FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: [9: Commission Regulation (EC) No 1825/2000 of 25 August 2000 laying down detailed rules for the application of Regulation (EC) No 1760/2000 of the European Parliament and of the Council as regards the labelling of beef and beef products (OJ L 216, 26.8.2000, p.
Slovenian: [9: Uredba Komisije (ES) št. 1825/2000 z dne 25. avgusta 2000 o podrobnih pravilih za uporabo Uredbe (ES) št. 1760/2000 Evropskega parlamenta in Sveta glede označevanja govejega mesa in izdelkov iz govejega mesa (UL L 216, 26.8.2000, str.
English: [2: Commission Regulation (EC) No 911/2004 of 29 April 2004 implementing Regulation (EC) No 1760/2000 of the European Parliament and of the Council as regards, ear tags, passports and holding registers (OJ L 163, 30.4.2004, p.
Slovenian: [2: Uredba Komisije (ES) št. 911/2004 z dne 29. aprila 2004 o izvajanju Uredbe (ES) št. 1760/2000 Evropskega parlamenta in Sveta v zvezi z ušesnimi znamkami, potnimi listi in registri živali na gospodarstvu (UL L 163, 30.4.2004, str.
English: On the basis of the predecessor to this empowerment, former Article 19, the Commission has laid down such rules in Article 3 of Regulation (EC) No 1825/2000;
Slovenian: Na podlagi predhodnika tega pooblastila, nekdanjega člena 19, je Komisija določila takšna pravila s členom 3 Uredbe (ES) št. 1825/2000;
English: On the basis of the predecessor to this empowerment, former Article 4(1), the Commission has adopted such requirements by Regulation (EC) No 644/2005;
Slovenian: Na podlagi predhodnika tega pooblastila, nekdanjega člena 4(1), je Komisija sprejela takšne zahteve z Uredbo (ES) št. 644/2005;
English: On the basis of the predecessor to this empowerment, former Article 19, the Commission has adopted such requirements by way of Regulation (EC) No 1825/20009;
Slovenian: Na podlagi predhodnika tega pooblastila, nekdanjega člena 19, je Komisija sprejela takšne zahteve z Uredbo (ES) št. 1825/20009;
English: On the basis of the predecessor to this empowerment, former Article 10(c), the Commission has adopted such requirements by Regulation (EC) No 911/20042;
Slovenian: Na podlagi predhodnika tega pooblastila, nekdanjega člena 10(c), je Komisija sprejela takšne zahteve z Uredbo (ES) št. 911/20042;
English: On the basis of the predecessor to this empowerment, former Article 10(a), the Commission has adopted the requirements for the conventional ear tags by Regulation (EC) No 911/2004.
Slovenian: Na podlagi predhodnika tega pooblastila, nekdanjega člena 10(a), je Komisija z Uredbo (ES) št. 911/2004 sprejela zahteve za običajne ušesne znamke.
English: On the basis of the predecessor to this empowerment, former Article 7(1), the Commission has adopted such requirements by way of Regulation (EC) No 911/20042;
Slovenian: Na podlagi predhodnika tega pooblastila, nekdanjega člena 7(1), je Komisija sprejela takšne zahteve z Uredbo (ES) št. 911/20042;
English: The percentage of non compliance was lower than in the previous report.
Slovenian: Odstotek neskladnosti je bil manjši kot v prejšnjem poročilu.
English: The data are for each Member State are available in Annex II and summarised in Figure 3.
Slovenian: Podatki za vsako državo članico so na voljo v Prilogi II in so povzeti v sliki 3.
English: a report on the information provided every year by the national supervisory authorities.
Slovenian: poročilo na podlagi informacij, ki jih nacionalni nadzorni organi predložijo vsako leto.
English: Radiant energy has differing wavelengths and degrees of power and disappears when the energy source is removed.
Slovenian: Sevalna energija ima različne valovne dolžine in stopnje moči in izgine, ko se odstrani vir energije.
English: Number of samples analysed: 11 162
Slovenian: Število analiziranih vzorcev: 11 162
English: The facilities are located in 14 Member States: five in France, four in Germany, two in Bulgaria, the Netherlands, and Spain, one in Belgium, Czech Republic, Croatia, Estonia, Italy, Hungary, Poland, Romania and United Kingdom.
Slovenian: Objekti se nahajajo v 14 državah članicah, in sicer pet v Franciji, štirje v Nemčiji, po dva v Bolgariji, na Nizozemskem in v Španiji ter po en v Belgiji, na Češkem, Hrvaškem, v Estoniji, Italiji, na Madžarskem, Poljskem, v Romuniji in Združenem kraljestvu.
English: Of those 14 Member States equipped with irradiation facilities, Bulgaria, Italy, Romania and the United Kingdom did not irradiate any foodstuffs over the period covered by this report.
Slovenian: Od teh 14 držav članic, ki imajo objekte za obsevanje, Bolgarija, Italija, Romunija in Združeno kraljestvo niso obsevali živil v obdobju, ki ga zajema to poročilo.
English: the details of the approved irradiation facilities in the Member States, as well as any changes in their status,
Slovenian: podrobne podatke o odobrenih objektih za obsevanje v državah članicah, pa tudi vse spremembe njihovega statusa,
English: It lays down specific provisions for the manufacturing, marketing and importation of treated foods and food ingredients.
Slovenian: Vsebuje posebne določbe za proizvodnjo, trženje in uvoz obsevanih živil in živilskih sestavin;
English: The non-compliance observed were mainly incorrect labelling and forbidden irradiation.
Slovenian: Ugotovljena neskladnost je večinoma zadevala nepravilno označevanje in prepovedano obsevanje.
English: Two previously approved irradiation facilities have been closed in 2015.
Slovenian: Dva že odobrena objekta za obsevanje sta bila zaprta leta 2015.
English: Five countries (four Member States and Norway) did not perform any analytical checks at product marketing stage in 2016-2017 due to budgetary restrictions (Croatia (2016), Denmark (2017) and Norway (2016 and 2017)), lack of laboratory capacity (Estonia and Cyprus (2016, 2017)) or other control priorities (Sweden (2016, 2017)).
Slovenian: Pet držav (štiri države članice in Norveška) v letih 2016 in 2017 ni izvedlo nobenih analitskih pregledov v fazi trženja proizvodov zaradi proračunskih omejitev (Hrvaška (2016), Danska (2017) in Norveška (2016 in 2017)), pomanjkanja laboratorijskih zmogljivosti (Estonija in Ciper (2016, 2017)) ali drugih prednostnih nalog nadzora (Švedska (2016, 2017)).
English: There are now 24 irradiation facilities in the EU.
Slovenian: V EU je trenutno 24 objektov za obsevanje.
English: To enforce correct labelling or to detect non-authorised products, several analytical methods have been standardised by the European Committee for Standardisation (CEN), following a mandate given by the European Commission.
Slovenian: Za izvajanje pravilnega označevanja ali odkrivanje proizvodov brez odobritve je Evropski odbor za standardizacijo (CEN) standardiziral več analitskih metod v skladu z nalogami in pooblastili, ki mu jih je podelila Evropska komisija.
English: products (22%)
Slovenian: njih (22 %)
English: For facilities in the EU, approval is given by the competent authorities of the Member State.
Slovenian: Odobritve za objekte v EU izdajajo pristojni organi držav članic.
English: Malta did not submit any data for the year 2017.
Slovenian: Malta ni predložila podatkov za leto 2017.
English: This report covers the period from 1 January 2016 to 31 December 2017.
Slovenian: To poročilo zajema obdobje od 1. januarja 2016 do 31. decembra 2017.
English: Quantity of products treated: 10 211 tonnes (-11.4%) compared to 2015 on average
Slovenian: Količina obsevanih proizvodov: 10 211 ton (-11,4 %) v primerjavi s povprečjem v letu 2015
English: vegetables seasoning(20.77%)
Slovenian: vrtna zelišča (20,77 %)
English: Cereals, seed, vegetables, fruits and their
Slovenian: žita, semena, vrtnine in sadje ter proizvodi iz
English: Irradiation is used for sanitary and phytosanitary purposes to kill bacteria (such as Salmonella, Campylobacter and E. coli) that can cause food poisoning and to eliminate organisms harmful to plant or plant products such as insects and other pests.
Slovenian: Obsevanje se uporablja za sanitarne in fitosanitarne namene, in sicer za uničenje bakterij (kot so Salmonella, Campylobacter in E. coli), ki lahko povzročijo zastrupitev s hrano, in uničenje organizmov, škodljivih za rastline ali rastlinske proizvode, kot so žuželke ali drugi škodljivi organizmi.
English: Number of closed facilities: 2
Slovenian: Število zaprtih objektov: 2
English: Irradiation of food cannot replace proper food handling and irradiated foods still require appropriate refrigeration and to be cooked prior to consumption when necessary.
Slovenian: Obsevanje živil ne more nadomestiti ustreznega ravnanja z živili, saj obsevana živila še vedno zahtevajo ustrezno hlajenje in kuhanje pred porabo, če je to potrebno.
English: Number of approved facilities: 24
Slovenian: Število odobrenih objektov: 24
English: The EU regulatory framework for irradiation of food ('food irradiation directives') thus consists of:
Slovenian: Regulativni okvir EU za obsevanje živil (v nadaljnjem besedilu: direktive o obsevanju živil) tako vključuje:
English: Malta did not report any sample in 2017.
Slovenian: Malta leta 2017 ni poročala o nobenem vzorcu.
English: This list currently includes one category of food: dried aromatic herbs, spices and vegetable seasonings.
Slovenian: Ta seznam trenutno vključuje eno kategorijo živil: posušena aromatična zelišča, začimbe in vrtna zelišča.
English: For the period 2016-2017, 11 162 samples were analysed by 24 Member States, i.e. overall 7.02% less in average than in 2015.
Slovenian: V letih 2016 in 2017 je 24 držav članic analiziralo 11 162 vzorcev, kar je skupno v povprečju za 7,02 % manj kot leta 2015.
English: Main place of irradiation: Belgium (68%) and the Netherlands (13%)
Slovenian: Glavni kraji obsevanja: Belgija (68 %) in Nizozemska (13 %)
English: Under category 'Other' (foods supplements and soup and sauces) the percentage was 17%.
Slovenian: Kategorija „drugo" (prehranska dopolnila, juhe in omake) je dosegla 17 %.
English: It contains a compilation of the information forwarded to the Commission by 28 Member States on 2016 and 27 Member States on 2017.
Slovenian: Vsebuje zbirko informacij, ki jih je Komisiji predložilo 28 držav članic za leto 2016 in 27 držav članic za leto 2017.
English: Food irradiation is the treatment of foodstuffs by a certain type of radiant energy known as ionising radiation.
Slovenian: Obsevanje živil je obdelava živil z določeno vrsto sevalne energije, imenovane ionizirajoče sevanje.
English: Number of non compliant samples: 87 (0.8%)
Slovenian: Število neskladnih vzorcev: 87 (0,8 %)
English: From the total of 11 162 samples, 87 were not compliant (0.8%) and 113 samples (1%) gave inconclusive results.
Slovenian: Od skupaj 11 162 vzorcev ni bilo skladnih 87 vzorcev (0,8 %), 113 vzorcev (1 %) pa je dalo neopredeljive rezultate.
English: Source: 28 Member States and Norway
Slovenian: Vir: 28 držav članic in Norveška
English: The quantities of foodstuffs (in tonnes) treated by ionising radiation in the EU are decreasing since 2010 as shown in Figure 2.
Slovenian: Količine živil (v tonah), obsevanih z ionizirajočim sevanjem v EU, so se od leta 2010 zmanjšale, kot je prikazano na sliki 2.
English: The treatment took place mainly in two Member States: Belgium, which treated two thirds of the irradiated food of the EU (68%), and the Netherlands (13%).
Slovenian: Obsevanje je potekalo zlasti v dveh državah članicah: v Belgiji, kjer sta bili obsevani dve tretjini obsevanih živil EU (68 %), in na Nizozemskem (13 %).
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'.
Slovenian: 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
Slovenian: 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
Slovenian: 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.
Slovenian: 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%).
Slovenian: 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.
Slovenian: 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%)
Slovenian: Glavne analizirane kategorije proizvodov: zelišča in začimbe (42 %)
English: [4: OJ C 37, 30.1.2019, p. 6]
Slovenian: [4: UL C 37, 30.1.2019, str.
English: Treatment data:
Slovenian: Podatki o obsevanju:
English: [1: OJ L 66, 13.3.1999, p.
Slovenian: [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
Slovenian: 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:
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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
Slovenian: 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%).
Slovenian: 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 .
Slovenian: 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
Slovenian: Odobreni objekti za obsevanje
English: Results of checks carried out in irradiation facilities in 2016-2017
Slovenian: Rezultati pregledov objektov za obsevanje v letih 2016 in 2017
English: Number of countries irradiating: 10 Member States & Norway
Slovenian: 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]
Slovenian: ][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
Slovenian: 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
Slovenian: 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.
Slovenian: 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
Slovenian: 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 .
Slovenian: 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.
Slovenian: 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.
Slovenian: Zato se ta uredba osredotoča zlasti na te tri bolezni.
English: Both companies transferred their HIV assets to the new company. ]
Slovenian: 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.
Slovenian: 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.
Slovenian: V obdobju poročanja ni bilo registriranih novih proizvodov.
English: GENERAL CRITERIA FOR THE IMPLEMENTATION OF ARTICLE 3
Slovenian: SPLOŠNA MERILA ZA IZVAJANJE ČLENA 3
English: The access price is based on the cost of producing the product.
Slovenian: Cena dostopa temelji na stroških proizvodnje proizvoda.
English: [6: COM(2015)0497 of 14 October 2015.]
Slovenian: [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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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,
Slovenian: 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.
Slovenian: 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.
Slovenian: [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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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)]
Slovenian: [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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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
Slovenian: 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
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: Cilj tega pristopa je spodbuditi trajnostno oskrbo z življenjsko pomembnimi zdravili in njihovo neprekinjeno distribucijo.
English: EVALUATION OF SCOPE OF DISEASES COVERED
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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.
Slovenian: 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
Slovenian: 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.
Slovenian: 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:
Slovenian: Spodaj navedeni proizvodi so bile izvoženi v skladu z vzporedno oblikovanimi cenami:
English: REFIT EVALUATION OF THE REGULATION
Slovenian: 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.
Slovenian: 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
Slovenian: PROIZVODI, IZVOŽENI V SKLADU Z VZPOREDNO OBLIKOVANIMI CENAMI
English: Only medicines for the treatment of HIV/AIDS have been registered by the manufacturer.
Slovenian: Proizvajalec je registriral samo zdravila za zdravljenje okužbe z virusom HIV ali aidsa.
English: RETROVIR Oral Solution 10 mg/ml - 200 ml
Slovenian: RETROVIR peroralna raztopina 10 mg/ml - 200 ml
English: EPIVIR Oral Solution 10mg/ml 240 ml
Slovenian: EPIVIR peroralna raztopina 10 mg/ml - 240 ml
English: *includes distribution costs
Slovenian: *zajema stroške distribucije
English: Product Country destinations Volume Avg. selling price ($)*
Slovenian: 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)
Slovenian: 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)
Slovenian: 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
Slovenian: Trizivir 750 mg ni prodaje ni prodaje ni prodaje
English: Ziagen 300mg x 60 Kenya 1,159 16.12
Slovenian: Ziagen 300 mg x 60 Kenija 1 159 16,12
English: Retrovir 300mg x 60 no sales no sales no sales
Slovenian: Retrovir 300 mg x 60 ni prodaje ni prodaje ni prodaje
English: Retrovir 250mg x 60 no sales no sales no sales
Slovenian: Retrovir 250 mg x 60 ni prodaje ni prodaje ni prodaje
English: Retrovir 100mg x 100 Indonesia, Kenya 463 19.92
Slovenian: Retrovir 100 mg x 100 Indonezija, Kenija 463 19,92
English: Epivir Oral Solution 10mg/ml 240 ml Honduras, Kenya, Moldova 541 21.69
Slovenian: Epivir Oral Solution 10 mg/ml - 240 ml Honduras, Kenija, Moldavija 541 21,69
English: Retrovir Oral Solution 10mg/ml 200ml Kenya 207 13.64
Slovenian: Retrovir Oral Solution 10 mg/ml - 200 ml Kenija 207 13,64
English: Ziagen 300mg x 60 China, Kenya 49,701 17.85
Slovenian: Ziagen 300 mg x 60 Kitajska, Kenija 49 701 17,85
English: Retrovir 100mg x 100 Indonesia, Kenya, Moldova 521 18.76
Slovenian: Retrovir 100 mg x 100 Indonezija, Kenija, Moldavija 521 18,76
English: Epivir Oral Solution 10mg/ml 240 ml China, Honduras, Kenya 16,230 17.28
Slovenian: Epivir Oral Solution 10 mg/ml - 240 ml Kitajska, Honduras, Kenija 16 230 17,28
English: Retrovir Oral Solution 10mg/ml 200ml China, Kenya, Moldova 17,609 14.75
Slovenian: Retrovir Oral Solution 10 mg/ml - 200 ml Kitajska, Kenija, Moldavija 17 609 14,75
English: Epivir 150mg x 60 Azerbaijan, Indonesia, Kenya, Tanzania 14,299 10.60
Slovenian: Epivir 150 mg x 60 Azerbajdžan, Indonezija, Kenija, Tanzanija 14 299 10,60
English: Combivir 300/150mg x 60 China, Kenya, Nigeria, Tanzania, Uganda 8,839 25.84
Slovenian: Combivir 300/150 mg x 60 Kitajska, Kenija, Nigerija, Tanzanija, Uganda 8 839 25,84
English: Epivir 150mg x 60 China, Indonesia, Kenya, Moldova, Tanzania 9,778 13.56
Slovenian: Epivir 150 mg x 60 Kitajska, Indonezija, Kenija, Moldavija, Tanzanija 9 778 13,56
English: Combivir 300/150mg x 60 China, Kenya, Nigeria, Tanzania, Uganda 10,716 26.11
Slovenian: Combivir 300/150 mg x 60 Kitajska, Kenija, Nigerija, Tanzanija, Uganda 10 716 26,11
English: The three legislative proposals in question are:
Slovenian: Ti trije zakonodajni predlogi so:
English: Regular return of the driver
Slovenian: Redno vračanje voznika
English: The Council position is therefore acceptable in this respect.
Slovenian: Stališče Sveta je zato v zvezi s tem sprejemljivo.
English: The same applies to the return journey.
Slovenian: Enako velja za povratno vožnjo.
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."
Slovenian: Komisija bo po oceni učinka po potrebi uveljavila pravico do predložitve ciljno usmerjenega zakonodajnega predloga pred začetkom veljavnosti obeh določb."
English: Introduction of new tachograph technology
Slovenian: Uvedba nove tahografske tehnologije
English: The new provisions will also constitute a solid basis for future enforcement of the road transport rules.
Slovenian: Nove določbe bodo tudi trdna podlaga za prihodnje izvrševanje cestnoprometnih pravil.
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.
Slovenian: Ta ukrepa nista bila vključena v predloge Komisije, sprejete 31. maja 2017, in v zvezi z njima ni bila opravljena ocena učinka.
English: Organisation of the weekly rest periods
Slovenian: Organizacija tedenskega časa počitka
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.
Slovenian: Komisija v duhu kompromisa sprejema stališče Sveta in tako Evropskemu parlamentu omogoča, da končno besedilo sprejme v drugi obravnavi.
English: The social improvements in this proposal are significant.
Slovenian: Ta predlog vključuje pomembne socialne izboljšave.
English: The Commission did not propose to modify the tachograph regulation.
Slovenian: Komisija ni predlagala spremembe uredbe o tahografih.
English: The Council does not follow the approach proposed by the Commission, which was mainly intended to facilitate enforcement.
Slovenian: Svet ne upošteva pristopa, ki ga je predlagala Komisija in ki je bil namenjen predvsem lažjemu izvrševanju.
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:
Slovenian: Zato je Komisija podala naslednjo izjavo o političnem dogovoru, ki sta ga Evropski parlament in Svet dosegla 12. decembra 2019:
English: The Commission did not propose specific dates for the application of the new rules.
Slovenian: Komisija ni predlagala posebnih datumov za začetek uporabe novih pravil.
English: Indeed, the Commission considers that adopting the social and market proposals would bring substantial benefits to the road transport sector.
Slovenian: Komisija meni, da bi sprejetje socialnih in tržnih predlogov prineslo znatne koristi za sektor cestnega prometa.
English: The Commission will now closely assess the climate, environmental, and single market functioning impact of these two aspects.
Slovenian: Komisija bo zdaj natančno ocenila učinek teh dveh vidikov na podnebje, okolje in delovanje enotnega trga.
English: The Council position does not go as far as the Commission proposal.
Slovenian: Stališče Sveta ne gre tako daleč kot predlog Komisije.
English: This should improve enforceability of the cabotage rules when compared to the present situation.
Slovenian: S tem bi se morala v primerjavi s sedanjim stanjem izboljšati izvršljivost pravil o kabotaži.
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.
Slovenian: 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.
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.
Slovenian: Kar zadeva prevoz potnikov, namerava Komisija nadalje preučiti organizacijo časa vožnje in počitka, da bi ocenila, ali so potrebna posebna pravila.
English: Establishment criteria relating to drivers (Rome I)
Slovenian: Merila sedeža za voznike (Rim I)
English: Date of transmission of the proposal to the European Parliament and to the Council:
Slovenian: Datum predložitve predlogov Evropskemu parlamentu in Svetu:
English: Since the two measures in question are part of the Council position, the Commission confirms the position taken in the declaration.
Slovenian: Ker sta zadevna ukrepa del stališča Sveta, Komisija potrjuje stališče iz izjave.
English: It leaves enough margin so as to not unduly restrict the freedom of operators when hiring personnel.
Slovenian: Zagotavlja dovolj manevrskega prostora, da ne bi neupravičeno omejevali svobode prevoznikov pri zaposlovanju osebja.
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.
Slovenian: 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.
English: Rules on cabotage
Slovenian: Pravila o kabotaži
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
Slovenian: (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
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.
Slovenian: „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.
English: Implementation deadlines / dates of application
Slovenian: Roki za izvedbo/datumi začetka uporabe
English: However, the Commission maintains its reservations concerning two of the measures included in the Council position.
Slovenian: Vendar Komisija ohranja pridržke glede dveh ukrepov iz stališča Sveta.
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.
Slovenian: Z uporabo sistema IMI se bo dodatno zmanjšalo upravno breme za uprave in prevozna podjetja, kar bo prispevalo k splošnemu cilju svežnja o mobilnosti.
English: This was intended to improve the working conditions of drivers and ensure that they have good conditions to rest.
Slovenian: Namen tega je bil izboljšati delovne pogoje voznikov in zagotoviti, da imajo dobre pogoje za počitek.
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.
Slovenian: 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.
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).
Slovenian: 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).
English: A recital clarifies that "drivers are free to choose where to spend their rest period".
Slovenian: V uvodni izjavi je pojasnjeno, da „vozniki lahko prosto izbirajo, kje želijo preživeti čas počitka".
English: Ban to take the regular weekly rest in the cabin of the vehicle and safe and secure parking areas
Slovenian: Prepoved rednega tedenskega počitka v kabini vozila ter varna in varovana parkirišča
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.
Slovenian: 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.
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.
Slovenian: Namen tega je bil preprečiti, da bi vozniki delali v tujini dolga obdobja, brez možnosti povratka k svojim družinam.
English: Application of posting rules to road transport
Slovenian: Uporaba pravil o napotitvi v cestnem prometu
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.
Slovenian: Komisija je predlagala tudi posebne upravne zahteve za uporabo pravil o napotitvi v cestnem prometu, da bi se izognili nepotrebnemu upravnemu bremenu za prevoznike.
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.
Slovenian: 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.
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:
Slovenian: 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:
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).
Slovenian: 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).