Metadata
Author: EurLex-2
Data
Bulgarian[bg]
Техническите указания за изпълнение по отношение на формата на полетата с данните (наричан по-долу „пълен набор от данни“) са публикувани в отделен документ в базата EudraLex — правила относно лекарствените продукти в Европейския съюз, като така на практика се допълват двата документа с технически указания за изпълнение от Списъка с полетата, които следва да се оповестят публично, от базата данни EudraCT за педиатрични клинични изпитвания в съответствие с член 41 от Регламент (ЕО) No 1901/2006 и Списъка с полета, съдържащи се в базата данни с клинични изпитвания EudraCT, които следва да бъдат оповестени публично, в съответствие с член 57, параграф 2 от Регламент (ЕО) No 726/2004 (9).
English[en]
The implementing technical guidance on the format of the data fields (hereinafter ‘full data set’) is published in a separate document in ‘EudraLex — the rules governing medicinal products in the European Union’, thus completing the two implementing technical guidances on the ‘List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006’ and the ‘List of fields contained in the “EudraCT” clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004.’ (9).
Spanish[es]
Las directrices técnicas de ejecución relativas al formato de los campos de datos (conjunto completo de datos) se publican en un documento separado en EudraLex y completan los dos directrices técnicas de ejecución sobre la Lista de campos de EudraCT que deben hacerse públicos para los ensayos clínicos pediátricos, de conformidad con el artículo 41 del Reglamento (CE) no 1901/2006, así como sobre la Lista de campos de la base de datos sobre ensayos clínicos «EudraCT» que deben hacerse públicos, de conformidad con el artículo 57, apartado 2, del Reglamento (CE) no 726/2004 (9).
Estonian[et]
Tehnilised suunised andmeväljade formaadi kohta (edaspidi „täielikud andmed”) on avaldatud eraldi dokumendina Euroopa Liidu ravimieeskirjades EudraLex ning see täiendab kaht rakendamise tehnilist suunist – „List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006” ja „List of fields contained in the ‘EudraCT’ clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004” (9).
Finnish[fi]
Tietokenttien, jäljempänä ’koko aineisto’, muotoa käsittelevä tekninen täytäntöönpano-ohjeisto on julkaistu erillisenä asiakirjana EudraLex-kokoelmassa The Rules Governing Medicinal Products in the European Union (Lääkkeisiin sovellettavat säännöt Euroopan unionissa). Kyseinen asiakirja täydentää teknisiä täytäntöönpano-ohjeita List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 ja List of fields contained in the ‧EudraCT‧ clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 (9).
French[fr]
Les orientations techniques concernant le format des champs de données (ci-après «ensemble complet de données») sont publiées dans un document séparé dans EudraLex — Rules Governing Medicinal Products in the European Union, qui vient compléter les deux documents d’orientation techniques List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 et the List of fields contained in the ‘EudraCT’ clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 (9).
Italian[it]
Gli orientamenti tecnici concernenti il formato dei campi di dati (d'ora in poi «insieme completo di dati») sono pubblicati in un documento separato in EudraLex — the rules governing medicinal products in the European Union, che completa i due documenti di orientamento tecnico List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 e List of fields contained in the ‘EudraCT’ clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 (9).
Lithuanian[lt]
Duomenų laukelių formatu pateikta techninio įgyvendinimo rekomendacija (toliau – išsamus duomenų rinkinys) gali būti skelbiama EudraLex atskirame dokumente – taisyklėse, reglamentuojančiose vaistus Europos Sąjungoje, taip papildant dvi techninio įgyvendinimo rekomendacijas – „Su pediatriniais klinikiniais tyrimais susijusių EudraCT duomenų laukelių, viešai skelbtinų pagal Reglamento (EB) Nr. 1901/2006 41 straipsnį, sąrašas“ ir „EudraCT klinikinių tyrimų duomenų bazės duomenų laukelių, viešai skelbtinų pagal Reglamento (EB) Nr. 726/2004 57 straipsnio 2 dalį, sąrašas“ (9).
Latvian[lv]
Īstenošanas tehniskie norādījumi par datu lauku formātu (turpmāk “pilns datu kopums”) ir publicēti kā atsevišķs dokuments izdevumā EudraLex — the rules governing medicinal products in the European Union un tādējādi papildina divus iepriekšminētos īstenošanas tehniskos norādījumus ar nosaukumu List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 un List of fields contained in the ‘EudraCT’ clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 (9).
Maltese[mt]
Il-gwida teknika ta' implimentazzjoni tal-format tal-oqsma tad-dejta (minn issa 'l quddiem “sett sħiħ ta' dejta”) hija ppubblikata f'dokument separat f’EudraLex — the rules governing medicinal products in the European Union, u b'hekk din tikkompleta ż-żewġ gwidi tekniċi ta' implimentazzjoni dwar il-List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 u l-List of fields contained in the ‘EudraCT’ clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 (9).
Dutch[nl]
De technische uitvoeringsleidraad voor het formaat van de gegevensvelden (hierna „volledig gegevensstel” genoemd) is bekendgemaakt in een afzonderlijk document in EudraLex — the rules governing medicinal products in the European Union en vult aldus de twee technische uitvoeringsleidraden aan inzake de List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 en de List of fields contained in the ‘EudraCT’ clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 (9).
Polish[pl]
Wykonawcze wytyczne techniczne w sprawie formatu pól danych (zwanych dalej „pełnym zestawem danych”) opublikowano w oddzielnym dokumencie w EudraLex – zasady dotyczące produktów leczniczych w Unii Europejskiej. Stanowią one uzupełnienie do wspomnianych dwóch dokumentów zawierających wykonawcze wytyczne techniczne w sprawie wykazu pól udostępnianych publicznie z bazy EudraCT w zakresie badań klinicznych z udziałem populacji pediatrycznej zgodnie z art. 41 rozporządzenia (WE) nr 1901/2006 oraz wykazu udostępnianych publicznie pól zawartych w bazie danych EudraCT dotyczącej badań klinicznych zgodnie z art. 57 ust. 2 rozporządzenia (WE) nr 726/2004 (9).
Portuguese[pt]
As diretrizes técnicas de execução sobre o formato dos campos de dados (a seguir designados «conjunto completo de dados») estão publicadas num documento à parte na Eudralex — Regras que regem os medicamentos na União Europeia, completando, desta forma, as duas diretrizes técnicas de execução sobre a Lista de campos a publicar da EudraCT para Ensaios Clínicos Pediátricos em conformidade com o artigo 41.o do regulamento (CE) n.o 1901/2006 e a Lista de campos da base de dados sobre ensaios clínicos «EudraCT» a publicar, em conformidade com o artigo 57.o, n.o 2, do Regulamento (CE) n.o 726/2004 (9).
Romanian[ro]
Orientarea tehnică pentru punerea în aplicare privind formatul câmpurilor de date (în continuare „setul complet de date”) este publicată într-un document separat în EudraLex — the rules governing medicinal products in the European Union, completând astfel cele două orientări tehnice pentru punerea în aplicare List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 și List of fields contained in the ‘EudraCT’ clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 (9).