Judgment of the Court (Fourth Chamber) of 27 March 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel and Remedia d.o.o. v European Commission.#Appeal — Medicinal products for human use — Directive 2001/83/EC — Article 30(1) — Committee for Medicinal Products for Human Use — Referral of a matter to the committee subject to the absence of a previous national decision — Active substance estradiol — Decision of the European Commission ordering the Member States to revoke or vary marketing authorisations for medicinal products with 0.01% estradiol by weight for topical use.#Case C-680/16 P.

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

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27 March 2019

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27 March 2019 · Decided

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Official record CELEX 62016CJ0680 from European Union at Court of Justice of the European Union. Dated 27 March 2019. Status: decided.

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27 March 2019
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23 official files

Arrêt de la Cour (quatrième chambre) du 27 mars 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel et Remedia d.o.o. contre Commission européenne.#Pourvoi – Médicaments à usage humain – Directive 2001/83/CE – Article 30, paragraphe 1 – Comité des médicaments à usage humain – Saisine du comité subordonnée à la condition qu’une décision nationale n’ait pas préalablement été prise – Substance active estradiol – Décision de la Commission européenne ordonnant aux États membres le retrait et la modification des autorisations nationales de mise sur le marché des médicaments à usage topique contenant 0,01 % en poids d’estradiol.#Affaire C-680/16 P.

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Arrêt de la Cour (quatrième chambre) du 27 mars 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel et Remedia d.o.o. contre Commission européenne.#Pourvoi – Médicaments à usage humain – Directive 2001/83/CE – Article 30, paragraphe 1 – Comité des médicaments à usage humain – Saisine du comité subordonnée à la condition qu’une décision nationale n’ait pas préalablement été prise – Substance active estradiol – Décision de la Commission européenne ordonnant aux États membres le retrait et la modification des autorisations nationales de mise sur le marché des médicaments à usage topique contenant 0,01 % en poids d’estradiol.#Affaire C-680/16 P.
judgment · FR · 27 March 2019
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Urteil des Gerichtshofs (Vierte Kammer) vom 27. März 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel und Remedia d.o.o. gegen Europäische Kommission.#Rechtsmittel – Humanarzneimittel – Richtlinie 2001/83/EG – Art. 30 Abs. 1 – Humanarzneimittelausschuss – Befassung des Ausschusses unter der Voraussetzung, dass nicht zuvor eine nationale Entscheidung erlassen worden ist – Wirkstoff Estradiol – Beschluss der Europäischen Kommission, mit dem gegenüber den Mitgliedstaaten der Widerruf bzw. die Änderung der nationalen Genehmigungen für das Inverkehrbringen von Arzneimitteln zur topischen Anwendung mit einem Massenanteil von 0,01 % Estradiol angeordnet wird.#Rechtssache C-680/16 P.
judgment · DE · 27 March 2019
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Unionin tuomioistuimen tuomio (neljäs jaosto) 27.3.2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel ja Remedia d.o.o. vastaan Euroopan komissio.#Muutoksenhaku – Ihmisille tarkoitetut lääkkeet – Direktiivi 2001/83/EY – 30 artiklan 1 kohta – Ihmisille tarkoitettuja lääkkeitä käsittelevä komitea – Asian komitealle saattamisen edellytyksenä on, ettei kansallista päätöstä ole tätä ennen tehty – Vaikuttava aine estradioli – Euroopan komission päätös, jolla jäsenvaltiot määrätään peruuttamaan paikallishoitoon tarkoitettujen 0,01 painoprosenttia (w/w) estradiolia sisältävien lääkevalmisteiden kansalliset myyntiluvat ja muuttamaan niitä.#Asia C-680/16 P.
judgment · FI · 27 March 2019
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Решение на Съда (четвърти състав) от 27 март 2019 г.#Dr. August Wolff GmbH & Co. KG Arzneimittel и Remedia d.o.o. срещу Европейска комисия.#Обжалване — Лекарствени продукти за хуманна употреба — Директива 2001/83/ЕО — Член 30, параграф 1 — Комитет по лекарствените продукти за хуманна употреба — Сезиране на комитета, подчинено на изискването преди това да не е постановено национално решение — Активно вещество естрадиол — Решение, с което Европейската комисия нарежда на държавите членки да отнемат и изменят националните разрешения за търговия с лекарствени продукти с локално приложение, съдържащи естрадиол 0,01 % w/w.#Дело C-680/16 P.
judgment · BG · 27 March 2019
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Rozsudok Súdneho dvora (štvrtá komora) z 27. marca 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel a Remedia d.o.o. proti Európskej komisii.#Odvolanie – Humánne lieky – Smernica 2001/83/ES – Článok 30 ods. 1 – Výbor pre lieky na humánne použitie – Obrátenie sa na výbor podriadené podmienke, že predtým nebolo prijaté vnútroštátne rozhodnutie – Aktívna látka estradiol – Rozhodnutie Európskej komisie nariaďujúce členským štátom odobratie a zmenu vnútroštátnych povolení na uvedenie na trh pre lieky na topické použitie obsahujúce 0,01 % hmotnostného podielu estradiolu.#Vec C-680/16 P.
judgment · SK · 27 March 2019
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Sodba Sodišča (četrti senat) z dne 27. marca 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel in Remedia d.o.o. proti Evropski komisiji.#Pritožba – Zdravila za uporabo v humani medicini – Direktiva 2001/83/ES – Člen 30, prvi odstavek – Odbor za zdravila za uporabo v humani medicini – Predložitev zadeve Odboru, ki je pogojena s tem, da predhodno ni sprejeta nacionalna odločba – Aktivna snov estradiol – Sklep Evropske komisije, ki državam članicam nalaga, naj razveljavijo in spremenijo nacionalna dovoljenja za dajanje na trg zdravil za topično uporabo z 0,01‑odstotnim masnim deležem estradiola.#Zadeva C-680/16 P.
judgment · SL · 27 March 2019
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Tiesas spriedums (ceturtā palāta), 2019. gada 27. marts.#Dr. August Wolff GmbH & Co. KG Arzneimittel un Remedia d.o.o. pret Eiropas Komisiju.#Apelācija – Cilvēkiem paredzētas zāles – Direktīva 2001/83/EK – 30. panta 1. punkts – Cilvēkiem paredzēto zāļu komiteja – Vēršanās komitejā, kas pakļauta nosacījumam, ka iepriekš nav ticis pieņemts valsts lēmums – Aktīvā viela estradiols – Eiropas Komisijas lēmums, ar kuru dalībvalstīm noteikts atsaukt un grozīt valsts tirdzniecības atļaujas lokālai lietošanai paredzētām zālēm ar estradiola koncentrāciju 0,01 masas procenti.#Lieta C-680/16 P.
judgment · LV · 27 March 2019
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Hotărârea Curții (Camera a patra) din 27 martie 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel și Remedia d.o.o. împotriva Comisiei Europene.#Recurs – Medicamente de uz uman – Directiva 2001/83/CE – Articolul 30 alineatul (1) – Comitetul pentru medicamente de uz uman – Sesizare a comitetului supusă condiției ca o decizie națională să nu fi fost adoptată în prealabil – Substanța activă estradiol – Decizie a Comisiei Europene de obligare a statelor membre să retragă și să modifice autorizațiile naționale de introducere pe piață a medicamentelor pentru uz topic cu un conținut de 0,01 % în greutate de estradiol.#Cauza C-680/16 P.
judgment · RO · 27 March 2019
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Euroopa Kohtu otsus (neljas koda), 27.3.2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel ja Remedia d.o.o. versus Euroopa Komisjon.#Apellatsioonkaebus – Inimtervishoius kasutatavad ravimid – Direktiiv 2001/83/EÜ – Artikli 30 lõige 1 – Inimtervishoius kasutatavate ravimite komitee – Komiteele esildise tegemise tingimus, et riigisisest otsust ei ole eelnevalt tehtud – Toimeaine östradiool – Euroopa Komisjoni otsus, millega pannakse liikmesriikidele kohustus tühistada niisuguste ravimite, mis on mõeldud lokaalseks kasutamiseks ja milles östradiooli sisaldus on 0,01%, riiklikud müügiload või muuta neid.#Kohtuasi C-680/16 P.
judgment · ET · 27 March 2019
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Presuda Suda (četvrto vijeće) od 27. ožujka 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel i Remedia d.o.o. protiv Europske komisije.#Žalba – Lijekovi za humanu primjenu – Direktiva 2001/83/EZ – Članak 30. stavak 1. – Odbor za lijekove za humanu primjenu – Pokretanje postupka pred odborom podložno uvjetu da nacionalna odluka prethodno nije donesena – Aktivna tvar estradiol – Odluka Europske komisije kojom se državama članicama nalaže ukidanje i izmjena nacionalnih odobrenja za stavljanje u promet lijekova namijenjenih lokalnoj primjeni koji sadržavaju 0,01 % masenog udjela estradiola.#Predmet C-680/16 P.
judgment · HR · 27 March 2019
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Acórdão do Tribunal de Justiça (Quarta Secção) de 27 de março de 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel e Remedia d.o.o. contra Comissão Europeia.#Recurso de decisão do Tribunal Geral — Medicamentos para uso humano — Diretiva 2001/83/CE — Artigo 30.o, n.o 1 — Comité dos medicamentos para uso humano — Consulta do Comité sujeita à condição de não ter sido tomada uma decisão nacional anteriormente — Substância ativa estradiol — Decisão da Comissão Europeia que impõe aos Estados‑Membros a revogação e a alteração das autorizações nacionais de introdução no mercado de medicamentos de aplicação tópica que contenham 0,01 % em peso de estradiol.#Processo C-680/16 P.
judgment · PT · 27 March 2019
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A Bíróság ítélete (negyedik tanács), 2019. március 27.#Dr. August Wolff GmbH & Co. KG Arzneimittel és Remedia d.o.o. kontra Európai Bizottság.#Fellebbezés – Emberi felhasználásra szánt gyógyszerek – 2001/83/EK irányelv – A 30. cikk (1) bekezdése – Emberi felhasználásra szánt gyógyszerek bizottsága (CHMP) – A CHMP elé történő, ahhoz a feltételhez kötött utalás, hogy előzetesen ne hozzanak nemzeti határozatot – Ösztradiol hatóanyag – Az Európai Bizottság azon határozata, amelyben elrendeli, hogy a tagállamok vonják vissza és módosítsák a 0,01 tömegszázalékban ösztradiolt tartalmazó, helyi alkalmazásra szánt gyógyszerek nemzeti forgalombahozatali engedélyeit.#C-680/16. P. sz. ügy.
judgment · HU · 27 March 2019
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Arrest van het Hof (Vierde kamer) van 27 maart 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel en Remedia d.o.o. tegen Europese Commissie.#Hogere voorziening – Geneesmiddelen voor menselijk gebruik – Richtlijn 2001/83/EG – Artikel 30, lid 1 – Comité voor geneesmiddelen voor menselijk gebruik – Voorlegging aan het Comité onderworpen aan de voorwaarde dat niet vooraf een nationaal besluit is genomen – Werkzame stof estradiol – Besluit van de Europese Commissie waarbij de lidstaten wordt gelast nationale vergunningen voor het in de handel brengen van geneesmiddelen voor lokale toepassing met 0,01 % m/m estradiol in te trekken en te wijzigen.#Zaak C-680/16 P.
judgment · NL · 27 March 2019
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Sentenza della Corte (Quarta Sezione) del 27 marzo 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel e Remedia d.o.o. contro Commissione europea.#Impugnazione – Medicinali per uso umano – Direttiva 2001/83/CE – Articolo 30, paragrafo 1 – Comitato per i medicinali per uso umano – Consultazione del comitato subordinata alla condizione che non sia stata previamente adottata una decisione nazionale – Sostanza attiva estradiolo – Decisione della Commissione europea che ordina agli Stati membri la revoca e la modifica delle autorizzazioni nazionali all’immissione in commercio dei medicinali per uso topico contenenti lo 0,01% di peso di estradiolo.#Causa C-680/16 P.
judgment · IT · 27 March 2019
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Sentencia del Tribunal de Justicia (Sala Cuarta) de 27 de marzo de 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel y Remedia d.o.o. contra Comisión Europea.#Recurso de casación — Medicamentos para uso humano — Directiva 2001/83/CE — Artículo 30, apartado 1 — Comité de Medicamentos de Uso Humano — Consulta del Comité sujeta al requisito de que no se haya adoptado previamente una decisión nacional — Sustancia activa estradiol — Decisión de la Comisión Europea por la que se ordena a los Estados miembros revocar y modificar autorizaciones nacionales de comercialización de medicamentos para uso tópico que contengan un 0,01 % en peso de estradiol.#Asunto C-680/16 P.
judgment · ES · 27 March 2019
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Sentenza tal-Qorti tal-Ġustizzja (Ir-Raba' Awla) tas-27 ta’ Marzu 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel u Remedia d.o.o. vs Il-Kummissjoni Ewropea.#Appell – Prodotti mediċinali għall-użu mill-bniedem – Direttiva 2001/83/KE – Artikolu 30(1) – Kumitat tal-Prodotti Mediċinali għall-Użu mill-Bniedem – Riferiment lill-Kumitat suġġett għall-kundizzjoni li deċiżjoni nazzjonali ma tkunx ittieħdet qabel – Sustanza attiva estradjol – Deċiżjoni tal-Kummissjoni Ewropea li tordna lill-Istati Membri l-irtirar u l-modifika tal-awtorizzazzjonijiet nazzjonali ta’ tqegħid fis-suq tal-prodotti mediċinali topiċi li f’termini ta’ piż fihom 0.01 % ta’ estradjol.#Kawża C-680/16 P.
judgment · MT · 27 March 2019
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Απόφαση του Δικαστηρίου (τέταρτο τμήμα) της 27ης Μαρτίου 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel και Remedia d.o.o. κατά Ευρωπαϊκής Επιτροπής.#Αίτηση αναιρέσεως – Φάρμακα που προορίζονται για ανθρώπινη χρήση – Οδηγία 2001/83/ΕΚ – Άρθρο 30, παράγραφος 1 – Επιτροπή Φαρμάκων για Ανθρώπινη Χρήση – Παραπομπή ενώπιον της εν λόγω επιτροπής εξαρτώμενη από την προϋπόθεση να μην έχει ληφθεί προηγουμένως εθνική απόφαση – Δραστική ουσία οιστραδιόλη – Απόφαση της Ευρωπαϊκής Επιτροπής με την οποία διατάσσονται τα κράτη μέλη να αποσύρουν από την αγορά τα φάρμακα για τοπική χρήση που περιέχουν οιστραδιόλη σε ποσότητα 0,01 % και να τροποποιήσουν τις εθνικές άδειες κυκλοφορίας των φαρμάκων αυτών.#Υπόθεση C-680/16 P.
judgment · EL · 27 March 2019
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Domstolens dom (fjärde avdelningen) av den 27 mars 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel och Remedia d.o.o. mot Europeiska kommissionen.#Överklagande – Humanläkemedel – Direktiv 2001/83/EG – Artikel 30.1 – Kommittén för humanläkemedel – En fråga kan hänskjutas till kommittén under förutsättning att det inte föreligger ett tidigare nationellt beslut – Den aktiva beståndsdelen östradiol – Europeiska kommissionens beslut i vilket medlemsstaterna åläggs att återkalla och ändra nationella godkännanden för försäljning av läkemedel för utvärtes bruk innehållande 0,01 viktprocent östradiol.#Mål C-680/16 P.
judgment · SV · 27 March 2019
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Rozsudek Soudního dvora (čtvrtého senátu) ze dne 27. března 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel a Remedia d.o.o. v. Evropská komise.#Kasační opravný prostředek – Humánní léčivé přípravky – Směrnice 2001/83/ES – Článek 30 odst. 1 – Výbor pro humánní léčivé přípravky – Podání žádosti k Výboru, které je podmíněno tím, že předtím nebylo přijato vnitrostátní rozhodnutí – Aktivní látka estradiol – Rozhodnutí Evropské komise, které nařizuje členským státům zrušení a změnu vnitrostátních registrací léčivých přípravků pro lokální použití s hmotnostním podílem estradiolu 0,01 %.#Věc C-680/16 P.
judgment · CS · 27 March 2019
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2019 m. kovo 27 d. Teisingumo Teismo (ketvirtoji kolegija) sprendimas.#Dr. August Wolff GmbH & Co. KG Arzneimittel ir Remedia d.o.o. prieš Europos Komisiją.#Apeliacinis skundas – Žmonėms skirti vaistai – Direktyva 2001/83/EB – 30 straipsnio 1 dalis – Žmonėms skirtų vaistų komitetas – Sąlyga, pagal kurią, norint kreiptis į komitetą, dar neturi būti priimtas nacionalinis sprendimas – Veiklioji medžiaga estradiolis – Komisijos sprendimas, įpareigojantis valstybes nares atšaukti ir pakeisti nacionalinius leidimus prekiauti vietiškai vartojamais vaistais, kurių sudėtyje yra 0,01 % masės estradiolio.#Byla C-680/16 P.
judgment · LT · 27 March 2019
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Wyrok Trybunału (czwarta izba) z dnia 27 marca 2019 r.#Dr. August Wolff GmbH & Co. KG Arzneimittel i Remedia d.o.o. przeciwko Komisji Europejskiej.#Odwołanie – Produkty lecznicze stosowane u ludzi – Dyrektywa 2001/83/WE – Artykuł 30 ust. 1 – Komitet ds. Produktów Leczniczych Stosowanych u Ludzi – Przekazanie sprawy do komitetu uzależnione od warunku, że nie została podjęta uprzednio decyzja krajowa – Substancja aktywna estradiol – Decyzja Komisji Europejskiej nakazująca państwom członkowskim cofnięcie i zmianę krajowych pozwoleń na dopuszczenie do obrotu produktów leczniczych do użytku miejscowego zawierających 0,01% estradiolu w swej masie.#Sprawa C-680/16 P.
judgment · PL · 27 March 2019
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Domstolens dom (Fjerde Afdeling) af 27. marts 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel og Remedia d.o.o. mod Europa-Kommissionen.#Appel – humanmedicinske lægemidler – direktiv 2001/83/EF – artikel 30, stk. 1 – Udvalget for Humanmedicinske Lægemidler – indbringelse for udvalget undergivet en betingelse om, at der ikke forinden er blevet truffet en national afgørelse – aktivstoffet estradiol – Europa-Kommissionens afgørelse, hvorved medlemsstaterne pålægges at tilbagekalde og ændre nationale markedsføringstilladelser for lægemidler til lokal anvendelse, der indeholder 0,01% estradiol.#Sag C-680/16 P.
judgment · DA · 27 March 2019
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Judgment of the Court (Fourth Chamber) of 27 March 2019.#Dr. August Wolff GmbH & Co. KG Arzneimittel and Remedia d.o.o. v European Commission.#Appeal — Medicinal products for human use — Directive 2001/83/EC — Article 30(1) — Committee for Medicinal Products for Human Use — Referral of a matter to the committee subject to the absence of a previous national decision — Active substance estradiol — Decision of the European Commission ordering the Member States to revoke or vary marketing authorisations for medicinal products with 0.01% estradiol by weight for topical use.#Case C-680/16 P.
judgment · EN · 27 March 2019
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Official source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:62016CJ0680
Open data entity: http://publications.europa.eu/resource/cellar/d26d67f8-5072-11e9-a8ed-01aa75ed71a1
eurlex · 62016CJ0680 · source updated 27 March 2019