FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Regulation as last amended by the 2003 Act of Accession.
French: Règlement modifié en dernier lieu par l'acte d'adhésion de 2003.
German: Zuletzt geändert durch die Beitrittsakte von 2003.
Spanish: Reglamento cuya última modificación la constituye el Acta de Adhesión de 2003.
Italian: Regolamento modificato da ultimo dall'atto di adesione del 2003.
Portuguese: Regulamento com a última redacção que lhe foi dada pelo Acto de Adesão de 2003.
Dutch: Verordening laatstelijk gewijzigd bij de Toetredingsakte van 2003.
Danish: Senest ændret ved tiltrædelsesakten af 2003.
Swedish: Förordningen senast ändrad genom 2003 års anslutningsakt.
Greek: Κανονισμός όπως τροποποιήθηκε τελευταία με την Πράξη Προσχώρησης του 2003.
Czech: Nařízení naposledy pozměněné aktem o přistoupení z roku 2003.
Slovak: Nariadenie naposledy zmenené a doplnené Aktom o pristúpení z roku 2003.
Polish: Rozporządzenie ostatnio zmienione Aktem Przystąpienia z 2003 r.
Slovenian: Uredba, kakor je bila nazadnje spremenjena z Aktom o pristopu iz leta 2003.
Estonian: Määrust on viimati muudetud 2003. aasta ühinemisaktiga.
Lithuanian: Reglamentas su paskutiniais pakeitimais, padarytais 2003 m. Stojimo aktu.
English: OJ L 18, 22.1.2000, p. 1.
French: JO L 18 du 22.1.2000, p. 1.
German: ABl. L 18 vom 22.1.2000, S. 1.
Spanish: DO L 18 de 22.1.2000, p. 1.
Italian: GU L 18 del 22.1.2000, pag. 1.
Portuguese: JO L 18 de 22.1.2000, p. 1.
Dutch: PB L 18 van 22.1.2000, blz. 1.
Danish: EFT L 18 af 22.1.2000, s. 1.
Swedish: EGT L 18, 22.1.2000, s. 1.
Finnish: EYVL L 18, 22.1.2000, s. 1.
Greek: ΕΕ L 18, 22.1.2000, σ. 1.
Czech: Úř. věst. L 18, 22.1.2000, s. 1.
Slovak: Ú. v. ES L 18, 22.1.2000, s. 1.
Polish: Dz.U. L 18 z 22.1.2000, str. 1.
Hungarian: HL L 18., 2000.1.22., 1. o.
Slovenian: UL L 18, 22.1.2000, str. 1.
Estonian: EÜT L 18, 22.1.2000, lk 1.
Latvian: OV L 18, 22.1.2000., 1. lpp.
Lithuanian: OL L 18, 2000 1 22, p. 1.
English: OJ L 184, 17.7.1999, p. 23.
French: JO L 184 du 17.7.1999, p. 23.
German: ABl. L 184 vom 17.7.1999, S. 23.
Spanish: DO L 184 de 17.7.1999, p. 23.
Italian: GU L 184 del 17.7.1999, pag. 23.
Portuguese: JO L 184 de 17.7.1999, p. 23 (Rectificação no JO L 269 de 19.10.1999, p. 45).
Dutch: PB L 184 van 17.7.1999, blz. 23.
Danish: EFT L 184 af 17.7.1999, s. 23.
Swedish: EGT L 184, 17.7.1999, s. 23.
Greek: ΕΕ L 184, 17.7.1999, σ. 23.
Czech: Úř. věst. L 184, 17.7.1999, s. 23.
Slovak: Ú. v. ES L 184, 17.7.1999, s. 23.
Polish: Dz.U. L 184 z 17.7.1999, str. 23.
Slovenian: UL L 184, 17.7.1999, str. 23.
Estonian: EÜT L 184, 17.7.1999, lk 23.
Lithuanian: OL L 184, 1999 7 17, p. 23.
English: Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).
French: Décision modifiée par la décision 2006/512/CE (JO L 200 du 22.7.2006, p. 11).
German: Geändert durch den Beschluss 2006/512/EG (ABl. L 200 vom 22.7.2006, S. 11).
Spanish: Decisión modificada por la Decisión 2006/512/CE (DO L 200 de 22.7.2006, p. 11).
Italian: Decisione modificata dalla decisione 2006/512/CE (GU L 200 del 22.7.2006, pag. 11).
Portuguese: Decisão com a redacção que lhe foi dada pela Decisão 2006/512/CE (JO L 200 de 22.7.2006, p. 11).
Dutch: Besluit gewijzigd bij Besluit 2006/512/EG (PB L 200 van 22.7.2006, blz. 11).
Danish: Ændret ved afgørelse 2006/512/EF (EUT L 200 af 22.7.2006, s. 11).
Swedish: Beslutet ändrat genom beslut 2006/512/EG (EUT L 200, 22.7.2006, s. 11).
Greek: Απόφαση όπως τροποποιήθηκε με την απόφαση 2006/512/ΕΚ (ΕΕ L 200, 22.7.2006, σ. 11).
Czech: Rozhodnutí ve znění rozhodnutí 2006/512/ES (Úř. věst. L 200, 22.7.2006, s. 11).
Slovak: Rozhodnutie zmenené a doplnené rozhodnutím 2006/512/ES (Ú. v. EÚ L 200, 22.7.2006, s. 11).
Polish: Decyzja zmieniona decyzją 2006/512/WE (Dz.U. L 200 z 22.7.2006, str. 11).
Slovenian: Sklep, kakor je bil spremenjen s Sklepom 2006/512/ES (UL L 200, 22.7.2006, str. 11).
Estonian: Otsust on muudetud otsusega 2006/512/EÜ (ELT L 200, 22.7.2006, lk 11).
Lithuanian: Sprendimas su pakeitimais, padarytais Sprendimu 2006/512/EB (OL L 200, 2006 7 22, p. 11).
English: OJ L 35, 15.2.1995, p. 1.
French: JO L 35 du 15.2.1995, p. 1.
German: ABl. L 35 vom 15.2.1995, S. 1.
Spanish: DO L 35 de 15.2.1995, p. 1.
Italian: GU L 35 del 15.2.1995, pag. 1.
Portuguese: JO L 35 de 15.2.1995, p. 1.
Dutch: PB L 35 van 15.2.1995, blz. 1.
Danish: EFT L 35 af 15.2.1995, s. 1.
Swedish: EGT L 35, 15.2.1995, s. 1.
Greek: ΕΕ L 35, 15.2.1995, σ. 1.
Czech: Úř. věst. L 35, 15.2.1995, s. 1.
Slovak: Ú. v. ES L 35, 15.2.1995, s. 1.
Polish: Dz.U. L 35 z 15.2.1995, str. 1.
Slovenian: UL L 35, 15.2.1995, str. 1.
Estonian: EÜT L 35, 15.2.1995, lk 1.
Latvian: OV L 35, 15.2.1995, 1. lpp. .
Lithuanian: OL L 35, 1995 2 15, p. 1.
English: Regulation as last amended by Regulation (EC) No 1905/2005 (OJ L 304, 23.11.2005, p. 1).
French: Règlement modifié en dernier lieu par le règlement (CE) no 1905/2005 (JO L 304 du 23.11.2005, p. 1).
German: Zuletzt geändert durch die Verordnung (EG) Nr. 1905/2005 (ABl. L 304 vom 23.11.2005, S. 1).
Spanish: Reglamento cuya última modificación la constituye el Reglamento (CE) no 1905/2005 (DO L 304 de 23.11.2005, p. 1).
Italian: Regolamento modificato da ultimo dal regolamento (CE) n. 1905/2005 (GU L 304 del 23.11.2005, pag. 1).
Portuguese: Regulamento com a última redacção que lhe foi dada pelo Regulamento (CE) n.o 1905/2005 (JO L 304 de 23.11.2005, p. 1).
Dutch: Verordening laatstelijk gewijzigd bij Verordening (EG) nr. 1905/2005 (PB L 304 van 23.11.2005, blz. 1).
Danish: Senest ændret ved forordning (EF) nr. 1905/2005 (EUT L 304 af 23.11.2005, s. 1).
Swedish: Förordningen senast ändrad genom förordning (EG) nr 1905/2005 (EUT L 304, 23.11.2005, s. 1).
Greek: Κανονισμός όπως τροποποιήθηκε τελευταία με τον κανονισμό (ΕΚ) αριθ. 1905/2005 (ΕΕ L 304, 23.11.2005, σ. 1).
Czech: Nařízení naposledy pozměněné nařízením (ES) č. 1905/2005 (Úř. věst. L 304, 23.11.2005, s. 1).
Slovak: Nariadenie naposledy zmenené a doplnené nariadením (ES) č. 1905/2005 (Ú. v. EÚ L 304, 23.11.2005, s. 1).
Polish: Rozporządzenie ostatnio zmienione rozporządzeniem (WE) nr 1905/2005 (Dz. U.L 304, 23.11.2005, str. 1).
Slovenian: Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1905/2005 (UL L 304, 23.11.2005, str. 1).
Estonian: Määrust on viimati muudetud määrusega (EÜ) nr 1905/2005 (ELT L 304, 23.11.2005, lk 1).
Latvian: Regulā jaunākie grozījumi izdarīti ar Regulā (EC) No 1905/2005 ( OV L 304, 23.11.2005, p. 1 ).
Lithuanian: Reglamentas su paskutiniais pakeitimais, padarytais Reglamentu (EB) Nr. 1905/2005 (OL L 304, 2005 11 23, p. 1).
English: OJ L 378, 27.12.2006, p. 1.’
French: JO L 378 du 27.12.2006, p. 1»
German: ABl. L 378 vom 27.12.2006, S. 1.“
Spanish: DO L 378 de 27.12.2006, p. 1»
Italian: GU L 378 del 27.12.2006, pag. 1»
Portuguese: JO L 378 de 27.12.2006, p. 1»
Dutch: PB L 378 van 27.12.2006, blz. 1”;.
Danish: EUT L 378 af 27.12.2006, s. 1«.
Swedish: EUT L 378, 27.12.2006, s. 1.”
Finnish: EUVL L 378, 27.12.2006, s. 1.”;
Greek: ΕΕ L 378, 27.12.2006, σ. 1.».
Czech: Úř. věst. L 378, 27.12.2006, s. 1.“
Slovak: Ú. v. EÚ L 378, 27.12.2006, s. 1.“
Polish: Dz.U. L 378 z 27.12.2006, str. 1.”
Hungarian: HL L 378., 2006.12.27., 1. o.”;
Slovenian: UL L 378, 27.12.2006, str. 1.“
Estonian: ELT L 378, 27.12.2006, lk 1”.
Latvian: OJ L 378, 27.12.2006, p. 1”.
Lithuanian: OL L 378, 2006 12 27, p. 1“.
English: COMMISSION STATEMENT
French: DÉCLARATION DE LA COMMISSION
German: ERKLÄRUNG DER KOMMISSION
Spanish: DECLARACIÓN DE LA COMISIÓN
Italian: DICHIARAZIONE DELLA COMMISSIONE
Portuguese: DECLARAÇÃO DA COMISSÃO
Dutch: VERKLARING VAN DE COMMISSIE
Danish: ERKLÆRING FRA KOMMISSIONEN
Swedish: UTTALANDE FRÅN KOMMISSIONEN
Finnish: KOMISSION LAUSUMA
Greek: ΔΗΛΩΣΗ ΤΗΣ ΕΠΙΤΡΟΠΗΣ
Czech: PROHLÁŠENÍ KOMISE
Slovak: VYHLÁSENIE KOMISIE
Polish: Oświadczenie Komisji
Hungarian: A BIZOTTSÁG NYILATKOZATA
Slovenian: IZJAVA KOMISIJE
Estonian: Komisjoni avaldus
Latvian: KOMISIJAS DEKLARĀCIJA
Lithuanian: Komisijos pareiškimas
English: The Commission will transmit the opinion of the Committee for Medicinal Products for Human Use to the European Parliament and the Council.
French: La Commission transmettra au Parlement et au Conseil l'avis formulé par le Comité des médicaments à usage humain.
German: Die Kommission wird die Stellungnahme des Ausschusses für Humanarzneimittel an das Europäische Parlament und den Rat weiterleiten.
Spanish: La Comisión transmitirá al Parlamento Europeo y al Consejo el dictamen del Comité de medicamentos de uso humano.
Italian: La Commissione trasmetterà il parere del comitato per i medicinali per uso umano al Parlamento europeo e al Consiglio.
Portuguese: A Comissão transmitirá o parecer do Comité dos Medicamentos para Uso Humano ao Parlamento Europeu e ao Conselho.
Dutch: De Commissie zal het advies van het Comité voor geneesmiddelen voor menselijk gebruik aan het Europees Parlement en de Raad zenden.
Danish: Kommissionen vil fremsende udtalelsen fra Udvalget for Humanmedicinske Lægemidler til Europa-Parlamentet og Rådet.
Swedish: Kommissionen kommer att översända yttrandet från kommittén för humanläkemedel till Europaparlamentet och rådet.
Finnish: Komissio toimittaa ihmisille tarkoitettuja lääkkeitä käsittelevän komitean lausunnon Euroopan parlamentille ja neuvostolle.
Greek: Η Επιτροπή θα διαβιβάσει τη γνωμοδότηση της επιτροπής φαρμάκων για ανθρώπινη χρήση στο Ευρωπαϊκό Κοινοβούλιο και το Συμβούλιο.
Czech: Komise předloží stanovisko Výboru pro humánní léčivé přípravky Parlamentu a Radě.
Slovak: Komisia doručí stanovisko Výboru pre lieky na humánne použitie Európskemu parlamentu a Rade.
Polish: Komisja przekaże opinię Komitetu ds. Produktów Leczniczych Stosowanych u Ludzi Parlamentowi Europejskiemu i Radzie.
Hungarian: A Bizottság közölni fogja az emberi felhasználásra szánt gyógyszerkészítményekkel foglalkozó bizottság véleményét az Európai Parlamenttel és a Tanáccsal.
Slovenian: Komisija bo mnenje Odbora za zdravila za uporabo v humani medicini posredovala Evropskemu parlamentu in Svetu.
Estonian: Komisjon edastab inimtervishoius kasutatavate ravimite alalise komitee arvamuse Euroopa Parlamendile ja nõukogule.
Latvian: Komisija Cilvēkiem paredzēto zāļu komitejas sagatavoto atzinumu iesniegs Parlamentam un Padomei.
Lithuanian: Komisija perduos Europos vaistų agentūros Žmonėms skirtų vaistų komiteto nuomonę Europos Parlamentui ir Tarybai.
English: Council Decision of 23 October 2006.
French: Décision du Conseil du 23 octobre 2006.
German: Beschluss des Rates vom 23. Oktober 2006.
Spanish: Decisión del Consejo de 23 de octubre de 2006.
Portuguese: Decisão do Conselho de 23 de Outubro de 2006.
Dutch: Besluit van de Raad van 23 oktober 2006.
Danish: Rådets afgørelse af 23.10.2006.
Swedish: Rådets beslut av den 23 oktober 2006.
Greek: Απόφαση του Συμβουλίου της 23ης Οκτωβρίου 2006.
Slovak: Rozhodnutie Rady z 23. októbra 2006.
Polish: Decyzja Rady z dnia 23 października 2006 r.
Hungarian: A Tanács 2006. október 23-i határozata.
Slovenian: Sklep Sveta z dne 23. oktobra 2006.
Estonian: Nõukogu 23. oktoobri 2006. aasta otsus.
Latvian: Padomes 2006. gada 23. oktobra Lēmums.
Lithuanian: 2006 m. spalio 23 d. Tarybos sprendimas.
English: five members, with their alternates, of the Committee for Medicinal Products for Human Use, having been appointed to that Committee in accordance with Article 61(1) of Regulation (EC) No 726/2004. These five members with their alternates shall be appointed to the Paediatric Committee by the Committee for Medicinal Products for Human Use;
Spanish: cinco miembros, con sus respectivos suplentes, del Comité de Medicamentos de Uso Humano, que hayan sido nombrados miembros de este último comité de conformidad con el artículo 61, apartado 1 del Reglamento (CE) no 726/2004; estos cinco miembros y sus suplentes serán nombrados miembros del Comité Pediátrico por el Comité de Medicamentos de Uso Humano;
Italian: cinque membri e rispettivi supplenti del comitato per i medicinali per uso umano, nominati ai sensi dell'articolo 61, paragrafo 1, del regolamento (CE) n. 726/2004; la nomina al comitato pediatrico dei cinque membri e rispettivi supplenti avviene ad opera del comitato per i medicinali per uso umano;
English: If such a consensus cannot be reached, the Paediatric Committee shall adopt an opinion consisting of the position of the majority of the members. The opinion shall mention the divergent positions, with the grounds on which they are based.
Spanish: Si no se pudiese llegar a tal consenso, el Comité Pediátrico adoptará un dictamen en el que constarán la posición de la mayoría de los miembros y las opiniones divergentes, debidamente fundamentadas.
Latvian: Ja šādu vienprātību nevar panākt, Pediatrijas komiteja pieņem atzinumu, kurā iekļauj locekļu vairākuma viedokli.
English: The Paediatric Committee shall draw up its rules of procedure for the implementation of its tasks. The rules of procedure shall enter into force after receiving a favourable opinion from the Management Board of the Agency and, subsequently, from the Commission.
Spanish: El Comité Pediátrico establecerá un reglamento interno para el desempeño de sus funciones, que entrará en vigor tras el dictamen favorable del Consejo de Administración de la Agencia y, ulteriormente, de la Comisión.
English: The Agency shall adopt a decision within a period not exceeding 10 days following receipt of the Paediatric Committee's definitive opinion. This decision shall be communicated to the applicant in writing and shall annex the definitive opinion of the Paediatric Committee.
Spanish: La Agencia tomará una decisión en el plazo de diez días a partir de la recepción del dictamen definitivo del Comité Pediátrico, que se comunicará al solicitante por escrito, adjuntándose el dictamen definitivo del Comité Pediátrico.
Italian: L'Agenzia adotta entro un termine non superiore a dieci giorni dal ricevimento del parere definitivo del comitato pediatrico, una decisione che viene comunicata al richiedente per iscritto e contiene in allegato il parere definitivo del comitato pediatrico.
Portuguese: A Agência, num prazo não superior a dez dias após a recepção do parecer definitivo do Comité Pediátrico, toma uma decisão, que é comunicada ao requerente por escrito e anexa ao parecer definitivo do Comité Pediátrico.
English: Borrell Fontelles
Spanish: Josep Borrell Fontelles
Portuguese: Josep Borrell Fontelles
Slovenian: Josep Borrell Fontelles
English: OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34).
Finnish: EYVL L 311, 28.11.2001, s. 67, direktiivi sellaisena kuin se on viimeksi muutettuna direktiivillä 2004/27/EY (EUVL L 136, 30.4.2004, s. 34).
Hungarian: HL L 311., 2001.11.28., 67. o. A legutóbb a 2004/27/EK irányelvvel (HL L 136., 2004.4.30., 34. o.) módosított irányelv.
English: OJ L 182, 2.7.1992, p. 1. Regulation as last amended by the 2003 Act of Accession.
Finnish: EYVL L 182, 2.7.1992, s. 1, asetus sellaisena kuin se on viimeksi muutettuna vuoden 2003 liittymisasiakirjalla.
Hungarian: HL L 182., 1992.7.2., 1. o. A legutóbb a 2003. évi csatlakozási okmánnyal módosított rendelet.
Latvian: OV L 182, 2.7.1992., 1. lpp. Regulā jaunākie grozījumi izdarīti ar 2003. gada Pievienošanās aktu.
English: OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).
Finnish: EYVL L 184, 17.7.1999, s. 23, päätös sellaisena kuin se on muutettuna päätöksellä 2006/512/EY (EUVL L 200, 22.7.2006, s. 11).
Hungarian: HL L 184., 1999.7.17., 23. o. A 2006/512/EK határozattal (HL L 200., 2006.7.22., 11. o.) módosított határozat.
Latvian: OV L 184, 17.7.1999., 23. lpp.
English: OJ L 35, 15.2.1995, p. 1. Regulation as last amended by Regulation (EC) No 1905/2005 (OJ L 304, 23.11.2005, p. 1).
Finnish: EYVL L 35, 15.2.1995, s. 1, asetus sellaisena kuin se on viimeksi muutettuna asetuksella (EY) N:o 1905/2005 (EUVL L 304, 23.11.2005, s. 1).
Hungarian: HL L 35., 1995.2.15., 1. o. A legutóbb az 1905/2005/EK rendelettel (HL L 304., 2005.11.23., 1. o.) módosított rendelet.
English: In order to establish incentives for authorised products no longer covered by intellectual property rights, it is necessary to establish a new type of marketing authorisation, the Paediatric Use Marketing Authorisation. A Paediatric Use Marketing Authorisation should be granted through existing marketing authorisation procedures but should apply specifically for medicinal products developed exclusively for use in the paediatric population.
Italian: Al fine di creare incentivi per i prodotti autorizzati non più protetti da diritti di proprietà intellettuale è necessario istituire un nuovo tipo di autorizzazione all'immissione in commercio, ossia l'autorizzazione all'immissione in commercio per uso pediatrico, la quale dovrebbe essere concessa con le attuali procedure di autorizzazione all'immissione in commercio, ma sarebbe destinata in maniera specifica ai medicinali sviluppati esclusivamente per uso pediatrico.
English: An inventory of the therapeutic needs of the paediatric population should be established by the Paediatric Committee after consultation with the Commission, the Member States and interested parties, and should be regularly updated. The inventory should identify the existing medicinal products used by the paediatric population and highlight the therapeutic needs of that population and the priorities for research and development.
Italian: Previa consultazione della Commissione, degli Stati membri e degli interessati, il comitato pediatrico dovrebbe istituire e aggiornare regolarmente un inventario delle esigenze terapeutiche della popolazione pediatrica, che dovrebbe individuare i medicinali esistenti utilizzati in pediatria ed evidenziare le esigenze terapeutiche di tale popolazione, nonché le priorità per la ricerca e lo sviluppo.
English: The marketing authorisation holder shall inform the Agency of its intention to discontinue the placing on the market of the product no less than six months before the discontinuation. The Agency shall make this fact public.
Italian: Il titolare dell'autorizzazione all'immissione in commercio comunica la propria intenzione di interrompere la commercializzazione del medicinale almeno sei mesi prima di tale interruzione all'Agenzia, la quale la rende pubblica.
English: Member States shall inform the Commission of these provisions by 26 October 2007. They shall notify any subsequent alterations as soon as possible.
Italian: Gli Stati membri informano la Commissione di tali disposizioni entro il 26 ottobre 2007 e provvedono a notificare al più presto qualsiasi modificazione successiva.
Polish: Państwa członkowskie informują Komisję o tych przepisach nie później niż 26 października 2007 r. O wszelkich późniejszych zmianach państwa członkowskie informują jak najszybciej.
English: While taking into account the fact that the regulation of medicinal products must be fundamentally aimed at safeguarding public health, this aim must be achieved by means that do not impede the free movement of safe medicinal products within the Community. The differences between the national legislative, regulatory and administrative provisions on medicinal products tend to hinder intra-Community trade and therefore directly affect the operation of the internal market.
Latvian: Kaut arī jāņem vērā fakts, ka tiesību aktu attiecībā uz zālēm galvenais mērķis ir aizsargāt sabiedrības veselību, šis mērķis jāsasniedz ar līdzekļiem, kas nekavē drošu zāļu brīvu apriti Kopienā.
English: Any action to promote the development and authorisation of medicinal products for paediatric use is therefore justified with a view to preventing or eliminating these obstacles. Article 95 of the Treaty is therefore the proper legal basis.
Latvian: Atšķirības valstu tiesiskajos un administratīvajos aktos attiecībā uz zālēm bieži vien kavē tirdzniecību Kopienā un tādēļ tiešā veidā ietekmē iekšējā tirgus darbību.
English: It is appropriate to create a scientific committee, the Paediatric Committee, within the European Medicines Agency, hereinafter ‘the Agency’, with expertise and competence in the development and assessment of all aspects of medicinal products to treat paediatric populations. The rules on scientific committees of the Agency, as laid down in Regulation (EC) No 726/2004 [4], should apply to the Paediatric Committee.
Latvian: Ir lietderīgi Eiropas zāļu aģentūras (turpmāk — “Aģentūra” ) sastāvā izveidot zinātnisku komiteju — Pediatrijas komiteju — ar ekspertīzi un kompetenci visos bērnu mērķgrupai paredzēto zāļu izstrādes un izvērtēšanas aspektos [4].
English: Furthermore, early submission of a paediatric investigation plan, combined with the submission of a deferral request as described below, will avoid delaying the authorisation for other populations. As the development of medicinal products is a dynamic process dependent on the result of ongoing studies, provision should be made for modifying an agreed plan where necessary.
Latvian: Tā kā zāļu attīstība ir dinamisks process, kas ir atkarīgs no pašreizējo pētījumu rezultātiem, vajadzētu paredzēt iespēju, ka apstiprināto plānu vajadzības gadījumā var grozīt.
English: For products falling within the scope of the requirement to submit paediatric data, if all the measures included in the agreed paediatric investigation plan are complied with, if the product is authorised in all Member States and if relevant information on the results of studies is included in product information, a reward should be granted in the form of a 6-month extension of the supplementary protection certificate created by Council Regulation (EEC) No 1768/92 [6]. Any decisions by Member States' authorities as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes have no bearing on the granting of this reward.
Latvian: Zālēm, uz kurām attiecas prasība iesniegt pediatrijas datus, ja ir izpildītas visas apstiprinātā pediatrijas pētījumu plāna prasības, ja zāles ir apstiprinātas visās dalībvalstīs un ja attiecīgā informācija par izpētes rezultātiem ir iekļauta zāļu informācijā, būtu jāpiešķir atlīdzība, kas ir 6 mēnešu pagarinājums papildu aizsardzības sertifikātam, kas izveidots ar Padomes Regulu (EEK) Nr. 1768/92 [6].
English: Within 30 days following receipt of a request for re-examination pursuant to paragraph 2, the Paediatric Committee, having appointed a new rapporteur, shall issue a new opinion confirming or revising its previous opinion. The rapporteur shall be able to question the applicant directly. The applicant may also offer to be questioned.
Latvian: 30 dienu laikā pēc tam, kad Pediatrijas komiteja saņēmusi pārskatīšanas lūgumu atbilstīgi 2. punktam, tā pēc jauna referenta iecelšanas sniedz jaunu atzinumu, apstiprinot vai pārskatot iepriekšējo atzinumu.
English: The rapporteur shall inform the Paediatric Committee without delay in writing about details of contacts with the applicant. The opinion shall be duly reasoned and a statement of reasons for the conclusion reached shall be annexed to the new opinion, which shall become definitive.
Latvian: Atzinumu pienācīgi pamato un iegūtā secinājuma pamatojumu pievieno jaunajam atzinumam, kas ir galīgs.
English: Assessment of the effectiveness of any risk management system and the results of any studies performed shall be included in the periodic safety update reports referred to in Article 104(6) of Directive 2001/83/EC and Article 24(3) of Regulation (EC) No 726/2004. In addition, the competent authority may request submission of additional reports assessing the effectiveness of any risk minimisation system and the results of any such studies performed. 3. In addition to paragraphs 1 and 2, the provisions on pharmacovigilance as laid down in Regulation (EC) No 726/2004 and in Directive 2001/83/EC shall apply to marketing authorisations for medicinal products which include a paediatric indication.
Latvian: Jebkuras riska pārvaldības sistēmas efektivitātes vērtējumu un jebkuras veiktās izpētes rezultātus iekļauj regulāros ziņojumos par jaunākajiem datiem attiecībā uz drošumu, kā paredzēts Direktīvas 2001/83/EK 104. panta 6. punktā un Regulas (EK) Nr. 726/2004 24. panta 3. punktā.