qanastek/ELRC-Medical-V2 huggingface dataset:
English: These products were registered in 2004 and all aim at the treatment of HIV/AIDS.
Translation (en-hr): Ti su proizvodi registrirani 2004., a namijenjeni su liječenju HIV-a/AIDS-a.
English: REFIT EVALUATION OF THE REGULATION
Translation (en-hr): EVALUACIJA UREDBE U OKVIRU PROGRAMA REFIT
English: The Regulation notes the report shall also examine the scope of countries and diseases and general criteria for the implementation of Article 3.
Translation (en-hr): U Uredbi se navodi da se u izvješću ispituju i opseg zemalja i bolesti te opći kriteriji za provedbu članka 3.
English: The Regulation was evaluated in 2016 as part of the Commission's regulatory fitness and performance programme (REFIT) including on the scope of countries and diseases and general criteria for the implementation of Article 3.
Translation (en-hr): Uredba je 2016. ocijenjena u okviru Komisijina programa za primjerenost i učinkovitost propisa (REFIT), uključujući u pogledu opsega zemalja i bolesti te opće kriterije za provedbu članka 3.
English: PRODUCTS EXPORTED UNDER TIERED PRICES
Translation (en-hr): PROIZVODI IZVEZENI PO DIFERENCIRANIM CIJENAMA
English: The products listed below were exported under tiered prices:
Translation (en-hr): Sljedeći proizvodi izvezeni su po diferenciranim cijenama:
English: NOTIFICATIONS UNDER ARTICLE 10
Translation (en-hr): OBAVIJEST IZ ČLANKA 10.
English: Both companies transferred their HIV assets to the new company. ]
Translation (en-hr): Oba su poduzeća prenijela svoju imovinu povezanu s istraživanjem i razvojem u području HIV-a na novoosnovano poduzeće.
English: EPIVIR Oral Solution 10mg/ml 240 ml
Translation (en-hr): EPIVIR oralna otopina 10 mg/ml 240 ml
English: An external contractor, Charles River Associates was commissioned to gather data to support the Commission evaluation of the Regulation,
Translation (en-hr): Uredbe sklopljen je ugovor s vanjskim suradnikom Charles River Associates,.
English: Only medicines for the treatment of HIV/AIDS have been registered by the manufacturer.
Translation (en-hr): Proizvođač je registrirao samo lijekove za liječenje HIV-a/AIDS-a.
English: The manufacturer noted that because the volumes supplied of some products to some countries are very low, the cost of goods increases and the distribution costs for the order(s) then become higher per pack.
Translation (en-hr): Proizvođač je istaknuo da su u određenim zemljama bile raspoložive samo male količine pojedinih lijekova te da se zbog toga povećala njihova cijena i troškovi distribucije po pakiranju.
English: RETROVIR Oral Solution 10 mg/ml - 200 ml
Translation (en-hr): RETROVIR oralna otopina 10 mg/ml 200 ml.
English: The low volumes of products being sold are a consequence of the market becoming supplied with generic products as a result of both the manufacturer's policy of voluntary licensing agreements and expiry of patents.
Translation (en-hr): Politika proizvođača u pogledu dobrovoljnih ugovora o licenciranju i istek patenata doveli su do ponude generičkih proizvoda na tržištu te je zbog toga prodana mala količina proizvoda.
English: The external study concluded that there was little scope of improving the effectiveness of the Regulation by modifying the lists of "communicable" diseases.
Translation (en-hr): Uredbe izmjenom popisâ „prenosivih" bolesti ograničene.
English: *includes distribution costs
Translation (en-hr): *uključeni troškovi distribucije
English: ANNEX
Translation (en-hr): PRILOG
English: Product Country destinations Volume Avg. selling price ($)*
Translation (en-hr): Proizvod Zemlje odredišta Količine Prosječna prodajna cijena (USD)*
English: ViiV Healthcare/GSK packs sold in 2015 under Regulation (EU) 2016/793 (in-country sales data)
Translation (en-hr): ViiV Healthcare / GSK - pakiranja prodana 2015. u skladu s Uredbom (EU) 2016/793 (podaci o prodaji u zemlji)
English: ViiV Healthcare/GSK packs sold in 2014 under Regulation (EU) 2016/793 (in-country sales data)
Translation (en-hr): ViiV Healthcare / GSK - pakiranja prodana 2014. u skladu s Uredbom (EU) 2016/793 (podaci o prodaji u zemlji)
English: Trizivir 750mg no sales no sales no sales
Translation (en-hr): Trizivir 750 mg nije se prodavalo nije se prodavalo nije se prodavalo
English: Retrovir 300mg x 60 no sales no sales no sales
Translation (en-hr): Retrovir 300 mg x 60 nije se prodavalo nije se prodavalo nije se prodavalo
English: Retrovir 250mg x 60 no sales no sales no sales
Translation (en-hr): Retrovir 250 mg x 60 nije se prodavalo nije se prodavalo nije se prodavalo
English: Retrovir 100mg x 100 Indonesia, Kenya 463 19.92
Translation (en-hr): Retrovir 100 mg x 100 Indonezija i Kenija 463 19,92
English: Ziagen 300mg x 60 Kenya 1,159 16.12
Translation (en-hr): Ziagen 300 mg x 60 Kenija 1159 16,12
English: Epivir Oral Solution 10mg/ml 240 ml Honduras, Kenya, Moldova 541 21.69
Translation (en-hr): Epivir oralna otopina 10 mg/ml 240 ml Honduras, Kenija i Moldova 541 21,69
English: Retrovir 100mg x 100 Indonesia, Kenya, Moldova 521 18.76
Translation (en-hr): Retrovir 100 mg x 100 Indonezija, Kenija i Moldova 521 18,76
English: Ziagen 300mg x 60 China, Kenya 49,701 17.85
Translation (en-hr): Ziagen 300 mg x 60 Kina i Kenija 49 701 17,85
English: Retrovir Oral Solution 10mg/ml 200ml Kenya 207 13.64
Translation (en-hr): Retrovir oralna otopina 10 mg/ml 200 ml Kenija 207 13,64
English: Epivir Oral Solution 10mg/ml 240 ml China, Honduras, Kenya 16,230 17.28
Translation (en-hr): Epivir oralna otopina 10 mg/ml 240 ml Kina, Honduras i Kenija 16 230 17,28
English: Epivir 150mg x 60 Azerbaijan, Indonesia, Kenya, Tanzania 14,299 10.60
Translation (en-hr): Epivir 150 mg x 60 Azerbajdžan, Indonezija, Kenija i Tanzanija 14 299 10,60
English: Combivir 300/150mg x 60 China, Kenya, Nigeria, Tanzania, Uganda 8,839 25.84
Translation (en-hr): Combivir 300/150 mg x 60 Kina, Kenija, Nigerija, Tanzanija i Uganda 8839 25,84
English: Epivir 150mg x 60 China, Indonesia, Kenya, Moldova, Tanzania 9,778 13.56
Translation (en-hr): Epivir 150 mg x 60 Kina, Indonezija, Kenija, Moldova i Tanzanija 9778 13,56
English: Retrovir Oral Solution 10mg/ml 200ml China, Kenya, Moldova 17,609 14.75
Translation (en-hr): Retrovir oralna otopina 10 mg/ml 200 ml Kina, Kenija i Moldova 17 609 14,75
English: Combivir 300/150mg x 60 China, Kenya, Nigeria, Tanzania, Uganda 10,716 26.11
Translation (en-hr): Combivir 300/150 mg x 60 Kina, Kenija, Nigerija, Tanzanija i Uganda 10 716 26,11
English: The same applies to the return journey.
Translation (en-hr): Isto vrijedi i za povratak.
English: Regular return of the driver
Translation (en-hr): Redovito vraćanje vozača
English: Introduction of new tachograph technology
Translation (en-hr): Uvođenje nove tehnologije tahografa
English: The three legislative proposals in question are:
Translation (en-hr): Riječ je o sljedećim zakonodavnim prijedlozima:
English: The Council position is therefore acceptable in this respect.
Translation (en-hr): Stoga je stajalište Vijeća u tom pogledu prihvatljivo.
English: Organisation of the weekly rest periods
Translation (en-hr): Organizacija tjednih razdoblja odmora
English: The social improvements in this proposal are significant.
Translation (en-hr): Predložena socijalna poboljšanja su važna.
English: These measures were not part of the Commission's proposals adopted on 31 May 2017 and have not been the subject of an impact assessment.
Translation (en-hr): Te mjere nisu bile dio Komisijinih prijedloga donesenih 31. svibnja 2017. te za njih nije provedena procjena učinka.
English: Establishment criteria relating to drivers (Rome I)
Translation (en-hr): Kriteriji za poslovni nastan u odnosu na vozače (Rim I)
English: After impact assessment, the Commission, if necessary, will exercise its right to come forward with a targeted legislative proposal before the two provisions enter into force."
Translation (en-hr): Nakon procjene učinka Komisija će, ako to bude potrebno, iskoristiti svoje pravo na podnošenje ciljanog zakonodavnog prijedloga prije nego što te dvije odredbe stupe na snagu."
English: The Commission did not propose specific dates for the application of the new rules.
Translation (en-hr): Komisija nije predložila konkretne datume primjene novih pravila.
English: The Commission did not propose to modify the tachograph regulation.
Translation (en-hr): Komisija nije predložila izmjenu Uredbe o tahografima.
English: Rules on cabotage
Translation (en-hr): Pravila o kabotaži
English: The Council does not follow the approach proposed by the Commission, which was mainly intended to facilitate enforcement.
Translation (en-hr): Vijeće ne slijedi pristup koji je predložila Komisija, a čiji je glavni cilj bio olakšavanje provedbe.
English: Date of transmission of the proposal to the European Parliament and to the Council:
Translation (en-hr): Datum prosljeđivanja prijedloga Europskom parlamentu i Vijeću:
English: (documents COM(2017)281 final - 2017/0123 (COD), COM(2017)278 final - 2017/0121 (COD) and COM(2017)277 final - 2017/0122 (COD) 01/06/2017
Translation (en-hr): (dokumenti COM(2017) 281 final - 2017/0123 (COD), COM(2017) 278 final - 2017/0121 (COD) i COM(2017) 277 final - 2017/0122 (COD)) 1. lipnja 2017.
English: On 31 May 2017, as part of the Mobility Package ("Europe on the Move"), the Commission adopted a comprehensive package of three legislative proposals covering social and internal market aspects of road transport in the EU.
Translation (en-hr): Komisija je 31. svibnja 2017. u sklopu paketa za mobilnost („Europa u pokretu") donijela sveobuhvatan paket od tri zakonodavna prijedloga koji obuhvaćaju socijalne aspekte i aspekte unutarnjeg tržišta za cestovni promet u EU-u.
English: The new provisions will also constitute a solid basis for future enforcement of the road transport rules.
Translation (en-hr): Nove će odredbe ujedno biti i solidan temelj za buduće provođenje pravila u cestovnom prometu.
English: The Commission regrets that the political agreement reached by the Council and European Parliament includes elements that are not in line with the ambitions of the European Green Deal and the EUCO endorsement of the objective of achieving a climate-neutral EU by 2050.
Translation (en-hr): Komisija izražava žaljenje jer politički dogovor Vijeća i Europskog parlamenta sadržava elemente koji nisu u skladu s ambicijama europskog zelenog plana i ciljem postizanja klimatski neutralnog EU-a do 2050. koji je potvrdilo Europsko vijeće.
English: In a spirit of compromise, the Commission accepts the position adopted by the Council, thus allowing the European Parliament to adopt the final text in a second reading.
Translation (en-hr): U duhu kompromisa Komisija prihvaća stajalište koje je donijelo Vijeće, čime se Europskom parlamentu omogućuje da u drugom čitanju donese konačni tekst.
English: As regards passenger transport, the Commission intends to further study the organisation of driving and rest periods to assess whether specific rules are necessary.
Translation (en-hr): Kad je riječ o putničkom prometu, Komisija namjerava dodatno proučiti organizaciju razdoblja vožnje i odmora kako bi procijenila jesu li potrebna posebna pravila.
English: Implementation deadlines / dates of application
Translation (en-hr): Rokovi za provedbu / datumi primjene
English: "The Commission takes note of the provisional agreement on the social and market aspects of Mobility Package I reached by the Council and European Parliament during the 4th trilogue which took place on 11-12 December 2019.
Translation (en-hr): „Komisija prima na znanje privremeni dogovor o socijalnim i tržišnim aspektima prvog paketa za mobilnost koji su Vijeće i Europski parlament postigli tijekom 4. trijaloga održanog 11. i 12. prosinca 2019.
English: It leaves enough margin so as to not unduly restrict the freedom of operators when hiring personnel.
Translation (en-hr): Time se ostavlja dovoljno prostora da se sloboda prijevoznika pri zapošljavanju osoblja nepotrebno ne ograničava.
English: Indeed, the Commission considers that adopting the social and market proposals would bring substantial benefits to the road transport sector.
Translation (en-hr): Naime, Komisija smatra da će donošenje prijedloga u vezi socijalnih i tržišnih pitanja donijeti znatne koristi sektoru cestovnog prometa.
English: This was intended to improve the working conditions of drivers and ensure that they have good conditions to rest.
Translation (en-hr): Time se nastojalo poboljšati radne uvjete vozača i osigurati da imaju dobre uvjete za odmor.
English: However, the Commission maintains its reservations concerning two of the measures included in the Council position.
Translation (en-hr): Ipak, Komisija zadržava svoje rezerve u pogledu dviju mjera navedenih u stajalištu Vijeća.
English: For this reason, the Commission issued the following declaration regarding the political agreement reached by the European Parliament and Council on 12 December 2019:
Translation (en-hr): Komisija je stoga dala sljedeću izjavu u pogledu političkog dogovora koji su 12. prosinca 2019. postigli Europski parlament i Vijeće:
English: The Council position does not go as far as the Commission proposal.
Translation (en-hr): Stajalište Vijeća nije dalekosežno kao prijedlog Komisije.
English: The Commission will do so in view of the Green Deal and measures to decarbonise transport and protect the environment, whilst ensuring a well-functioning Single Market.
Translation (en-hr): Komisija će to učiniti uzimajući u obzir zeleni plan i mjere za dekarbonizaciju prometa i zaštitu okoliša, osiguravajući pritom dobro funkcioniranje jedinstvenog tržišta.
English: The use of IMI will further reduce the administrative burden, both for administrations and undertakings, and will therefore contribute to the overall objective of the Mobility Package.
Translation (en-hr): Uporabom IMI-ja dodatno će se smanjiti administrativno opterećenje za javne uprave i poduzeća te tako pridonijeti sveukupnom cilju paketa za mobilnost.
English: The Commission will now closely assess the climate, environmental, and single market functioning impact of these two aspects.
Translation (en-hr): Komisija će sada pobliže procijeniti učinak obaju aspekata na klimu, okoliš i funkcioniranje jedinstvenog tržišta.
English: This was intended to prevent a situation where drivers are working abroad for long periods, without the possibility to return home to their families.
Translation (en-hr): Time se namjeravalo spriječiti da vozači dugo rade u inozemstvu, bez mogućnosti da se vrate kući svojim obiteljima.
English: The Council position is a meaningful step forward compared to the current EU social and internal market rules for road transport for several reasons:
Translation (en-hr): Stajalište Vijeća važan je korak naprijed u odnosu na trenutačna EU-ova pravila o socijalnim pitanjima i unutarnjem tržištu za cestovni promet zbog nekoliko razloga:
English: A recital clarifies that "drivers are free to choose where to spend their rest period".
Translation (en-hr): U uvodnoj izjavi pojašnjava se da „vozači mogu slobodno odlučiti o tome gdje provode svoje razdoblje odmora".
English: The Council position is fully in line with a core objective of the Mobility Package, which is to allow for effective and efficient enforcement of the new social and internal market rules.
Translation (en-hr): Stajalište Vijeća u potpunosti je u skladu s temeljnim ciljem paketa za mobilnost, a to je omogućivanje djelotvorne i učinkovite provedbe novih pravila o socijalnim pitanjima i unutarnjem tržištu.
English: Since the two measures in question are part of the Council position, the Commission confirms the position taken in the declaration.
Translation (en-hr): Budući da su predmetne dvije mjere dio stajališta Vijeća, Komisija potvrđuje stajalište izneseno u navedenoj izjavi.
English: The Commission also proposed specific administrative requirements for the application of the posting rules in road transport, to avoid undue administrative burden on operators.
Translation (en-hr): Komisija je predložila i posebne administrativne zahtjeve za primjenu pravila o upućivanju u cestovnom prometu kako bi se izbjeglo nepotrebno administrativno opterećenje za prijevoznike.
English: The Council position specifies a time schedule for the uptake of this new technology in new vehicles (two years from the date of adoption of the technical specifications) and in the existing fleet (retrofit three years from the date of adoption of the technical specifications for all vehicles equipped with a tachograph other than the smart tachograph version 1; retrofit four years from the date of adoption of the technical specifications for all vehicles equipped with a smart tachograph version 1).
Translation (en-hr): U stajalištu Vijeća navodi se vremenski plan za uvođenje te nove tehnologije u nova vozila (dvije godine od datuma donošenja tehničkih specifikacija) i u postojeći vozni park (naknadna ugradnja tri godine od datuma donošenja tehničkih specifikacija za sva vozila opremljena tahografom koji nije prva verzija pametnog tahografa; naknadna ugradnja četiri godine od datuma donošenja tehničkih specifikacija za sva vozila opremljena prvom verzijom pametnog tahografa).
English: The Commission did not propose any new requirement on the hiring of workers in relation to the criterion of stable and effective establishment for access to the occupation of road transport operator.
Translation (en-hr): Komisija nije predložila nijedan novi zahtjev u vezi sa zapošljavanjem radnika kad je riječ o kriteriju stabilnog i stvarnog poslovnog nastana za pristup djelatnosti cestovnog prijevoznika.
English: Whereas the revised Regulations (EC) No 561/2006 and 165/2014 will be applicable immediately upon entry into force, they include transitional provisions for the application of the provisions related to the implementation of the smart tachograph (see above) and the application of the rules to light commercial vehicles (from 1 July 2026).
Translation (en-hr): Budući da će se revidirane uredbe (EZ) br. 561/2006 i 165/2014 primjenjivati odmah nakon stupanja na snagu, uključuju prijelazne odredbe za primjenu odredaba povezanih s uvođenjem pametnih tahografa (vidjeti prethodno navedeno) i primjenu pravila na laka gospodarska vozila (od 1. srpnja 2026.).
English: Application of rules on access to the profession and driving and rest times to light commercial vehicles
Translation (en-hr): Primjena pravila o pristupu djelatnosti i o razdobljima vožnje i odmora na laka gospodarska vozila
English: Keeping the current model for cabotage is more challenging in terms of enforcement, but the Commission believes that with the new generation of ‘smart' tachographs, which is part of the Council position, it will be easier to identify the type of operation carried out by hauliers and the respective number.
Translation (en-hr): Zadržavanje postojećeg modela kabotaže provedbeno je zahtjevnije, no Komisija vjeruje da će se zahvaljujući novoj generaciji „pametnih" tahografa, koja je dio stajališta Vijeća, moći lakše utvrditi koju vrstu i koliko prijevoza obavljaju prijevoznici.
English: Finally, the Council position clarifies the application of the concept of long-term posting which was introduced in the revised posting directive (Directive (EU) 2018/957), to international road transport operations, to the effect that periods accomplished in one Member State are not cumulated with those accomplished in any other Member State.
Translation (en-hr): Naposljetku, u stajalištu Vijeća pojašnjava se primjena koncepta dugoročnog upućivanja radnika, koji je uveden u revidiranoj Direktivi o upućivanju (Direktiva (EU) 2018/957), u međunarodnom cestovnom prijevozu tako da se razdoblja provedena u jednoj državi članici ne zbrajaju s onima provedenima ni u kojoj drugoj državi članici.
English: The obligation of return of the truck will lead to inefficiencies in the transport system and an increase in unnecessary emissions, pollution and congestion, while the restrictions on combined transport diminish its effectiveness to support multimodal freight operations.
Translation (en-hr): Zbog obveze vraćanja kamiona prometni sustav postat će neučinkovitiji, povećat će se nepotrebne emisije, onečišćenje i zagušenje, a ograničenjima za kombinirani prijevoz smanjit će se njegova učinkovitost u podupiranju multimodalnog prijevoza tereta.
English: (1) A proposal to amend Regulation 1071/2009 on access to the occupation of road transport operator and Regulation 1072/2009 on access to the international road transport market;
Translation (en-hr): (1) prijedlog izmjene Uredbe 1071/2009 o pristupu obavljanju djelatnosti cestovnog prijevoznika i Uredbe 1072/2009 o pristupu međunarodnom tržištu cestovnog prijevoza;
English: The Commission considers that, despite some shortcomings of the Council position, the introduction of new and clearer provisions described above will provide better working and social conditions, fair competition and more legal certainty in the road transport sector.
Translation (en-hr): Unatoč određenim nedostacima stajališta Vijeća, Komisija smatra da će uvođenje novih i jasnijih prethodno opisanih odredaba omogućiti bolje radne i socijalne uvjete, pošteno tržišno natjecanje i veću pravnu sigurnost u sektoru cestovnog prometa.
English: However, Regulation (EC) No 1071/2009 in its entirety and the requirement to hold a Community licence under Regulation (EC) No 1072/2009 will only apply to operators using light commercial vehicles above 2.5 tons engaged in international transport 21 months following the date of entry into force of the amending regulation.
Translation (en-hr): Međutim, Uredba (EZ) br. 1071/2009 u cjelini i zahtjev za obveznim posjedovanjem licencije Zajednice na temelju Uredbe (EZ) br. 1072/2009 primjenjivat će se samo na prijevoznike koji upotrebljavaju laka gospodarska vozila teža od 2,5 tona u međunarodnom prijevozu 21 mjesec nakon datuma stupanja na snagu uredbe o izmjeni.
English: The revised enforcement directive (Directive 2006/22/EC) and the lex specialis on the posting of workers will have a date of transposition of the national measures by the Member States of 18 months from the entry into force of the act.
Translation (en-hr): Revidiranu direktivu o provedbi (Direktiva 2006/22/EZ) i lex specialis o upućivanju radnika u nacionalna će zakonodavstva trebati prenijeti 18 mjeseci od stupanja akta na snagu.
English: The Council goes further than the Commission proposal, by mandating the Commission to come up with detailed provisions concerning safe and secure parking areas, i.e. the level of service and the procedure for the certification of these parking areas.
Translation (en-hr): Prijedlog Vijeća dalekosežniji je od prijedloga Komisije jer se od nje traži da sastavi detaljne odredbe o sigurnim i zaštićenim parkiralištima, odnosno o razini usluge i postupku certifikacije tih parkirališta.
English: However, the Council considered necessary to introduce a new generation of ‘smart' tachographs to make it possible to more precisely position vehicles used for cross-border transport operations, thereby easing enforcement of the social and internal market rules.
Translation (en-hr): Međutim, Vijeće je smatralo potrebnim uvesti novu generaciju „pametnih" tahografa kako bi se omogućilo preciznije pozicioniranje vozila u prekograničnom prijevozu i tako olakšala provedba pravila o socijalnim pitanjima i unutarnjem tržištu.
English: The Council position upholds the Commission proposal and provides that exchanges of information between national authorities and the submission of posting declarations by road transport undertakings will be done through the Internal Market Information System (IMI).
Translation (en-hr): U stajalištu Vijeća podupire se prijedlog Komisije i omogućuje da nacionalna tijela podatke razmjenjuju, a poduzeća za cestovni prijevoz izjave o upućivanju dostavljaju putem Informacijskog sustava unutarnjeg tržišta (IMI).
English: The Commission proposed to revise the rules on cabotage, by allowing an unlimited number of operations within a period of 5 days from the unloading of the international incoming carriage in the host Member State.
Translation (en-hr): Komisija je predložila da se pravila o kabotaži revidiraju omogućivanjem neograničenog broja prijevoza u razdoblju od pet dana od istovara međunarodnog dolaznog prijevoza u državi članici domaćinu.