FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Whereas, in the case of medicinal products for human use, the criteria of quality, safety and efficacy have been extensively harmonized by Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, and the Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation and administrative action relating to proprietary medicinal products, and by Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products;
Portuguese: Considerando que, no que respeita aos medicamentos de uso humano, os critérios de eficácia, qualidade e segurança foram objecto de vasta harmonização na Directiva 65/65/CEE do Conselho, de 26 de Janeiro de 1965, relativa à aproximação das disposições legislativas, regulamentares e administrativas respeitantes aos medicamentos, na Segunda Directiva 75/319/CEE do Conselho, de 20 de Maio de 1975, relativa à aproximação das disposições legislativas, regulamentares e administrativas respeitantes às especialidades farmacêuticas, e na Directiva 75/318/CEE do Conselho, de 20 de Maio de 1975, relativa à aproximação das legislações dos Estados-membros respeitantes às normas e protocolos analíticos, tóxico-farmacológicos e clínicos em matéria de ensaios de medicamentos;
Estonian: inimtervishoius kasutatavate ravimite puhul on kvaliteedi, ohutuse ja tõhususe kriteeriume ulatuslikult ühtlustatud nõukogu 26. jaanuari 1965. aasta direktiiviga 65/65/EMÜ ravimitega seotud ning õigus- ja haldusnormidega kehtestatud sätete ühtlustamise kohta, nõukogu 20. mai 1975. aasta direktiiviga 75/319/EMÜ ravimpreparaatidega seotud ning õigus- ja haldusnormidega kehtestatud sätete ühtlustamise kohta ja nõukogu 20. mai 1975. aasta direktiiviga 75/318/EMÜ ravimite kontrolliga seotud analüütilisi, farmakoloogilis-toksikoloogilisi ja kliinilisi standardeid ning protokolle käsitlevate liikmesriikide õigusaktide ühtlustamise kohta;
English: Whereas in the case of veterinary medicinal products, the same results have been achieved by Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products and by Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products;
Portuguese: Considerando que, no que respeita aos medicamentos veterinários, foram obtidos resultados idênticos com a Directiva 81/851/CEE do Conselho, de 28 de Setembro de 1981, relativa à aproximação das legislações dos Estados-membros respeitantes aos medicamentos veterinários, e com a Directiva 81/852/CEE do Conselho, de 28 de Setembro de 1981, relativa à aproximação das legislações dos Estados-membros respeitantes às normas e protocolos analíticos, tóxico-farmacológicos e clínicos em matéria de ensaios de medicamentos veterinários;
Estonian: veterinaarravimite osas saavutati samad tulemused nõukogu 28. septembri 1981. aasta direktiiviga 81/851/EMÜ veterinaarravimeid käsitlevate liikmesriikide seaduste ühtlustamise kohta ja nõukogu 28. septembri 1981. aasta direktiiviga 81/852/EMÜ veterinaarravimite analüütilisi, farmakoloogilis-toksikoloogilisi ja kliinilisi standardeid ning katseprotokolle käsitlevate liikmesriikide õigusaktide ühtlustamise kohta;
English: Whereas Council Directive 93/39/EEC of 14 June 1993 amending Directive 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products has provided that in the event of a disagreement between Member States about the quality, safety or efficacy of a medicinal product which is the subject of the decentralized Community authorization procedure, the matter should be resolved by a binding Community decision following a scientific evaluation of the issues involved within a European medicinal product evaluation agency;
Portuguese: Considerando que a Directiva 93/39/CEE do Conselho, de 14 de Junho de 1993, que altera as Directivas 65/65/CEE, 75/318/CEE e 75/319/CEE respeitantes aos medicamentos, estabelece que, caso haja desacordo entre os Estados-membros quanto à eficácia, qualidade ou segurança de um medicamento sujeito ao procedimento descentralizado comunitário de autorização, a questão deve ser solucionada através de uma decisão comunitária de carácter vinculativo, após avaliação científica das questões envolvidas a nível da Agência Europeia de Avaliação dos Medicamentos;
Finnish: lääkkeitä koskevien direktiivien 65/65/ETY, 75/318/ETY ja 75/319/ETY muuttamisesta 14 päivänä kesäkuuta 1993 annetussa neuvoston direktiivissä 93/39/ETY säädetään, että jäsenvaltioiden ollessa eri mieltä yhteisön hajautetun lupamenettelyn alaisen lääkkeen laadusta, turvallisuudesta ja tehokkuudesta, ongelma on ratkaistava Euroopan lääkearviointiviraston suorittamaan asianomaisten kysymysten tieteelliseen arviointiin perustuvalla sitovalla yhteisön päätöksellä;
Polish: dyrektywa Rady 93/39/EWG z dnia 14 czerwca 1993 r., zmieniająca dyrektywy 65/65/EWG, 75/318/EWG oraz 75/319/EWG dotyczące produktów leczniczych przewiduje, iż w przypadku różnicy zdań między Państwami Członkowskimi co do jakości, bezpieczeństwa lub skuteczności produktu leczniczego poddanego wspólnotowej zdecentralizowanej procedurze wydawania pozwoleń, problem ten powinien być rozstrzygnięty przez wiążącą decyzję wspólnotową opartą o naukowe badanie spornych kwestii, prowadzone w ramach Europejskiej Agencji ds. Oceny Produktów Leczniczych;
Estonian: nõukogu 14. juuni 1993. aasta direktiivis 93/39/EMÜ (millega muudetakse direktiive 65/65/EMÜ, 75/318/EMÜ ja 75/319/EMÜ ravimite osas) on sätestatud, et kui liikmesriikide vahel tekib lahkarvamus ühenduse loaandmise detsentraliseeritud korrale allutatud ravimi kvaliteedi, ohutuse või tõhususe suhtes, peaks küsimuse lahendama ühenduse siduva otsuse alusel pärast seda, kui Euroopa Ravimihindamisamet on kõnealuste küsimuste kohta andnud teadusliku hinnangu;
English: whereas similar provisions have been laid down in respect of veterinary medicinal products by Council Directive 93/40/EEC of 14 June 1993 amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products;
Portuguese: que foram estabelecidas disposições análogas no que respeita aos medicamentos veterinários, através da Directiva 93/40/CEE do Conselho, de 14 de Junho de 1993, que altera as Directivas 81/851/CEE e 81/852/CEE relativas à aproximação das legislações dos Estados-membros respeitantes aos medicamentos veterinários;
Estonian: veterinaarravimite osas on samasugused sätted kehtestatud nõukogu 14. juuni 1993. aasta direktiivis 93/40/EMÜ, millega muudetakse direktiive 81/851/EMÜ ja 81/852/EMÜ veterinaarravimeid käsitlevate liikmesriikide õigusaktide ühtlustamise kohta;
English: whereas therefore it is necessary to provide for an environmental risk assessment of such products similar to that provided for by Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms, together with the assessment of the quality, safety and efficacy of the product concerned within a single Community procedure;
Portuguese: que, além disso, é necessário proceder a uma avaliação dos riscos ambientais de tais produtos do tipo da constante da Directiva 90/220/CEE do Conselho, de 23 de Abril de 1990, relativa à libertação deliberada no ambiente de organismos geneticamente modificados, bem como a uma avaliação da eficácia, qualidade e segurança dos produtos em questão mediante um procedimento comunitário único;
Estonian: seepärast tuleb ühenduse ühtse korraga ette näha selliste ravimite keskkonnaohtlikkuse hindamine, nagu on sätestatud ka nõukogu 23. aprilli 1990 direktiivis 90/220/EMÜ geneetiliselt muundatud organismide tahtliku keskkonda viimise kohta, koos asjaomase toote kvaliteedi, ohutuse ja tõhususe hindamisega;
English: Without prejudice to Article 4 of Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products, and laying down additional provisions for immunological veterinary medicinal products, a marketing authorization which has been granted in accordance with the procedure laid down in this Regulation shall apply throughout the Community.
Portuguese: Sem prejuízo do disposto no artigo 4º da Directiva 90/677/CEE do Conselho, de 13 de Dezembro de 1990, que alarga o âmbito da Directiva 81/851/CEE, relativa à aproximação das legislações dos Estados-membros respeitantes aos medicamentos veterinários, e estabelece disposições adicionais no que respeita aos medicamentos veterinários imunológicos, qualquer autorização de introdução no mercado concedida em conformidade com o procedimento previsto no presente regulamento é válida em toda a Comunidade.
Estonian: Ilma et see piiraks nõukogu 13. detsembri 1990. aasta direktiivi 90/677/EMÜ (millega laiendatakse direktiivi 90/677/EMÜ reguleerimisala veterinaarravimeid käsitlevate liikmesriikide seaduste ühtlustamise kohta) artikli 4 kohaldamist ja sätestades lisanormid immunoloogiliste veterinaarravimite kohta, kehtib käesolevas määruses sätestatud korra alusel antud müügiluba kogu ühenduses.
English: details of any conditions or restrictions which should be imposed on the supply or use of the medicinal product concerned, including the conditions under which the medicinal product may be made available to patients, having regard to the criteria laid down in Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use, without prejudice to the provisions in Article 3 (4) of that Directive;
Italian: i particolari relativi ad eventuali condizioni o limiti che dovrebbero essere imposti alla fornitura del medicinale di cui trattasi, comprese le condizioni alle quali il medicinale può essere fornito ai pazienti, in conformità dei criteri stabiliti nella direttiva 92/26/CEE del Consiglio, del 31 marzo 1992, concernente la classificazione in materia di fornitura dei medicinali per uso umano, fatte salve le disposizioni di cui all'articolo 3, paragrafo 4 di detta direttiva;
Estonian: üksikasjad mis tahes tingimuste või piirangute kohta, mis tuleks kehtestada asjaomase ravimi tarnimise või kasutamise kohta, sealhulgas tingimused, mille alusel ravim patsientidele kättesaadavaks tehakse, võttes arvesse kriteeriume, mis on sätestatud nõukogu 31. märtsi 1992. aasta direktiivis 92/26/EMÜ inimtervishoius kasutatavate ravimite tarnete liigituse kohta, ilma et see piiraks nimetatud direktiivi artikli 3 lõike 4 kohaldamist;
English: the labelling or package leaflet of the product is not in compliance with Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets, or
Portuguese: o rótulo ou o folheto informativo do produto não satisfazem o disposto na Directiva 92/27/CEE do Conselho, relativa à rotulagem e à bula dos medicamentos para uso humano, ou
Estonian: toote markeeringus või infolehes ei järgita nõukogu 31. märtsi 1992. aasta direktiivi 92/27/EMÜ inimtervishoius kasutatavate ravimite markeerimise ja infolehtede kohta, või et
English: Having regard to the proposal from the Commission ,
Finnish: ottaa huomioon komission ehdotuksen,
English: Having regard to the opinion of the European Parliament ,
Finnish: ottaa huomioon Euroopan parlamentin lausunnon,
English: Whereas, in the case of medicinal products for human use, the criteria of quality, safety and efficacy have been extensively harmonized by Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products , and the Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation and administrative action relating to proprietary medicinal products , and by Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products ;
Finnish: ihmisille tarkoitettujen lääkkeiden osalta laatua, turvallisuutta ja tehokkuutta koskevat perusteet on laajalti yhdenmukaistettu lääkevalmisteita koskevien lakien, asetusten ja hallinnollisten määräysten lähentämisestä 26 päivänä tammikuuta 1965 annetulla neuvoston direktiivillä 65/65/ETY, lääkevalmisteita koskevien lakien, asetusten ja hallinnollisten määräysten lähentämisestä 20 päivänä toukokuuta 1975 annetulla toisella neuvoston direktiivillä 75/319/ETY ja lääkevalmisteiden tutkimiseen liittyviä analyyttisiä, farmakologis-toksikologisia ja kliinisiä standardeja ja tutkimussuunnitelmia koskevan jäsenvaltioiden lainsäädännön lähentämisestä 20 päivänä toukokuuta 1975 annetulla neuvoston direktiivillä 75/318/ETY,
English: Whereas in the case of veterinary medicinal products, the same results have been achieved by Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products and by Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products ;
Finnish: samat tulokset on eläinlääkkeiden osalta saatu eläinlääkkeitä koskevan jäsenvaltioiden lainsäädännön lähentämisestä 28 päivänä syyskuuta 1981 annetulla direktiivillä 81/851/ETY ja eläinlääkkeiden tutkimiseen liittyviä analyyttisiä, farmakologis-toksikologisia ja kliinisiä standardeja ja tutkimussuunnitelmia koskevan jäsenvaltioiden lainsäädännön lähentämisestä 28 päivänä syyskuuta 1981 annetulla neuvoston direktiivillä 81/852/ETY,
English: whereas similar provisions have been laid down in respect of veterinary medicinal products by Council Directive 93/40/EEC of 14 June 1993 amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products ;
Finnish: vastaavia säännöksiä on annettu eläinlääkkeistä eläinlääkkeitä koskevan jäsenvaltioiden lainsäädännön lähentämisestä annettujen direktiivien 81/851/ETY ja 81/852/ETY muuttamisesta 14 päivänä kesäkuuta 1993 annetussa neuvoston direktiivissä 93/40/ETY,
English: whereas therefore it is necessary to provide for an environmental risk assessment of such products similar to that provided for by Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms , together with the assessment of the quality, safety and efficacy of the product concerned within a single Community procedure;
Finnish: näiden tuotteiden osalta on siten tarpeen säätää samanlaisesta ympäristövaarojen arvioinnista kuin geneettisesti muunnettujen organismien tarkoituksellisesta levittämisestä ympäristöön 23 päivänä huhtikuuta 1990 annetussa neuvoston direktiivissä 90/220/ETY, samansuuntaisesti asianomaisen tuotteen laadun, turvallisuuden ja tehokkuuden arvioinnin kanssa yhtenäisellä yhteisön menettelyllä, ja
English: TITLE
Finnish: OSASTO
English: details of any conditions or restrictions which should be imposed on the supply or use of the medicinal product concerned, including the conditions under which the medicinal product may be made available to patients, having regard to the criteria laid down in Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use , without prejudice to the provisions in Article 3 (4) of that Directive;
Finnish: kaikkien asianomaisen lääkkeen luovutukselle tai käytölle asetettavien edellytysten tai rajoitusten yksityiskohdat, mukaan lukien edellytykset, joilla lääkettä voidaan antaa potilaille, ottaen huomioon ihmisille tarkoitettujen lääkkeiden luovutusluokittelusta 31 päivänä maaliskuuta 1992 annetussa neuvoston direktiivissä 92/26/ETY vahvistetut vaatimukset, sanotun kuitenkaan rajoittamatta mainitun direktiivin 3 artiklan 4 kohdan soveltamista;
English: CHAPTER Submission and examination of applications - authorization - reneval of authorization
Finnish: LUKU Hakemusten jättäminen ja tutkiminen - Luvat - Luvan uusiminen
English: the authorization should be granted subject to the conditions provided for in Article 35 ,
Finnish: luvan antaminen edellyttää tiettyjen 35 artiklan 2 kohdassa säädettyjen edellytysten täyttämistä,
English: Additives covered by Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs , where they are intended to be administered to animals in accordance with that Directive, shall not be considered as veterinary medicinal products for the purposes of this Regulation.
Finnish: Rehujen lisäaineista 23 päivänä marraskuuta 1970 annetussa neuvoston direktiivissä 70/524/ETY tarkoitettuja lisäaineita, jos ne on tarkoitettu annosteltavaksi eläimille kyseisen direktiivin mukaisesti, ei pidetä tässä asetuksessa eläinlääkkeinä.
English: ANNEX PART
Finnish: LIITE OSA
English: PART
Finnish: OSA
English: Whereas it is therefore necessary to establish a European Agency for the Evaluation of Medicinal Products («the Agency»);
Italian: considerando che è pertanto necessario istituire un'agenzia europea di valutazione dei medicinali (di seguito denominata «l'Agenzia»);
English: TITLE 1
Italian: TITOLO 1
English: In order to obtain the authorization referred to in Article 3, the person responsible for placing a medicinal product on the market shall submit an application to the European Agency for the Evaluation of Medicinal Products, hereinafter referred to as «the Agency», set up under Title IV.
Italian: Al fine di ottenere l'autorizzazione di cui all'articolo 3, il responsabile dell'immissione in commercio presenta una domanda all'Agenzia europea di valutazione dei medicinali, istituita in virtù del titolo IV, di seguito denominata «l'Agenzia».
English: the summary of the product characteristics proposed by the applicant in accordance with Article 28 should be amended, or
Italian: il riassunto delle caratteristiche del prodotto presentato dal richiedente ai sensi dell'articolo 28 deve essere modificato, oppure
English: Submission and examination of applications authorizations renewal of authorization
Italian: Presentazione ed istruzione delle domande autorizzazioni rinnovo delle autorizzazioni
English: The Committee for Proprietary Medicinal Products established by Article 8 of Directive 75/319/EEC, in this Title referred to as «the Committee», shall be responsible for formulating the opinion of the Agency on any question concerning the admissibility of the files submitted in accordance with the centralized procedure, the granting, variation, suspension or withdrawal of an authorization to place a medicinal product for human use on the market arising in accordance with the provisions of this Title and pharmacovigilance.
Italian: Il comitato per le specialità medicinali, istituito dall'articolo 8 della direttiva 75/319/CEE, designato nel presente titolo «il comitato», è competente a formulare il parere dell'Agenzia su qualsiasi problema relativo alla ricevibilità dei fascicoli presentati secondo la procedura centralizzata, al rilascio, alle modifiche, alla sospensione o alla revoca di un'autorizzazione all'immissione in commercio di un medicinale per uso umano conformemente alle disposizioni del presente titolo nonché alla farmacovigilanza.
English: These arrangements shall include a notification system or administrative procedures concerning minor variations and define precisely the concept of «a minor variation».
Italian: Tali provvedimenti devono prevedere un sistema di notifica o procedure amministrative per le modifiche d'importanza minore nonché definire con precisione la nozione di «modifica d'importanza minore».
English: Submission and examination of applications authorization reneval of authorization
Italian: Presentazione ed istruzione delle domande autorizzazioni rinnovo delle autorizzazioni
English: The Committee for Veterinary Medicinal Products established by Article 16 of Directive 81/851/EEC, in this Title referred to as «the Committee», shall be responsible for formulating the opinion of the Agency on any question concerning the admissibility of the files submitted in accordance with the centralized procedure, the granting, variation, suspension or withdrawal of an authorization to place a veterinary medicinal product on the market arising in accordance with the provisions of this Title and pharmacovigilance.
Italian: Il comitato per i medicinali veterinari, istituito dall'articolo 16 della direttiva 81/851/CEE, denominato nel presente titolo «il comitato», è competente a formulare il parere dell'Agenzia su qualsiasi problema relativo alla ricevibilità dei fascicoli presentati secondo la procedura centralizzata, al rilascio, alle modifiche, alla sospensione o alla revoca di un'autorizzazione all'immissione in commercio di un medicinale veterinario, conformemente alle disposizioni del presente titolo, nonché alla farmacovigilanza.
English: the labelling or package insert of the product is not in compliance with Directive 81/851/EEC, or
Italian: l'etichettatura o il foglietto illustrativo del prodotto non rispetta il disposto della direttiva 81/851/CEE, oppure
English: Veterinary medicinal products containing a new active substance which, on the date of entry into force of this Regulation, was not authorised by any Member State for use in animals.
Italian: Medicinali veterinari che contengono una nuova sostanza attiva la cui utilizzazione per gli animali non era autorizzata da nessuno Stato membro alla data di entrata in vigore del presente regolamento.