natgillin/translations-raw huggingface dataset:
It shall apply from six months after the date of publication in the Official Journal of the European Union of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014 or 1 April 2018, whichever is the later.
Uporabljati se začne šest mesecev po objavi obvestila iz člena 82(3) Uredbe (EU) št. 536/2014 v Uradnem listu Evropske unije ali s 1. aprilom 2018, pri čemer se upošteva poznejši datum.
Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (See page 44 of this Official Journal).
Direktiva Komisije (EU) 2017/1572 z dne 15. septembra 2017 o dopolnitvi Direktive 2001/83/ES Evropskega parlamenta in Sveta glede načel in smernic dobre proizvodne prakse za zdravila za uporabo v humani medicin (glej stran 44 tega Uradnega lista).
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p.
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 311, 28.11.2001, str. 67).
67).
Direktiva Komisije 2003/94/ES z dne 8. oktobra 2003 o določitvi načel in smernic dobre proizvodne prakse v zvezi z zdravili za uporabo v humani medicini in zdravili za uporabo v humani medicini v preskušanju (UL L 262, 14.10.2003, str. 22).
Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p.
Direktiva 2001/20/ES evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi (UL L 121, 1.5.2001, str. 34).
Commission Implementing Regulation (EU) 2017/1570
Izvedbena uredba Komisije (EU) 2017/1570
amending Implementing Regulation (EU) 2017/366 and Implementing Regulation (EU) 2017/367 imposing definitive countervailing and anti-dumping duties on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China and repealing Implementing Decision 2013/707/EU confirming the acceptance of an undertaking offered in connection with the anti-dumping and anti-subsidy proceedings concerning imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China for the period of application of definitive measures
o spremembi Izvedbene uredbe (EU) 2017/366 in Izvedbene uredbe (EU) 2017/367 o uvedbi dokončnih izravnalnih dajatev in dokončne protidampinške dajatve na uvoz fotonapetostnih modulov iz kristalnega silicija in njihovih ključnih sestavnih delov (tj. celic) s poreklom iz Ljudske republike Kitajske ali ki so od tam poslani, ter razveljavitvi Izvedbenega sklepa št. 2013/707/EU o potrditvi sprejetja zaveze, ponujene v okviru protidampinškega in protisubvencijskega postopka v zvezi z uvozom fotonapetostnih modulov iz kristalnega silicija in njihovih ključnih sestavnih delov (tj. celic) s poreklom iz Ljudske republike Kitajske ali ki so od tam poslani, za obdobje uporabe dokončnih ukrepov
Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union [1] (‘the basic anti-dumping Regulation’), and in particular Article 11(3) and Article 8(9) thereof,
ob upoštevanju Uredbe (EU) 2016/1036 Evropskega parlamenta in Sveta z dne 8. junija 2016 o zaščiti proti dampinškemu uvozu iz držav, ki niso članice Evropske unije [1] („osnovna protidampinška uredba“), ter zlasti členov 11(3) in 8(9) Uredbe,
Having regard to Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union [2] (‘the basic anti-subsidy Regulation’), and in particular Article 19 and Article 13(9) thereof,
ob upoštevanju Uredbe (EU) 2016/1037 Evropskega parlamenta in Sveta z dne 8. junija 2016 o zaščiti proti subvencioniranemu uvozu iz držav, ki niso članice Evropske unije [2] („osnovna protisubvencijska uredba“), ter zlasti člena 19 in člena 13(9) Uredbe,
By Regulation (EU) No 1238/2013 [3] the Council imposed a definitive anti-dumping duty on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China (or ‘PRC’) (the original anti-dumping investigation).
Svet je z Uredbo (EU) št. 1238/2013 [3] uvedel dokončno protidampinško dajatev na uvoz fotonapetostnih modulov iz kristalnega silicija in njihovih ključnih sestavnih delov (tj. celic) s poreklom iz Ljudske republike Kitajske (ali „LRK“) ali ki so od tam poslani („prvotna protidampinška preiskava“).
The measures took the form of an ad valorem duty ranging between 27,3 % and 64,9 %.
Ukrepi so bili uvedeni kot dajatev ad valorem v višini od 27,3 % do 64,9 %.
By Regulation (EU) No 1239/2013 [4], the Council imposed definitive countervailing duties up to 11,5 % on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China (the original anti-subsidy investigation).
Svet je z Uredbo (EU) št. 1239/2013 [4] uvedel dokončno izravnalno dajatev v višini do 11,5 % na uvoz fotonapetostnih modulov iz kristalnega silicija in njihovih ključnih sestavnih delov (tj. celic) s poreklom iz Ljudske republike Kitajske ali ki so od tam poslani („prvotna protidampinška preiskava“).
The China Chamber of Commerce for Import and Export of Machinery and Electronic Products (‘CCCME’) submitted, on behalf of a group of exporting producers, a price undertaking to the Commission.
Kitajska gospodarska zbornica za uvoz in izvoz strojev in elektronskih izdelkov („CCCME“) je v imenu skupine proizvajalcev izvozniku Komisiji predložila cenovno zavezo.
By Decision 2013/423/EU [5], the Commission accepted that price undertaking with regard to the provisional anti-dumping duty.
Komisija je s Sklepom 2013/423/EU [5] sprejela navedeno cenovno zavezo glede začasne protidampinške dajatve.
Following the notification of an amended version of the price undertaking by a group of exporting producers together with the CCCME, the Commission confirmed by Implementing Decision 2013/707/EU [6] the acceptance of the price undertaking as amended for the period of application of anti-dumping and countervailing definitive measures.
Komisija je, potem ko sta jo skupina proizvajalcev izvoznikov in CCCME uradno obvestili o spremenjeni različici cenovne zaveze, z Izvedbenim sklepom 2013/707/EU [6] potrdila sprejetje cenovne zaveze, kot je bila spremenjena za obdobje uporabe dokončne protidampinške dajatve in dokončnih izravnalnih dajatev.
The Commission also adopted a Decision clarifying the implementation of the undertaking [7] and 11 Regulations withdrawing the acceptance of the undertaking for several exporting producers [8].
Komisija je prav tako sprejela sklep o pojasnilih v zvezi z izvajanjem zaveze [7] in enajst uredb o umiku sprejetja zaveze več proizvajalcev izvoznikov [8].
By Implementing Regulation (EU) 2016/12 [9], following a partial interim review limited in scope to the benchmark used as a reference for the price adaption mechanism set out in the above undertaking, the Commission terminated the partial interim review without amending the measures.
Komisija je z Izvedbeno uredbo (EU) 2016/12 [9] po delnem vmesnem pregledu, ki je bil po obsegu omejen na referenčno vrednost, ki se uporablja za mehanizem prilagoditve cen, določenih v navedeni zavezi, ta pregled zaključila, ne da bi spremenila ukrepe.
By Implementing Regulations (EU) 2016/185 [10] and (EU) 2016/184 [11], the Commission extended the definitive anti-dumping and countervailing duties on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China to imports of crystalline silicon photovoltaic modules and key components (i.e. cells) consigned from Malaysia and Taiwan with the exception of a number of genuine producers.
Komisija je z izvedbenima uredbama (EU) 2016/185 [10] in (EU) 2016/184 [11] dokončno protidampinško in dokončno izravnalno dajatev na uvoz fotonapetostnih modulov iz kristalnega silicija in njihovih ključnih sestavnih delov (tj. celic) s poreklom iz Ljudske republike Kitajske ali ki so od tam poslani, razširila na uvoz fotonapetostnih modulov iz kristalnega silicija in njihovih ključnih sestavnih delov (tj. celic), poslanih iz Malezije ali Tajvana, razen za nekatere dejanske proizvajalce.
By Implementing Regulation (EU) 2017/367 [12] the Commission extended the definitive anti-dumping duty on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China following an expiry review pursuant to Article 11(2) of the basic anti-dumping Regulation and terminated the partial interim review investigation pursuant to Article 11(3) of the basic anti-dumping Regulation (‘expiry review anti-dumping investigation’).
Komisija je po pregledu zaradi izteka ukrepov v skladu s členom 11(2) osnovne protidampinške uredbe z Izvedbeno uredbo (EU) 2017/367 [12] razširila dokončno protidampinško dajatev na uvoz fotonapetostnih modulov iz kristalnega silicija in njihovih ključnih sestavnih delov (tj. celic) s poreklom iz Ljudske republike Kitajske ali ki so od tam poslani in zaključila preiskavo v zvezi z delnim vmesnim pregledom v skladu s členom 11(3) osnovne protidampinške uredbe („protidampinška preiskava v zvezi s pregledom zaradi izteka ukrepa“).
By Implementing Regulation (EU) 2017/366 [13] the Commission extended a definitive countervailing duty on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China following an expiry review pursuant to Article 18(2) of the basic anti-subsidy Regulation and terminated the partial interim review investigation pursuant to Article 19(3) of the basic anti-subsidy Regulation (expiry review anti-subsidy investigation) (the expiry review anti-dumping investigation and the expiry review anti-subsidy investigation are hereinafter commonly referred as ‘expiry review investigations’).
Komisija je z Izvedbeno uredbo (EU) 2017/366 [13] razširila dokončno izravnalno dajatev na uvoz fotonapetostnih modulov iz kristalnega silicija in njihovih ključnih sestavnih delov (tj. celic) s poreklom iz Ljudske republike Kitajske ali ki so od tam poslani po pregledu zaradi izteka ukrepov v skladu s členom 18(2) osnovne protisubvencijske uredbe ter zaključila preiskavo v zvezi z delnim vmesnim pregledom v skladu s členom 19(3) osnovne protisubvencijske uredbe („protisubvencijska preiskava v zvezi s pregledom zaradi izteka ukrepov“) („protidampinška preiskava v zvezi s pregledom zaradi izteka ukrepa“ in „protisubvencijska preiskava v zvezi s pregledom zaradi izteka ukrepa“ sta v nadaljnjem besedilu skupaj imenovani „preiskavi v zvezi s pregledom zaradi izteka ukrepov“).
By Implementing Decision (EU) 2017/615 [14], the Commission accepted the proposal from the exporting producers to maintain the minimum import price (‘MIP’) at the level applicable in March 2017.
Komisija je z Izvedbenim sklepom (EU) 2017/615 [14] sprejela predlog proizvajalcev izvoznikov o ohranitvi minimalne uvozne cene („MIP“) na stopnji, ki se je uporabljala marca 2017.
On 3 March 2017 the Commission initiated ex officio this partial interim review limited to the form of the measures pursuant to Article 11(3) of the basic anti-dumping Regulation and Article 19 of the basic anti-subsidy Regulation [15] (‘the Notice of Initiation’).
Komisija je 3. marca 2017 po uradni dolžnosti začela ta delni vmesni pregled, omejen na obliko ukrepov, v skladu s členom 11(3) osnovne protidampinške uredbe in členom 19 osnovne protisubvencijske uredbe [15] („obvestilo o začetku“).
The Commission's intention to initiate this review was announced in the Union Interest chapter of the two expiry review regulations as a means to strike the right balance between the diverging interests that the expiry review investigations had found to exist on the solar market for the remaining period of the measures' duration [16].
Namera Komisije, da začne ta pregled, je bila objavljena v poglavju o interesu Unije obeh uredb o pregledu zaradi izteka ukrepov kot način za dosego pravega ravnovesja med različnimi interesi, odkritimi pri preiskavah v zvezi s pregledom zaradi izteka ukrepov na trgu sončne energije za preostalo obdobje trajanja ukrepov [16].
In addition, the Commission informed the CCCME, known exporting producers in the PRC and the PRC authorities of the investigations and invited them to participate.
Poleg tega je o začetku preiskav obvestila CCCME, znane proizvajalce izvoznike v LRK in organe LRK ter jih povabila k sodelovanju.
On 19 July 2017, the Commission disclosed to all interested parties the essential facts and considerations of the investigation and invited them to comment within 14 days.
Komisija je 19. julija 2017 vsem zainteresiranim stranem razkrila bistvena dejstva in pomisleke o preiskavi ter jih pozvala, naj ji v 14 dneh pošljejo pripombe.
The Commission received replies, within the deadline, from 20 interested parties, namely the association of the Union producers, seven Union producers, two associations of users, four upstream and downstream interested parties in the Union, four Chinese exporting producers, the CCCME and the Government of the PRC.
V roku je prejela odgovore 20 zainteresiranih strani, in sicer združenja proizvajalcev Unije, sedmih proizvajalcev Unije, dveh združenj uporabnikov, štirih zainteresiranih strani, ki so višje in nižje v prodajni verigi, v Uniji, štirih kitajskih proizvajalcev izvoznikov, CCCME in vlade LRK.
Subsequently, the Commission sent an additional disclosure document to all interested parties and invited them to comment.
Komisija je pozneje vsem zainteresiranim stranem poslala dodatni dokument o razkritju in jih pozvala, naj predložijo pripombe.
This redisclosure was limited to only two elements of the methodology for establishing the MIP and a provision regarding the entry into force of this regulation.
Ponovno razkritje je bilo omejeno na dva elementa metodologije za določitev MIP in določbo v zvezi z začetkom veljavnosti te uredbe.
The Commission sent a request for information on 21 March 2017 to more than 100 interested parties.
Komisija je 21. marca 2017 več kot 100 zainteresiranim stranem poslala zahtevo po informacijah.
It received replies from 26 interested parties: two Union producers; five European upstream and downstream companies as well as three associations; the CCCME; the Government of the PRC; 13 exporting producers and one Malaysian exporting producer.
Prejela je pripombe 26 zainteresiranih strank: dveh proizvajalcev Unije; petih evropskih podjetij višje in nižje v prodajni verigi ter treh združenj; CCCME; vlade LRK; 13 proizvajalcev izvoznikov in enega malezijskega proizvajalca izvoznika.
Variable duty under the form of a minimum import price
Spremenljiva dajatev v obliki najnižje uvozne cene
The current form of the measures is an ad valorem anti-dumping duty set out in Article 1 of Implementing Regulation (EU) 2017/367 and ad valorem countervailing duty set out in Article 1 of Implementing Regulation (EU) 2017/366.
Sedanja oblika ukrepov je protidampinška dajatev ad valorem, določena v členu 1 Izvedbene uredbe (EU) 2017/367, in izravnalna dajatev ad valorem, določena v členu 1 Izvedbene uredbe (EU) 2017/366.
A price undertaking was offered by a group of cooperating exporting producers together with the CCCME and accepted by the Commission.
Skupina sodelujočih proizvajalcev izvoznikov je skupaj s CCCME ponudila cenovno zavezo, Komisija pa jo je sprejela.
One of the core elements of the undertaking is the MIP which is subject to a quarterly adjustment mechanism.
Ena od ključnih delov zaveze je MIP, ki je predmet četrtletnega mehanizma prilagoditve.
Under the price undertaking accepted by the Commission, the MIP for the modules and cells is adjusted quarterly by reference to international spot prices of modules including Chinese prices as reported by the Bloomberg database.
V skladu s cenovno zavezo, ki jo je Komisija sprejela, se MIP modulov in celic prilagodi vsako četrtletje glede na mednarodne promptne cene modulov, vključno s kitajskimi cenami, kot jih navaja Bloombergova podatkovna zbirka.
The undertaking was initially accepted from more than 120 companies/company groups.
Zavezo je sprva sprejelo več kot 120 družb/skupin podjetij.
In the meantime, the Commission withdrew its acceptance of the undertaking for 14 companies.
Komisija je med tem preklicala sprejetje zaveze za 14 družb.
Twelve of these were found to have breached the undertaking while the remaining two companies had business models that made it impracticable to monitor their compliance with the undertaking.
Pri 12 izmed njih je bilo ugotovljeno, da so kršile zavezo, preostali dve pa sta imeli poslovna modela, zaradi katerih spremljanje njune združljivosti z zavezo ni bilo izvedljivo.
In addition, 15 other Chinese companies voluntarily withdrew from the undertaking [17].
Poleg tega se je 15 drugih kitajskih družb prostovoljno umaknilo iz zaveze [17].
When reviewing the interests of unrelated importers and non-vertically integrated Union module manufactures in the expiry review investigations, the Commission received complaints about the heavy administrative burden put on them, while the Union producers complained about ongoing circumvention [18].
Pri preiskavah v zvezi s pregledom zaradi izteka ukrepov je Komisija med pregledom interesov nepovezanih uvoznikov in proizvajalcev modulov Unije, ki niso vertikalno integrirani, prejela pritožbe glede velikega upravnega bremena, ki jim je naloženo, medtem ko so se proizvajalci Unije pritožili glede tekočega izogibanja [18].
For instance, both the CCCME and the exporting producers have to submit monthly and quarterly reports to the Commission for the monitoring of the undertaking.
CCCME in proizvajalci izvozniki morajo Komisiji na primer predložiti mesečna in četrtletna poročila o spremljanju zaveze.
These reports have been essential to verify that the annual level is not exceeded and to carry out a first analysis whether the reported sales transactions comply with the MIP.
Ta poročila so bistvena za preverjanje, da letna stopnja ni presežena, in izvedbo prve analize, ali so prodajne transakcije, o katerih se poroča, skladne z MIP.
All the interested parties who replied to the request for information considered that a variable duty in the form of a MIP (‘variable duty MIP’) is a more appropriate form of measures than the previous ad valorem duty coupled with the price undertaking (‘undertaking MIP’).
Po mnenju vseh zainteresiranih strani, ki so odgovorile na zahtevo po informacijah, je spremenljiva dajatev v obliki minimalne uvozne cene („spremenljiva dajatev v obliki MIP“) ustreznejša oblika ukrepov od prejšnje dajatve ad valorem, združene s cenovno zavezo („zaveza glede MIP“).
In particular the interested parties considered that a variable duty MIP will be more transparent, predictable and enforceable.
Zainteresirane strani so zlasti menile, da bo spremenljiva dajatev v obliki MIP preglednejša, bolj predvidljiva in bolj izvedljiva.
The interested parties considered that a variable duty MIP would reduce the administrative burden and costs for the importers.
Po njihovem mnenju bi morala spremenljiva dajatev v obliki MIP zmanjšati upravno breme in stroške uvoznikov.
Some of the interested parties encouraged the Commission to ensure that the new form of the measures does not impose significant restrictions on the Union companies in terms of their business deals with manufacturers worldwide.
Nekatere zainteresirane strani so Komisijo pozvale, naj zagotovi, da se z novo obliko ukrepov družbam Unije ne bodo naložile precejšnje omejitve v smislu njihovega poslovanja s proizvajalci po vsem svetu.
In their view, these restrictions resulted in significant risks, liabilities, expensive due diligence and delays for the Union importers.
Po njihovem mnenju so zaradi teh omejitev nastali precejšnja tveganja, obveznosti, draga primerna skrbnost in zamude za uvoznike Unije.
The same parties also claimed that the existing cap on volumes of imports contained in the undertaking should be removed as it added further administrative burden and did not serve any purpose as the imports were anyway significantly below it.
Iste zainteresirane strani so tudi trdile, da bi bilo treba obstoječo omejitev obsega uvoza, ki jo vsebuje zaveza, odpraviti, saj je nalagala dodatno upravno breme in ni služila nobenemu namenu, saj je bil uvoz vedno precej pod njo.
The Commission accepted these points.
Komisija se je strinjala s temi točkami.
It considered that the measures should take the form of a variable duty MIP.
Menila je, da bi morali biti ukrepi oblikovani kot spremenljiva dajatev v obliki MIP.
The variable duty MIP means that eligible [19] imports with a declared value at, or above, the MIP would not be subject to duties and customs authorities will levy duties immediately if the product is imported at a price below the MIP.
Spremenljiva dajatev v obliki MIP pomeni, da za upravičeni [19] uvoz z deklarirano vrednostjo, ki je enaka MIP ali višja od nje, dajatve ne bi več veljale, carinski organi pa bi obračunali dajatve takoj, ko se izdelek uvozi po ceni, ki je nižja od MIP.
The variable duty MIP will alleviate the administrative burden on the exporting producers, the importers and the Commission as the monthly reporting by the CCCME and the quarterly reporting to the Commission by all the exporting producers will no longer be necessary.
S spremenljivo dajatvijo v obliki MIP se bo zmanjšalo upravno breme proizvajalcev izvoznikov, uvoznikov in Komisije, saj ne bo več potrebno, da bi Komisiji CCCME poročala mesečno, vsi proizvajalci izvozniki pa četrtletno.
In addition, the level of the variable duty MIP will be published.
Poleg tega bo stopnja spremenljive dajatve v obliki MIP objavljena.
This will provide transparency and enable a better enforcement of the measures.
Tako se bo zagotovila preglednost in omogočilo boljše izvajanje ukrepov.
The Commission also agreed with the interested parties that the variable duty MIP should not be accompanied by a list of additional restrictions and caps.
Komisija se je z zainteresiranimi stranmi tudi dogovorila, da spremenljive dajatve v obliki MIP ne bi smel spremljati seznam dodatnih ovir in omejitev.
Indeed, the exports have always been well below the annual level.
Dejansko je bil uvoz vedno precej pod letno stopnjo.
It will be up to the Union customs authorities to verify if the companies involved did not enter into any cross compensation agreements and other arrangements circumventing the MIP.
Carinski organi Unije bodo morali preveriti, ali sodelujoče družbe niso sklenile kakršnih koli sporazumov o navzkrižni kompenzaciji in drugih dogovorov, s katerimi bi se izogibale MIP.
Distinction between mono-crystalline and multi-crystalline products
Razlika med monokristalnimi in polikristalnimi izdelki
Several interested parties companies, including the Union producers, considered that there should be separate variable duty MIP for different product types.
Več zainteresiranih družb, vključno s proizvajalci Unije, je menilo, da bi morala za različne vrste izdelkov obstajati ločena spremenljiva dajatev v obliki MIP.
Most of the interested parties also considered that the best differentiation is based on technology i.e. mono-crystalline vs multi-crystalline (sometimes also called poly-crystalline) products.
Večina zainteresiranih strani je tudi menila, da bi bilo najbolje razlikovati na podlagi tehnologije, tj. monokristalni v primerjavi s polikristalnimi izdelki (ki so včasih imenovani tudi multikristalni izdelki).