FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: ANNEXEd to the administrative data shall be a document showing that the manufacturer is authorized to produce the veterinary medicinal products concerned, as defined in Article 44, together with a list of countries in which authorization has been granted, copies of all the summaries of product characteristics in accordance with Article 14 as approved by Member States and a list of countries in which an application has been submitted.
French: Le demandeur joint aux renseignements d'ordre administratif un document prouvant que le fabricant est autorisé à produire les médicaments vétérinaires en question, défini à l'article 44, ainsi que la liste des pays où une autorisation a été délivrée, une copie de tous les résumés des caractéristiques du produit selon l'article 14 tels qu'approuvés par les États membres, et la liste des pays dans lesquels une demande a été présentée.
English: All the test procedure(s) shall be described in sufficiently precise detail so as to be reproducible in control tests, carried out at the request of the competent authority; any special apparatus and equipment which may be used shall be described in adequate detail, possibly accompanied by a diagram.
French: Là où les procédures d'analyse doivent être suffisamment détaillées pour être reproductibles lors des contrôles effectués à la demande des autorités compétentes, le matériel particulier qui pourrait être employé doit faire l'objet d'une description suffisante, avec schéma éventuel à l'appui.
Slovak: Všetky skúšobné postupy musia byť popísané s dostatočnou presnosťou a podrobnosťou tak, aby ich bolo možné zopakovať v rámci kontrolných skúšaní vykonávaných na požiadanie kompetentného orgánu akékoľvek použité zvláštne zariadenie alebo vybavenie sa dostatočne podrobne popíše, ak je to možné, pripojí sa nákres.
English: At least two different routes of administration should normally be studied. One of these may be the same as, or similar to, that proposed for the target species.
French: Au moins deux voies d'administration différentes doivent normalement être étudiées, l'une d'elles devant être identique ou semblable à celle préconisée pour l'animal de destination.
Italian: In genere devono essere usate almeno due diverse vie di somministrazione, una delle quali identica o simile a quella proposta per l'animale di destinazione.
Finnish: Yleensä on tutkittava vähintään kaksi eri annostelureittiä, joista toinen voi olla sama tai samanlainen kuin kohde-eläimelle käytettäväksi ehdotettu annostelureitti.
English: Member States shall ensure that homeopathic veterinary medicinal products manufactured and marketed within the Community are registered or authorized in accordance with the provisions of Articles 17(1) and (2), 18 and 19. Each Member State shall take due account of registrations and authorizations previously granted by another Member State.
Portuguese: Os Estados-Membros devem velar por que os medicamentos homeopáticos veterinários fabricados e introduzidos no mercado comunitário sejam registados ou autorizados em conformidade com o disposto nos n.os 1 e 2 do artigo 17.o, no artigo 18.o e no artigo 19.o Cada Estado-Membro deve tomar em devida consideração os registos ou autorizações já concedidos por outros Estados-Membros.
English: A Member State may refrain from establishing a special, simplified registration procedure for the homeopathic veterinary medicinal products referred to in Article 17(1) and (2). A Member State applying this provision shall inform the Commission accordingly.
Portuguese: Os Estados-Membros podem abster-se de criar um processo de registo simplificado especial dos medicamentos homeopáticos veterinários referidos nos n.os 1 e 2 do artigo 17.o, devendo informar a Comissão em conformidade.
English: may, where appropriate, require the applicant to provide further information as regards the items listed in Articles 12 and 13(1). Where the competent authorities take this course of action, the time-limits specified in Article 21 shall be suspended until the further data required have been provided.
Portuguese: Pode, se for caso disso, exigir ao requerente que complete o processo no que respeita aos elementos referidos no artigo 12.o e no n.o 1 do artigo 13.o Quando a autoridade competente fizer uso desta faculdade, os prazos previstos no artigo 21.o ficam suspensos, até que tenham sido fornecidos os dados complementares pedidos.
English: In order to obtain the recognition according to the procedure laid down in this Chapter in one or more of the Member States of a marketing authorization issued by a Member State, the holder of the authorization shall submit an application to the competent authority of the Member State or Member States concerned, together with the information and particulars referred to in Articles 12, 13(1), 14 and 25. He shall testify that the dossier is identical to that accepted by the reference Member State, or shall identify any additions or amendments it may contain.
Portuguese: Segundo o processo estabelecido no presente capítulo, para obter o reconhecimento da autorização de introdução no mercado emitida por um Estado-Membro, em um ou mais Estados-Membros, o titular da autorização deve apresentar um pedido nesse sentido à autoridade competente do ou dos Estados-Membros em questão, acompanhado da informação e dos elementos constantes no artigo 12.o, no n.o 1 do artigo 13.o, no artigo 14.o e no artigo 25.o O titular deve certificar que se trata de um processo em tudo idêntico ao admitido pelo Estado-Membro de referência ou indicar quaisquer aditamentos ou alterações que possa conter.
English: In the latter case, he shall certify that the summary of the product characteristics proposed by him in accordance with Article 14 is identical to that accepted by the reference Member State in accordance with Article 25. Moreover, he shall certify that all the dossiers filed as part of this procedure are identical.
Portuguese: Neste último caso, deve certificar que o resumo das características do produto que propôs em conformidade com o artigo 14.o é idêntico ao aceite pelo Estado-Membro de referência nos termos do artigo 25.o Deve também certificar que todos os processos registados no âmbito deste processo são idênticos.
English: Without prejudice to the provisions of Article 35, in exceptional cases, where urgent action is essential to protect human or animal health or the environment, until a definitive decision is adopted, a Member State may suspend the marketing and the use of the veterinary medicinal product concerned on its territory. It shall inform the Commission and the other Member States no later than the following working day of the reasons for its action.
Portuguese: Sem prejuízo do disposto no artigo 35.o, nos casos excepcionais em que seja necessária uma acção urgente para proteger a saúde humana ou animal ou o ambiente, os Estados-Membros podem suspender a introdução no mercado e a utilização do medicamento veterinário em questão no seu território, devendo notificar a Comissão e os outros Estados-Membros, o mais tardar no dia útil seguinte, dos motivos dessa medida.
English: The officials representing the competent authority shall report after each of the inspections mentioned in the first paragraph on whether the manufacturer complies with the principles and guidelines of good manufacturing practice referred to in Article 51. The inspected manufacturer shall be informed of the content of such reports.
Portuguese: Os funcionários que representam a autoridade competente comunicarão, após cada uma das inspecções referidas no n.o 1, se o fabricante respeita os princípios e linhas de orientação relativos às boas práticas de fabrico estabelecidos no artigo 51.o O fabricante submetido à inspecção será informado do conteúdo desses relatórios.
English: Upon reasoned request, Member States shall forthwith communicate the reports referred to in Article 80(3) to the competent authorities of another Member State. If, after considering the reports, the Member State receiving the reports considers that it cannot accept the conclusions reached by the competent authority of the Member State in which the report was established, it shall inform the competent authorities concerned of its reasons and may request further information.
Portuguese: A pedido fundamentado, os Estados-Membros transmitirão de imediato às autoridades competentes de outro Estado-Membro os relatórios referidos no n.o 3 do artigo 80.o Se, depois de apreciar estes relatórios, o Estado-Membro que os recebeu considerar não poder aceitar as conclusões da autoridade competente do Estado-Membro em que o relatório foi elaborado, informará a autoridade competente em causa dos seus motivos e poderá pedir informações complementares.
English: At the request of the manufacturer or exporter of veterinary medicinal products, or the authorities of an importing third country, Member States shall certify that such manufacturer is in possession of the manufacturing authorization. When issuing such certificates, Member States shall comply with the following conditions:
Portuguese: A pedido do fabricante, do exportador de medicamentos veterinários, ou das autoridades de um país terceiro importador, os Estados-Membros certificarão que esse fabricante possui a autorização a que se refere o artigo 44.o Ao emitirem tais certificados, os Estados-Membros devem respeitar as seguintes condições:
English: An explanation shall be provided with regard to the choice of composition, constituents and container and the intended function of the excipients in the finished product. This explanation shall be supported by scientific data on development pharmaceutics.
Portuguese: A escolha da composição, dos componentes e dos recipiente e a função prevista dos excipientes no produto acabado deve ser justificada e apoiada por dados científicos no domínio do desenvolvimento de medicamentos.
Finnish: Koostumuksen, ainesosien ja pakkauksen valinta ja apuaineille lopputuotteessa tarkoitettu tehtävä on selostettava ja perusteltava farmaseuttiseen tuotekehitykseen liittyvillä tieteellisillä tiedoilla.
Greek: Η επιλογή της συνθέσεως, των συστατικών και του περιέκτη όπως και ο επιδιωκόμενος ρόλος των εκδόχων στο τελικό προϊόν πρέπει να επεξηγούνται και αιτιολογούνται με επιστημονικά δεδομένα σχετικά με τη φαρμακευτική ανάπτυξη.
English: The particulars and documents accompanying the application for marketing authorization pursuant to Article 12(3)(i) and (j) and Article 13(1), shall include the results of the tests, including batch analyses particularly for active substances, relating to quality control of all the constituents used. These shall be submitted in accordance with the following provisions.
Portuguese: Os elementos e documentos apensos ao pedido de autorização de introdução no mercado, por força do n.o 3, alíneas i) e j), do artigo 12.o e do n.o 1 do artigo 13.o, devem abranger os resultados dos testes relativos ao controlo de qualidade de todos os componentes utilizados, incluindo as análises dos lotes, especialmente no que respeita às substâncias activas, e ser apresentados em conformidade com as disposições que se seguem.
English: The frequency of the tests which are not carried out routinely shall be stated. Release limits shall be indicated.
Portuguese: Devem indicar-se a frequência dos testes não efectuados por rotina e as especificações das quais depende a sua aprovação.
English: The particulars and documents accompanying the application for marketing authorization pursuant to Article 12(3)(i) and (j) and also Article 13(1), shall include particulars relating to control tests on the finished product at release. They shall be submitted in accordance with the following requirements.
Portuguese: Os elementos e documentos apensos ao pedido de autorização de introdução no mercado, por força do n.o 3, alíneas i) e j), do artigo 12.o e do n.o 1 do artigo 13.o, devem incluir informações relativas aos testes de controlo do produto acabado e ser apresentados em conformidade com os requisitos que se seguem.
English: PART 3 Safety and residues testing The particulars and documents which shall accompany the application for marketing authorization pursuant to Articles 12(3)(j) and 13(1) shall be submitted in accordance with the requirements below.
Portuguese: Os elementos e documentos apensos ao pedido de autorização de introdução no mercado, por força do n.o 3, alínea j), do artigo 12.o e do n.o 1 do artigo 13.o, devem ser apresentados em conformidade com os requisitos que se seguem.
English: and Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products(6)
Polish: oraz dyrektywa Rady 92/74/EWG z dnia 22 września 1992 r. rozszerzająca zakres dyrektywy 81/851/EWG w sprawie zbliżenia przepisów ustawowych, wykonawczych lub działań administracyjnych dotyczących weterynaryjnych produktów leczniczych i ustanawiająca dodatkowe przepisy w odniesieniu do weterynaryjnych homeopatycznych produktów leczniczych[6]
English: have been frequently and substantially amended;
Polish: zostały wielokrotnie i istotnie zmienione;
English: human blood
Polish: krew ludzka
English: and human blood products;
Polish: i produkty z krwi ludzkiej;
English: micro-organisms,
Polish: mikroorganizmy,
English: whole animals,
Polish: całe zwierzęta,
English: parts of organs,
Polish: części organów,
English: animal secretions,
Polish: wydzieliny zwierzęce,
English: toxins,
Polish: toksyny,
English: extracts,
Polish: wyciągi,
English: blood products;
Polish: produkty z krwi;
English: plants,
Polish: rośliny,
English: parts of plants,
Polish: części roślin,
English: vegetable secretions,
Polish: wydzieliny warzyw,
English: extracts;
Polish: wyciągi;
English: elements,
Polish: pierwiastki,
English: naturally occurring chemical materials
Polish: naturalnie występujące materiały chemiczne
English: and chemical products obtained by chemical change or synthesis.
Polish: i produkty chemiczne uzyskane drogą przemiany chemicznej lub syntezy.
English: the method and route of administration;
Czech: způsob a cesta podání;
Slovak: určený spôsob a cesta podávania lieku
Polish: metoda i sposób podawania;
Hungarian: az alkalmazás módja és útja;
Slovenian: način dajanja zdravila;
Bulgarian: методът и пътя на предписване начин на прилагане;
Estonian: manustamisviis ja -tee;
Latvian: lietošanas paņēmiens un lietošanas veids;
Maltese: il-metodu u r-rotta tas-somministrazzjoni;
English: an active substance described in the European Pharmacopoeia or in the pharmacopoeia of a Member State when prepared by a method liable to leave impurities not mentioned in the pharmacopoeial monograph and for which the monograph is inappropriate to adequately control its quality, which is manufactured by a person different from the applicant, the latter may arrange for the detailed description of the manufacturing method, quality control during manufacture and process validation to be supplied directly to the competent authorities by the manufacturer of the active substance.
Polish: substancji czynnej opisanej w Farmakopei Europejskiej lub w farmakopei Państwa Członkowskiego, jeżeli jest przygotowana za pomocą metody, która może pozostawić zanieczyszczenia o których nie wspomniano w monografii w farmakopei i z którego to powodu monografia ta nie jest odpowiednia do tego, aby można było odpowiednio kontrolować jakość substancji, która jest wytwarzana przez osobę inną niż składający wniosek, to ten ostatni może spowodować, aby szczegółowy opis metody wytwórczej, kontroli jakości podczas wytwarzania oraz atestacji procesu został przesłany bezpośrednio przez wytwórcę substancji czynnej do właściwych władz.
Bulgarian: активна субстанция, описана в Европейската фармакопея или във фармакопеята на държава-членка, когато се приготвя по метод, който може да остави примеси, непосочени във фармакопейската монография и за която монографията е неподходяща за адекватно контролиране на нейното качество, която е произведена от лице, различно от заявителя, последният може да вземе мерки, за да се предостави подробното описание на производствения метод, качествения контрол по време на производство и валидизация на процеса директно на компетентните органи от производителя на активната субстанция.
English: Council Directive 81/851/EEC
Czech: Směrnice Rady 81/851/EHS
Polish: Dyrektywa Rady 81/851/EWG
Estonian: Nõukogu direktiiv 81/851/EMÜ
Latvian: Padomes Direktīva 81/851/EEK
Lithuanian: Tarybos direktyva 81/851/EEB
Maltese: Id-Direttiva tal-Kunsill 81/851/KEE
English: Council Directive 90/676/EEC
Czech: Směrnice Rady 90/676/EHS
Polish: Dyrektywa Rady 90/676/EWG
Estonian: Nõukogu direktiiv 90/676/EMÜ
Latvian: Padomes Direktīva 90/676/EEK
Lithuanian: Tarybos direktyva 90/676/EEB
Maltese: Id-Direttiva tal-Kunsill 90/676/KEE
English: Council Directive 90/677/EEC
Czech: Směrnice Rady 90/677/EHS
Polish: Dyrektywa Rady 90/677/EWG
Estonian: Nõukogu direktiiv 90/677/EMÜ
Latvian: Padomes Direktīva 90/677/EEK
Lithuanian: Tarybos direktyva 90/677/EEB
Maltese: Id-Direttiva tal-Kunsill 90/677/KEE
English: Council Directive 92/74/EEC
Czech: Směrnice Rady 92/74/EHS
Polish: Dyrektywa Rady 92/74/EWG
Estonian: Nõukogu direktiiv 92/74/EMÜ
Latvian: Padomes Direktīva 92/74/EEK
Lithuanian: Tarybos direktyva 92/74/EEB
Maltese: Id-Direttiva tal-Kunsill 92/74/KEE
English: Commission Directive 2000/37/EC
Czech: Směrnice Komise 2000/37/ES
Polish: Dyrektywa Komisji 2000/37/WE
Estonian: Komisjoni direktiiv 2000/37/EÜ
Latvian: Komisijas Direktīva 2000/37/EK
Lithuanian: Tarybos direktyva 2000/37/EB
Maltese: Id-Direttiva tal-Kunsill 2000/37/KE
English: Council Directive 81/852/EEC
Czech: Směrnice Rady 81/852/EHS
Polish: Dyrektywa Rady 81/852/EWG
Estonian: Nõukogu direktiiv 81/852/EMÜ
Latvian: Padomes Direktīva 81/852/EEK
Lithuanian: Tarybos direktyva 81/852/EEB
Maltese: Id-Direttiva tal-Kunsill 81/852/KEE
English: Council Directive 87/20/EEC
Czech: Směrnice Rady 87/20/EHS
Polish: Dyrektywa Rady 87/20/EWG
Estonian: Nõukogu direktiiv 87/20/EMÜ
Latvian: Padomes Direktīva 87/20/EEK
Lithuanian: Tarybos direktyva 87/20/EEB
Maltese: Id-Direttiva tal-Kunsill 87/20/KEE
English: Council Directive 92/18/EEC
Czech: Směrnice Rady 92/18/EHS (
Polish: Dyrektywa Rady 92/18/EWG
Estonian: Nõukogu direktiiv 92/18/EMÜ
Latvian: Padomes Direktīva 92/18/EEK
Lithuanian: Tarybos direktyva 92/18/EEB
Maltese: Id-Direttiva tal-Kunsill 92/18/KEE
English: Commission Directive 1999/104/EC
Czech: Směrnice Komise 1999/104/ES
Polish: Dyrektywa Komisji 1999/104/WE
Estonian: Komisjoni direktiiv 1999/104/EÜ
Latvian: Komisijas Direktīva 1999/104/EK
Lithuanian: Komisijos direktyva 1999/104/EB
Maltese: Id-Direttiva tal-Kunsill 1999/104/KE
English: Having regard to the opinion of the Economic and Social Committee,
Italian: visto il parere del Comitato economico e sociale,
Bulgarian: като взеха предвид становището на Икономическия и социален комитет ,
English: Acting in accordance with the procedure laid down in Article 251 of the Treaty,
Italian: deliberando in conformità con la procedura prevista all'articolo 251 del trattato,
Bulgarian: в съответствие с процедурата, посочена в член 251 от Договора , като имат предвид, че:
English: With the exception of those medicinal products which are subject to the centralised Community authorization procedure established by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, a marketing authorization in one Member State ought to be recognized by the competent authority of the other Member States unless there are serious grounds for supposing that the authorization of the veterinary medicinal product concerned may present a risk to human or animal health, or to the environment;
Italian: Ad eccezione dei medicinali soggetti alla procedura di autorizzazione comunitaria centralizzata, istituita con il regolamento (CEE) n. 2309/93 del Consiglio, del 22 luglio 1993, che stabilisce le procedure comunitarie per l'autorizzazione e la vigilanza dei medicinali per uso umano e veterinario e che istituisce un'Agenzia europea di valutazione dei medicinali, un'autorizzazione all'immissione in commercio di un medicinale veterinario rilasciata da un'autorità competente di uno Stato membro deve essere riconosciuta dalle autorità competenti degli altri Stati membri, salvo vi siano motivi fondati di ritenere che l'autorizzazione di detto medicinale presenti un rischio per la salute delle persone o degli animali o per l'ambiente.
Bulgarian: С изключение на тези лекарствени продукти, които подлежат на централизирана процедура на Общността за разрешаване, предвидена от Регламент (ЕИО) 2309/93 на Съвета от 22 юли 1993 г., определящ процедурите на Общността за разрешаването и надзора върху лекарствени продукти за хуманна и ветеринарна употреба и създаването на Европейска агенция за оценка на лекарствените продукти , разрешителното за пускане на пазара в една държава-членка трябва да бъде признато от компетентните органи в другите държави-членки, освен ако съществуват сериозни основания да се предполага, че разрешаването на съответния ветеринарен лекарствен продукт може да представлява риск за човешкото здраве или за здравето на животните, или за околната среда;
English: The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission.
Italian: E' opportuno adottare le misure necessarie per l'applicazione della presente direttiva conformemente all'articolo 2 della decisione 1999/468/CE del Consiglio, del 28 giugno 1999, recante modalità per l'esercizio delle competenze d'esecuzione conferite alla Commissione.
Bulgarian: Мерките, необходими за прилагането на настоящата директива, следва да бъдат приети в съответствие с Решение 1999/468/ЕО на Съвета от 28 юни 1999 г., определящо процедурите за упражняване на изпълнителните правомощия, предоставени на Комисията .
English: In order to improve the protection of public health, it is necessary to specify that foodstuffs for human consumption may not be taken from animals which have been used in clinical trials of veterinary medicinal products unless a maximum residue limit has been laid down for residues of the veterinary medicinal product concerned in accordance with the provisions of Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.
Italian: Per migliorare la tutela della sanità pubblica occorre specificare che gli alimenti destinati al consumo umano non possono provenire da animali soggetti a prove cliniche di medicinali veterinari, salvo sia stato stabilito un livello massimo per i residui dei medicinali veterinari in questione, a norma del regolamento (CEE) n. 2377/90 del Consiglio, del 26 giugno 1990, che definisce una procedura comunitaria per la determinazione dei limiti massimi di residui di medicinali veterinari negli alimenti di origine animale.
Bulgarian: За да се подобри опазването на общественото здраве, е необходимо да се уточни, че храните, предназначени за консумация от хора, не могат да се произвеждат от животни, използвани при клинични опити на ветеринарни лекарствени продукти, освен ако не е установена максимална граница на остатъчни количества от съответния ветеринарен лекарствен продукт, съгласно разпоредбите на Регламент (ЕИО) на Съвета № 2377/90 от 26 юни 1990 г., предвиждащ процедурата на Общността за установяване на максимални граници на остатъчните количества от ветеринарни лекарствени продукти в храни от животински произход.