natgillin/translations-raw huggingface dataset:
The analysis of stakeholders' and experts' input by the external contractor found no evidence that there was scope for improving the effectiveness of the Regulation by modifying the list of countries of destination.
V skladu z analizo prispevkov zainteresiranih strani in strokovnjakov zunanji izvajalec ni našel dokazov, da obstajajo možnosti za izboljšanje učinkovitosti Uredbe s spremembo seznama namembnih držav.
The advantage of such a policy is that it encourages manufacturers to distribute the medicines in question in the target countries at the lowest possible ("tiered") price, while at the same time recouping their research and development expenditure with the higher prices charged in developed countries.
Prednost takšne politike je, da spodbuja proizvajalce k distribuciji zadevnih zdravil v ciljne države po najnižjih možnih („vzporedno oblikovanih") cenah, medtem ko njihove izdatke za raziskave in razvoj nadomestijo z zaračunavanjem višjih cen v razvitih državah.
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.
Majhne količine prodanih proizvodov so posledica dobave generičnih proizvodov na trgu, kar je posledica proizvajalčeve politike prostovoljnih licenčnih sporazumov in izteka veljavnosti patentov.
The evaluation concluded that the objective of improving access to medicines in the poorest developing countries remains relevant, that tiered pricing still has value, and that in view of the small administrative burden, the benefits that have been realised, the added value of a signal of support for tiered pricing, and its place in the overall context of action targeting major diseases, the Regulation still has a role in the future in the context of the Commission's aim, as stated in the Trade for all Communication, to promote an ambitious global health agenda and better access to medicines in poor countries.
Na podlagi vrednotenja je bilo ugotovljeno, da je cilj izboljšati dostop do zdravil v najrevnejših državah v razvoju še vedno ustrezen, da je vzporedno oblikovanje cen še vedno koristno in da ima glede na majhno upravno breme, uresničene koristi, dodano vrednost signala za podporo vzporednemu oblikovanju cen in njeno mesto v skupnem okviru za ukrepanje proti hudim boleznim Uredba še vedno pomembno vlogo v prihodnosti v okviru cilja Komisije, kot je navedeno v sporočilu „Trgovina za vse", spodbujati ambiciozno agendo na področju zdravja v svetu in boljši dostop do zdravil v revnih državah.
Supplying poor and developing countries with medicines at sustainable low prices is one of the objectives in the fight against the major diseases of HIV/AIDS, malaria and tuberculosis.
Oskrba revnih držav in držav v razvoju z zdravili po trajno nizkih cenah je eden ključnih ciljev boja proti hudim boleznim, in sicer HIV/aids, malarija in tuberkuloza.
The external study concluded that there was little scope of improving the effectiveness of the Regulation by modifying the lists of "communicable" diseases.
Zunanja študija je pokazala, da obstaja malo možnosti za izboljšanje učinkovitosti Uredbe s spreminjanjem seznama nalezljivih bolezni.
The Regulation was evaluated on four criteria: effectiveness, efficiency, coherence and relevance and assessed against the REFIT criteria of being fit for purpose, having delivered on its objectives at minimum cost and whether there is potential for simplification.
Uredba je bila ocenjena na osnovi štirih meril: uspešnost, učinkovitost, skladnost in ustreznost ter po merilih programa REFIT, da ustreza svojemu namenu, je dosegla svoje cilje s čim nižjimi stroški in ali obstaja možnost za poenostavitev.
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.
Uredba je bila ocenjena leta 2016 kot del programa ustreznosti in uspešnosti predpisov Komisije (REFIT), vključno z obsegom držav in bolezni ter splošnimi merili za izvajanje člena 3.
NOTIFICATIONS UNDER ARTICLE 10
URADNO OBVESTILO V SKLADU S ČLENOM 10
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.
Proizvajalec je navedel, da ker so dobavljene količine nekaterih proizvodov v nekatere države zelo nizke, se povečajo stroški blaga in distribucijski stroški na paket za naročilo se nato zvišajo.
The products listed below were exported under tiered prices:
Spodaj navedeni proizvodi so bile izvoženi v skladu z vzporedno oblikovanimi cenami:
REFIT EVALUATION OF THE REGULATION
VREDNOTENJE UREDBE V OKVIRU PROGRAMA REFIT
Regulation (EU) 2016/793 to avoid trade diversion into the European Union of certain key medicines ("the Regulation"), adopted in May 2016, puts in place safeguards to prevent diversion of medicines from poor developing countries into the European Union.
Uredba (EU) št. 2016/793 Evropskega parlamenta in Sveta za preprečevanje preusmerjanja trgovine nekaterih ključnih zdravil v Evropsko unijo (v nadaljnjem besedilu: Uredba), ki je bila sprejeta maja 2016, vzpostavlja zaščitne ukrepe za preprečevanje preusmerjanja zdravil iz revnih držav v razvoju v Evropsko unijo.
PRODUCTS EXPORTED UNDER TIERED PRICES
PROIZVODI, IZVOŽENI V SKLADU Z VZPOREDNO OBLIKOVANIMI CENAMI
Only medicines for the treatment of HIV/AIDS have been registered by the manufacturer.
Proizvajalec je registriral samo zdravila za zdravljenje okužbe z virusom HIV ali aidsa.
RETROVIR Oral Solution 10 mg/ml - 200 ml
RETROVIR peroralna raztopina 10 mg/ml - 200 ml
EPIVIR Oral Solution 10mg/ml 240 ml
EPIVIR peroralna raztopina 10 mg/ml - 240 ml
*includes distribution costs
*zajema stroške distribucije
ANNEX
PRILOGA
Product Country destinations Volume Avg. selling price ($)*
Proizvod Namembna država Količina Povprečna prodajna cena (v USD)*
ViiV Healthcare/GSK packs sold in 2015 under Regulation (EU) 2016/793 (in-country sales data)
Paketi podjetja ViiV Healthcare/GSK, ki so bili prodani v letu 2015 na podlagi Uredbe (EU) 2016/793 (podatki o prodaji znotraj države)
ViiV Healthcare/GSK packs sold in 2014 under Regulation (EU) 2016/793 (in-country sales data)
Paketi podjetja ViiV Healthcare/GSK, ki so bili prodani v letu 2014 na podlagi Uredbe (EU) 2016/793 (podatki o prodaji znotraj države)
Trizivir 750mg no sales no sales no sales
Trizivir 750 mg ni prodaje ni prodaje ni prodaje
Ziagen 300mg x 60 Kenya 1,159 16.12
Ziagen 300 mg x 60 Kenija 1 159 16,12
Retrovir 300mg x 60 no sales no sales no sales
Retrovir 300 mg x 60 ni prodaje ni prodaje ni prodaje
Retrovir 250mg x 60 no sales no sales no sales
Retrovir 250 mg x 60 ni prodaje ni prodaje ni prodaje
Retrovir 100mg x 100 Indonesia, Kenya 463 19.92
Retrovir 100 mg x 100 Indonezija, Kenija 463 19,92
Epivir Oral Solution 10mg/ml 240 ml Honduras, Kenya, Moldova 541 21.69
Epivir Oral Solution 10 mg/ml - 240 ml Honduras, Kenija, Moldavija 541 21,69
Retrovir Oral Solution 10mg/ml 200ml Kenya 207 13.64
Retrovir Oral Solution 10 mg/ml - 200 ml Kenija 207 13,64
Ziagen 300mg x 60 China, Kenya 49,701 17.85
Ziagen 300 mg x 60 Kitajska, Kenija 49 701 17,85
Retrovir 100mg x 100 Indonesia, Kenya, Moldova 521 18.76
Retrovir 100 mg x 100 Indonezija, Kenija, Moldavija 521 18,76
Epivir Oral Solution 10mg/ml 240 ml China, Honduras, Kenya 16,230 17.28
Epivir Oral Solution 10 mg/ml - 240 ml Kitajska, Honduras, Kenija 16 230 17,28
Retrovir Oral Solution 10mg/ml 200ml China, Kenya, Moldova 17,609 14.75
Retrovir Oral Solution 10 mg/ml - 200 ml Kitajska, Kenija, Moldavija 17 609 14,75
Epivir 150mg x 60 Azerbaijan, Indonesia, Kenya, Tanzania 14,299 10.60
Epivir 150 mg x 60 Azerbajdžan, Indonezija, Kenija, Tanzanija 14 299 10,60
Combivir 300/150mg x 60 China, Kenya, Nigeria, Tanzania, Uganda 8,839 25.84
Combivir 300/150 mg x 60 Kitajska, Kenija, Nigerija, Tanzanija, Uganda 8 839 25,84
Epivir 150mg x 60 China, Indonesia, Kenya, Moldova, Tanzania 9,778 13.56
Epivir 150 mg x 60 Kitajska, Indonezija, Kenija, Moldavija, Tanzanija 9 778 13,56
Combivir 300/150mg x 60 China, Kenya, Nigeria, Tanzania, Uganda 10,716 26.11
Combivir 300/150 mg x 60 Kitajska, Kenija, Nigerija, Tanzanija, Uganda 10 716 26,11
The three legislative proposals in question are:
Ti trije zakonodajni predlogi so:
Regular return of the driver
Redno vračanje voznika
The Council position is therefore acceptable in this respect.
Stališče Sveta je zato v zvezi s tem sprejemljivo.
The same applies to the return journey.
Enako velja za povratno vožnjo.
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."
Komisija bo po oceni učinka po potrebi uveljavila pravico do predložitve ciljno usmerjenega zakonodajnega predloga pred začetkom veljavnosti obeh določb."
Introduction of new tachograph technology
Uvedba nove tahografske tehnologije
The new provisions will also constitute a solid basis for future enforcement of the road transport rules.
Nove določbe bodo tudi trdna podlaga za prihodnje izvrševanje cestnoprometnih pravil.
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.
Ta ukrepa nista bila vključena v predloge Komisije, sprejete 31. maja 2017, in v zvezi z njima ni bila opravljena ocena učinka.
Organisation of the weekly rest periods
Organizacija tedenskega časa počitka
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.
Komisija v duhu kompromisa sprejema stališče Sveta in tako Evropskemu parlamentu omogoča, da končno besedilo sprejme v drugi obravnavi.
The social improvements in this proposal are significant.
Ta predlog vključuje pomembne socialne izboljšave.
The Commission did not propose to modify the tachograph regulation.
Komisija ni predlagala spremembe uredbe o tahografih.
The Council does not follow the approach proposed by the Commission, which was mainly intended to facilitate enforcement.
Svet ne upošteva pristopa, ki ga je predlagala Komisija in ki je bil namenjen predvsem lažjemu izvrševanju.
For this reason, the Commission issued the following declaration regarding the political agreement reached by the European Parliament and Council on 12 December 2019:
Zato je Komisija podala naslednjo izjavo o političnem dogovoru, ki sta ga Evropski parlament in Svet dosegla 12. decembra 2019:
The Commission did not propose specific dates for the application of the new rules.
Komisija ni predlagala posebnih datumov za začetek uporabe novih pravil.
Indeed, the Commission considers that adopting the social and market proposals would bring substantial benefits to the road transport sector.
Komisija meni, da bi sprejetje socialnih in tržnih predlogov prineslo znatne koristi za sektor cestnega prometa.
The Commission will now closely assess the climate, environmental, and single market functioning impact of these two aspects.
Komisija bo zdaj natančno ocenila učinek teh dveh vidikov na podnebje, okolje in delovanje enotnega trga.
The Council position does not go as far as the Commission proposal.
Stališče Sveta ne gre tako daleč kot predlog Komisije.
This should improve enforceability of the cabotage rules when compared to the present situation.
S tem bi se morala v primerjavi s sedanjim stanjem izboljšati izvršljivost pravil o kabotaži.
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.
Komisija obžaluje, da politični dogovor, ki sta ga dosegla Svet in Evropski parlament, vključuje elementa, ki nista v skladu s cilji evropskega zelenega dogovora in podporo Evropskega sveta cilju, da se do leta 2050 doseže podnebno nevtralna EU.
As regards passenger transport, the Commission intends to further study the organisation of driving and rest periods to assess whether specific rules are necessary.
Kar zadeva prevoz potnikov, namerava Komisija nadalje preučiti organizacijo časa vožnje in počitka, da bi ocenila, ali so potrebna posebna pravila.
Establishment criteria relating to drivers (Rome I)
Merila sedeža za voznike (Rim I)
Date of transmission of the proposal to the European Parliament and to the Council:
Datum predložitve predlogov Evropskemu parlamentu in Svetu:
Since the two measures in question are part of the Council position, the Commission confirms the position taken in the declaration.
Ker sta zadevna ukrepa del stališča Sveta, Komisija potrjuje stališče iz izjave.
It leaves enough margin so as to not unduly restrict the freedom of operators when hiring personnel.
Zagotavlja dovolj manevrskega prostora, da ne bi neupravičeno omejevali svobode prevoznikov pri zaposlovanju osebja.
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.
Komisija je 31. maja 2017 v okviru svežnja o mobilnosti („Evropa v gibanju") sprejela celovit sveženj treh zakonodajnih predlogov, ki zajemajo socialne vidike in vidike notranjega trga v cestnem prometu v EU.
(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
(dokumenti COM(2017) 281 final - 2017/0123 (COD), COM(2017) 278 final - 2017/0121 (COD) in COM(2017) 277 final - 2017/0122 (COD) 1. junij 2017
"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.
„Komisija je seznanjena z začasnim dogovorom o socialnih in tržnih vidikih svežnja o mobilnosti I, ki sta ga Svet in Evropski parlament dosegla na četrtem trialogu 11. in 12. decembra 2019.
Implementation deadlines / dates of application
Roki za izvedbo/datumi začetka uporabe
However, the Commission maintains its reservations concerning two of the measures included in the Council position.
Vendar Komisija ohranja pridržke glede dveh ukrepov iz stališča Sveta.
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.
Z uporabo sistema IMI se bo dodatno zmanjšalo upravno breme za uprave in prevozna podjetja, kar bo prispevalo k splošnemu cilju svežnja o mobilnosti.
This was intended to improve the working conditions of drivers and ensure that they have good conditions to rest.
Namen tega je bil izboljšati delovne pogoje voznikov in zagotoviti, da imajo dobre pogoje za počitek.
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.
Stališče Sveta je v celoti skladno z glavnim ciljem svežnja o mobilnosti, tj. omogočiti uspešno in učinkovito izvrševanje novih socialnih pravil in pravil notranjega trga.
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).
Svet v svojem stališču podpira predlog Komisije in določa, da bodo izmenjave informacij med nacionalnimi organi in predložitev izjav o napotitvi s strani podjetij za cestni prevoz izvedene prek informacijskega sistema za notranji trg (IMI).
A recital clarifies that "drivers are free to choose where to spend their rest period".
V uvodni izjavi je pojasnjeno, da „vozniki lahko prosto izbirajo, kje želijo preživeti čas počitka".
Ban to take the regular weekly rest in the cabin of the vehicle and safe and secure parking areas
Prepoved rednega tedenskega počitka v kabini vozila ter varna in varovana parkirišča
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.
Ohranitev sedanjega modela kabotaže je v smislu izvrševanja zahtevnejša, vendar Komisija meni, da bo z novo generacijo „pametnih" tahografov, ki je del stališča Sveta, lažje prepoznati vrsto kabotaže, ki jo opravljajo prevozniki, in ustrezno številko.
This was intended to prevent a situation where drivers are working abroad for long periods, without the possibility to return home to their families.
Namen tega je bil preprečiti, da bi vozniki delali v tujini dolga obdobja, brez možnosti povratka k svojim družinam.
Application of posting rules to road transport
Uporaba pravil o napotitvi v cestnem prometu
The Commission also proposed specific administrative requirements for the application of the posting rules in road transport, to avoid undue administrative burden on operators.
Komisija je predlagala tudi posebne upravne zahteve za uporabo pravil o napotitvi v cestnem prometu, da bi se izognili nepotrebnemu upravnemu bremenu za prevoznike.
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.
Zaradi obveznega vračanja tovornjakov bo prišlo do neučinkovitosti prometnega sistema in povečanja nepotrebnih emisij, onesnaževanja in zastojev, z omejitvijo kombiniranega prevoza pa se bo zmanjšala njegova učinkovitost pri podpori večmodalnega prevoza tovora.
The Council position is a meaningful step forward compared to the current EU social and internal market rules for road transport for several reasons:
Stališče Sveta je iz več razlogov pomemben korak naprej v primerjavi s sedanjimi pravili EU na področju socialnih pravil in pravil notranjega trga za cestni promet:
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).
V stališču Sveta je določen časovni razpored za uvedbo te nove tehnologije v novih vozilih (dve leti od datuma sprejetja tehničnih specifikacij) in obstoječemu voznemu parku (naknadna vgradnja tri leta od datuma sprejetja tehničnih specifikacij za vsa vozila, opremljena s tahografom, ki ni prva različica pametnih tahografov; naknadna vgradnja štiri leta od datuma sprejetja tehničnih specifikacij za vsa vozila, opremljena s prvo različico pametnih tahografov).
Notably, the further development of the Internal Market Information System for the application of the posting rules, the new training and examination requirements for operators using light commercial vehicles and the technical developments required for the new tachograph technologies require sufficient implementation time.
Zlasti nadaljnji razvoj informacijskega sistema za notranji trg za uporabo pravil o napotitvi, nove zahteve glede usposabljanja in preverjanja za prevoznike, ki uporabljajo lahka gospodarska vozila, ter tehnični razvoj, ki je potreben za nove tahografske tehnologije, zahtevajo dovolj časa za izvedbo.
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.
Revidirana direktiva o izvrševanju (Direktiva 2006/22/ES) in lex specialis glede napotitve delavcev bosta določala datum prenosa nacionalnih ukrepov s strani držav članic 18 mesecev po začetku veljavnosti akta.
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.
Poleg tega je v stališču Sveta pojasnjena uporaba koncepta dolgoročne napotitve, ki je bil uveden z revidirano direktivo o napotitvi (Direktiva (EU) 2018/957), v dejavnostih mednarodnega cestnega prevoza, in sicer tako, da se obdobja, ki se opravijo v eni državi članici, ne seštevajo s tistimi, ki se opravijo v kateri koli drugi državi članici.
The Council position fully meets the Commission's objective to guarantee appropriate resting conditions for drivers and is even more ambitious in this respect.
Stališče Sveta je v celoti v skladu s ciljem Komisije, da se zagotovijo primerni pogoji za počitek voznikov, in je v zvezi s tem še bolj ambiciozno.
The clarifications in the Council position as regards long-term posting and application of posting rules to third countries are needed and welcome in order to remove doubts on the application of posting rules by Member States.
Potrebna in dobrodošla so pojasnila v stališču Sveta glede dolgoročne napotitve in uporabe pravil o napotitvi v tretjih državah, da bi se odpravili pomisleki glede uporabe pravil o napotitvi s strani držav članic.
Application of rules on access to the profession and driving and rest times to light commercial vehicles
Uporaba pravil o dostopu do poklica prevoznika ter času vožnje in počitka za lahka gospodarska vozila
Namely, these operators would be subject to the criteria on stable and effective establishment and appropriate financial standing.
Za te prevoznike bi se namreč uporabljala merila stalnega in dejanskega sedeža ter ustreznega finančnega položaja.
The Council position upholds the objective of the Commission proposal.
Svet v svojem stališču podpira cilj predloga Komisije.
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.
Vendar je Svet menil, da je treba uvesti novo generacijo „pametnih" tahografov, s katero bi se lahko natančneje določil položaj vozil, ki se uporabljajo za dejavnosti čezmejnega prevoza, s čimer bi se olajšalo izvrševanje socialnih pravil in pravil notranjega trga.
Additionally, the Council position extends the rules on driving and rest times and tachographs to these operators.
Poleg tega se v stališču Sveta na te prevoznike razširjajo pravila o času vožnje in počitka ter tahografih.
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.
Svet se ne ustavi pri predlogu Komisije in Komisijo pooblašča, da pripravi podrobne določbe o varnih in varovanih parkiriščih, tj. o ravni storitve in postopku certificiranja teh parkirišč.
The Council position to, in addition, subject these operators to driving and rest time rules and tachographs is acceptable, as it will further increase road safety for this type of vehicles involved in international transport for hire and reward.
Stališče Sveta, da se za te prevoznike uporabljajo tudi pravila o času vožnje in počitka ter tahografih, je sprejemljivo, saj se bo s tem nadalje povečala varnost v cestnem prometu za ta tip vozil, ki so vključena v mednarodni prevoz za najem in plačilo.