FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: In terms of inspection outcomes, mostly minor shortcomings were recorded with few suspensions and revocations of authorisations (Fig. 6).
Slovenian: Rezultati inšpekcijskih pregledov kažejo, da so bili ugotovljene samo manjše pomanjkljivosti, pri čemer je bilo samo nekaj odobritev začasno odvzetih ali preklicanih (slika 6).
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: An important issue is how and by whom the decision concerning the value and form of compensations for tissue and cell donors is taken.
Slovenian: Pomembno vprašanje je, kako se sprejme odločitev o vrednosti in obliki nadomestila za darovalce tkiv in celic ter kdo jo sprejme.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Register of tissue establishments and reporting obligations.
Slovenian: Register ustanov za tkiva in celice ter obveznosti poročanja.
English: Provisions associated with procurement, but also with donation and testing, are regulated by the tissue and cell legislation and verified during tissue establishment inspection.
Slovenian: 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.
English: Donor selection and evaluation.
Slovenian: Izbiranje in vrednotenje darovalcev.
English: 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.
Slovenian: 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.
English: Import/export of human tissues and cells to/from third countries.
Slovenian: Uvoz človeških tkiv in celic v tretje države članice in izvoz iz njih.
English: 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.
Slovenian: 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.
English: Such difficulties were also reported by operators manufacturing ATMP from human tissues and cells.
Slovenian: O takih težavah so poročali tudi subjekti, ki proizvajajo zdravila za napredno zdravljenje iz človeških tkiv in celic.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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).
English: On the other hand, ten Member States indicated that, especially for sperm donors, such registries are maintained by the tissue establishments.
Slovenian: Po drugi strani pa je deset držav članic navedlo, da take registre vzdržujejo ustanove za tkiva in celice, zlasti za darovalce sperme.
English: 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.
Slovenian: 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.
English: Fig. 8.
Slovenian: Slika 8
English: Legend: HSC = haematopietic stem cells
Slovenian: Legenda: KMC = krvotvorne matične celice
English: 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.
Slovenian: 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.
English: Tissue and cell reception, processing, storage, labelling and packaging.
Slovenian: Prevzem, predelava, hranjenje, označevanje in pakiranje tkiv in celic.
English: Non-reproductive tissues and cells.
Slovenian: Nereproduktivna tkiva in celice.
English: 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).
Slovenian: 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).
English: 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)
Slovenian: 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)
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Relations between tissue establishments and third parties.
Slovenian: Odnosi med ustanovami za tkiva in celice ter tretjimi osebami.
English: 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.
Slovenian: 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.
English: [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.
Slovenian: [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.]
English: Verification by the competent authorities of the implementation of the VUD principle in tissue establishments is focused on inspecting documentation related to donor consent.
Slovenian: 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.
English: Five Member States have both central oocyte and sperm donor registries.
Slovenian: Pet držav članic ima osrednje registre tako za darovalce jajčnih celic kot tudi za darovalce sperme.
English: Quality and safety of tissues and cells
Slovenian: Kakovost in varnost tkiv in celic
English: Legend: ART = assisted reproductive technologies
Slovenian: Legenda: OBMP = oploditev z biomedicinsko pomočjo
English: [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.
Slovenian: [2: Podrobni odgovori držav članic (ter odgovori Norveške in Lihtenštajna) so na voljo na http://ec.europa.eu/health/blood_tissues_organs/key_documents/.
English: Distribution of tissues and cells for human application.
Slovenian: Razdeljevanje tkiv in celic za uporabo pri zdravljenju ljudi.
English: 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.
Slovenian: Na dveletnih srečanjih nacionalnih pristojnih organov je potekala razprava o več merilih za izbor in nalogah odgovornih oseb v državah članicah s strožjimi zahtevami.
English: [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).
Slovenian: [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).
English: Authorisation of tissue and cell preparation processes.
Slovenian: Odobritev postopkov priprave tkiv in celic.
English: [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.
Slovenian: [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.
English: 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.
Slovenian: 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.
English: Number of procurement organisations (POs) reported by the EU and EEA countries
Slovenian: Slika 3 Število organizacij za pridobivanje v skladu s poročanjem držav EU in EGP
English: Tissue establishments' status (public vs. private)/type of tissue (2011 data; data submitted by 25 Member States and one EEA country)
Slovenian: 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)
English: [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). ]
Slovenian: [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). ]
English: 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.
Slovenian: 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.
English: ][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.
Slovenian: ][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.
English: ][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).
Slovenian: ][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).
English: 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)
Slovenian: 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)
English: Fig. 7.
Slovenian: Slika 7
English: Developing more detailed requirements for these activities as part of GTP was supported by several national competent authorities for tissues and cells.
Slovenian: 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.
English: b. Volume of tissues and cells (units) exported in 2011 (data reported by 11 Member States)
Slovenian: b. Količina tkiv in celic (enot), izvoženih leta 2011 (podatke je poslalo 11 držav članic)
English: Support for the implementation of the EU tissue and Cell Directives
Slovenian: Podpora izvajanju direktiv EU o tkivih in celicah
English: a. Volume of tissues and cells (units) imported in 2011 (data reported by 15 Member States)
Slovenian: a. Količina tkiv in celic (enot), uvoženih leta 2011 (podatke je poslalo 15 držav članic)
English: Supervision of human tissue and cell procurement.
Slovenian: Nadzor pridobivanja človeških tkiv in celic.
English: [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.
Slovenian: [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.
English: Tissues and cells competent authorities in the reporting EU Member States and EEA countries (2011 data)
Slovenian: Slika 1 Pristojni organi za tkiva in celice v državah članicah EU in državah EGP, ki so poročale (podatki za leto 2011)
English: 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)
Slovenian: 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)
English: Other responsibilities of tissues and cells competent authorities in the reporting EU Member States and EEA countries (2011 data)
Slovenian: Slika 2 Druge odgovornosti pristojnih organov za tkiva in celice v državah članicah EU in državah EGP, ki so poročale (podatki za leto 2011)
English: Implementation of the EU tissues and cells legislation
Slovenian: Izvajanje zakonodaje EU o tkivih in celicah
English: Procurement of tissues and cells.
Slovenian: Pridobivanje tkiv in celic.
English: 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.]
Slovenian: ][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.]
English: Transposition of the EU tissue and cell legislation
Slovenian: Prenos zakonodaje EU o tkivih in celicah
English: [12: http://ec.europa.eu/health/blood_tissues_organs/docs/manual_en.pdf ]
Slovenian: [12: http://ec.europa.eu/health/blood_tissues_organs/docs/manual_sl.pdf. ]
English: These reasons are still valid.
Slovenian: Ti razlogi so še vedno relevantni.
English: Reasons for action at European level (ex-ante)
Slovenian: Razlogi za ukrepanje na evropski ravni (predhodno)
English: (g) the annual report of its activities;
Slovenian: (g) letno poročilo o svojih dejavnostih;
English: The political response was to adopt a White Paper on Food Safety in January 2000.
Slovenian: Politični odziv je bil sprejetje bele knjige o varnosti hrane januarja 2000.
English: The Commission open public consultation is published on:
Slovenian: Odprto javno posvetovanje Komisije je objavljeno na:
English: The Authority shall carry out its activities with a high level of transparency.
Slovenian: Agencija izvaja svoje dejavnosti z visoko stopnjo preglednosti.
English: framework 5 ‘Administrative expenditure'
Slovenian: okvira 5 „Upravni odhodki"
English: from candidate countries[46: Candidate countries and, where applicable, potential candidates from the Western Balkans.]
Slovenian: držav kandidatk[46: Države kandidatke in po potrebi potencialne države kandidatke z Zahodnega Balkana.]
English: Risk communication was also found not to be effective enough.
Slovenian: Tudi za obveščanje o tveganju je bilo ugotovljeno, da ni dovolj učinkovito.
English: "(m) a summary of the dossier in a standardised form.
Slovenian: „(m) povzetek dokumentacije v standardizirani obliki.
English: These controls shall be organised in cooperation with the competent authorities of the Member States.
Slovenian: Ta nadzor se organizira v sodelovanju s pristojnimi organi držav članic.
English: Member States may nominate nationals of other Member States.
Slovenian: Države članice lahko predlagajo tudi državljane drugih držav članic.
English: Subsidiarity (for non-exclusive competence)
Slovenian: Subsidiarnost (za neizključno pristojnost)
English: Compatibility and possible synergy with other appropriate instruments
Slovenian: Skladnost in možnosti sinergij z drugimi ustreznimi instrumenti
English: (e) The Management Board shall ensure that the broadest possible geographical distribution is achieved in the final appointments.
Slovenian: (e) Upravni odbor zagotovi, da se pri končnem imenovanju doseže najširša možna geografska pokritost.
English: Therefore experience and knowledge exist on this substance or product.
Slovenian: Zato obstajajo izkušnje in znanje o tej snovi ali izdelku.
English: Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications.
Slovenian: Vlagatelji ter zlasti mala in srednja podjetja pa teh specifikacij ne razumejo vedno jasno.
English: It underlined that this lack should be addressed in future policy development, for instance by making better coordinated use of existing reporting requirements.
Slovenian: Poudarjeno je bilo, da je treba to pomanjkanje obravnavati pri prihodnjem razvoju politike, na primer z boljšim usklajevanjem obstoječih zahtev glede poročanja.
English: The public may make comments to the Commission within 30 days from such publication.
Slovenian: Javnost lahko Komisiji predloži pripombe v 30 dneh od take objave.
English: Such measures are therefore not expected to have significant socio-economic and environmental impacts that are clearly identifiable ex ante.
Slovenian: Zato se ne pričakuje, da bodo takšni ukrepi imeli znatne družbeno-gospodarske in okoljske vplive, ki jih je mogoče jasno opredeliti vnaprej.
English: In particular a series of measures will be put in place such as:
Slovenian: Uvedena bo zlasti vrsta ukrepov, kot so:
English: It shall apply from [18 months after its entry into force], except for the following provisions:
Slovenian: Uporablja se od [18 mesecev po začetku njene veljavnosti], razen naslednjih določb:
English: (a) Article 1(2) shall apply from 1st July 2022.
Slovenian: (a) člen 1(2) se uporablja od 1. julija 2022;
English: (i) A high level of scientific expertise;
Slovenian: (i) visoka raven strokovnega znanja;
English: The findings of the evaluation shall be made public."
Slovenian: Ugotovitve ocene se objavijo."
English: Title 2: Infrastructure and operating expenditure Commitments (1a)
Slovenian: Naslov 2: Infrastruktura in odhodki iz poslovanja obveznosti (1a)
English: [51: Mainly for the Structural Funds, the European Agricultural Fund for Rural Development (EAFRD) and the European Fisheries Fund (EFF).]
Slovenian: [51: Zlasti za strukturna sklada, Evropski kmetijski sklad za razvoj podeželja (EKSRP) in Evropski sklad za ribištvo (ESR).]
English: (22) Food safety is a sensitive matter of prime interest for all Union citizens.
Slovenian: (22) Varnost hrane je občutljivo vprašanje bistvenega pomena za vse državljane Unije.
English: framework 3 Security and Citizenship
Slovenian: okvira 3 Varnost in državljanstvo
English: Those implementing acts shall be adopted in accordance with Article 58(2).
Slovenian: Navedeni izvedbeni akti se sprejmejo v skladu s členom 58(2).
English: The regulatory regime on food safety needs to be strong to ensure its credibility and effectiveness.
Slovenian: Regulativna ureditev na področju varnosti hrane mora biti močna, da zagotavlja verodostojnost in učinkovitost.
English: Transitions measures are provided.
Slovenian: Določeni so prehodni ukrepi.
English: Each Member State shall nominate at least 12 scientific experts.
Slovenian: Vsaka država članica predlaga vsaj 12 znanstvenih strokovnjakov.
English: (c) information on the complete composition of a plant protection product.
Slovenian: (c) informacij o celotni sestavi fitofarmacevtskega sredstva.
English: Added value of Union involvement (it may result from different factors, e.g. coordination gains, legal certainty, greater effectiveness or complementarities).
Slovenian: Dodana vrednost ukrepanja Unije (ki je lahko posledica različnih dejavnikov, npr. usklajevalnih koristi, pravne varnosti, večje učinkovitosti ali dopolnjevanja).
English: In addition, the role of the Management Board is focussed on administration and finances.
Slovenian: Poleg tega se upravni odbor osredotoča na področji uprave in financ.
English: The term of office of members and alternate members shall be four years.
Slovenian: Mandat članov in nadomestnih članov traja štiri leta.
English: The Commission shall ensure the regular review of the application of this Regulation.
Slovenian: Komisija zagotovi redne preglede uporabe te uredbe.
English: (e) be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data.
Slovenian: (e) biti dostopno tudi tistim, ki niso neposredno udeleženi v postopku, ob upoštevanju zaupnosti in varstva osebnih podatkov.
English: The impact in terms of costs and resources needed is mostly on EFSA.
Slovenian: Učinek v smislu stroškov in potrebnih virov se nanaša predvsem na agencijo EFSA.
English: The system shall ensure that any access to it is fully auditable.
Slovenian: Sistem mora zagotavljati, da je vsak dostop do njega v celoti preverljiv.
English: Business and civil society stakeholders are of the same mind.
Slovenian: Enako menijo predstavniki podjetij in civilne družbe.
English: Payments (2a)
Slovenian: plačila (2 a)
English: Appropriate provisions are included to protect the rights of commercial applicants.
Slovenian: Vključene so tudi ustrezne določbe za zaščito pravic poslovnih vlagateljev.
English: (f) its scientific studies in accordance with Articles 32 and 32e;
Slovenian: (f) svoje znanstvene študije v skladu s členoma 32 in 32e;
English: The results of all consultation activities are summarised in the synopsis report.
Slovenian: Rezultati vseh posvetovanj so povzeti v zbirnem poročilu.
English: N° of documents (or parts of) subject to claims of confidentiality;
Slovenian: Št. dokumentov (ali njihovih delov), ki so predmet zahtev za zaupnost;
English: Notwithstanding paragraphs 2 and 3, the following information shall nevertheless be made public:
Slovenian: Ne glede na odstavka 2 in 3 se naslednje informacije kljub temu objavijo:
English: XX is the policy area or budget title concerned.
Slovenian: XX je zadevno področje ali naslov.
English: Description of the calculation of cost for FTE units should be included in the Annex V, section 3.
Slovenian: Opis izračuna stroškov za enote EPDČ mora biti vključen v oddelek 3 Priloge V.
English: […] [XX.YY.YY.YY] […] […] YES/
Slovenian: […] [XX YY YY YY] […] […] DA/
English: (15) It is essential to ensure the efficient operation of the Authority and to improve the sustainability of its expertise.
Slovenian: (15) Bistveno je, da se zagotovi učinkovito delovanje Agencije in izboljša trajnost njenega strokovnega znanja.
English: - the rules governing the eligibility of costs will be simplified in accordance with the provisions of the Financial Regulation;
Slovenian: - poenostavitev pravil za upravičenost stroškov v skladu z določbami finančne uredbe;
English: Since duly justified confidential information is protected, incentives for innovation should remain unchanged.
Slovenian: Ker so informacije, ustrezno utemeljene kot zaupne, zaščitene, bi morale spodbude za inovacije ostati nespremenjene.
English: 1) improve and clarify the rules on transparency
Slovenian: 1) Izboljšati in pojasniti pravila o preglednosti
English: "Unless otherwise provided, the Management Board shall act by a majority of its members.
Slovenian: „Če ni drugače določeno, upravni odbor odloča z večino svojih članov.
English: Fundamental rights
Slovenian: Temeljne pravice
English: The Commission shall report to the European Parliament, the Council and the Management Board on the evaluation findings.
Slovenian: Komisija Evropskemu parlamentu, Svetu in upravnemu odboru poroča o ugotovitvah ocene.
English: Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.
Slovenian: Navedena pooblastila bi bilo treba izvajati v skladu z Uredbo (EU) št. 182/2011 Evropskega parlamenta in Sveta.
English: (f) ensure appropriate exchange of information with interested parties in relation to risks associated with the agri-food chain.
Slovenian: (f) zagotavljanje primerne izmenjave informacij z zainteresiranimi stranmi v zvezi s tveganji, povezanimi z agroživilsko verigo.
English: It is proportionate to harmonise these rules while preserving, where needed, the specific balance of interests in sectoral legislations.
Slovenian: Ta pravila je sorazmerno uskladiti, hkrati pa po potrebi ohranjati specifično ravnovesje interesov v sektorski zakonodaji.
English: 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.
Slovenian: 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.
English: (17) Provisions exist on the content of applications for authorisations.
Slovenian: (17) Obstajajo določbe o vsebini vlog za odobritev.
English: 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.
Slovenian: Vendar se v nekaterih primerih lahko pojavijo težave glede skladnosti z veljavnimi standardi, zato so vzpostavljeni nacionalni sistemi za preverjanje te skladnosti.
English: Information systems
Slovenian: Informacijski sistemi
English: X Indirect management by entrusting budget implementation tasks to:
Slovenian: X Posredno upravljanje s poverjanjem nalog izvrševanja proračuna:
English: Access to the information for renewal
Slovenian: Dostop do informacij za obnovitev
English: That section shall be publicly available and easily accessible.
Slovenian: Navedeni razdelek je na voljo javnosti in je zlahka dostopen.
English: Consistency with other Union policies
Slovenian: Skladnost z drugimi politikami Unije
English: (b) breeding patterns and strategies.
Slovenian: (b) vzorcev in strategij žlahtnjenja.
English: (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.
Slovenian: (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.
English: 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.
Slovenian: 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.
English: The evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification.
Slovenian: Pri oceni se obravnavajo morebitna potreba po spremembi pooblastil agencije in finančne posledice kakršnih koli tovrstnih sprememb.
English: (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.
Slovenian: (h) zaprosila Evropskega parlamenta, Komisije ali države članice za znanstvena mnenja, ki so bila zavrnjena ali spremenjena, in utemeljitev za zavrnitev ali spremembo;
English: (a) the name and address of the applicant;
Slovenian: (a) ime in naslov vlagatelja,
English: It shall forthwith transmit this opinion to the Commission, the authorisation-holder and the Member States.
Slovenian: To mnenje nemudoma pošlje Komisiji, imetniku odobritve in državam članicam.
English: (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.
Slovenian: (19) V primeru vlog za obnovitev odobritve je odobrena snov ali izdelek na trgu že več let.
English: X bodies referred to in Articles 208 and 209;
Slovenian: X organom iz členov 208 in 209,
English: In parallel, the Commission's Scientific Advice Mechanism has been asked to prepare an opinion on the authorisation process of plant protection products.
Slovenian: Vzporedno s tem je bil mehanizem Komisije za znanstveno svetovanje zaprošen, da pripravi mnenje o postopku registracije fitofarmacevtskih sredstev.
English: The consultation carried out demonstrates an overall support of stakeholders to the initiative.
Slovenian: Pri posvetovanju se je pokazalo, da zainteresirane strani na splošno podpirajo pobudo.
English: The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents.
Slovenian: Seznam, ki ga sestavi Komisija, se posreduje Evropskemu parlamentu skupaj s zadevnimi referenčnimi dokumenti.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: O razlogih za razlike med ocenami in ugotovitvami znanstvenih organov bi bilo treba bolje obveščati javnost, da bi se olajšalo njihovo razumevanje.
English: In particular, there has been a decrease in the number of candidates applying to be members of the Scientific Panels.
Slovenian: Zlasti se je zmanjšalo število kandidatov, ki se prijavljajo za člane znanstvenih svetov.
English: Alternate members shall represent the member in his absence and vote on his behalf.
Slovenian: Nadomestni člani predstavljajo člane v njihovi odsotnosti in glasujejo v njihovem imenu.
English: Risk communication is an essential part of the risk analysis process.
Slovenian: Obveščanje o tveganju je bistven del postopka analize tveganja.
English: (4) the following Articles 32a, 32b, 32c, 32d and 32e are inserted:
Slovenian: (4) vstavijo se naslednji členi 32a, 32b, 32c, 32d in 32e:
English: N° of requests for access to documents addressed to EFSA and the Commission.
Slovenian: št. prošenj za dostop do dokumentov, naslovljenih na agencijo EFSA in Komisijo.
English: In particular EFSA will be able to cross-check the information on the studies performed (the laboratories being an external source of information).
Slovenian: EFSA bo lahko zlasti navzkrižno preverila informacije o izvedenih študijah (laboratoriji so zunanji vir informacij).
English: The main objectives of this initiative are to update the GFL Regulation so as to:
Slovenian: Glavni cilj te pobude je bil posodobiti uredbo o splošni živilski zakonodaji z namenom:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: [Body]: <EFSA.> Year
Slovenian: [Organ]: <EFSA.> Leto
English: The proposal also stipulates that personal data be protected taking into account the applicable Union legislative framework on the processing of such data.
Slovenian: Predlog tudi določa varstvo osebnih podatkov in pri tem upošteva veljavni zakonodajni okvir Unije za obdelavo takih podatkov.
English: Implementation with a start-up period from 2020 to 2022
Slovenian: izvajanje z obdobjem uvajanja med letoma 2020 in 2022,
English: 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).
Slovenian: 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).
English: The fourth measure provides for controls and audits by Commission inspectors in relation to studies.
Slovenian: Četrti ukrep določa nadzor in presoje, ki jih izvajajo inšpektorji Komisije v zvezi s študijami.