FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: After a marketing authorisation has been granted, the holder of the authorisation shall inform the Agency of the dates of actual marketing of the medicinal product for human use in the Member States, taking into account the various presentations authorised. The holder shall also notify the Agency if the product ceases to be placed on the market, either temporarily or permanently.
Slovak: Držiteľ povolenia informuje po udelení povolenia na uvedenie na trh agentúru o dátumoch skutočného uvedenia lieku na humánne použitie na trh v členských štátoch, pričom zohľadní rôzne povolené prezentácie. Držiteľ tiež informuje agentúru, ak sa liek dočasne alebo trvale prestáva umiestňovať na trh.
English: After an authorisation has been granted in accordance with this Regulation, the holder of the marketing authorisation for a medicinal product for human use shall, in respect of the methods of manufacture and control provided for in Article 8(3)(d) and (h) of Directive 2001/83/EC, take account of technical and scientific progress and make any variations that may be required to enable the medicinal products to be manufactured and checked by means of generally accepted scientific methods. He shall apply for approval of such variations in accordance with this Regulation.
Slovak: Držiteľ povolenia na uvedenie na trh pre liek na humánne použitie po udelení povolenia v súlade s týmto nariadením zohľadňuje, v súvislosti s metódami výroby a kontroly ustanovenými v článku 8 ods. 3 písm. d) a h) smernice 2001/83/ES, technický a vedecký pokrok a vykonáva všetky zmeny, ktoré môžu byť požadované, aby sa umožnila výroba liekov a kontrola prostredníctvom všeobecne uznávaných vedeckých metód. O schválenie takýchto zmien požiada v súlade s týmto nariadením.
Lithuanian: Pagal šį reglamentą išdavus leidimą, leidimo prekiauti turėtojas, vadovaudamasis Direktyvos 2001/83/EB 8 straipsnio 3 dalies d ir h nustatytais gamybos ir kontrolės metodais, atsižvelgia į mokslo ir technikos pažangą ir daro reikiamas pataisas, kad vaistai būtų gaminami ir tikrinami visuotinai priimtais moksliniais metodais. Jis turi pateikti prašymą, kad šios pataisos būtų patvirtintos pagal šį reglamentą.
English: In particular, he shall forthwith inform the Agency, the Commission and the Member States of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product for human use is marketed and of any other new information which might influence the evaluation of the benefits and risks of the medicinal product for human use concerned. In order that the risk-benefit balance may be continuously assessed, the Agency may at any time ask the holder of the marketing authorisation to forward data demonstrating that the risk-benefit balance remains favourable. 3.
Slovak: Predovšetkým je povinný bezodkladne informovať agentúru, Komisiu a členské štáty o každom zákaze alebo obmedzení, uloženom príslušnými orgánmi akejkoľvek krajiny, v ktorej je liek na humánne použitie uvedený na trh, a o všetkých nových informáciách, ktoré môžu mať vplyv na hodnotenie prínosov a rizík daného lieku na humánne použitie. Na účely nepretržitého hodnotenia vyváženosti rizík a prínosov môže agentúra kedykoľvek požiadať držiteľa povolenia na uvedenie na trh o poskytnutie údajov, ktoré preukazujú, že je zachovaná priaznivá rovnováha rizika a prínosu. 3.
English: When it does so on its own initiative, it shall inform the Commission and the Agency of the reasons for its action at the latest on the next working day following the suspension. The Agency shall inform the other Member States without delay.
Slovak: Ak tak urobí z vlastnej iniciatívy, informuje Komisiu a agentúru o dôvodoch týchto opatrení najneskôr na nasledujúci deň po tomto pozastavení. Agentúra informuje bezodkladne ostatné členské štáty.
English: The marketing authorisation may be renewed after five years on the basis of a re-evaluation by the Agency of the risk-benefit balance. To this end, the marketing authorisation holder shall submit a consolidated list of all documents submitted in respect of quality, safety and efficacy, including all variations introduced since the marketing authorisation was granted, at least six months before the marketing authorisation ceases to be valid in accordance with paragraph 1. The Agency may require the applicant to submit the listed documents at any time.
Slovak: Povolenie na uvedenie na trh sa môže predĺžiť po piatich rokoch na základe prehodnotenia vyváženosti rizík a prínosov agentúrou. Na tento účel držiteľ povolenia na uvedenie na trh predloží konsolidovaný zoznam všetkých predložených dokumentov, ktoré sa vzťahujú na kvalitu, bezpečnosť a účinnosť, vrátane všetkých zmien, zavedených od udelenia povolenia na uvedenie na trh, aspoň šesť mesiacov predtým, ako prestane byť povolenie na uvedenie na trh platné v súlade s odsekom 1. Agentúra môže požadovať, aby žiadateľ kedykoľvek predložil uvedené doklady.
English: Article 41 1.
Slovak: Článok 41 1.
English: After an authorisation has been granted in accordance with this Regulation, the holder of the marketing authorisation shall, in respect of the methods of manufacture and control provided for in Article 12(3)(d) and (i) of Directive 2001/82/EC, take account of technical and scientific progress and make any variations that may be required to enable the medicinal products to be manufactured and checked by means of generally accepted scientific methods. He shall apply for approval of these variations in accordance with this Regulation.
Slovak: Po udelení povolenia v súlade s týmto nariadením, držiteľ povolenia na uvedenie na trh zohľadní, pokiaľ ide o metódy výroby a kontroly, ustanovené v článku 12 ods. 3 písm. d) a i) smernice 2001/82/ES, technický a vedecký pokrok a všetky zmeny, ktoré sa môžu požadovať na umožnenie výroby a kontroly liekov pomocou všeobecne uznávaných vedeckých metód. O tieto zmeny požiada v súlade s týmto nariadením.
Lithuanian: Pagal šį reglamentą išdavus leidimą, leidimo prekiauti turėtojas, vadovaudamasis Direktyvos 2001/82/EB 12 straipsnio 3 dalies d ir i punktuose nustatytais gamybos ir kontrolės metodais, atsižvelgia į mokslo ir technikos pažangą ir daro reikiamas pataisas, kad vaistai būtų gaminami ir tikrinami visuotinai priimtais moksliniais metodais. Jis turi pateikti paraišką, kad šios pataisos būtų patvirtintos pagal šį reglamentą.
English: The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4, which shall be published on its website. Article 24(1) and Article 25 shall apply mutatis mutandis.
Slovak: Agentúra vedie aktualizovaný zoznam stanovísk, prijatých v súlade s odsekom 4, ktoré sa uverejnia na internetovej stránke. článok 24 ods. 1 a článok 25 sa uplatňuje mutatis mutandis.
English: For the European Parliament The President P. Cox
Czech: Za Evropský parlament předseda P. Cox
Slovak: Za Európsky parlament predseda P. Cox
Polish: W imieniu Parlamentu Europejskiego P. Cox Przewodniczący
Lithuanian: Europos Parlamento vardu Pirmininkas P. Cox
English: For the Council The President
Czech: Za Radu předseda
Slovak: Za Radu predseda
Lithuanian: Tarybos vardu Pirmininkas
English: Roche
French: Roche
German: Roche
Spanish: Roche
Italian: Roche
Portuguese: Roche
Dutch: Roche
Swedish: Roche (2) EUT C 61, 14.3.2003, s. 1.
Finnish: Roche (2) EUVL C 61, 14.3.2003, s. 1.
Greek: Roche
Czech: Roche
Slovak: Roche
Slovenian: Roche
Lithuanian: Roche
English: ANNEX MEDICINAL PRODUCTS TO BE AUTHORISED BY THE COMMUNITY
Slovak: PRÍLOHA LIEKY, KTORÉ MAJÚ BYŤ POVOLENÉ SPOLOČENSTVOM
Lithuanian: PRIEDAS VAISTAI, KURIEMS LEIDIMUS IŠDUODA BENDRIJA
English: for all staff matters; (g) for providing the secretariat for the Management Board.
Spanish: tener a su cargo la secretaría del Consejo de Administración y del Consejo consultivo.
Slovak: zabezpečenie sekretariátu pre správnu radu.
English: Cox
French: Cox
German: Cox
Spanish: Cox
Italian: Cox
Portuguese: Cox
Dutch: Cox
Swedish: Cox
Finnish: Cox
Greek: Cox
Slovak: Cox
Slovenian: Cox
English: Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).ANNEX
French: Règlement (CE) n° 178/2002 du Parlement européen et du Conseil du 28 janvier 2002 établissant les principes généraux et les prescriptions générales de la législation alimentaire, instituant l'Autorité européenne de sécurité des aliments et fixant des procédures relatives à la sécurité des denrées alimentaires (JO L 31 du 1.2.2002, p. 1).ANNEXE
German: Verordnung (EG) Nr. 178/2002 des Europäischen Parlaments und des Rates vom 28. Januar 2002 zur Festlegung der allgemeinen Grundsätze und Anforderungen des Lebensmittelrechts, zur Errichtung der Europäischen Behörde für Lebensmittelsicherheit und zur Festlegung von Verfahren zur Lebensmittelsicherheit (ABl. L 31 vom 1.2.2002, S. 1).ANHANG
Spanish: Reglamento (CE) n° 178/2002 del Parlamento Europeo y del Consejo, de 28 de enero de 2002, por el que se establecen los principios y los requisitos generales de la legislación alimentaria, se crea la Autoridad Europea de Seguridad Alimentaria y se fijan procedimientos relativos a la seguridad alimentaria (DO L 31 de 1.2.2002, p. 1).ANEXO
Dutch: Verordening (EG) nr. 178/2002 van het Europees Parlement en de Raad van 28 januari 2002 tot vaststelling van de algemene beginselen en voorschriften van de levensmiddelenwetgeving, tot oprichting van een Europese Autoriteit voor voedselveiligheid en tot vaststelling van procedures voor voedselveiligheidsaangelegenheden. (PB L 31 van 1.2.2002, blz. 1).BIJLAGE
Danish: Europa-Parlamentets og Rådets forordning (EF) nr. 178/2002 af 28. januar 2002 om generelle principper og krav i fødevarelovgivningen, om oprettelse af Den Europæiske Fødevaresikkerhedsautoritet og om procedurer vedrørende fødevaresikkerhed (EFT L 31 af 1.2.2002, s. 1).BILAG
Finnish: Euroopan parlamentin ja neuvoston asetus (EY) N:o 178/2002, annettu 28 päivänä tammikuuta 2002, elintarvikelainsäädäntöä koskevista yleisistä periaatteista ja vaatimuksista, Euroopan elintarviketurvallisuusviranomaisen perustamisesta sekä elintarvikkeiden turvallisuuteen liittyvistä menettelyistä (EYVL L 31, 1.2.2002, s. 1).LIITE
Polish: Rozporządzenie (WE) nr 178/2002 Parlamentu Europejskiego i Rady z dnia 28 stycznia 2002 r. ustanawiające ogólne zasady i wymagania prawa żywnościowego, powołujące Europejski Urząd ds. Bezpieczeństwa Żywności i ustanawiające procedury w zakresie bezpieczeństwa żywności (Dz.U. L 31 z 1.2.2002, str. 1).
English: The President D. Roche
Polish: Roche Przewodniczący
English: Article 8 1.
Czech: Článek 8 1.
English: Where a draft decision envisages the granting of a marketing authorisation, it shall include or make reference to the documents mentioned in Article 9(4)(a), (b), (c) and (d). Where the draft decision is not in accordance with the opinion of the Agency, the Commission shall annex a detailed explanation of the reasons for the differences. The draft decision shall be forwarded to Member States and the applicant.
Lithuanian: Jei sprendimo projekte numatoma išduoti leidimą prekiauti, prie jo pridedami dokumentai, nurodyti 9 straipsnio 4 dalies a, b, c ir d punktuose arba į juos daroma nuoroda. Jei sprendimo projektas neatitinka Agentūros išvados, Komisija prideda išsamų skirtumų priežasčių paaiškinimą. Sprendimo projektas siunčiamas valstybėms narėms ir pareiškėjui.
English: The holder shall also notify the Agency if the product ceases to be placed on the market, either temporarily or permanently. Such notification shall, otherwise than in exceptional circumstances, be made no less than 2 months before the interruption in the placing on the market of the product. Upon request by the Agency, particularly in the context of pharmacovigilance, the marketing authorisation holder shall provide the Agency with all data relating to the volume of sales of the medicinal product at Community level, broken down by Member State, and any data in the holder's possession relating to the volume of prescriptions. Article 14 1.
Lithuanian: Toks pranešimas padaromas, išskyrus išimtinius atvejus, ne vėliau kaip likus dviem mėnesiams iki produkto pateikimo į rinką sustabdymo. Agentūrai pareikalavus farmakologinio budrumo tikslu, leidimo prekiauti turėtojas pateikia Agentūrai visus duomenis apie valstybės narės sustabdytų vaisto pardavimų Bendrijoje skaičių ir bet kuriuos kitus duomenis apie turėtojo turimų receptų skaičių. 14 straipsnis 1.
English: Without prejudice to paragraphs 4, 5 and 7 a marketing authorisation shall be valid for five years. 2.
Lithuanian: Nepažeidžiant 4, 5 ir 7 straipsnio dalies, leidimas prekiauti galioja penkerius metus. 2.
English: Where appropriate, the Committee for Medicinal Products for Human Use shall, in accordance with Article 5 of this Regulation, draw up opinions on the measures necessary. These opinions shall be made publicly accessible.
Lithuanian: Prireikus Žmonėms skirtų vaistų komitetas, remdamasis šio reglamento 5 straipsniu, gali suformuluoti išvadas dėl priemonių, reikalingų tokių vaistų saugiam ir efektyviam vartojimui užtikrinti.
English: To this end, the marketing authorisation holder shall submit a consolidated list of all documents submitted in respect of quality, safety and efficacy, including all variations introduced since the marketing authorisation was granted, at least six months before the marketing authorisation ceases to be valid in accordance with paragraph 1. The Agency may require the applicant to submit the listed documents at any time.
Lithuanian: Tuo tikslu leidimo prekiauti turėtojas pateikia visų dokumentų apie kokybę, saugą ir efektyvumą, įskaitant visas pataisas nuo leidimo prekiauti išdavimo pradžios, bendrą sąrašą ne vėliau kaip šeši mėnesiai iki leidimo prekiauti galiojimo pabaigos pagal 1 straipsnio dalį. Agentūra bet kokiu metu gali pareikalauti pareiškėjo pateikti išvardintus dokumentus.
English: Where appropriate the Committee for Medicinal Products for Veterinary Use shall, in accordance with Article 30 of this Regulation, draw up opinions on the measures necessary. These opinions shall be made publicly accessible.
Lithuanian: Prireikus, Veterinarinių vaistų komitetas, remdamasis šio reglamento 30 straipsniu, gali suformuluoti išvadas dėl priemonių, reikalingų tokių vaistų saugiam ir efektyviam vartojimui užtikrinti.
English: The holder of the marketing authorisation for a veterinary medicinal product shall ensure that all suspected serious adverse reactions, and adverse human reactions to a veterinary medicinal product authorised in accordance with the provisions of this Regulation occurring within the Community which a health-care professional brings to his attention are recorded and reported promptly to the Member States in the territory of which the incident occurred no later than 15 days following receipt of the information. The holder of the marketing authorisation shall record any other suspected serious adverse reactions and human adverse reactions occurring within the Community, in accordance with the guidelines referred to in Article 51, of which he may reasonably be expected to be aware, and promptly notify Member States in the territory of which the incident occurred and the Agency, and no later than 15 days following receipt of the information.
Lithuanian: Leidimo prekiauti veterinariniu vaistu turėtojas užtikrina, kad visos įtariamos pavojingos nepageidaujamos reakcijos, kurias sukelia Bendrijoje pagal šio reglamento nuostatas patvirtintas veterinarinis vaistas ir į kurias šio asmens dėmesį atkreipia sveikatos apsaugos specialistas, būtų registruojamos ir apie jas valstybėms narėms, kurių teritorijoje tas incidentas įvyko, pranešama nedelsiant ir jokiu būdu ne vėliau kaip per 15 dienų nuo tos informacijos gavimo. Pagal 51 straipsnyje nurodytus nurodymus leidimo prekiauti turėtojas registruoja bet kokias kitas įtariamas pavojingas netikėtas nepageidaujamas reakcijas, pasitaikančias Bendrijoje, apie kurias jis gali žinoti ir iškart praneša valstybės narės, kurios teritorijoje pasitaikė įvykis, kompetentingai institucijai ir Agentūrai ir jokiu būdu ne vėliau kaip per 15 dienų nuo tos informacijos gavimo.
English: and (b) consultation of these working parties and scientific advisory groups.
Lithuanian: konsultavimąsi su šiomis darbo grupėmis ir mokslinėmis patariamosiomis grupėmis.
English: When compassionate use is envisaged, the Committee for Medicinal Products for Human Use, after consulting the manufacturer or the applicant, may adopt opinions on the conditions for use, the conditions for distribution and the patients targeted. The opinions shall be updated on a regular basis.
Lithuanian: Kai numatomas panaudojimas labdaros tikslu, Žmonėms skirtų vaistų komitetas, pasikonsultavęs su gamintoju ir arba pareiškėju, gali priimti nuomones dėl naudojimo sąlygų, paskirstymo sąlygų ir tikslinių pacientų. Nuomonės atnaujinamos reguliariai.
English: Chapter 2 Supervision and penalties
Slovak: Kapitola 2 Dozor a pokuty
English: This document shall be published immediately after its adoption. Article 60
Slovak: Tento dokument sa uverejní ihneď po jeho schválení. Článok 60
English: Article 63 1. The membership of the committees referred to in Article 56(1) shall be made public.
Slovak: Článok 63 1. Zloženie výborov, uvedených v článku 56 ods. 1 sa zverejňuje.
English: His mandate may be renewed once. The Management Board may, upon a proposal from the Commission, remove the Executive Director from his post.
Slovak: Jeho mandát sa môže raz obnoviť. Správna Rada môže na návrh Komisie odvolať výkonného riaditeľa z jeho funkcie.
English: Article 66 The Management Board shall:
Slovak: Článok 66 Správna Rada:
English: Article 73 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(22) shall apply to documents held by the Agency.
Slovak: Článok 73 Nariadenie (ES) č. 1049/2001 Európskeho parlamentu a Rady z 30. mája 2001, ktoré sa týka verejného prístupu k dokumentom Európskeho parlamentu, Rady a Komisie [22], sa uplatňuje na dokumenty, ktoré vedie agentúra.
English: Article 74 The Protocol on the Privileges and Immunities of the European Communities shall apply to the Agency.
Slovak: Článok 74 Na agentúru sa uplatňuje Protokol o privilégiách a imunitách Európskych spoločenstiev.
English: Article 75 The staff of the Agency shall be subject to the rules and regulations applicable to officials and other staff of the European Communities.
Slovak: Článok 75 Pracovníci agentúry podliehajú pravidlám a nariadeniam, uplatniteľným na úradníkov a ostatných pracovníkov Európskych spoločenstiev.
English: Article 80 To ensure an appropriate level of transparency, the Management Board, on the basis of a proposal by the Executive Director and in agreement with the Commission, shall adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the authorisation or supervision of medicinal products which is not of a confidential nature.
Slovak: Článok 80 Na zabezpečenie vhodnej úrovne prehľadnosti, správna Rada, na základe návrhu výkonného riaditeľa a po dohode s Komisiou, prijme pravidlá na zabezpečenie prístupu verejnosti k regulačným, vedeckých alebo technickým informáciám, týkajúcim sa povoľovania alebo kontroly liekov, ktoré nemajú povahu obchodného tajomstva.
English: Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. T
Slovak: Ak sa vykonáva odkaz na tento odsek, uplatňujú sa články 4 a 7 rozhodnutia 1999/468/ES, s ohľadom na ustanovenia jeho článku 8.
English: he period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.
Slovak: Obdobie, stanovené v článku 4 ods. 3 rozhodnutia 1999/468/ES, sa stanovuje na jeden mesiac.
English: In accordance with the procedure laid down in Article 251 of the Treaty
Romanian: în conformitate cu procedura prevăzută la articolul 251 din tratat
English: Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products provides that, within six years of the entry into force of the Regulation, the Commission is to publish a general report on the experience acquired as a result of the operation of the procedures laid down in the Regulation.
Romanian: Articolul 71 din Regulamentul (CEE) nr. 2309/93 al Consiliului din 22 iulie 1993 de stabilire a procedurilor Comunității privind autorizarea și supravegherea medicamentelor de uz uman și veterinar și de instituire a unei Agenții europene pentru evaluarea medicamentelor prevede că în termen de șase ani de la intrarea în vigoare a regulamentului, Comisia are obligația de a publica un raport general privind experiența dobândită ca rezultat al funcționării procedurilor stabilite de prezentul regulament.
English: The provisions of Regulation (EC) No 1647/2003 amending Regulation (EC) No 2309/93 as regards the budgetary and financial rules applicable to the Agency and access to the Agency's documents should be fully incorporated into this Regulation,
Romanian: Dispozițiile Regulamentului (CE) nr. 1647/2003 de modificare a Regulamentului (CE) nr. 2309/93 în ceea ce privește normele bugetare și financiare aplicabile agenției și accesul la documentele agenției ar trebui să fie încorporate în totalitate în prezentul regulament,
English: the authorisation needs to be granted subject to the conditions provided for in Article 14(7) and (8). 2.
Romanian: autorizația trebuie să fie acordată sub rezerva condițiilor prevăzute la articolul 14 alineatele (7) și (8).
English: Article 10 1.
Romanian: Articolul 10
English: Member States shall take account of any available opinions
Romanian: Statele membre țin seama de orice aviz disponibil.
English: This Regulation shall not affect the competences vested in the European Food Safety Authority created by Regulation (EC) No 178/2002.
Romanian: Prezentul regulament nu afectează competențele acordate Autorității europene pentru Siguranța Alimentară instituită prin Regulamentul (CE) nr. 178/2002 .