FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: The power to adopt the delegated acts referred to in Article 22b shall be conferred on the Commission for a period of 5 years from 20 January 2011.
French: Le pouvoir d’adopter les actes délégués visés à l’article 22 ter est conféré à la Commission pour une période de cinq ans à compter du 20 janvier 2011.
German: Die Befugnis zum Erlass der in Artikel 22b genannten delegierten Rechtsakte wird der Kommission für einen Zeitraum von fünf Jahren ab dem 20. Januar 2011 übertragen.
Spanish: Los poderes para adoptar los actos delegados a que se refiere el artículo 22 ter se otorgan a la Comisión por un período de cinco años a partir del 20 de enero de 2011.
Italian: Il potere di adottare gli atti delegati di cui all’articolo 22 ter è conferito alla Commissione per un periodo di cinque anni a decorrere dal 20 gennaio 2011.
Portuguese: O poder de adoptar os actos delegados a que se refere o artigo 22.o-B é conferido à Comissão por um prazo de cinco anos a contar de 20 de Janeiro de 2011.
Dutch: De bevoegdheid om de in artikel 22 ter bedoelde gedelegeerde handelingen vast te stellen, wordt aan de Commissie verleend voor een termijn van vijf jaar na 20 januari 2011.
Danish: Kommissionen tillægges beføjelse til at vedtage de delegerede retsakter, der er omhandlet i artikel 22b i en periode på fem år fra den 20. januar 2011.
Swedish: Befogenheten att anta de delegerade akter som avses i artikel 22b ska ges till kommissionen för en period på fem år från den 20 januari 2011.
Finnish: Siirretään komissiolle viiden vuoden ajaksi 20 päivästä tammikuuta 2011 lukien valta antaa 22 b artiklassa tarkoitettuja delegoituja säädöksiä.
Greek: Η εξουσία έκδοσης κατ’ εξουσιοδότηση πράξεων που αναφέρονται στο άρθρο 22β ανατίθεται στην Επιτροπή για περίοδο πέντε ετών από τις 20 Ιανουαρίου 2011.
Czech: Pravomoc přijímat akty v přenesené pravomoci uvedené v článku 22b je svěřena Komisi na dobu pěti let počínaje dnem 20. ledna 2011.
Slovak: Právomoc prijímať delegované akty uvedené v článku 22b sa Komisii udeľuje na obdobie piatich rokov od 20. januára 2011. Komisia predloží správu týkajúcu sa delegovaných právomocí najneskôr šesť mesiacov pred uplynutím tohto päťročného obdobia.
Hungarian: A Bizottságot 2011. január 20-át követő ötéves időszakra felhatalmazást kap a 22b. cikkben említett felhatalmazáson alapuló jogi aktusok elfogadására.
Slovenian: Pooblastilo za sprejemanje delegiranih aktov iz člena 22b se prenese na Komisijo za obdobje 5 let z začetkom 20. januarja 2011.
Romanian: Competența de a adopta actele delegate menționate la articolul 22b este conferită Comisiei pentru o perioadă de cinci ani de la 20 ianuarie 2011.
Estonian: Komisjonile antakse viieks aastaks alates 20. jaanuarist 2011 õigus võtta vastu artiklis 22b osutatud delegeeritud õigusakte.
Latvian: Pilnvaras pieņemt 22.b pantā minētos deleģētos aktus Komisijai piešķir uz piecu gadu laikposmu pēc 2011. gada 20. janvāra.
Maltese: Is-setgħa biex jiġu adottati l-atti ddelegati msemmija fl-Artikolu 22b għandha tiġi konferita fuq il-Kummissjoni għal perjodu ta’ ħames snin mill-20 ta’ Jannar 2011.
English: The Commission shall draw up a report in respect of the delegated powers not later than 6 months before the end of the 5 year period.
French: La Commission rédige un rapport relatif aux pouvoirs délégués au plus tard six mois avant la fin de la période de cinq ans.
German: Die Kommission legt spätestens sechs Monate vor Ablauf des Zeitraums von fünf Jahren einen Bericht über die übertragenen Befugnisse vor.
Spanish: La Comisión elaborará un informe sobre los poderes delegados a más tardar seis meses antes de que finalice el período de cinco años.
Italian: La Commissione redige una relazione sui poteri delegati entro sei mesi prima che giunga a scadenza il periodo di cinque anni.
Portuguese: A Comissão elabora um relatório sobre os poderes delegados o mais tardar seis meses antes do final do período de cinco anos.
Dutch: De Commissie stelt uiterlijk zes maanden vóór het einde van de periode van vijf jaar een verslag op over de bevoegdheidsdelegatie.
Danish: Kommissionen aflægger rapport vedrørende de delegerede beføjelser senest seks måneder inden udløbet af femårsperioden.
Swedish: Kommissionen ska utarbeta en rapport om de delegerade befogenheterna senast sex månader innan perioden på fem år löpt ut.
Finnish: Komissio laatii siirrettyä säädösvaltaa koskevan kertomuksen viimeistään kuusi kuukautta ennen viiden vuoden kauden päättymistä.
Greek: Το αργότερο έξη μήνες πριν από τη λήξη της πενταετούς περιόδου, η Επιτροπή συντάσσει έκθεση ως προς την εξουσία αυτή.
Czech: Komise předloží zprávu o přenesené pravomoci nejpozději šest měsíců před koncem tohoto pětiletého období.
Hungarian: A Bizottság legkésőbb 6 hónappal az ötéves időszak vége előtt jelentést készít a felhatalmazásról.
Slovenian: Komisija pripravi poročilo o prenesenih pooblastilih najpozneje 6 mesecev pred iztekom petletnega obdobja.
Romanian: Comisia prezintă un raport privind competențele delegate cu cel puțin 6 luni înainte de încheierea perioadei de 5 ani.
Estonian: Komisjon esitab delegeeritud volituste kohta aruande hiljemalt kuus kuud enne viieaastase ajavahemiku lõppu.
Latvian: Komisija sagatavo ziņojumu par deleģētajām pilnvarām vēlākais sešus mēnešus pirms piecu gadu laikposma beigām.
Maltese: Il-Kummissjoni għandha tfassal rapport fir-rigward tas-setgħat delegati mhux aktar tard minn 6 xhur qabel tmiem il-perjodu ta’ 5 snin.
English: may request the competent authority in that Member State to submit copies of the assessment report referred to in Article 21(4) and of the marketing authorisation in force in respect of the medicinal product concerned. If so requested, the competent authority in that Member State shall supply, within 30 days of receipt of the request, a copy of the assessment report and the marketing authorisation in respect of the medicinal product concerned.’.
Danish: eventuelt anmode den kompetente myndighed i den pågældende medlemsstat om at fremlægge et eksemplar af den evalueringsrapport, der er omhandlet i artikel 21, stk. 4, og af den markedsføringstilladelse, der gælder for det pågældende lægemiddel; modtager den kompetente myndighed i den pågældende medlemsstat en sådan anmodning, skal den senest 30 dage efter modtagelsen af anmodningen fremsende et eksemplar af evalueringsrapporten og af markedsføringstilladelsen for det pågældende lægemiddel.«
English: ‘(iaa) The risk management plan describing the risk management system which the applicant will introduce for the medicinal product concerned, together with a summary thereof.’;
German: iaa) Risikomanagement-Plan, mit einer Beschreibung des Risikomanagementsystems, das der Antragsteller für das betreffende Arzneimittel einführen wird, verbunden mit einer Zusammenfassung;
English: Member States shall ensure that reports of suspected adverse reactions arising from an error associated with the use of a medicinal product that are brought to their attention are made available to the Eudravigilance database and to any authorities, bodies, organisations and/or institutions, responsible for patient safety within that Member State. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of any other authority within that Member State.
German: Die Mitgliedstaaten stellen sicher, dass Meldungen über vermutete Nebenwirkungen infolge eines Fehlers bei der Anwendung eines Arzneimittels, die sie erhalten, in die EudraVigilance-Datenbank eingegeben werden und allen in ihrem Hoheitsgebiet für die Patientensicherheit zuständigen Behörden, Stellen, Organisationen oder Institutionen zugänglich gemacht werden Sie sorgen außerdem dafür, dass ihre für Arzneimittel zuständigen Behörden über alle vermuteten Nebenwirkungen in Kenntnis gesetzt werden, die einer ihrer sonstigen Behörden gemeldet werden.
Swedish: Medlemsstaterna ska se till att rapporter om misstänkta biverkningar som uppkommit på grund av ett fel förknippat med användningen av ett läkemedel som de får kännedom om görs tillgängliga för Eudravigilance-databasen och för alla myndigheter, organ, organisationer och/eller institutioner som ansvarar för patientsäkerhet i den medlemsstaten De ska också se till att de myndigheter som ansvarar för läkemedel i den medlemsstaten får information om alla misstänkta biverkningar som någon annan myndighet i den medlemsstaten fått kännedom om.
English: Marketing authorisation holders should plan pharmacovigilance measures for each individual medicinal product in the context of a risk management system. The measures should be proportionate to the identified risks, the potential risks, and the need for additional information on the medicinal product.
Italian: La programmazione delle misure di farmacovigilanza per ogni singolo medicinale da parte del titolare dell’autorizzazione all’immissione in commercio dovrebbe essere effettuata nel contesto di un sistema di gestione del rischio e dovrebbe essere proporzionata ai rischi individuati, ai rischi potenziali e alla necessità di ulteriori informazioni sul medicinale.
Greek: Ο σχεδιασμός μέτρων φαρμακοεπαγρύπνησης για κάθε επιμέρους φάρμακο από τον κάτοχο της άδειας κυκλοφορίας θα πρέπει να γίνεται στο πλαίσιο ενός συστήματος διαχείρισης του κινδύνου και θα πρέπει να είναι ανάλογος προς τους προσδιορισθέντες και δυνητικούς κινδύνους και προς την ανάγκη για πρόσθετες πληροφορίες σχετικά με το φάρμακο.
English: The public assessment report shall include a summary written in a manner that is understandable to the public. The summary shall contain, in particular, a section relating to the conditions of use of the medicinal product.’.
Greek: Η δημόσια έκθεση αξιολόγησης περιλαμβάνει περίληψη συντεταγμένη κατά τρόπον ώστε να είναι κατανοητή από το κοινό, όπου περιέχεται, μεταξύ άλλων, τμήμα σχετικό με τους όρους χρήσης του φαρμάκου.».
English: If an agreement by consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall be forwarded to the Commission which shall apply the procedure laid down in Articles 33 and 34. However, by way of derogation from Article 34(1), the procedure referred to in Article 121(2) shall apply.
Greek: Αν δεν μπορεί να εξευρεθεί συμφωνία με συναίνεση, η θέση της πλειοψηφίας των κρατών μελών που αντιπροσωπεύονται στους κόλπους της ομάδας συντονισμού διαβιβάζεται στην Επιτροπή, η οποία εφαρμόζει τη διαδικασία που προβλέπεται στα άρθρα 33 και 34 Ωστόσο, κατά παρέκκλιση από το άρθρο 34 παράγραφος 1, εφαρμόζεται η διαδικασία που αναφέρεται στο άρθρο 121 παράγραφος 2.
English: This cooperation shall consist in sharing information with the Agency on both inspections that are planned and that have been conducted. Member States and the Agency shall cooperate in the coordination of inspections in third countries.’;
Greek: Η εν λόγω συνεργασία συνίσταται στην ανταλλαγή πληροφοριών με τον Οργανισμό σχετικά με προγραμματισθείσες και πραγματοποιηθείσες επιθεωρήσεις. κράτη μέλη και Οργανισμός συνεργάζονται ως προς τον συντονισμό των επιθεωρήσεων σε τρίτες χώρες.»·
English: the expiry of a period of 3 years starting from 21 July 2011, whichever is earlier.
Greek: τη λήξη περιόδου τριών ετών που αρχίζει να υπολογίζεται από τις 21 Ιουλίου 2011, ανάλογα με το ποια ημερομηνία είναι προγενέστερη.
English: Before a study is conducted, the marketing authorisation holder shall submit a draft protocol to the Pharmacovigilance Risk Assessment Committee, except for studies to be conducted in only one Member State that requests the study according to Article 22a. For such studies, the marketing authorisation holder shall submit a draft protocol to the national competent authority of the Member State in which the study is conducted.
Spanish: Antes de llevar a cabo el estudio, se requerirá al titular de la autorización de comercialización que presente un proyecto de protocolo al Comité para la evaluación de riesgos en farmacovigilancia, excepto en el caso de los estudios que deban efectuarse en un solo Estado miembro que requiera la realización del estudio con arreglo al artículo 22 bis. Para estos estudios, el titular de la autorización de comercialización presentará un proyecto de protocolo a la autoridad nacional competente del Estado miembro en el que se realice el estudio.
English: In order to simplify the reporting of suspected adverse reactions, the marketing authorisation holders and the Member States should report those reactions only to the Union pharmacovigilance database and data-processing network referred to in Article 57(1)(d) of Regulation (EC) No 726/2004 (the ‘Eudravigilance database’). The Eudravigilance database should be equipped to immediately forward reports on suspected adverse reactions received from marketing authorisation holders to the Member States on whose territory the reaction occurred.
Estonian: Et võimalike kõrvaltoimete kohta aruannete esitamine oleks lihtsam, peaksid müügiloa omanikud ja liikmesriigid teatama sellistest kõrvaltoimetest ainult liidu ravimiohutuse järelevalve andmebaasi ja andmetöötlusvõrku (edaspidi „Eudravigilance’i andmebaas”), millele on osutatud määruse (EÜ) nr 726/2004 artikli 57 lõike 1 punktis d. Eudravigilance’i andmebaas tuleks sisse seada selliselt, et see võimaldaks viivitamata edastada müügiloa omanikelt võimalike kõrvaltoimete kohta saadud teated liikmesriikidele, kelle territooriumil kõrvaltoime ilmnes.
English: Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof, Having regard to the proposal from the European Commission,
Hungarian: tekintettel az Európai Unió működéséről szóló szerződésre és különösen annak 114. cikkére és 168. cikke (4) bekezdésének c) pontjára,
English: to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed. Such an obligation to conduct such studies shall be based on the delegated acts adopted pursuant to Article 22b while taking into account the scientific guidance referred to in Article 108a.
Italian: effettuare studi sull’efficacia dopo l’autorizzazione ove siano individuate problematiche connesse ad alcuni aspetti dell’efficacia del medicinale ed esse possano essere risolte soltanto dopo l’immissione in commercio del medesimo; tale obbligo di effettuare tali studi si basa sugli atti delegati adottati a norma dell’articolo 22 ter, tenendo conto degli orientamenti scientifici di cui all’articolo 108 bis.
English: Articles 33 and 34 of this Directive shall apply to the adoption of the decision referred to in point (a) of the first subparagraph of this paragraph and to its implementation by the Member States. However, by way of derogation from Article 34(1) of this Directive, the procedure referred to in Article 121(2) thereof shall apply.
Lithuanian: Šios direktyvos 33 ir 34 straipsniai taikomi priimant šios dalies pirmos pastraipos a punkte nurodytą sprendimą ir valstybėms narėms jį įgyvendinant Tačiau, nukrypstant nuo šios direktyvos 34 straipsnio 1 dalies, taikoma 121 straipsnio 2 dalyje nurodyta procedūra.
English: When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Maltese: Meta l-Istati Membri jadottaw dawk id-dispożizzjonijiet, dawn għandhom jinkludu referenza għal din id-Direttiva jew tali referenza għandha takkumpanjahom meta jiġu pubblikati uffiċjalment.. Il-metodi kif issir tali referenza għandhom jiġu stabbiliti mill-Istati Membri.
English: However, some medicinal products are authorised subject to additional monitoring. This includes all medicinal products with a new active substance and biological medicinal products, including biosimilars, which are priorities for pharmacovigilance.
Dutch: Sommige geneesmiddelen worden echter toegelaten op voorwaarde dat er aanvullende monitoring gebeurt, zoals alle geneesmiddelen met een nieuwe werkzame stof en biologische geneesmiddelen waaronder biologisch gelijkwaardige geneesmiddelen, die bij geneesmiddelenbewaking voorrang krijgen.
English: The coordination group shall be composed of one representative per Member State appointed for a renewable period of 3 years. Member States may appoint an alternate for a renewable period of 3 years.
Dutch: De coördinatiegroep bestaat uit een vertegenwoordiger van iedere lidstaat, die wordt benoemd voor een termijn van drie jaar met mogelijkheid tot verlenging. lidstaten kunnen een plaatsvervanger aanwijzen voor een termijn van drie jaar met mogelijkheid tot verlenging.
English: to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product. If the same concerns apply to more than one medicinal product, the national competent authority shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study;
Romanian: să efectueze un studiu de siguranță post-autorizare dacă există preocupări privind riscurile unui medicament autorizat În cazul în care aceleași preocupări se aplică la mai multe medicamente, autoritatea națională competentă încurajează titularii autorizațiilor de introducere pe piață implicați, după consultarea Comitetului pentru evaluarea riscurilor în materie de farmacovigilență, să efectueze un studiu de siguranță post-autorizare comun;
English: For all medicinal products, a standard text shall be included expressly asking healthcare professionals to report any suspected adverse reaction in accordance with the national spontaneous reporting system referred to in Article 107a(1). Different ways of reporting, including electronic reporting, shall be available in compliance with the second subparagraph of Article 107a(1).’.
Slovak: Na všetkých liekoch sa uvádza štandardizovaný text, v ktorom sa od zdravotníckeho personálu výslovne žiada, aby nahlasovali všetky podozrenia na nežiaduce účinky v súlade s vnútroštátnym systémom spontánneho nahlasovania uvedeným v článku 107a ods. 1 Sú možné aj iné formy nahlasovania, a to i elektronicky, v súlade s článkom 107a ods. 1 druhý pododsek.“;
English: ‘Where the referral results from the evaluation of data relating to pharmacovigilance of an authorised medicinal product, the matter shall be referred to the Pharmacovigilance Risk Assessment Committee and Article 107j(2) may be applied. The Pharmacovigilance Risk Assessment Committee shall issue a recommendation according to the procedure laid down in Article 32.
Slovak: „Ak je postúpenie výsledkom hodnotenia údajov týkajúcich sa dohľadu nad povoleným liekom, postúpi sa vec Výboru pre hodnotenie rizík dohľadu nad liekmi a môže sa uplatniť článok 107j ods. 2 Výbor pre hodnotenie rizík dohľadu nad liekmi vydá odporúčanie podľa postupu stanoveného v článku 32.
English: The Commission shall draw up a report in respect of the delegated powers not later than 6 months before the end of the 5 year period. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 121b.
Slovak: Delegovanie právomocí sa automaticky predlžuje na rovnako dlhé obdobia, pokiaľ ho Európsky parlament alebo Rada v súlade s článkom 121b neodvolajú.
English: The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein.
Slovenian: Z odločitvijo o preklicu prenehajo veljati pooblastila, navedena v tej odločitvi.
English: It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.
Slovenian: Odločitev začne veljati takoj ali na dan, ki je v njej določen.
English: Article 121c 1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification.
Slovenian: Odločitev ne vpliva na veljavnost že veljavnih delegiranih aktov.