natgillin/translations-raw huggingface dataset:
In the implementation of this Directive, Member States are to ensure that the processing of donors’ and recipients’ personal data complies with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [2].
Pri izvajanju te direktive morajo države članice zagotoviti, da je obdelava osebnih podatkov darovalcev in prejemnikov v skladu z Direktivo Evropskega parlamenta in Sveta 95/46/ES z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov [2].
In order to enhance awareness of the persons processing information transmitted pursuant to this Directive, it is appropriate to include a reminder in the written communications pursuant to this Directive.
Zaradi povečanja ozaveščenosti oseb, ki obdelujejo podatke, prenesene v skladu s to direktivo, je v pisna sporočila primerno vključiti opozorilo v skladu s to direktivo.
In order to allow for rapid responses in case of alerts, and in order to facilitate the implementation of the obligation, provided for in Article 10(3)(b) of Directive 2010/53/EU, to keep data needed to ensure full traceability for a minimum of 30 years after donation, and without prejudice to the obligations of other bodies in that respect, it is appropriate that competent authorities or delegated bodies handle and record that information.
Zaradi zagotavljanja hitrega odziva v nujnih primerih in lažjega izvajanja obveznosti iz člena 10(3)(b) Direktive 2010/53/EU glede hranjenja potrebnih podatkov za zagotavljanje popolne sledljivosti najmanj 30 let po darovanju je brez poseganja v obveznosti drugih organov v zvezi s tem ustrezno, da pristojni organi ali pooblaščeni organi obravnavajo in evidentirajo te informacije.
Procurement organisations and transplantation centres should therefore ensure that their respective competent authorities or delegated bodies receive a copy of the information on organ and donor characterisation exchanged pursuant to this Directive, where applicable.
Organizacije za pridobivanje organov in transplantacijski centri bi morali zato zagotoviti, da njihovi zadevni pristojni ali pooblaščeni organi po potrebi prejmejo izvod izmenjanih informacij o značilnostih organa in darovalca v skladu s to direktivo.
Given the current variety of practices between Member States, it is not appropriate at this stage to provide for a standard form for the transmission of information on organ and donor characterisation in this Directive.
Glede na sedanje različne prakse v državah članicah ni ustrezno, da se na tej stopnji v tej direktivi uveljavi standardni obrazec za prenos informacij o značilnostih organa in darovalca.
However, in order to facilitate mutual understanding of the information transmitted, such a standard form should be developed in the future, in cooperation with the Member States.
Vendar bi bilo treba zaradi olajšanja medsebojnega razumevanja poslanih informacij tak standardni obrazec pripraviti v prihodnosti v sodelovanju z državami članicami.
A serious adverse event or reaction may be detected in a Member State of origin or destination and may be of concern for the quality and safety of the donated organs and as a consequence for the health of recipients, and in case of living donation also for the health of the donor.
V državi članici izvora organov ali državi članici prejemnici organov se lahko pojavijo resni neželeni dogodki ali učinki, ki lahko vplivajo na kakovost in varnost darovanih organov in posledično tudi na zdravje prejemnikov, v primeru živih darovalcev pa tudi na njihovo zdravje.
When organs are exchanged between Member States, such concerns may occur in different Member States.
Pri izmenjavi organov med državami članicami se taki dogodki ali učinki lahko pojavijo v različnih državah članicah.
Moreover, organs from one donor might be transplanted into recipients in different Member States so that, if a serious adverse event or reaction is first detected in one Member State of destination, the competent authorities or delegated bodies in the Member State of origin and in the other Member States of destination have to be informed.
Ker je organe enega darovalca mogoče presaditi v prejemnike v različnih državah članicah, morajo biti v primeru pojava resnega neželenega dogodka ali učinka v eni državi članici prejemnici o tem obveščeni pristojni ali pooblaščeni organi v državi članici izvora organa in v drugih državah članicah prejemnicah.
It is essential to ensure that all competent authorities or delegated bodies of all the Member States concerned are informed without undue delay.
Bistveno je zagotoviti, da se o tem nemudoma obvestijo vsi pristojni ali pooblaščeni organi iz vseh zadevnih držav članic.
In order to reach this objective, Member States should ensure that all relevant information is disseminated among all Member States concerned through a set of written reports.
Zato bi morale države članice zagotoviti, da vse zadevne informacije krožijo med vsemi zadevnimi državami članicami v obliki pisnih poročil.
Initial reports should be updated if additional relevant information becomes available.
Prva poročila bi bilo treba posodobiti, če so na voljo dodatne zadevne informacije.
The transmission of information is very often a matter of urgency.
Prenos informacij je zelo pogosto nujen.
It is essential that the senders of information are able to identify and inform rapidly the relevant addressees.
Bistveno je, da pošiljatelji informacij hitro določijo in obvestijo zadevne naslovnike.
The competent authorities or delegated bodies of a Member State should, where appropriate in accordance with the repartition of competence in the Member State concerned, transfer the information received pursuant to this Directive to the appropriate recipient.
Pristojni ali pooblaščeni organi države članice bi morali po potrebi glede na porazdelitev pristojnosti v zadevni državi članici ustreznemu prejemniku prenesti informacije, prejete v skladu s to direktivo.
A list of national contact points, including their contact details, should be made available at Union level and be constantly kept up to date.
Seznam nacionalnih kontaktnih točk, vključno s kontaktnimi podatki, bi moral biti na voljo na ravni Unije in se stalno posodabljati.
The measures provided for in this Directive are in accordance with the opinion of the Committee on organ transplantation, established under Article 30 of Directive 2010/53/EU,
Ukrepi, predvideni v tej direktivi, so v skladu z mnenjem Odbora za presaditve organov, ustanovljenega v skladu s členom 30 Direktive 2010/53/EU –
This Directive shall apply to the cross-border exchange of human organs intended for transplantation within the European Union.
Ta direktiva se uporablja za čezmejno izmenjavo človeških organov za presaditev v Evropski uniji.
In line with Article 29 of Directive 2010/53/EU, this Directive sets out:
V skladu s členom 29 Direktive 2010/53/EU določa ta direktiva naslednje:
procedures for the transmission of information on organ and donor characterisation;
postopke za pošiljanje informacij o značilnostih organa in darovalca;
procedures for the transmission of the necessary information to ensure the traceability of organs;
postopke za pošiljanje potrebnih informacij za zagotovitev sledljivosti organov;
procedures for ensuring the reporting of serious adverse events and reactions.
postopke za poročanje o resnih neželenih dogodkih in učinkih.
‘Member State of origin’ means the Member State where the organ is procured with the purpose of transplantation;
„država članica izvora“ pomeni državo članico, v kateri se pridobi organ za presaditev;
‘Member State of destination’ means the Member State to which the organ is sent for the purpose of transplantation;
„država članica prejemnica“ pomeni državo članico, v katero se pošlje organ za presaditev;
‘National donor/recipient identification number’ means the identification code attributed to a donor or a recipient in accordance with the identification system established at national level pursuant to Article 10(2) of Directive 2010/53/EU;
„nacionalna identifikacijska številka darovalca/prejemnika“ pomeni identifikacijsko oznako, dodeljeno darovalcu ali prejemniku v skladu z nacionalnim sistemom identifikacije v skladu s členom 10(2) Direktive 2010/53/EU;
‘Specification of the organ’ means (1) the anatomical description of an organ including: its type (e.g. heart, liver); (2) where applicable, its position (left or right) in the body; and (3) whether it is a whole organ or a part of an organ, mentioning the lobe or segment of the organ;
„specifikacija organa“ pomeni (1) anatomski opis organa, ki vključuje: vrsto organa (npr. srce, jetra), (2) po potrebi položaj v telesu (levo ali desno) in (3) podatek o tem, ali gre za cel organ ali njegov del z navedbo režnja, krila ali dela;
‘a delegated body’ means a body to which tasks have been delegated in accordance with Article 17(1) of Directive 2010/53/EU or a European organ exchange organisation to which tasks have been delegated in accordance with Article 21 of Directive 2010/53/EU.
„pooblaščeni organ“ pomeni organ, ki so mu bile dodeljene naloge v skladu s členom 17(1) Direktive 2010/53/EU, ali evropska organizacija za izmenjavo organov, ki so ji bile naloge dodeljene v skladu s členom 21 Direktive 2010/53/EU.
Common procedural rules
Skupna postopkovna pravila
Member States shall ensure that the information transmitted pursuant to this Directive between competent authorities or delegated bodies, procurement organisations and/or transplantation centres:
Države članice zagotovijo, da so informacije, ki si jih v skladu s to direktivo izmenjujejo pristojni ali pooblaščeni organi, organizacije za pridobivanje organov in/ali transplantacijski centri:
is transmitted in writing either electronically or by fax;
poslane v pisni obliki, in sicer elektronsko ali po telefaksu;
is written in a language mutually understood by the sender and the addressee or, in absence thereof, in a mutually agreed language, or, in absence thereof, in English;
napisane v jeziku, ki ga razumeta pošiljatelj in prejemnik, ali če to ni mogoče, v medsebojno dogovorjenem jeziku ali v angleščini;
is transmitted without undue delay;
nemudoma poslane;
is recorded and can be made available upon request;
evidentirane in so na voljo na zahtevo;
indicates the date and time of the transmission;
da sta navedena datum in ura prenosa informacij;
includes the contact details of the person responsible for the transmission;
da so vključeni kontaktni podatki o odgovorni osebi za pošiljanje informacij;
contains the following reminder:
da je vključeno naslednje opozorilo:
‘Contains personal data. To be protected against unauthorised disclosure or access.’.
„Vključuje osebne podatke, ki jih je treba zaščititi pred nepooblaščenim razkritjem ali dostopom.“
In case of urgencies, the information can be exchanged in a verbal form, in particular for exchanges pursuant to Articles 5 and 7.
V nujnih primerih se informacije lahko izmenjujejo v ustni obliki, zlasti pri izmenjavi informacij v skladu s členoma 5 in 7.
These verbal contacts must be followed by a transmission in writing in accordance with those Articles.
Tej ustni komunikaciji mora slediti prenos informacij v pisni obliki v skladu z navedenima členoma.
The Member States of destination or origin shall ensure that the receipt of the information transmitted in accordance with this Directive is confirmed to the sender, in accordance with the requirements set out in paragraph 1.
Države članice prejemnice ali države članice izvora zagotovijo, da se prejem informacij, prenesenih v skladu s to direktivo, prejemniku potrdi v skladu z zahtevami iz odstavka 1.
Member States shall ensure that designated personnel in competent authorities or delegated bodies:
Države članice zagotovijo, da je imenovano osebje v pooblaščenih ali pristojnih organih:
are available 24 hours a day and 7 days a week, for urgent situations;
za nujne primere na voljo 24 ur na dan, 7 dni na teden
are able to receive and transmit information pursuant to this Directive without undue delay.
in da lahko prejema ter nemudoma posreduje informacije v skladu s to direktivo.
Information on organ and donor characterisation
Informacije o značilnostih organa in darovalca
Member States shall ensure that, where organs are envisaged for exchange between Member States, prior to exchanging the organ, the competent authority or delegated body of the Member State of origin transmits the information collected to characterise the procured organs and the donor, as specified in Article 7 and in the Annex to Directive 2010/53/EU, to the competent authorities or delegated bodies of the potential Member States of destination.
Države članice zagotovijo, da pri predvideni izmenjavi organov med državami članicami pristojni ali pooblaščeni organ države članice izvora pred izmenjavo organa pošlje pristojnim ali pooblaščenim organom morebitnih držav članic prejemnic zbrane informacije o značilnostih pridobljenih organov in darovalcev v skladu s členom 7 in Prilogo k Direktivi 2010/53/EU.
Member States shall ensure that, where some of the information to be transmitted in accordance with paragraph 1 is not available at the time of the initial transmission and becomes available later, it is transmitted in due time to allow for medical decisions:
Kadar nekatere informacije, ki jih je treba poslati v skladu z odstavkom 1, ob prvem pošiljanju niso na voljo, ampak se jih pridobi naknadno, države članice zagotovijo pravočasen prenos teh informacij, da se lahko upoštevajo pri zdravstvenih odločitvah; te informacije pošlje:
by the competent authority or delegated body of the Member State of origin to the competent authority or delegated body of the Member State of destination; or
pristojni ali pooblaščeni organ države članice izvora pristojnemu ali pooblaščenemu organu države članice prejemnice ali
directly by the procurement organisation to the transplantation centre.
neposredno organizacija za pridobivanje organov transplantacijskemu centru.
Member States shall take appropriate measures to ensure that procurement organisations and transplantation centres transmit to their respective competent authorities or delegated bodies a copy of the information pursuant to this Article.
Države članice sprejmejo ustrezne ukrepe za zagotovitev, da organizacije za pridobivanje organov in transplantacijski centri pošljejo izvod informacij svojim pristojnim ali pooblaščenim organom v skladu s tem členom.
Information to ensure the traceability of organs
Informacije za zagotovitev sledljivosti organov
Member States shall ensure that the competent authority or delegated body of the Member State of origin inform the competent authority or delegated body of the Member State of destination of:
Države članice zagotovijo, da pristojni ali pooblaščeni organ države članice izvora obvesti pristojni ali pooblaščeni organ države članice prejemnice o:
the specification of the organ;
specifikaciji organa;
the national donor identification number;
nacionalni identifikacijski številki darovalca;
the date of procurement;
datumu pridobitve organa;
name and contact details of the procurement centre.
imenu in kontaktnih podatkih centra za pridobivanje organov.
Member States shall ensure that the competent authority or delegated body of the Member State of destination inform the competent authority or delegated body of the Member State of origin of:
Države članice zagotovijo, da pristojni ali pooblaščeni organ države članice prejemnice obvesti pristojni ali pooblaščeni organ države članice izvora o:
the national recipient identification number or, if the organ was not transplanted, of its final use;
nacionalni identifikacijski številki prejemnika ali če organ ni bil presajen, o končni uporabi;
the date of transplantation, if applicable;
datumu presaditve, če je ustrezno;
name and contact details of the transplantation centre.
imenu in kontaktnih podatkih transplantacijskega centra.
Reporting of serious adverse events and reactions
Poročanje o resnih neželenih dogodkih in učinkih
Member States shall ensure that the following procedure is implemented by their competent authorities or delegated bodies:
Države članice zagotovijo, da njihovi pristojni ali pooblaščeni organi izvajajo naslednji postopek:
Whenever the competent authority or delegated body of the Member State of destination is notified of a serious adverse event or reaction that it suspects to relate to an organ that was received from another Member State, it shall immediately inform the competent authority or delegated body of the Member State of origin and transmit without undue delay to that competent authority or delegated body an initial report containing the information set out in Annex I, in so far as this information is available.
kadar je pristojni ali pooblaščeni organ države članice prejemnice obveščen o resnem neželenem dogodku ali učinku, za katerega sumi, da je povezan s človeškim organom, ki ga je prejel iz druge države članice, o tem takoj obvesti pristojni ali pooblaščeni organ države članice izvora in mu nemudoma pošlje prvo poročilo z informacijami iz Priloge I, če so te informacije na voljo;
The competent authority or delegated body of the Member State of origin shall immediately inform the competent authorities or delegated bodies of each concerned Member State of destination and transmit them each an initial report containing the information set out in Annex I, whenever it is notified of a serious adverse event or reaction that it suspects to be related to a donor whose organs were also sent to other Member States.
če je pristojni ali pooblaščeni organ države članice izvora obveščen o resnem neželenem dogodku ali učinku, za katerega sumi, da je povezan z darovalcem, katerega organi so bili poslani tudi v druge države članice, o tem nemudoma obvesti pristojne ali pooblaščene organe vsake zadevne države članice prejemnice in jim pošlje prvo poročilo z informacijami iz Priloge I;
When additional information becomes available following the initial report, it shall be transmitted without undue delay.
če so po poslanem prvem poročilo na voljo dodatne informacije, se te nemudoma pošljejo;
The competent authority or delegated body of the Member State of origin shall, as a rule within three months of the initial report transmitted pursuant to point (a) or (b), transmit to the competent authorities or delegated bodies of all Member States of destination, a common final report containing the information set out in Annex II.
pristojni ali pooblaščeni organ države članice izvora praviloma v 3 mesecih po prvem poročilu, poslanem v skladu s točko (a) ali (b), pošlje pristojnim ali pooblaščenim organom vseh držav članic prejemnic skupno končno poročilo z informacijami iz Priloge II.
The competent authorities or delegated bodies of the Member States of destination shall provide relevant information in a timely manner to the competent authority or delegated body of the Member State of origin.
Pristojni ali pooblaščeni organi držav članic prejemnic pravočasno pošljejo zadevne informacije pristojnim ali pooblaščenim organom države članice izvora.
The final report shall be drawn up after collecting relevant information from all Member States involved.
Končno poročilo se pripravi po končanem zbiranju ustreznih informacij iz vseh vpletenih držav članic.
Interconnection between Member States
Povezanost držav članic
Member States shall communicate to the Commission the contact details of the competent authority or delegated bodies to which the relevant information shall be transmitted for the purpose of, on the one hand, Article 5, and, on the other hand, Articles 6 and 7.
Države članice sporočijo Komisiji kontaktne podatke pristojnih ali pooblaščenih organov, ki jim je treba poslati ustrezne informacije za izvajanje člena 5 ter za izvajanje členov 6 in 7.
These contact details include at least the following data: the organisation’s name, telephone number, e-mail address, fax number and postal address.
Ti kontaktni podatki morajo vključevati vsaj naslednje podatke: ime organizacije, telefonsko številko, elektronski naslov, številko telefaksa in poštni naslov.
Where a Member State has several competent authorities or delegated bodies, it shall ensure that the information received by one of them pursuant to Article 5, 6 or 7 is forwarded to the appropriate competent authority or delegated body at national level, in accordance with the repartition of competences in that Member State.
Če ima država članica več pristojnih ali pooblaščenih organov, zagotovi, da se informacije, ki jih prejme eden od organov v skladu s členi 5, 6 ali 7, posredujejo ustreznemu nacionalnemu pristojnemu ali pooblaščenemu organu v skladu z razdelitvijo pristojnosti v navedeni državi članici.
The Commission shall make available to the Member States a list of all competent authorities and delegated bodies designated by Member States in accordance with paragraph 1.
Komisija da državam članicam na voljo seznam vseh pristojnih in pooblaščenih organov, ki so jih države članice imenovale v skladu z odstavkom 1.
The Member States shall keep the information in that list up to date.
Države članice posodabljajo navedeni seznam.
The Commission may entrust the establishment and maintenance of this list to a third party.
Komisija lahko vzpostavitev in vzdrževanje tega seznama zaupa tretji strani.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 10 April 2014 at the latest.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 10. aprila 2014.
Member States shall determine how such reference is to be made.
Države članice določijo način takega sklicevanja.
Done at Brussels, 9 October 2012.
V Bruslju, 9. oktobra 2012
OJ L 207, 6.8.2010, p. 14, corrected by OJ L 243, 16.9.2010, p. 68.
UL L 207, 6.8.2010, str. 14, popravljena v UL L 243, 16.9.2010, str. 68.
Initial Report for suspected serious adverse events or reactions
Prvo poročilo o sumih na resne neželene dogodke ali učinke
Reporting Member State
Država članica poročevalka
Report identification number: country (ISO)/national number
Identifikacijska številka poročila: država (ISO)/nacionalna številka
Contact details of the reporter (competent authority or delegated body in the reporting Member State): telephone, e-mail and, when available, fax
Kontaktni podatki o poročevalcu (pristojni ali pooblaščeni organ v državi članici poročevalki): telefon, e-pošta in telefaks, če je na voljo.
Reporting centre/organisation
Center/organizacija, ki poroča
Contact details of coordinator/contact person (transplant/procurement centre in the reporting Member State): telephone, e-mail and, when available, fax
Kontaktni podatki koordinatorja/kontaktne osebe (transplantacijski center/center za pridobivanje organov v državi članici poročevalki): telefon, e-pošta in telefaks, če je na voljo.
Reporting date and time (yyyy/mm/dd/hh/mm)
Datum in ura poročila (llll/mm/dd/hh/mm)
Member State of origin
Država članica izvora
National donor identification number, as communicated under Article 6
Nacionalna identifikacijska številka darovalca v skladu s členom 6
All Member States of destination (if known)
Vse države članice prejemnice (če so znane)
National recipient identification number(s), as communicated under Article 6
Nacionalne identifikacijske številke prejemnikov v skladu s členom 6
Onset date and time of serious adverse event or reaction (yyyy/mm/dd/hh/mm)
Datum in čas pojava resnega neželenega dogodka ali učinka (llll/mm/dd/hh/mm)
Detection date and time of serious adverse event or reaction (yyyy/mm/dd/hh/mm)
Datum in čas ugotovitve resnega neželenega dogodka ali učinka (llll/mm/dd/hh/mm)
Description of serious adverse event or reaction
Opis resnega neželenega dogodka ali učinka
Immediate measures taken/proposed
Takojšnji/predlagani ukrepi
Final Report of serious adverse events or reactions
Končno poročilo o resnih neželenih dogodkih ali učinkih
Contact details of the reporter: telephone, e-mail and, when available, fax
Kontaktni podatki o poročevalcu: telefon, e-pošta in telefaks, če je na voljo.
Identification number(s) of initial report(s) (Annex I)
Identifikacijske številke prvih poročil (Priloga I)