/83/CE - Medicamentos para uso humano - Autorización de comercialización - Motivos de denegación - Medicamentos genéricos - Concepto de "medicamento de referencia".#Asunto C-527/07.

  judgment · ES · 26 March 2009

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• Conclusioni dell'avvocato generale Mazák del 26 marzo 2009.#The Queen, su istanza di Generics (UK) Ltd contro Licensing Authority.#Domanda di pronuncia pregiudiziale: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Regno Unito.#Domanda di pronuncia pregiudiziale - Direttiva 2001/83/CE - Medicinali per uso umano - Autorizzazione all’immissione in commercio - Motivi di diniego - Medicinali generici - Nozione di "medicinale di riferimento".#Causa C-527/07.

  judgment · IT · 26 March 2009

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• Προτάσεις του γενικού εισαγγελέα Mazák της 26ης Μαρτίου 2009.#The Queen, κατόπιν αιτήσεως των Generics (UK) Ltd κατά Licensing Authority.#Αίτηση για την έκδοση προδικαστικής αποφάσεως: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Ηνωμένο Βασίλειο.#Αίτηση εκδόσεως προδικαστικής αποφάσεως - Οδηγία 2001/83/ΕΚ -Φάρμακα που προορίζονται για ανθρώπινη χρήση - Άδεια εμπορίας - Λόγοι αποκλείοντες τη χορήγησή της - Γενόσημα φάρμακα - Έννοια του "φαρμάκου αναφοράς".#Υπόθεση C-527/07.

  judgment · EL · 26 March 2009

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• Kohtujuristi ettepanek - Mazák - 26. märts 2009.#The Queen, taotluse alusel, mille esitasid Generics (UK) Ltd versus Licensing Authority.#Eelotsusetaotlus: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Ühendkuningriik.#Eelotsusetaotlus - Direktiiv 2001/83/EÜ - Inimtervishoius kasutatavad ravimid - Müügiluba - Keeldumispõhjused - Geneerilised ravimid - Mõiste "originaalravim".#Kohtuasi C-527/07.

  judgment · ET · 26 March 2009

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• Schlussanträge des Generalanwalts Mazák vom 26. März 2009.#The Queen, auf Antrag von/der Generics (UK) Ltd gegen Licensing Authority.#Ersuchen um Vorabentscheidung: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Vereinigtes Königreich.#Vorabentscheidungsersuchen - Richtlinie 2001/83/EG -Humanarzneimittel - Genehmigung für das Inverkehrbringen - Versagungsgründe - Generika - Begriff ‚Referenzarzneimittel.#Rechtssache C-527/07.

  judgment · DE · 26 March 2009

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• Sklepni predlogi generalnega pravobranilca - Mazák - 26. marca 2009.#The Queen, na predlog Generics (UK) Ltd proti Licensing Authority.#Predlog za sprejetje predhodne odločbe: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Združeno kraljestvo.#Predlog za sprejetje predhodne odločbe - Direktiva 2001/83/ES - Zdravila za uporabo v humani medicini - Dovoljenje za promet - Razlogi za zavrnitev - Generična zdravila - Pojem ‚referenčno zdravilo‘.#Zadeva C-527/07.

  judgment · SL · 26 March 2009

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• Mazák főtanácsnok indítványa, az ismertetés napja: 2009. március 26.#The Queen, kérelme alapján Generics (UK) Ltd kontra Licensing Authority.#Előzetes döntéshozatal iránti kérelem: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Egyesült Királyság.#Előzetes döntéshozatal iránti kérelem - 2001/83/EK irányelv - Emberi felhasználásra szánt gyógyszerek - Forgalombahozatali engedély - Kizáró okok - Generikus gyógyszerek - Referencia-gyógyszer fogalma.#C-527/07. sz. ügy.

  judgment · HU · 26 March 2009

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• Konklużjonijiet ta' l-Avukat Ġenerali - Mazák - 26 ta' Marzu 2009.#The Queen, fuq talba ta' Generics (UK) Ltd vs Licensing Authority.#Talba għal deċiżjoni preliminari: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - ir-Renju Unit.#Talba għal deċiżjoni preliminari - Direttiva 2001/83/KE - Prodotti mediċinali għall-użu mill-bniedem - Awtorizzazzjoni għat-tqegħid fis-suq - Raġunijiet għal rifjut - Prodotti mediċinali ġeneriċi - Kunċett ta’ ‘prodott mediċinali ta’ referenza’.#Kawża C-527/07.

  judgment · MT · 26 March 2009

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• Förslag till avgörande av generaladvokat Mazák föredraget den 26 mars 2009.#The Queen, på begäran av Generics (UK) Ltd mot Licensing Authority.#Begäran om förhandsavgörande: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Förenade kungariket.#Begäran om förhandsavgörande - Direktiv 2001/83/EG - Humanläkemedel - Godkännande för försäljning - Skäl för avslag - Generiska läkemedel - Begreppet ’referensläkemedel’.#Mål C-527/07.

  judgment · SV · 26 March 2009

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• Julkisasiamiehen ratkaisuehdotus Mazák 26 päivänä maaliskuuta 2009.#The Queen, seuraavien hakemuksesta Generics (UK) Ltd vastaan Licensing Authority.#Ennakkoratkaisupyyntö: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Yhdistynyt kuningaskunta.#Ennakkoratkaisupyyntö - Direktiivi 2001/83/EY - Ihmisille tarkoitetut lääkkeet - Myyntilupa - Epäämisperusteet - Geneeriset lääkkeet - "Vertailulääkkeen" käsite.#Asia C-527/07.

  judgment · FI · 26 March 2009

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• Ģenerāladvokāta Mazák secinājumi, sniegti 2009. gada 26.martā.#The Queen, ko lūdza Generics (UK) Ltd pret Licensing Authority.#Lūgums sniegt prejudiciālu nolēmumu: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Apvienotā Karaliste.#Lūgums sniegt prejudiciālu nolēmumu - Direktīva 2001/83/EK - Cilvēkiem paredzētas zāles - Tirdzniecības atļauja - Atteikuma pamatojumi - Ģenēriskās zāles - Atsauces (references) zāļu jēdziens.#Lieta C-527/07.

  judgment · LV · 26 March 2009

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• Conclusions de l'avocat général Mazák présentées le 26 mars 2009.#The Queen, à la demande de Generics (UK) Ltd contre Licensing Authority.#Demande de décision préjudicielle: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court)- Royaume-Uni.#Demande de décision préjudicielle - Directive 2001/83/CE - Médicaments à usage humain - Autorisation de mise sur le marché - Motifs de refus - Médicaments génériques - Notion de 'médicament de référence'.#Affaire C-527/07.

  judgment · FR · 26 March 2009

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• Conclusie van advocaat-generaal Mazák van 26 maart 2009.#The Queen, op verzoek van Generics (UK) Ltd tegen Licensing Authority.#Verzoek om een prejudiciële beslissing: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Verenigd Koninkrijk.#Verzoek om prejudiciële beslissing - Richtlijn 2001/83/EG - Geneesmiddelen voor menselijk gebruik - Vergunning voor in handel brengen - Gronden voor weigering - Generieke geneesmiddelen - Begrip ‚referentiegeneesmiddel’.#Zaak C-527/07.

  judgment · NL · 26 March 2009

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• Návrhy generálneho advokáta - Mazák - 26. marca 2009.#The Queen, na návrh Generics (UK) Ltd proti Licensing Authority.#Návrh na začatie prejudiciálneho konania: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Spojené kráľovstvo.#Návrh na začatie prejudiciálneho konania - Smernica 2001/83/ES - Humánne lieky - Povolenie na uvedenie na trh - Dôvody zamietnutia - Generické lieky - Pojem ‚referenčný liek.#Vec C-527/07.

  judgment · SK · 26 March 2009

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• Generalinio advokato Mazák išvada, pateikta 2009 m. kovo 26 d.#The Queen, prašoma Generics (UK) Ltd prieš Licensing Authority.#Prašymas priimti prejudicinį sprendimą: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Jungtinė Karalystė.#Prašymas priimti prejudicinį sprendimą - Direktyva 2001/83/CE - Žmonėms skirti vaistai - Leidimas prekiauti - Atsisakymo pagrindai - Generiniai vaistai - "Referencinio vaisto" sąvoka.#Byla C-527/07.

  judgment · LT · 26 March 2009

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• Stanovisko generálního advokáta - Mazák - 26 března 2009.#The Queen, na žádost Generics (UK) Ltd proti Licensing Authority.#Žádost o rozhodnutí o předběžné otázce: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Spojené království.#Žádost o rozhodnutí o předběžné otázce - Směrnice 2001/83/ES - Humánní léčivé přípravky - Registrace - Důvody pro odmítnutí - Generika - Pojem ‚referenční léčivý přípravek‘.#Věc C-527/07.

  judgment · CS · 26 March 2009

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• Conclusões do advogado-geral Mazák apresentadas em 26 de Março de 2009.#The Queen, a pedido de Generics (UK) Ltd contra Licensing Authority.#Pedido de decisão prejudicial: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Reino Unido.#Pedido de decisão prejudicial - Directiva 2001/83/CE - Medicamentos para uso humano - Autorização de introdução no mercado - Fundamentos de recusa - Medicamentos genéricos - Conceito de ‘medicamento de referência’.#Processo C-527/07.

  judgment · PT · 26 March 2009

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• Opinia rzecznika generalnego Mazák przedstawione w dniu 26 marca 2009 r.#The Queen, na wniosek Generics (UK) Ltd przeciwko Licensing Authority.#Wniosek o wydanie orzeczenia w trybie prejudycjalnym: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Zjednoczone Królestwo.#Wniosek o wydanie orzeczenia w trybie prejudycjalnym - Dyrektywa 2001/83/WE - Produkty lecznicze przeznaczone do użytku przez człowieka - Pozwolenie na dopuszczenie do obrotu - Podstawy odmowy - Odpowiednik produktu leczniczego - Pojęcie referencyjnego produktu leczniczego.#Sprawa C-527/07.

  judgment · PL · 26 March 2009

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• Forslag til afgørelse fra generaladvokat Mazák fremsat den 26. marts 2009.#The Queen, på vegne af Generics (UK) Ltd mod Licensing Authority.#Anmodning om præjudiciel afgørelse: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Forenede Kongerige.#Anmodning om præjudiciel afgørelse - direktiv 2001/83/EF - humanmedicinske lægemidler - markedsføringstilladelse - begrundelse for afslag - generiske lægemidler - begrebet »referencelægemiddel.#Sag C-527/07.

  judgment · DA · 26 March 2009

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• Заключение на генералния адвокат Mazák представено на26 март 2009 г.#The Queen, по искане на Generics (UK) Ltd срещу Licensing Authority.#Искане за преюдициално заключение: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - Обединеното кралство.#Преюдициално запитване - Директива 2001/83/ЕО - Лекарствени продукти за хуманна употреба - Разрешение за търговия - Основания за отказ - Генерични лекарствени продукти - Понятие за референтен лекарствен продукт.#Дело C-527/07.

  judgment · BG · 26 March 2009

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