natgillin/translations-raw huggingface dataset:
In order to guarantee that the Network has genuine European Union added value and is big enough to enable the sharing of expertise and to improve access to care for patients across the Union, only applications from the minimum required numbers of healthcare providers and Member States, submitted in line with the call of interest, should be approved.
Da se zagotovi, da ima mreža dejansko dodano vrednost Evropske unije in je dovolj velika, da omogoča izmenjavo strokovnega znanja ter izboljšuje dostop do zdravstvene oskrbe za paciente po vsej Uniji, bi bilo treba odobriti samo vloge od najmanjšega potrebnega števila izvajalcev zdravstvenega varstva in držav članic, poslane v skladu z razpisom za prijavo interesa.
If an insufficient number of healthcare providers apply or applications cover an insufficient number of Member States, the Commission should ask Member States to encourage their healthcare providers to join the proposed Network.
Če se ne prijavi zadostno število izvajalcev zdravstvenega varstva ali vloge ne zajemajo zadostnega števila držav članic, bi morala Komisija pozvati države članice, naj spodbujajo svoje izvajalce zdravstvenega varstva, da se pridružijo predlagani mreži.
It might be difficult to reach the required minimum number of healthcare providers or Member States for some rare diseases or conditions due to a lack of expertise.
Zaradi pomanjkanja strokovnega znanja je mogoče, da bo za nekaj redkih bolezni ali stanj težko doseči najmanjše zahtevano število izvajalcev zdravstvenega varstva ali držav članic.
It would therefore be a good idea to group healthcare providers that focus on related rare diseases or conditions in a thematic Network.
Zato bi bilo koristno, če bi se izvajalci zdravstvenega varstva, ki so osredotočeni na sorodne redke bolezni ali stanja, združili v tematsko mrežo.
Networks could also include providers of high technology services which usually require very high capital investment, such as laboratories, radiology services or nuclear medicine services.
Mreže bi lahko zajemale tudi izvajalce visokotehnoloških storitev, ki običajno zahtevajo zelo visoke kapitalske naložbe, kot so laboratoriji, radiološke storitve ali storitve nuklearne medicine.
Member States none of whose healthcare providers are Members of a Network should designate collaborative and associated national centres to encourage them to cooperate with the relevant Network.
Države članice, ki nimajo nobenega izvajalca zdravstvenega varstva, ki bi bil član mreže, bi morale določiti sodelujoče in povezane nacionalne centre, da bi izvajalce spodbudili k sodelovanju z zadevno mrežo.
Each Network's and healthcare provider's application, once their completeness has been established, should be technically assessed according to the criteria set out in Delegated Decision 2014/286/EU.
Vsako vlogo mreže in izvajalca zdravstvenega varstva bi bilo po ugotovljeni popolnosti vloge treba oceniti s tehničnega vidika po merilih iz Delegiranega sklepa 2014/286/EU.
The assessment should, on the basis of a common assessment manual, include an exhaustive documentation review and on-site audits of a selected number of applicants.
Na podlagi skupnega priročnika za ocenjevanje bi morala ocena vključevati izčrpen pregled dokumentacije in revizij na kraju samem izbranega števila kandidatov.
It should be carried out by an independent assessment body appointed by the Commission.
Opraviti bi jo moral neodvisni organ za ocenjevanje, ki ga imenuje Komisija.
Member States are invited to set up a Board of Member States which should decide on the approval of proposed Networks and on their membership.
Države članice so pozvane, da ustanovijo odbor držav članic, ki bi moral odločati o odobritvi predlaganih mrež in njihovem članstvu.
Member States' participation should be voluntary.
Sodelovanje držav članic bi moralo biti prostovoljno.
Only a positive assessment issued by an assessment body should generally prompt Member States to approve the establishment of a Network and to grant membership of the Network.
Samo pozitivna ocena, ki jo je izdal organ za ocenjevanje, bi morala na splošno spodbuditi države članice, da odobrijo ustanovitev mreže in članstvo v njej.
Networks' Members should be licensed to use the ‘European Reference Network’ logo.
Člani mrež bi morali imeti licenco za uporabo logotipa „evropska referenčna mreža“.
The logo, owned by the European Union, should constitute the visual identity of the Networks and their Members.
Logotip, ki je last Evropske unije, bi moral predstavljati vizualno podobo mrež in njihovih članov.
Using a common evaluation manual, an independent evaluation body appointed by the Commission should periodically evaluate Networks and their Members.
Neodvisni organ za vrednotenje, ki ga imenuje Komisija, bi moral občasno vrednotiti mreže in njihove člane ter pri tem uporabljati skupni priročnik za vrednotenje.
The evaluation should conclude with a technical evaluation report detailing the extent to which the objectives set out in Article 12(2) of Directive 2011/24/EU have been achieved and the criteria and conditions set out in Delegated Decision 2014/286/EU fulfilled.
Vrednotenje bi se moralo končati s poročilom o tehničnem vrednotenju, v katerem bi bilo podrobno navedeno, v kolikšni meri so bili cilji iz člena 12(2) Direktive 2011/24/EU doseženi ter merila in pogoji iz Delegiranega sklepa 2014/286/EU izpolnjeni.
It should also describe the outcomes and performance of the Network and the contribution of its Members.
V poročilu bi morali biti opisani tudi rezultati in uspešnost mreže ter prispevek njenih članov.
A negative evaluation report should generally prompt Member States to approve the termination of a Network.
Negativno poročilo o vrednotenju bi na splošno moralo spodbuditi države članice, da odobrijo prenehanje delovanja mreže.
Compliance with the requirement to have a minimum number of healthcare providers and Member States should be monitored after the evaluation so that the European Union added value of the Network can be maintained.
Skladnost z zahtevo po najmanjšem potrebnem številu izvajalcev zdravstvenega varstva in držav članic bi bilo treba spremljati po vrednotenju, tako da se lahko ohrani mrežina dodana vrednost Evropske unije.
The assessment and evaluation manuals should be based on internationally recognised practices and contain the core principles and methodologies for carrying out assessments and evaluations.
Priročnika za ocenjevanje in vrednotenje bi morala temeljiti na mednarodno priznanih praksah in vsebovati temeljna načela in metodologije za izvedbo ocen in vrednotenj.
The Commission should facilitate the exchange of information and expertise on establishing and evaluating the Networks.
Komisija bi morala olajšati izmenjavo informacij in strokovnega znanja o ustanavljanju in vrednotenju mrež.
It should make general information on the Networks and their Members and the technical documentation and manuals on establishing and evaluating the Networks and their Members available to the public.
Splošne informacije o mrežah in njihovih članih ter tehnično dokumentacijo in priročnike o ustanavljanju in vrednotenju mrež in njihovih članov bi morala dati na voljo javnosti.
It may offer to the Networks and their Members the use of specific communication media and tools.
Mrežam in njihovim članom lahko ponudi uporabo posebnih komunikacijskih medijev in orodij.
Conferences and experts meetings should be organised to provide a forum for technical and scientific debate among Networks.
Organizirati bi bilo treba konference in strokovna srečanja, da se vzpostavi forum za tehnično in znanstveno razpravo med mrežami.
The personal data related to establishing and evaluating the Networks should be processed in compliance with Regulation (EC) No 45/2001 of the European Parliament and of the Council [3] as appropriate.
Osebne podatke, ki se nanašajo na ustanavljanje in vrednotenje mrež, bi bilo treba obdelati v skladu z Uredbo (ES) št. 45/2001 Evropskega parlamenta in Sveta [3], kakor je primerno.
The measures provided for in this Decision are in accordance with the opinion of the Committee set up under Article 16 of Directive 2011/24/EU,
Ukrepi iz tega sklepa so v skladu z mnenjem odbora, ustanovljenega na podlagi člena 16 Direktive 2011/24/EU –
This Decision sets out:
Ta sklep določa:
the criteria for establishing and evaluating the Networks referred to in Article 12 of Directive 2011/24/EU; and
merila za ustanavljanje in vrednotenje mrež iz člena 12 Direktive 2011/24/EU ter
the measures to facilitate the exchange of information and expertise on establishing and evaluating the Networks referred to in Article 12 of Directive 2011/24/EU.
ukrepe za lažjo izmenjavo informacij in strokovnega znanja o ustanavljanju in vrednotenju mrež iz člena 12 Direktive 2011/24/EU.
ESTABLISHMENT OF EUROPEAN REFERENCE NETWORKS
USTANAVLJANJE EVROPSKIH REFERENČNIH MREŽ
Call for interest to establish a European Reference Network
Razpis za prijavo interesa za ustanovitev evropske referenčne mreže
The Commission shall publish a call for interest to establish Networks within two years following the entry into force of this Decision.
Komisija objavi razpis za prijavo interesa za ustanovitev mrež v dveh letih po začetku veljavnosti tega sklepa.
Any group of at least 10 healthcare providers established in at least 8 Member States may collectively respond by the deadline indicated in the call for interest with an application containing a proposal to establish a Network in a given field of expertise.
Katera koli skupina vsaj desetih izvajalcev zdravstvenega varstva s sedežem v najmanj osmih državah članicah lahko do roka, navedenega v razpisu za prijavo interesa, skupaj vloži vlogo, ki vsebuje predlog za ustanovitev mreže na določenem področju strokovnega znanja.
The content of the application shall be as set out in Annex I.
Vsebina vloge je določena v Prilogi I.
On receiving an application, the Commission shall verify whether the conditions on the minimum number of healthcare providers and Member States as set out in paragraph 2 are met.
Ob prejemu vloge Komisija preveri, ali so izpolnjeni pogoji glede najmanjšega potrebnega števila izvajalcev zdravstvenega varstva in držav članic, kot je določeno v odstavku 2.
If either of those conditions is not met, the application shall not be entitled to assessment and the Commission shall ask Member States to encourage their healthcare providers to join the proposed Network in order to help reach the required number(s).
Če kateri koli pogoj ni izpolnjen, vloga ni upravičena do ocene, Komisija pa zaprosi države članice, naj pozovejo svoje izvajalce zdravstvenega varstva, da se pridružijo predlagani mreži in pomagajo doseči zahtevano(-ni) število(-li).
After consulting the Member States, the Commission shall decide on the appropriate timing for the publication of subsequent calls for interest.
Komisija po posvetovanju z državami članicami določi primerno časovnico objav naslednjih razpisov za prijavo interesa.
Membership applications
Vloge za članstvo
The application containing a proposal to establish a Network shall be accompanied by a membership application for each healthcare provider concerned.
Vlogi, ki vsebuje predlog za ustanovitev mreže, se priloži vloga za članstvo za vsakega zadevnega izvajalca zdravstvenega varstva.
The content of the membership application shall be as set out in Annex II.
Vsebina vloge za članstvo je določena v Prilogi II.
The membership application shall be accompanied by a written statement from the healthcare provider's Member State of establishment certifying that its participation in the proposal to establish a Network is in accordance with the Member State's national legislation.
Vlogi za članstvo se priloži pisna izjava države članice sedeža izvajalca zdravstvenega varstva, ki potrjuje, da je njegova udeležba v predlogu za ustanovitev mreže v skladu z nacionalno zakonodajo države članice.
Technical assessment of applications
Tehnična ocena vlog
If the Commission concludes that the requirements set out in Article 2(2) and in Article 3(2) and (3) are fulfilled, it shall appoint an assessment body to assess applications.
Če Komisija ugotovi, da so zahteve iz člena 2(2) in člena 3(2) in (3) izpolnjene, imenuje organ za ocenjevanje prejetih vlog.
The assessment body shall verify whether:
Organ za ocenjevanje preveri, ali:
the content of an application containing a proposal to establish a Network fulfils the requirements set out in Annex I to this Decision;
vsebina vloge, ki vsebuje predlog za ustanovitev mreže, izpolnjuje zahteve iz Priloge I k temu sklepu;
the content of the membership applications fulfils the requirements of Annex II to this Decision;
vsebina vlog za članstvo izpolnjuje zahteve iz Priloge II k temu sklepu;
the proposed Network fulfils the requirement to provide highly specialised healthcare in point 1(a) of Annex I to Delegated Decision 2014/286/EU;
predlagana mreža izpolnjuje zahtevo za zagotavljanje visokospecializiranega zdravstvenega varstva iz točke 1(a) Priloge I k Delegiranemu sklepu 2014/286/EU;
the proposed Network fulfils the other criteria and conditions set out in Annex I to Delegated Decision 2014/286/EU;
predlagana mreža izpolnjuje ostala merila in pogoje iz Priloge I k Delegiranemu sklepu 2014/286/EU;
the applicant healthcare providers fulfil the criteria and conditions set out in Annex II to Delegated Decision 2014/286/EU.
izvajalci zdravstvenega varstva, ki kandidirajo, izpolnjujejo merila in pogoje iz Priloge II k Delegiranemu sklepu 2014/286/EU.
The assessment pursuant to points (d) and (e) of paragraph 2 shall only take place if the assessment body concludes that the proposal fulfils the requirements referred to in points (a), (b) and (c) of paragraph 2.
Ocena v skladu s točkama (d) in (e) odstavka 2 se opravi le, če organ za ocenjevanje ugotovi, da predlog izpolnjuje zahteve iz točk (a), (b) in (c) odstavka 2.
The assessment body shall draw up an assessment report on the application containing a proposal to establish a Network and the membership applications and send all reports to the Commission.
Organ za ocenjevanje pripravi poročilo o oceni vloge, ki vsebuje predlog za ustanovitev mreže, in vlog za članstvo ter vsa poročila pošlje Komisiji.
The assessment body shall send to each applicant healthcare provider the assessment report on the proposed Network and on its own membership application.
Organ za ocenjevanje pošlje vsakemu izvajalcu zdravstvenega varstva, ki kandidira, poročilo o oceni predlagane mreže in poročilo o njegovi vlogi za članstvo.
The healthcare provider may send comments to the assessment body within two months of receiving the reports.
Izvajalec zdravstvenega varstva lahko v dveh mesecih po prejemu poročil pošlje svoje pripombe organu za ocenjevanje.
On receiving the comments, the assessment body shall amend its assessment reports explaining whether the comments justify a change in its assessment.
Po prejemu pripomb organ za ocenjevanje spremeni svoja poročila o oceni in pojasni, ali pripombe upravičujejo spremembo ocene.
Approval of Networks and Members
Odobritev mrež in članov
On receiving an assessment report on a proposal for a Network and the proposed list of Members, drawn up pursuant to Article 4, and after verifying that the minimum number of healthcare providers and Member States set out in Article 2(2) is reached, Member States shall, within a Board of Member States as provided in Article 6, decide on the approval of the proposed Network and its Members.
Po prejemu poročila o oceni predloga mreže in predlaganega seznama članov, sestavljenega v skladu s členom 4, ter potem ko se preveri, da sta doseženi najmanjši potrebni števili izvajalcev zdravstvenega varstva in držav članic iz člena 2(2), države članice v odboru držav članic, kot je določeno v členu 6, odločijo o odobritvi predlagane mreže in njenih članov.
By virtue of the approval referred to in paragraph 1, the proposed Networks shall be established as European Reference Networks.
Na podlagi odobritve iz odstavka 1 se predlagane mreže ustanovijo kot evropske referenčne mreže.
If the minimum number of healthcare providers or of Member States set out in Article 2(2) is not reached, the Network shall not be established and the Commission shall ask Member States to encourage their healthcare providers to join the proposed Networks.
Če najmanjše potrebno število izvajalcev zdravstvenega varstva ali držav članic iz člena 2(2) ni doseženo, se mreža ne ustanovi in Komisija zaprosi države članice, da pozovejo svoje izvajalce zdravstvenega varstva k pridružitvi predlaganim mrežam.
If a healthcare provider is given a negative assessment, it will be for that healthcare provider to decide whether it wants to submit its membership application, with the assessment report on the application, to the Board of Member States for review.
Če izvajalec zdravstvenega varstva prejme negativno oceno, se ta izvajalec zdravstvenega varstva odloči, ali želi predložiti vlogo za članstvo s poročilom o oceni vloge v pregled odboru držav članic.
Board of Member States
Odbor držav članic
Member States are invited to set up a Board of Member States which shall decide whether or not to approve the proposals for Networks, their membership and the termination of a Network.
Države članice so pozvane k ustanovitvi odbora držav članic, ki odloča o odobritvi predlogov za mreže, njihovem članstvu in prenehanju delovanja mreže.
If their decision differs from the assessment of the assessment body, the Member States shall give the reasons for this.
Če je njihova odločitev drugačna od ocene organa za ocenjevanje, države članice navedejo razloge za to.
Member States wishing to be on the Board of Member States shall notify the Commission the national authority that shall represent them.
Države članice, ki želijo biti v odboru držav članic, Komisiji uradno sporočijo ime nacionalnega organa, ki jih bo zastopal.
The Board of Member States shall adopt by a simple majority of its members its own rules of procedures, on the proposal of the Commission services.
Odbor držav članic na predlog služb Komisije z navadno večino svojih članov sprejme svoj poslovnik.
The rules of procedure shall cover the functioning and decision-making process of the Board of Member States and specify which of its members are entitled to vote on the approval of a specific Network, which majority will determine the outcome of a vote, and what procedure to follow if the Board's decision differs from the assessment report on a Network proposal or membership application.
Poslovnik zajema postopek delovanja in odločanja odbora držav članic ter navaja, kateri njegovi člani so upravičeni do glasovanja o odobritvi določene mreže, s kakšno večino se bo odločalo o izidu glasovanja in kateri postopek se uporabi, če se odločitev odbora razlikuje od poročila o oceni predloga mreže ali vloge za članstvo.
The Commission shall provide the secretariat of the Board of Member States.
Komisija zagotovi sekretariat odbora držav članic.
The personal data of representatives of Member States on the Board of Member States shall be collected, processed and published in accordance with Regulation (EC) No 45/2001.
Osebni podatki predstavnikov držav članic v odboru držav članic se zbirajo, obdelujejo in objavljajo v skladu z Uredbo (ES) št. 45/2001.
When a Network is approved, the Commission shall license the use of a unique graphic identifier (‘logo’), which that Network and its Members shall use for the activities organised by the Network.
Ko je mreža odobrena, Komisija izda licenco za uporabo enkratnega grafičnega identifikatorja („logotipa“), ki ga ta mreža in njeni člani uporabljajo za dejavnosti, ki jih organizira mreža.
Applications for membership of existing Networks
Vloge za članstvo v obstoječih mrežah
A healthcare provider wishing to join an existing Network shall submit a membership application to the Commission.
Izvajalec zdravstvenega varstva, ki se želi pridružiti obstoječi mreži, Komisiji predloži vlogo za članstvo.
The membership application shall be accompanied by a written statement from the healthcare provider's Member State of establishment certifying that its participation in the Network is in accordance with the Member State's national legislation.
Vlogi za članstvo se priloži pisna izjava države članice sedeža izvajalca zdravstvenega varstva, ki potrjuje, da je njegova udeležba v mreži v skladu z nacionalno zakonodajo države članice.
Technical assessment of applications for membership of existing Networks
Tehnična ocena vlog za članstvo v obstoječih mrežah
If the Commission concludes that the requirements set out in Article 8(2) and (3) are fulfilled, it shall appoint a body to assess the membership application.
Če Komisija ugotovi, da so zahteve iz člena 8(2) in (3) izpolnjene, imenuje organ za ocenjevanje vloge za članstvo.
the content of the membership application fulfils the requirements set out in Annex II to this Decision; and
vsebina vloge za članstvo izpolnjuje zahteve iz Priloge II k temu sklepu in
the healthcare provider concerned fulfils the criteria and conditions set out in Annex II to Delegated Decision 2014/286/EU.
zadevni izvajalec zdravstvenega varstva izpolnjuje merila in pogoje iz Priloge II k Delegiranemu sklepu 2014/286/EU.
The assessment pursuant to point (b) of paragraph 2 shall only take place if the assessment body concludes that the membership application fulfils the requirements referred to in point (a) of paragraph 2.
Ocena v skladu s točko (b) odstavka 2 se opravi le, če organ za ocenjevanje ugotovi, da vloga za članstvo izpolnjuje zahteve iz točke (a) odstavka 2.
The assessment body shall draw up an assessment report and send it to the Commission and to the applicant healthcare provider.
Organ za ocenjevanje pripravi poročilo o oceni ter ga pošlje Komisiji in izvajalcu zdravstvenega varstva, ki kandidira.
The healthcare provider may send comments to the assessment body within two months of receiving the report.
Izvajalec zdravstvenega varstva lahko v dveh mesecih po prejemu poročila pošlje pripombe organu za ocenjevanje.
On receiving of such comments, the assessment body shall amend its assessment report explaining whether the comments justify a change in its assessment.
Po prejemu takšnih pripomb organ za ocenjevanje spremeni svoje poročilo o oceni in pojasni, ali pripombe upravičujejo spremembo ocene.
Approval of new Members
Ocena novih članov
On receiving a positive assessment report drawn up pursuant to Article 9, the Board of Member States shall decide whether or not to approve the new Member.
Odbor držav članic po prejemu pozitivnega poročila o oceni, pripravljenega v skladu s členom 9, odloči, ali bo odobril novega člana.
Termination of the Network
Prenehanje delovanja mreže
A Network shall be terminated in the following cases:
Mreža preneha delovati v naslednjih primerih:
one of the minimum numbers set out in Article 2(2) is no longer reached;
eno od najmanjših potrebnih števil iz člena 2(2) ni več doseženo;
a negative evaluation report of the Network has been drawn up pursuant to Article 14;
v skladu s členom 14 je bilo pripravljeno negativno poročilo o vrednotenju mreže;
by decision of the Board of the Network according to its rules and procedures;
s sklepom odbora mreže v skladu z njegovimi pravili in postopki;
if the Coordinator fails to request an evaluation of the Network within the five- year period after it was set up or since its last evaluation.
če koordinator ne zahteva vrednotenja mreže v petletnem obdobju po njeni ustanovitvi ali po njenem zadnjem vrednotenju.
The termination of a Network, on the grounds listed in paragraph 1(a) and (b), must be approved by the Board of Member States referred to in Article 6.
Prenehanje delovanja mreže iz razlogov iz odstavka 1(a) in (b) mora odobriti odbor držav članic iz člena 6.
Loss of membership
Prenehanje članstva
A Member of a Network may lose membership for any of the following reasons:
Članstvo v mreži lahko preneha iz naslednjih razlogov:
voluntary withdrawal, according to the rules and procedures agreed by the Board of the Network;
prostovoljni umik po pravilih in postopkih, ki jih je sprejel odbor mreže;
by decision of the Board of the Network, according to the rules and procedures agreed by the Board;
s sklepom odbora mreže v skladu z njegovimi pravili in postopki;