en	Among more than 400 initiatives analysed in the mapping exercise, the large majority took place between countries with similar welfare state traditions and concerned knowledge sharing and management and shared treatment and diagnosis of patients.
sl	Velika večina od več kot 400 pobud, ki so bile analizirane pri vzporejanju, je potekala med državami s podobnimi tradicijami socialne države, nanašale pa so se na izmenjavo in upravljanje znanja ter skupno obravnavo in diagnosticiranje pacientov.

en	Besides exchanging information on relevant policy developments in the area of HTA, in the past three years the HTA Network developed important policy papers such as the 'Added Value of the European Cooperation in the Joint HTA of Medical Devices' in October 2015 and a 'Reflection Paper on Synergies between Regulatory and HTA issues' in November 2016.
sl	Mreža za ocenjevanje zdravstvene tehnologije je poleg izmenjave informacij o zadevnem razvoju politike na področju ocenjevanja zdravstvene tehnologije v zadnjih treh letih pripravila pomembne dokumente o politiki, kot sta „Added Value of the European Cooperation in the Joint HTA of Medical Devices" (Dodana vrednost evropskega sodelovanja pri skupnem ocenjevanju zdravstvene tehnologije za medicinske pripomočke) iz oktobra 2015 in „Reflection Paper on Synergies between Regulatory and HTA issues" (Dokument o razmisleku o sinergijah med regulativnimi vprašanji in vprašanji na področju ocenjevanja zdravstvene tehnologije) iz novembra 2016.

en	Member States may define the fees for the delivery of healthcare in their territory.
sl	Države članice lahko določijo cene za izvajanje zdravstvenega varstva na svojem ozemlju.

en	This refers to Member States granting reimbursement of cross-border healthcare on the basis of lower levels of reimbursement, applicable to healthcare received from private or non-contracted healthcare providers within their own territory, compared to the level of reimbursement within the system of public healthcare or contracted healthcare providers.
sl	To se nanaša na države članice, ki odobrijo povračilo stroškov čezmejnega zdravstvenega varstva na podlagi nižjih ravni povračil, ki se uporabljajo za zdravstveno varstvo pri zasebnih ali nepogodbenih izvajalcih zdravstvenega varstva na njihovem ozemlju, v primerjavi z ravnjo povračila v javnem sistemu zdravstvenega varstva ali pri pogodbenih izvajalcih zdravstvenega varstva.

en	[44: Communication on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society, COM(2018) 233 final, 25.4.2018.]
sl	[44: Sporočilo o omogočanju digitalne preobrazbe zdravstva in oskrbe na enotnem digitalnem trgu; krepitev vloge državljanov in oblikovanje bolj zdrave družbe (COM(2018) 233 final z dne 25. aprila 2018).]

en	b) Prior authorisation
sl	(b) Predhodna odobritev

en	According to Article 7(4) of the Directive, the costs of cross-border healthcare shall be reimbursed or paid up to the level of costs that would have been assumed by the Member State of affiliation, had this healthcare been provided in its territory, without exceeding the actual cost of the healthcare received.
sl	V skladu s členom 7(4) Direktive se stroški čezmejnega zdravstvenega varstva povrnejo ali neposredno plačajo do višine stroškov, ki bi jih prevzela država članica zdravstvenega zavarovanja, če bi bilo to zdravstveno varstvo zagotovljeno na njenem ozemlju, ne da bi bili preseženi dejanski stroški prejetega zdravstvenega varstva.

en	Article 7(11) requires such limitations to be necessary and proportionate, and not to constitute a means of arbitrary discrimination or an unjustified obstacle to free movement.
sl	V skladu s členom 7(11) morajo biti take omejitve potrebne in sorazmerne ter ne bi smele predstavljati sredstva za samovoljno diskriminacijo ali neutemeljene ovire za prosti pretok.

en	Any system of prior authorisation shall be restricted to what is necessary and proportionate to the objective to be achieved, and may not constitute a means of arbitrary discrimination or an unjustified obstacle to the free movement of patients.
sl	Vsak sistem predhodne odobritve je omejen na to, kar je potrebno in sorazmerno z zadanim ciljem, in ne sme predstavljati sredstva za samovoljno diskriminacijo ali neutemeljene ovire za prost pretok pacientov.

en	This is reflected as well in Article 8(2)(a) of the Directive, which allows Member States to use a system of prior authorisation in particular for healthcare that is subject to planning requirements if it involves overnight hospital accommodation or if it requires use of highly specialised and cost-intensive medical infrastructure or medical equipment.
sl	To je izraženo tudi v členu 8(2)(a) Direktive, ki državam članicam omogoča, da sistem predhodne odobritve uporabijo zlasti za zdravstveno varstvo, ki je predmet potreb za načrtovanje, vključuje prenočitev v bolnišnici ali zahteva uporabo visoko specializirane in drage medicinske infrastrukture ali medicinske opreme.

en	A little less than half of the NCP websites provide information on both pieces of legislation.
sl	Informacije o obeh zakonodajnih aktih zagotavlja malo manj kot polovica spletišč nacionalnih kontaktnih točk.

en	The main difference between the Directive and the Regulations as regards the reimbursement rights is that under the Regulations, patients are entitled to healthcare abroad as if they were insured under the social security system of the Member State of treatment.
sl	Kar zadeva pravice do povračila stroškov, je glavna razlika med Direktivo in zadevnima uredbama, da so na podlagi uredb pacienti upravičeni do zdravstvenega varstva v tujini, kot če bi bili zavarovani v okviru sistema socialne varnosti države članice zdravljenja.

en	Such choice may be driven by a desire to return ‘home' to a country of birth for healthcare, or to bring a relative closer to a place where a family member can care for them or it may be driven by a desire to find expertise not available in their home country.
sl	Razlogi za tako izbiro so morda želja po vrnitvi „domov" v državo rojstva, da bi bil pacient tam deležen zdravstvenega varstva, premestitev sorodnika bližje kraju, kjer lahko zanj skrbi družinski član, ali strokovno znanje, ki ni na voljo v domači državi.

en	This would suggest that while 50% of patient mobility may be driven by issues of proximity, and possibly also collaborations between clinicians in border regions, a very significant part may also reflect patients' desires to receive healthcare in a place of their choice.
sl	To bi pomenilo, da 50 % mobilnosti pacientov spodbudita bližina ter morda celo sodelovanje med zdravniki v obmejnih regijah, zelo pomemben del mobilnosti pa morda kaže tudi željo pacientov, da so deležni zdravstvenega varstva v kraju po lastni izbiri.

en	Under the Directive, they are reimbursed for treatment abroad as if the treatment was provided in their home countries (Member State of affiliation).
sl	Na podlagi Direktive se jim stroški zdravljenja v tujini povrnejo, kot če bi bilo zdravljenje zagotovljeno v njihovih domačih državah (državi članici zdravstvenega zavarovanja).

en	Article 9(1) of the Directive requires Member States to ensure that administrative procedures for cross-border reimbursement are based on objective, non-discriminatory criteria which are necessary and proportionate to the objective to be achieved.
sl	Države članice morajo v skladu s členom 9(1) Direktive zagotoviti, da upravni postopki za čezmejno povračilo stroškov temeljijo na objektivnih, nediskriminatornih merilih, ki so nujna in sorazmerna za zadani cilj.

en	[51: See more details in the Commission report on the operation of the Directive published on 4 September 2015 (COM(2015) 421 final).]
sl	[51: Za več podrobnosti glej Poročilo Komisije o izvajanju Direktive, objavljeno 4. septembra 2015 (COM(2015) 421 final).]

en	Adjusting for the number of countries reporting data, this shows that EU citizens' use of the rights granted under the Directive had no significant growth or reduction over the three years of the reporting period.
sl	Ob prilagoditvi zaradi števila držav, ki so sporočile podatke, je iz navedenega razvidno, da se v treh letih obdobja poročanja število državljanov EU, ki so uveljavljali pravice iz Direktive, ni bistveno povečalo ali zmanjšalo.

en	If this number is compared to the reported number of PA for cross-border care under the Directive in 2016 (the latter being the most comparable year), it may be estimated that cross-border with PA under the Directive amounts to approximately 6% of the authorised treatments in another Member State.
sl	Če se to število primerja s sporočenim številom predhodnih odobritev za čezmejno oskrbo na podlagi Direktive leta 2016 (ki je najbolj primerljivo leto), je mogoče oceniti, da čezmejno zdravstveno varstvo s predhodno odobritvijo na podlagi Direktive zajema približno 6 % odobrenih zdravljenj v drugi državi članici.

en	The present report gives a high-level overview of the data received in 2015, 2016 and 2017.
sl	To poročilo vsebuje splošni pregled podatkov, prejetih v letih 2015, 2016 in 2017.

en	Moreover, it was also difficult for some Member States to implement the principle which extends patients' choice to healthcare providers located in another Member State, irrespective of whether or not they are contracted by the statutory health system in that Member State.
sl	Poleg tega so nekatere države članice tudi težko izvajale načelo, s katerim se izbira, ki jo imajo pacienti, razširja na izvajalce zdravstvenega varstva v drugi državi članici, in sicer ne glede na to, ali imajo v navedeni državi članici sklenjeno pogodbo z obveznim zdravstvenim sistemom.

en	Figure 1: Prior Authorisation Requests and Authorisations
sl	Slika 1: Zahtevki za predhodno odobritev in odobritve

en	The concern of the Commission in this respect is that systems of prior authorisation should not suffer from the lack of legal certainty and transparency about which treatments are subject to and fit the criteria of prior authorisation.
sl	Komisija ima v zvezi s tem pomislek, da na sisteme predhodne odobritve ne bi smeli vplivati slaba pravna varnost in nepreglednost glede tega, za katere oblike zdravljenja veljajo merila za predhodno odobritev in katere oblike zdravljenja jih izpolnjujejo.

en	The National Contact Points (NCPs) have an essential role to play in relation to this, providing information to citizens upon demand and, more generally, in raising awareness on patient rights and responding to information needs.
sl	Pri tem imajo bistveno vlogo nacionalne kontaktne točke, saj državljanom na zahtevo zagotavljajo informacije, splošneje pa so pomembne tudi pri ozaveščanju o pravicah pacientov in odzivanju na potrebe po informacijah.

en	While about half the patient mobility is accounted for by movements from France to its neighbouring countries, the other half of the flow is made up by small numbers of patients travelling throughout the EU to receive care - both to neighbouring countries and to countries further away.
sl	Premiki iz Francije v njene sosednje države predstavljajo približno polovico mobilnosti pacientov, drugo polovico pretoka pa sestavlja majhno število pacientov, ki zaradi oskrbe potujejo po vsej EU, in sicer v sosednje in bolj oddaljene države.

en	[24: https://www.oecd-ilibrary.org/social-issues-migration-health/health-at-a-glance-2017/health-expenditure-in-relation-to-gdp_health_glance-2017-45-en][25: http://ec.europa.eu/eurostat/tgm/refreshTableAction.do;jsessionid=9ea7d07e30dd3bf0a52b9a8a474c872db039e243c026.e34OaN8Pc3mMc40Lc3aMaNyTa3eQe0?tab=table&plugin=1&pcode=tec00001&language=en]
sl	][25: http://ec.europa.eu/eurostat/tgm/refreshTableAction.do;jsessionid=9ea7d07e30dd3bf0a52b9a8a474c872db039e243c026.e34OaN8Pc3mMc40Lc3aMaNyTa3eQe0?tab=table&plugin=1&pcode=tec00001&language=en.]

en	][53: Commission Delegated Decision 2014/286/EU of 10 March 2014 setting out criteria and conditions that European Reference Networks and healthcare providers wishing to join a European Reference Network must fulfil (OJ L 147, 17.5.2014, p.
sl	][53: Delegirani sklep Komisije 2014/286/EU z dne 10. marca 2014 o določitvi meril in pogojev, ki jih morajo izpolnjevati evropske referenčne mreže in izvajalci zdravstvenega varstva, ki se želijo pridružiti evropski referenčni mreži (UL L 147, 17.5.2014, str.

en	After patients travelling from France, the next most frequent cases of patient mobility were patients travelling from Denmark to Germany; followed by Poland to Czech Republic and Norway to Spain.
sl	Za pacienti, ki potujejo iz Francije, so bili naslednji najpogostejši primeri mobilnosti pacientov pacienti, ki so potovali iz Danske v Nemčijo, sledili so jim pacienti, ki so potovali iz Poljske na Češko in iz Norveške v Španijo.

en	[21: It should be noted that France was able to report data on healthcare subject to PA only in 2016.
sl	[21: Opozoriti je treba, da je lahko Francija podatke o zdravstvenem varstvu, za katero se zahteva predhodna odobritev, sporočila le leta 2016.

en	The proposal seeks to build on the on-going project based cooperation on HTA and to address certain shortcomings identified in the reflection process.
sl	Namen predloga je nadgraditi trenutno projektno sodelovanje na področju ocenjevanja zdravstvene tehnologije in odpraviti nekatere pomanjkljivosti, ugotovljene v okviru razmisleka.

en	Under the eHDSI Infrastructure, the first wave of voluntary cross-border exchanges of patient summaries and ePrescriptions is set to begin by a few pioneering countries by the end of 2018; with around 20 Member States expected to participate by 2020.
sl	V okviru infrastrukture za digitalne storitve e-zdravja je nekaj prvih držav pripravljenih, da bodo do konca leta 2018 začele prvi sklop prostovoljnih čezmejnih izmenjav povzetkov podatkov o pacientih in e-receptov, do leta 2020 pa naj bi sodelovalo približno 20 držav članic.

en	Article 8(7) of the Directive requires Member States to ‘make publicly available which healthcare is subject to prior authorisation'.
sl	Države članice morajo v skladu s členom 8(7) Direktive „javno objavi[ti], za katero zdravstveno varstvo je potrebna predhodna odobritev".

en	Nevertheless, a steady increase has occurred since 2015, with more than twice as many requests for PA being made and authorised in 2017 as in 2015 across the Member States.
sl	Kljub temu se njihovo število od leta 2015 nenehno povečuje, pri čemer je bilo leta 2017 na ravni vseh držav članic vloženih in odobrenih več kot dvakrat toliko zahtevkov za predhodno odobritev kot leta 2015.

en	Accordingly, Figure 2 should be interpreted knowing that in 2016 France accounted for 3510 of the 5162 requests for PA and 2579 of the 3644 authorisations for PA.
sl	V skladu s tem bi bilo treba sliko 2 razlagati ob upoštevanju, da je leta 2016 Francija prejela 3 510 od 5 162 zahtevkov za predhodno odobritev in da je bilo njenih 2 579 od 3 644 odobrenih zahtevkov.

en	[40: 2011/890/EU: Commission Implementing Decision of 22 December 2011 providing the rules for the establishment, the management and the functioning of the network of national responsible authorities on eHealth]
sl	[40: 2011/890/EU: Izvedbeni sklep Komisije z dne 22. decembra 2011 o pravilih za vzpostavitev, upravljanje in delovanje mreže nacionalnih organov, pristojnih za e-zdravje.]

en	Some Member States require patients to provide a certified translation of their medical documentation in order to obtain their reimbursement.
sl	Nekatere države članice zahtevajo, da morajo pacienti za povračilo stroškov zagotoviti sodno overjeni prevod zdravstvene dokumentacije.

en	Looking at flows of patients travelling for healthcare after receiving prior authorisation, the greatest flow was from France to Spain.
sl	Kar zadeva pretoke pacientov, ki po izdani predhodni odobritvi potujejo zaradi zdravstvenega varstva, je bil največji pretok iz Francije v Španijo.

en	Delegated powers
sl	Prenos pooblastil

en	An additional call took place in 2018 allowing more Member States to participate in the eHDSI.
sl	Leta 2018 je bil izveden dodatni razpis, s katerim se je še več državam članicam omogočilo sodelovanje v infrastrukturi za digitalne storitve e-zdravja.

en	Based on responses provided by Member States approximately €65,000,000 was spent across all EU countries collectively on care with and without PA in 2016.
sl	Glede na odgovore držav članic je bilo leta 2016 za oskrbo s predhodno odobritvijo in brez nje v vseh državah EU skupaj porabljenih približno 65 000 000 EUR.

en	[45: Based on Article 11(2)(a), (c) and (d) of the Directive.
sl	[45: Na podlagi člena 11(2)(a), (c) in (d) Direktive.

en	However, Article 4(4) requires Member States to ensure that healthcare providers apply the same scale of fees to patients from other Member States as they do for domestic patients in a comparable medical situation.
sl	Pri tem pa morajo v skladu s členom 4(4) zagotoviti, da izvajalci zdravstvenega varstva pacientom iz drugih držav članic zaračunajo enake cene kot domačim pacientom s primerljivim zdravstvenim stanjem.

en	Data was received in 2015 from 23 Member States and Norway; in 2016, from all 28 Member States plus Norway and Iceland; and in 2017 from 26 Member States.
sl	Leta 2015 je podatke predložilo 23 držav članic in Norveška, leta 2016 jih je predložilo vseh 28 držav članic ter Norveška in Islandija, leta 2017 pa 26 držav članic.

en	The Directive (Article 8(2)) introduces the possibility for Member States to make reimbursement of costs for healthcare received in another Member State subject to prior authorisation.
sl	Z Direktivo (člen 8(2)) se za države članice uvaja možnost, da za povračilo stroškov zdravstvenega varstva, prejetega v drugi državi članici, zahtevajo predhodno odobritev.

en	However, the fact that there has been a slow but steady increase in the number of citizens travelling to receive care suggests that the increase of information available on NCP websites has reduced the number of requests patients made to NCPs.
sl	Vendar dejstvo, da se število državljanov, ki potujejo zaradi oskrbe, počasi, a vztrajno povečuje, kaže, da se je s povečanjem količine razpoložljivih informacij na spletiščih nacionalnih kontaktnih točk zmanjšalo število poizvedb pacientov pri nacionalnih kontaktnih točkah.

en	][46: Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State (OJ L 356, 22.12.2012, p.
sl	][46: Izvedbena direktiva Komisije 2012/52/EU z dne 20. decembra 2012 o določitvi ukrepov za olajšanje priznavanja zdravniških receptov, predpisanih v drugi državi članici (UL L 356, 22.12.2012, str.

en	][6: Article 7(6) and Article 9.
sl	][6: Člen 7(6) in člen 9.

en	Patient mobility with prior authorisation
sl	Mobilnost pacientov s predhodno odobritvijo

en	][8: Article 4(2)(c), (e)-(f), 4(3), 4(4), 5(b)-(d), 7(1), 9(4)-(5).
sl	][8: Člen 4(2)(c), (e) in (f), člen 4(3), člen 4(4), člen 5(b), (c) in (d), člen 7(1), člen 9(4) in (5).

en	For the years 2015 and 2017, when France was not able to provide data on patient mobility with PA, Luxembourg to Germany and Ireland to UK were amongst the most common cases of patient mobility.
sl	V letih 2015 in 2017, ko Francija ni mogla predložiti podatkov o mobilnosti pacientov s predhodno odobritvijo, so bili najpogostejši primeri mobilnosti pacientov mobilnost iz Luksemburga v Nemčijo in iz Irske v Združeno kraljestvo.

en	The flow maps, as well as the raw data, show clearly that most patients travel from France to other countries, with patient mobility from France to Spain and France to Germany being the most prevalent.
sl	Diagrami pretoka tako kot neobdelani podatki jasno kažejo, da največ pacientov potuje iz Francije v druge države, pri čemer prevladuje mobilnost pacientov iz Francije v Španijo in iz Francije v Nemčijo.

en	Patient mobility not subject to prior authorisation
sl	Mobilnost pacientov, za katero se ne zahteva predhodna odobritev

en	The aggregated data reported by Member States on the number of requests for PA in 2015, 2016 and 2017 show that such requests remain generally low.
sl	Zbirni podatki, ki so jih države članice sporočile o številu zahtevkov za predhodno odobritev v letih 2015, 2016 in 2017, kažejo, da jih je na splošno še vedno malo.

en	[28: IF SBH (International Federation for Spina Bifida and Hydrocephalus) and EDF (European Disability Forum), "Impact of Cross-border Healthcare on Persons with Disabilities and Chronic Conditions", 2017 ][29: https://ec.europa.eu/health/sites/health/files/cross_border_care/docs/2015_operation_report_dir201124eu_en.pdf]
sl	[28: IF SBH (Mednarodna zveza za spino bifido in hidrocefalijo) in EDF (Evropski invalidski forum), „Impact of Cross-border Healthcare on Persons with Disabilities and Chronic Conditions" (Učinek čezmejnega zdravstvenega varstva na invalide in osebe s kroničnimi obolenji), 2017.

en	[27: https://ec.europa.eu/health/cross_border_care/key_documents_en]
sl	[27: https://ec.europa.eu/health/cross_border_care/key_documents_sl.]

en	Regarding the voluntary cooperation structure (eHealth, HTA, ERNs), the Directive provides the basis for the Commission and Member States to enhance cross-border cooperation and on how broader technological and societal challenges might be met. A number of developments regarding these new perspectives are already underway.
sl	Kar zadeva strukturo prostovoljnega sodelovanja (e-zdravje, ocenjevanje zdravstvene tehnologije, evropske referenčne mreže), je Direktiva podlaga, na kateri Komisija in države članice krepijo čezmejno sodelovanje in morebitne načine spopadanja s širšimi tehnološkimi in družbenimi izzivi.

en	Compliance check
sl	Preverjanje skladnosti

en	[1: Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p.
sl	[1: Direktiva 2011/24/EU Evropskega parlamenta in Sveta z dne 9. marca 2011 o uveljavljanju pravic pacientov pri čezmejnem zdravstvenem varstvu (UL L 88, 4.4.2011, str.

en	Financial Implications of Patient Mobility
sl	Finančne posledice mobilnosti pacientov

en	[32: https://ec.europa.eu/health/sites/health/files/technology_assessment/docs/2018_mapping_npc_en.pdf][33: Mapping of HTA national organisations programmes and processes in EU and Norway, 2017, Contract nr. 17010402/2016/734820, ISBN: 978-92-79-77080-7]
sl	][33: Vzporejanje nacionalnih organizacij, programov in postopkov za ocenjevanje zdravstvene tehnologije v EU in na Norveškem, 2017, pogodba št. 17010402/2016/734820, ISBN: 978-92-79-77080-7.]

en	][31: https://ec.europa.eu/health/cross_border_care/events/ev_20161024_en]
sl	][31: https://ec.europa.eu/health/cross_border_care/events/ev_20161024_sl.]

en	[34: https://ec.europa.eu/health/technology_assessment/policy/network_en][35: Commission Implementing Decision 2013/329/EU of 26 June 2013 providing the rules for the establishment,management and transparent functioning of the network of national authorities or bodies responsible for healthtechnology assessment (OJ L 175, 27.6.2013, p.
sl	][35: Izvedbeni sklep Komisije 2013/329/EU z dne 26. junija 2013 o pravilih za vzpostavitev,upravljanje in pregledno delovanje mreže nacionalnih organov ali teles, pristojnih za ocenjevanjezdravstvene tehnologije (UL L 175, 27.6.2013, str.

en	[47: Article 10(3) of the Directive.
sl	[47: Člen 10(3) Direktive.

en	[41: Regulation (EU) No 1316/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Connecting Europe Facility, amending Regulation (EU) No 913/2010 and repealing Regulations (EC) No 680/2007 and (EC) No 67/2010, OJ L 348, 20.12.2013, p.
sl	[41: Uredba (EU) št. 1316/2013 Evropskega parlamenta in Sveta z dne 11. decembra 2013 o vzpostavitvi Instrumenta za povezovanje Evrope, spremembi Uredbe (EU) št. 913/2010 in razveljavitvi uredb (ES) št. 680/2007 in (ES) št. 67/2010 (UL L 348, 20.12.2013, str.

en	][9: Article 4(2)(d).]
sl	][9: Člen 4(2)(d).]

en	Completeness check
sl	Preverjanje popolnosti

en	][2: Regulations (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (OJ L 166, 30.4.2004, p. 1) and 987/2009 laying down the procedure for implementing Regulation (EC) No 883/2004 (OJ L 284, 30.10.2009, p.1).]
sl	][2: Uredba (ES) št. 883/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o koordinaciji sistemov socialne varnosti (UL L 166, 30.4.2004, str. 1) in Uredba (ES) št. 987/2009 o določitvi podrobnih pravil za izvajanje Uredbe (ES) št. 883/2004 (UL L 284, 30.10.2009, str.

en	In 2017 a total of 74,589 enquiries were received across 22 Member States and Norway, reflecting a very similar use of NCPs to that reported for 2016 when a total of 69,723 enquires were counted across 28 Member States and Norway and in 2015 when a total of 59,558 requests were received in 19 Member States.
sl	Leta 2017 je bilo v 22 državah članicah in na Norveškem prejetih skupno 74 589 poizvedb, kar kaže na zelo podobno uporabo nacionalnih kontaktnih točk, kot je bila sporočena za leto 2016, ko je bilo v 28 državah članicah in na Norveškem skupno podanih 69 723 poizvedb, ter za leto 2015, ko je bilo v 19 državah članicah prejetih 59 558 zahtevkov.

en	[49: "Study on Cross-Border Cooperation: Capitalising on existing initiatives for cooperation in cross-border regions", Gesundheit Österreich Forschungs und Planungs GmbH, SOGETI, Maastricht University, 2017][50: See the General Secretariat of the Benelux Union studies, e.g. "Barriers and Opportunities in the Benelux", February 2018.]
sl	[49: „Study on Cross-Border Cooperation: Capitalising on existing initiatives for cooperation in cross-border regions" (Študija o čezmejnem sodelovanju: izkoriščanje obstoječih pobud za sodelovanje v čezmejnih regijah), Gesundheit Österreich Forschungs und Planungs GmbH, SOGETI, Univerza v Maastrichtu, 2017.

en	[52: Article 12(5), read together with Article 12(4)(a).
sl	[52: Člen 12(5) v povezavi s členom 12(4)(a).

en	[11: Recital 38 of the Directive.]
sl	[11: Uvodna izjava 38 Direktive.]

en	Two significant trends emerge from the data on the direction of patient flows, whether it is mobility with or without PA.
sl	Iz podatkov o cilju pretoka pacientov, in to ne glede na to, ali gre za mobilnost s predhodno odobritvijo ali brez nje, izhajata dva pomembna trenda.

en	Firstly, the HTA Network which connects national authorities or bodies responsible for HTA.
sl	Prvi je mreža za ocenjevanje zdravstvenih tehnologij, ki povezuje nacionalne organe ali telesa, pristojne za ocenjevanje zdravstvene tehnologije.

en	[3: Commission Report on the operation of Directive 2011/24/EU on the application of patients' rights in cross-border healthcare, COM(2015) 421 final, 04.09.2015.]
sl	[3: Poročilo Komisije o izvajanju Direktive 2011/24/EU o uveljavljanju pravic pacientov pri čezmejnem zdravstvenem varstvu (COM(2015) 421 final z dne 4. septembra 2015).]

en	Flow Map 2 in Annex B represents the aggregated flows across 2015, 2016 and 2017 for treatment without prior authorisation.
sl	V diagramu pretoka 2 v Prilogi B so prikazani zbirni pretoki v letih 2015, 2016 in 2017 v zvezi z zdravljenjem brez predhodne odobritve.

en	It requires the Commission to prepare a report in respect of the delegated powers.
sl	Komisija mora v skladu s tem členom pripraviti poročilo o pooblastilu.

en	In 2015 the total number of requests granted was 180,704 across 19 Member States plus Norway; in 2016 the number of requests granted over 22 Member States amounted to 209,568; and in 2017 the total number of requests granted was 194,292 across 20 Member States.
sl	Leta 2015 so bili skupno odobreni 180 704 zahtevki v 19 državah članicah in na Norveškem, leta 2016 je bilo odobrenih zahtevkov v 22 državah članicah 209 568, leta 2017 pa v 20 državah članicah 194 292.

en	Flow Map 1 in Annex B represents the aggregated flows across 2015, 2016 and 2017 for treatment requiring prior authorisation.
sl	V diagramu pretoka 1 v Prilogi B so prikazani zbirni pretoki v letih 2015, 2016 in 2017 v zvezi z zdravljenjem, za katero se zahteva predhodna odobritev.

en	][15: See e.g. Case C-205/99 Analir and Others [2001] ECR I 1271, paragraphs 35-38; case C-157/99 Smits and Peerbooms, paragraphs 80- 90.
sl	][15: Glej na primer zadevo C-205/99, Analir in drugi, Recueil 2001, str. I-1271, točke od 35 do 38; zadevo C-157/99, Smits in Peerbooms, točke od 80 do 90.

en	First, the Commission has made a legislative proposal on health technology assessment (see Chapter 4.1).
sl	Komisija je na primer pripravila zakonodajni predlog o ocenjevanju zdravstvene tehnologije (glej poglavje 4.1) ter v sporočilu o digitalni preobrazbi zdravstvenega varstva in oskrbe predlagala nadaljnje ukrepe v zvezi z e-zdravjem (glej poglavje 4.2).

en	A great majority of the issues of compliance examined with Member States at issue have led to a common agreement.
sl	Soglasje je bilo doseženo v zvezi z veliko večino vprašanj glede skladnosti, proučenih z zadevnimi državami članicami.

en	Figure 3: Requests for information made to NCPs
sl	Slika 3: Zahtevki za informacije, ki so jih prejele nacionalne kontaktne točke

en	[17: Article 8(1) of the Directive.]
sl	[17: Člen 8(1) Direktive.]

en	[14: See e.g. Case C205/99 Analir and Others [2001] ECR I1271, paragraph 38; case C-157/99 Smits and Peerbooms, paragraph 90.
sl	[14: Glej na primer zadevo C-205/99, Analir in drugi, Recueil 2001, str. I-1271, točka 38; zadevo C-157/99, Smits in Peerbooms, točka 90.

en	Twenty-one infringement procedures were started for non-communication of national transposal measures.
sl	Ker države članice niso sporočile nacionalnih ukrepov za prenos, je bilo začetih 21 postopkov za ugotavljanje kršitev.

en	Three Member States, with varying conditions and extent, use the former lower reimbursement level as the reference point for reimbursement of the costs of cross-border healthcare under the Directive.
sl	Prejšnjo nižjo stopnjo povračila kot referenčno točko za povračilo stroškov čezmejnega zdravstvenega varstva na podlagi Direktive z različnimi pogoji in v različnem obsegu uporabljajo tri države članice.

en	[18: Article 7(4) of the Directive.]
sl	[18: Člen 7(4) Direktive.]

en	[38: https://ec.europa.eu/health/technology_assessment/eu_cooperation_en][39: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on health technology assessment and amending Directive 2011/24/EU, COM(2018)51 final, 31.01.2018. https://ec.europa.eu/health/technology_assessment/eu_cooperation_en]
sl	][39: Predlog uredbe Evropskega parlamenta in Sveta o ocenjevanju zdravstvene tehnologije in spremembi Direktive 2011/24/EU (COM(2018) 51 final z dne 31. januarja 2018).

en	][7: Article 4(2) (a)-(b), 5(b), 6(3).
sl	][7: Člen 4(2)(a) in (b), člen 5(b) in člen 6(3).

en	Data on patient mobility
sl	Podatki o mobilnosti pacientov

en	Direction of Patient Mobility
sl	Cilj mobilnosti pacientov

en	][42: https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20161121_co10_en.pdf][43: https://ec.europa.eu/health//sites/health/files/ehealth/docs/eprescription_guidelines_en.pdf]
sl	][42: https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20161121_co10_en.pdf.

en	This can lead to certain discrepancies.
sl	Zaradi tega lahko nastanejo določena razhajanja.

en	In such cases this report contains the updated information.
sl	V takih primerih to poročilo vsebuje posodobljene informacije.

en	Traceability.
sl	Sledljivost.

en	In the latter case, an infringement proceeding pursuant to Article 258 TFEU is ongoing.
sl	V tem zadnjem primeru še poteka postopek za ugotavljanje kršitev v skladu s členom 258 PDEU.

en	Import and export.
sl	Uvoz in izvoz.

en	Some Member States would welcome an exchange of best practices in this respect.
sl	Nekatere države članice bi pozdravile izmenjavo dobrih praks v zvezi s tem.

en	Cross-border movement of donors.
sl	Čezmejno gibanje darovalcev.

en	According to reports from Member States, no such penalties have so far been imposed.
sl	Po poročanju držav članic take kazni do zdaj še niso bile uporabljene.

en	Time off work varies from less than half a day to up to two days.
sl	Dopust lahko traja od manj kot pol dneva do dveh dni.

en	Shortages, surpluses and self-sufficiency.
sl	Pomanjkanje, presežek in samozadostnost.

en	At the end of 2011, 1363 blood establishments were authorised in the EU.
sl	Konec leta 2011 je bilo v EU odobrenih 1 363 transfuzijskih ustanov.

en	Member States can add tests for specific components or epidemiological situations.
sl	Države članice lahko dodajo teste za specifične komponente ali epidemiološke razmere.

en	Designation of competent authority or authorities
sl	Imenovanje pristojnega organa ali organov

en	Data protection and confidentiality.
sl	Varstvo podatkov in zaupnost.

en	In all Member States these tests are performed by authorised laboratories.
sl	V vseh državah članicah te teste opravljajo pooblaščeni laboratoriji.

en	Public, national suppliers are predominant in a minority of EU countries.
sl	Javni, nacionalni dobavitelji prevladujejo v manjšini držav EU.

en	The gaps and difficulties identified may suggest that a further in-depth evaluation might be useful.
sl	Ugotovljene vrzeli in težave lahko kažejo, da bi lahko bila koristna nadaljnja podrobnejša ocena.

en	The Commission will follow-up with Member States to address situations where the legislation might not have been fully or correctly implemented.
sl	Komisija bo nadalje spremljala države članice, da bi rešila primere, v katerih se zakonodaja morda ne izvaja v celoti ali ustrezno.

en	Combining the implementation of all three pillars, where possible, is probably the most effective way to minimise risks.
sl	Združevanje izvajanja vseh treh stebrov, kadar je to mogoče, je verjetno najučinkovitejši način za zmanjšanje tveganj na najnižjo mogočo raven.

en	No problems were reported regarding the implementation of the provisions related to data protection.
sl	V zvezi z izvajanjem določb o varstvu podatkov niso bile sporočene nobene težave.

en	The Commission is required to transmit these national reports to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.
sl	Komisija mora ta nacionalna poročila poslati Evropskemu parlamentu, Svetu, Ekonomsko-socialnemu odboru in Odboru regij.

en	Views vary on whether such cross-border donations are desirable.
sl	Mnenja o tem, ali so taka čezmejna darovanja zaželena, se razlikujejo.

en	Significant progress has been made in many areas, often through the active support of Commission funded projects and other initiatives.
sl	Na številnih področjih je napredek znaten, pogosto zaradi dejavne podpore projektov, ki jih financira Komisija, in drugih pobud.

en	[7: Links to be added once published]
sl	[7: Povezave bodo dodane, ko bosta objavljena.]

en	There are a small number of international companies that supply the majority of countries.
sl	Majhno število mednarodnih družb dobavlja večini držav.

en	Several Member States expressed interest in applying instead a risk-based prioritisation planning for inspections.
sl	Več držav članic je izrazilo zanimanje, da se namesto tega uporabi prednostno načrtovanje inšpekcijskih pregledov na podlagi tveganja.

en	Some Member States called for more common procedures for authorisation across the Union.
sl	Nekatere države članice so pozvale k enotnejšim postopkom odobritve po vsej Uniji.

en	In 2012, 22 countries reported having performed 760 on-site inspections.
sl	Leta 2012 je 22 držav poročalo, da je bilo opravljenih 760 inšpekcijskih pregledov na kraju samem.

en	All Member States replied to the transposition questionnaire.
sl	Vse države članice so odgovorile na vprašalnik o prenosu.

en	Irrespective of the organisational set-up, it is important that authorities have appropriate resources at their disposal to enable them to carry out the required duties, as well as to ensure their independence from economic operators in the sector and from other influences.
sl	Ne glede na organizacijsko strukturo je pomembno, da imajo organi na voljo ustrezne vire, ki jim omogočajo opravljanje zahtevanih nalog ter zagotavljajo njihovo neodvisnost od gospodarskih subjektov v sektorju in od drugih vplivov.

en	Voluntary and unpaid donation (VUD)
sl	Prostovoljno in brezplačno darovanje (PBD)

en	One national competent authority has taken the lead on developing such an initiative within the network of national competent authorities.
sl	Eden od nacionalnih pristojnih organov je prevzel vodilno vlogo pri razvoju take pobude znotraj mreže nacionalnih pristojnih organov.

en	All Member States have appointed competent authorities for blood.
sl	Vse države članice so imenovale pristojne organe za kri.

en	In some Member States, donors receive a fixed payment that is not directly related to actual costs incurred.
sl	V nekaterih državah članicah darovalci prejmejo fiksno plačilo, ki ni neposredno povezano z dejanskimi stroški.

en	VUD is a factor which is not only ethical in nature, but which might also contribute to higher safety standards and, therefore, be important for the protection of human health.
sl	PBD je dejavnik, ki ni zgolj etičen, temveč lahko prispeva tudi k višjim varnostnim standardom ter je zato lahko pomemben za varstvo zdravja ljudi.

en	These authorisations also cover 731 mobile sites, 534 satellite sites and 253 plasma collection centres.
sl	Te odobritve vključujejo tudi 731 mobilnih enot, 534 satelitskih enot in 253 centrov za zbiranje krvne plazme.

en	The Commission will consider the need for an evaluation in order to assess the relevance, effectiveness, efficiency, coherence and the EU added value of Directive 2002/98/EC and its implementing Directives.
sl	Komisija bo razmislila o potrebi po ocenjevanju za ovrednotenje ustreznosti, učinkovitosti, uspešnosti, skladnosti in dodane vrednosti EU Direktive 2002/98/ES in njenih izvedbenih direktiv.

en	Inspections and control measures.
sl	Inšpekcijski pregledi in kontrolni ukrepi.

en	Fig. 4: Countries reporting regular shortages
sl	Slika 4: Države, ki poročajo o rednem pomanjkanju

en	Testing and inactivation technologies.
sl	Testiranje in tehnologije inaktivacije.

en	However, some difficulties in interpretation, implementation and enforcement of the legislation were identified, in some cases due to technological and scientific advances since its adoption.
sl	Vendar je bilo ugotovljenih nekaj težav pri razlagi, izvajanju in izvrševanju zakonodaje, v nekaterih primerih zaradi tehnološkega in znanstvenega napredka od njenega sprejetja.

en	In almost every country, donation promotion activities are the main actions taken to increase supply.
sl	V skoraj vseh državah so dejavnosti spodbujanja darovanja glavni ukrepi za povečanje dobave.

en	Quality and safety of blood and blood components
sl	Kakovost in varnost krvi in komponent krvi

en	Less than half of the countries reported having national guiding principles to define what form of compensation or other practice is allowed and under which circumstances.
sl	Manj kot polovica držav je poročala, da imajo nacionalna vodilna načela za opredelitev, katera oblika nadomestila ali druga praksa je dovoljena in v kakšnih okoliščinah.

en	This topic is intrinsically linked with the promotion and success of the principle of VUD, as highlighted in recital 23 of Directive 2002/98/EC.
sl	Ta tema je neločljivo povezana s spodbujanjem in uspehom načela PBD, kot je poudarjeno v uvodni izjavi 23 Direktive 2002/98/ES.

en	The implementation survey confirmed that this core responsibility of national competent authorities is well developed across the Union.
sl	Anketa o izvajanju je potrdila, da je ta ključna odgovornost nacionalnih pristojnih organov dobro razvita po vsej Uniji.

en	There are differences between Member States in relation to the duration and terms of renewal of the individual authorisations.
sl	Med državami članicami obstajajo razlike glede trajanja in pogojev obnove posameznih odobritev.

en	The UK and Ireland apply this policy as part of their risk mitigation strategy for transmission of variant Creutzfeldt Jacob disease.
sl	Združeno kraljestvo in Irska to politiko uporabljata kot del strategije za blažitev tveganj prenosa različice Creutzfeldt-Jacobove bolezni.

en	In order to address shortages, countries can put in place policies to increase supply and to optimise usage.
sl	Za reševanje težav s pomanjkanjem lahko države vzpostavijo politike za povečanje dobave in optimizacijo uporabe.

en	The ways in which EU Member States have implemented the principle of VUD are difficult to assess in a comprehensive manner.
sl	Načine, kako države članice EU izvajajo načelo PBD, je težko celovito oceniti.

en	Reimbursement of travel costs can cover the actual costs or be a standard lump sum.
sl	Povračilo potnih stroškov lahko krije dejanske stroške ali pa je izplačano v obliki standardnega pavšalnega zneska.

en	Almost all countries report that a donor identification system was implemented in their country, in the majority of countries at national level.
sl	Skoraj vse države poročajo, da je bil v njihovi državi vzpostavljen sistem identifikacije darovalcev, v večini držav na nacionalni ravni.

en	A verification of the completeness of transposition into national legislation of the EU blood legislation, carried out by the Commission, demonstrated that it is fully transposed in all but one Member State.
sl	Preverjanje popolnosti prenosa zakonodaje EU o krvi v nacionalno zakonodajo, ki ga je izvedla Komisija, je pokazalo, da je v celoti prenesena v vseh državah članicah, razen v eni.

en	There appears to be a good interconnectivity with other health-related vigilance systems, in particular on medical devices and communicable diseases.
sl	Videti je, da obstaja dobra medsebojna povezanost z drugimi sistemi vigilance v zvezi z zdravjem, zlasti glede medicinskih pripomočkov in nalezljivih bolezni.

en	Accreditation, designation, authorisation or licensing of blood establishments.
sl	Akreditacija, imenovanje, odobritev ali izdajanje dovoljenj transfuzijskim ustanovam.

en	Other challenges to the principle of (self-) sufficiency are outlined below.
sl	Spodaj so prikazane še druge težave v zvezi z načelom (samo)zadostnosti.

en	Wherever different oversight activities (authorisation, inspection, haemovigilance) are undertaken by different authorities, good communication and coordination between respective authorities needs to be ensured.
sl	Kadar različne nadzorne dejavnosti (odobritev, inšpekcija, hemovigilanca) izvajajo različni organi, je treba zagotoviti dobro komunikacijo in usklajevanje med zadevnimi organi.

en	Since 2003, a number of projects have been funded under the multi-annual programmes for Union action in the field of health addressing the area of blood and blood components.
sl	Od leta 2003 je bilo financiranih več projektov v okviru večletnih programov za ukrepanje Unije na področju zdravja, ki so se nanašali na kri in komponente krvi.

en	The debate on possible compensation and incentives for donors plays an important role in supply management (see below).
sl	Razprava o morebitnem nadomestilu in spodbudah za darovalce ima pomembno vlogo pri upravljanju dobave (glej spodaj).

en	The VUD survey addressed questions on the balance between supply and demand, and the measures taken to achieve sufficiency.
sl	Anketa o PBD se je nanašala na vprašanja ravnotežja med ponudbo in povpraševanjem ter ukrepe, sprejete za zagotovitev zadostnosti.

en	Finally, the Commission developed, in close cooperation with the Member States, a Rapid Alert Platform for Blood (RAB) which facilitates web-based communications between Member States in case of alerts with relevance in two or more Member States.
sl	Nazadnje, Komisija je v tesnem sodelovanju z državami članicami razvila platformo za hitro obveščanje o krvi (RAB), ki olajšuje spletno komuniciranje med državami članicami v primeru opozoril, ki se nanašajo na dve ali več držav članic.

en	Member States also highlight the need for good validation of testing technologies, and also pathogen inactivation technologies, in order to achieve an effective level of safety and quality.
sl	Države članice poudarjajo tudi potrebo po dobri validaciji tehnologij testiranja in tehnologij inaktivacije patogenov za dosego učinkovite stopnje varnosti in kakovosti.

en	They reported conducting additional tests for syphilis, malaria, hepatitis A, hepatitis E and Parvovirus B19.
sl	Poročale so o izvajanju dodatnih testov za sifilis, malarijo, hepatitis A, hepatitis E in parvovirus B19.

en	While most cross-border donations seem to be individual initiatives, Hungary and Slovakia reported organised transport for their citizens to travel to Austria for plasma donation.
sl	Medtem ko je za večino čezmejnih darovanj videti, da gre za individualno pobudo, sta Madžarska in Slovaška poročali o organiziranem prevozu državljanov, ki potujejo v Avstrijo darovat krvno plazmo.

en	In a system allowing donor payment, some individuals may find the monetary remuneration so important that they might not disclose relevant medical and/or behavioural information.
sl	V sistemu, ki bi dovoljeval plačevanje darovalcem, bi lahko bila denarna nagrada za nekatere tako pomembna, da ne bi razkrili bistvenih zdravstvenih in/ali vedenjskih informacij.

en	Article 26 of Directive 2002/98/EC requires Member States to submit to the European Commission, before 31 December 2003 and every three years thereafter, a report on the activities carried out in relation to the provisions of the Directive, including an account of the measures taken in relation to inspection and control.
sl	V skladu s členom 26 Direktive 2002/98/ES morajo države članice pred 31. decembrom 2003 in nato vsaka tri leta Evropski komisiji predložiti poročilo o dejavnostih, ki se izvajajo v zvezi z določbami navedene direktive, skupaj s poročilom o ukrepih, sprejetih v zvezi z inšpekcijskim pregledom in kontrolo.

en	On the basis of these national reports, the Commission is required to inform the European Parliament and the Council of any necessary further measures in relation to VUD it intends to take at Union level.
sl	Komisija mora na podlagi teh nacionalnih poročil Evropski parlament in Svet obvestiti o morebitnih nadaljnjih potrebnih ukrepih v zvezi s PBD, ki jih namerava sprejeti na ravni Unije.

en	3.2 Obligations of blood competent authorities
sl	3.2 Obveznosti pristojnih organov za kri

en	The European Commission has been supporting the implementation of the legislation by the Member States by encouraging the active participation of national Competent Authorities in a series of actions, from bi-annual expert meetings to EU-funded projects.
sl	Evropska komisija podpira izvajanje zakonodaje s strani držav članic s spodbujanjem dejavnega sodelovanja nacionalnih pristojnih organov v več dejavnostih, od dveletnih strokovnih srečanj do projektov, ki jih financira EU.

en	Many countries reported financially supporting blood establishments and local players in the organisation of such promotion activities (although the financial support in many of these countries also relates to collection, processing, storage and distribution activities).
sl	Številne države so poročale, da finančno podpirajo transfuzijske ustanove in lokalne akterje pri organizaciji takih dejavnosti spodbujanja (čeprav se finančna podpora v številnih od teh držav nanaša tudi na dejavnosti zbiranja, predelave, shranjevanja in razdeljevanja).

en	While two of these latter six countries also report regular shortages in national supply, the information provided was not sufficient to establish a causal link between these shortages and the cross-border movement of donors.
sl	Čeprav sta dve od teh zadnjih šestih držav poročali tudi o rednem pomanjkanju v nacionalni dobavi, poslane informacije niso bile zadostne, da bi lahko sklepali o vzročni povezavi med tem pomanjkanjem in čezmejnim gibanjem darovalcev.

en	The maximum reported values of compensation and incentives are around EUR 25-30 per donation while the reported values of refreshments and small tokens are between EUR 1 and EUR 10 per donation.
sl	Najvišja sporočena vrednost nadomestil in spodbud je približno 25 EUR-30 EUR na darovanje, medtem ko je sporočena vrednost okrepčil in majhnih daril med 1 EUR in 10 EUR na darovanje.

en	Several Member States mentioned the limited role of authorities at federal/national level and pointed to the important tasks attributed to/carried out by regional competent authorities.
sl	Več držav članic je omenilo omejeno vlogo organov na zvezni/nacionalni ravni in opozorilo na pomembne naloge, ki so dodeljene regionalnim pristojnim organom/jih regionalni pristojni organi izvajajo.

en	While all countries report having recall procedures in place, only 14 reported recalls (1867 in total).
sl	Medtem ko vse države poročajo, da imajo vzpostavljene postopke za odpoklic, jih je o odpoklicih poročalo samo 14 (skupaj 1 867 primerov).

en	The Commission is also required to provide them with an overview report on the implementation of the requirements of the Directive, in particular as regards inspections and control.
sl	Predložiti jim mora tudi pregledno poročilo o izvajanju zahtev Direktive, zlasti glede inšpekcijske in kontrolnih ukrepov.

en	As the legislation in question does not provide a basis for full harmonisation and as Directives allow the Member States a certain degree of discretion as to how to ensure their implementation, there are accordingly many differences between Member States in the approaches they have taken to implementation.
sl	Ker zadevna zakonodaja ne daje podlage za popolno uskladitev in ker direktive državam članicam dopuščajo določeno stopnjo proste presoje glede tega, kako zagotoviti njihovo izvajanje, med državami članicami obstajajo številne razlike v pristopih k izvajanju.

en	To facilitate good regulatory communication between Member States, as well as to comply with the annual reporting requirements to the Commission, a well-informed national coordinating contact point is essential, even where competent authority responsibilities are shared among multiple organisations or regions.
sl	Za dobro regulativno komunikacijo med državami članicami in izpolnjevanje zahtev po letnem poročanju Komisiji je bistvena dobro obveščena nacionalna usklajevalna kontaktna točka, tudi če so odgovornosti pristojnih organov razdeljene na več organizacij ali regij.

en	Every change in deferral, testing or pathogen inactivation policy has a possible impact not only on safety and quality, but also on the economics and on the volume of donations and supply.
sl	Vsaka sprememba politike glede odklona, testiranja ali inaktivacije patogenov lahko vpliva tako na varnost in kakovost kot tudi na ekonomičnost ter količino darovanj in dobave.

en	It is important to note that the hyperlinks contain the original replies of Member States, whilst the report reflects the updated information provided by Member States.
sl	Opozoriti je treba, da povezave vsebujejo prvotne odgovore držav članic, medtem ko so v poročilu upoštevane posodobljene informacije, ki so jih poslale države članice.

en	These policies involve players at multiple levels, national competent authorities as well as local clinicians.
sl	Te politike vključujejo akterje na več ravneh, nacionalne pristojne organe in lokalne klinične zdravnike.

en	These actions brought improvements in areas of common interest such as quality management and inspection and donor selection and included training courses for Member States Competent Authorities and their inspectors.
sl	Ti ukrepi so prinesli izboljšanja na področjih, ki so v splošnem interesu, kot so upravljanje kakovosti, inšpekcija in izbira darovalcev, ter so vključevali usposabljanja za pristojne organe držav članic in njihove inšpektorje.

en	The service contract aims to develop best practices, which could allow for a significant reduction of blood demand for many treatments.
sl	Namen naročila storitev je razviti dobre prakse, ki bi lahko omogočile znatno zmanjšanje potrebe po krvi pri številnih zdravljenjih.

en	From an EU perspective, the relevant question is whether blood collected from these donors might have a different safety and quality profile (see below).
sl	Z vidika EU je pomembno vprašanje, ali ima lahko kri, zbrana od teh darovalcev, drugačne lastnosti glede varnosti in kakovost (glej spodaj).

en	These shortages often occur in summer/holiday seasons when the number of donors is reduced and the risk of epidemiological outbreaks, such as West Nile Virus, can temporarily reduce the number of eligible donors.
sl	Do takega pomanjkanja pogosto pride poleti / med počitnicami, ko je število darovalcev manjše in lahko nevarnost epidemioloških izbruhov, kot je izbruh virusa zahodnega Nila, začasno zmanjša število ustreznih darovalcev.

en	In almost all countries, the inspections of blood establishments overlap with inspections in other areas.
sl	Skoraj v vseh državah se inšpekcijski pregledi transfuzijskih ustanov prekrivajo z inšpekcijskimi pregledi na drugih področjih.

en	A limited number of countries report surpluses for some blood components which indicates the potential for cross-border agreements.
sl	Omejeno število držav poroča o presežku nekaterih komponent krvi, kar kaže na možnost čezmejnih sporazumov.

en	Policies towards them vary, from prohibition to seeing replacement donations as an opportunity to contribute to national self-sufficiency by converting them into regular donors.
sl	Politike v odnosu do njih so različne, od prepovedi do razumevanja nadomestnega darovanja kot priložnosti za prispevanje k nacionalni samozadostnosti, tako da postanejo redni darovalci.

en	The value of international projects, at EU level and organised by the Council of Europe, are clearly appreciated by most of the national competent authorities as a means to help maintain an adequate level of training and know-how within the group of inspectors and to help ensure a uniform level of compliance verification throughout the EU.
sl	Večina nacionalnih pristojnih organov očitno ceni mednarodne projekte, tiste na ravni EU in tiste, ki jih organizira Svet Evrope, kot pomoč pri vzdrževanju ustrezne ravni usposabljanja in strokovnega znanja v skupini inšpektorjev ter pomoč pri zagotavljanju enotne ravni preverjanja skladnosti po vsej EU.

en	Overall, the implementation of the EU blood legislation by Member States is considered adequate and the legislation has resulted in the establishment of a network of competent authorities that oversee the field through authorisation, inspection, and vigilance.
sl	Na splošno se izvajanje zakonodaje EU o krvi šteje za ustrezno, zaradi zakonodaje pa je bila vzpostavljena mreža pristojnih organov, ki to področje nadzorujejo z odobritvami, inšpekcijo in vigilanco.

en	In contrast, 47-48% considered that receiving refreshments, free blood testing or a free physical check-up were acceptable.
sl	Nasprotno jih je 47 %-48 % menilo, da je sprejemljivo prejetje okrepčil, brezplačno testiranje krvi ali brezplačen zdravniški pregled.

en	The practical application of the VUD principle varies across the Union.
sl	Praktična uporaba načela PBD se po Uniji razlikuje.

en	Although the large majority of the responding countries (26) reported that the principle of VUD is mandatory at national level, their legislations often refer to an "encouragement" or to a "strong recommendation".
sl	Čeprav je velika večina držav, ki so se odzvale (26), poročala, da je načelo PBD obvezno na nacionalni ravni, njihove zakonodaje pogosto govorijo o „spodbujanju" ali „močno priporočljivem" ravnanju.

en	Most countries have additional supportive measures in place, primarily focused on promoting VUD or defining compensation and incentives (see below).
sl	Večina držav je sprejela dodatne podporne ukrepe, ki so osredotočeni predvsem na spodbujanje PBD ali opredelitev nadomestil in spodbud (glej spodaj).

en	Overall, Member States expressed interest in an increased level of donor protection and in an overview of additional national eligibility criteria in order to increase transparency and mutual trust in exchanges.
sl	Na splošno so države članice izrazile zanimanje za povečano stopnjo zaščite darovalcev in pregled dodatnih nacionalnih meril za ustreznost, da bi izboljšale preglednost in medsebojno zaupanje pri izmenjavah.

en	The 2013 implementation survey was answered by all Member States and also by two EEA countries, Liechtenstein and Norway.
sl	Na anketo o izvajanju iz leta 2013 so odgovorile vse države članice in dve državi EGP, in sicer Lihtenštajn in Norveška.

en	Fig. 2: Overlapping inspection schemes
sl	Slika 2: Prekrivajoči se inšpekcijski programi

en	Countries identify an increase of the maximum donor age as the most promising initiative to improve the supply of blood and blood components.
sl	Države ugotavljajo, da je povečanje najvišje dovoljene starosti darovalca najobetavnejša pobuda za izboljšanje dobave krvi in komponent krvi.

en	Countries also see value in further centralisation of laboratory test results at EU level to facilitate benchmarking against average EU rates of positivity.
sl	Državam se zdi koristna tudi nadaljnja centralizacija rezultatov laboratorijskih testov na ravni EU za lažjo primerjavo s povprečnimi stopnjami pozitivnosti v EU.

en	The global growth of utilisation of plasma derivatives, particularly intravenous immunoglobulin (IVIG), requires a growing number of donations.
sl	Zaradi splošne rasti uporabe derivatov krvne plazme, zlasti intravenskih imunoglobulinov (IVIG), je potrebno vse večje število darovalcev.

en	Projects such as EUBIS, CATIE, DOMAINE, Optimal Blood Use, EU-Q-Blood-SOP and the on-going joint action VISTART provide strong support to Member States in their efforts to implement the requirements of the blood directives.
sl	Projekti, kot so EUBIS, CATIE, DOMAINE, Optimal Blood Use, EU-Q-Blood-SOP in trenutni skupni ukrep VISTART, so državam članicam v veliko oporo pri prizadevanjih za izvajanje zahtev direktiv o krvi.

en	Ten countries reported facilitating donations by donors from abroad by providing donor questionnaires in different languages.
sl	Deset držav je poročalo o tem, da so olajšale darovanje za darovalce iz tujine z zagotovitvijo vprašalnikov za darovalce v različnih jezikih.

en	These differences facilitate successful integration of the requirements into national legislation but in some cases they may limit the mutual acceptance of authorisations with consequences for potential cross-border movement of blood and blood components.
sl	Te razlike omogočajo uspešno vključitev zahtev v nacionalno zakonodajo, vendar lahko v nekaterih primerih omejijo vzajemno priznavanje odobritev, kar pomeni posledice za morebitni čezmejni prenos krvi in komponent krvi.

en	Fig. 5: Policy setting to ensure effective use of blood, blood components and plasma derivatives
sl	Slika 5: Oblikovanje politike za zagotovitev učinkovite uporabe krvi, komponent krvi in derivatov krvne plazme

en	Eight countries reported regular shortages of one or more blood components in the survey.
sl	V anketi je osem držav poročalo o rednem pomanjkanju ene ali več komponent krvi.

en	Many countries are largely supplied with plasma derivatives by just one supplier, either public or private.
sl	Številne države večinoma dobivajo derivate krvne plazme od enega samega dobavitelja, javnega ali zasebnega.

en	However, Member States' perceptions of what is considered compensation and incentive vary.
sl	Vendar se razlage držav članic, kaj se šteje za nadomestilo in spodbudo, razlikujejo.

en	There is considerable heterogeneity across the EU, with certain practices perceived as compensation in one country and as incentives in another.
sl	V EU obstaja precejšnja raznolikost, pri čemer se nekatere prakse v eni državi štejejo za nadomestilo, v drugi pa za spodbudo.

en	However, the Report also points to some gaps and difficulties in relation to the application and enforcement of the existing provisions (e.g. definitions, provisions for donor safety, inspections framework), some due to different approaches taken by the Member States and others due to technological advances and changing risks observed since the legislation was adopted.
sl	Vendar poročilo kaže tudi na nekatere vrzeli in težave v zvezi z uporabo in izvrševanjem obstoječih določb (npr. opredelitve, določbe o varnosti darovalcev, okvir inšpekcijskih pregledov), pri čemer so nekatere posledica različnih pristopov držav članic, druge pa tehnološkega napredka in sprememb v tveganjih, ugotovljenih od sprejetja zakonodaje.

en	Sixteen reported discouraging such donations by requiring a local ID document or a proof or local residence.
sl	Šestnajst jih je poročalo o odvračanju od takega darovanja z zahtevo po lokalnem osebnem dokumentu ali dokazilu o lokalnem prebivališču.

en	In addition, and in accordance with Article 20(2) of the Directive 2002/98/EC, Member States have to submit to the Commission reports on the application of the principle of voluntary and unpaid donation (VUD) every three years.
sl	Poleg tega morajo države članice v skladu s členom 20(2) Direktive 2002/98/ES Komisiji vsaka tri leta predložiti poročila o uporabi načela prostovoljnega in brezplačnega darovanja (PBD).

en	Most common are awareness building campaigns for specific donor groups, such as students, or events such as the World Blood Donor Day (WHO, 14 June) or Thalassemia day (8 May in Greece and Cyprus).
sl	Najpogostejše so kampanje ozaveščanja za posebne skupine darovalcev, kot so študenti, ali dogodki, kot sta svetovni dan krvodajalcev (SZO, 14. junij) ali dan talasemije (8. maj v Grčiji in na Cipru).

en	Fig. 1: Additional fields of competence for national blood competent authorities
sl	Slika 1: Dodatna področja pristojnosti za nacionalne pristojne organe za kri

en	In half of the countries one authority is responsible for the entire oversight of the blood sector, whereas in others the tasks are divided amongst two or three authorities (based on duties, e.g. accreditation/authorisation versus inspections/vigilance, or based on the allocation of tasks between federal and regional levels).
sl	V polovici držav je en organ odgovoren za celoten nadzor nad sektorjem krvi, v drugih pa so naloge razdeljene med dva ali tri organe (glede na naloge, npr. akreditacija/odobritev v primerjavi z inšpekcijskim pregledom/vigilanco, ali glede na razdelitev nalog med zvezno in regionalno ravnjo).

en	While many countries report having data on imported volumes, it is difficult to draw conclusions in the absence of a harmonised data collection system on import and export volumes.
sl	Čeprav številne države poročajo, da imajo podatke o količini uvoza, je iz njih težko sklepati, ker ni usklajenega sistema zbiranja podatkov o količinah uvoza in izvoza.

en	In contrast to blood components for transfusion, the demand for plasma derivatives is steadily increasing (around 6% per year) which also generates import flows from third countries into the EU.
sl	Povpraševanje po derivatih krvne plazme v nasprotju s komponentami krvi za transfuzijo stalno narašča (za približno 6 % letno), kar tudi ustvarja uvozne tokove iz tretjih držav v EU.

en	The ageing EU population could exacerbate supply challenges, leading both to increased demand and reduced numbers of eligible donors.
sl	Zaradi staranja prebivalstva EU se lahko izzivi glede dobave povečajo, saj to pomeni povečano povpraševanje in zmanjšano število ustreznih darovalcev.

en	Seventeen Member States reported having penalties in place, addressing different situations such as making financial gain or collection of donations without consent.
sl	Sedemnajst držav članic je poročalo, da so pri njih uvedene kazni za različne primere, kot je pridobivanje finančne koristi ali zbiranje darovanj brez soglasja.

en	All Member States, Liechtenstein and Norway also provided answers to the survey on the implementation of the principle of VUD.
sl	Vse države članice ter Lihtenštajn in Norveška so predložili tudi odgovore na anketo o izvajanju načela PBD.

en	As regards the risk of transmission of communicable diseases thorough blood and blood components, the collaboration with ECDC proved extremely valuable.
sl	Kar zadeva tveganje prenosa nalezljivih bolezni prek krvi in komponent krvi, se je sodelovanje z Evropskim centrom za preprečevanje in obvladovanje bolezni (ECDC) izkazalo za izredno dragoceno.

en	Many countries reported in 2013 on the feasibility/appropriateness of deferring donors on the grounds of sexual risk behaviour and about two-thirds of the countries have national guidance in place.
sl	Leta 2013 so številne države poročale o izvedljivosti/ustreznosti odklona darovalcev zaradi tveganega (spolnega) vedenja, približno dve tretjini držav pa ima glede tega sprejeta nacionalna navodila.

en	Sixteen countries report having pathogen inactivation technologies in place.
sl	Šestnajst držav poroča, da imajo vzpostavljene tehnologije inaktivacije patogenov.

en	Other Member States reported to be negotiating agreements for fractionation, while one reported having difficulties finding a partner to carry out fractionation.
sl	Druge države članice so poročale, da se pogajajo o sporazumih o frakcioniranju, medtem ko je ena poročala, da ima težave pri iskanju partnerja za izvajanje frakcioniranja.

en	In the vast majority of Member States, the authorities for blood are also responsible for the oversight of other sectors (e.g. organs, tissues, cells and/or medicinal products), which can be beneficial for achieving greater efficiency and coherence.
sl	V veliki večini držav članic so organi za kri odgovorni tudi za nadzor nad drugimi sektorji (npr. organi, tkiva, celice in/ali zdravila), kar je lahko koristno z vidika učinkovitosti in skladnosti.

en	Additionally, the distinction between import/export from/to third countries and distribution from/to other EU Member States is not consistently applied.
sl	Poleg tega ni doslednega razlikovanja med uvozom v tretje države oz. izvozom iz njih ter razdeljevanjem iz drugih držav članic EU in vanje.

en	Therefore, information provided by the donor contributes to an accurate assessment of all risks associated to the transfusion of blood and blood components and the clinical application of plasma derivatives.
sl	Zato informacije, ki jih predloži darovalec, prispevajo k točni oceni vseh tveganj v zvezi s transfuzijo krvi in komponent krvi ter klinično uporabo derivatov krvne plazme.

en	For the purpose of the survey, "compensation" was defined as "reparation strictly limited to making good the expenses and inconveniences related to the donation" and "incentive" was defined as "inducement or stimulus for donation with a view to seeking financial gain or comparable advantage", but even with these (non-binding) definitions Member States reached divergent classifications.
sl	Za namene ankete je bilo „nadomestilo" opredeljeno kot „odškodnina, strogo omejena na povračilo stroškov in kompenzacijo za neprijetnosti v zvezi z darovanjem", „spodbuda" pa kot „stimulacija ali motivacija za darovanje za pridobitev finančne koristi ali podobne ugodnosti", vendar so države članice kljub tem (nezavezujočim) opredelitvam uporabile različne razvrstitve.

en	A majority of countries report having policies to also optimise the clinical use of plasma derivatives, with a small number of countries having national prioritisation strategies to ensure supply to those patient groups who are highly dependent on treatment with these products.
sl	Večina držav poroča, da imajo tudi politike za optimiziranje klinične uporabe derivatov krvne plazme, majhno število držav pa ima nacionalne strategije za prednostno razvrščanje za zagotovitev dobave tistim skupinam pacientov, ki so močno odvisni od zdravljenja s temi pripravki.

en	The majority of Member States have rules to authorise and control import of blood and blood components for transfusion, while only about half have such rules for plasma for fractionation.
sl	Večina držav članic ima pravila za odobritev in kontrolo uvoza krvi in komponent krvi za transfuzijo, medtem ko jih ima taka pravila za krvno plazmo za frakcioniranje samo približno polovica.

en	National rules for export often limit or place conditions on export of blood and blood components, e.g. only in situations of emergency, which is seen by many countries as part of their national policy to ensure self-sufficiency (see below).
sl	Nacionalna pravila o izvozu pogosto omejujejo izvoz krvi in komponent krvi ali zanj postavljajo pogoje, na primer samo v nujnih primerih, kar številne države razumejo kot del svoje nacionalne politike za zagotavljanje samozadostnosti (glej spodaj).

en	Besides complying with the legal obligations, the current report sets out how Directive 2002/98/EC and its implementing Directives 2004/33/EC, 2005/61/EC and 2005/62/EC (henceforth commonly referred to as the EU blood legislation) function in practice, against a backdrop of significant scientific and organisational developments (internationalisation, commercialisation) that have taken place in the European blood and blood components sector over the past decade.
sl	Poleg tega, da se s tem poročilom izpolnjujejo zakonske obveznosti, je v njem prikazano, kako Direktiva 2002/98/ES ter izvedbene direktive 2004/33/ES, 2005/61/ES in 2005/62/ES (v nadaljnjem besedilu skupaj: zakonodaja EU o krvi) delujejo v praksi glede na znaten znanstveni in organizacijski razvoj (internacionalizacija, komercializacija) v sektorju krvi in komponent krvi v zadnjem desetletju.

en	Safety and quality of blood depends on the implementation of a combination of three pillars: donor screening for deferral criteria, donor testing and, where possible, pathogen inactivation techniques.
sl	Varnost in kakovost krvi sta odvisni od izvajanja kombinacije treh stebrov: presejalni test darovalcev glede na merila za odklon, testiranje darovalcev in, kadar je to mogoče, tehnike inaktivacije patogenov.

en	Also the inspection approaches vary significantly towards mobile and satellite sites, hospital blood banks, plasma collection centres and potential third country players.
sl	Pristopi k inšpekcijskim pregledom se znatno razlikujejo tudi pri mobilnih in satelitskih enotah, transfuzijskih bankah v bolnišnicah, centrih za zbiranje krvne plazme in morebitnih akterjih iz tretjih držav.

en	Although the definition of serious adverse reaction (SAR) in Directive 2002/98/EC, Article 3, gives equal importance to SAR in donors and in recipients, the current requirements refer only to reporting of SAR in recipients.
sl	Čeprav opredelitev hude neželene reakcije iz člena 3 Direktive 2002/98/ES daje enak pomen hudim neželenim reakcijam pri darovalcih in prejemnikih, se sedanje zahteve nanašajo samo na poročanje o hudih neželenih reakcijah pri prejemnikih.

en	The main causes leading to deferrals of candidate donors reported by Member States were low haemoglobin levels (putting at risk the health of the donor) as well as risk of transmission of infectious diseases, (sexual) risk behaviours, travel, medication and other medical reasons (putting the health of the recipient at risk).
sl	Glavni vzroki za odklon kandidatov za darovalce, o katerih so poročale države članice, so bili nizka raven hemoglobina (ki ogroža zdravje darovalca) ter nevarnost prenosa nalezljivih bolezni, tvegano (spolno) vedenje, potovanje, jemanje zdravil in drugi zdravstveni razlogi (ki ogrožajo zdravje prejemnika).

en	The authorities interact effectively with the RAB system, although many mention a need to improve communication of the information from RAB to the local blood establishments, which needs to be accomplished at national level.
sl	Organi učinkovito sodelujejo prek sistema RAB, čeprav številni navajajo, da je treba izboljšati pošiljanje informacij lokalnim transfuzijskim ustanovam od RAB, kar je treba doseči na nacionalni ravni.

en	Whilst overall Member States seem to correctly implement the provisions concerning inspections, a number of Member States reported difficulties related to staffing, which makes compliance with the required 2-year inspection interval challenging.
sl	Medtem ko je videti, da države članice na splošno ustrezno izvajajo določbe glede inšpekcijskih pregledov, je več držav članic poročalo o kadrovskih težavah, zaradi česar je težko izpolniti zahteve v zvezi z dveletnimi inšpekcijskimi pregledi.

en	Most countries organise root cause analyses to understand the reasons behind SARE, however there is a generally reported interest in developing this approach further, in particular to address the challenge of involving local professionals and hospitals in these analyses.
sl	Večina držav organizira analize izvornega vzroka, da bi razumele razloge za hude neželene reakcije in dogodke, vendar na splošno poročajo o interesu za nadaljnji razvoj tega pristopa, zlasti za spopadanje z izzivom, da bi v take analize vključili lokalne strokovnjake in bolnišnice.

en	Rules for export of plasma for fractionation are usually less restrictive, although practice was reported of plasma export for contract fractionation of derivatives which are subsequently to be used for patients only in the country of collection.
sl	Pravila o izvozu krvne plazme za frakcioniranje so običajno manj omejevalna, čeprav se poroča o praksi izvoza krvne plazme za pogodbeno frakcioniranje derivatov, ki se nato uporabijo samo za paciente v državi zbiranja.

en	To engage these local stakeholders, countries mention the use of audits and programmes such as the implementation of patient blood management (PBM) (for which there is currently a tendered study on-going under the Union's Third Health Programme).
sl	Države za vključitev teh lokalnih deležnikov navajajo uporabo revizij in programov, kot je izvajanje upravljanja krvi pacientov (glede katerega trenutno v okviru tretjega progama zdravja Unije poteka študija, ki se izvaja na podlagi javnega razpisa).

en	EU legislation defines the minimum serological testing for human immunodeficiency virus (HIV) 1/2, hepatitis B and hepatitis C to be carried out for every whole blood and apheresis donation.
sl	Zakonodaja EU opredeljuje minimalno serološko testiranje na virus človeške imunske pomanjkljivosti (HIV) 1/2, hepatitis B in hepatitis C, ki ga je treba opraviti pri vsakem darovanju polne krvi in darovanju z uporabo afereze.

en	The full analysis of the Member States' replies to the 2013 implementation survey and the 2014 survey on the implementation of the VUD principle is included in the two Staff Working Documents accompanying this Report.
sl	Celotna analiza odgovorov držav članic na anketo o izvajanju iz leta 2013 in anketo o izvajanju načela PBD iz leta 2014 je vključena v dva delovna dokumenta služb Komisije, priložena temu poročilu.

en	In around half of the Member States, donors have their travel costs reimbursed and get time off work in the public and private sector.
sl	V približno polovici držav članic so darovalcem povrnjeni potni stroški, v javnem in zasebnem sektorju pa jim je odobren tudi dopust.

en	The regular meetings of the expert sub-group on blood and blood components (which is part of the Competent Authorities on Substances of Human Origin Expert Group - CASoHO E01718) allow for sharing best practices and clarification of common difficulties encountered at national and EU level.
sl	Redna srečanja strokovne podskupine za kri in komponente krvi (ki je del strokovne skupine pristojnih organov za snovi človeškega izvora - CASoHO E01718) omogočajo izmenjavo dobrih praks in pojasnjevanje pogostih težav, do katerih pride na nacionalni ravni in ravni EU.

en	The EU is significantly reliant on importation of plasma for the manufacture of plasma derived medicinal products, mainly from the United States.
sl	EU je precej odvisna od uvoza krvne plazme za izdelavo zdravil iz krvne plazme, predvsem iz ZDA.

en	The role of common assessments by ECDC and the Commission was recognised in this context, e.g. when developing a preparedness plan to help blood establishments address the seasonal outbreaks of West Nile Virus in some southern EU countries.
sl	V tem okviru je bila priznana vloga skupnih ocenjevanj Evropskega centra za preprečevanje in obvladovanje bolezni (ECDC) in Komisije, na primer pri razvoju načrta pripravljenosti na pomoč transfuzijskim ustanovam pri spopadanju z izbruhi virusa zahodnega Nila v nekaterih južnih državah EU.

en	Replacement donors, i.e. donors that are encouraged to make donations to replace those being used for a relative or friend, are reported as important for maintaining supply in five countries.
sl	Po poročanju so nadomestni darovalci, tj. darovalci, ki jih spodbujajo k darovanju za nadomestitev krvi, ki se je uporabila za sorodnika ali prijatelja, pomembni za vzdrževanje dobave v petih državah.

en	In their responses to the implementation survey, several countries suggested making syphilis testing mandatory at EU level, while some suggest making NAT testing for HIV and hepatitis mandatory, despite the reservations mentioned by other countries.
sl	Več držav je v svojih odgovorih na anketo o izvajanju predlagalo obvezno testiranje na sifilis na ravni EU, nekatere pa predlagajo obvezno testiranje na HIV in hepatitis z NAT, in to kljub zadržkom, ki jih navajajo druge države.

en	Some countries foresee compensation for loss of earnings in some circumstances, e.g. one Member State foresees this for plasma apheresis donations.
sl	Nekatere države predvidevajo nadomestilo za izgubo dohodka v določenih okoliščinah, ena od držav članic pa to na primer predvideva za darovanje krvne plazme z aferezo.

en	These include standards for verifying equivalent safety and quality standards, which in half of the Member States go beyond the requirements of the EU blood legislation, e.g. adding requirements for the use of the more sensitive nucleic acid testing (NAT) now available as a routine test for hepatitis and HIV screening.
sl	Ta vključujejo standarde za preverjanje enakovrednih standardov glede varnosti in kakovosti, ki v polovici držav članic presegajo zahteve zakonodaje EU o krvi, na primer dodatne zahteve za uporabo občutljivejšega testiranja z nukleinsko kislino (NAT), ki je zdaj na voljo kot redni presejalni test za hepatitis in HIV.

en	Additional screening and testing may reduce, but cannot completely eliminate, the possibility of a transmission from donor to recipient.
sl	Dodatni presejalni test in testiranje lahko zmanjšata možnost prenosa z darovalca na prejemnika, vendar je ne moreta povsem izločiti.

en	Other eligibility criteria that several countries would wish to reflect on relate to the history of malignancy, donor risk behaviour and haemoglobin levels.
sl	Druga merila za ustreznost, o katerih bi želelo razmisliti več držav, se nanašajo na preteklo malignost, tvegano vedenje darovalca in ravni hemoglobina.

en	Inactivation techniques are mainly used for plasma although pathogen inactivation of platelets is likely to be more common going forward.
sl	Tehnike inaktivacije se večinoma uporabljajo za krvno plazmo, čeprav bo v prihodnosti inaktivacija patogenov pri trombocitih verjetneje pogostejša.

en	Donor screening for eligibility.
sl	Presejalni test darovalcev glede ustreznosti.

en	About two thirds of the countries mention that blood establishments also apply more sensitive nucleic acid testing (NAT), along with serological testing, although several countries also raised questions regarding the cost-benefit ratio of this relatively costly testing technique.
sl	Približno dve tretjini držav navaja, da transfuzijske ustanove poleg serološkega testiranja uporabljajo tudi občutljivejše testiranje z nukleinsko kislino (NAT), čeprav je nekaj držav odprlo vprašanja glede stroškovne učinkovitosti te razmeroma drage tehnike testiranja.

en	Support for the Implementation of the Blood Directives
sl	Podpora pri izvajanju direktiv o krvi

en	All Member States reported that the same rules on traceability apply to blood establishments and hospital blood banks, allowing tracing of blood and blood components from donor to recipient and vice versa.
sl	Vse države članice poročajo, da se ista pravila o sledljivosti uporabljajo za transfuzijske ustanove in transfuzijske banke v bolnišnicah, kar omogoča sledenje krvi in komponent krvi od darovalca do prejemnika in obratno.

en	Plasma and plasma derivatives can have a longer shelf-life and as fractionation plants exist only in twelve Member States, both plasma (the starting material) and plasma derivatives (the end product) are frequently exchanged across borders, within the EU and with third (non-EU) countries.
sl	Krvna plazma in derivati krvne plazme imajo lahko daljši rok uporabe, in ker obrati za frakcioniranje obstajajo samo v 12 državah članicah, se krvna plazma (vhodni material) in derivati krvne plazme (končni izdelek) pogosto prenašajo prek meja znotraj EU in s tretjimi državami (ki niso v EU).

en	Men having sex with men (MSM) is the most commonly reported sexual risk exclusion criterion due to the higher incidence of infections such as HIV within this population.
sl	Spolni odnosi med moškimi je najpogosteje navedeno merilo za izključitev zaradi spolnega tveganja, ker je v tej populaciji večja pojavnost okužb, kot je HIV.

en	It is common practice to provide refreshments to donors (27 countries) and to give them small tokens such as pin badges, pens, towels, t-shirts and mugs (24 countries).
sl	Običajna praksa je, da darovalci dobijo okrepčila (27 držav) in majhna darila, kot so značke, pisala, brisače, majice in skodelice (24 držav).

en	In the Eurobarometer survey on Blood and Cell and Tissue Donation, only 12% of EU citizens reported that they thought compensation additional to the costs related to donation was acceptable, when donating blood or plasma.
sl	V anketi Eurobarometra o darovanju krvi, celic in tkiv je samo 12 % državljanov EU navedlo, da je nadomestilo poleg stroškov v zvezi z darovanjem sprejemljivo pri darovanju krvi ali krvne plazme.

en	Nonetheless, the voluntary reporting of SAR in donors has increased, suggesting the Member States' increasing interest in the protection of living donors.
sl	Vendar se je prostovoljno poročanje o hudih neželenih reakcijah pri darovalcih kljub temu povečalo, kar kaže na povečan interes držav članic za zaščito živih darovalcev.

en	Twenty one Member States have dedicated vigilance officer(s) in place.
sl	Enaindvajset držav članic ima imenovane posebne uradnike za vigilanco.

en	In half of the countries, the blood establishments either determine, or are involved in determining, the value of the compensations and incentives, while in one-third of the countries the national blood competent authorities are involved.
sl	V polovici držav transfuzijske ustanove določijo vrednost nadomestil in spodbud ali pa so vključene v njihovo določanje, medtem ko so v eni tretjini držav v to vključeni nacionalni pristojni organi za kri.

en	This overarching Report is a summary, drawing from the replies to questionnaires that the Commission sent to Member States in 2012 (verification of the completeness of transposition), 2013 (implementation survey), and 2014 (implementation of the VUD principle) and follows up on the Report in 2006 and the Commission Communication in 2010, as well as on the two Reports on the application of the principle of VUD for blood and blood components issued in 2006 and 2011.
sl	To krovno poročilo je povzetek, ki temelji na odgovorih na vprašalnike, ki jih je Komisija poslala državam članicam leta 2012 (preverjanje popolnosti prenosa), leta 2013 (anketa o izvajanju), in leta 2014 (izvajanje načela PBD), ter sledi poročilu iz leta 2006 in sporočilu Komisije iz leta 2010 ter poročiloma o uporabi načela PBD za kri in komponente krvi, izdanima leta 2006 oziroma leta 2011.

en	No additional testing was reported for plasma collection, compared with collection of whole blood donations.
sl	V zvezi z zbiranjem krvne plazme ni bilo sporočeno nobeno dodatno testiranje v primerjavi z zbiranjem polne krvi.

en	Since the survey was conducted, changes in national policies have been reported by some countries during the bi-annual meetings of Competent Authorities; the trend is to move from permanent to temporary (usually 12 months) deferral for MSM.
sl	Od izvedbe ankete so nekatere države na dveletnih srečanjih pristojnih organov poročale o spremembah nacionalnih politik; trend je prehajanje s trajnega odklona na začasni (običajno 12-mesečni) odklon zaradi spolnih odnosov med moškimi.

en	The VUD survey shows that Member States overall comply with Article 20 of Directive 2002/98/EC requiring them to take the necessary measures to encourage VUD.
sl	Anketa o PBD je pokazala, da države članice na splošno ravnajo v skladu s členom 20 Direktive 2002/98/ES, ki zahteva, da sprejmejo potrebne ukrepe za spodbujanje prostovoljnega in brezplačnega darovanja.

en	There is diversity between Member States in organisation (e.g. desk-based versus on-site), and outcome (i.e. classification and follow-up of deficiencies) of inspections.
sl	Med državami članicami obstajajo razlike glede organizacije (npr. dokumentacijski pregled v primerjavi s pregledom na kraju samem) in rezultatov (tj. razvrščanje in nadaljnje spremljanje pomanjkljivosti) inšpekcijskih pregledov.

en	Seven countries do not recover all plasma from whole blood donations for plasma fractionation into derivatives.
sl	Sedem držav ne dobi nazaj vse krvne plazme v primeru darovanja polne krvi za frakcioniranje krvne plazme v derivate.

en	In conclusion, this Report reveals an overall adequate level of application of the current quality and safety requirements of the EU blood legislation.
sl	To poročilo kaže, da se obstoječe zahteve glede kakovosti in varnosti iz zakonodaje EU o krvi na splošno ustrezno uporabljajo.

en	The reported picture seems not to be complete, with some inconsistencies between the information provided by countries whose citizens travel to donate and those who have donors coming from another Member State to donate.
sl	Videti je, da sporočena slika ni popolna, saj obstajajo nedoslednosti med informacijami iz držav, katerih državljani dajejo kri v tujini, in tistih, v katere prispejo darovalci iz druge države članice, da bi dali kri.

en	In order to manage demand and supply of blood and blood components, almost all countries have policies in place that combine annual forecasting with weekly monitoring.
sl	Skoraj vse države imajo za upravljanje povpraševanja in ponudbe krvi in komponent krvi vzpostavljene politike, ki združujejo letno napovedovanje s tedenskim spremljanjem.

en	Whole blood and blood components such as platelets and red blood cells have a limited shelf-life and are rarely exchanged between Member States, with the exception of rare emergency or humanitarian situations.
sl	Polna kri in komponente krvi, kot so trombociti in eritrociti, imajo omejen rok uporabe in si jih države članice redko izmenjujejo, razen v redkih nujnih primerih ali v primeru humanitarne pomoči.

en	Safety and quality of the blood supply is an important issue for EU citizens, with 56% of respondents to the Eurobarometer survey on Blood and Cell and Tissue Donation citing the risk of contracting a disease as a major concern when accepting donated substances.
sl	Varnost in kakovost dobave krvi je pomembno vprašanje za državljane EU, pri čemer je 56 % tistih, ki so ogovorili na anketo Eurobarometra o darovanju krvi, celic in tkiv, tveganje prenosa bolezni navedlo kot glavno skrb pri sprejetju darovanih snovi.

en	Where appropriate, data gathered through other channels and supporting the findings of the two surveys (e.g. exchanges with the national blood competent authorities during the bi-annual meetings with the Commission, mandatory annual reporting to the Commission of serious adverse reactions and events (SARE), alerts launched in the Rapid Alerts for Blood (RAB) platform, a study mapping the economic landscape of the sector and more recently a Eurobarometer survey as well as outputs of EU-funded projects were also taken into account.
sl	Kadar je bilo to ustrezno, so bili upoštevani tudi podatki, zbrani po drugih poteh in v podporo ugotovitvam obeh anket (npr. izmenjava informacij s pristojnimi nacionalnimi organi za kri na dveletnih srečanjih s Komisijo, obvezno letno poročanje Komisiji o hudih neželenih reakcijah in dogodkih, opozorila, poslana prek platforme za hitro obveščanje o krvi (RAB), študija o ekonomskem okolju v sektorju in novejša anketa Eurobarometra ter rezultati projektov, ki jih je financirala EU).

en	While not mandatory, two-thirds of countries have put in place donor self-exclusion systems.
sl	Dve tretjini držav sta vzpostavili sisteme za samoizključitev darovalca, čeprav tak sistem ni obvezen.

en	Fig. 6: Main causes leading to deferrals/country
sl	Slika 6: Glavni vzroki za odklon po državah

en	A common reason for these recalls is information received from the donor regarding his/her health situation and made available after the donation event.
sl	Pogost vzrok za odpoklic so informacije, ki jih darovalec predloži v zvezi s svojim zdravstvenim stanjem in ki so dane na voljo po darovanju.

en	In addition, thematic/focused inspections, inspections following SARE and desk-based assessments are organised.
sl	Poleg tega so organizirani tematski/usmerjeni inšpekcijski pregledi, inšpekcijski pregledi po hudih neželenih reakcijah in dogodkih ter dokumentacijska ocenjevanja.

en	In this context, it is challenging for MS to apply a requirement for the exclusive importation of plasma sourced from voluntary and unpaid donors.
sl	V teh okoliščinah države članice težko uporabijo zahtevo po izključnem uvozu krvne plazme, ki jo darovalci dajo prostovoljno in brezplačno.

en	However blood competent authorities in one third of the countries do not believe that all blood establishments are reporting SARE.
sl	Vendar pristojni organi za kri v eni tretjini držav ne verjamejo, da vse transfuzijske ustanove poročajo o hudih neželenih reakcijah in dogodkih.

en	Implementation of the EU blood legislation
sl	Izvajanje zakonodaje EU o krvi

en	These two areas are often cause for general alerts in the blood sector, as demonstrated since the launch of the Commission managed Rapid Alert System for Blood (RAB), where a number of alerts relating to emerging disease risks with relevance to blood donor selection or testing and to medical device defects that were important in blood collection or processing were shared among the national blood competent authorities.
sl	Ti dve področji sta pogosto vzrok za splošni preplah v sektorju krvi, kot se je pokazalo od uvedbe sistema za hitro obveščanje o krvi (RAB), ki ga upravlja Komisija in v okviru katerega so si nacionalni pristojni organi za kri izmenjali več opozoril v zvezi s nevarnostmi nastajajočih bolezni, pomembnih pri izbiri krvodajalcev ali njihovem testiranju, ter v zvezi z okvarami medicinskih pripomočkov, pomembnih pri zbiranju ali predelavi krvi.

en	Five countries reported having donations by donors from abroad, while six countries reported having citizens that travel to donate abroad.
sl	Pet držav je poročalo, da so pri njih kri dali darovalci iz tujine, šest pa jih je poročalo o državljanih, ki dajejo kri v tujini.

en	Notification of serious adverse reactions and events (SARE).
sl	Obveščanje o hudih neželenih reakcijah in dogodkih.

en	All Member States except Hungary reported having a SARE notification system in place, in the majority of them based on the practical guidance developed in co-operation with the Member States for the compilation of the online annual SARE report.
sl	Vse države članice, razen Madžarske, so poročale, da imajo vzpostavljen sistem za obveščanje o hudih neželenih reakcijah in dogodkih, večinoma na podlagi praktičnih navodil, oblikovanih v sodelovanju z državami članicami, za pripravo spletnega letnega poročila o hudih neželenih reakcijah in dogodkih.

en	Transposition of EU Blood legislation
sl	Prenos zakonodaje EU o krvi

en	The difference in purchasing power between Member States might be one factor which explains the diverging views on what is or is not an incentive to donate.
sl	Eden od dejavnikov, ki pojasnjuje različna mnenja o tem, kaj je in kaj ni spodbuda za darovanje, je lahko razlika v kupni moči med državami članicami.

en	Levels of inspector empowerment and training were regularly commented upon in the replies to the implementation survey.
sl	V odgovorih na anketo o izvajanju so bile redno navedene pripombe o stopnjah pooblastitve in usposabljanja inšpektorjev.

en	[8: http://ec.europa.eu/health/blood_tissues_organs/docs/20150408_cc_report_en.pdf;http://ec.europa.eu/health/blood_tissues_organs/docs/20150408_key_findings_cc_en.pdfhttp://ec.europa.eu/health/blood_tissues_organs/eurobarometers/eb822_en.htm]
sl	[8: http://ec.europa.eu/health/blood_tissues_organs/docs/20150408_cc_report_en.pdf;http://ec.europa.eu/health/blood_tissues_organs/docs/20150408_key_findings_cc_en.pdf;http://ec.europa.eu/health/blood_tissues_organs/eurobarometers/eb822_en.htm.]

en	[1: Detailed Member State replies (as well as replies from Norway and Liechtenstein) can be accessed at: http://ec.europa.eu/health/blood_tissues_organs/key_documents/][2: In a number of cases clarification requests were sent to Member States for verification.
sl	[1: Podrobni odgovori držav članic (ter odgovori Norveške in Lihtenštajna) so na voljo na: http://ec.europa.eu/health/blood_tissues_organs/key_documents/.

en	In addition to providing regular updates during the bi-annual meeting of the blood expert sub-group on the epidemiological situation relevant to the blood sector, the development of risk assessments (e.g. for HTLV, malaria, dengue and chikungunya) and preparedness plans (e.g. for WNV outbreaks) provide a valuable contribution to policy and decision making in this sector at both national and EU level.
sl	Razvoj ocenjevanja tveganja (npr. za HTLV, malarijo, dengo in čikungunjo) in načrtov pripravljenosti (npr. za izbruhe virusa zahodnega Nila) je, poleg tega da je zagotovil redno obveščanje o epidemioloških razmerah v zvezi s sektorjem krvi na dveletnih srečanjih strokovne podskupine za kri, dragoceno prispeval k oblikovanju politik in sprejemanju odločitev v tem sektorju na nacionalni ravni in ravni EU.

en	Fig. 3: Percentage of reporting blood establishments/country
sl	Slika 3: Delež transfuzijskih ustanov poročevalk po državah

en	][3: http://ec.europa.eu/health/blood_tissues_organs/docs/blood_reportdonation_en.pdf][4: http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52010DC0003][5: http://ec.europa.eu/health/ph_threats/human_substance/documents/blood_com_0217_en.pdf][6: http://ec.europa.eu/health/blood_tissues_organs/docs/blood_reportdonation_en.pdf]
sl	][3: http://ec.europa.eu/health/blood_tissues_organs/docs/blood_reportdonation_sl.pdf][4: http://eur-lex.europa.eu/legal-content/SL/ALL/?uri=CELEX:52010DC0003.

en	Clarification of the operational rules on reporting SARE at EU level would be perceived as helpful by Member State haemovigilance experts.
sl	Strokovnjaki držav članic za hemovigilanco bi razjasnitev operativnih pravil o poročanju hudih neželenih reakcij in dogodkov šteli za koristno.

en	The Commission is closely following this case.
sl	Komisija to pozorno spremlja.

en	In any event, the number of penalties imposed is very low.
sl	Vsekakor je število naloženih kazni zelo majhno.

en	These are of particular importance given the numerous technological developments in the field in recent years.
sl	Te so zlasti pomembne glede na obsežen tehnološki razvoj na tem področju v zadnjih letih.

en	Obligations of Member State competent authorities
sl	Obveznosti pristojnih organov držav članic

en	[11: Case C-29/14, judgment pronounced on 11 June 2015.
sl	[11: Zadeva C-29/14, sodba razglašena 11. junija 2015.

en	It was also suggested that the full list of these more stringent requirements could be made available by the Commission.
sl	Predlagano je bilo tudi, da bi lahko Komisija dala na voljo celoten seznam teh strožjih zahtev.

en	Concerning joint inspections by authorities from more than one Member State, a small number have been organised in recent years.
sl	Kar zadeva skupne inšpekcijske preglede organov iz več kot ene države članice, jih je bilo v zadnjih letih organiziranih manjše število.

en	Quality management, responsible person and personnel.
sl	Upravljanje kakovosti, odgovorna oseba in osebje.

en	The gaps and difficulties identified suggest that a further in-depth evaluation might be useful.
sl	Ugotovljene vrzeli in težave kažejo, da bi lahko bila koristna nadaljnja podrobnejša ocena.

en	No problems were reported regarding the implementation of the provisions related to data protection.
sl	V zvezi z izvajanjem določb o varstvu podatkov ni bilo sporočenih nobenih težav.

en	Significant progress has been made in many areas, also through the active support by Commission funded projects and other initiatives.
sl	Na številnih področjih je napredek znaten, tudi zaradi dejavne podpore projektov, ki jih financira Komisija, in drugih pobud.

en	Other practices include compensation for the inconveniences related to the donation.
sl	Druge prakse vključujejo nadomestilo za neprijetnosti v zvezi z darovanjem.

en	The application of selection criteria should be transparent and subject to continuous evaluation in order to minimize safety risks.
sl	Uporaba meril za izbor bi morala biti pregledna in predmet stalnega vrednotenja, da se čim bolj zmanjšajo varnostna tveganja.

en	Designation of competent authority or authorities responsible for the implementation of Directive 2004/23/EC
sl	Imenovanje pristojnega organa ali organov, odgovornih za izvajanje Direktive 2004/23/ES

en	Another important issue highlighted by some Member States was the need to foster harmonisation of the inspection practices in the Member States.
sl	Še eno pomembno vprašanje, na katero so opozorile nekatere države članice, je bila potreba po spodbujanju usklajevanja inšpekcijskih praks v državah članicah.

en	Penalties.
sl	Kazni.

en	More generally speaking, it was difficult to assess how divisions of tasks impacts oversight of the sector, especially as some of the national competent authorities did not provide precise/complete information.
sl	Splošneje je bilo težko oceniti, kako razdelitev nalog vpliva na nadzor nad sektorjem, zlasti ker nekateri nacionalni pristojni organi niso predložili natančnih/popolnih informacij.

en	In some Member States the sector is fully controlled by public organisations, whilst in others private operators make a significant contribution (Fig. 5).
sl	V nekaterih državah članicah sektor v celoti obvladujejo javne organizacije, v drugih pa znatno prispevajo zasebni subjekti (slika 5).

en	Donor testing.
sl	Testiranje darovalcev.

en	Consent, data protection and confidentiality.
sl	Soglasje, varstvo podatkov in zaupnost.

en	The survey confirmed that this core responsibility of competent authorities is well implemented across the Union.
sl	Anketa je potrdila, da se ta ključna odgovornost pristojnih organov dobro izvaja po vsej Uniji.

en	As a consequence, pursuant to Article 258 TFEU, the Commission has brought action against one Member State to the Court of Justice, and launched an infringement proceeding against another Member State, which is ongoing.
sl	Zato je Komisija v skladu s členom 258 PDEU zoper eno državo članico vložila tožbo na Sodišču, zoper drugo pa sprožila postopek za ugotavljanje kršitev, ki še poteka.

en	However, the ways in which Member States have implemented the principle of VUD are difficult to assess in a comprehensive manner.
sl	Vendar je načine, na katere države članice izvajajo načelo PBD, težko celovito oceniti.

en	The penalties foreseen in national legislation, their criteria for implementation and their effective implementation can differ significantly between Member States.
sl	Kazni, predvidene v nacionalni zakonodaji, merila za njihovo izvajanje in učinkovitost njihovega izvajanja se lahko znatno razlikujejo med državami članicami.

en	It has to be highlighted that, irrespective of the organisational set up in each country, it is important that authorities have appropriate resources at their disposal in order to ensure their independence from economic operators, in the sector and from other influences.
sl	Poudariti je treba, da je ne glede na organizacijsko strukturo v posamezni državi pomembno, da imajo organi na voljo ustrezne vire za zagotovitev svoje neodvisnosti od gospodarskih subjektov v sektorju in od drugih vplivov.

en	The high number of procurement organisations shows that this activity is well developed across the Union.
sl	Veliko število organizacij za pridobivanje kaže, da je ta dejavnost dobro razvita po vsej Uniji.

en	However, Member States interpretation of what is considered compensation and incentive vary.
sl	Vendar se razlage držav članic, kaj se šteje za nadomestilo in spodbudo, razlikujejo.

en	Even though only trained personnel are allowed to provide appropriate information to donors, this information has been standardised at national level in a small number of countries.
sl	Čeprav lahko samo usposobljeno osebje darovalcem zagotovi ustrezne informacije, so bile te informacije na nacionalni ravni standardizirane le v majhnem številu držav.

en	There is no harmonisation in defining or applying such penalties, therefore it is difficult to evaluate whether similar measures are applied by all the Member States in case of a specific breach of the legislation in this area.
sl	Opredelitev in uporaba takih kazni nista usklajeni, zato je težko oceniti, ali vse države članice uporabljajo podobne ukrepe v primeru specifične kršitve zakonodaje na tem področju.

en	The differences in purchasing power between Member States might also explain why a measure is considered a "compensation" in one country and an "incentive" in another.
sl	Tudi razlike v kupni moči med državami članicami lahko pojasnijo, zakaj se nek ukrep v eni državi šteje za „nadomestilo", v drugi pa za „spodbudo".

en	The importance of inspections was highlighted again in the context of compliance with the requirements in the Directive 2006/86/EC, as the most frequent approach to verify their implementation.
sl	Pomen inšpekcijskih pregledov je bil znova poudarjen v okviru izpolnjevanja zahtev Direktive 2006/86/ES kot najpogostejši pristop k preverjanju izvajanja.

en	It should be highlighted that several Member States indicated that there is no national legal requirement for organising national follow-up registries for living donors.
sl	Poudariti je treba, da je več držav članic navedlo, da ni nacionalne zakonske zahteve po organizaciji nacionalnih registrov za nadaljnje spremljanje za žive darovalce.

en	It has to be highlighted that VUD is a factor which is not only ethical in nature, but which may contribute to higher safety standards for tissues and cells and therefore to the protection of human health.
sl	Poudariti je treba, da je PBD dejavnik, ki ni zgolj etičen, temveč lahko prispeva tudi k višjim varnostnim standardom v zvezi s tkivi in celicami ter s tem k varstvu zdravja ljudi.

en	Although the principle of VUD is mandatory in the large majority of the Member States, its concrete application varies across the Union.
sl	Čeprav je načelo PBD obvezno v veliki večini držav članic, se njegova dejanska uporaba po Uniji razlikuje.

en	However, some difficulties in interpretation, implementation and enforcement of the legislation have been identified, which in some cases could be explained by the scientific and technological advances since its adoption.
sl	Vendar je bilo ugotovljenih nekaj težav pri razlagi, izvajanju in izvrševanju zakonodaje, ki jih je mogoče v nekaterih primerih pojasniti z znanstvenim in tehnološkim napredkom od njenega sprejetja.

en	Concerning donor anonymity, most countries rely on the EU and national data protection legislation, but also on coding.
sl	V zvezi z anonimnostjo darovalca se večina držav opira na zakonodajo EU in nacionalno zakonodajo o varstvu podatkov, pa tudi na kodiranje.

en	The Commission will consider the need for an evaluation in order to assess the relevance, effectiveness, efficiency, coherence and the EU added value of Directive 2004/23/EC and its implementing Directives.
sl	Komisija bo razmislila o potrebi po ocenjevanju za ovrednotenje ustreznosti, učinkovitosti, uspešnosti, skladnosti in dodane vrednosti EU Direktive 2004/23/ES in njenih izvedbenih direktiv.

en	Their outcome was in general satisfying and in particular allowed bringing expertise where this might be missing within the own Member State.
sl	Njihovi rezultati so bili na splošno zadovoljivi in omogočali so zlasti uporabo strokovnega znanja, ki morda ne bi bilo na voljo v eni sami državi članici.

en	The large majority of the responding countries (28) reported that the principle of VUD is mandatory at national level.
sl	Velika večina držav, ki so se odzvale (28), je poročala, da je načelo PBD obvezno na nacionalni ravni.

en	A majority also supported European legislation to ensure the safety and quality of blood, tissues and cells.
sl	Večina je tudi podprla evropsko zakonodajo za zagotavljanje varnosti in kakovosti krvi, tkiv in celic.

en	Wherever accreditation and inspections are undertaken by different authorities, a good communication and coordination between respective authorities needs to be ensured.
sl	Kadar akreditacijo in inšpekcijske preglede izvajajo različni organi, je treba zagotoviti dobro komunikacijo in usklajevanje med zadevnimi organi.

en	These consist mainly in providing administrative support for the funeral and ensuring full or partial coverage of the cost of the funeral/burial/cremation.
sl	Večinoma zagotavljajo upravno podporo glede pogrebnih storitev in zagotavljajo celotno ali delno kritje stroškov pogreba/pokopa/upepelitve.

en	At the end of 2011, 2047 tissue establishments were authorised in the EU, showing an almost 20% increase compared to the 2008 data (Fig. 4).
sl	Konec leta 2011 je bilo v EU odobrenih 2 047 ustanov za tkiva in celice, kar je bilo skoraj 20-odstotno povečanje v primerjavi s podatki za leto 2008 (slika 4).

en	If donor payment were allowed, some individuals could find the monetary remuneration so important that they might hide relevant medical and/or behavioural information.
sl	Če bi bilo plačevanje darovalcem dovoljeno, bi bila lahko za nekatere denarna nagrada tako pomembna, da bi lahko prikrili pomembne zdravstvene in/ali vedenjske informacije.

en	The European Commission has been supporting the implementation of the legislation by the Member States by encouraging the active participation of national Competent Authorities in a series of actions, from bi-annual expert group meetings to EU-funded projects.
sl	Evropska komisija podpira izvajanje zakonodaje s strani držav članic, tako da spodbuja dejavno sodelovanje nacionalnih pristojnih organov v več dejavnostih, od dveletnih srečanj strokovne skupine do projektov, ki jih financira EU.

en	Another Member State and one EEA country have not yet defined national provisions on the application of the VUD principle.
sl	Druga država članica in ena država EGP še nista opredelili nacionalnih določb o uporabi načela PBD.

en	This may also explain why some Member States have not put in place a coherent policy to ensure national sufficiency at least for some type of tissues or cells.
sl	S tem je mogoče tudi pojasniti, zakaj nekatere države članice niso vzpostavile usklajene politike za zagotavljanje nacionalne zadostnosti vsaj za nekatere vrste tkiv ali celic.

en	Several Member States suggested that a common list of diagnostic tests (panel) for some genetic diseases may be valuable for increasing safety in the EU ART sector.
sl	Več držav članic je predlagalo, da bi skupni seznam diagnostičnih testov (panel) za nekatere genske bolezni lahko bil koristen za povečanje varnosti v sektorju OBMP UE.

en	Therefore information provided by the donor or his/her family contributes to an accurate assessment of all risks associated to the application of donated tissues or cells.
sl	Zato informacije, ki jih predloži darovalec ali njegova družina, prispevajo k točni oceni vseh tveganj v zvezi z uporabo darovanih tkiv ali celic.

en	On the basis of these national reports, the Commission is required to report to the European Parliament and the Council and to inform them of any necessary further measures in relation to VUD it intends to take at Union level.
sl	Komisija mora na podlagi teh nacionalnih poročil poročati Evropskemu parlamentu in Svetu ter ju obvestiti o morebitnih nadaljnjih potrebnih ukrepih v zvezi s PBD, ki jih namerava sprejeti na ravni Unije.

en	The overall aim of the annual reporting, to identify the most frequent causes of SARE and provide appropriate corrective measures, has not yet been fully achieved.
sl	Splošni cilj letnega poročanja, tj. določiti najpogostejše vzroke za hude neželene reakcije in dogodke ter zagotoviti ustrezne korektivne ukrepe, še ni bil v celoti dosežen.

en	This may suggest a role for the EU in supporting Member States to develop national sufficiency policies although the exact impact of such policies on cross-border exchanges and the supply of starting materials for medicinal product manufacture would need to be carefully analysed.
sl	To lahko kaže na vlogo EU pri podpori državam članicam za razvoj politik nacionalne zadostnosti, čeprav je treba natančno analizirati točen vpliv takih politik na čezmejne izmenjave in dobavo vhodnih snovi za proizvodnjo zdravil.

en	Most Member States allow compensation to be offered to living donors (22 countries for living donors of non-reproductive tissues and cells; 17 countries for donors of reproductive cells).
sl	Večina držav članic dovoljuje, da se živim darovalcem ponudi nadomestilo (22 držav živim darovalcem nereproduktivnih tkiv in celic; 17 držav darovalcem reproduktivnih celic).

en	Only in a small number of Member States is the value of the compensation provided to tissue and cell donors connected to national economic indicators (e.g. monthly income, purchasing capacity).
sl	Samo v majhnem številu držav članic je vrednost nadomestila za darovalce tkiv in celic povezana z nacionalnimi gospodarskimi kazalniki (npr. mesečni dohodek, kupna moč).

en	Diverse practices related to the implementation of the requirements of Article 4 of Directive 2006/86/EC were reported.
sl	Sporočene so bile različne prakse v zvezi z izvajanjem zahtev iz člena 4 Direktive 2006/86/ES.

en	The implementation survey was answered by all Member States except Greece, and also by two EEA countries, Liechtenstein and Norway.
sl	Na anketo o izvajanju so odgovorile vse države članice, razen Grčije, in dve državi EGP, in sicer Lihtenštajn in Norveška.

en	It was underlined that Member States introducing more stringent safety and quality requirements should inform the other Member States and EEA countries, as well as the Commission, regarding these measures, in a transparent manner.
sl	Poudarjeno je bilo, da bi morale države članice, ki uvedejo strožje zahteve glede varnosti in kakovosti, na pregleden način obvestiti druge države članice in države EGP ter Komisijo o takih ukrepih.

en	Since 2003, a number of projects have been funded under the multi-annual programmes for Union action in the field of health addressing the area of human tissue and cells for clinical application.
sl	Od leta 2003 je bilo financiranih več projektov v okviru večletnih programov za ukrepanje Unije na področju zdravja, ki so se nanašali na človeško tkivo in celice za klinično uporabo.

en	It has to be underlined that countries which reported difficulties in implementing the donation identification system were either developing a central allocation system for identifiers or were waiting for the adoption of the implementing legislation introducing a Single European Code for tissues and cells.
sl	Poudariti je treba, da so države, ki so poročale o težavah pri vzpostavljanju sistema za identifikacijo darovanj, razvijale centralni sistem dodeljevanja za identifikatorje ali čakale na sprejetje izvedbene zakonodaje o uvedbi enotne evropske kode za tkiva in celice.

en	The Commission is also required to provide the European Parliament and the Council with an overview report on the implementation of the requirements of the Directive, in particular as regards inspections and monitoring.
sl	Evropskemu parlamentu in Svetu mora predložiti tudi pregledno poročilo o izvajanju zahtev Direktive, zlasti glede inšpekcijske in kontrolnih ukrepov.

en	On the basis of the information collected, the Commission will follow up with the Member States in order to promote, where desirable, a common understanding of Article 12 in the Directive 2004/23/EC.
sl	Komisija bo na podlagi zbranih informacij spremljala države članice za spodbujanje, kadar je to zaželeno, enotnega razumevanja člena 12 Direktive 2004/23/ES.

en	Reimbursement of costs linked to travel and medication based on actual costs/receipts are among the most commonly used type of compensation for living donors.
sl	Povračila stroškov v zvezi s potovanjem in zdravili na podlagi dejanskih stroškov/potrdil so med najpogostejšimi vrstami nadomestil za žive darovalce.

en	It is also interesting to highlight the split between private and public ownership of tissue establishments.
sl	Zanimivo je tudi opozoriti na vrzel med zasebnim in javnim lastništvom ustanov za tkiva in celice.

en	Article 26 of Directive 2004/23/EC requires Member States to submit to the European Commission, before 7 April 2009 and every three years thereafter, a report on the activities carried out in relation to the provisions of the Directive, including an account of the measures taken in relation to inspection and control.
sl	V skladu s členom 26 Direktive 2004/23/ES morajo države članice pred 7. aprilom 2009 in nato vsaka tri leta Evropski komisiji predložiti poročilo o dejavnostih, ki se izvajajo v zvezi z določbami navedene direktive, skupaj s poročilom o ukrepih, sprejetih v zvezi z inšpekcijskim nadzorom in kontrolo.

en	These differences facilitate successful integration of the requirements into national legislation but in some cases they may limit the mutual acceptance of authorisations with consequences on the cross-border movement of tissues and cells.
sl	Te razlike omogočajo uspešno vključitev zahtev v nacionalno zakonodajo, vendar lahko v nekaterih primerih omejijo vzajemno priznavanje odobritev, kar pomeni posledice za čezmejni prenos tkiv in celic.

en	Donor selection and evaluation
sl	Izbiranje in vrednotenje darovalcev

en	Additional tests required by Member States are usually justified for local reasons, like e.g. the increased prevalence of a certain infectious disease.
sl	Dodatni testi, ki jih zahtevajo države članice, so običajno utemeljeni zaradi lokalnih dejavnikov, kot je večja prevalenca neke nalezljive bolezni.

en	To facilitate good regulatory communication between Member States, as well as to comply with the annual reporting requirements to the Commission, a well-informed national coordinating contact is essential, even where responsibilities of national competent authorities are shared among multiple organisations or regions.
sl	Za dobro ureditveno komunikacijo med državami članicami in izpolnjevanje zahtev po letnem poročanju Komisiji je bistvena dobro obveščena nacionalna usklajevalna kontaktna točka, tudi če so odgovornosti pristojnih nacionalnih organov razdeljene na več organizacij ali regij.

en	Overall, the implementation of the EU tissues and cells legislation by the Member States is considered adequate and the legislation has resulted in the establishment of a network of competent authorities that oversee the sector through authorisation, inspection, and vigilance.
sl	Na splošno se izvajanje zakonodaje EU o tkivih in celicah šteje za ustrezno, zaradi zakonodaje pa je bila vzpostavljena mreža pristojnih organov, ki sektor nadzorujejo z odobritvami, inšpekcijo in vigilanco.

en	This may suggest that tissue establishments are striving to comply with the EU quality and safety requirements, but it may also indicate under-enforcement, e.g. in countries which have never reported any shortcomings.
sl	To lahko pomeni, da si ustanove za tkiva in celice prizadevajo izpolniti zahteve EU glede kakovosti in varnosti, vendar lahko pomeni tudi nezadostno izvrševanje zakonodaje, na primer v državah, ki nikoli niso poročale o pomanjkljivostih.

en	In this context, the new requirements on the application of the Single European Code for tissues and cells laid down in Directive (EU) 2015/565 may be considered an additional tool for ensuring that donor data are not disclosed to the recipient14.
sl	V tem okviru se lahko nove zahteve glede uporabe enotne evropske kode za tkiva in celice iz Direktive (EU) 2015/565 štejejo za dodatno orodje za zagotavljanje, da se podatki o darovalcu ne razkrijejo prejemniku14.

en	In 2015 the MS concerned has adopted new legislation for the ART sector and is in process of implementing it.]
sl	Leta 2015 je zadevna država članica sprejela novo zakonodajo za sektor oploditve z biomedicinsko pomočjo (OBMP) in jo zdaj izvaja.]

en	Projects such as EUSTITE, EuroGTP, SOHO V&S, and the on-going joint actions ARTHIQS and VISTART have provided a strong support to Member States in their efforts to implement the requirements of the EU tissue and cell legislation.
sl	Projekti, kot so EUSTITE, EuroGTP, SOHO V&S in trenutna skupna ukrepa ARTHIQS in VISTART, so bili v veliko oporo državam članicam pri prizadevanjih za izvajanje zahtev zakonodaje EU o tkivih in celicah.

en	As the EU legislation in the tissue and cell does not provide a basis for full harmonisation and as Directives allow the Member States a certain degree of discretion as to how to ensure their implementation, there are accordingly many differences between Member States in the approaches they have taken to implementation.
sl	Ker zakonodaja EU o tkivih in celicah ne daje podlage za popolno uskladitev in ker direktive državam članicam dopuščajo določeno stopnjo proste presoje glede tega, kako zagotoviti njihovo izvajanje, med državami članicami obstajajo številne razlike v pristopih k izvajanju.

en	However, one Member State who reported that the VUD principle is mandatory indicated that payment of gamete donors is allowed at national level.
sl	Vendar je ena država, ki je poročala, da je načelo PBD obvezno, navedla, da je plačilo darovalcem gamet dovoljeno na nacionalni ravni.

en	All reporting Member States have appointed competent authorities for tissues and cells.
sl	Vse države članice poročevalke so imenovale pristojne organe za tkiva in celice.

en	Only 17 Member States reported having guiding principles regarding the possibility to compensate tissue and cell donors, but in many cases these principles were just a description of the practices allowed at national level.
sl	Samo 17 držav članic je poročalo, da imajo vzpostavljena vodilna načela glede možnosti nadomestila za darovalce tkiv in celic, vendar so v številnih primerih ta načela samo opis praks, ki so dovoljene na nacionalni ravni.

en	(Total POs = 4825; 2011 data)
sl	(skupno število organizacij za pridobivanje = 4 825; podatki za leto 2011)

en	Some mixed models have emerged where, for example, the private sector may take the role of a third party for processing or storage, with all donation, promotion and distribution activities remaining in public hands.
sl	Nastalo je nekaj mešanih modelov, pri katerih lahko ima zasebni sektor na primer vlogo tretje strani za predelavo ali hranjenje, dejavnosti darovanja, promocije in razdeljevanja pa ostajajo v javnih rokah.

en	In this respect, it should be highlighted that the new Directive (EU) 2015/566 provides for the harmonisation of the minimum requirements in terms of contents of written agreements between importing tissue establishments and their third country suppliers.
sl	V zvezi s tem je treba poudariti, da nova Direktiva (EU) 2015/566 določa uskladitev minimalnih zahtev glede vsebine pisnih sporazumov med ustanovami uvoznicami za tkiva in celice in njihovimi dobavitelji iz tretjih držav.

en	One concern raised during national tissue and cell competent authorities meetings was direct distribution of gametes (i.e. sperm) to individuals for self-application without the involvement of a health professional.
sl	Ena od skrbi, ki so jih nacionalni pristojni organi za tkiva in celice izrazili na srečanjih, je bilo neposredno razdeljevanje gamet (tj. sperme) posameznicam za samouporabo brez sodelovanja zdravstvenih delavcev.

en	Overall, the survey showed that regardless of the consent system, all responding countries have put measures in place for verifying donor consent.
sl	Na splošno je anketa pokazala, da so vse države, ki so se odzvale, ne glede na sistem soglasij sprejele ukrepe za preverjanje soglasja darovalca.

en	It is noted that an additional support on training of tissue establishment personnel was given through EU-funded projects such as European Quality System for Tissue Banking (EQSTB) and European Good Tissue Practices (EuroGTPs).
sl	Opozoriti je treba, da je bila dodatna podpora usposabljanju osebja ustanov za tkiva in celice zagotovljena s projekti, ki jih financira EU, kot sta evropski sistem kakovosti za shranjevanje tkiv (European Quality System for Tissue Banking, EQSTB) in evropske dobre prakse v zvezi s tkivi (European Good Tissue Practices, EuroGTPs).

en	A verification of the completeness of transposition into national legislation has been carried out by the Commission and demonstrated that the EU tissues and cells legislation is fully transposed into national legislation in all but two Member (which have failed to fully transpose the requirements of the Directives for reproductive cells).
sl	Preverjanje popolnosti prenosa v nacionalno zakonodajo, ki ga je izvedla Komisija, je pokazalo, da je zakonodaja EU o tkivih in celicah v celoti prenesena v nacionalno zakonodajo v vseh državah članicah, razen v dveh (ki nista v celoti prenesli zahtev direktiv glede reproduktivnih celic).

en	There is a need to find the most appropriate solutions to ensure both the respect of the Article 12 of Directive 2004/23/EC and an adequate supply of tissues and cells to the patients in need across the Union.
sl	Poiskati je treba najustreznejše rešitve za zagotovitev skladnosti s členom 12 Direktive 2004/23/ES ter zadostno preskrbo tkiv in celic pacientom, ki jih potrebujejo, po vsej Uniji.

en	However, the report points to some gaps and difficulties in relation to the application and enforcement of the existing provisions (e.g. definitions, requirements on the safety aspects regarding living donors, inspections framework), some of them owing to the different approaches taken by the Member States when transposing and implementing the current EU legislation and others due to the scientific and technologic developments since the adoption of the Directives.
sl	Vendar poročilo kaže na nekatere vrzeli in težave v zvezi z uporabo in izvrševanjem obstoječih določb (npr. opredelitve, zahteve glede varnostnih vidikov v zvezi z živimi darovalci, okvir inšpekcijskih pregledov), pri čemer so nekatere posledica različnih pristopov držav članic pri prenosu in izvajanju sedanje zakonodaje EU, druge pa znanstvenega in tehnološkega razvoja od sprejetja direktiv.

en	The data provided, even though incomplete and sometimes not precisely defined, confirm that increasing volumes of human tissues and cells are imported from or exported to third countries (Fig. 7).
sl	Poslani podatki, čeprav nepopolni in ponekod nenatančno opredeljeni, potrjujejo, da se iz tretjih držav uvažajo in vanje izvažajo vse večje količine človeških tkiv in celic (slika 7).

en	As regards the risk of transmission of communicable diseases thorough tissues and cells, the collaboration with ECDC proved extremely valuable.
sl	Kar zadeva tveganje prenosa nalezljivih bolezni prek tkiv in celic, se je sodelovanje z Evropskim centrom za preprečevanje in obvladovanje bolezni (ECDC) izkazalo za izredno dragoceno.

en	However, the tissue establishment reports are not always publicly available, mainly due to different interpretations of this provision by the Member States authorities.
sl	Vendar poročila ustanov za tkiva in celice niso povsod na voljo javnosti, predvsem zato, ker si organi držav članic to določbo različno razlagajo.

en	Mandatory SOPs are also required during the authorisation/accreditation/designation or licensing process in most of the responding countries.
sl	Obvezni standardni operativni postopki se zahtevajo tudi pri odobritvi/akreditaciji/imenovanju ali izdaji dovoljenj v večini držav, ki so se odzvale.

en	In some Member States the authorities for tissues and cells are also responsible for the oversight of other sectors (e.g. organs, blood and/or medicinal products) (Fig.1 and 2), which can be beneficial from an efficiency point of view.
sl	V nekaterih državah članicah so organi za tkiva in celice odgovorni tudi za nadzor nad drugimi sektorji (npr. organi, kri in/ali zdravila) (sliki 1 in 2), kar je lahko koristno z vidika učinkovitosti.

en	Some national competent authorities considered that it would be useful to strengthen the consideration of pharmacovigilance data regarding medicinal products that are used in the context of donations of tissues and cells.
sl	Nekateri nacionalni pristojni organi so menili, da bi bilo koristno okrepiti upoštevanje podatkov o farmakovigilanci v zvezi z zdravili, ki se uporabljajo v okviru darovanja tkiv in celic.

en	Nevertheless, it has to be noted that it is difficult to draw firm conclusions regarding the volume of imports and exports of human tissues and cells due the lack of mandatory reporting of such information at national level and absence of a harmonised framework for data collection in the Member States.
sl	Vendar je treba opozoriti, da je težko oblikovati trdne sklepe glede količine uvoza in izvoza človeških tkiv in celic, ker na nacionalni ravni ni obveznega poročanja o teh informacijah in ker v državah članicah ni usklajenega okvira za zbiranje podatkov.

en	Regarding data storage for at least 30 years, almost all Member States and EEA countries comply with the requirements of Article 9 of Directive 2006/86/EC, by requesting both paper and electronic records to be maintained for that period.
sl	Kar zadeva hranjenje podatkov vsaj 30 let, skoraj vse države članice in države EGP izpolnjujejo zahteve iz člena 9 Direktive 2006/86/ES ter zahtevajo, da se za navedeno obdobje hranijo evidence na papirju in v elektronski obliki.

en	However, a significant percentage of the respondents (48%) considered that receiving refreshments, free testing, or a free physical check-up seem suitable when donating human tissues and cells.
sl	Vendar je znaten delež anketirancev (48 %) menil, da se prejetje okrepčil, brezplačno testiranje ali brezplačen zdravniški pregled zdijo primerni ob darovanju človeških tkiv in celic.

en	It is important to note that a recent Eurobarometer survey on blood and cell and tissue donation showed that only 13% of EU citizens considered acceptable to receive cash amounts in addition to the reimbursement of the costs related to the donation.
sl	Opozoriti je treba, da je nedavna anketa Eurobarometra o darovanju krvi, celic in tkiv pokazala, da se samo 13 % državljanom EU zdi sprejemljivo, da bi poleg povračila stroškov v zvezi z darovanjem prejeli denarne zneske.

en	Several countries have introduced more stringent testing requirements such as nucleic acid testing (NAT) for hepatitis B (HBV), hepatitis C (HCV) and/or human immunodeficiency virus (HIV) for non-reproductive and/or reproductive tissue and cells, whereas in most Member States and EEA countries the use of this type of testing is not required on the basis of a cost-benefit analysis and/or the epidemiological context.
sl	Nekatere države so uvedle strožje zahteve glede testiranja, kot je testiranje z nukleinsko kislino (NAT) na hepatitis B (HBV), hepatitis C (HCV) in/ali virus človeške imunske pomanjkljivosti (HIV) za nereproduktivna in/ali reproduktivna tkiva in celice, medtem ko se v večini držav članic in držav EGP uporaba te vrste testiranja ne zahteva na podlagi analize stroškov in koristi in/ali glede na epidemiološki okvir.

en	In addition, the survey showed that nineteen countries (17 Member States and two EEA countries) did not put in place national policies for promoting national self-sufficiency/sufficiency for tissues and cells and do not always collect data on cross-border movement of tissues and cells at national level.
sl	Poleg tega je anketa pokazala, da 19 držav (17 držav članic in dve državi EGP) ni vzpostavilo nacionalnih politik za spodbujanje nacionalne samozadostnosti/zadostnosti za tkiva in celice ter da na nacionalni ravni ne zbirajo vedno podatkov o čezmejnem prenosu tkiv in celic.

en	Giving lump sums to reproductive cell donors, as practised in some countries, may alleviate administrative burden, but it also raises questions when the value is determined solely by tissue establishments or when the value is significantly high in relation to average national monthly income.
sl	Plačevanje pavšalnih zneskov darovalcem reproduktivnih celic, kot je praksa v nekaterih državah, lahko olajša upravno breme, vendar odpira tudi vprašanja, kadar vrednost določijo samo ustanove za tkiva in celice ali kadar je vrednost precej visoka glede na povprečni nacionalni mesečni dohodek.

en	Even though such movements may be explained by the globalisation of healthcare products and services, the common quality and safety standards laid down in the EU tissues and cells legislation have created the framework for facilitating trans-national movements within the Union.
sl	Čeprav je mogoče tak promet pojasniti z globalizacijo zdravstvenih proizvodov in storitev, so enotni standardi kakovosti in varnosti iz zakonodaje EU o tkivih in celicah oblikovali okvir za lažji transnacionalni promet znotraj Unije.

en	Moreover, most of the Member States stated that the new coding requirements, now laid down in Directive (EU) 2015/565 amending Directive 2006/86/EC, should contribute to a harmonised implementation of the Single European Code for tissues and cells and actively supported their development.
sl	Poleg tega je večina držav članic navedla, da bi morale nove zahteve glede kodiranja, zdaj določene v Direktivi (EU) 2015/565 o spremembi Direktive 2006/86/ES, prispevati k usklajenemu izvajanju enotnega evropskega kodnega sistema za tkiva in celice ter dejavno podpirati njegov razvoj.

en	Reproductive cells (ART sector).
sl	Reproduktivne celice (sektor OBMP).

en	The data reported show that the EU and EEA countries comply with the minimal testing requirements stipulated in the Directive 2006/17/EC.
sl	Posredovani podatki kažejo, da države EU in EGP izpolnjujejo minimalne zahteve glede testiranja iz Direktive 2006/17/ES.

en	Outcome of tissue establishment inspections performed in 2011
sl	Slika 6 Rezultati inšpekcijskih pregledov ustanov za tkiva in celice, opravljenih leta 2011

en	Even though this practice is considered as compensation by the competent authorities, it may be perceived as an incentive by the family/relatives of the deceased donors, especially in the absence of an expressed consent of the deceased person or when, due to financial constraints, the relatives have difficulty covering the costs of the funeral/burial/cremation.
sl	Čeprav pristojni organi to prakso štejejo za nadomestilo, jo lahko družinski člani/sorodniki pokojnih darovalcev razumejo kot spodbudo, zlasti kadar ni izrecnega soglasja pokojne osebe ali kadar sorodniki zaradi finančnih omejitev težko krijejo stroške pogreba/pokopa/upepelitve.

en	The regular meetings of the national competent authorities as part of the Competent Authorities on Substances of Human Origin Expert Group (CASoHO E01718) developed into a well-appreciated platform for discussions, allowing for sharing best practices and clarification of common difficulties encountered at national and EU level.
sl	Redna srečanja nacionalnih pristojnih organov v okviru strokovne skupine pristojnih organov za snovi človeškega izvora (CASoHO E01718) so se razvila v cenjeno platformo za razprave, ki omogoča izmenjavo dobrih praks ter pojasnjevanje pogostih težav, ki nastajajo na nacionalni ravni in ravni EU.

en	Finally the Commission developed - in close cooperation with Member States - a Rapid Alert Platform for Tissues and Cells (RATC) which facilitates web-based communications between Member States in case of alerts relating to human tissues or cells transferred across borders.
sl	Nazadnje, Komisija je v tesnem sodelovanju z državami članicami razvila platformo za hitro obveščanje o tkivih in celicah (RATC), ki olajšuje spletno komuniciranje med državami članicami v primeru opozoril v zvezi s človeškimi tkivi in celicami, ki se prenašajo čez meje.

en	Even though the current requirements in Directive 2006/86/EC refer only to reporting of serious adverse reactions (SAR) in recipients of tissues and cells, the voluntary reporting of SAR in donors has gradually improved in the past years, suggesting the Member States' increasing interest in the protection of living donors.
sl	Čeprav se obstoječe zahteve iz Direktive 2006/86/ES nanašajo samo na poročanje o hudih neželenih reakcijah pri prejemnikih tkiv in celic, se prostovoljno poročanje o hudih neželenih reakcijah pri darovalcih v zadnjih letih postopno izboljšuje, kar kaže na povečan interes držav članic za zaščito živih darovalcev.

en	In addition, some countries do not distinguish between distribution within the Union and import/export from/to third countries which may be considered an important hurdle, not only against data collection and analysis, but also against optimal circulation of tissues and cells for patient benefit across the EU.
sl	Poleg tega nekatere države ne razlikujejo med razdelitvijo znotraj Unije ter uvozom v tretje države in izvozom iz njih, kar se lahko šteje za bistveno oviro ne samo za zbiranje podatkov in analizo, temveč tudi za optimalni promet s tkivi in celicami za paciente po vsej EU.

en	Total inspections = 443; data reported by 21 Member States
sl	Skupno število inšpekcijskih pregledov = 443; podatke je poslalo 21 držav članic

en	The current survey showed that in addition to the requirements in the Directive 2006/17/EC, the more stringent selection criteria required by Member States are usually justified for local reasons, such as the increased prevalence of a certain disease.
sl	Anketa je pokazala, da so poleg zahtev iz Direktive 2006/17/ES strožja merila za izbor, ki jih zahtevajo države članice, običajno utemeljena zaradi lokalnih dejavnikov, kot je večja prevalenca določene bolezni.

en	Only 15 Member States reported putting in place additional measures like examination/inspection/approval of advertising materials, training of professionals to spot illegal and fraudulent activities, verification that the VUD principle is also respected for imported tissues and cells.
sl	Samo 15 držav članic je poročalo o vzpostavitvi dodatnih ukrepov, kot so preučitev / inšpekcijski pregled / odobritev gradiva za oglaševanje, usposabljanje strokovnjakov za odkrivanje nezakonitih in goljufivih dejavnosti ter preverjanje, da se načelo PBD spoštuje tudi pri uvoženih tkivih in celicah.

en	It has to be highlighted that safety and quality is a major concern for EU citizens, with 56% of respondents to the Eurobarometer survey on blood and cell and tissue donation18 citing the risk of contracting a disease as a major concern when accepting donated substances.
sl	Poudariti je treba, da sta varnost in kakovost zelo pomembna za državljane EU, pri čemer je 56 % tistih, ki so odgovorili na anketo Eurobarometra o darovanju krvi, celic in tkiv18, tveganje prenosa bolezni navedlo kot glavno skrb pri sprejetju darovanih snovi.

en	All Member States, and also Liechtenstein and Norway provided answers to the survey on the implementation of the VUD principle.
sl	Vse države članice ter Lihtenštajn in Norveška so predložili odgovore na anketo o izvajanju načela PBD.

en	The analysis of the replies concerning inspections of tissue establishments indicates, overall, an adequate implementation of the EU requirements.
sl	Analiza odgovorov v zvezi z inšpekcijskimi pregledi ustanov za tkiva in celice kaže, da je izvajanje zahtev EU na splošno ustrezno.

en	As demonstrated by the Member State replies, there are important cross-border movements of human tissues and cells within the EU and EEA countries (Fig. 8).
sl	Kot dokazujejo odgovori držav članic, znotraj EU in držav EGP obstaja znatni čezmejni promet s človeškimi tkivi in celicami (slika 8).

en	In spite of this, both the Commission and national competent authorities for tissues and cells acknowledge that there is still a high degree of under-reporting requiring careful consideration when analysing the data.
sl	Kljub temu Komisija in nacionalni pristojni organi za tkiva in celice priznavajo, da je nezadostno poročanje še vedno precej prisotno, kar je treba pazljivo upoštevati pri analizi podatkov.

en	Divergent criteria might however also create barriers for exchanging tissues and cells between Member States for healthcare professionals requesting tissues or cells from another Member State.
sl	Različna merila pa lahko predstavljajo tudi ovire za izmenjavo tkiv in celic med državami članicami za zdravstvene delavce, ki zaprosijo za tkiva ali celice iz druge države članice.

en	This report is based on the replies to questionnaires that the Commission sent to Member States in 2012 (verification of the completeness of transposition), 2013 (implementation survey), and 2014 (implementation of the VUD principle) and follows up on the Commission communication published in January 2010 as well as the two reports on the application of the principle of VUD for tissues and cells issued in 2006 and 2011.
sl	To poročilo temelji na odgovorih na vprašalnike, ki jih je Komisija poslala državam članicam leta 2012 (preverjanje popolnosti prenosa), leta 2013 (anketa o izvajanju) in leta 2014 (izvajanje načela PBD), ter sledi sporočilu Komisije, objavljenemu januarja 2010 ter poročiloma o uporabi načela PBD za tkiva in celice, izdanima leta 2006 oziroma leta 2011.

en	Limited information was provided on the value of most of the practices related to tissue and cell donation, probably because the costs vary considerably depending on the donation circumstances (e.g. need of prior testing/medical treatment, duration of hospitalisation, effects on the overall health and capacity to work) or depend on the clinic where the donation takes place.
sl	O vrednosti večine praks v zvezi z darovanjem tkiv in celic so bile poslane omejene informacije, verjetno zato, ker se stroški znatno razlikujejo glede na okoliščine darovanja (npr. potreba po predhodnem testiranju/zdravljenju, trajanje hospitalizacije, učinki na splošno zdravje in sposobnost za delo) ali pa so odvisni od klinike, na kateri se darovanje izvede.

en	These actions allowed for the development of guidelines and manuals in areas of common interest such as inspections and vigilance, included training courses for Member States Competent Authorities and their inspectors and brought together professionals in the tissue banking sector for the development of detailed technical guidance in line with the EU legal requirements.
sl	Ti ukrepi so omogočili razvoj smernic in priročnikov na področjih, ki so v splošnem interesu, kot so inšpekcijski pregledi in vigilanca, vključevali so usposabljanja za pristojne organe držav članic in njihove inšpektorje ter združili strokovnjake iz sektorja shranjevanja tkiv za razvoj podrobnih tehničnih navodil v skladu z zakonskimi zahtevami EU.

en	In this regard, several national competent authorities have called for an EU-level endorsement of Good Tissue Practice guidelines (GTP), similar to Good Manufacturing Practice guidelines (GMP) approach in the pharmaceutical sector and for continuing to provide support for training of inspectors at the EU level.
sl	V zvezi s tem je več nacionalnih pristojnih organov pozvalo, da se na ravni EU potrdijo smernice za dobro prakso v zvezi s tkivi, podobne pristopu s smernicami za dobro proizvodno prakso v farmacevtskem sektorju, in da se nadalje zagotavlja podpore za usposabljanje inšpektorjev na ravni EU.

en	In addition, and in accordance with Article 12(1) of Directive 2004/23/EC, Member States also have to submit to the Commission reports on the application of the principle of voluntary and unpaid donation (VUD) every three years.
sl	Poleg tega morajo države članice v skladu s členom 12(1) Direktive 2004/23/ES Komisiji vsaka tri leta predložiti poročilo o uporabi načela prostovoljnega in brezplačnega darovanja (PBD).

en	When verifying the compliance of tissues establishments with the EU donor evaluation and selection requirements, inspections are the most important verification method used by the Member State competent authorities.
sl	Pri preverjanju skladnosti ustanov za tkiva in celice z zahtevami EU glede vrednotenja in izbiranja darovalcev so inšpekcijski pregledi najpomembnejši način preverjanja, ki ga uporabljajo pristojni organi držav članic.

en	As a consequence, identical shortcomings may result in different outcomes for the inspected establishments depending on their geographical location (e.g. penalties vs. revocation or suspension of license for the same deficiency).
sl	Zato imajo lahko enake pomanjkljivosti različne posledice za ustanove, v katerih so bili opravljeni inšpekcijski pregledi, glede na njihovo geografsko lokacijo (npr. kazni v primerjavi s preklicem ali začasnim odvzemom dovoljenja za enako pomanjkljivost).

en	In this regard, 18 Member States and one EEA country reported to have a follow-up registry or database of haematopoietic stem cell donors, but the type of the follow-up examinations, their periodicity and the responsible healthcare facilities/professionals may vary from country to country.
sl	V zvezi s tem je 18 držav članic in držav EGP poročalo, da imajo register za nadaljnje spremljanje ali podatkovno zbirko o darovalcih krvotvornih matičnih celic, vendar se lahko vrsta nadaljnjih pregledov, njihova pogostost in odgovorne zdravstvene ustanove/delavci razlikujejo po posameznih državah.

en	Regarding practices vis-à-vis deceased donors of tissues and cells, only three Member States reported that they provide compensation to donor relatives.
sl	V zvezi s praksami glede pokojnih darovalcev tkiv in celic so samo tri države članice poročale, da dajejo nadomestilo sorodnikom darovalca.

en	Total inspections = 549; data reported by 22 Member States
sl	Skupno število inšpekcijskih pregledov = 549; podatke je poslalo 22 držav članic

en	This may explain the considerable heterogeneity across the EU in the practices vis-à-vis tissue and cell donors, with some practices being regarded as compensation in one country and incentives or other practices in others.
sl	To lahko pojasni znatno raznolikost praks v zvezi z darovalci tkiv in celic po EU, pri čemer nekatere države določene prakse štejejo za nadomestilo, druge pa za spodbudo ali druge prakse.

en	In this regard, more training of both healthcare professionals and vigilance officers in tissue establishments and competent authorities will be needed for an appropriate identification and analysis of the "root causes" of these SARE, which should lead to the identification and correction of systematic errors.
sl	V zvezi s tem bo potrebnega več usposabljanja zdravstvenih delavcev in uradnikov za vigilanco v ustanovah za tkiva in celice ter pristojnih organih za ustrezno določitev in analizo „temeljnih vzrokov" za te hude neželene reakcije in dogodke, kar bi moralo privesti do prepoznavanja in odprave sistemskih napak.

en	Besides complying with the legal obligations pursuant to Article 12 (1) and Article 26 of Directive 2004/23/EC, the current report sets out how Directive 2004/23/EC and its implementing Directives 2006/17/EC and 2006/86/EC (hereafter commonly referred to as the EU tissue and cell legislation) function in practice, against a backdrop of significant scientific and organisational developments (internationalisation, commercialisation) that have taken place in the tissue and cell sector over the past decade.
sl	Poleg tega, da se s tem poročilom izpolnjujejo zakonske obveznosti v skladu s členom 12(1) in členom 26 Direktive 2004/23/ES, je v njem prikazano, kako Direktiva 2004/23/ES ter izvedbeni direktivi 2006/17/ES in 2006/86/ES (v nadaljnjem besedilu skupaj: zakonodaja EU o tkivih in celicah) delujejo v praksi glede na znaten znanstveni in organizacijski razvoj (internacionalizacija, komercializacija) v sektorju tkiv in celic v zadnjem desetletju.

en	Several authorities underlined that in such situations there is a significant risk of losing traceability, including inappropriate reporting of pregnancy rate and serious adverse reactions following medical application (e.g. children born with genetic diseases not reported back to the distributing tissue establishment).
sl	Več organov je poudarilo, da v takih primerih obstaja znatno tveganje izgube sledljivosti, vključno z neustreznim poročanjem o stopnji nosečnosti in hudih neželenih reakcijah po medicinski uporabi (npr. otroci, rojeni z genskimi boleznimi, o katerih razdeljevalna ustanova za tkiva in celice ni obveščena).

en	The new legal provisions for the application of the Single European Code shall also satisfy the requirement in Article 10(3) of the Directive 2004/23/EC, by establishing the EU Tissue Establishment Compendium including all tissues establishments with their coordinates and the status of their accreditation/designation/authorised or licence.
sl	Nove zakonske določbe za uporabo enotne evropske kode morajo izpolniti tudi zahtevo iz člena 10(3) Direktive 2004/23/ES z vzpostavitvijo EU-kompendija ustanov za tkiva in celice, vključno z vsemi ustanovami za tkiva in celice s svojimi koordinatami in statusom glede akreditacije/imenovanja/odobritve ali izdaje dovoljenja.

en	As suggested by some Member States, a procedure setting higher (minimum) standards for the authorisation of tissue and cell preparation processes at the tissue establishments (as referred to in Article 4 of Directive 2006/86/EC) may encourage mutual trust and acceptance between Member States and thus strengthen the cross-border movement of tissues and cells across EU.
sl	Kot predlagajo nekatere države članice, bi lahko postopek, ki bi določal višje (minimalne) standarde za odobritev postopkov priprave tkiv in celic v ustanovah za tkiva in celice (iz člena 4 Direktive 2006/86/ES), spodbudil medsebojno zaupanje in sprejemanje med državami članicami ter s tem okrepil čezmejni prenos tkiv in celic po vsej EU.

en	The competent authorities allowing such practices were requested to evaluate if and/or how traceability and reporting requirements are ensured by the tissue establishments distributing gametes to individuals and to take the necessary measures in case such practices do not fulfil the safety and quality requirements laid down in the EU tissue and cell legislation.
sl	Od pristojnih organov, ki take prakse dovoljujejo, se je zahtevalo, naj ocenijo, če in/ali kako ustanove za tkiva in celice, ki razdeljujejo gamete posameznicam, zagotavljajo izpolnjevanje zahtev glede sledljivosti in poročanja, ter sprejmejo potrebne ukrepe, če take prakse ne izpolnjujejo zahtev glede varnosti in kakovosti iz zakonodaje EU o tkivih in celicah.

en	Even though most respondents confirmed respecting the required 2-year interval between inspections, some Member States suggested that prioritising inspections based on factors like the size of establishment, range of activity, experience of inspectors and compliance history may prove valuable especially in a period when financial constraints have a considerable influence on the staffing of departments in charge of inspections.
sl	Čeprav je večina anketirancev potrdila, da upoštevajo zahtevano dveletno obdobje med inšpekcijskimi pregledi, je nekaj držav članic predlagalo, da je lahko koristno določiti prednostni vrstni red inšpekcijskih pregledov glede na dejavnike, kot so velikost ustanove, razpon dejavnosti, izkušnje inšpektorjev in izpolnjevanje zakonskih obveznosti v preteklosti, zlasti v obdobju, ko finančne omejitve znatno vplivajo na kadrovske zmogljivosti oddelkov, odgovornih za inšpekcijske preglede.

en	As underlined by several national competent authorities, a more harmonised procedure for the accreditation, designation, authorisation or licensing of tissue establishments would foster mutual trust and acceptance between Member States which are essential for ensuring a prompt supply of tissues and cells to the patients in need for the cases in which tissues and cells are distributed from another Member State than the one where the patient is treated.
sl	Kot je poudarilo več nacionalnih pristojnih organov, bi bolj usklajen postopek akreditacije, imenovanja, odobritve ali izdaje dovoljenja ustanovam za tkiva in celice spodbudil vzajemno zaupanje in sprejemanje med državami članicami, ki sta bistvena za zagotavljanje hitre dostave tkiv in celic pacientom, ki jih potrebujejo, kadar tkiva in celice prihajajo iz druge države članice, ki ni tista, v kateri se pacient zdravi.

en	The fact that third parties may be involved in all steps of the chain from donation and procurement to distribution in most Member States highlights the importance that needs to be given to the written agreements established by tissue establishments and their verification by the national competent authorities.
sl	Dejstvo, da so lahko v večini držav članic v vse stopnje v verigi od darovanja in pridobivanja do razdeljevanja vključene tretje osebe, poudarja pomen, ki ga je treba dati pisnim sporazumom z ustanovami za tkiva in celice ter njihovemu preverjanju s strani nacionalnih pristojnih organov.

en	The full analysis of the Member States' replies to the 2013 implementation survey and the 2014 survey on the implementation of the VUD principle is included in the two staff working documents accompanying this report.
sl	Celotna analiza odgovorov držav članic na anketo o izvajanju iz leta 2013 in anketo o izvajanju načela PBD iz leta 2014 je vključena v delovna dokumenta služb Komisije, priložena temu poročilu.

en	However, it has to be noted that, as for import and export, data collected by the Member States probably serve different purposes and use various methodologies, so it is very difficult to draw a clear conclusion on the importance of EU distribution compared to import/export from/to third countries and therefore to evaluate tissue and cell sufficiency at EU level.
sl	Vendar je treba opozoriti, da se podatki, ki so jih države članice zbrale v zvezi z uvozom in izvozom, verjetno uporabljajo za različne namene in da se zanje uporabljajo različne metodologije, zato je zelo težko oblikovati jasen sklep glede pomena razdeljevanja v EU v primerjavi z uvozom v tretje države in izvozom iz njih ter ovrednotiti zadostnost glede tkiv in celic na ravni EU.

en	Accreditation, designation, authorisation or licensing of tissue establishments.
sl	Akreditacija, imenovanje, odobritev ali izdajanje dovoljenj ustanovam za tkiva in celice.

en	Concerning the number of competent authorities, in some Member States only one authority is responsible for the oversight of the tissue and cell sector, whereas in other countries the tasks are divided amongst two or three authorities (based either on type of tissues and cells or on duties e.g. accreditation/authorisation v. inspections/vigilance or the allocation of tasks between federal and regional levels).
sl	Kar zadeva število pristojnih organov, je v nekaterih državah članicah samo en organ odgovoren za nadzor nad sektorjem tkiv in celic, v drugih pa so naloge razdeljene med dva ali tri organe (glede na vrsto tkiv in celic ali glede na naloge, npr. akreditacija/odobritev v primerjavi z inšpekcijskimi pregledi/vigilanco, ali glede na razdelitev nalog med zvezno in regionalno ravnjo).

en	In relation to the supply-demand balance, 17 Member States and one EEA country reported experiencing regular shortages of tissues and cells on a national level, mostly for bone marrow and haematopoietic stem cells, corneas and bone.
sl	V zvezi z ravnotežjem med ponudbo in povpraševanjem je 17 držav članic in ena država EGP poročalo o rednem pomanjkanju tkiv in celic na nacionalni ravni, večinoma za kostni mozeg in krvotvorne matične celice, roženice in kosti.

en	Development of follow-up registries as an additional tool for ensuring safety of living donors was also addressed in the survey.
sl	Anketa se je nanašala tudi na razvoj registrov za nadaljnje spremljanje kot dodatnega orodja za zagotavljanje varnosti živih darovalcev.

en	In most of the Member States compliance with the requirements for tissue and cell procurement set by Directive 2006/17/EC is verified by the competent authorities when performing inspections, but also by auditing procurement organisations and centres of human application.
sl	V večini držav članic skladnost z zahtevami glede pridobivanja tkiv in celic iz Direktive 2006/17/ES pristojni organi preverjajo pri opravljanju inšpekcijskih pregledov, pa tudi pri revizijskih pregledih organizacij za pridobivanje in centrov za zdravljenje ljudi.

en	The main reasons for shortages were the lack of donors, followed by insufficient procurement capacity at national level and technical reasons (e.g. practical difficulties in finding a compatible match for patients in need of an HSC transplantation).
sl	Glavni razlogi za pomanjkanje so pomanjkanje darovalcev ter nezadostna zmogljivost pridobivanja na nacionalni ravni in tehnični razlogi (npr. praktične težave pri iskanju ustreznega darovalca za paciente, ki potrebujejo presaditev krvotvornih matičnih celic).

en	Best practices to ensure tissue and cell sufficiency/self-sufficiency or measures to reduce shortages might be addressed as well as best practices on verification of the implementation of the VUD principle by the competent authorities.
sl	Obravnavajo se lahko dobre prakse za zagotavljanje zadostnosti/samozadostnosti glede tkiv in celic ali ukrepi za zmanjšanje pomanjkanja ter dobre prakse preverjanja, kako pristojni organi izvajajo načelo PBD.

en	The survey showed that a donor identification system was implemented by most Member States, with a unique code for each donation being assigned, predominantly at the level of the tissue establishment.
sl	Anketa je pokazala, da je večina držav članic vzpostavila sistem identifikacije darovalcev z določitvijo edinstvene kode za vsako darovanje, predvsem na ravni ustanove za tkiva in celice.

en	Nevertheless, it has to be underlined that a small number of countries rely only on the medical records of the donor and/or the autopsy report without interviewing the donor's family or his/her treating physician/general practitioner.
sl	Kljub temu pa je treba poudariti, da se le majhno število držav zanaša samo na zdravstveno kartoteko darovalca in/ali obdukcijski izvid, ne da bi bil opravljen razgovor z družino darovalca ali zdravnikom, ki ga zdravi, oziroma izbranim splošnim zdravnikom.

en	Only six Member States have national registries of oocyte and sperm donors.
sl	Samo šest držav članic ima nacionalne registre darovalcev jajčnih celic in sperme.

en	Even though most of the Member States reported using the Operational Manual for Competent Authorities on inspection of tissue and cell procurement and tissue establishments, there is no common agreement on the classification of shortcomings identified during inspections (e.g. classification of minor, major and critical deficiencies).
sl	Čeprav je večina držav članic poročala, da uporabljajo Operativni priročnik za pristojne organe o inšpekcijskih pregledih pridobivanja tkiv in celic ter ustanov za tkiva in celice, niso soglasne glede razvrščanja pomanjkljivosti, ugotovljenih pri inšpekcijskih pregledih (npr. razvrščanje manjših, velikih in kritičnih pomanjkljivosti).

en	Good practices developed by the EU-funded initiatives were also included by the Council of Europe in a dedicated Guide to the Quality and Safety of Tissues and Cells.
sl	Dobre prakse, razvite v okviru pobud, ki jih financira EU, je Svet Evrope vključil tudi v namenski vodnik za kakovost in varnost tkiv in celic (Guide to the Quality and Safety of Tissues and Cells).

en	In conclusion, this Report reveals an overall adequate application of the current quality and safety requirements of the EU tissues and cells legislation in most of the responding EU Member States and EEA countries.
sl	To poročilo kaže, da se obstoječe zahteve glede kakovosti in varnosti iz zakonodaje EU o tkivih in celicah na splošno ustrezno uporabljajo v večini držav članic EU in držav EGP, ki so se odzvale.

en	The present implementation survey confirmed that Member States are trying to ensure an appropriate level of training for their tissue establishment personnel, and the compliance with the requirements of Directive 2004/23/EC is systematically verified during inspections and also before granting authorisation/accreditation/licence to tissue establishments.
sl	Anketa o izvajanju je potrdila, da države članice poskušajo zagotoviti ustrezno raven usposabljanja za osebje ustanov za tkiva in celice ter da se izpolnjevanje zahtev Direktive 2004/23/ES sistematično preverja med inšpekcijskimi pregledi in pred odobritvijo/akreditacijo/izdajo dovoljenja ustanovam za tkiva in celice.

en	Moreover, the inclusion in the EU Tissue Establishment Compendium will reinforce the credentials of the EU tissue establishments to their partners and customers around the world.
sl	Poleg tega bo vključitev v EU-kompendij ustanov za tkiva in celice okrepila zaupanje partnerjev in strank po vsem svetu v ustanove za tkiva EU.

en	By updating the data in this Compendium, the tissues and cells competent authorities demonstrate full transparency and provide support to healthcare professionals searching for an authorised tissue or cell provider within the Union.
sl	Pristojni organi za tkiva in celice s posodabljanjem podatkov v tem kompendiju dokažejo celovito preglednost in zagotavljajo podporo zdravstvenim delavcem, ki iščejo odobrenega dobavitelja tkiv in celic v Uniji.

en	In terms of inspection outcomes, mostly minor shortcomings were recorded with few suspensions and revocations of authorisations (Fig. 6).
sl	Rezultati inšpekcijskih pregledov kažejo, da so bili ugotovljene samo manjše pomanjkljivosti, pri čemer je bilo samo nekaj odobritev začasno odvzetih ali preklicanih (slika 6).

en	Additionally, for cases in which tissues/cells from one donor will be used for both transplantation and manufacturing of ATMP, consideration should be given on how to best exchange relevant data between the pharmacovigilance and biovigilance systems (e.g. donation of cells from a living donor which may be found to develop a tumour after donating cells to an ATMP manufacturer or recipient developing a tumour/communicable disease following therapy with donated cells from a donor who may have donated cells transplanted in another recipient).
sl	Poleg tega je treba za primere, v katerih se tkiva/celice enega darovalca uporabijo za presaditev in izdelavo zdravil za napredno zdravljenje, razmisliti o tem, kako najbolje izmenjati zadevne podatke med sistemoma farmakovigilance in biovigilance (npr. darovanje celic živega darovalca, pri katerem se lahko po darovanju celic proizvajalcu zdravil za napredno zdravljenje odkrije tumor, ali prejemnik, pri katerem se tumor/nalezljiva bolezen pojavi po zdravljenju z darovanimi celicami darovalca, ki je morda daroval celice, presajene na drugega prejemnika).

en	Verification during inspections of standard operating procedures (SOP) prepared by the tissue establishments and inspecting patient and donor information provided by licensed fertility clinics were reported only by two Member States.
sl	O preverjanju med inšpekcijskimi pregledi standardnih operativnih postopkov, ki so jih pripravile ustanove za tkiva in celice, ter inšpekcijskem pregledovanju informacij o pacientih in darovalcih, ki jih pošljejo klinike za zdravljenje neplodnosti, sta poročali samo dve državi članici.

en	New processing methodologies, unthought-of of when the Directives were adopted, are now commonly applied: pre-cutting of corneas with the transplant of only the anterior or posterior segment to one patient, decellularisation of skin and heart valves in the tissue establishment to enhance cellularisation in vivo in the recipient, numerous new pathogen inactivation or sterilisation techniques including the use of radioprotectants to allow treatment with high doses of gamma irradiation, transplantation of highly selected cell populations to be used for the same essential function in the recipient as in the donor, have all increased the importance of robust preparation process authorisation.
sl	Nove metodologije predelave, ki si jih ob sprejetju direktiv ni bilo mogoče zamišljati, so danes v splošni rabi: predhodno rezanje roženice, pri čemer se na enega pacienta presadi samo prednji ali zadnji del, decelularizacija kože in srčnih zaklopk v ustanovah za tkiva in celice za povečanje celularizacije in vivo pri prejemniku, številne nove tehnike inaktivacije patogenov in sterilizacije, vključno z uporabo radioprotektorjev, ki omogočajo zdravljenje z velikimi odmerki obsevanja z žarki gama, presajanje strogo izbranih populacij celic, ki se pri prejemniku uporabljajo za isto bistveno funkcijo kot pri darovalcu, in zaradi vsega tega se je povečal pomen odobritve postopkov priprave.

en	Concerning testing laboratories, the survey showed that in most of the reporting Member States accreditation/designation/authorisation or licensing of testing laboratories is the responsibility of authorities other than the tissue and cell competent authorities.
sl	Anketa je v zvezi z laboratoriji za testiranje pokazala, da je v večini držav članic poročevalk akreditacija/imenovanje/odobritev/izdajanje dovoljenj laboratorijem za testiranje odgovornost drugih organov in ne pristojnih organov za tkiva in celice.

en	In addition, in several Member States, only tissue establishments are authorised to procure tissues and cells, with some countries authorising tissue establishments just for procurement activities.
sl	Poleg tega je v nekaterih državah članicah samo ustanovam za tkiva in celice dovoljeno pridobivanje tkiv in celic, pri čemer nekatere države odobrijo ustanove za tkiva in celice samo za dejavnosti pridobivanja.

en	Issues to be addressed include transparency of the decisions regarding donor compensation, the type and value of the compensations for donors, especially for the situations when such decisions were conveyed to procurement organisations or tissue establishments.
sl	Vprašanja, ki jih je treba obravnavati, vključujejo preglednost odločitev glede nadomestil darovalcem ter vrste in vrednosti nadomestil darovalcem, zlasti kadar so take odločitve prepuščene organizacijam za pridobivanje ali ustanovam za tkiva in celice.

en	Furthermore, besides procurement of replacement tissues, haematopoietic stem cells and reproductive cells, some Member States also reported a significant number of procurement organisations carrying out procurement of tissue and cells to be used for manufacturing of advanced therapy medicinal products (ATMP) (Fig. 3).
sl	Poleg tega so nekatere države poleg pridobivanja nadomestnih tkiv, krvotvornih matičnih celic in reproduktivnih celic poročale tudi o znatnem številu organizacij za pridobivanje, ki pridobivajo tkivo in celice, ki se uporabljajo za izdelavo zdravil za napredno zdravljenje (slika 3).

en	An important issue is how and by whom the decision concerning the value and form of compensations for tissue and cell donors is taken.
sl	Pomembno vprašanje je, kako se sprejme odločitev o vrednosti in obliki nadomestila za darovalce tkiv in celic ter kdo jo sprejme.

en	The findings of the VUD survey suggest that Member States should collect more information on the day-to-day practices vis-à-vis donors in both procurement organisations and tissue establishments, especially when these operators are responsible for deciding the type and/or value of the compensation provided to donors.
sl	Ugotovitve ankete o PBD kažejo, da bi morale države članice zbirati več informacij o dnevnih praksah glede darovalcev v organizacijah za pridobivanje in ustanovah za tkiva in celice, zlasti kadar so ti subjekti odgovorni za odločanje o vrsti in/ali vrednosti nadomestila darovalcem.

en	The analysis of the annual SARE reports submitted by the Member States demonstrates notable efforts to comply with the requirements in Article 7 of Directive 2006/86/EC.
sl	Analiza letnih poročil o hudih neželenih reakcijah in dogodkih, ki so jih predložile države članice, dokazuje vidna prizadevanja za izpolnjevanje zahtev iz člena 7 Direktive 2006/86/ES.

en	The survey revealed a variety of approaches for the implementation of the procurement requirements laid down in Directive 2006/17/EC, especially when granting authorisation (e.g. prior on-site inspection vs. desk-based review of documentation, differing criteria for major changes requiring a notification of the competent authorities, differing duration of authorisation and conditions of renewal).
sl	Anketa je razkrila raznolikost pristopov k izvajanju zahtev glede pridobivanja iz Direktive 2006/17/ES, zlasti v zvezi z odobritvijo (npr. predhodni inšpekcijski pregled na kraju samem v primerjavi s pisarniškim pregledom dokumentacije, različna merila za pomembne spremembe, ki jih je treba priglasiti pristojnim organom, različno trajanje odobritve in različni pogoji za njeno obnovo).

en	Register of tissue establishments and reporting obligations.
sl	Register ustanov za tkiva in celice ter obveznosti poročanja.

en	Provisions associated with procurement, but also with donation and testing, are regulated by the tissue and cell legislation and verified during tissue establishment inspection.
sl	Določbe v zvezi s pridobivanjem ter darovanjem in testiranjem so urejene z zakonodajo o tkivih in celicah ter preverjene pri inšpekcijskem pregledu ustanove za tkiva in celice.

en	Donor selection and evaluation.
sl	Izbiranje in vrednotenje darovalcev.

en	An alert issued in RATC accompanied by recall of products from an EU tissue establishment revealed that the consent form and its verification may be very different from one Member State to another, depending also on the legal framework under which the EU tissue and cell legislation has been transposed.
sl	Opozorilo, poslano prek platforme za hitro obveščanje o tkivih in celicah (RATC), je skupaj z odpoklicem proizvodov ustanove za tkiva in celice iz EU razkrilo, da se lahko obrazec za soglasje in njegovo preverjanje po posameznih državah članicah zelo razlikujeta, odvisno tudi od pravnega okvira, v katerem je bila prenesena zakonodaja EU o tkivih in celicah.

en	Import/export of human tissues and cells to/from third countries.
sl	Uvoz človeških tkiv in celic v tretje države članice in izvoz iz njih.

en	Responses to the survey showed that this is also the case for procurement of tissues and cells for ATMP manufacturers, in line with Article 3 of the ATMP Regulation.
sl	Odgovori na anketo so pokazali, da je tako tudi v primeru pridobivanja tkiv in celic za proizvajalce zdravil za napredno zdravljenje v skladu s členom 3 uredbe o zdravilih za napredno zdravljenje.

en	Such difficulties were also reported by operators manufacturing ATMP from human tissues and cells.
sl	O takih težavah so poročali tudi subjekti, ki proizvajajo zdravila za napredno zdravljenje iz človeških tkiv in celic.

en	This report shows that Member States overall comply with Article 12 of Directive 2004/23/EC requiring Member States to take the necessary measures to endeavour to ensure VUD of tissues and cells.
sl	To poročilo kaže, da države članice na splošno ravnajo v skladu s členom 12 Direktive 2004/23/ES, ki od držav članic zahteva, da sprejmejo potrebne ukrepe ter si prizadevajo zagotoviti prostovoljno in brezplačno darovanje tkiv in celic.

en	Where appropriate data gathered through other channels and supporting the findings of the two surveys (e.g. exchanges with the national competent authorities during the bi-annual meetings with the Commission, mandatory annual reporting to the Commission of serious adverse reactions and events (SARE), alerts launched in the Rapid Alerts for Tissues and Cells (RATC) platform, Eurobarometer survey exploring the views of EU citizens on tissue and cell donation and the output of a number of relevant EU-funded projects and studies) were also taken into account.
sl	Kadar je bilo to ustrezno, so bili upoštevani tudi podatki, zbrani po drugih poteh in v podporo ugotovitvam obeh anket (npr. izmenjava informacij s pristojnimi nacionalnimi organi na dveletnih srečanjih s Komisijo, obvezno letno poročanje Komisiji o hudih neželenih reakcijah in dogodkih, opozorila, poslana prek platforme za hitro obveščanje o tkivih in celicah (RATC), raziskava Eurobarometra o mnenju državljanov EU o darovanju tkiv in celic ter rezultati več zadevnih projektov in študij, ki jih je financirala EU).

en	On the other hand, ten Member States indicated that, especially for sperm donors, such registries are maintained by the tissue establishments.
sl	Po drugi strani pa je deset držav članic navedlo, da take registre vzdržujejo ustanove za tkiva in celice, zlasti za darovalce sperme.

en	It has to be noted that similar to donor selection, more stringent testing requirements introduced by some Member States are sometimes perceived by healthcare professionals ordering tissues or cells from other Member States as barriers hampering development and the cross-border movement of tissues and cells between Member States.
sl	Opozoriti je treba, da - podobno kot pri izbiranju darovalcev - zdravstveni delavci, ki naročajo tkiva ali celice iz drugih držav članic, včasih strožje zahteve, ki so jih uvedle nekatere države članice, vidijo kot ovire, ki zavirajo razvoj in čezmejni prenos tkiv in celic med državami članicami.

en	Fig. 8.
sl	Slika 8

en	Legend: HSC = haematopietic stem cells
sl	Legenda: KMC = krvotvorne matične celice

en	As regards the implementation of the VUD principle, the Commission survey showed that Member States overall comply with Article 12 of Directive 2004/23/EC requiring them to take the necessary measures to encourage VUD.
sl	V zvezi z izvajanjem načela PBD je anketa Komisije pokazala, da države članice na splošno ravnajo v skladu s členom 12 Direktive 2004/23/ES, ki zahteva, da sprejmejo potrebne ukrepe za spodbujanje prostovoljnega in brezplačnega darovanja.

en	Tissue and cell reception, processing, storage, labelling and packaging.
sl	Prevzem, predelava, hranjenje, označevanje in pakiranje tkiv in celic.

en	Non-reproductive tissues and cells.
sl	Nereproduktivna tkiva in celice.

en	The importance of SARE reporting is confirmed by the interest of the Member States in collaborating with the Commission to improve the current reporting system (e.g. refining the SARE reporting templates for improving collection of data in the sector of assisted reproduction technology (ART)) and to expand communication with other countries and other sectors (e.g. fostering cooperation with relevant third countries with regard to SARE reporting).
sl	Pomembnost poročanja o hudih neželenih reakcijah in dogodkih potrjuje interes držav članic za sodelovanje s Komisijo za izboljšanje sedanjega sistema poročanja (npr. izpopolnitev predlog za poročanje o hudih neželenih reakcijah in dogodkih v sektorju oploditve z biomedicinsko pomočjo (OBMP)) ter za razširitev komunikacije z drugimi državami in sektorji (npr. spodbujanje sodelovanja z zadevnimi tretjimi državami glede poročanja o hudih neželenih reakcijah in dogodkih).

en	Number of accredited/designated/authorised/licensed tissue establishments per type of human tissues and cells (comparative data; data submitted by 27 Member States and two EEA countries)
sl	Slika 4 Število akreditiranih/imenovanih/odobrenih ustanov za tkiva in celice ali ustanov za tkiva in celice z dovoljenjem glede na vrsto človeških tkiv in celic (primerjalni podatki; podatki, ki jih je posredovalo 27 držav članic in dve državi EGP)

en	Several of the testing requirements (e.g. no requirement for NAT testing, the 24 hours limit for blood sample collection from a deceased donor, testing of gamete donors at the time of donation) have been subject to debate at the bi-annual national competent authorities meetings and the various practices shared by the competent authorities showed the need for an evidence-based risk assessment of some practical situations which were not clearly defined/foreseen in Directive 2006/17/EC.
sl	Na dveletnih srečanjih nacionalnih pristojnih organov je potekala razprava o več zahtevah glede testiranja (npr. neobstoj zahteve po testiranju z NAT, 24-urna omejitev za odvzem vzorca krvi pokojnega darovalca, testiranje darovalcev gamet ob darovanju) in različne prakse, ki so si jih izmenjali pristojni organi, so pokazale potrebo po ocenjevanju tveganj na podlagi dokazov v zvezi z nekaterimi praktičnimi primeri, ki v Direktivi 2006/17/ES niso bili jasno opredeljeni/predvideni.

en	The survey showed that all reporting Member States authorise the conditions of procurement by inspecting procurement organisations and/or by evaluating the procurement-related documentation made available by the tissue establishment working with procurement organisations.
sl	Anketa je pokazala, da vse države članice poročevalke odobrijo pogoje pridobivanja na podlagi inšpekcijskega pregleda organizacij za pridobivanje in/ali z vrednotenjem dokumentacije v zvezi s pridobivanjem, ki jo da na voljo ustanova za tkiva in celice, ki sodeluje z organizacijami za pridobivanje.

en	Relations between tissue establishments and third parties.
sl	Odnosi med ustanovami za tkiva in celice ter tretjimi osebami.

en	In line with the requirements in Article 10 of Directive 2004/23/EC, national registers of tissues establishments appear to be available in most of the responding Member States.
sl	Videti je, da so nacionalni registri ustanov za tkiva in celice v skladu z zahtevami iz člena 10 Direktive 2004/23/ES na voljo v večini držav članic, ki so se odzvale.

en	[18: For the purpose of the survey, in order to facilitate a consistency in replies, those terms were defined as follows: 'National self-sufficiency' was defined as fulfilling the needs of human tissue and cell products for medical application (e.g. transplantation, ART procedures) of the resident population by accessing resources from within the country's population.
sl	[18: Za namen ankete sta bila za zagotovitev skladnosti odgovorov ta izraza opredeljena, kot sledi: „nacionalna samozadostnost" je bila opredeljena kot zadovoljevanje potreb stalnega prebivalstva po proizvodih iz človeških tkiv in celic za uporabo v medicini (npr. presaditve, postopki OBMP) z dostopanjem do virov znotraj prebivalstva države; „nacionalna zadostnost" je bila opredeljena kot zadovoljevanje potreb stalnega prebivalstva po proizvodih iz človeških tkiv in celic za uporabo v medicini (npr. presaditve, postopki OBMP) z dostopanjem do virov znotraj države in prek regionalnega/mednarodnega sodelovanja.]

en	Verification by the competent authorities of the implementation of the VUD principle in tissue establishments is focused on inspecting documentation related to donor consent.
sl	Preverjanje izvajanja načela PBD v ustanovah za tkiva in celice, ki ga opravljajo pristojni organi, je osredotočeno na inšpekcijsko pregledovanje dokumentacije v zvezi s soglasjem darovalcev.

en	Five Member States have both central oocyte and sperm donor registries.
sl	Pet držav članic ima osrednje registre tako za darovalce jajčnih celic kot tudi za darovalce sperme.

en	Quality and safety of tissues and cells
sl	Kakovost in varnost tkiv in celic

en	Legend: ART = assisted reproductive technologies
sl	Legenda: OBMP = oploditev z biomedicinsko pomočjo

en	[2: Detailed Member States' replies (as well as replies from Norway and Liechtenstein) can be accessed at http://ec.europa.eu/health/blood_tissues_organs/key_documents/][3: In a number of cases clarification requests were sent to Member States.
sl	[2: Podrobni odgovori držav članic (ter odgovori Norveške in Lihtenštajna) so na voljo na http://ec.europa.eu/health/blood_tissues_organs/key_documents/.

en	Distribution of tissues and cells for human application.
sl	Razdeljevanje tkiv in celic za uporabo pri zdravljenju ljudi.

en	Several of the selection criteria, as well as the tasks of the responsible persons in Member States with more stringent requirements, have been subject to discussion during the bi-annual national competent authority meetings.
sl	Na dveletnih srečanjih nacionalnih pristojnih organov je potekala razprava o več merilih za izbor in nalogah odgovornih oseb v državah članicah s strožjimi zahtevami.

en	[7: Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L102, 07.04.2004, p. 48).
sl	[7: Direktiva 2004/23/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o določitvi standardov kakovosti in varnosti, darovanja, pridobivanja, testiranja, predelave, konzerviranja, shranjevanja in razdeljevanja človeških tkiv in celic (UL L 102, 7.4.2004, str. 48).

en	Authorisation of tissue and cell preparation processes.
sl	Odobritev postopkov priprave tkiv in celic.

en	[14: Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells.
sl	[14: Direktiva Komisije (EU) 2015/565 z dne 8. aprila 2015 o spremembi Direktive 2006/86/ES v zvezi z nekaterimi tehničnimi zahtevami za kodiranje človeških tkiv in celic.

en	It should be noted that, although much has been achieved and reporting improves every year, challenges related to under-reporting by organisations responsible for human application and the lack of accurate data remain.
sl	Opozoriti je treba, da izzivi glede nezadostnega poročanja organizacij, pristojnih za zdravljenje ljudi, in pomanjkanja točnih podatkov ostajajo, čeprav je bilo že veliko doseženega in se poročanje vsako leto izboljšuje.

en	Number of procurement organisations (POs) reported by the EU and EEA countries
sl	Slika 3 Število organizacij za pridobivanje v skladu s poročanjem držav EU in EGP

en	Tissue establishments' status (public vs. private)/type of tissue (2011 data; data submitted by 25 Member States and one EEA country)
sl	Slika 5 Status ustanov za tkiva in celice (javni v primerjavi z zasebnim) glede na vrsto tkiva (podatki za leto 2011; podatki, ki jih je poslalo 25 držav članic in ena država EGP)

en	[22: Commission Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (OJ L 93, 9.4.2015, p. 56). ]
sl	[22: Direktiva Komisije (EU) 2015/566 z dne 8. aprila 2015 o izvajanju Direktive 2004/23/ES v zvezi s postopki za preverjanje ustreznosti standardov kakovosti in varnosti uvoženih tkiv in celic (UL L 93, 9.4.2015, str. 56). ]

en	In addition to providing regular updates during the bi-annul meeting of the tissue and cell expert sub-group on the epidemiological situation relevant to the tissue and cell sector, the development of risk assessments (e.g. for HTLV, malaria, dengue and chikungunya) and preparedness plans (e.g. for WNV outbreaks) provided a valuable contribution to policy and decision making in this sector at both national and EU level.
sl	Razvoj ocenjevanja tveganja (npr. za HTLV, malarijo, dengo in čikungunjo) in načrtov pripravljenosti (npr. za izbruhe virusa zahodnega Nila) je, poleg tega da je zagotovil redno obveščanje o epidemioloških razmerah v zvezi s sektorjem tkiv in celic na dveletnih srečanjih strokovne podskupine za tkiva in celice, dragoceno prispeval k oblikovanju politik in sprejemanju odločitev v tem sektorju na nacionalni ravni in ravni EU.

en	][9: Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ L294, 25.10.2006, p.
sl	][9: Direktiva Komisije 2006/86/ES z dne 24. oktobra 2006 o izvajanju Direktive 2004/23/ES Evropskega parlamenta in Sveta o zahtevah po sledljivosti, obveščanju o hudih in neželenih reakcijah in pojavih ter nekaterih tehničnih zahtevah za kodiranje, predelavo, konzerviranje, shranjevanje in razdeljevanje človeških tkiv in celic (UL L 294, 25.10.2006, str.

en	][8: Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (OJ L38, 9.2.2006, p. 40).
sl	][8: Direktiva Komisije 2006/17/ES z dne 8. februarja 2006 o izvajanju Direktive 2004/23/ES Evropskega parlamenta in Sveta o nekaterih tehničnih zahtevah za darovanje, pridobivanje in testiranje človeških tkiv in celic (UL L 38, 9.2.2006, str. 40).

en	a. Volume of tissues and cells (units) distributed from one MS to other EU MS and/or EEA countries in 2011 (Data reported by 18 countries)
sl	a. Količina tkiv in celic (enot), razdeljenih iz ene države članice v druge države članice EU in/ali države EGP leta 2011 (podatke je poslalo 18 držav)

en	Fig. 7.
sl	Slika 7

en	Developing more detailed requirements for these activities as part of GTP was supported by several national competent authorities for tissues and cells.
sl	Več nacionalnih pristojnih organov za tkiva in celice je podprlo razvoj podrobnejših zahtev za te dejavnosti kot del smernic za dobro prakso v zvezi s tkivi.

en	b. Volume of tissues and cells (units) exported in 2011 (data reported by 11 Member States)
sl	b. Količina tkiv in celic (enot), izvoženih leta 2011 (podatke je poslalo 11 držav članic)

en	Support for the implementation of the EU tissue and Cell Directives
sl	Podpora izvajanju direktiv EU o tkivih in celicah

en	a. Volume of tissues and cells (units) imported in 2011 (data reported by 15 Member States)
sl	a. Količina tkiv in celic (enot), uvoženih leta 2011 (podatke je poslalo 15 držav članic)

en	Supervision of human tissue and cell procurement.
sl	Nadzor pridobivanja človeških tkiv in celic.

en	[13: Commission Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (OJ L 93, 9.4.2015, p.
sl	[13: Direktiva Komisije (EU) 2015/565 z dne 8. aprila 2015 o spremembi Direktive 2006/86/ES v zvezi z nekaterimi tehničnimi zahtevami za kodiranje človeških tkiv in celic (UL L 93, 9.4.2015, str.

en	Tissues and cells competent authorities in the reporting EU Member States and EEA countries (2011 data)
sl	Slika 1 Pristojni organi za tkiva in celice v državah članicah EU in državah EGP, ki so poročale (podatki za leto 2011)

en	b. Volume of tissues and cells (units) received by MS from other EU MS and/or EEA countries in 2011 (Data reported by 15 Member States)
sl	b. Količina tkiv in celic (enot), ki so jih države članice prejele od drugih držav članic EU in/ali držav EGP leta 2011 (podatke je poslalo 15 držav členic)

en	Other responsibilities of tissues and cells competent authorities in the reporting EU Member States and EEA countries (2011 data)
sl	Slika 2 Druge odgovornosti pristojnih organov za tkiva in celice v državah članicah EU in državah EGP, ki so poročale (podatki za leto 2011)

en	Implementation of the EU tissues and cells legislation
sl	Izvajanje zakonodaje EU o tkivih in celicah

en	Procurement of tissues and cells.
sl	Pridobivanje tkiv in celic.

en	OJ L 93, 9.4.2015, p. 43-55][15: EU Tissue establishment compendium is part of the EU Coding platform that was introduced by the Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells.]
sl	][15: EU-kompendij ustanov za tkiva in celice je del platforme EU za kodiranje, uvedene z Direktivo (EU) 2015/565 z dne 8. aprila 2015 o spremembi Direktive 2006/86/ES v zvezi z nekaterimi tehničnimi zahtevami za kodiranje človeških tkiv in celic.]

en	Transposition of the EU tissue and cell legislation
sl	Prenos zakonodaje EU o tkivih in celicah

en	[12: http://ec.europa.eu/health/blood_tissues_organs/docs/manual_en.pdf ]
sl	[12: http://ec.europa.eu/health/blood_tissues_organs/docs/manual_sl.pdf. ]

en	These reasons are still valid.
sl	Ti razlogi so še vedno relevantni.

en	Reasons for action at European level (ex-ante)
sl	Razlogi za ukrepanje na evropski ravni (predhodno)

en	(g) the annual report of its activities;
sl	(g) letno poročilo o svojih dejavnostih;

en	The political response was to adopt a White Paper on Food Safety in January 2000.
sl	Politični odziv je bil sprejetje bele knjige o varnosti hrane januarja 2000.

en	The Commission open public consultation is published on:
sl	Odprto javno posvetovanje Komisije je objavljeno na:

en	The Authority shall carry out its activities with a high level of transparency.
sl	Agencija izvaja svoje dejavnosti z visoko stopnjo preglednosti.

en	framework 5 ‘Administrative expenditure'
sl	okvira 5 „Upravni odhodki"

en	from candidate countries[46: Candidate countries and, where applicable, potential candidates from the Western Balkans.]
sl	držav kandidatk[46: Države kandidatke in po potrebi potencialne države kandidatke z Zahodnega Balkana.]

en	Risk communication was also found not to be effective enough.
sl	Tudi za obveščanje o tveganju je bilo ugotovljeno, da ni dovolj učinkovito.

en	"(m) a summary of the dossier in a standardised form.
sl	„(m) povzetek dokumentacije v standardizirani obliki.

en	These controls shall be organised in cooperation with the competent authorities of the Member States.
sl	Ta nadzor se organizira v sodelovanju s pristojnimi organi držav članic.

en	Member States may nominate nationals of other Member States.
sl	Države članice lahko predlagajo tudi državljane drugih držav članic.

en	Subsidiarity (for non-exclusive competence)
sl	Subsidiarnost (za neizključno pristojnost)

en	Compatibility and possible synergy with other appropriate instruments
sl	Skladnost in možnosti sinergij z drugimi ustreznimi instrumenti

en	(e) The Management Board shall ensure that the broadest possible geographical distribution is achieved in the final appointments.
sl	(e) Upravni odbor zagotovi, da se pri končnem imenovanju doseže najširša možna geografska pokritost.

en	Therefore experience and knowledge exist on this substance or product.
sl	Zato obstajajo izkušnje in znanje o tej snovi ali izdelku.

en	Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications.
sl	Vlagatelji ter zlasti mala in srednja podjetja pa teh specifikacij ne razumejo vedno jasno.

en	It underlined that this lack should be addressed in future policy development, for instance by making better coordinated use of existing reporting requirements.
sl	Poudarjeno je bilo, da je treba to pomanjkanje obravnavati pri prihodnjem razvoju politike, na primer z boljšim usklajevanjem obstoječih zahtev glede poročanja.

en	The public may make comments to the Commission within 30 days from such publication.
sl	Javnost lahko Komisiji predloži pripombe v 30 dneh od take objave.

en	Such measures are therefore not expected to have significant socio-economic and environmental impacts that are clearly identifiable ex ante.
sl	Zato se ne pričakuje, da bodo takšni ukrepi imeli znatne družbeno-gospodarske in okoljske vplive, ki jih je mogoče jasno opredeliti vnaprej.

en	In particular a series of measures will be put in place such as:
sl	Uvedena bo zlasti vrsta ukrepov, kot so:

en	It shall apply from [18 months after its entry into force], except for the following provisions:
sl	Uporablja se od [18 mesecev po začetku njene veljavnosti], razen naslednjih določb:

en	(a) Article 1(2) shall apply from 1st July 2022.
sl	(a) člen 1(2) se uporablja od 1. julija 2022;

en	(i) A high level of scientific expertise;
sl	(i) visoka raven strokovnega znanja;

en	The findings of the evaluation shall be made public."
sl	Ugotovitve ocene se objavijo."

en	Title 2: Infrastructure and operating expenditure Commitments (1a)
sl	Naslov 2: Infrastruktura in odhodki iz poslovanja obveznosti (1a)

en	[51: Mainly for the Structural Funds, the European Agricultural Fund for Rural Development (EAFRD) and the European Fisheries Fund (EFF).]
sl	[51: Zlasti za strukturna sklada, Evropski kmetijski sklad za razvoj podeželja (EKSRP) in Evropski sklad za ribištvo (ESR).]

en	(22) Food safety is a sensitive matter of prime interest for all Union citizens.
sl	(22) Varnost hrane je občutljivo vprašanje bistvenega pomena za vse državljane Unije.

en	framework 3 Security and Citizenship
sl	okvira 3 Varnost in državljanstvo

en	Those implementing acts shall be adopted in accordance with Article 58(2).
sl	Navedeni izvedbeni akti se sprejmejo v skladu s členom 58(2).

en	The regulatory regime on food safety needs to be strong to ensure its credibility and effectiveness.
sl	Regulativna ureditev na področju varnosti hrane mora biti močna, da zagotavlja verodostojnost in učinkovitost.

en	Transitions measures are provided.
sl	Določeni so prehodni ukrepi.

en	Each Member State shall nominate at least 12 scientific experts.
sl	Vsaka država članica predlaga vsaj 12 znanstvenih strokovnjakov.

en	(c) information on the complete composition of a plant protection product.
sl	(c) informacij o celotni sestavi fitofarmacevtskega sredstva.

en	Added value of Union involvement (it may result from different factors, e.g. coordination gains, legal certainty, greater effectiveness or complementarities).
sl	Dodana vrednost ukrepanja Unije (ki je lahko posledica različnih dejavnikov, npr. usklajevalnih koristi, pravne varnosti, večje učinkovitosti ali dopolnjevanja).

en	In addition, the role of the Management Board is focussed on administration and finances.
sl	Poleg tega se upravni odbor osredotoča na področji uprave in financ.

en	The term of office of members and alternate members shall be four years.
sl	Mandat članov in nadomestnih članov traja štiri leta.

en	The Commission shall ensure the regular review of the application of this Regulation.
sl	Komisija zagotovi redne preglede uporabe te uredbe.

en	(e) be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data.
sl	(e) biti dostopno tudi tistim, ki niso neposredno udeleženi v postopku, ob upoštevanju zaupnosti in varstva osebnih podatkov.

en	The impact in terms of costs and resources needed is mostly on EFSA.
sl	Učinek v smislu stroškov in potrebnih virov se nanaša predvsem na agencijo EFSA.

en	The system shall ensure that any access to it is fully auditable.
sl	Sistem mora zagotavljati, da je vsak dostop do njega v celoti preverljiv.

en	Business and civil society stakeholders are of the same mind.
sl	Enako menijo predstavniki podjetij in civilne družbe.

en	Payments (2a)
sl	plačila (2 a)

en	Appropriate provisions are included to protect the rights of commercial applicants.
sl	Vključene so tudi ustrezne določbe za zaščito pravic poslovnih vlagateljev.

en	(f) its scientific studies in accordance with Articles 32 and 32e;
sl	(f) svoje znanstvene študije v skladu s členoma 32 in 32e;

en	The results of all consultation activities are summarised in the synopsis report.
sl	Rezultati vseh posvetovanj so povzeti v zbirnem poročilu.

en	N° of documents (or parts of) subject to claims of confidentiality;
sl	Št. dokumentov (ali njihovih delov), ki so predmet zahtev za zaupnost;

en	Notwithstanding paragraphs 2 and 3, the following information shall nevertheless be made public:
sl	Ne glede na odstavka 2 in 3 se naslednje informacije kljub temu objavijo:

en	XX is the policy area or budget title concerned.
sl	XX je zadevno področje ali naslov.

en	Description of the calculation of cost for FTE units should be included in the Annex V, section 3.
sl	Opis izračuna stroškov za enote EPDČ mora biti vključen v oddelek 3 Priloge V.

en	[…] [XX.YY.YY.YY] […] […] YES/
sl	[…] [XX YY YY YY] […] […] DA/

en	(15) It is essential to ensure the efficient operation of the Authority and to improve the sustainability of its expertise.
sl	(15) Bistveno je, da se zagotovi učinkovito delovanje Agencije in izboljša trajnost njenega strokovnega znanja.

en	- the rules governing the eligibility of costs will be simplified in accordance with the provisions of the Financial Regulation;
sl	- poenostavitev pravil za upravičenost stroškov v skladu z določbami finančne uredbe;

en	Since duly justified confidential information is protected, incentives for innovation should remain unchanged.
sl	Ker so informacije, ustrezno utemeljene kot zaupne, zaščitene, bi morale spodbude za inovacije ostati nespremenjene.

en	1) improve and clarify the rules on transparency
sl	1) Izboljšati in pojasniti pravila o preglednosti

en	"Unless otherwise provided, the Management Board shall act by a majority of its members.
sl	„Če ni drugače določeno, upravni odbor odloča z večino svojih članov.

en	Fundamental rights
sl	Temeljne pravice

en	The Commission shall report to the European Parliament, the Council and the Management Board on the evaluation findings.
sl	Komisija Evropskemu parlamentu, Svetu in upravnemu odboru poroča o ugotovitvah ocene.

en	Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.
sl	Navedena pooblastila bi bilo treba izvajati v skladu z Uredbo (EU) št. 182/2011 Evropskega parlamenta in Sveta.

en	(f) ensure appropriate exchange of information with interested parties in relation to risks associated with the agri-food chain.
sl	(f) zagotavljanje primerne izmenjave informacij z zainteresiranimi stranmi v zvezi s tveganji, povezanimi z agroživilsko verigo.

en	It is proportionate to harmonise these rules while preserving, where needed, the specific balance of interests in sectoral legislations.
sl	Ta pravila je sorazmerno uskladiti, hkrati pa po potrebi ohranjati specifično ravnovesje interesov v sektorski zakonodaji.

en	Please indicate the planned recruitment date and adapt the amount accordingly (if recruitment occurs in July, only 50 % of the average cost is taken into account) and provide further explanations in an annex.
sl	Navedite predvideni datum zaposlitve in ustrezno prilagodite znesek (če pride do zaposlitve v juliju, se upošteva samo 50 % povprečnih stroškov) ter navedite dodatna pojasnila v prilogi.

en	(17) Provisions exist on the content of applications for authorisations.
sl	(17) Obstajajo določbe o vsebini vlog za odobritev.

en	However, issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance.
sl	Vendar se v nekaterih primerih lahko pojavijo težave glede skladnosti z veljavnimi standardi, zato so vzpostavljeni nacionalni sistemi za preverjanje te skladnosti.

en	Information systems
sl	Informacijski sistemi

en	X Indirect management by entrusting budget implementation tasks to:
sl	X Posredno upravljanje s poverjanjem nalog izvrševanja proračuna:

en	Access to the information for renewal
sl	Dostop do informacij za obnovitev

en	That section shall be publicly available and easily accessible.
sl	Navedeni razdelek je na voljo javnosti in je zlahka dostopen.

en	Consistency with other Union policies
sl	Skladnost z drugimi politikami Unije

en	(b) breeding patterns and strategies.
sl	(b) vzorcev in strategij žlahtnjenja.

en	(c) four members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations and one from industry organisations.
sl	(c) štirje člani z glasovalno pravico, ki predstavljajo civilno družbo in interese prehranske verige, in sicer en član iz združenja potrošnikov, eden iz okoljske nevladne organizacije, eden iz organizacije kmetov in eden iz industrijske organizacije.

en	X The proposal is compatible with the current multiannual financial framework and may entail the use of special instruments as defined in Council Regulation (EU, Euratom) No 1311/2013.
sl	X Predlog je v skladu z veljavnim večletnim finančnim okvirom in lahko vključuje uporabo posebnih instrumentov, kot so opredeljeni v Uredbi Sveta (EU, Euratom) št. 1311/2013.

en	The evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification.
sl	Pri oceni se obravnavajo morebitna potreba po spremembi pooblastil agencije in finančne posledice kakršnih koli tovrstnih sprememb.

en	(h) requests from the European Parliament, the Commission or a Member State for scientific opinions which have been refused or modified and the justifications for the refusal or modification.
sl	(h) zaprosila Evropskega parlamenta, Komisije ali države članice za znanstvena mnenja, ki so bila zavrnjena ali spremenjena, in utemeljitev za zavrnitev ali spremembo;

en	(a) the name and address of the applicant;
sl	(a) ime in naslov vlagatelja,

en	It shall forthwith transmit this opinion to the Commission, the authorisation-holder and the Member States.
sl	To mnenje nemudoma pošlje Komisiji, imetniku odobritve in državam članicam.

en	(19) In the case of applications to request the renewal of an authorisation, the authorised substance or product has already been on the market for several years.
sl	(19) V primeru vlog za obnovitev odobritve je odobrena snov ali izdelek na trgu že več let.

en	X bodies referred to in Articles 208 and 209;
sl	X organom iz členov 208 in 209,

en	In parallel, the Commission's Scientific Advice Mechanism has been asked to prepare an opinion on the authorisation process of plant protection products.
sl	Vzporedno s tem je bil mehanizem Komisije za znanstveno svetovanje zaprošen, da pripravi mnenje o postopku registracije fitofarmacevtskih sredstev.

en	The consultation carried out demonstrates an overall support of stakeholders to the initiative.
sl	Pri posvetovanju se je pokazalo, da zainteresirane strani na splošno podpirajo pobudo.

en	The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents.
sl	Seznam, ki ga sestavi Komisija, se posreduje Evropskemu parlamentu skupaj s zadevnimi referenčnimi dokumenti.

en	For the purposes of this point ‘added value of Union involvement' is the value resulting from Union intervention which is additional to the value that would have been otherwise created by Member States alone.
sl	Za namene te točke je „dodana vrednost ukrepanja Unije" vrednost, ki izhaja iz ukrepanja Unije in predstavlja dodatno vrednost poleg tiste, ki bi jo sicer ustvarile države članice same.

en	The reasons underlying differences in the assessments and conclusions of scientific bodies should be better communicated to the public in order to facilitate their understanding.
sl	O razlogih za razlike med ocenami in ugotovitvami znanstvenih organov bi bilo treba bolje obveščati javnost, da bi se olajšalo njihovo razumevanje.

en	In particular, there has been a decrease in the number of candidates applying to be members of the Scientific Panels.
sl	Zlasti se je zmanjšalo število kandidatov, ki se prijavljajo za člane znanstvenih svetov.

en	Alternate members shall represent the member in his absence and vote on his behalf.
sl	Nadomestni člani predstavljajo člane v njihovi odsotnosti in glasujejo v njihovem imenu.

en	Risk communication is an essential part of the risk analysis process.
sl	Obveščanje o tveganju je bistven del postopka analize tveganja.

en	(4) the following Articles 32a, 32b, 32c, 32d and 32e are inserted:
sl	(4) vstavijo se naslednji členi 32a, 32b, 32c, 32d in 32e:

en	N° of requests for access to documents addressed to EFSA and the Commission.
sl	št. prošenj za dostop do dokumentov, naslovljenih na agencijo EFSA in Komisijo.

en	In particular EFSA will be able to cross-check the information on the studies performed (the laboratories being an external source of information).
sl	EFSA bo lahko zlasti navzkrižno preverila informacije o izvedenih študijah (laboratoriji so zunanji vir informacij).

en	The main objectives of this initiative are to update the GFL Regulation so as to:
sl	Glavni cilj te pobude je bil posodobiti uredbo o splošni živilski zakonodaji z namenom:

en	This should have a positive impact since experience from other Union agencies demonstrates that this model ensures efficient supervision of the functioning of agencies and coordinated views between the Union and national level.
sl	To naj bi imelo pozitiven učinek, saj izkušnje z drugimi agencijami Unije kažejo, da ta model zagotavlja učinkovit nadzor nad delovanjem agencij in usklajena stališča na ravni Unije in na nacionalni ravni.

en	To address these issues, the Commission has come up with a wide ranging and ambitious proposal requiring a significant increase in the resources available to the EFSA to enable it to discharge its existing and proposed new responsibilities.
sl	Za obravnavo teh vprašanj je Komisija pripravila obsežen in ambiciozen predlog, ki zahteva znatno povečanje virov agencije EFSA, da bo lahko izpolnila svoje obstoječe in predlagane nove naloge.

en	[Body]: <EFSA.> Year
sl	[Organ]: <EFSA.> Leto

en	The proposal also stipulates that personal data be protected taking into account the applicable Union legislative framework on the processing of such data.
sl	Predlog tudi določa varstvo osebnih podatkov in pri tem upošteva veljavni zakonodajni okvir Unije za obdelavo takih podatkov.

en	Implementation with a start-up period from 2020 to 2022
sl	izvajanje z obdobjem uvajanja med letoma 2020 in 2022,

en	A public consultation on the initiative in all Union official languages was launched on 23 January 2018 and ran until 20 March 2018; 471 replies were received (318 from individuals and 153 from organisations).
sl	23. januarja 2018 se je začelo javno posvetovanje o pobudi v vseh uradnih jezikih Unije, ki je trajalo do 20. marca 2018; prejetih je bilo 471 odgovorov (od tega 318 odgovorov posameznikov in 153 odgovorov organizacij).

en	The fourth measure provides for controls and audits by Commission inspectors in relation to studies.
sl	Četrti ukrep določa nadzor in presoje, ki jih izvajajo inšpektorji Komisije v zvezi s študijami.

en	It has also strengthened the cooperation with national and international scientific bodies as well as the exchange of information between Member States, the Commission and EFSA itself.
sl	Prav tako je okrepila sodelovanje z nacionalnimi in mednarodnimi znanstvenimi organi ter izmenjavo informacij med državami članicami, Komisijo in agencijo EFSA.

en	This paved the way for a complete overhaul of the regulatory framework, with the focus on the GFL Regulation in 2002.
sl	To je utrlo pot popolni prenovi regulativnega okvira s poudarkom na uredbi o splošni živilski zakonodaji v letu 2002.

en	There are no negative impacts in the duration of authorisation procedures since this is a parallel activity.
sl	Ni negativnih učinkov na trajanje odobritvenih postopkov, ker gre za vzporedno dejavnost.

en	[4: C(2017) 8414 final.]
sl	[4: COM(2017) 8414 final.]

en	They also seriously undermined public confidence in the Union food safety regulatory framework.
sl	Prav tako so te krize resno omajale zaupanje javnosti v regulativni okvir Unije za varnost hrane.

en	The notification obligation under paragraph 1, also applies to Union laboratories carrying out those studies.
sl	Obveznost uradnega obveščanja iz odstavka 1 velja tudi za laboratorije Unije, ki izvajajo navedene študije.

en	In addition to monitoring compliance, DG SANTE identifies and disseminates good practices in collaboration with the agencies.
sl	GD SANTE poleg spremljanja skladnosti tudi opredeljuje in razširja dobre prakse v sodelovanju z agencijami.

en	(a) the study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use as defined in Article 6(1) and Annex I to this Regulation; and,
sl	(a) načrtov študij, ki dokazujejo učinkovitost krmnega dodatka glede na cilje njegove nameravane uporabe, kakor je opredeljena v členu 6(1) in Prilogi I k tej uredbi; ter

en	Expected generated Union added value (ex-post)
sl	Pričakovana ustvarjena dodana vrednost Unije (naknadno)

en	Their interplay can impact on the acceptability of the risk assessment by the general public.
sl	Njihovo medsebojno učinkovanje lahko vpliva na sprejemljivost ocene tveganja za splošno javnost.

en	The Commission shall make the application available to the Member States without delay.
sl	Komisija brez odlašanja da vlogo na voljo državam članicam.

en	(c) any other information deemed confidential within the specific procedural rules referred to in Article 5(1)(n) of this Regulation.
sl	(c) vseh drugih informacij, ki veljajo za zaupne v posebnih postopkovnih pravilih iz člena 5(1)(n) te uredbe.

en	(a) ensure that accurate, appropriate and timely information is interactively exchanged, based on the principles of transparency, openness, and responsiveness;
sl	(a) zagotavljati interaktivno izmenjavo točnih, ustreznih in pravočasnih informacij na podlagi načel preglednosti, odprtosti in odzivnosti;

en	(a) to any intellectual property right which may exist over documents or their content; and,
sl	(a) katero koli pravico intelektualne lastnine, ki lahko obstaja na dokumentih ali njihovi vsebini; ter

en	Its primary mission is to provide scientific advice at the request of the Commission, Member States and the European Parliament and on its own motion.
sl	Njena glavna naloga je zagotavljati znanstveno svetovanje na zahtevo Komisije, držav članic in Evropskega parlamenta ter tudi na lastno pobudo.

en	Where the Commission considers that the continuation of the Authority is no longer justified with regard to its assigned objectives, mandate and tasks, it may propose that the relevant provisions of this Regulation be amended accordingly or repealed.
sl	Če Komisija meni, da nadaljnji obstoj agencije glede na zastavljene cilje, pooblastila in naloge ni več upravičen, lahko predlaga ustrezno spremembo ali razveljavitev zadevnih določb te uredbe.

en	Setting up the EFSA has given Union measures a sounder scientific basis.
sl	Z ustanovitvijo agencije EFSA so ukrepi Unije dobili trdnejšo znanstveno podlago.

en	[41: OJ L 123, 12.5.2016, p.
sl	[41: UL L 123, 12.5.2016, str.

en	[42: As referred to in Article 54(2)(a) or (b) of the Financial Regulation.]
sl	[42: Po členu 54(2)(a) oz. (b) finančne uredbe.]

en	Each Member State shall nominate a member and an alternate member to the Management Board.
sl	Vsaka država članica predlaga člana in nadomestnega člana upravnega odbora.

en	Protection of personal data
sl	Varstvo osebnih podatkov

en	The EFSA also regularly fine-tunes and strengthens its strict policies on independence, transparency and openness.
sl	EFSA prav tako redno prilagaja in krepi svoje stroge politike neodvisnosti, preglednosti in odprtosti.

en	The Commission shall adopt the general plan for risk communication within [two years from the date of application of this Regulation] and shall keep it updated, taking into account technical and scientific progress and experience gained.
sl	Komisija sprejme splošni načrt obveščanja o tveganju v [dveh letih od začetka uporabe te uredbe] in ga redno posodablja, pri čemer se upoštevajo tehnični in znanstveni napredek ter pridobljene izkušnje.

en	(20) There are certain public concerns about the Authority's assessment in the area of authorisation being primarily based on industry studies.
sl	(20) Obstajajo nekateri pomisleki javnosti, da ocena Agencije v zvezi z odobritvijo temelji predvsem na študijah industrije.

en	Member States that provide the EFSA with expertise also need to receive more compensation.
sl	Države članice, ki agenciji EFSA zagotavljajo strokovno znanje, morajo prav tako prejeti višja nadomestila.

en	The involvement of the EFSA Executive Director in the selection process is an additional guarantee that the independence criteria will be met.
sl	Vključenost izvršnega direktorja agencije EFSA v izbirni postopek je dodatno jamstvo, da bodo izpolnjena merila glede neodvisnosti.

en	Transparency and confidentiality rules currently vary depending on the sub-area of regulation concerned.
sl	Pravila o preglednosti in zaupnosti se trenutno razlikujejo glede na zadevno podpodročje urejanja.

en	With regard to the reliability and robustness of studies submitted by industry in the context of authorisation procedures, the following impacts were in particular considered:
sl	Kar zadeva zanesljivost in trdnost študij, ki jih predloži industrija v okviru odobritvenih postopkov, so bili zlasti upoštevani naslednji učinki:

en	Provisions in relation to the nomination, selection and appointment of experts include strict criteria on independence, thus providing appropriate safeguards.
sl	Določbe v zvezi s predlaganjem, izbiro in imenovanjem strokovnjakov vključujejo stroga merila glede neodvisnosti, kar zagotavlja ustrezne zaščitne ukrepe.

en	Estimate to be expressed in full amounts (or at most to one decimal place)
sl	ocena, izražena v celih številkah (ali na največ eno decimalno mesto natančno)

en	As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.
sl	Kakor hitro je mogoče in v treh mesecih od uradnega obvestila, lahko Evropski parlament predloži svoje mnenje v presojo Svetu, ki potem imenuje navedene člane.

en	Impact on the European Food Safety Authority (EFSA)
sl	Posledice za Evropsko agencijo za varnost hrane (EFSA)

en	Although in principle a revision of Regulation (EC) No 178/2002 could be used as an opportunity to set up a more comprehensive monitoring system of the implementation of Union food law, the targeted scope of this proposal is too limited to accommodate the establishment of such a system.
sl	Čeprav bi načeloma lahko revizijo Uredbe (ES) št. 178/2002 izkoristili kot priložnost za vzpostavitev celovitejšega sistema za spremljanje izvajanja živilske zakonodaje Unije, je ciljno področje uporabe tega predloga preveč omejeno, da bi omogočalo vzpostavitev takega sistema.

en	The proposal also provides for a better organisation of the Panels' work.
sl	Predlog prav tako zagotavlja boljšo organizacijo dela znanstvenih svetov.

en	[43: Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx.]
sl	[43: Pojasnila o načinih upravljanja in sklici na finančno uredbo so na voljo na spletišču BudgWeb: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx.]

en	(d) facilitate understanding and dialogue amongst all interested parties; and,
sl	(d) olajšati razumevanje in dialog med vsemi zainteresiranimi stranmi ter

en	Problems in relation to safety have a huge impact on consumers' confidence and consequently on market stability, trade flows and the climate for innovation.
sl	Težave v zvezi z varnostjo močno vplivajo na zaupanje potrošnikov in posledično na stabilnost trga, trgovinske tokove in okolje za inovacije.

en	A delegated act adopted pursuant to Article 8(c) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.
sl	Delegirani akt, sprejet na podlagi člena 8(c), začne veljati le, če mu niti Evropski parlament niti Svet ne nasprotuje v roku dveh mesecev od uradnega obvestila Evropskemu parlamentu in Svetu o tem aktu ali če pred iztekom tega roka tako Evropski parlament kot Svet obvestita Komisijo, da mu ne bosta nasprotovala.

en	The impact on the timing of authorisation is minimal as detailed for each measure.
sl	Učinek na časovni potek odobritve je minimalen, kot je podrobno opisano za vsak ukrep.

en	It shall in particular make public without delay:
sl	Brez odlašanja objavi zlasti:

en	(25) It is therefore necessary to strengthen the transparency of the risk assessment process in a proactive manner.
sl	(25) Zato je treba proaktivno okrepiti preglednost postopka ocenjevanja tveganja.

en	Type[47: Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).]
sl	vrsta[47: Realizacije so dobavljeni proizvodi in opravljene storitve (npr. število financiranih izmenjav študentov, število kilometrov novozgrajenih cest itd.).]

en	The delegation of power referred to in Article 8(c) may be revoked at any time by the European Parliament or by the Council.
sl	Prenos pooblastila iz člena 8(c) lahko kadar koli prekliče Evropski parlament ali Svet.

en	Indeed, the notification of planned studies represents a relatively small burden for the applicant.
sl	Dejansko predstavlja obveščanje o načrtovanih študijah razmeroma majhno breme za vlagatelja.

en	The Commission does not see scope to simplify or reduce these steps as this could have a negative impact not only on the perception of the transparency of the system but also on ensuring that the evidence presented for EFSA's assessments is complete.
sl	Komisija ne vidi možnosti za poenostavitev ali zmanjšanje teh ukrepov, saj bi to lahko imelo negativne posledice ne le na dojemanje preglednosti sistema, temveč tudi na zagotavljanje popolnosti dokazov, predloženih v oceno agenciji EFSA.

en	The register shall be managed by the Authority.
sl	Register upravlja agencija.

en	It provides, amongst others, that food law must be based on risk analysis, except where this is not appropriate to the circumstances or the nature of the measure.
sl	Med drugim določa, da mora živilska zakonodaja temeljiti na analizi tveganja, razen če to glede na okoliščine ali vrsto ukrepa ni primerno.

en	Budget revenue line: Appropriations available for the current financial year Impact of the proposal/initiative[53: As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 25 % for collection costs.]
sl	Prihodkovna proračunska vrstica Odobritve na voljo za tekoče proračunsko leto Posledice predloga/pobude[53: Pri tradicionalnih lastnih sredstvih (carine, prelevmani na sladkor) se navedejo neto zneski, tj. bruto zneski po odbitku 25 % stroškov pobiranja.]

en	These put public health at great risk and the resulting market support measures and trade disruption cost a huge amount.
sl	Zaradi tega je bilo močno ogroženo javno zdravje, posledični ukrepi za podporo trgu in motnje v trgovanju pa so povzročili ogromne stroške.

en	It addresses industry demands (in particular SMEs) for further support in the preparation of the authorisation application.
sl	Postopek je odgovor na zahteve industrije (zlasti MSP) po nadaljnji podpori pri pripravi vlog za odobritev.

en	Access shall be based at the minimum on a system requiring two factor authentication or providing an equivalent level of security.
sl	Dostop mora temeljiti najmanj na sistemu, ki zahteva dvostopenjsko avtentikacijo, ali sistemu, ki zagotavlja enakovredno raven varnosti.

en	Difficulties in attracting new experts due to insufficient recognition of scientists' career, inadequate financial compensation in particular for their employers and excessive demand on their time.
sl	težave pri privabljanju novih strokovnjakov zaradi nezadostnega priznavanja poklicne poti znanstvenikov, neustreznih finančnih nadomestil, zlasti za njihove delodajalce, ter prevelikega časovnega vložka;

en	European stakeholder organisations representing farmers, cooperatives, the food industry, retailers, consumers, professionals and civil society were consulted at an ad hoc meeting of the Advisory Group on the Food Chain, Animal and Plant Health on 5 February 2018.
sl	Posvetovanja z evropskimi organizacijami zainteresiranih strani, ki zastopajo kmete, zadruge, živilsko industrijo, trgovce na drobno, potrošnike, strokovnjake in civilno družbo, so potekala na ad hoc sestanku svetovalne skupine za prehranjevalno verigo ter zdravje živali in rastlin 5. februarja 2018.

en	As this is a revision of an existing piece of legislation falling under the Commission's Regulatory Fitness and Performance Programme REFIT, the Commission has looked at opportunities to simplify and reduce burdens.
sl	Glede na to, da gre za revizijo obstoječega zakonodajnega akta, ki spada v okvir programa Komisije za ustreznost in uspešnost predpisov (REFIT), je Komisija preučila možnosti za poenostavitev in zmanjšanje bremena.

en	Activity: [General Food Law]
sl	Dejavnost: [splošna živilska zakonodaja]

en	(38) In order to enable the Authority and the business operators to adapt to the new requirements while ensuring that the Authority continues its smooth operation, it is necessary to provide for transitional measures for the application of this Regulation.
sl	(38) Da bi Agenciji in nosilcem dejavnosti omogočili, da se prilagodijo novim zahtevam, in hkrati zagotovili, da Agencija še naprej nemoteno deluje, je treba določiti prehodne ukrepe za uporabo te uredbe.

en	This should also lead to more adequate and complete evidence being submitted and thus improve the efficiency of the risk assessment process in EFSA.
sl	To bi moralo prispevati tudi k predložitvi ustreznejših in popolnejših dokazov, s čimer bi se izboljšala učinkovitost postopka ocenjevanja tveganja v agenciji EFSA.

en	Policy area: [Food Safety]
sl	Področje: [varnost hrane]

en	from EFTA countries[45: EFTA: European Free Trade Association. ]
sl	držav Efte[45: Efta: Evropsko združenje za prosto trgovino. ]

en	(11) Experience shows that the role of the Management Board of the Authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the Authority.
sl	(11) Izkušnje kažejo, da je vloga upravnega odbora Agencije usmerjena v upravne in finančne vidike in ne vpliva na neodvisnost njenega znanstvenega dela.

en	Where necessary, networking groups and adequate IT tools dedicated to analysing fraud cases related to the financing implementing activities of this Regulation will be set up.
sl	Po potrebi bodo vzpostavljene skupine za mrežno povezovanje in ustrezna informacijska orodja, namenjena analizi primerov goljufij, povezanih z dejavnostmi izvajanja financiranja iz te uredbe.

en	Each Panel shall include a maximum of 21 members.
sl	Vsak znanstveni svet vključuje največ 21 članov.

en	(c) take into account risk perceptions;
sl	(c) upoštevati dojemanje tveganja;

en	Public access to the dossiers
sl	Javni dostop do dokumentacije

en	This in turn ensures that there is a common understanding of and approach to food safety that promotes both the effective implementation and enforcement of legislation and facilitates the operation of the internal market in a key sector of the European economy.
sl	To pa zagotavlja, da obstajata skupno razumevanje in pristop k varnosti hrane, ki spodbuja učinkovito izvajanje in izvrševanje zakonodaje ter olajšuje delovanje notranjega trga v ključnem sektorju evropskega gospodarstva.

en	Member States shall ensure that the members of the Scientific Panels do not receive any instruction at any national level and that their independent scientific contribution to the risk assessment system at Union level is recognised as a priority task for the protection of the safety of the food chain.
sl	Države članice zagotovijo, da člani znanstvenih svetov ne prejemajo nobenih navodil na nobeni nacionalni ravni ter da je njihov neodvisni znanstveni prispevek k sistemu ocenjevanja tveganja na ravni Unije prepoznan kot prednostna naloga pri zaščiti varnosti prehranske verige.

en	(32) Having regard to the fact that the Authority would be required to store scientific data, including confidential and personal data, it is necessary to ensure that such storage is carried out in accordance with a high level of security.
sl	(32) Ob upoštevanju dejstva, da bi Agencija morala shranjevati znanstvene podatke, vključno z zaupnimi in osebnimi podatki, je treba zagotoviti, da je takšno shranjevanje v skladu z visoko stopnjo varnosti.

en	In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
sl	Za zagotovitev enakopravnega sodelovanja pri pripravi delegiranih aktov Evropski parlament in Svet zlasti prejmeta vse dokumente sočasno s strokovnjaki iz držav članic, njuni strokovnjaki pa se lahko sistematično udeležujejo sestankov strokovnih skupin Komisije, ki zadevajo pripravo delegiranih aktov.

en	Furthermore, the EFSA staff will provide the advice without the involvement of the Scientific Panels.
sl	Poleg tega bo osebje agencije EFSA svetovalo brez udeležbe znanstvenih svetov.

en	It establishes certain general principles to underpin all future Union and national food law, the most important of which is the risk analysis principle.
sl	Določa nekatera splošna načela, na katerih temelji vsa prihodnja živilska zakonodaja Unije in nacionalna živilska zakonodaja, med katerimi je najpomembnejše načelo analize tveganja.

en	That process should be combined with an open dialogue between all interested parties to ensure the coherence and consistency within the risk analysis process.
sl	Navedeni postopek bi bilo treba združiti z odprtim dialogom med vsemi zainteresiranimi stranmi, da se zagotovita skladnost in doslednost v postopku analize tveganja.

en	It shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1) of this Regulation.
sl	Objavi tudi vsako zaprosilo za mnenje in vsako podaljšanje roka v skladu s členom 6(1) te uredbe.

en	This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
sl	Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.

en	Problems that the initiative aims to tackle
sl	Vprašanja, ki naj bi jih pobuda obravnavala

en	However, the term of office of the members referred to in paragraph 1a(a) and (b) shall not be limited in duration.
sl	Vendar se mandat članov iz odstavkov 1a(a) in (b) časovno ne omeji.

en	(12) The Management Board should be selected in such a way as to secure the highest standards of competence and a broad range of relevant experience available amongst the representatives of the Member States, the European Parliament and the Commission.
sl	(12) Upravni odbor bi bilo treba izbrati tako, da se zagotovijo najvišji standardi strokovne usposobljenosti in širok obseg ustreznih izkušenj predstavnikov držav članic, Evropskega parlamenta in Komisije.

en	The contributions received from citizens and stakeholders confirmed the importance of the aspects of the Union food safety risk assessment model this proposal addresses and the need to ensure that the proposal strengthens all those aspects, while safeguarding the principles on which the Union food safety system is based.
sl	Prejeti prispevki državljanov in zainteresiranih strani so potrdili pomembnost vidikov modela za oceno tveganja v zvezi z varnostjo hrane v Uniji, ki jih obravnava ta predlog, ter potrebo zagotoviti, da predlog krepi vse te vidike, obenem pa ohranja načela, na katerih temelji sistem Unije za varnost hrane.

en	Ex-post evaluations/fitness checks of existing legislation
sl	Naknadne ocene/preverjanja ustreznosti obstoječe zakonodaje

en	(ii) Independence and absence of conflict of interests in accordance with Article 37(2) and the Authority's independence policy and implementing rules on the independence of the Scientific Panels' members;
sl	(ii) neodvisnost in odsotnost nasprotja interesov v skladu s členom 37(2) in politiko neodvisnosti agencije ter izvedbenimi pravili o neodvisnosti članov znanstvenih svetov;

en	If the applicant disagrees with the assessment of the Authority it may state its views or withdraw its application within two weeks from the date on which it was notified of the Authority's position.
sl	Če se vlagatelj ne strinja z oceno agencije, lahko izrazi svoje mnenje ali umakne svojo vlogo v dveh tednih od datuma, ko je bil obveščen o stališču agencije.

en	The following factors have an impact on this:
sl	Na to vplivajo naslednji dejavniki:

en	In order to ensure uniform conditions for the implementation of Regulation (EC) No 178/2002 with regard to the adoption of standard data formats and software packages, implementing powers should be conferred on the Commission.
sl	Za zagotovitev enotnih pogojev za izvajanje Uredbe (ES) št. 178/2002 v zvezi s sprejetjem standardnih formatov podatkov in paketov programske opreme, bi bilo treba na Komisijo prenesti izvedbena pooblastila.

en	The proposal is based on Articles 43, 114, and 168(4)(b) of the Treaty on the Functioning of the European Union.
sl	Predlog temelji na členih 43, 114 in členu 168(4)(b) Pogodbe o delovanju Evropske unije (PDEU).

en	In particular, the existing strict criteria on independence are maintained and specific provisions require Member States to set up specific measures ensuring that the experts have concrete means to act independently as required by the proposal.
sl	Ohranjajo se zlasti obstoječa stroga merila glede neodvisnosti, države članice pa morajo v skladu s posebnimi določbami vzpostaviti posebne ukrepe za zagotovitev, da imajo strokovnjaki na voljo konkretna sredstva za neodvisno delovanje, kot se zahteva v predlogu.

en	"The number of members in each Scientific Panel within the maximum provided for in paragraph 5g.
sl	„število članov v posameznem znanstvenem svetu, ob upoštevanju največjega števila, navedenega v odstavku 5g.

en	External staff (in Full Time Equivalent unit: FTE)[49: AC = Contract Staff; AL = Local Staff; END = Seconded National Expert; INT = agency staff; JED = Junior Experts in Delegations. ]
sl	Zunanji sodelavci (v ekvivalentu polnega delovnega časa: EPDČ)[49: PU = pogodbeni uslužbenec; LU = lokalni uslužbenec; NNS = napoteni nacionalni strokovnjak; ZU = začasni uslužbenec; MSD = mladi strokovnjak na delegaciji. ]

en	of the multiannual financial framework (Total commitments = Total payments)
sl	večletnega finančnega okvira SKUPAJ (obveznosti skupaj = plačila skupaj)

en	The Commission therefore committed to come forward with a legislative proposal by May 2018 covering these and other aspects such as the governance of EFSA drawing up on the results of the Fitness Check of the GFL Regulation and after a public consultation.
sl	Komisija se je zato zavezala, da bo do maja 2018 pripravila zakonodajni predlog, ki bo zajemal te in druge vidike, kot je upravljanje agencije EFSA, na podlagi preverjanja ustreznosti uredbe o splošni živilski zakonodaji in po javnem posvetovanju.

en	The estimated impact on expenditure and staffing for the years 2021 and beyond in this legislative financial statement is added for illustrative purpose and does not pre-judge the next multiannual financial framework.
sl	Ocena posledic za odhodke in zaposlovanje za leto 2021 in naslednja leta iz te ocene finančnih posledic zakonodajnega predloga je priložena v informativni namen in ne posega v prihodnji večletni finančni okvir.

en	This is also partly due to the different transparency and confidentiality rules that are laid down not only in Regulation (EC) No 178/2002 but also in other Union legislative acts covering the agri-food chain.
sl	To je deloma tudi posledica tega, da so različna pravila o preglednosti in zaupnosti določena v Uredbi (ES) št. 178/2002 in tudi v drugih zakonodajnih aktih Unije, ki zajemajo agroživilsko verigo.

en	The disclosure of the information mentioned in paragraph (1)(c) to the public shall be without prejudice:
sl	Razkritje informacij iz odstavka (1)(c) javnosti ne posega v:

en	(e) promote appropriate involvement of all interested parties; and,
sl	(e) spodbujanje ustrezne udeležbe vseh zainteresiranih strani ter

en	The power to adopt delegated acts is conferred upon the Commission subject to the conditions laid down in this Article.
sl	Pooblastilo za sprejemanje delegiranih aktov je preneseno na Komisijo pod pogoji, določenimi v tem členu.

en	These draft standard data formats and software packages shall not be based on proprietary standards and shall ensure interoperability with existing data submission approaches to the extent possible.
sl	Te predlagane standardne oblike zapisa podatkov in predlagani paketi programske opreme ne temeljijo na lastniških standardih ter v največji možni meri zagotavljajo interoperabilnost s sedanjimi pristopi za predložitev podatkov.

en	(b) proceed, without delay, to a concrete and individual examination of the confidentiality request in accordance with this Article;
sl	(b) nemudoma konkretno in posamično pregleda zahteve za zaupnost v skladu s tem členom;

en	GRAND TOTAL 34 60 85 85 85
sl	VSE SKUPAJ 34 60 85 85 85

en	Citizens demand that the risk assessment process in the area of food law (and the decision-making based on it) be more transparent.
sl	Državljani zahtevajo večjo preglednost postopka ocene tveganja na področju živilske zakonodaje (in odločanja na podlagi tega postopka).

en	The human resources required will be met by staff from the DG who are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
sl	Potrebe po človeških virih se krijejo z osebjem GD, ki je že dodeljeno za upravljanje ukrepa in/ali je bilo prerazporejeno znotraj GD, po potrebi skupaj z dodatnimi viri, ki se lahko pristojnemu GD dodelijo v okviru postopka letne dodelitve virov glede na proračunske omejitve.

en	The current term of office of the Scientific Committee and Panel members shall be prolonged until that date.
sl	Sedanji mandat članov znanstvenega odbora in znanstvenih svetov se podaljša do navedenega datuma.

en	This provision does not apply to the submission of any supplementary information by the applicants during the risk assessment process.
sl	Ta določba se ne uporablja za predložitev nobenih dodatnih informacij, ki jih vlagatelji predložijo v postopku ocenjevanja tveganja.

en	In addition to the application of all regulatory control mechanisms, the responsible services will devise an anti-fraud strategy in line with the Commission's anti-fraud strategy (CAFS) adopted on 24 June 2011 in order to ensure inter alia that its internal anti-fraud related controls are fully aligned with the CAFS and that its fraud risk management approach is geared to identify fraud risk areas and adequate responses.
sl	Pristojne službe bodo poleg uporabe vseh regulativnih kontrolnih mehanizmov pripravile strategijo za boj proti goljufijam, ki bo skladna s strategijo Komisije na področju boja proti goljufijam, sprejeto 24. junija 2011, da bi med drugim zagotovile, da so njene notranje kontrole, povezane z bojem proti goljufijam, v celoti skladne z navedeno strategijo ter da je njen pristop k obvladovanju tveganja goljufij usmerjen v opredelitev področij, na katerih obstaja tveganje goljufij, in ustreznih odzivov nanje.

en	Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the Commission shall assess the Authority's performance in relation to its objectives, mandate, tasks, procedures and location, in accordance with Commission guidelines.
sl	Najpozneje pet let po datumu iz člena [začetek veljavnosti uredbe o spremembi uredbe o splošnih načelih živilske zakonodaje], nato pa vsakih pet let Komisija v skladu s svojimi smernicami oceni uspešnost agencije v zvezi z njenimi cilji, pooblastili, nalogami, postopki in lokacijo.

en	In addition to members and alternate members referred to in paragraph 1, the Management Board shall include:
sl	Poleg članov in nadomestnih članov iz odstavka 1 upravni odbor sestavljajo:

en	Any actions in these areas need to take place at Union level and primarily within the existing Union legislative framework established by the GFL Regulation and in seven other relevant sectoral legislative acts.
sl	Ukrepe na teh področjih je treba izvajati na ravni Unije in predvsem v obstoječem zakonodajnem okviru Unije, vzpostavljenem z uredbo o splošni živilski zakonodaji in sedmimi drugimi zadevnimi sektorskimi zakonodajnimi akti.

en	In addition, the current rules on confidentiality vary according to the sub-area concerned, thus not ensuring a consistent way to manage transparency.
sl	Poleg tega se sedanja pravila o zaupnosti razlikujejo glede na zadevno podpodročje, zato ne zagotavljajo dosledne uporabe načela preglednosti.

en	(a) Where urgent action is essential to protect public health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; and,
sl	(a) agencija lahko v primeru, kadar je nujno takojšnje ukrepanje za zaščito zdravja ljudi, živali ali okolja, npr. v izrednih razmerah, razkrije informacije iz odstavkov 2 in 3; ter

en	The national food safety authorities of the Member States (meeting of the EFSA Advisory Forum on 6 February 2018) and the Scientific Committee of EFSA (15 February 2018) were also consulted.
sl	Potekala so tudi posvetovanja z nacionalnimi organi držav članic za varnost hrane (sestanek posvetovalnega foruma agencije EFSA z dne 6. februarja 2018) in znanstvenim odborom agencije EFSA (15. februarja 2018).

en	Detailed explanation of the specific provisions of the proposal
sl	Natančnejša pojasnitev posameznih določb predloga

en	Moreover, a strict application of the rules on conflict of interests provided in the proposal will be ensured.
sl	Poleg tega se bo zagotovila dosledna uporaba pravil o nasprotju interesov, ki jih določa predlog.

en	Collection and use of expertise
sl	Zbiranje in uporaba strokovnih mnenj

en	This has resulted in a mutual understanding of risks, minimised duplications of work and limited the number of scientific divergences between the EFSA and other risk assessment bodies.
sl	Tako se je spodbudilo vzajemno razumevanje tveganja, kar najbolj zmanjšalo podvajanje dela in omejilo število znanstvenih razhajanj med agencijo EFSA in drugimi organi za oceno tveganja.

en	[2: Food law authorisations cover different subject matters: substances, products, health claims and processes but for the ease of reading, the reference to substances in the text covers all.]
sl	[2: Predmet odobritve na podlagi živilske zakonodaje je lahko: snov, izdelek, zdravstvena trditev in postopek, zaradi lažjega branja pa izraz „snov" v tem besedilu zajema vse to.]

en	Member States shall assess the confidentiality requests.
sl	Države članice ocenijo zahteve za zaupnost.

en	(b) Article 1(3) shall apply as from the date of appointment of the members of the Scientific Panels, which shall be announced in a notice in the ‘C' series of the Official Journal of the European Union.
sl	(b) člen 1(3) se uporablja od dneva imenovanja članov znanstvenih svetov, ki se objavi z obvestilom v seriji C Uradnega lista Evropske unije.

en	In addition, the confidentiality regime established by the proposal provides that any information revealing the business strategy of the applicant is confidential.
sl	Poleg tega ureditev glede zaupnosti, vzpostavljena s tem predlogom, določa, da so kakršne koli informacije, ki razkrivajo poslovno strategijo vlagatelja, zaupne.

en	2) It will help to improve citizens' confidence in the credibility of scientific studies and consequently confidence in the Union risk assessment system.
sl	2) Predlog bo pomagal izboljšati zaupanje državljanov v verodostojnost znanstvenih študij in posledično v sistem Unije za ocenjevanje tveganja.

en	Other simplification aspects include the harmonisation of the confidentiality rules across different sectors providing a similar baseline to all industry applicants in terms of predictability.
sl	Drugi vidiki poenostavitve vključujejo uskladitev pravil o zaupnosti v različnih sektorjih, kar vsem vlagateljem iz industrije omogoča podobno izhodišče v smislu predvidljivosti.

en	Many stakeholders and citizens complain that the EFSA's evaluations of authorisation applications are essentially based on studies, data and information generated (and paid for) by the applicant for authorisation.
sl	Številne zainteresirane strani in državljani se pritožujejo, da ocene vlog za odobritev, ki jih opravi agencija EFSA, v bistvu temeljijo na študijah, podatkih in informacijah, ki jih je pripravil (in plačal) vlagatelj vloge za odobritev.

en	The proposal respects the needs of EFSA for independence, excellence and multi-disciplinary expertise.
sl	Predlog upošteva potrebe agencije EFSA po neodvisnosti, odličnosti in večdisciplinarnem strokovnem znanju.

en	"Where environmental information is concerned, Articles 6 and Article 7 of Regulation (EC) No 1367/2006 of the European Parliament and of the Council shall also apply.
sl	„Kadar gre za okoljske informacije, se uporabljata tudi člena 6 in 7 Uredbe (ES) št. 1367/2006 Evropskega parlamenta in Sveta.

en	(b) promote consistency and transparency in formulating risk management recommendations;
sl	(b) spodbujanje doslednosti in preglednosti pri oblikovanju priporočil za obvladovanje tveganja;

en	[23: https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf.]
sl	[23: https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_sl.pdf.]

en	Those items referred to in the first subparagraph shall be made public on a dedicated section of the Authority's website.
sl	Dokumenti iz prvega pododstavka se objavijo na posebnem razdelku spletišča agencije.

en	Its mandate is broad and covers all issues impacting directly or indirectly on food and feed safety (including the evaluation of dossiers put forward for the approval of substances), animal health and animal welfare, plant health, human nutrition, and GMO issues.
sl	Njena pooblastila so široka in zajemajo vsa vprašanja, ki neposredno ali posredno vplivajo na varnost živil in krme (vključno z oceno dokumentacije za odobritev snovi), zdravje in dobrobit živali, zdravje rastlin, prehrano ljudi in vprašanja na področju gensko spremenjenih organizmov.

en	Union Register of Studies
sl	Register študij Unije

en	Implementation plans and monitoring, evaluation and reporting arrangements
sl	Načrti za izvedbo ter ureditev spremljanja, ocenjevanja in poročanja

en	It is therefore necessary to strengthen the support provided by the Authority and the Member States to the work of the Authority's Scientific Panels.
sl	Zato je treba okrepiti podporo, ki jo Agencija in države članice zagotavljajo za delo znanstvenih svetov Agencije.

en	The powers to adopt delegated acts referred to in Article 8(c) shall be conferred upon the Commission for an indeterminate period of time from [date of entry into force of this Regulation].
sl	Pooblastilo za sprejemanje delegiranih aktov iz člena 8c se prenese na Komisijo za nedoločen čas od [datum začetka veljavnosti te uredbe].

en	- decisions, agreements and contracts resulting from the financing implementing activities of the Regulation will expressly entitle the Commission/EFSA, including OLAF, and the Court of Auditors to conduct audits, on-the-spot checks and inspections;
sl	- v sklepih, sporazumih in pogodbah, ki izhajajo iz dejavnosti izvajanja financiranja iz Uredbe, bosta Komisija/EFSA, vključno z uradom OLAF, in Računsko sodišče izrecno pooblaščena za izvajanje revizij, pregledov na kraju samem in inšpekcijskih pregledov;

en	EFSA's evaluations of authorisation applications are essentially based on industry studies (burden of proof of safety of products on the applicant) also perceived as non-transparent by civil society.
sl	Ocene agencije EFSA v zvezi z vlogami za odobritev v glavnem temeljijo na študijah industrije (dokazno breme o varnosti izdelkov nosi vlagatelj), ki jih civilna družba prav tako dojema kot nepregledne.

en	3 17.03 11 European Food Safety Authority Diff.
sl	3 17.03 11 Evropska agencija za varnost hrane dif. DA NE NE NE

en	This means taking into account the general objectives of the GFL Regulation, namely a high level of protection of human health and consumers' interests and the effective functioning of the internal market.
sl	To pomeni, da se upoštevajo splošni cilji uredbe o splošni živilski zakonodaji, torej visoka raven varovanja zdravja ljudi in interesov potrošnikov ter učinkovito delovanje notranjega trga.

en	Information requested to be treated as confidential in the confidential version shall be clearly marked.
sl	Informacije, ki jih je treba obravnavati kot zaupne, morajo biti v zaupni različici jasno označene.

en	It is thus appropriate to include representatives of all Member States in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment.
sl	Zato je v upravni odbor Agencije primerno vključiti predstavnike vseh držav članic, hkrati pa zagotoviti, da imajo navedeni predstavniki izkušnje zlasti na področju ocenjevanja tveganja.

en	DG SANTE actively monitors the compliance of agencies' independence policies with the Commission's guidelines on independence through a DG SANTE's task force including all SANTE's agencies and through bilateral contacts.
sl	GD SANTE dejavno spremlja skladnost politik neodvisnosti v agencijah s smernicami Komisije o neodvisnosti prek svoje projektne skupine, ki vključuje vse agencije GD SANTE, in prek dvostranskih odnosov.

en	To ensure the transparency of this process, the advice of the Authority should be made public.
sl	Za preglednost tega postopka bi bilo treba nasvet Agencije objaviti.

en	As risks due to an important exposure to potential conflicts of interest in EU decentralised agencies and Scientific Committees are assessed as significant (see DG SANTE's 2017 MP), DG SANTE's planned actions focus on improving the handling of conflict of interest situations.
sl	Ker so tveganja zaradi velike izpostavljenosti morebitnim nasprotjem interesov v decentraliziranih agencijah EU in znanstvenih odborih ocenjena kot pomembna (glej načrt upravljanja 2017 GD SANTE), so predvideni ukrepi GD SANTE usmerjeni v izboljšanje obravnavanja primerov nasprotij interesov.

en	The risk of this tool being disproportionally used to unnecessarily commission studies is limited: it is to be triggered by the Commission since it will be financed by the Union budget and only in exceptional circumstances.
sl	Tveganje, da bi se to orodje nesorazmerno uporabljalo za nepotrebno naročanje študij, je omejeno: ker se financira iz proračuna Unije, ga lahko uporabi Komisija in samo v izjemnih okoliščinah.

en	The Executive Director shall submit the list to the Management Board for appointment.
sl	Izvršni direktor predloži seznam upravnemu odboru v imenovanje.

en	A number of impacts were however considered during the preparation process as follows:
sl	Kljub temu pa so bili pri pripravi upoštevani številni učinki:

en	Globally, all these measures will also contribute to an increased involvement of stakeholders in the risk assessment system and thus to a more effective risk communication.
sl	Skupaj bodo vsi ti ukrepi prispevali tudi k večji vključenosti zainteresiranih strani v sistem ocenjevanja tveganja in s tem k učinkovitejšemu obveščanju o tveganju.

en	The provisions of this Regulation shall not apply to applications for authorisations under Union food law as well as requests for scientific outputs submitted to the Authority prior to [general date of entry of application:18 months after its entry into force].
sl	Določbe te uredbe se ne uporabljajo za vloge za odobritev na podlagi živilske zakonodaje Unije niti za zaprosila za znanstvene prispevke, predložene Agenciji pred [splošni datum začetka uporabe: 18 mesecev po začetku njene veljavnosti].

en	The challenges to be addressed related to transparency, sustainability of the EU risk assessment system (which for authorisations of products/substances is an EU centralised system, with the exception of pesticides dual system) and the demand for risk communication to be more effective.
sl	Izzivi, ki jih je treba obravnavati v zvezi s preglednostjo in trajnostjo sistema EU za ocenjevanje tveganja (ki je za odobritve izdelkov/snovi centraliziran sistem EU, z izjemo dvojnega sistema za pesticide) ter potrebo po učinkovitejšem obveščanju o tveganju.

en	(33) Furthermore, in order to assess the effectiveness and efficiency of the different provisions applying to the Authority, it is also appropriate to provide for a Commission evaluation of the Authority, in accordance with the Common Approach on Decentralised Agencies.
sl	(33) Poleg tega je za oceno uspešnosti in učinkovitosti različnih določb, ki se uporabljajo za Agencijo, primerno tudi določiti, da Komisija oceni Agencijo, in sicer v skladu s skupnim pristopom k decentraliziranim agencijam.

en	In parallel to the legislative measures, the Commission will also continue to provide support to food safety via its Research and Innovation policies and contribute to strengthening coordination, cooperation and cohesion of food safety research and innovation activities in the Union and its Member States in particular when building the forthcoming ninth European Research and Innovation Framework Programme.
sl	Vzporedno z zakonodajnimi ukrepi bo Komisija s svojimi politikami na področju raziskav in inovacij še naprej zagotavljala podporo varnosti hrane ter prispevala h krepitvi usklajevanja, sodelovanja in kohezije raziskovalnih in inovacijskih dejavnosti na področju varnosti hrane v Uniji in njenih državah članicah, zlasti pri oblikovanju prihodnjega devetega evropskega okvirnega programa za raziskave in inovacije.

en	(b) the names of authors of published, or publicly available, studies supporting such requests; and
sl	(b) imena avtorjev objavljenih ali javno dostopnih študij v podporo takim zaprosilom ter

en	The proposal/initiative relates to a new action following a pilot project/preparatory action
sl	Predlog/pobuda se nanaša na nov ukrep na podlagi pilotnega projekta/ pripravljalnega ukrepa.

en	The application provided for in Article 14 of this Regulation shall be submitted by a producer of the active substance to a Member State, with a copy to the other Member States, the Commission and the Authority, no later than three years before the expiry of the approval.
sl	Zahtevek iz člena 14 te uredbe predloži proizvajalec aktivne snovi državi članici, pri čemer pošlje po en izvod drugim državam članicam, Komisiji in Agenciji, in sicer najpozneje tri leta pred iztekom odobritve.

en	(d) foster public understanding of the risk analysis process so as to enhance confidence in its outcome;
sl	(d) povečanje razumevanja postopka analize tveganja v javnosti, da se poveča zaupanje v njegove rezultate;

en	Estimated requirements of human resources for the parent DG
sl	Ocenjene potrebe po človeških virih za matični GD

en	Since some specific changes of EFSA's functioning (pre-submission advice, composition of the Panels) are proposed, care has been taken to take into account procedures followed by other scientific agencies with special attention to European Chemicals Agency (ECHA) and European Medicines Agency (EMA).
sl	Ker so predlagane nekatere specifične spremembe v delovanju agencije EFSA (svetovanje pred vložitvijo vloge, sestava svetov), je bila pozornost namenjena upoštevanju postopkov drugih znanstvenih agencij, zlasti Evropske agencije za kemikalije (ECHA) in Evropske agencija za zdravila (EMA).

en	This proposal is addressing those challenges directly linked to the GFL Regulation and EFSA.
sl	Ta predlog obravnava te izzive, ki so neposredno povezani z uredbo o splošni živilski zakonodaji in agencijo EFSA.