FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
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.
Croatian: Ažuriranjem podataka u ovom pregledniku nadležna tijela za tkiva i stanice pokazuju potpunu transparentnost i pružaju potporu zdravstvenim djelatnicima u potrazi za davateljem tkiva ili stanica na području Unije.
English: Only six Member States have national registries of oocyte and sperm donors.
Croatian: Samo šest država članica ima uspostavljene nacionalne registre darivatelja jajnih stanica i sjemene tekućine.
English: Therefore information provided by the donor or his/her family contributes to an accurate assessment of all risks associated to the application of donated tissues or cells.
Croatian: Stoga se podacima koje je dao darivatelj i/ili njegova obitelj pridonosi procjeni rizika povezanih s primjenom darovanih tkiva ili stanica.
English: The new legal provisions for the application of the Single European Code shall also satisfy the requirement in Article 10(3) of the Directive 2004/23/EC, by establishing the EU Tissue Establishment Compendium including all tissues establishments with their coordinates and the status of their accreditation/designation/authorised or licence.
Croatian: Nove pravne odredbe za primjenu jedinstvenog europskog sustava označivanja moraju udovoljavati i zahtjevu iz članka 10. stavka 3. Direktive 2004/23/EZ uspostavljanjem EU-ova preglednika banaka tkiva koji sadržava informacije o svim bankama tkiva s podacima za kontakt i statusom njihove akreditacije/imenovanja/odobrenja ili izdane dozvole.
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.
Croatian: Nadalje, uključivanjem u EU-ov preglednik banaka tkiva osnažit će povjerenje partnera i klijenata diljem svijeta u banke tkiva EU-a.
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.
Croatian: Nekoliko je zahtjeva u pogledu testiranja (npr. odsutnost zahtjeva u pogledu testiranja nukleinske kiseline, vremensko ograničenje od 24 sata za prikupljanje uzoraka krvi preminulog darivatelja, testiranje darivatelja gameta u trenutku darivanja) bilo predmet rasprave na sastancima nacionalnih nadležnih tijela koji se održavaju dva puta godišnje, a različite prakse koje su navela nadležna tijela ukazuju na potrebu za procjenom rizika na temelju dokaza za određene praktične situacije koje nisu jasno utvrđene/predviđene Direktivom 2006/17/EZ.
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.
Croatian: Upozorenje izdano na platformi za brza upozorenja o tkivima i stanicama (RATC) popraćeno povlačenjem proizvoda banke tkiva iz EU-a pokazalo je da se obrazac pristanka i njegova provjera mogu znatno razlikovati u različitim državama članicama, a to ovisi i o pravnom okviru na temelju kojeg je preneseno zakonodavstvo EU-a o tkivima i stanicama.
English: In most of the Member States compliance with the requirements for tissue and cell procurement set by Directive 2006/17/EC is verified by the competent authorities when performing inspections, but also by auditing procurement organisations and centres of human application.
Croatian: U većini država članica usklađenost za zahtjevima u pogledu prikupljanja tkiva i stanica utvrđenima Direktivom 2006/17/EZ provjeravaju nadležna tijela pri provođenju inspekcija, ali i revizijom ustanova za prikupljanje i centara za primjenu kod ljudi.
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.
Croatian: Uz redovito pružanje najnovijih podataka tijekom sastanaka stručnih podskupina o epidemiološkoj situaciji bitnoj za sektor tkiva i stanica, koji se održavaju dva puta godišnje, razvoj procjena rizika (npr. za HTLV, malariju, denga groznicu i bolest chikungunya) i planova pripravnosti (npr. za groznicu uzrokovanu virusom zapadnog Nila) pokazali su se vrijednim doprinosom politici i donošenju odluka u ovom sektoru na nacionalnoj razini i razini EU-a.
English: Development of follow-up registries as an additional tool for ensuring safety of living donors was also addressed in the survey.
Croatian: U ovom je istraživanju razmatran i razvoj registara za praćenje kao dodatni alat za osiguravanje sigurnosti živih darivatelja.
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).
Croatian: Usto, u slučajevima u kojima će se tkiva/stanice jednog darivatelja upotrebljavati za presađivanje i proizvodnju lijekova za naprednu terapiju, potrebno je razmotriti najbolji način razmjene bitnih podataka između sustava za farmakovigilanciju i biovigilanciju (npr. darivanje stanica živog darivatelja u kojima je utvrđen razvoj tumora nakon darivanja stanica proizvođaču lijekova za naprednu terapiju ili razvoj tumora / zarazne bolesti kod primatelja nakon terapije darovanim stanicama darivatelja koji su darovali stanice presađene drugom primatelju).
English: In relation to the supply-demand balance, 17 Member States and one EEA country reported experiencing regular shortages of tissues and cells on a national level, mostly for bone marrow and haematopoietic stem cells, corneas and bone.
Croatian: Kad je riječ o ravnoteži između potražnje i ponude, 17 država članica i jedna zemlja EGP-a izvijestile su o redovitom suočavanju s nedostatkom tkiva i stanica na nacionalnoj razini, uglavnom koštane srži i krvotvornih matičnih stanica, tkiva rožnice i koštanog tkiva.
English: Quality and safety of tissues and cells
Croatian: Kvaliteta i sigurnost tkiva i stanica
English: Besides complying with the legal obligations pursuant to Article 12 (1) and Article 26 of Directive 2004/23/EC, the current report sets out how Directive 2004/23/EC and its implementing Directives 2006/17/EC and 2006/86/EC (hereafter commonly referred to as the EU tissue and cell legislation) function in practice, against a backdrop of significant scientific and organisational developments (internationalisation, commercialisation) that have taken place in the tissue and cell sector over the past decade.
Croatian: Direktive 2004/23/EZ, u ovom se izvješću utvrđuje način na koji Direktiva 2004/23/EZ i pripadajuće provedbene direktive 2006/17/EZ i 2006/86/EZ (dalje u tekstu na njih se upućuje kao na zakonodavstvo EU-a o tkivima i stanicama) funkcioniraju u praksi s obzirom na važna znanstvena i organizacijska zbivanja (internacionalizacija, komercijalizacija) do kojih je došlo u sektoru tkiva i stanica tijekom proteklog desetljeća.
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.
Croatian: U pogledu laboratorija za ispitivanja istraživanje je pokazalo da su u većini država članica koje podnose izvješće za akreditaciju/imenovanje/odobrenje ili izdavanje dozvola za laboratorije za ispitivanja odgovorna druga tijela, a ne nadležna tijela za tkiva i stanice.
English: Legend: HSC = haematopietic stem cells
Croatian: Legenda: KMS = krvotvorne matične stanice
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.
Croatian: Važno je istaknuti da, slično kao u slučaju odabira darivatelja, zdravstveni djelatnici koji naručuju tkiva ili stanice iz drugih država članica ponekad strože zahtjeve u pogledu testiranja koje su uvele pojedine države članice smatraju preprekama razvoju i prekograničnom kretanju tkiva i stanica između država članica.
English: Such difficulties were also reported by operators manufacturing ATMP from human tissues and cells.
Croatian: O takvim su poteškoćama izvijestili i subjekti koji proizvode lijekove za naprednu terapiju iz ljudskih tkiva i stanica.
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.
Croatian: Rezultati istraživanja načela dobrovoljnog i neplaćenog darivanja ukazuju na to da bi države članice trebale prikupiti više podataka o svakodnevnim praksama u pogledu darivatelja u ustanovama za prikupljanje i bankama tkiva, posebno kad su ti subjekti odgovorni za donošenje odluke o vrsti i/ili vrijednosti naknade koja se isplaćuje darivateljima.
English: Register of tissue establishments and reporting obligations.
Croatian: Registar banaka tkiva i obveze u pogledu izvješćivanja.
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)
Croatian: Slika 4. Broj akreditiranih/imenovanih/odobrenih banaka tkiva/banaka tkiva s izdanom dozvolom po vrsti ljudskih tkiva i stanica (usporedni podaci, podatke je predalo 27 država članica i dvije zemlje EGP-a)
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.
Croatian: 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.
Croatian: 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
Croatian: 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.
Croatian: 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.
Croatian: 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). ]
Croatian: [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.
Croatian: Pet država članica ima uspostavljene središnje registre darivatelja jajnih stanica i sjemene tekućine.
English: Fig. 1.
Croatian: 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.
Croatian: 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.
Croatian: 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)
Croatian: 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.
Croatian: 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.
Croatian: 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.
Croatian: [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
Croatian: 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.
Croatian: 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.
Croatian: Slika 7.
English: Support for the implementation of the EU tissue and Cell Directives
Croatian: 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)
Croatian: 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.
Croatian: 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.
Croatian: 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.
Croatian: 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.
Croatian: 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.
Croatian: 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.
Croatian: Nadzor prikupljanja ljudskih tkiva i stanica.
English: b. Volume of tissues and cells (units) exported in 2011 (data reported by 11 Member States)
Croatian: 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.
Croatian: 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.]
Croatian: 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.
Croatian: [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
Croatian: 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.
Croatian: 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
Croatian: 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)
Croatian: 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)
Croatian: 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
Croatian: 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)
Croatian: 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.
Croatian: Ti su razlozi i dalje valjani.
English: The Commission will bear the limited costs.
Croatian: Komisija će snositi ograničene troškove.
English: (g) the annual report of its activities;
Croatian: (g) godišnjem izvještaju o svojim aktivnostima;
English: Member States may nominate nationals of other Member States.
Croatian: Države članice mogu nominirati državljane drugih država članica.
English: […] [XX.YY.YY.YY] […] […] YES/
Croatian: […] [XX.YY.YY.YY] […] […] DA/
English: Each Member State shall nominate at least 12 scientific experts.
Croatian: Svaka država članica nominira najmanje 12 znanstvenih stručnjaka.
English: framework 3 Security and Citizenship
Croatian: okvira 3 Sigurnost i građanstvo
English: Reasons for action at European level (ex-ante)
Croatian: 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).]
Croatian: [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.
Croatian: (e) Upravno vijeće osigurava da se konačnim imenovanjima postiže najšira moguća geografska pokrivenost.
English: Policy area: [Food Safety]
Croatian: Područje politike: [Sigurnost hrane]
English: The political response was to adopt a White Paper on Food Safety in January 2000.
Croatian: Politika je na to odgovorila donošenjem Bijele knjige o sigurnosti hrane u siječnju 2000.
English: X bodies referred to in Articles 208 and 209;
Croatian: 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.
Croatian: Komisija osigurava redovito preispitivanje provedbe ove Uredbe.
English: In addition, the role of the Management Board is focussed on administration and finances.
Croatian: 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.
Croatian: 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).
Croatian: 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.
Croatian: 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.
Croatian: Države članice objavljuju poziv na iskaz interesa kao temelj za svoje nominacije.
English: The findings of the evaluation shall be made public."
Croatian: Rezultati evaluacije moraju se objaviti."
English: It shall apply from [18 months after its entry into force], except for the following provisions:
Croatian: 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.
Croatian: (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.
Croatian: 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;
Croatian: - pravila kojima se regulira prihvatljivost troškova pojednostavnit će se u skladu s odredbama Financijske uredbe,
English: 1) improve and clarify the rules on transparency
Croatian: 1. poboljšati i razjasniti pravila o transparentnosti
English: Expected generated Union added value (ex-post)
Croatian: Očekivana ostvarena dodana vrijednost Unije (ex post)
English: Problems that the initiative aims to tackle
Croatian: Problemi koje se želi riješiti inicijativom
English: Impact on the European Food Safety Authority (EFSA)
Croatian: Učinak na Europsku agenciju za sigurnost hrane (EFSA)
English: 3 17.03 11 European Food Safety Authority Diff.
Croatian: 3 17.03 11 Europska agencija za sigurnost hrane Dif.
English: Appropriate provisions are included to protect the rights of commercial applicants.
Croatian: Uključene su odgovarajuće odredbe za zaštitu prava trgovačkih podnositelja zahtjeva.
English: "(m) a summary of the dossier in a standardised form.
Croatian: „(m) sažetak dosjea u standardiziranom obliku.";
English: The Commission open public consultation is published on:
Croatian: 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.
Croatian: 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".
Croatian: 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;
Croatian: (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.
Croatian: (22) Sigurnost hrane osjetljivo je pitanje izuzetno važno svim građanima Unije.
English: Consistency with other Union policies
Croatian: Dosljednost u odnosu na druge politike Unije
English: Protection of personal data
Croatian: Zaštita osobnih podataka
English: Risk communication was also found not to be effective enough.
Croatian: Utvrđeno je i da obavješćivanje o riziku nije dovoljno djelotvorno.
English: Since duly justified confidential information is protected, incentives for innovation should remain unchanged.
Croatian: Budući da su opravdano povjerljive informacije zaštićene, mjere za poticanje inovacija trebale bi ostati nepromijenjene.
English: Duration and financial impact
Croatian: Trajanje i financijski utjecaj
English: Detailed explanation of the specific provisions of the proposal
Croatian: Detaljno obrazloženje posebnih odredbi prijedloga
English: EFSA provides the advice in a transparent way since it makes it public.
Croatian: 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.
Croatian: 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.
Croatian: Nadalje, osigurat će se stroga primjena pravila o sukobima interesa predviđena prijedlogom.
English: Business and civil society stakeholders are of the same mind.
Croatian: 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.
Croatian: 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.
Croatian: „1. Agencija svoje zadaće obavlja uz visoku razinu transparentnosti.
English: (a) Article 1(2) shall apply from 1st July 2022.
Croatian: (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.
Croatian: 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.
Croatian: Navesti metodu izračuna utjecaja na prihode.
English: Notwithstanding paragraphs 2 and 3, the following information shall nevertheless be made public:
Croatian: 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.
Croatian: 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.
Croatian: 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.]
Croatian: [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.
Croatian: 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.
Croatian: (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.
Croatian: 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.
Croatian: „Ako se ne utvrdi drukčije, Upravno vijeće odlučuje većinom glasova svojih članova.
English: N° of documents (or parts of) subject to claims of confidentiality;
Croatian: 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).
Croatian: 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.
Croatian: Stoga o toj tvari ili proizvodu već postoji iskustvo i znanje.
English: (a) the name and address of the applicant;
Croatian: (a) ime i adresu podnositelja zahtjeva;
English: Public access to the dossiers
Croatian: Javni pristup dosjeima
English: Fundamental rights
Croatian: Temeljna prava
English: Standard data formats
Croatian: Standardni formati podataka
English: Title 2: Infrastructure and operating expenditure Commitments (1a)
Croatian: Glava 2.: Rashodi za infrastrukturu i poslovanje Preuzete obveze (1a)
English: The proposal also stipulates that personal data be protected taking into account the applicable Union legislative framework on the processing of such data.
Croatian: U prijedlogu se određuje i zaštita osobnih podataka s obzirom na primjenjivi zakonodavni okvir Unije o obradi tih podataka.
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.
Croatian: (19) U slučaju zahtjeva kojim se traži obnova odobrenja, odobrena tvar ili proizvod na tržištu je već nekoliko godina.
English: (b) breeding patterns and strategies.
Croatian: (b) uzgojni uzorci i strategije.
English: This is because companies going to laboratories outside the Union would take the risk to be perceived as evading the rules.
Croatian: To je tako jer poduzeća koja angažiraju laboratorije izvan EU-a preuzimaju rizik da ih se smatra osobama koje izbjegavaju pravila.
English: The public may make comments to the Commission within 30 days from such publication.
Croatian: Javnost Komisiji može uputiti svoje primjedbe u roku od 30 dana od takve objave.";
English: The fourth measure provides for controls and audits by Commission inspectors in relation to studies.
Croatian: Četvrta su mjera kontrole i revizije koje provode inspektori Komisije u vezi sa studijama.
English: The register shall be managed by the Authority.
Croatian: Registrom upravlja Agencija.
English: (b) proceed, without delay, to a concrete and individual examination of the confidentiality request in accordance with this Article;
Croatian: (b) bez odgode pristupiti konkretnom i individualnom razmatranju zahtjeva za povjerljivost u skladu s ovim člankom;
English: [43: Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx.]
Croatian: [43: Informacije o načinima upravljanja i upućivanju na Financijsku uredbu dostupne su na internetskim stranicama BudgWeb: https://myintracomm.ec.europa.eu/budgweb/HR/man/budgmanag/Pages/budgmanag.aspx.]
English: Ex-post evaluations/fitness checks of existing legislation
Croatian: Ex post evaluacije/provjere primjerenosti postojećeg zakonodavstva
English: of the multiannual financial framework (Total commitments = Total payments)
Croatian: višegodišnjeg financijskog okvira (ukupne preuzete obveze = ukupna plaćanja)
English: (i) A high level of scientific expertise;
Croatian: i. visoka razina stručnog znanja;
English: (a) the study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use as defined in Article 6(1) and Annex I to this Regulation; and,
Croatian: (a) plan studije za studije kojima se dokazuje učinkovitost dodatka hrani za životinje u smislu ciljeva njezine namjene kako je definirano u članku 6. stavku 1. i prilogu I. ovoj Uredbi; i
English: In addition to monitoring compliance, DG SANTE identifies and disseminates good practices in collaboration with the agencies.
Croatian: Osim što nadzire usklađenost, GU SANTE utvrđuje i širi dobre prakse u suradnji s agencijama.
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.
Croatian: (c) četiri člana koji imaju pravo glasa a predstavljaju civilno društvo i interese prehrambenog lanca, konkretno jednog iz organizacija potrošača, jednog iz nevladinih organizacija za zaštitu okoliša, jednog iz organizacija poljoprivrednika i jednog iz industrijskih organizacija.
English: (a) to any intellectual property right which may exist over documents or their content; and,
Croatian: (a) pravo intelektualnog vlasništva koje može postojati nad dokumentima ili njihovim sadržajem; i
English: It shall forthwith transmit this opinion to the Commission, the authorisation-holder and the Member States.
Croatian: Ona odmah dostavlja to mišljenje Komisiji, nositelju odobrenja i državama članicama.
English: Moreover, public money should not be used to commission costly studies (several thousand to several million Euros) that will eventually help the industry to place a product on the market.
Croatian: Nadalje, javna sredstva ne bi se trebala upotrebljavati za naručivanje skupih studija (od nekoliko tisuća do nekoliko milijuna eura) koje će naposljetku pomoći industriji da proizvod stavi na tržište.
English: Those implementing acts shall be adopted in accordance with Article 58(2).
Croatian: Ti provedbeni akti donose se u skladu s člankom 58. stavkom 2.
English: Member States shall assess the confidentiality requests.
Croatian: Države članice procjenjuju zahtjeve za povjerljivost.
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.
Croatian: Kako bi riješila te probleme, Komisija je sastavila iscrpan i ambiciozan prijedlog za koji je potrebno znatno povećanje resursa dostupnih EFSA-i kako bi ona mogla obaviti svoje postojeće i predložene nove odgovornosti.
English: Where the Commission considers that the continuation of the Authority is no longer justified with regard to its assigned objectives, mandate and tasks, it may propose that the relevant provisions of this Regulation be amended accordingly or repealed.
Croatian: Ako Komisija smatra da daljnje postojanje Agencije više nije opravdano s obzirom na ciljeve, mandat i zadaće koji su joj dodijeljeni, ona može predložiti da se relevantne odredbe ove Uredbe u skladu s tim izmijene ili stave izvan snage.
English: (c) information on the complete composition of a plant protection product.
Croatian: (c) informacije o cjelokupnom sastavu proizvoda za zaštitu bilja.";
English: In parallel, the Commission's Scientific Advice Mechanism has been asked to prepare an opinion on the authorisation process of plant protection products.
Croatian: Istodobno je Komisijinu mehanizmu za znanstveno savjetovanje upućen zahtjev za pripremu mišljenja o procesu odobravanja sredstava za zaštitu bilja.
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).
Croatian: Javno savjetovanje o inicijativi na svim službenim jezicima Unije počelo je 23. siječnja 2018. i trajalo do 20. ožujka 2018.; zaprimljen je 471 odgovor (318 odgovora fizičkih osoba i 153 odgovora organizacija).
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.
Croatian: To bi trebalo imati pozitivan učinak jer iskustvo drugih agencija Unije pokazuje da taj model osigurava učinkoviti nadzor rada agencija i usklađena mišljenja na razini Unije i nacionalnoj razini.
English: In particular, there has been a decrease in the number of candidates applying to be members of the Scientific Panels.
Croatian: Točnije, zabilježen je pad broja kandidata koji se prijavljuju za članove znanstvenih panela.
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.
Croatian: Za potrebe ove točke „dodana vrijednost angažmana Unije" vrijednost je intervencije Unije koja je dodana vrijednosti koju bi inače ostvarile države članice svojim zasebnim djelovanjima.
English: YES NO NO NO
Croatian: DA NE NE NE
English: It provides, amongst others, that food law must be based on risk analysis, except where this is not appropriate to the circumstances or the nature of the measure.
Croatian: Njome se utvrđuje, među ostalim, da se zakon o hrani mora temeljiti na analizi rizika, osim kada to nije primjereno okolnostima ili prirodi mjere.
English: The Commission does not see scope to simplify or reduce these steps as this could have a negative impact not only on the perception of the transparency of the system but also on ensuring that the evidence presented for EFSA's assessments is complete.
Croatian: Komisija smatra da nema prostora za pojednostavnjenje ili smanjivanje količine tih koraka jer bi to moglo negativno utjecati ne samo na poimanje transparentnosti sustava, nego i na osiguravanje potpunosti dokaza dostavljenih za procjene EFSA-e.
English: Information systems
Croatian: Informacijski sustavi
English: The proposal/initiative requires application of the flexibility instrument or revision of the multiannual financial framework.
Croatian: Za prijedlog/inicijativu potrebna je primjena instrumenta za financijsku fleksibilnost ili revizija višegodišnjeg financijskog okvira.
English: (17) Provisions exist on the content of applications for authorisations.
Croatian: (17) Postoje odredbe o sadržaju zahtjeva za izdavanje odobrenja.
English: GRAND TOTAL 34 60 85 85 85
Croatian: SVEUKUPNO 34 60 85 85 85
English: executive agencies
Croatian: izvršne agencije
English: The EFSA also regularly fine-tunes and strengthens its strict policies on independence, transparency and openness.
Croatian: EFSA redovito prilagođava i jača svoje stroge politike o neovisnosti, transparentnosti i otvorenosti.
English: Problems in relation to safety have a huge impact on consumers' confidence and consequently on market stability, trade flows and the climate for innovation.
Croatian: Problemi povezani sa sigurnošću znatno utječu na povjerenje potrošača, a time i na stabilnost tržišta, trgovinske tokove i inovacijsku klimu.
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.
Croatian: O razlozima zbog kojih nastaju razlike u procjenama i zaključcima znanstvenih tijela trebalo bi bolje obavješćivati javnost radi lakšeg razumijevanja.
English: The proposal also provides for a better organisation of the Panels' work.
Croatian: Prijedlogom je predviđena i bolja organizacija rada panela.
English: It is proportionate to harmonise these rules while preserving, where needed, the specific balance of interests in sectoral legislations.
Croatian: Svrhovito je da se ta pravila usklade a istodobno, ondje gdje je to potrebno, očuva posebna ravnoteža interesa u sektorskom zakonodavstvu.
English: N° of requests for access to documents addressed to EFSA and the Commission.
Croatian: Broj zahtjeva za pristup dokumentima upućenima EFSA-i i Komisiji
English: (d) The nominations by the Member States, the selection by the Executive Director and the appointments by the Management Board shall be made on the basis of the following criteria:
Croatian: (d) Nominacije od strane država članica, odabir od strane ravnatelja i imenovanja od strane Upravnog vijeća temelje se na sljedećim kriterijima:
English: (11) Experience shows that the role of the Management Board of the Authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the Authority.
Croatian: (11) Iskustvo je pokazalo da se Upravno vijeće Agencije pretežno bavi administrativnim i financijskim pitanjima i ne utječe na neovisnost znanstvenog rada Agencije.
English: Divergences between Union and national risk assessors, however, do not necessarily question the work of the different scientific bodies.
Croatian: No neslaganje EU-ovih i nacionalnih procjenitelja rizika ne dovodi nužno u pitanje rad različitih znanstvenih tijela.
English: X The proposal/initiative has no financial impact on revenue.
Croatian: X Prijedlog/inicijativa nema financijski utjecaj na prihode.
English: The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents.
Croatian: Popis koji sastavlja Komisija dostavlja se Europskom parlamentu, zajedno s relevantnim popratnim dokumentima.
English: Only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health, animal health or the environment, such information should be disclosed.
Croatian: Samo u vrlo ograničenim i iznimnim okolnostima kada se radi o predvidljivim učincima na zdravlje i hitnoj potrebi zaštite zdravlja ljudi, zdravlja životinja ili okoliša, te bi se informacije smjele objaviti.
English: Access shall be based at the minimum on a system requiring two factor authentication or providing an equivalent level of security.
Croatian: Za pristup mora biti obvezan barem autentifikacijski sustav s dva faktora ili sustav koji pruža ekvivalentnu razinu sigurnosti.
English: Human Resources
Croatian: Ljudski resursi
English: Their interplay can impact on the acceptability of the risk assessment by the general public.
Croatian: Njihovo međusobno djelovanje može utjecati na prihvatljivost procjene rizika u široj javnosti.
English: (12) The Management Board should be selected in such a way as to secure the highest standards of competence and a broad range of relevant experience available amongst the representatives of the Member States, the European Parliament and the Commission.
Croatian: (12) Upravno vijeće treba biti odabrano tako da osigura najviše standarde stručnosti i širok raspon relevantnih iskustava raspoloživih među predstavnicima država članica, Europskog parlamenta i Komisije.
English: (15) It is essential to ensure the efficient operation of the Authority and to improve the sustainability of its expertise.
Croatian: (15) Od ključne je važnosti osigurati efikasan rad Agencije i poboljšati održivost njezine stručnosti.
English: (40) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council and delivered an opinion on […],
Croatian: (40) Provedeno je savjetovanje s Europskim nadzornikom za zaštitu podataka u skladu s člankom 28. stavkom 2. Uredbe (EZ) br. 45/2001 Europskog parlamenta i Vijeća, i on je dao mišljenje o […],
English: Provisions in relation to the nomination, selection and appointment of experts include strict criteria on independence, thus providing appropriate safeguards.
Croatian: Odredbe povezane s predlaganjem, odabirom i imenovanjem stručnjaka uključuju stroge kriterije za neovisnost i tako pružaju primjerenu zaštitu.
English: Alternatives considered:
Croatian: Razmatrana alternativna rješenja: