qanastek/ELRC-Medical-V2 huggingface dataset:
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.
Translation (en-hr): Iz ovog je izvješća vidljivo da su države članice uglavnom usklađene s člankom 12. Direktive 2004/23/EZ u kojem se od država članica zahtijeva da poduzmu potrebne mjere kako bi pokušale osigurati dobrovoljno i neplaćeno darivanje tkiva i stanica.
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.
Translation (en-hr): Iz odgovora na anketu vidljivo je da to vrijedi i u slučaju prikupljanja tkiva i stanica za proizvođače lijekova za naprednu terapiju, u skladu s člankom 3. Uredbe o lijekovima za naprednu terapiju.
English: Donor selection and evaluation
Translation (en-hr): Odabir i ocjena darivatelja
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.
Translation (en-hr): Istraživanje je pokazalo da sve države članice koje podnose izvješća izdaju odobrenja za uvjete prikupljanja provođenjem inspekcija u ustanovama za prikupljanje i/ili ocjenjivanjem dokumentacije povezane s prikupljanjem koju na raspolaganje stavlja banka tkiva koja surađuje s ustanovama za prikupljanje.
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.
Translation (en-hr): Važno je pitanje tko donosi odluku o vrijednosti i obliku naknade za darivatelje tkiva i stanica i kako to čini.
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). ]
Translation (en-hr): [22: Direktiva Komisije (EU) 2015/566 o provedbi Direktive 2004/23/EZ s obzirom na postupke provjere ekvivalentnosti standarda kvalitete i sigurnosti uvezenih tkiva i stanica (SL L 93, 9.4.2015., str. 56.). ]
English: Five Member States have both central oocyte and sperm donor registries.
Translation (en-hr): Pet država članica ima uspostavljene središnje registre darivatelja jajnih stanica i sjemene tekućine.
English: Fig. 1.
Translation (en-hr): Slika 1.
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.
Translation (en-hr): Usto, u nekoliko država članica odobrenje za prikupljanje tkiva i stanica imaju isključivo banke za tkiva, dok određene države članice bankama tkiva izdaju odobrenja samo u svrhu aktivnosti prikupljanja.
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.
Translation (en-hr): Kad je riječ o primjeni načela dobrovoljnog i neplaćenog darivanja, istraživanje Komisije pokazalo je da države članice uglavnom poštuju članak 12. Direktive 2004/23/EZ u kojem se od njih zahtijeva da poduzmu potrebne mjere kako bi potaknule dobrovoljno i neplaćeno darivanje.
English: Tissue establishments' status (public vs. private)/type of tissue (2011 data; data submitted by 25 Member States and one EEA country)
Translation (en-hr): Slika 5. Status banaka tkiva (javne ili privatne) / vrsta tkiva (podaci iz 2011. godine; podatke je predalo 25 država članica i jedna zemlja EGP-a)
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.
Translation (en-hr): Odredbe povezane s prikupljanjem, ali i darivanjem te testiranjem uređuju se zakonodavstvom o tkivima i stanicama te provjeravaju tijekom inspekcija banaka tkiva.
English: Donor selection and evaluation.
Translation (en-hr): Odabir i ocjena darivatelja.
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.
Translation (en-hr): [14: Direktiva Komisije (EU) 2015/565 od 8. travnja 2015. o izmjeni Direktive 2006/86/EZ s obzirom na određene tehničke zahtjeve za označivanje ljudskih tkiva i stanica.
English: Number of procurement organisations (POs) reported by the EU and EEA countries
Translation (en-hr): Slika 3. Broj ustanova za prikupljanje o kojima su izvijestile zemlje EU-a i EGP-a
English: 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.
Translation (en-hr): Nadležna tijela mogu preispitati najbolje prakse za osiguravanje dostatnosti/samodostatnosti za tkiva i stanice ili mjere za smanjenje nedostataka te najbolje prakse u pogledu provjere provedbe načela dobrovoljnog i neplaćenog darivanja.
English: Fig. 7.
Translation (en-hr): Slika 7.
English: Support for the implementation of the EU tissue and Cell Directives
Translation (en-hr): Potpora za provedbu direktiva EU-a o tkivima i stanicama
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)
Translation (en-hr): Količina tkiva i stanica (jedinica) distribuirana iz jedne države članice u drugu državu članicu EU-a i/ili zemlju EGP-a tijekom 2011. (podatke je dostavilo 18 zemalja)
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.
Translation (en-hr): Provjera provedbe načela dobrovoljnog i neplaćenog darivanja u bankama tkiva koju provode nadležna tijela usmjerena je na pregled dokumentacije o pristanku darivatelja.
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.
Translation (en-hr): Samo su dvije države članice izvijestile da tijekom inspekcija provode provjeru standardnih operativnih postupaka koje su pripremile banke tkiva te podataka o pacijentima i darivateljima koje su dostavile klinike za liječenje neplodnosti s izdanom dozvolom.
English: Distribution of tissues and cells for human application.
Translation (en-hr): Distribucija tkiva i stanica za primjenu kod ljudi.
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.
Translation (en-hr): Analiza godišnjih izvješća o ozbiljnim štetnim reakcijama i događajima koja su podnijele države članice pokazuje znatna nastojanja u pogledu usklađivanja sa zahtjevima iz članka 7.
English: 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.
Translation (en-hr): E01718) razvili su se u iznimno vrijednu platformu za rasprave u okviru koje je omogućena razmjena najboljih praksi i pojašnjavanje zajedničkih poteškoća na koje se nailazi na nacionalnoj razini i razini EU-a.
English: Supervision of human tissue and cell procurement.
Translation (en-hr): Nadzor prikupljanja ljudskih tkiva i stanica.
English: b. Volume of tissues and cells (units) exported in 2011 (data reported by 11 Member States)
Translation (en-hr): Količina tkiva i stanica (jedinica) izvezena u 2011. (podatke je dostavilo 11 država članica)
English: Developing more detailed requirements for these activities as part of GTP was supported by several national competent authorities for tissues and cells.
Translation (en-hr): Nekoliko je nacionalnih nadležnih tijela za tkiva i stanice pružilo potporu razvoju podrobnijih zahtjeva za te aktivnosti kao dio dobre prakse za tkiva.
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.]
Translation (en-hr): 43. - 55.][15: EU-ov preglednik banaka tkiva dio je platforme EU-a za označivanje koja je uvedena Direktivom (EU) 2015/565 o izmjeni Direktive 2006/86/EZ s obzirom na određene tehničke zahtjeve za označivanje ljudskih tkiva i stanica.]
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.
Translation (en-hr): [13: Direktiva Komisije (EU) 2015/565 o izmjeni Direktive 2006/86/EZ s obzirom na određene tehničke zahtjeve za označivanje ljudskih tkiva i stanica (SL L 93, 9.4.2015., str. 43.).]
English: EN EN
Translation (en-hr): a.
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.
Translation (en-hr): Prema potrebi, u obzir su uzeti i podaci prikupljeni drugim kanalima, a kojima se podupiru rezultati dvaju istraživanja (npr. razmjenom s nacionalnim nadležnim tijelima tijekom sastanaka s Komisijom koji se održavaju dva puta godišnje, obveznim godišnjim izvješćivanjem Komisiji o ozbiljnim štetnim reakcijama i događajima, upozorenjima objavljenima na platformi za brza upozorenja o tkivima i stanicama (engl.
English: Implementation of the EU tissues and cells legislation
Translation (en-hr): Provedba zakonodavstva EU-a o tkivima i stanicama
English: a. Volume of tissues and cells (units) imported in 2011 (data reported by 15 Member States)
Translation (en-hr): Količina tkiva i stanica (jedinica) uvezena u 2011. (podatke je dostavilo 15 država članica)
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)
Translation (en-hr): Količina tkiva i stanica (jedinica) primljena iz jedne države članice u drugu državu članicu EU-a i/ili zemlju EGP-a tijekom 2011. (podatke je dostavilo 15 država članica)
English: Transposition of the EU tissue and cell legislation
Translation (en-hr): Prenošenje zakonodavstva EU-a o tkivima i stanicama
English: Tissues and cells competent authorities in the reporting EU Member States and EEA countries (2011 data)
Translation (en-hr): Nadležna tijela za tkiva i stanice u državama članicama EU-a i zemljama EGP-a koje podnose izvješća (podaci iz 2011. godine)
English: These reasons are still valid.
Translation (en-hr): Ti su razlozi i dalje valjani.
English: The Commission will bear the limited costs.
Translation (en-hr): Komisija će snositi ograničene troškove.
English: (g) the annual report of its activities;
Translation (en-hr): (g) godišnjem izvještaju o svojim aktivnostima;
English: Member States may nominate nationals of other Member States.
Translation (en-hr): Države članice mogu nominirati državljane drugih država članica.
English: […] [XX.YY.YY.YY] […] […] YES/
Translation (en-hr): […] [XX.YY.YY.YY] […] […] DA/
English: Each Member State shall nominate at least 12 scientific experts.
Translation (en-hr): Svaka država članica nominira najmanje 12 znanstvenih stručnjaka.
English: framework 3 Security and Citizenship
Translation (en-hr): okvira 3 Sigurnost i građanstvo
English: Reasons for action at European level (ex-ante)
Translation (en-hr): Razlozi za djelovanje na europskoj razini (ex ante)
English: [51: Mainly for the Structural Funds, the European Agricultural Fund for Rural Development (EAFRD) and the European Fisheries Fund (EFF).]
Translation (en-hr): [51: Uglavnom za strukturne fondove, Europski poljoprivredni fond za ruralni razvoj (EPFRR) i Europski ribarski fond (EFR).]
English: (e) The Management Board shall ensure that the broadest possible geographical distribution is achieved in the final appointments.
Translation (en-hr): (e) Upravno vijeće osigurava da se konačnim imenovanjima postiže najšira moguća geografska pokrivenost.
English: Policy area: [Food Safety]
Translation (en-hr): Područje politike: [Sigurnost hrane]
English: The political response was to adopt a White Paper on Food Safety in January 2000.
Translation (en-hr): Politika je na to odgovorila donošenjem Bijele knjige o sigurnosti hrane u siječnju 2000.
English: X bodies referred to in Articles 208 and 209;
Translation (en-hr): X tijelima na koja se upućuje u člancima 208. i 209.;
English: The Commission shall ensure the regular review of the application of this Regulation.
Translation (en-hr): Komisija osigurava redovito preispitivanje provedbe ove Uredbe.
English: In addition, the role of the Management Board is focussed on administration and finances.
Translation (en-hr): Osim toga, uloga Upravnog vijeća usmjerena je na administraciju i financije.
English: It underlined that this lack should be addressed in future policy development, for instance by making better coordinated use of existing reporting requirements.
Translation (en-hr): Istaknuto je da bi se taj nedostatak trebao riješiti u budućem razvoju politika, primjerice, bolje koordiniranom uporabom postojećih izvještajnih zahtjeva.
English: Added value of Union involvement (it may result from different factors, e.g. coordination gains, legal certainty, greater effectiveness or complementarities).
Translation (en-hr): Dodana vrijednost angažmana Unije (može biti posljedica različitih čimbenika, npr. bolje koordinacije, pravne sigurnosti, veće djelotvornosti ili komplementarnosti).
English: The impact in terms of costs and resources needed is mostly on EFSA.
Translation (en-hr): Učinak u smislu troškova i potrebnih resursa uglavnom se odnosi na EFSA-u.
English: Member States shall launch a call for interest as a basis for their nominations.
Translation (en-hr): Države članice objavljuju poziv na iskaz interesa kao temelj za svoje nominacije.
English: The findings of the evaluation shall be made public."
Translation (en-hr): Rezultati evaluacije moraju se objaviti."
English: It shall apply from [18 months after its entry into force], except for the following provisions:
Translation (en-hr): Primjenjuje se od [18 mjeseci nakon njezina stupanja na snagu], osim sljedećih odredbi:
English: (e) be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data.
Translation (en-hr): (e) biti dostupno, među ostalim, i onima koji nisu izravno uključeni u proces, uzimajući pritom u obzir povjerljivost i zaštitu osobnih podataka.
English: Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.
Translation (en-hr): Te bi ovlasti trebalo izvršavati u skladu s Uredbom (EU) br. 182/2011 Europskog parlamenta i Vijeća.
English: - the rules governing the eligibility of costs will be simplified in accordance with the provisions of the Financial Regulation;
Translation (en-hr): - pravila kojima se regulira prihvatljivost troškova pojednostavnit će se u skladu s odredbama Financijske uredbe,
English: 1) improve and clarify the rules on transparency
Translation (en-hr): 1. poboljšati i razjasniti pravila o transparentnosti
English: Expected generated Union added value (ex-post)
Translation (en-hr): Očekivana ostvarena dodana vrijednost Unije (ex post)
English: Problems that the initiative aims to tackle
Translation (en-hr): Problemi koje se želi riješiti inicijativom
English: Impact on the European Food Safety Authority (EFSA)
Translation (en-hr): Učinak na Europsku agenciju za sigurnost hrane (EFSA)
English: 3 17.03 11 European Food Safety Authority Diff.
Translation (en-hr): 3 17.03 11 Europska agencija za sigurnost hrane Dif.
English: Appropriate provisions are included to protect the rights of commercial applicants.
Translation (en-hr): Uključene su odgovarajuće odredbe za zaštitu prava trgovačkih podnositelja zahtjeva.
English: "(m) a summary of the dossier in a standardised form.
Translation (en-hr): „(m) sažetak dosjea u standardiziranom obliku.";
English: The Commission open public consultation is published on:
Translation (en-hr): Otvoreno javno savjetovanje Komisije objavljeno je na stranici:
English: The regulatory regime on food safety needs to be strong to ensure its credibility and effectiveness.
Translation (en-hr): Regulatorni sustav za sigurnost hrane mora biti snažan da bi bio vjerodostojan i djelotvoran.
English: Laboratory related audit can be performed by existing service SANTE.F "Health and Food audits and analysis".
Translation (en-hr): Reviziju laboratorija može provesti postojeća služba SANTE.F „Revizije i analize u području zdravlja i hrane".
English: (f) its scientific studies in accordance with Articles 32 and 32e;
Translation (en-hr): (f) svojim znanstvenim studijama u skladu s člancima 32. i 32.e;
English: (22) Food safety is a sensitive matter of prime interest for all Union citizens.
Translation (en-hr): (22) Sigurnost hrane osjetljivo je pitanje izuzetno važno svim građanima Unije.
English: Consistency with other Union policies
Translation (en-hr): Dosljednost u odnosu na druge politike Unije
English: Protection of personal data
Translation (en-hr): Zaštita osobnih podataka
English: Risk communication was also found not to be effective enough.
Translation (en-hr): Utvrđeno je i da obavješćivanje o riziku nije dovoljno djelotvorno.
English: Since duly justified confidential information is protected, incentives for innovation should remain unchanged.
Translation (en-hr): Budući da su opravdano povjerljive informacije zaštićene, mjere za poticanje inovacija trebale bi ostati nepromijenjene.
English: Duration and financial impact
Translation (en-hr): Trajanje i financijski utjecaj
English: Detailed explanation of the specific provisions of the proposal
Translation (en-hr): Detaljno obrazloženje posebnih odredbi prijedloga
English: EFSA provides the advice in a transparent way since it makes it public.
Translation (en-hr): EFSA pruža mišljenja na transparentan način jer ih javno objavljuje.
English: The Commission shall report to the European Parliament, the Council and the Management Board on the evaluation findings.
Translation (en-hr): Komisija izvješćuje Europski parlament, Vijeće i Upravni odbor o rezultatima evaluacije.
English: Moreover, a strict application of the rules on conflict of interests provided in the proposal will be ensured.
Translation (en-hr): Nadalje, osigurat će se stroga primjena pravila o sukobima interesa predviđena prijedlogom.
English: Business and civil society stakeholders are of the same mind.
Translation (en-hr): Dionici iz poslovnog sektora i civilnog društva slažu se s time.
English: As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
Translation (en-hr): Čim donese delegirani akt, Komisija o njemu istodobno obavještava Europski parlament i Vijeće.
English: The Authority shall carry out its activities with a high level of transparency.
Translation (en-hr): „1. Agencija svoje zadaće obavlja uz visoku razinu transparentnosti.
English: (a) Article 1(2) shall apply from 1st July 2022.
Translation (en-hr): (a) članak 1. stavak 2. primjenjuje se od 1. srpnja 2022.
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.
Translation (en-hr): Navesti datum predviđenog zapošljavanja te prema tome prilagoditi iznos (ako se zapošljava u srpnju, uzima se u obzir samo 50 % prosječnog troška) i iznijeti daljnja objašnjenja u prilogu.
English: Specify the method for calculating the impact on revenue.
Translation (en-hr): Navesti metodu izračuna utjecaja na prihode.
English: Notwithstanding paragraphs 2 and 3, the following information shall nevertheless be made public:
Translation (en-hr): Bez obzira na stavke 2. i 3., sljedeće informacije ipak se moraju objaviti:
English: Such measures are therefore not expected to have significant socio-economic and environmental impacts that are clearly identifiable ex ante.
Translation (en-hr): Stoga se ne očekuje da će te mjere imati znatan socijalno-gospodarski učinak i učinak na okoliš koji se lako mogu utvrditi ex ante.
English: These controls shall be organised in cooperation with the competent authorities of the Member States.
Translation (en-hr): Te se kontrole organiziraju u suradnji s nadležnim tijelima država članica.
English: [42: As referred to in Article 54(2)(a) or (b) of the Financial Regulation.]
Translation (en-hr): [42: Kako je navedeno u članku 54. stavku 2. točki (a) ili (b) Financijske uredbe.]
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.
Translation (en-hr): X Prijedlog je u skladu s tekućim višegodišnjim financijskim okvirom i može uključivati upotrebu posebnih instrumenata kako je definirano u Uredbi Vijeća (EU, Euratom) br. 1311/2013.
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.
Translation (en-hr): (h) zahtjevima Europskog parlamenta, Komisije ili neke države članice za znanstveno mišljenje koji su odbijeni ili izmijenjeni i obrazloženjima tih odbijanja ili izmjena;
English: They also seriously undermined public confidence in the Union food safety regulatory framework.
Translation (en-hr): Ujedno su i znatno smanjili povjerenje javnosti u regulatorni okvir Unije za sigurnost hrane.
English: "Unless otherwise provided, the Management Board shall act by a majority of its members.
Translation (en-hr): „Ako se ne utvrdi drukčije, Upravno vijeće odlučuje većinom glasova svojih članova.
English: N° of documents (or parts of) subject to claims of confidentiality;
Translation (en-hr): Broj dokumenata (ili njihovih dijelova) koji su predmet zahtjeva za povjerljivost
English: In particular EFSA will be able to cross-check the information on the studies performed (the laboratories being an external source of information).
Translation (en-hr): EFSA će osobito moći unakrsno provjeriti informacije o provedenim studijama (laboratoriji su vanjski izvori informacija).
English: Therefore experience and knowledge exist on this substance or product.
Translation (en-hr): Stoga o toj tvari ili proizvodu već postoji iskustvo i znanje.
English: (a) the name and address of the applicant;
Translation (en-hr): (a) ime i adresu podnositelja zahtjeva;
English: Public access to the dossiers
Translation (en-hr): Javni pristup dosjeima
English: Fundamental rights
Translation (en-hr): Temeljna prava
English: Standard data formats
Translation (en-hr): Standardni formati podataka
English: Title 2: Infrastructure and operating expenditure Commitments (1a)
Translation (en-hr): Glava 2.: Rashodi za infrastrukturu i poslovanje Preuzete obveze (1a)