natgillin/translations-raw huggingface dataset:
Taking into account that the possibility to adopt Union-wide derogations, for a transitional period, is to be given to the Commission in relation to national derogations from Directives 90/385/EEC and 93/42/EEC, certain amendments to the relevant provisions of Regulation (EU) 2017/745 are necessary.
Ob upoštevanju, da mora imeti Komisija v prehodnem obdobju možnost, da sprejme odstopanja na ravni Unije v zvezi z nacionalnimi odstopanji od direktiv 90/385/EGS in 93/42/EGS, so potrebne nekatere spremembe ustreznih določb Uredbe (EU) 2017/745.
Taking into account the COVID-19 outbreak and the associated public health crisis, its epidemiological development, as well as the additional resources required by Member States, health institutions, economic operators and other relevant parties, it is appropriate to defer the application of those provisions of Regulation (EU) 2017/745 by one year.
Ob upoštevanju izbruha COVID-19 in s tem povezane javnozdravstvene krize, epidemiološkega razvoja ter dodatnih virov, ki jih potrebujejo države članice, zdravstvene ustanove, gospodarski subjekti in druge zadevne strani, je primerno, da se začetek uporabe teh določb Uredbe (EU) 2017/745 odloži za eno leto.
Since the objectives of this Regulation, namely to defer the application of certain provisions of Regulation (EU) 2017/745 and to allow for the extension of the validity of national derogations, authorised under Directive 90/385/EEC or 93/42/EEC, to the territory of the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of their scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (‘TEU').
Ker ciljev te uredbe, in sicer odložiti začetek uporabe nekaterih določb Uredbe (EU) 2017/745 in omogočiti razširitev veljavnosti nacionalnih odstopanj, odobrenih v skladu z Direktivo 90/385/EGS ali Direktivo 93/42/EGS, na ozemlje Unije, države članice ne morejo zadovoljivo doseči, temveč se zaradi njunega obsega in učinkov lažje dosežeta na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji (PEU).
Both Directives 90/385/EEC and 93/42/EEC, as well as Regulation (EU) 2017/745, empower national competent authorities, on a duly justified request, to authorise the placing on the market of medical devices for which the relevant conformity assessment procedures have not been carried out, but the use of which is in the interest of protection of health, or in the interest of public health or patient safety or health respectively (‘national derogation').
Direktivi 90/385/EGS in 93/42/EGS ter Uredba (EU) 2017/745 nacionalne pristojne organe pooblaščajo, da na podlagi ustrezno utemeljene zahteve odobrijo dajanje na trg medicinskih pripomočkov, za katere niso bili opravljeni ustrezni postopki ugotavljanja skladnosti, vendar je njihova uporaba v interesu varovanja zdravja ali v interesu javnega zdravja ali pa varnosti ali zdravja pacientov (v nadaljnjem besedilu: nacionalno odstopanje).
Regulation (EU) 2020/402, and its amendment, apply for a limited period of 6 weeks.
Uredba (EU) 2020/402 in njena sprememba se uporabljata za omejeno obdobje šestih tednov.
This is the case notably for the Principality of Monaco (4) .
To velja zlasti za Kneževino Monako (4) .
The main objective of such system would be to protect public health within the Union.
Glavni cilj takega sistema bi bil varovanje javnega zdravja v Uniji.
Pursuant to Article 127(3) of the Withdrawal Agreement, during the transition period, the United Kingdom of Great Britain and Northern Ireland is to be considered as a Member State, and not as a third country.
V skladu s členom 127(3) sporazuma o izstopu se v prehodnem obdobju Združeno kraljestvo Velika Britanija in Severna Irska šteje kot država članica in ne kot tretja država.
These initiatives are proving successful, and equipment is planned to be made available 2 weeks after the Member States sign the contracts with the bidders.
Te pobude so se izkazale za uspešne, oprema pa naj bi bila na voljo dva tedna po tem, ko države članice podpišejo pogodbe s ponudniki.
On that basis, a need may arise to review the scope of Annex I and products covered by this Regulation.
Na podlagi tega bi se lahko pojavila potreba po pregledu področja uporabe Priloge I in izdelkov, ki jih zajema ta uredba.
These measures, aimed at protecting health and impacting on trade, should be targeted, proportionate, transparent and temporary.
Ti ukrepi, katerih cilj je varovati zdravje in vplivati na trgovino, bi morali biti ciljno usmerjeni, sorazmerni, pregledni in začasni.
This concerns the territories of Büsingen, Heligoland, Livigno, Ceuta and Melilla.
To zadeva naslednja ozemlja: Büsingen, Helgoland, Livigno ter Ceuta in Melilla.
This is particularly the case of the member States of the European Free Trade Association, and the Western Balkans which are engaged in a process of deep integration with the Union.
To še zlasti velja za države članice Evropskega združenja za prosto trgovino in države Zahodnega Balkana, ki sodelujejo v procesu tesnega povezovanja z Unijo.
It is therefore appropriate to exclude such countries from the scope of application of this Regulation.
Zato je primerno, da se te države izključijo iz področja uporabe te uredbe.
The Commission finalised a joint procurement for personal protective equipment, in which 25 Member States took part.
Komisija je zaključila skupno javno naročilo za osebno zaščitno opremo, pri katerem je sodelovalo 25 držav članic.
A review of the scope should be based on a continuous assessment of needs of critical equipment related to the fight against COVID-19 and their potential shortages.
Pregled področja uporabe bi moral temeljiti na stalnem ocenjevanju potreb po kritični opremi za boj proti COVID-19 in njenega morebitnega pomanjkanja.
Continuous efforts are being made to help ensuring urgent and adequate provision of protective equipment throughout the EU.
Po vsej EU potekajo stalna prizadevanja za pomoč pri zagotavljanju nujne in ustrezne zaščitne opreme.
The measures provided for in this Regulation should not apply to trade between the EU Member States.
Ukrepi iz te uredbe se ne bi smeli uporabljati za trgovino med državami članicami EU.
The production capacities of personal protective equipment have been ramped-up.
Proizvodne zmogljivosti za osebno zaščitno opremo so se močno povečale.
An export authorisation system should remedy or prevent a situation of a shortage of essential products within the borders of the Union.
Sistem izvoznih dovoljenj bi moral odpraviti ali preprečiti pomanjkanje bistvenih izdelkov znotraj meja Unije.
Union measures should therefore be proportionate and ensure that exports remain possible, subject to a prior authorisation.
Ukrepi Unije bi morali zato biti sorazmerni in zagotoviti, da izvoz ostane mogoč s predhodnim dovoljenjem.
This Regulation should apply to exports of Union goods from the customs territory of the Union.
Ta uredba bi se morala uporabljati za izvoz blaga Unije s carinskega območja Unije.
The single market for medical and personal protective equipment is closely integrated beyond the boundaries of the Union, and so are its production value chains and distribution networks.
Enotni trg za zdravstveno in osebno zaščitno opremo je tesno povezan onkraj meja Unije, kot tudi njegove proizvodne vrednostne verige in distribucijska omrežja.
Entirely financed by the Commission via direct grants, this reserve will be hosted in one or several Member States.
Te zaloge v celoti financira Komisija z neposrednimi nepovratnimi sredstvi in se bodo skladiščile v eni ali več državah članicah.
In a Joint Statement of 26 March the members of the European Council underlined that the adoption of the decision on the authorisation for export of PPE should lead to the full and effective lifting of all forms of internal bans or restrictions.
Člani Evropskega sveta so v skupni izjavi z dne 26. marca poudarili, da bi s sprejetjem sklepa o dovoljenjih za izvoz osebne zaščitne opreme moralo biti mogoče v celoti umakniti vse oblike notranjih prepovedi ali omejitev.
The CN codes should be given for information only.
Oznake KN bi bilo treba navesti samo informativno.
The demand for certain types of PPE has especially led to shortages on the internal market.
Predvsem povpraševanje po nekaterih vrstah osebne zaščitne opreme je povzročilo pomanjkanje na notranjem trgu.
As the epidemiological crisis caused by the COVID-19 disease continues, the demand within the Union for personal protective equipment (‘PPE'), which consists of protective masks (and surgical masks), gloves, goggles, face-shields, and overalls, remains very high and is even continuously increasing.
Ker se epidemiološka kriza zaradi bolezni COVID-19 nadaljuje, je povpraševanje po osebni zaščitni opremi, ki zajema zaščitne (in kirurške) maske, rokavice, očala, zaščito za obraz in kombinezone, v Uniji še vedno zelo veliko in se celo še povečuje.
Special attention should be given to the products covered by the Joint Procurement as well as requested under the Union Civil Protection Mechanism such as other types of PPE, ventilators and laboratory products (test kits).
Posebno pozornost bi bilo treba nameniti izdelkom, ki jih zajemajo skupna javna naročila, in tistim, ki se zahtevajo v okviru mehanizma Unije na področju civilne zaščite, kot so druge vrste osebne zaščitne opreme, ventilatorji in laboratorijski izdelki (kompleti za testiranje).
It is likewise appropriate to exclude from the export authorisation requirement the overseas countries and territories listed in Annex II to the Treaty, as well as the Faeroe Islands, Andorra, San Marino, the Vatican City and Gibraltar, since they have a particular dependency on the metropolitan supply chains of the Member States to which they are attached or on the supply chains of neighbouring Member States, respectively.
Prav tako je primerno, da se iz obveznosti predložitve izvoznega dovoljenja izključijo čezmorske države in ozemlja iz Priloge II k Pogodbi kot tudi Ferski otoki, Andora, San Marino, Vatikanska mestna država in Gibraltar, saj so posebej odvisni od metropolitanskih dobavnih verig držav članic, ki jim pripadajo, oziroma od dobavnih verig sosednjih držav članic.
The administrative modalities for these authorisations should be left to the discretion of the Member States during the time of this temporary system.
Odločitve glede upravnih ureditev za izdajo navedenih dovoljenj bi bilo treba v času tega začasnega sistema prepustiti državam članicam.
Therefore countries that form part of that customs territory need not be exempted in order to receive unrestricted shipments from within the Union.
Zato je treba države, ki so del navedenega carinskega območja, izvzeti, da bi lahko prejemale neomejene pošiljke iz Unije.
In deciding whether to grant an export authorisation, the Member States should also take into consideration the fulfilment of a supply obligation under joint procurement or rescEU by the Union and the Member States, the support of the activities of the World Health Organization (WHO), the support of EU-level coordinated responses to crisis situations or the request for assistance by third countries or international organisations.
Države članice bi morale pri odločanju, ali odobrijo izvozno dovoljenje, upoštevati tudi izpolnjevanje obveznosti glede dobave v okviru skupnega javnega naročanja ali rescEU Unije in držav članic, podporo dejavnostim Svetovne zdravstvene organizacije (WHO), podporo usklajenim odzivom na krizne razmere na ravni EU ali prošnjo za pomoč s strani tretjih držav ali mednarodnih organizacij.
Conversely, territories of Member States specifically excluded from the customs territory of the Union should not fall under the requirement of export authorisation and should therefore be exempted as well.
Nasprotno pa za ozemlja držav članic, ki so izrecno izključena s carinskega območja Unije, ne bi smela veljati obveznost izvoznega dovoljenja in bi jih bilo zato tudi treba izvzeti.
Based on the principle of international solidarity, Member States should authorise exports to enable the provisions of emergency supplies in the context of humanitarian aid.
Države članice bi na podlagi načela mednarodne solidarnosti morale dovoliti izvoz, da omogočijo zagotavljanje nujne oskrbe v okviru humanitarne pomoči.
Under the Union Civil Protection Mechanism (UCPM), the European Commission has decided to create a strategic rescEU stockpile of medical equipment such as ventilators and protective masks to help EU countries in the context of the COVID-19 pandemic.
Evropska komisija se je odločila, da v okviru mehanizma Unije na področju civilne zaščite oblikuje strateško zalogo medicinske opreme v okviru rescEU, kot so ventilatorji in zaščitne maske, da bi državam članicam EU pomagala v pandemiji COVID-19.
The degree of market integration for the products concerned between parts of the customs territory of the Union and other countries or territories, whether achieved under an arrangement establishing a free-trade area or for other reasons such as geographic proximity or historic ties, should also be considered.
Upoštevati bi morale tudi stopnjo povezanosti trga za zadevne izdelke med deli carinskega območja Unije in drugimi državami in ozemlji, doseženo na podlagi dogovora o vzpostavitvi območja proste trgovine ali zaradi drugih razlogov kot so geografska bližina ali zgodovinske vezi.
The Commission also set up a Clearing House, including for PPE, with the objective to coordinate efforts to match supply and demand in the EU, and facilitate an adequate functioning of the internal market.
Komisija je vzpostavila tudi posredovalni mehanizem, vključno za osebno zaščitno opremo, da bi koordinirala prizadevanja za uskladitev ponudbe in povpraševanja v EU ter pomagala pri ustreznem delovanju notranjega trga.
In contrast, Member States should not authorise exports that would create speculative distortion and serve stockpiling and hoarding of essential equipment by those with little or no objective need.
Po drugi strani pa države članice ne bi smele dovoliti izvoza, ki bi ustvaril špekulativno izkrivljanje ter omogočil ustvarjanje in kopičenje nujne opreme, čeprav za to objektivno obstajajo majhne potrebe ali jih sploh ni.
In order to ensure coherence, the description of the types of PPE subject to this authorisation system laid down by this Regulation should be aligned with the corresponding specifications of the equipment subject to the Joint Procurement, which has identified the specific needs in the Union.
Za zagotovitev skladnosti bi bilo treba opis nekaterih vrst osebne zaščitne opreme, za katere velja ta sistem dovoljenj, določen s to uredbo, uskladiti z ustreznimi specifikacijami za opremo, ki je predmet skupnega javnega naročila, v katerem so se opredelile posebne potrebe v Uniji.
Member States do however not have to contact the Clearing House in the case of authorisations for emergency supplies in the context of humanitarian aid.
Vendar se državam članicam ni treba obrniti na posredovalni mehanizem v primeru dovoljenj za nujno oskrbo v okviru humanitarne pomoči.
Authorisations should be granted only to the extent that the volume of exports is not such that it poses a threat to the availability of PPE on the market of the Member State in question or elsewhere in the Union for the purpose of meeting the objective of this Regulation.
Izvozna dovoljenja se lahko izdajo le, če obseg izvoza ne ogroža razpoložljivosti osebne zaščitne opreme na trgu zadevne države članice ali drugje v Uniji za namene izpolnjevanja cilja te uredbe.
Likewise, it would be counterproductive to disrupt closely integrated value chains and distribution networks established on the basis of those arrangements or otherwise, in particular in the case of neighbouring countries and economies.
Motnje tesno povezanih vrednostnih verig in distribucijskih mrež, ki so vzpostavljene na podlagi teh dogovorov ali kako drugače, bi bile podobno kontraproduktivne, zlasti v primeru sosednjih držav in gospodarstev.
Member States should positively consider granting authorisations when the exports are destined to State bodies, public bodies and other bodies governed by public law and in charge of distributing or making PPE available to the persons affected by or at risk from COVID-19 or involved in combating the COVID-19 outbreak.
Države članice bi morale sprejeti pozitivno odločitev glede odobritve dovoljenj, kadar je izvoz namenjen za državne organe, javne organe in druge organe javnega prava, ki so odgovorni za distribucijo ali dajanje osebne zaščitne opreme na voljo osebam, ki jih je prizadel izbruh COVID-19, ki so tej bolezni izpostavljene ali se z njo spopadajo.
In light of these efforts to overcome the critical situation of shortage of certain types of PPE in the Union, further measures are warranted to contribute to remedying and preventing shortages of PPE.
Glede na ta prizadevanja za odpravo kritičnega pomanjkanja nekaterih vrst osebne zaščitne opreme v Uniji so upravičeni dodatni ukrepi, ki bodo prispevali k odpravi in preprečevanju pomanjkanja osebne zaščitne opreme.
Despite these actions, and given increased needs for PPE in the Union, a gap between demand and supply within the Union still exists, in particular concerning certain types of PPE, which are vital to prevent the spreading of the disease and treat the patients.
Kljub tem ukrepom in glede na povečane potrebe po osebni zaščitni opremi v Uniji še vedno obstaja vrzel med ponudbo in povpraševanjem znotraj Unije, zlasti v zvezi z nekaterimi vrstami osebne zaščitne opreme, ki so ključne za preprečevanje širjenja bolezni in zdravljenje bolnikov.
Given its nature and the prevailing circumstances, such type of equipment is an essential product since it is necessary to prevent the further spreading of the disease, and safeguard the health of medical staff treating infected patients.
Takšna oprema je glede na svojo naravo in prevladujoče okoliščine bistven izdelek, saj je nujno potrebna za preprečevanje nadaljnjega širjenja bolezni in zaščito zdravja zdravstvenega osebja, ki zdravi okužene bolnike.
It is not the intention of the Union to restrict exports any more than absolutely necessary, and the Union also wishes to uphold the principle of international solidarity in this situation of a global pandemic.
Unija v tem času svetovne pandemije ne želi omejiti izvoza bolj, kot je nujno potrebno, poleg tega želi spoštovati načelo mednarodne solidarnosti.
Subjecting exports of certain personal protection equipment to these countries to an export authorisation requirement would be counterproductive, given the close integration of the production value chains and distribution networks, when such equipment is an essential product necessary to prevent the further spreading of the disease and safeguard the health of medical staff treating infected patients.
Določitev obvezne predložitve izvoznega dovoljenja pri izvozu nekatere osebne zaščitne opreme v te države bi imela zaradi tesne povezanosti proizvodnih vrednostnih verig in distribucijskih omrežij nasproten učinek, saj je ta oprema nujna za preprečevanje nadaljnjega širjenja bolezni in varovanje zdravja zdravstvenih delavcev, ki zdravijo okužene bolnike.
For this purpose, Member States should contact the Clearing House established by the Commission before granting such an authorisation.
V ta namen bi se morale države članice pred izdajo takega dovoljenja obrniti na posredovalni mehanizem, ki ga je ustanovila Komisija.
Likewise, exports to the continental shelf of a Member State or the exclusive economic zone declared by a Member State pursuant to UNCLOS should be exempted from the application of this regulation.
Prav tako bi bilo treba iz uporabe te uredbe izvzeti izvoz v epikontinentalni pas države članice ali v izključno ekonomsko cono, ki jo prijavi država članica v skladu z UNCLOS.
The objective of the Clearing House is to ensure adequacy of the supply to meet the demand for all types of PPE on the Union market.
Cilj posredovalnega mehanizma je zagotoviti ustreznost ponudbe glede na povpraševanje po vseh vrstah osebne zaščitne opreme na trgu Unije.
This Regulation should apply to certain types of PPE.
Ta uredba bi se morala uporabljati za nekatere vrste osebne zaščitne opreme.
To this effect, Member States should grant export authorisations under specific circumstances, where the shipment in question poses no threat to the actual need for PPE within the Union and serves to satisfy a legitimate need for official or professional medical use in a third country.
Zato bi morale države članice v posebnih primerih, kadar zadevna pošiljka ne predstavlja nobene grožnje dejanski potrebi po osebni zaščitni opremi v Uniji in izpolnjuje pravno potrebo po uradni ali poklicni zdravstveni uporabi v tretji državi, izdati izvozna dovoljenja.
of 30 April 2020
z dne 30. aprila 2020
The amount of the aid should be fixed in advance so as to allow for a rapid and flexible operational system.
Znesek pomoči bi bilo treba določiti vnaprej, da se omogoči hiter in prožen operativni sistem.
The amount of aid should be fixed on the basis of storage costs and other relevant market elements.
Znesek pomoči bi moral biti določen na podlagi stroškov skladiščenja in drugih ustreznih tržnih elementov.
In addition, buyers in the Union and on the world market are cancelling contracts and delaying the conclusion of new ones in anticipation of further price falls.
Poleg tega kupci v Uniji in na svetovnem trgu preklicujejo pogodbe in odlagajo sklepanje novih pogodb v pričakovanju nadaljnjih znižanj cen.
It is therefore appropriate to grant aid for private storage of cheese.
Zato je primerno dodeliti pomoč za zasebno skladiščenje sira.
Cheese exports to third countries represent 8 % of total Union cheese production.
Izvoz sira v tretje države predstavlja 8 % celotne proizvodnje sira v Uniji.
Yet, many cheese-manufacturing sites in the Union do not have the capacity to process the milk into different products, and have to continue producing cheeses for which the demand has exceptionally fallen.
Vendar številni obrati za proizvodnjo sira v Uniji nimajo zmogljivosti za predelavo mleka v različne proizvode in morajo še naprej proizvajati sire, za katere je povpraševanje močno upadlo.
It is appropriate to provide flexibility to the Member States concerned by those measures, by allowing the carrying out of physical checks only on a representative statistical sample, by prolonging the period for carrying out the entry into storage checks or by substituting them by the use of other relevant evidence, and by not requiring the carrying out of unannounced checks.
Primerno je, da se državam članicam, ki jih zadevajo navedeni ukrepi, zagotovi prožnost, in sicer tako, da se omogoči izvedba fizičnih pregledov samo na reprezentativnem statističnem vzorcu, da se podaljša obdobje za izvedbo pregledov uskladiščenja proizvodov ali da se pregledi nadomestijo z drugimi ustreznimi dokazi in da se ne zahteva izvedba nenapovedanih pregledov.
In order to have an immediate impact on the market and to contribute to stabilise prices, the temporary measure provided for in this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union,
Da bi imel začasni ukrep iz te uredbe takojšen učinek na trg in bi prispeval k ustalitvi cen, bi moral začeti veljati na dan po objavi v Uradnem listu Evropske unije -
However, cheeses with a protected designation of origin or a protected geographical indication represent only a small share of the total Union cheese production.
Vendar siri z zaščiteno označbo porekla ali zaščiteno geografsko označbo predstavljajo le majhen delež celotne proizvodnje sira v Uniji.
It is appropriate to exclude cheeses that are not suitable for storage.
Primerno je, da se iz nje izključijo siri, ki niso primerni za skladiščenje.
opening a temporary exceptional private storage aid scheme for certain cheeses and fixing the amount of aid in advance
o vzpostavitvi začasne izredne sheme pomoči za zasebno skladiščenje nekaterih sirov in vnaprejšnji določitvi zneska pomoči