natgillin/translations-raw huggingface dataset:
Where appropriate, experts on organ transplantation, representatives from European organ exchange organisations, as well as data protection supervisory authorities and other relevant parties may be associated with this network.
Kadar je primerno, se lahko strokovnjaki za presajanje organov, predstavniki evropskih organizacij za izmenjavo organov, nadzorni organi za varovanje podatkov in druge zadevne strani vključijo v to mrežo.
ORGAN EXCHANGE WITH THIRD COUNTRIES AND EUROPEAN ORGAN EXCHANGE ORGANISATIONS
IZMENJAVA ORGANOV S TRETJIMI DRŽAVAMI IN EVROPSKE ORGANIZACIJE ZA IZMENJAVO ORGANOV
Organ exchange with third countries
Izmenjava organov s tretjimi državami
Member States shall ensure that organ exchange with third countries is supervised by the competent authority.
Države članice zagotovijo, da izmenjavo organov s tretjimi državami članicami v obe smeri nadzira pristojni organ.
For this purpose, the competent authority and European organ exchange organisations may conclude agreements with counterparts in third countries.
V ta namen lahko pristojni organ in evropske organizacije za izmenjavo organov sklenejo sporazume z ustreznimi organi v tretjih državah.
The supervision of organ exchange with third countries may be delegated by the Member States to European organ exchange organisations.
Za nadzor nad izmenjavo organov s tretjimi državami lahko države članice pooblastijo evropske organizacije za izmenjavo organov.
Organ exchange, as referred to in paragraph 1, shall be allowed only where the organs:
Izmenjava organov iz odstavka 1 je dovoljena samo, kadar:
can be traced from the donor to the recipient and vice versa;
je organe mogoče slediti od darovalca do prejemnika in obratno;
meet quality and safety requirements equivalent to those laid down in this Directive.
organi izpolnjujejo enake zahteve glede kakovosti in varnosti, kot so določene v tej direktivi.
European organ exchange organisations
Evropske organizacije za izmenjavo organov
Member States may conclude or allow a competent authority to conclude agreements with European organ exchange organisations, provided that such organisations ensure compliance with the requirements laid down in this Directive, delegating to those organisations, inter alia:
Države članice lahko sklepajo sporazume ali pristojnemu organu dovolijo sklenitev sporazumov z evropskimi organizacijami za izmenjavo organov, pod pogojem, da takšne organizacije zagotavljajo izpolnjevanje zahtev iz te direktive, in te organizacije med drugim pooblastijo za:
the performance of activities provided for under the framework for quality and safety;
izvajanje dejavnosti, ki jih predvideva okvir za kakovost in varnost;
specific tasks in relation to the exchanges of organs to and from Member States and third countries.
posebne naloge v zvezi z izmenjavo organov v države članice in tretje države ter iz njih.
Reports concerning this Directive
Poročila v zvezi s to direktivo
Member States shall report to the Commission before 27 August 2013 and every three years thereafter on the activities undertaken in relation to the provisions of this Directive, and on the experience gained in implementing it.
Države članice Komisiji do 27. avgusta 2013 in nato vsaka tri leta poročajo o izvedenih dejavnostih v zvezi z določbami te direktive ter o izkušnjah, ki so jih pridobile pri njenem izvajanju.
Before 27 August 2014 and every three years thereafter, the Commission shall transmit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, a report on the implementation of this Directive.
Komisija do 27. avgusta 2014 in nato vsaka tri leta pošlje Evropskemu parlamentu, Svetu, Evropskemu ekonomsko-socialnemu odboru in Odboru regij poročilo o izvajanju te direktive.
Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that the penalties are implemented.
Države članice določijo pravila o kaznih, ki se uporabljajo za kršitve nacionalnih predpisov, sprejetih na podlagi te direktive, in sprejmejo vse ukrepe, potrebne za zagotovitev izvrševanja teh kazni.
Member States shall notify those provisions to the Commission by 27 August 2012 and shall notify it without delay of any subsequent amendments affecting them.
Države članice uradno obvestijo Komisijo o navedenih predpisih do 27. avgusta 2012 in jo brez odlašanja uradno obvestijo tudi o vseh poznejših spremembah navedenih predpisov.
The Commission may adopt delegated acts in accordance with Article 25 and subject to the conditions of Articles 26, 27 and 28 in order to:
Komisija lahko sprejme delegirane akte v skladu s členom 25 in pod pogoji iz členov 26, 27 in 28 z namenom da:
supplement or amend the minimum data set specified in Part A of the Annex only in exceptional situations where it is justified by a serious risk to human health considered as such on the basis of the scientific progress;
dopolni ali spremeni sklop minimalnih podatkov, določen v delu A Priloge, le v izrednih primerih, kadar je to upravičeno zaradi hude nevarnosti za človekovo zdravje, ki je kot taka opredeljena na podlagi znanstvenega napredka;
supplement or amend the complementary data set specified in Part B of the Annex in order to adapt it to scientific progress and international work carried out in the field of quality and safety of organs intended for transplantation.
dopolni ali spremeni sklop dodatnih podatkov, določen v delu B Priloge, da se ga prilagodi znanstvenemu napredku in mednarodnemu delu na področju kakovosti in varnosti organov, namenjenih za presaditev.
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 26.
Prenos pooblastila se samodejno podaljša za enako obdobje, razen če Evropski parlament ali Svet pooblastilo prekliče v skladu s členom 26.
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 26 and 27.
Pooblastilo za sprejemanje delegiranih aktov je prenešeno na Komisijo pod pogoji, določenimi v členih 26 in 27.
Where, in the case of the emergence of new serious risk to human health, imperative grounds of urgency so require, the procedure provided for in Article 28 shall apply to delegated acts adopted pursuant to Article 24(a).
V primeru pojava nove hude nevarnosti za človekovo zdravje in kadar tako zahtevajo razlogi nujnosti, se za delegirane akte, sprejete na podlagi točke (a) člena 24, uporabi postopek iz člena 28.
The delegation of powers referred to in Article 24 may be revoked at any time by the European Parliament or by the Council.
Pooblastilo iz člena 24 lahko kadar koli prekliče Evropski parlament ali Svet.
Objection to delegated acts
Nasprotovanje delegiranim aktom
Urgency procedure
Postopek v nujnih primerih
Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2.
Delegirani akti, sprejeti po tem členu, začnejo veljati nemudoma in se uporabljajo, dokler ni izraženo nasprotovanje v skladu z odstavkom 2.
The notification of a delegated act adopted under this Article to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.
Uradno obvestilo Evropskemu parlamentu in Svetu o sprejetju delegiranega akta po tem členu utemelji uporabo postopka v nujnih primerih.
The European Parliament or the Council may object to a delegated act adopted under this Article in accordance with the procedure referred to in Article 27(1).
2. Evropski parlament ali Svet lahko nasprotuje delegiranemu aktu, sprejetemu po tem členu, v skladu s postopkom iz člena 27(1).
In such a case, the act shall cease to apply.
V takem primeru se delegirani akt preneha uporabljati.
The institution which objects to such a delegated act shall state its reasons therefor.
Institucija, ki nasprotuje takemu delegiranemu aktu, navede svoje razloge za nasprotovanje.
The Commission shall adopt, where organs are exchanged between Member States, detailed rules for the uniform implementation of this Directive in accordance with the procedure referred to in Article 30(2), on the following:
Kadar gre za izmenjavo organov med državami članicami, Komisija v skladu s postopkom iz člena 30(2) sprejme podrobna pravila za enotno izvajanje te direktive glede:
procedures for the transmission of information on organ and donor characterisation as specified in the Annex in accordance with Article 7(6);
postopkov za posredovanje informacij o značilnostih organa in darovalca, kot je določeno v Prilogi, v skladu s členom 7(6);
procedures for the transmission of the necessary information to ensure the traceability of organs in accordance with Article 10(4);
postopkov za posredovanje potrebnih informacij za zagotovitev sledljivosti organov v skladu s členom 10(4);
procedures for ensuring the reporting of serious adverse events and reactions in accordance with Article 11(4).
postopkov za zagotavljanje poročanja o hudih neželenih dogodkih in reakcijah v skladu s členom 11(4).
The Commission shall be assisted by the Committee on organ transplantation, hereinafter referred to as ‘the Committee’.
Komisiji pomaga Odbor za presaditve organov, v nadaljnjem besedilu: Odbor.
The period laid down to in Article 5(6) of Decision 1999/468/EC shall be set at three months.
Rok iz člena 5(6) Sklepa 1999/468/ES je tri mesece.
This Directive shall not prevent any Member State from maintaining or introducing more stringent rules, provided that they comply with the provisions of the Treaty on the Functioning of the European Union.
Ta direktiva nobeni državi članici ne preprečuje ohranjanja ali uvajanja strožjih zaščitnih ukrepov pod pogojem, da so ti v skladu z določbami Pogodbe o delovanju Evropske unije.
OJ C 306, 16.12.2009, p. 64.
UL C 306, 16.12.2009, str. 64.
OJ C 192, 15.8.2009, p. 6.
UL C 192, 15.8.2009, str. 6.
Position of the European Parliament of 19 May 2010 (not yet published in the Official Journal) and decision of the Council of 29 June 2010.
Stališče Evropskega parlamenta z dne 19. maja 2010 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 29. junija 2010.
ORGAN AND DONOR CHARACTERISATION
DOLOČANJE ZNAČILNOSTI ORGANA IN DAROVALCA
Minimum data set
Sklop minimalnih podatkov
Minimum data – information for the characterisation of organs and donors, which has to be collected for each donation in accordance with second subparagraph of Article 7(1) and without prejudice to Article 7(2).
Minimalni podatki so informacije o značilnosti organov in darovalcev, ki jih je treba zbrati pri vsakem darovanju v skladu z drugim pododstavkom člena 7(1) in brez poseganja v člen 7(2).
The establishment where the procurement takes place and other general data
Ustanova, kjer poteka pridobivanje, in drugi splošni podatki
Type of donor
Vrsta darovalca
Blood group
Krvna skupina
Cause of death
Vzrok smrti
Date of death
Datum smrti
Date of birth or estimated age
Datum rojstva ali ocenjena starost
Past or present history of IV drug abuse
Intravenozna uporaba drog (sedaj ali v preteklosti)
Past or present history of malignant neoplasia
Maligna neoplazija (sedaj ali v preteklosti)
Present history of other transmissible disease
Druge prenosljive bolezni (sedaj)
HIV; HCV; HBV tests
Testi za HIV; HCV; HBV
Basic information to evaluate the function of the donated organ
Osnovne informacije za oceno delovanja darovanega organa
Complementary data set
Sklop dodatnih podatkov
Complementary data – information for the characterisation of organs and donors to be collected in addition to minimum data specified in Part A, based on the decision of the medical team, taking into account the availability of such information and the particular circumstances of the case, in accordance with the second subparagraph of Article 7(1).
Dodatni podatki so informacije o značilnosti organov in darovalcev, ki jih je treba zbrati poleg minimalnih podatkov, določenih v delu A, na podlagi odločitve medicinske ekipe ob upoštevanju razpoložljivosti teh informacij ter posebnih okoliščin primera, v skladu z drugim pododstavkom člena 7(1).
Contact details of the procurement organisation/the establishment where the procurement takes place necessary for coordination, allocation and traceability of the organs from donors to recipients and vice versa.
Kontaktni podatki organizacije za pridobivanje/ustanove, kjer poteka pridobivanje, ki so potrebni za usklajevanje, dodelitev in sledljivost organov od darovalcev do prejemnikov in obratno.
Donor data
Podatki o darovalcu
Demographic and anthropometrical data required in order to guarantee an appropriate matching between the donor/organ and the recipient.
Demografski in antropometrični podatki, ki so potrebni za potrditev ujemanja med darovalcem/organom in prejemnikom.
Donor medical history
Zdravstvena anamneza darovalca
Medical history of the donor, in particular the conditions which might affect the suitability of the organs for transplantation and imply the risk of disease transmission.
Zdravstvena anamneza darovalca, zlasti stanj, ki bi lahko vplivala na primernost organov za presaditev in pomenila tveganje prenosa bolezni.
Physical and clinical data
Fizični in klinični podatki
Data from clinical examination which are necessary for the evaluation of the physiological maintenance of the potential donor as well as any finding revealing conditions which remained undetected during the examination of the donor’s medical history and which might affect the suitability of organs for transplantation or might imply the risk of disease transmission.
Podatki kliničnega pregleda, ki so potrebni za oceno fiziološkega stanja morebitnega darovalca, ter kakršna koli odkrita stanja, ki so ostala neopažena med pregledom zdravstvene anamneze darovalca in ki bi lahko vplivala na primernost organov za presaditev ali bi lahko pomenila tveganje prenosa bolezni.
Laboratory parameters
Parametri laboratorija
Data needed for the assessment of the functional characterisation of the organs and for the detection of potentially transmissible diseases and of possible contraindications with respect to organ donation.
Podatki, ki so potrebni za oceno funkcionalnih značilnosti organov in za odkrivanje potencialno prenosljivih bolezni in možnih kontraindikacij v zvezi z darovanjem organa.
Image tests
Slikovne preiskave
Image explorations necessary for the assessment of the anatomical status of the organs for transplantation.
Uporaba slikovnih raziskav, potrebnih za oceno anatomskega stanja organov za presaditev.
Therapy
Zdravljenje
Treatments administered to the donor and relevant for the assessment of the functional status of the organs and the suitability for organ donation, in particular the use of antibiotics, inotropic support or transfusion therapy.
Zdravljenje, ki ga prejme darovalec in je pomembno za oceno delovanja organov ter primernost organa za darovanje, zlasti uporaba antibiotikov, inotropne podpore ali zdravljenje s transfuzijo.
Statement of the European Parliament, the Council and the Commission on Article 290 TFEU
Izjava Evropskega parlamenta, Sveta in Komisije o členu 290 PDEU
The European Parliament, the Council and the Commission declare that the provisions of this Directive shall be without prejudice to any future position of the institutions as regards the implementation of Article 290 TFEU or individual legislative acts containing such provisions.
Evropski parlament, Svet in Komisija izjavljajo, da določbe te direktive ne vplivajo na nobeno prihodnje stališče institucij glede izvajanja člena 290 PDEU ali posameznih zakonodajnih aktov, ki vsebujejo takšne določbe.
Statement of the European Commission (Urgency)
Izjava Evropske komisije (nujni primeri)
The European Commission undertakes to keep the European Parliament and the Council fully informed on the possibility of a delegated act being adopted under the urgency procedure.
Evropska komisija se zavezuje, da bo Evropski parlament in Svet v celoti obveščala o možnosti sprejetja delegiranih aktov v nujnih primerih.
As soon as the Commission’s services foresee that a delegated act might be adopted under the urgency procedure, they will informally warn the secretariats of the European Parliament and of the Council.
Takoj ko službe Komisije predvidijo možnost, da bi lahko bil delegirani akt sprejet na podlagi postopka za nujne primere, na to neuradno opozorijo sekretariat Evropskega parlamenta in Sveta.
The power to adopt the delegated acts referred to in Article 24 shall be conferred on the Commission for a period of five years following 27 August 2010.
Pooblastilo za sprejemanje delegiranih aktov iz člena 24 se prenese na Komisijo za obdobje petih let z začetkom 27. avgusta 2010.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 27 August 2012.
Države članice uveljavijo zakone in druge predpise, potrebne za uskladitev s to direktivo, do 27. avgusta 2012.
Corrigendum to Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation
Popravek Direktive 2010/45/EU Evropskega parlamenta in Sveta z dne 7. julija 2010 o standardih kakovosti in varnosti človeških organov, namenjenih za presaditev
(Official Journal of the European Union L 207 of 6 August 2010)
(Uradni list Evropske unije L 207 z dne 6. avgusta 2010)
On the cover, in the title:
Naslovna stran, naslov direktive:
‘Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 …’,
„Direktiva 2010/45/EU Evropskega parlamenta in Sveta z dne 7. julija 2010 …“
‘Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 …’;
„Direktiva 2010/53/EU Evropskega parlamenta in Sveta z dne 7. julija 2010 …“.
on page 14, in the title of the Directive:
Stran 14, naslov direktive:
‘DIRECTIVE 2010/45/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 July 2010 …’,
„DIREKTIVA 2010/45/EU EVROPSKEGA PARLAMENTA IN SVETA z dne 7. julija 2010 …“
‘DIRECTIVE 2010/53/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 July 2010 …’.
„DIREKTIVA 2010/53/EU EVROPSKEGA PARLAMENTA IN SVETA z dne 7. julija 2010 …“.
Commission Directive 2010/54/EU
Direktiva Komisije 2010/54/EU
amending Annex I to Council Directive 91/414/EEC to renew the inclusion of azimsulfuron as active substance
o spremembi Priloge I k Direktivi Sveta 91/414/EGS zaradi podaljšanja vključitve azimsulfurona kot aktivne snovi
That notification was found to be admissible by Commission Decision 2008/656/EC of 28 July 2008 on the admissibility of the notifications concerning the renewal of the inclusion in Annex I to Council Directive 91/414/EEC of the active substances azimsulfuron, azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl, prohexadion-calcium and spiroxamin, and establishing the list of the notifiers concerned [3].
Navedena prijava je bila ugotovljena za sprejemljivo z Odločbo Komisije 2008/656/ES z dne 28. julija 2008 o sprejemljivosti prijav za podaljšanje uvrstitve aktivnih snovi azimsulfuron, azoksistrobin, fluroksipir, imazalil, kresoksim-metil, proheksadion-kalcij in spiroksamin v Prilogo I k Direktivi Sveta 91/414/EGS in oblikovanju seznama zadevnih prijaviteljev [3].
Within the time period provided for in Article 6 of Regulation (EC) No 737/2007, the notifier submitted the data required in accordance with Article 6 of Regulation (EC) No 737/2007 together with an explanation as regards the relevance of each new study submitted.
Prijavitelj je v skladu s členom 6 Uredbe (ES) št. 737/2007 predložil zahtevane podatke v roku iz člena 6 Uredbe (ES) št. 737/2007 skupaj s pojasnilom o pomenu vsake nove predložene študije.
The Authority communicated the assessment report to the notifier and to all the Member States and forwarded the comments received to the Commission.
Agencija je prijavitelju in vsem državam članicam poslala poročilo o oceni ter Komisiji posredovala prejete pripombe.
The Authority also made the assessment report available to the public.
Agencija je dala poročilo o oceni tudi na voljo javnosti.
At the request of the Commission, the assessment report was peer reviewed by the Member States and the Authority, and the Authority presented its conclusion on the peer review of the risk assessment of azimsulfuron [4] to the Commission on 12 March 2010.
Na zahtevo Komisije so poročilo o oceni pregledali strokovnjaki držav članic in Agencije, Agencija pa je 12. marca 2010 Komisiji predložila sklep o strokovnem pregledu ocene nevarnosti azimsulfurona [4].
The assessment report and the conclusion from the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 9 July 2010 in the format of the Commission review report for azimsulfuron.
Poročilo o oceni in sklep Agencije so države članice in Komisija pregledale v Stalnem odboru za prehranjevalno verigo in zdravje živali ter končno različico pripravile 9. julija 2010 v obliki poročila Komisije o pregledu za azimsulfuron.
It has appeared from the various examinations made that plant protection products containing azimsulfuron may be expected to continue to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo azimsulfuron, lahko pričakuje, da še naprej na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti za uporabe, ki so bile obravnavane in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to renew the inclusion of azimsulfuron in Annex I to Directive 91/414/EEC, in order to ensure that plant protection products containing this active substance may continue to be authorised where they comply with that Directive.
Zato je primerno podaljšati vključitev azimsulfurona v Prilogo I k Direktivi 91/414/EGS, da so fitofarmacevtska sredstva, ki vsebujejo to aktivno snov, lahko še naprej registrirana, kadar so skladna z navedeno direktivo.
Based on the review report which points out that the manufacturing impurity phenol is of toxicological concern a maximum level of 2 g/kg should, however, be set for that impurity in the technical material.
Na podlagi poročila o pregledu, po katerem je proizvodna nečistoča fenol toksikološko zaskrbljiva, je za navedeno nečistočo treba določiti zgornjo mejo 2 g/kg v tehničnem materialu.
From the new data submitted, it appears that azimsulfuron and its degradation products in aqueous photolysis may cause risks for aquatic organisms.
Iz novih predloženih podatkov je videti, da azimsulfuron in njegovi razgradni produkti v vodni fotolizi lahko povzročajo tveganje za vodne organizme.
Without prejudice to the conclusion that the inclusion of azimsulfuron is to be renewed, it is therefore appropriate to obtain further information on those specific points.
Brez poseganja v sklep, da je treba podaljšati vključitev azimsulfurona, je zato primerno pridobiti dodatne podatke o navedenih točkah.
Therefore it is appropriate to require that the notifier submit further information as regards the assessment of the risks azimsulfuron may pose for aquatic organisms and to complete the identification of its degradation products in aqueous photolysis.
Zato je primerno zahtevati, da prijavitelj predloži dodatne podatke o oceni tveganja pri azimsulfuronu za vodne organizme in dopolnjeno ugotovitev njegovih razgradnih produktov v vodni fotolizi.
A reasonable period should be allowed to elapse before the inclusion of an active substance in Annex I to Directive 91/414/EEC is renewed in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the renewal.
Določiti je treba ustrezen rok pred podaljšanjem vključitve aktivne snovi v Prilogo I k Direktivi 91/414/EGS, da se državam članicam in zainteresiranim stranem omogoči, da se pripravijo na izpolnjevanje novih zahtev pri podaljšanju.