Judgment of the Court (Third Chamber) of 19 July 2012.#European Commission v French Republic.#Failure of a Member State to fulfil obligations — Directive 2001/82/EC — Veterinary medicinal products — Decentralised procedure for the grant of marketing authorisation for a veterinary medicinal product in a number of Member States — Generic medicinal products similar to the reference medicinal products already authorised — Refusal to approve request by a Member State — Composition and form of the medicinal product.#Case C‑145/11.

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

Introduced

19 July 2012

Last action

19 July 2012 · Decided

Status

decided

Records

Official record CELEX 62011CJ0145 from European Union at Court of Justice of the European Union. Dated 19 July 2012. Status: decided.

Timeline

19 July 2012
Decided
Source: work_date_document

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

23 official files

Wyrok Trybunału (trzecia izba) z dnia 19 lipca 2012 r.#Komisja Europejska przeciwko Republice Francuskiej.#Uchybienie zobowiązaniom państwa członkowskiego – Dyrektywa 2001/82/WE – Weterynaryjne produkty lecznicze – Zdecentralizowana procedura w celu wydania pozwolenia na dopuszczenie do obrotu weterynaryjnego produktu leczniczego w różnych państwach członkowskich – Generyczne produkty lecznicze podobne do referencyjnych produktów leczniczych, na które wydano już pozwolenie – Odmowa zatwierdzenia wniosku przez państwo członkowskie – Skład i postać produktu leczniczego.#Sprawa C‑145/11.

View file Download file

Reading translation

Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.

Translate to

On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.

Wyrok Trybunału (trzecia izba) z dnia 19 lipca 2012 r.#Komisja Europejska przeciwko Republice Francuskiej.#Uchybienie zobowiązaniom państwa członkowskiego – Dyrektywa 2001/82/WE – Weterynaryjne produkty lecznicze – Zdecentralizowana procedura w celu wydania pozwolenia na dopuszczenie do obrotu weterynaryjnego produktu leczniczego w różnych państwach członkowskich – Generyczne produkty lecznicze podobne do referencyjnych produktów leczniczych, na które wydano już pozwolenie – Odmowa zatwierdzenia wniosku przez państwo członkowskie – Skład i postać produktu leczniczego.#Sprawa C‑145/11.
judgment · PL · 19 July 2012
View Download Open at official source
Presuda Suda (treće vijeće) od 2012. srpanj 19.#Europska komisija protiv Francuska Republika.#Predmet C-145/11.
judgment · HR · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Domstolens dom (Tredje Afdeling) af 19. juli 2012.#Europa-Kommissionen mod Den Franske Republik.#Traktatbrudssøgsmål – direktiv 2001/82/EF – veterinærlægemidler – decentraliseret procedure med henblik på udstedelse af en markedsføringstilladelse for et lægemiddel i mere end én medlemsstat – generiske lægemidler, der svarer til allerede godkendte referencelægemidler – en medlemsstats nægtelse af at anerkende ansøgningen – lægemidlets sammensætning og form.#Sag C-145/11.
judgment · DA · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Hotărârea Curții (Camera a treia) din 19 iulie 2012.#Comisia Europeană împotriva Republicii Franceze.#Neîndeplinirea obligațiilor de către un stat membru — Directiva 2001/82/CE — Medicamente de uz veterinar — Procedură descentralizată în vederea acordării unei autorizații de introducere pe piață a unui medicament de uz veterinar în mai multe state membre — Medicamente generice similare medicamentelor de referință deja autorizate — Refuz de validare a cererii de către un stat membru — Compoziția și forma medicamentului.#Cauza C-145/11.
judgment · RO · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Domstolens dom (tredje avdelningen) av den 19 juli 2012.#Europeiska kommissionen mot Republiken Frankrike.#Fördragsbrott – Direktiv 2001/82/EG – Veterinärmedicinska läkemedel – Decentraliserat förfarande för att erhålla ett godkännande för försäljning av ett veterinärmedicinskt läkemedel i flera medlemsstater – Generiska läkemedel som liknar redan tillåtna referensläkemedel – En medlemsstats vägran att företa en validering – Läkemedlets sammansättning och form.#Mål C‑145/11.
judgment · SV · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
2012 m. liepos 19 d. Teisingumo Teismo (trečioji kolegija) sprendimas.#Europos Komisija prieš Prancūzijos Respubliką.#Valstybės įsipareigojimų neįvykdymas – Direktyva 2001/82/EB – Veterinariniai vaistai – Leidimo prekiauti veterinariniais vaistais keliose valstybėse narėse išdavimas pagal decentralizuotą tvarką – Generiniai vaistai, panašūs į referentinius vaistus, kuriems jau suteiktas leidimas – Valstybės narės atsisakymas tenkinti paraišką – Vaisto sudėtis ir forma.#Byla C‑145/11.
judgment · LT · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
A Bíróság (harmadik tanács) 2012. július 19‑i ítélete.#Európai Bizottság kontra Francia Köztársaság.#Tagállami kötelezettségszegés – 2001/82/EK irányelv – Állatgyógyászati készítmények – Állatgyógyászati készítmény több tagállamban való forgalomba hozatala iránti engedély megadására irányuló decentralizált eljárás – Már engedélyezett referencia‑gyógyszerekhez hasonló generikus gyógyszerek – A kérelem érvényesítésének tagállam általi megtagadása – A gyógyászati készítmény összetétele és formája.#C‑145/11. sz. ügy.
judgment · HU · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Sodba Sodišča (tretji senat) z dne 19. julija 2012.#Evropska komisija proti Francoska republika.#Neizpolnitev obveznosti države – Direktiva 2001/82/ES – Zdravila za uporabo v veterinarski medicini – Decentralizirani postopek z namenom dodelitve dovoljenja za dajanje v promet v več kot eni državi članici – Generična zdravila, ki so podobna že odobrenim referenčnim zdravilom – Zavrnitev validacije vloge s strani države članice – Sestava in oblika zdravila.#Zadeva C‑145/11.
judgment · SL · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Sentenza tal-Qorti tal-Ġustizzja (It-Tielet Awla) tad-19 ta’ Lulju 2012.#Il-Kummissjoni Ewropea vs Ir-Repubblika Franċiża.#Nuqqas ta’ Stat li jwettaq obbligu — Direttiva 2001/82/KE — Prodotti mediċinali veterinarji — Proċedura deċentralizzata bil-għan li tinħareġ awtorizzazzjoni għat-tqegħid fis-suq ta’ prodott mediċinali veterinarju f’diversi Stati Membri wieħed — Prodotti mediċinali ġeneriċi simili għall-mediċini ta’ riferiment diġà awtorizzati — Rifjut ta’ validazzjoni tat-talba ta’ Stat Membru — Kompożizzjoni u forma tal-prodott mediċinali.#Kawża C-145/11.
judgment · MT · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Urteil des Gerichtshofs (Dritte Kammer) vom 19. Juli 2012.#Europäische Kommission gegen Französische Republik.#Vertragsverletzung eines Mitgliedstaats – Richtlinie 2001/82/EG – Tierarzneimittel – Dezentralisiertes Verfahren zur Erteilung einer Genehmigung für das Inverkehrbringen eines Tierarzneimittels in mehreren Mitgliedstaaten – Generika, die bereits genehmigten Referenzarzneimitteln ähnlich sind – Ablehnung der Validierung eines Antrags durch einen Mitgliedstaat – Zusammensetzung und Form des Arzneimittels.#Rechtssache C‑145/11.
judgment · DE · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Unionin tuomioistuimen tuomio (kolmas jaosto) 19.7.2012.#Euroopan komissio vastaan Ranskan tasavalta.#Jäsenyysvelvoitteiden noudattamatta jättäminen – Direktiivi 2001/82/EY – Eläinlääkkeet – Hajautettu menettely eläinlääkkeiden markkinoille saattamista koskevan luvan myöntämiseksi useammassa jäsenvaltiossa – Jo luvan saaneiden viitelääkkeiden kanssa samankaltaiset geneeriset lääkkeet – Jäsenvaltio kieltäytyy vahvistamasta hakemusta – Lääkkeen koostumus ja muoto.#Asia C-145/11.
judgment · FI · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Arrest van het Hof (Derde kamer) van 19 juli 2012.#Europese Commissie tegen Franse Republiek.#Niet-nakoming – Richtlijn 2001/82/EG – Geneesmiddelen voor diergeneeskundig gebruik – Gedecentraliseerde procedure voor verlening van vergunning voor in handel brengen van geneesmiddel voor diergeneeskundig gebruik in meerdere lidstaten – Generieke geneesmiddelen die vergelijkbaar zijn met referentiegeneesmiddelen waarvoor al vergunning is verleend – Weigering van validatie van aanvraag door lidstaat – Samenstelling en vorm van geneesmiddel.#Zaak C‑145/11.
judgment · NL · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Euroopa Kohtu otsus (kolmas koda), 19.7.2012.#Euroopa Komisjon versus Prantsuse Vabariik.#Liikmesriigi kohustuste rikkumine – Direktiiv 2001/82/EÜ – Veterinaarravimid – Detsentraliseeritud menetlus veterinaarravimile müügiloa andmiseks enam kui ühes liikmesriigis – Referentsliikmesriigis juba lubatud ravimitele olemuselt sarnased ravimid – Liikmesriigi poolt valideerimata jätmine – Ravimi koostis ja selle vorm.#Kohtuasi C-145/11.
judgment · ET · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Acórdão do Tribunal de Justiça (Terceira Secção) de 19 de julho de 2012.#Comissão Europeia contra República Francesa.#Incumprimento de Estado — Diretiva 2001/82/CE — Medicamentos veterinários — Processo descentralizado para a concessão de uma autorização de introdução no mercado vários Estados‑Membros — Medicamentos genéricos semelhantes aos medicamentos de referência já autorizados — Recusa de validação do pedido por um Estado‑Membro — Composição e forma do medicamento.#Processo C‑145/11.
judgment · PT · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Rozsudek Soudního dvora (třetího senátu) ze dne 19. července 2012.#Evropská komise v. Francouzská republika.#Nesplnění povinnosti státem – Směrnice 2001/82/CE – Veterinární léčivé přípravky – Decentralizovaný postup za účelem udělení registrace ve více než jednom členském státě – Generické léčivé přípravky podobné referenčním již registrovaným léčivým přípravkům – Odmítnutí validace členským státem – Složení léčivého přípravku a jeho podoba.#Věc C‑145/11.
judgment · CS · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Rozsudok Súdneho dvora (tretia komora) z 19. júla 2012.#Európska komisia proti Francúzskej republike.#Nesplnenie povinnosti členským štátom – Smernica 2001/82/ES – Veterinárne lieky – Decentralizovaný postup zameraný na získanie povolenia na uvádzanie veterinárnych liekov na trh viacerých členských štátov – Generické lieky podobné už povoleným referenčným prípravkom – Odmietnutie povolenia členským štátom – Zloženie a aplikačná podoba lieku.#Vec C-145/11.
judgment · SK · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Sentencia del Tribunal de Justicia (Sala Tercera) de 19 de julio de 2012.#Comisión Europea contra República Francesa.#Incumplimiento de Estado — Directiva 2001/82/CE — Medicamentos veterinarios — Procedimiento descentralizado para la concesión de una autorización de comercialización de un medicamento veterinario en varios Estados miembros — Medicamentos genéricos similares a los medicamentos de referencia ya autorizados — Negativa de un Estado miembro a validar la solicitud — Composición y forma del medicamento.#Asunto C‑145/11.
judgment · ES · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Решение на Съда (трети състав) от 19 юли 2012 г.#Европейска комисия срещу Френска република.#Неизпълнение на задължения от държава членка — Директива 2001/82/ЕО — Ветеринарномедицински продукти — Децентрализирана процедура за предоставяне на разрешително за пускане на пазара на ветеринарен лекарствен продукт в няколко държави членки — Генерични лекарствени продукти, сходни с вече разрешените референтни лекарствени продукти — Отказ за одобряване на заявлението от държава членка — Състав и форма на лекарствения продукт.#Дело C‑145/11.
judgment · BG · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Tiesas (trešā palāta) 2012. gada 19. jūlija spriedums.#Eiropas Komisija pret Francijas Republiku.#Valsts pienākumu neizpilde – Direktīva 2001/82/EK – Veterinārās zāles – Decentralizēta procedūra veterināro zāļu tirdzniecības atļaujas piešķiršanai vairākās dalībvalstīs – Ģenēriskās zāles, kas ir līdzīgas references zālēm, par kurām jau ir izsniegta tirdzniecības atļauja – Dalībvalsts tirdzniecības atļaujas atteikums – Zāļu sastāvs un forma.#Lieta C‑145/11.
judgment · LV · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Απόφαση του Δικαστηρίου (τρίτο τμήμα) της 19ης Ιουλίου 2012.#Ευρωπαϊκή Επιτροπή κατά Γαλλικής Δημοκρατίας.#Παράβαση κράτους μέλους — Οδηγία 2001/82/ΕΚ — Κτηνιατρικά φάρμακα — Αποκεντρωμένη διαδικασία για τη χορήγηση αδείας κυκλοφορίας κτηνιατρικού φαρμάκου στην αγορά εντός πλειόνων κρατών μελών — Γενόσημα φάρμακα παρόμοια με τα φάρμακα αναφοράς για τα οποία έχει ήδη χορηγηθεί άδεια — Άρνηση αναγνωρίσεως της αιτήσεως εκ μέρους κράτους μέλους — Σύνθεση και φαρμακευτική μορφή του φαρμάκου.#Υπόθεση C‑145/11.
judgment · EL · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Arrêt de la Cour (troisième chambre) du 19 juillet 2012.#Commission européenne contre République française.#Manquement d’État – Directive 2001/82/CE – Médicaments vétérinaires – Procédure décentralisée en vue de l’octroi d’une autorisation de mise sur le marché d’un médicament vétérinaire dans plusieurs États membres – Médicaments génériques similaires aux médicaments de référence déjà autorisés – Refus de validation de la demande par un État membre – Composition et forme du médicament.#Affaire C‑145/11.
judgment · FR · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Sentenza della Corte (Terza Sezione) del 19 luglio 2012.#Commissione europea contro Repubblica francese.#Inadempimento di uno Stato – Direttiva 2001/82/CE – Medicinali veterinari – Procedura decentralizzata prevista per il rilascio di un’autorizzazione di immissione in commercio di un medicinale veterinario in più Stati membri – Medicinali generici simili ai medicinali di riferimento già autorizzati – Diniego di convalida della domanda da parte di uno Stato membro – Composizione e forma del medicinale.#Causa C‑145/11.
judgment · IT · 19 July 2012
View Download Open at official source
Reading translation
Translate this document into your language. PoliticalRepo does not store a separate copy per EU language.
Translate to
On-demand whole-document translation with a downloadable PDF (logo + link to the official source). The official file stays authoritative.
Judgment of the Court (Third Chamber) of 19 July 2012.#European Commission v French Republic.#Failure of a Member State to fulfil obligations — Directive 2001/82/EC — Veterinary medicinal products — Decentralised procedure for the grant of marketing authorisation for a veterinary medicinal product in a number of Member States — Generic medicinal products similar to the reference medicinal products already authorised — Refusal to approve request by a Member State — Composition and form of the medicinal product.#Case C‑145/11.
judgment · EN · 19 July 2012
View Download Open at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Vertaal naar
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Related records

No cross-record relationships stored yet.

Sources

PoliticalRepo is an index and interpretation layer, not the authoritative legal source.

Official source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:62011CJ0145
Open data entity: http://publications.europa.eu/resource/cellar/0fa54a17-a26a-46d0-bb14-73b1ea3739d8
eurlex · 62011CJ0145 · source updated 19 July 2012