natgillin/translations-raw huggingface dataset:
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).
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).
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)
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)
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.
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.
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.
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.
Relations between tissue establishments and third parties.
Odnosi med ustanovami za tkiva in celice ter tretjimi osebami.
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.
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.
[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.
[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.]
Verification by the competent authorities of the implementation of the VUD principle in tissue establishments is focused on inspecting documentation related to donor consent.
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.
Five Member States have both central oocyte and sperm donor registries.
Pet držav članic ima osrednje registre tako za darovalce jajčnih celic kot tudi za darovalce sperme.
Quality and safety of tissues and cells
Kakovost in varnost tkiv in celic
Legend: ART = assisted reproductive technologies
Legenda: OBMP = oploditev z biomedicinsko pomočjo
[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.
[2: Podrobni odgovori držav članic (ter odgovori Norveške in Lihtenštajna) so na voljo na http://ec.europa.eu/health/blood_tissues_organs/key_documents/.
Distribution of tissues and cells for human application.
Razdeljevanje tkiv in celic za uporabo pri zdravljenju ljudi.
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.
Na dveletnih srečanjih nacionalnih pristojnih organov je potekala razprava o več merilih za izbor in nalogah odgovornih oseb v državah članicah s strožjimi zahtevami.
[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).
[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).
Authorisation of tissue and cell preparation processes.
Odobritev postopkov priprave tkiv in celic.
[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.
[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.
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.
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.
Number of procurement organisations (POs) reported by the EU and EEA countries
Slika 3 Število organizacij za pridobivanje v skladu s poročanjem držav EU in EGP
Tissue establishments' status (public vs. private)/type of tissue (2011 data; data submitted by 25 Member States and one EEA country)
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)
[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). ]
[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). ]
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.
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.
][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.
][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.
][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).
][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).
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)
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)
Fig. 7.
Slika 7
Developing more detailed requirements for these activities as part of GTP was supported by several national competent authorities for tissues and cells.
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.
b. Volume of tissues and cells (units) exported in 2011 (data reported by 11 Member States)
b. Količina tkiv in celic (enot), izvoženih leta 2011 (podatke je poslalo 11 držav članic)
Support for the implementation of the EU tissue and Cell Directives
Podpora izvajanju direktiv EU o tkivih in celicah
a. Volume of tissues and cells (units) imported in 2011 (data reported by 15 Member States)
a. Količina tkiv in celic (enot), uvoženih leta 2011 (podatke je poslalo 15 držav članic)
Supervision of human tissue and cell procurement.
Nadzor pridobivanja človeških tkiv in celic.
[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.
[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.
Tissues and cells competent authorities in the reporting EU Member States and EEA countries (2011 data)
Slika 1 Pristojni organi za tkiva in celice v državah članicah EU in državah EGP, ki so poročale (podatki za leto 2011)
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)
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)
Other responsibilities of tissues and cells competent authorities in the reporting EU Member States and EEA countries (2011 data)
Slika 2 Druge odgovornosti pristojnih organov za tkiva in celice v državah članicah EU in državah EGP, ki so poročale (podatki za leto 2011)
Implementation of the EU tissues and cells legislation
Izvajanje zakonodaje EU o tkivih in celicah
Procurement of tissues and cells.
Pridobivanje tkiv in celic.
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.]
][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.]
Transposition of the EU tissue and cell legislation
Prenos zakonodaje EU o tkivih in celicah
[12: http://ec.europa.eu/health/blood_tissues_organs/docs/manual_en.pdf ]
[12: http://ec.europa.eu/health/blood_tissues_organs/docs/manual_sl.pdf. ]
These reasons are still valid.
Ti razlogi so še vedno relevantni.
Reasons for action at European level (ex-ante)
Razlogi za ukrepanje na evropski ravni (predhodno)
(g) the annual report of its activities;
(g) letno poročilo o svojih dejavnostih;
The political response was to adopt a White Paper on Food Safety in January 2000.
Politični odziv je bil sprejetje bele knjige o varnosti hrane januarja 2000.
The Commission open public consultation is published on:
Odprto javno posvetovanje Komisije je objavljeno na:
The Authority shall carry out its activities with a high level of transparency.
Agencija izvaja svoje dejavnosti z visoko stopnjo preglednosti.
framework 5 ‘Administrative expenditure'
okvira 5 „Upravni odhodki"
from candidate countries[46: Candidate countries and, where applicable, potential candidates from the Western Balkans.]
držav kandidatk[46: Države kandidatke in po potrebi potencialne države kandidatke z Zahodnega Balkana.]
Risk communication was also found not to be effective enough.
Tudi za obveščanje o tveganju je bilo ugotovljeno, da ni dovolj učinkovito.
"(m) a summary of the dossier in a standardised form.
„(m) povzetek dokumentacije v standardizirani obliki.
These controls shall be organised in cooperation with the competent authorities of the Member States.
Ta nadzor se organizira v sodelovanju s pristojnimi organi držav članic.
Member States may nominate nationals of other Member States.
Države članice lahko predlagajo tudi državljane drugih držav članic.
Subsidiarity (for non-exclusive competence)
Subsidiarnost (za neizključno pristojnost)
Compatibility and possible synergy with other appropriate instruments
Skladnost in možnosti sinergij z drugimi ustreznimi instrumenti
(e) The Management Board shall ensure that the broadest possible geographical distribution is achieved in the final appointments.
(e) Upravni odbor zagotovi, da se pri končnem imenovanju doseže najširša možna geografska pokritost.
Therefore experience and knowledge exist on this substance or product.
Zato obstajajo izkušnje in znanje o tej snovi ali izdelku.
Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications.
Vlagatelji ter zlasti mala in srednja podjetja pa teh specifikacij ne razumejo vedno jasno.
It underlined that this lack should be addressed in future policy development, for instance by making better coordinated use of existing reporting requirements.
Poudarjeno je bilo, da je treba to pomanjkanje obravnavati pri prihodnjem razvoju politike, na primer z boljšim usklajevanjem obstoječih zahtev glede poročanja.
The public may make comments to the Commission within 30 days from such publication.
Javnost lahko Komisiji predloži pripombe v 30 dneh od take objave.
Such measures are therefore not expected to have significant socio-economic and environmental impacts that are clearly identifiable ex ante.
Zato se ne pričakuje, da bodo takšni ukrepi imeli znatne družbeno-gospodarske in okoljske vplive, ki jih je mogoče jasno opredeliti vnaprej.
In particular a series of measures will be put in place such as:
Uvedena bo zlasti vrsta ukrepov, kot so:
It shall apply from [18 months after its entry into force], except for the following provisions:
Uporablja se od [18 mesecev po začetku njene veljavnosti], razen naslednjih določb:
(a) Article 1(2) shall apply from 1st July 2022.
(a) člen 1(2) se uporablja od 1. julija 2022;
(i) A high level of scientific expertise;
(i) visoka raven strokovnega znanja;
The findings of the evaluation shall be made public."
Ugotovitve ocene se objavijo."
Title 2: Infrastructure and operating expenditure Commitments (1a)
Naslov 2: Infrastruktura in odhodki iz poslovanja obveznosti (1a)
[51: Mainly for the Structural Funds, the European Agricultural Fund for Rural Development (EAFRD) and the European Fisheries Fund (EFF).]
[51: Zlasti za strukturna sklada, Evropski kmetijski sklad za razvoj podeželja (EKSRP) in Evropski sklad za ribištvo (ESR).]
(22) Food safety is a sensitive matter of prime interest for all Union citizens.
(22) Varnost hrane je občutljivo vprašanje bistvenega pomena za vse državljane Unije.
framework 3 Security and Citizenship
okvira 3 Varnost in državljanstvo
Those implementing acts shall be adopted in accordance with Article 58(2).
Navedeni izvedbeni akti se sprejmejo v skladu s členom 58(2).
The regulatory regime on food safety needs to be strong to ensure its credibility and effectiveness.
Regulativna ureditev na področju varnosti hrane mora biti močna, da zagotavlja verodostojnost in učinkovitost.
Transitions measures are provided.
Določeni so prehodni ukrepi.
Each Member State shall nominate at least 12 scientific experts.
Vsaka država članica predlaga vsaj 12 znanstvenih strokovnjakov.
(c) information on the complete composition of a plant protection product.
(c) informacij o celotni sestavi fitofarmacevtskega sredstva.
Added value of Union involvement (it may result from different factors, e.g. coordination gains, legal certainty, greater effectiveness or complementarities).
Dodana vrednost ukrepanja Unije (ki je lahko posledica različnih dejavnikov, npr. usklajevalnih koristi, pravne varnosti, večje učinkovitosti ali dopolnjevanja).
In addition, the role of the Management Board is focussed on administration and finances.
Poleg tega se upravni odbor osredotoča na področji uprave in financ.
The term of office of members and alternate members shall be four years.
Mandat članov in nadomestnih članov traja štiri leta.
The Commission shall ensure the regular review of the application of this Regulation.
Komisija zagotovi redne preglede uporabe te uredbe.
(e) be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data.
(e) biti dostopno tudi tistim, ki niso neposredno udeleženi v postopku, ob upoštevanju zaupnosti in varstva osebnih podatkov.
The impact in terms of costs and resources needed is mostly on EFSA.
Učinek v smislu stroškov in potrebnih virov se nanaša predvsem na agencijo EFSA.
The system shall ensure that any access to it is fully auditable.
Sistem mora zagotavljati, da je vsak dostop do njega v celoti preverljiv.
Business and civil society stakeholders are of the same mind.
Enako menijo predstavniki podjetij in civilne družbe.
Payments (2a)
plačila (2 a)
Appropriate provisions are included to protect the rights of commercial applicants.
Vključene so tudi ustrezne določbe za zaščito pravic poslovnih vlagateljev.
(f) its scientific studies in accordance with Articles 32 and 32e;
(f) svoje znanstvene študije v skladu s členoma 32 in 32e;
The results of all consultation activities are summarised in the synopsis report.
Rezultati vseh posvetovanj so povzeti v zbirnem poročilu.
N° of documents (or parts of) subject to claims of confidentiality;
Št. dokumentov (ali njihovih delov), ki so predmet zahtev za zaupnost;
Notwithstanding paragraphs 2 and 3, the following information shall nevertheless be made public:
Ne glede na odstavka 2 in 3 se naslednje informacije kljub temu objavijo:
XX is the policy area or budget title concerned.
XX je zadevno področje ali naslov.
Description of the calculation of cost for FTE units should be included in the Annex V, section 3.
Opis izračuna stroškov za enote EPDČ mora biti vključen v oddelek 3 Priloge V.
[…] [XX.YY.YY.YY] […] […] YES/
[…] [XX YY YY YY] […] […] DA/
(15) It is essential to ensure the efficient operation of the Authority and to improve the sustainability of its expertise.
(15) Bistveno je, da se zagotovi učinkovito delovanje Agencije in izboljša trajnost njenega strokovnega znanja.
- the rules governing the eligibility of costs will be simplified in accordance with the provisions of the Financial Regulation;
- poenostavitev pravil za upravičenost stroškov v skladu z določbami finančne uredbe;
Since duly justified confidential information is protected, incentives for innovation should remain unchanged.
Ker so informacije, ustrezno utemeljene kot zaupne, zaščitene, bi morale spodbude za inovacije ostati nespremenjene.
1) improve and clarify the rules on transparency
1) Izboljšati in pojasniti pravila o preglednosti
"Unless otherwise provided, the Management Board shall act by a majority of its members.
„Če ni drugače določeno, upravni odbor odloča z večino svojih članov.
The Commission shall report to the European Parliament, the Council and the Management Board on the evaluation findings.
Komisija Evropskemu parlamentu, Svetu in upravnemu odboru poroča o ugotovitvah ocene.
Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.
Navedena pooblastila bi bilo treba izvajati v skladu z Uredbo (EU) št. 182/2011 Evropskega parlamenta in Sveta.
(f) ensure appropriate exchange of information with interested parties in relation to risks associated with the agri-food chain.
(f) zagotavljanje primerne izmenjave informacij z zainteresiranimi stranmi v zvezi s tveganji, povezanimi z agroživilsko verigo.
It is proportionate to harmonise these rules while preserving, where needed, the specific balance of interests in sectoral legislations.
Ta pravila je sorazmerno uskladiti, hkrati pa po potrebi ohranjati specifično ravnovesje interesov v sektorski zakonodaji.
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.
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.
(17) Provisions exist on the content of applications for authorisations.
(17) Obstajajo določbe o vsebini vlog za odobritev.
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.
Vendar se v nekaterih primerih lahko pojavijo težave glede skladnosti z veljavnimi standardi, zato so vzpostavljeni nacionalni sistemi za preverjanje te skladnosti.
Information systems
Informacijski sistemi
X Indirect management by entrusting budget implementation tasks to:
X Posredno upravljanje s poverjanjem nalog izvrševanja proračuna:
Access to the information for renewal
Dostop do informacij za obnovitev
That section shall be publicly available and easily accessible.
Navedeni razdelek je na voljo javnosti in je zlahka dostopen.
Consistency with other Union policies
Skladnost z drugimi politikami Unije
(b) breeding patterns and strategies.
(b) vzorcev in strategij žlahtnjenja.