qanastek/ELRC-Medical-V2 huggingface dataset:
English: Under Article 6 of Directive 1999/2/EC, any irradiated food or any irradiated food ingredient of a compound food must be labelled with the words ‘irradiated' or ‘treated with ionising radiation'.
Translation (en-sl): V skladu s členom 6 Direktive 1999/2/ES morajo biti vsa obsevana živila ali vse obsevane živilske sestavine sestavljenih živil označena z besedami „obsevano" ali „obsevano z ionizirajočim sevanjem".
English: the results of checks carried out in ionising irradiation facilities, including, in particular, the categories and quantities of foodstuff treated with ionising radiation and the doses administered, and
Translation (en-sl): rezultate pregledov objektov za ionizirajoče obsevanje, zlasti kar zadeva skupine in količine obsevanih proizvodov in uporabljenih doz, ter
English: Period: 1/1/2016 - 31/12/2017
Translation (en-sl): Obdobje: od 1. 1. 2016 do 31. 12. 2017
English: It is also used to delay fruit ripening, to stop vegetables (such as onions and potatoes) from sprouting or germination and ultimately to extend the shelf life of foods.
Translation (en-sl): Uporablja se tudi za upočasnitev zorenja sadja, preprečevanje brstenja ali klitja zelenjave (kot je čebula in krompir), da se tako podaljša rok uporabnosti živil.
English: At marketing stage, as illustrated in Figure 4, the majority of the products analysed were 'herbs and spices' (42%) and the 'cereals, seed, vegetables, fruit and their products' (22%).
Translation (en-sl): Kot je prikazano na sliki 4, je bila na stopnji trženja večina analiziranih proizvodov „zelišča in začimbe" (42 %) ter „žita, semena, vrtnine in sadje ter proizvodi iz njih" (22 %).
English: Article 7(3) of Directive 1999/2/EC requires Member States to inform the Commission of the list of their approved irradiation facilities.
Translation (en-sl): V skladu s členom 7(3) Direktive 1999/2/ES morajo države članice Komisijo obvestiti o odobrenih objektih za obsevanje.
English: Main commodities analysed: Herbs and spices (42%)
Translation (en-sl): Glavne analizirane kategorije proizvodov: zelišča in začimbe (42 %)
English: [4: OJ C 37, 30.1.2019, p. 6]
Translation (en-sl): [4: UL C 37, 30.1.2019, str.
English: Treatment data:
Translation (en-sl): Podatki o obsevanju:
English: [1: OJ L 66, 13.3.1999, p.
Translation (en-sl): [1: UL L 66, 13.3.1999, str.
English: Figure 2 - Quantities of foodstuffs treated by ionising radiation in approved irradiation establishments within the European Union since 2010
Translation (en-sl): Slika 2 - Količine živil, ki so bile od leta 2010 obsevane z ionizirajočim sevanjem v odobrenih objektih za obsevanje v Evropski uniji
English: According to Article 7(3) of Directive 1999/2/EC, of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation, the Member States shall forward to the Commission every year:
Translation (en-sl): V skladu s členom 7(3) Direktive 1999/2/ES Evropskega parlamenta in Sveta z dne 22. februarja 1999 o približevanju zakonodaje držav članic o živilih in živilskih sestavinah, obsevanih z ionizirajočim sevanjem, države članice Komisiji vsako leto predložijo:
English: the results of checks carried out at product marketing stage.
Translation (en-sl): rezultate pregledov v fazi trženja proizvodov.
English: A total quantity of 10 211 tonnes of products were treated with ionising irradiation in EU Member States during the years 2016 and 2017.
Translation (en-sl): V letih 2016 in 2017 je bila v državah članicah EU z ionizirajočim sevanjem obsevana skupna količina 10 211 ton proizvodov.
English: Directive 1999/2/EC (framework Directive) of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation.
Translation (en-sl): Direktivo 1999/2/ES (okvirno direktivo) Evropskega parlamenta in Sveta z dne 22. februarja 1999 o približevanju zakonodaje držav članic o živilih in živilskih sestavinah, obsevanih z ionizirajočim sevanjem.
English: Figure 1 shows the distribution of products irradiated in approved facilities in the EU Member States in 2016 and 2017.
Translation (en-sl): Slika 1 prikazuje porazdelitev obsevanih proizvodov v odobrenih objektih v državah članicah EU v letih 2016 in 2017.
English: Directive 1999/3/EC (implementing Directive) of the European Parliament and of the Council of 22 February 1999 on the establishment of a Community list of foods and food ingredients treated with ionising treatment.
Translation (en-sl): Direktivo 1999/3/ES (izvedbeno direktivo) Evropskega parlamenta in Sveta z dne 22. februarja 1999 o izdelavi seznama Skupnosti za živila in živilske sestavine, obsevane z ionizirajočim sevanjem.
English: Main commodities treated: Frog legs (57%) and dried aromatic herbs, spices and
Translation (en-sl): Glavne obsevane kategorije proizvodov: žabji kraki (57 %) ter posušena aromatična zelišča, začimbe in
English: The two main commodities irradiated in the EU are frog legs (ca 57%) and dried aromatic herbs, spices and vegetables seasoning (ca 21%).
Translation (en-sl): Glavni obsevani kategoriji proizvodov v EU sta bili žabji kraki (približno 57 %) ter posušena aromatična zelišča, začimbe in vrtna zelišča (približno 21 %).
English: The list of national authorisations of food and food ingredients which may be treated with ionising radiation is published by the Commission in the Official Journal of the European Union .
Translation (en-sl): Komisija v Uradnem listu Evropske unije objavi seznam nacionalnih dovoljenj za živila in živilske sestavine, ki se lahko obsevajo z ionizirajočim sevanjem.
English: Approved irradiation facilities
Translation (en-sl): Odobreni objekti za obsevanje
English: Results of checks carried out in irradiation facilities in 2016-2017
Translation (en-sl): Rezultati pregledov objektov za obsevanje v letih 2016 in 2017
English: Number of countries irradiating: 10 Member States & Norway
Translation (en-sl): Število držav, v katerih se izvaja obsevanje: 10 držav članic in Norveška
English: [2: OJ L 66, 13.3.1999, p. 24][3: OJ C 283, 24.11.2009, p. 5]
Translation (en-sl): ][3: UL C 283, 24.11.2009, str.
English: Figure 4 - Foodstuffs category analysed at product marketing stage within the European Union in 2016-17
Translation (en-sl): Slika 4 - Kategorija živil, analizirana v fazi trženja proizvodov v Evropski uniji v letih 2016 in 2017
English: Figure 3 - Samples analysed at product marketing stage within each Member State in 2016-2017
Translation (en-sl): Slika 3 - Število vzorcev, analiziranih v fazi trženja proizvodov v posamezni državi članici v letih 2016 in 2017
English: Any food irradiated or containing irradiated ingredients must have been treated (irradiated) only at approved facilities.
Translation (en-sl): Vsa obsevana živila ali tista, ki vsebujejo obsevane sestavine, morajo biti obsevana samo v odobrenih objektih.
English: Figure 1 - Distribution by category of irradiated foodstuffs in the EU in 2016-2017
Translation (en-sl): Slika 1 - Porazdelitev po kategorijah obsevanih živil v EU v letih 2016 in 2017
English: The list of approved irradiation facilities in Member States is published by the Commission in the Official Journal of the European Union .
Translation (en-sl): Komisija v Uradnem listu Evropske unije objavi seznam odobrenih objektov za obsevanje v državah članicah.
English: This report covers the period from 1 January 2014 to 31 December 2015.
Translation (en-sl): To poročilo zajema obdobje od 1. januarja 2014 do 31. decembra 2015.
English: This is why this Regulation, is more specifically focusing on these three diseases.
Translation (en-sl): Zato se ta uredba osredotoča zlasti na te tri bolezni.
English: Both companies transferred their HIV assets to the new company. ]
Translation (en-sl): Obe podjetji sta svoja sredstva za HIV prenesli na novo podjetje. ]
English: Countries of destination during the reporting period were: China, Honduras, Indonesia, Kenya, Moldova, Nigeria, South Africa, and Uganda.
Translation (en-sl): Namembne države v obdobju poročanja so bile: Kitajska, Honduras, Indonezija, Kenija, Moldavija, Nigerija, Južna Afrika in Uganda.
English: No new products were registered during the reporting period.
Translation (en-sl): V obdobju poročanja ni bilo registriranih novih proizvodov.
English: GENERAL CRITERIA FOR THE IMPLEMENTATION OF ARTICLE 3
Translation (en-sl): SPLOŠNA MERILA ZA IZVAJANJE ČLENA 3
English: The access price is based on the cost of producing the product.
Translation (en-sl): Cena dostopa temelji na stroških proizvodnje proizvoda.
English: [6: COM(2015)0497 of 14 October 2015.]
Translation (en-sl): [6: COM(2015) 0497 z dne 14. oktobra 2015.]
English: The competent authority shall inform the Commission of all decisions adopted pursuant to the Regulation.
Translation (en-sl): Pristojni organ obvesti Komisijo o vseh sklepih, sprejetih na podlagi Uredbe.
English: The EU contributes for example to the Global Fund to fight AIDS, tuberculosis and malaria that spends USD 3.5 billion a year in developing countries to which the EU collectively contributes about 50% and the Commission contributed EUR 370 million from the Development Cooperation Instrument and the European Development Fund for 2014-2016.
Translation (en-sl): EU prispeva na primer k Svetovnemu skladu za boj proti aidsu, tuberkulozi in malariji, ki letno porabi 3,5 milijarde USD na leto v državah v razvoju, katerim EU skupaj prispeva okoli 50 %, Komisija pa je prispevala 370 milijonov EUR iz instrumenta za razvojno sodelovanje in Evropskega razvojnega sklada za obdobje 2014-2016.
English: Information on products registered under the Regulation, instructions for pharmaceutical companies wishing to register products, and previous reports are available on-line.
Translation (en-sl): Informacije o proizvodih, registriranih v skladu z Uredbo, navodila za farmacevtske družbe, ki želijo registrirati proizvode, in prejšnja poročila so na voljo na spletu.
English: An external contractor, Charles River Associates was commissioned to gather data to support the Commission evaluation of the Regulation,
Translation (en-sl): Izbran je bil zunanji izvajalec, podjetje Charles River Associates, za zbiranje podatkov za podporo vrednotenju Uredbe s strani Komisije,
English: The Commission received no notification pursuant to Article 10 of the Regulation.
Translation (en-sl): Komisija ni prejela nobenega uradnega obvestila v skladu s členom 10 Uredbe.
English: [7: GSK set up ViiV Healthcare as a joint venture with Pfizer in November 2009.
Translation (en-sl): [7: Podjetje GSK je novembra 2009 ustanovilo podjetje ViiV Healthcare kot skupno podjetje s podjetjem Pfizer.
English: These diseases are generally considered the gravest public health concerns for developing countries and a major obstacle to development.
Translation (en-sl): Te bolezni se splošno obravnavajo kot največja grožnja za javno zdravje v državah v razvoju ter kot ena večjih ovir za razvoj.
English: These products were registered in 2004 and all aim at the treatment of HIV/AIDS.
Translation (en-sl): Ti proizvodi so bili registrirani leta 2004 in vsi so namenjeni za zdravljenje HIV/aidsa.
English: GlaxoSmithKline also registered Retrovir 300 mg x 60, Retrovir 250 mg x 40 and Trizivir 750 mg x 60 under the Regulation in 2004, but there were no sales under tiered prices of these products in the reporting period.
Translation (en-sl): Podjetje GlaxoSmithKline je leta 2004 registriralo tudi Retrovir 300 mg x 60, Retrovir 250 mg x 40 in Trizivir 750 mg x 60 v skladu z uredbo, vendar se v obdobju poročanja prodaja teh proizvodov ni izvajala v skladu z vzporedno oblikovanimi cenami.
English: The Regulation complements other EU actions such as support for the World Trade Organisation's November 2015 Decision to exempt least developed countries from obligations to provide patent protection for pharmaceutical products until at least 2033, so as to support access to medicines.
Translation (en-sl): Uredba dopolnjuje druge ukrepe EU, kot so podpora sklepu Svetovne trgovinske organizacije iz novembra 2015, da se najmanj razvite države izvzamejo iz obveznosti zagotavljanja patentnega varstva za farmacevtske proizvode vsaj do leta 2033, da bi se podprl dostop do zdravil.
English: [1: OJ L 135, 24.5.2016, p. 39 (replacing Council Regulation (EC) No 953/2003)]
Translation (en-sl): [1: UL L 135, 24.5.2016, str. 39 (ki razveljavlja Uredbo Sveta (ES) št. 953/2003)]
English: Other actions include Commission-funded development programmes supporting low- and middle-income countries' public health systems and research and development programmes for medicines needed by these countries.
Translation (en-sl): Drugi ukrepi vključujejo razvoj programov, ki jih financira Komisija in ki podpirajo sisteme javnega zdravja držav z nizkimi in srednjimi dohodki ter razvojne programe za zdravila, ki jih potrebujejo te države.
English: The products were sold to the countries listed at the price of production, with no mark-up, and therefore in accordance with the criteria of Article 3.
Translation (en-sl): Proizvodi so bili prodani v države na seznamu po proizvodnih cenah, brez pribitka, in zato v skladu z merili iz člena 3.
English: One company, GlaxoSmithKline / ViiV Healthcare, has medicines registered under the Regulation.
Translation (en-sl): Podjetje GlaxoSmithKline / ViiV Healthcare je registriralo zdravila v skladu s to uredbo.
English: This is the ninth Report under Article 12(2) of the Regulation which foresees biennially reports by the Commission to the European Parliament and to the Council on the volumes exported under tiered prices registered under the Regulation.
Translation (en-sl): To je deveto poročilo v skladu s členom 12(2) Uredbe, ki določa, da Komisija vsaki dve leti poroča Evropskemu parlamentu in Svetu o količinah, izvoženih po vzporedno oblikovanih cenah, registriranih v skladu z Uredbo.
English: EVALUATION OF LIST OF COUNTRIES OF DESTINATION
Translation (en-sl): VREDNOTENJE SEZNAMA NAMEMBNIH DRŽAV
English: Report on the application of Regulation (EU) 2016/793 of the European Parliament and of the Council of 11 May 2016 to avoid trade diversion into the European Union of certain key medicines
Translation (en-sl): Poročilo o uporabi Uredbe (EU) 2016/793 Evropskega parlamenta in Sveta z dne 11. maja 2016 za preprečevanje preusmerjanja trgovine nekaterih ključnih zdravil v Evropsko unijo
English: In order to achieve this, the European Commission has consistently advocated a policy of "tiered pricing" for medicines, combined with market segmentation between rich and poor countries.
Translation (en-sl): Zato si Evropska komisija stalno prizadeva za politiko „vzporednega oblikovanja cen" za zdravila skupaj s segmentacijo trga med bogatimi in revnimi državami.
English: The Regulation allows for the registration of medicines treating HIV/AIDS, malaria and tuberculosis.
Translation (en-sl): Uredba omogoča registracijo zdravil za zdravljenje okužbe z virusom HIV ali aidsa, malarije in tuberkuloze.
English: This approach is designed to promote sustainable supplies and continuous distribution of life-saving medicines.
Translation (en-sl): Cilj tega pristopa je spodbuditi trajnostno oskrbo z življenjsko pomembnimi zdravili in njihovo neprekinjeno distribucijo.
English: EVALUATION OF SCOPE OF DISEASES COVERED
Translation (en-sl): VREDNOTENJE OBSEGA BOLEZNI, KI JIH ZAJEMA TO POROČILO
English: Where there is reason to suspect that, contrary to the prohibition in Article 2, tiered priced products will be imported into the Union, customs authorities shall suspend the release of, or detain, the products concerned for the time necessary to obtain a decision of the competent authorities on the character of the merchandise.
Translation (en-sl): Kjer obstaja sum, da bodo, v nasprotju s prepovedjo iz člena 2, proizvodi z vzporedno oblikovanimi cenami, uvoženi v Unijo, carinski organi ustavijo sprostitev zadevnih proizvodov ali jih zadržijo toliko časa, kolikor je potrebno za pridobitev odločbe pristojnih organov o značaju blaga.
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-sl): Uredba navaja, da se v poročilu pregleda tudi obseg držav in bolezni ter splošna merila za izvajanje člena 3.
English: 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.
Translation (en-sl): 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.
English: 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.
Translation (en-sl): 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.
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-sl): Majhne količine prodanih proizvodov so posledica dobave generičnih proizvodov na trgu, kar je posledica proizvajalčeve politike prostovoljnih licenčnih sporazumov in izteka veljavnosti patentov.
English: 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.
Translation (en-sl): 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.
English: 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.
Translation (en-sl): 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.
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-sl): Zunanja študija je pokazala, da obstaja malo možnosti za izboljšanje učinkovitosti Uredbe s spreminjanjem seznama nalezljivih bolezni.
English: 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.
Translation (en-sl): 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.
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-sl): 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.
English: NOTIFICATIONS UNDER ARTICLE 10
Translation (en-sl): URADNO OBVESTILO V SKLADU S ČLENOM 10
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-sl): 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.
English: The products listed below were exported under tiered prices:
Translation (en-sl): Spodaj navedeni proizvodi so bile izvoženi v skladu z vzporedno oblikovanimi cenami:
English: REFIT EVALUATION OF THE REGULATION
Translation (en-sl): VREDNOTENJE UREDBE V OKVIRU PROGRAMA REFIT
English: 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.
Translation (en-sl): 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.
English: PRODUCTS EXPORTED UNDER TIERED PRICES
Translation (en-sl): PROIZVODI, IZVOŽENI V SKLADU Z VZPOREDNO OBLIKOVANIMI CENAMI
English: Only medicines for the treatment of HIV/AIDS have been registered by the manufacturer.
Translation (en-sl): Proizvajalec je registriral samo zdravila za zdravljenje okužbe z virusom HIV ali aidsa.
English: RETROVIR Oral Solution 10 mg/ml - 200 ml
Translation (en-sl): RETROVIR peroralna raztopina 10 mg/ml - 200 ml
English: EPIVIR Oral Solution 10mg/ml 240 ml
Translation (en-sl): EPIVIR peroralna raztopina 10 mg/ml - 240 ml
English: *includes distribution costs
Translation (en-sl): *zajema stroške distribucije
English: ANNEX
Translation (en-sl): PRILOGA
English: Product Country destinations Volume Avg. selling price ($)*
Translation (en-sl): Proizvod Namembna država Količina Povprečna prodajna cena (v USD)*
English: ViiV Healthcare/GSK packs sold in 2015 under Regulation (EU) 2016/793 (in-country sales data)
Translation (en-sl): Paketi podjetja ViiV Healthcare/GSK, ki so bili prodani v letu 2015 na podlagi Uredbe (EU) 2016/793 (podatki o prodaji znotraj države)
English: ViiV Healthcare/GSK packs sold in 2014 under Regulation (EU) 2016/793 (in-country sales data)
Translation (en-sl): Paketi podjetja ViiV Healthcare/GSK, ki so bili prodani v letu 2014 na podlagi Uredbe (EU) 2016/793 (podatki o prodaji znotraj države)
English: Trizivir 750mg no sales no sales no sales
Translation (en-sl): Trizivir 750 mg ni prodaje ni prodaje ni prodaje
English: Ziagen 300mg x 60 Kenya 1,159 16.12
Translation (en-sl): Ziagen 300 mg x 60 Kenija 1 159 16,12
English: Retrovir 300mg x 60 no sales no sales no sales
Translation (en-sl): Retrovir 300 mg x 60 ni prodaje ni prodaje ni prodaje
English: Retrovir 250mg x 60 no sales no sales no sales
Translation (en-sl): Retrovir 250 mg x 60 ni prodaje ni prodaje ni prodaje
English: Retrovir 100mg x 100 Indonesia, Kenya 463 19.92
Translation (en-sl): Retrovir 100 mg x 100 Indonezija, Kenija 463 19,92