natgillin/translations-raw huggingface dataset:
With regard to the requirement for the inclusion of a summary of the essential information necessary to use the medicine safely and effectively in the summary of the product characteristics and the package leaflet provided for in point 3a of Article 11 and in point (aa) of Article 59(1) of Directive 2001/83/EC as amended by this Directive, the Member States shall ensure that the requirement applies to a marketing authorisation granted before the date set out in the second subparagraph of Article 3(1) of this Directive from renewal of that authorisation or from the expiry of a period of three years starting from that date, whichever is the earliest.
Glede zahteve po vključitvi povzetka osnovnih informacij, potrebnih za varno in učinkovito uporabo zdravila, v povzetek glavnih značilnosti zdravila in navodilo za uporabo iz točke 3a člena 11 in točke (aa) člena 59(1) Direktive 2001/83/ES, kakor je bila spremenjena s to direktivo, države članice zagotovijo, da se zahteva uporablja za dovoljenje za promet, izdano pred datumom, določenim v drugem pododstavku člena 3(1) te direktive, od podaljšanja navedenega dovoljenja za promet ali po izteku triletnega obdobja, ki se začne na navedeni datum, kar nastopi prej.
With regard to the requirement for the marketing authorisation holder to maintain and make available on request a pharmacovigilance system master file in respect of one or more medicinal products provided for in point (b) of Article 104(3) of Directive 2001/83/EC as amended by this Directive, the Member States shall ensure that that requirement applies to marketing authorisations granted before the date set out in the second subparagraph of Article 3(1) of this Directive or from the expiry of a period of three years starting from that date
Glede zahteve, da imetnik dovoljenja za promet vodi in na zahtevo daje na voljo glavno dokumentacijo sistema farmakovigilance glede enega ali več zdravil iz točke (b) člena 104(3) Direktive 2001/83/ES, kakor je bila spremenjena s to direktivo, države članice zagotovijo, da se zahteva uporablja za dovoljenja za promet, izdana pred datumom, določenim v drugem pododstavku člena 3(1) te direktive, ali po izteku triletnega obdobja, ki se začne na navedeni datum.
With regard to the requirements covering tyres, there have been a number of meetings with tyre manufacturers' organisations, research groups and environmental interest groups, with the aim of achieving a balanced and feasible set of requirements.
V zvezi z zahtevami za pnevmatike so potekala številna srečanja z organizacijami proizvajalcev pnevmatik, raziskovalnimi skupinami in interesnimi združenji na področju okolja, katerih cilj je bil sprejeti uravnotežen in izvedljiv sklop zahtev.
With regard to the resources allocated to the Connecting Europe Facility to fund transport, energy and communication projects (a total of EUR 50 billion, 10 billion of which from the Cohesion Fund which is already pursuing these goals (proportionality principle)), the Committee considers that further discussion of supports this decision, but recommends that previous experience be taken into account so as to avoid duplicating work, is necessary, in order to explain why the Commission has chosen as the Commission intends to:
V zvezi s sredstvi, dodeljenimi instrumentu Povezovanje Evrope za financiranje projektov na področju prometa, energije in komunikacij – skupno 50 milijard eurov, od tega 10 milijard iz Kohezijskega sklada, v okviru katerega se ti cilji že uresničujejo (načelo sorazmernosti) – EESO meni, da je treba podpira to odločitev, vendar priporoča upoštevanje preteklih izkušenj, zlasti zato, da bi se izognili podvajanju deladodatno preučiti, ker niso jasni razlogi, zaradi katerih je Komisija namerava
With regard to the restructuring scheme, an ad hoc restructuring amount will be charged to finance it and will be assigned to a restructuring fund.
V zvezi s shemo za prestrukturiranje se bo zaračunal ad hoc znesek za prestrukturiranje, da bi shemo lahko financirali, ta znesek pa se bo pripisal skladu za prestrukturiranje.
With regard to the revision of the thresholds laid down in Article 6, the time limits laid down in Article 5a, paragraphs (3c), (4b) and (4e) of Decision 1999/468/EC shall be set at two weeks, in view of the time constraints resulting from the calculation and publication methods laid down in the second subparagraph of Article 78(1) and Article 78(4) of Directive 2004/18/EC.
Kar zadeva popravek pragov iz člena 6, se roki iz člena 5a(3c), (4b) in (4e) Sklepa 1999/468/ES določijo na dva tedna, zaradi časovnih omejitev, ki so posledica načina izračuna in objave iz drugega pododstavka člena 78(1) in člena 78(4) Direktive 2004/18/ES.
With regard to the Roadmap for a resource-efficient Europe13, attention was drawn during a workshop held recently in Brussels14 to the programme's vital importance for promoting the transition to the green economy and the complementarity of the two initiatives, particularly as regards implementation, natural resources and ecosystem management.
V zvezi s časovnim okvirom za Evropo, gospodarno z viri13 sta bila med delavnico, ki je bila nedavno organizirana v Bruslju14, poudarjena pomen tega programa za prehod na zeleno gospodarstvo in komplementarnost obeh pobud, zlasti glede izvajanja ukrepov, naravnih virov in upravljanja ekosistemov.
With regard to the role of the Remuneration Committee, only a few Member States recommend or require that it periodically reviews the remuneration policy for executive directors, whereas one Member State24 gives this task to the supervisory board.
V zvezi z vlogo komisije za prejemke le nekaj držav članic priporoča ali zahteva, da mora ta komisija redno pregledovati politiko prejemkov za izvršne direktorje, medtem ko ena od držav članic24 to nalogo pripisuje nadzornemu svetu.
With regard to the rule of law in China, many civil society representatives who met the EESC delegation suggested that the enforcement of existing laws rather than the drafting of new laws should be a priority.
V zvezi s pravno državo na Kitajskem so mnogi predstavniki civilne družbe, ki so se sestali z delegacijo EESO, menili, da je treba dati prednost uveljavljanju obstoječih zakonov pred oblikovanjem novih.
With regard to the safe opening of equipment parts, requirement 2.1.1.3 applies.
2.1.2.4. Kar zadeva varno odpiranje delov opreme, se uporablja zahteva iz 2.1.1.3.
With regard to the safe opening of equipment parts, requirement 2.2.1.3 applies.
2.2.2.4. Kar zadeva varno odpiranje delov opreme, se uporablja zahteva iz 2.2.1.3.
With regard to the science and technology aspects of this work, the Commission will develop its programmes in close co-operation with the international community through the following fora:
Ob upoštevanju znanstvenih in tehnoloških vidikov tega dela, bo Komisija razvila svoje programe v tesnem sodelovanju z mednarodno skupnostjo s pomočjo naslednjih forumov:
With regard to the scope of application of the Directive, the common position takes account to a great extent of the amendments adopted by the European Parliament in its first reading.
Glede na področje uporabe Direktive skupno stališče v veliki meri upošteva spremembe, ki jih je sprejel Evropski parlament ob prvi obravnavi.
With regard to the scope of application of the Directive, there is a need to clarify whether the national transposing legislation in some countries covers also undertakings which do not operate for gain.
Glede na področje uporabe Direktive je treba pojasniti, ali nacionalna zakonodaja za prenos v nekaterih državah zajema tudi nepridobitna podjetja.
With regard to the scope of the proposal and the inclusion of imports, the EESC would like clarification on what will happen when the legal minimum sizes of imported products are smaller than EU minimum sizes.
Glede področja uporabe in vključitve uvoza bi EESO želel, da se pojasni, kaj se zgodi, če so minimalne zakonite velikosti uvoženih proizvodov manjše od tistih, ki so predpisane v EU.
With regard to the scope of the proposed Directive, the position of the Council at first reading clarifies that this Directive does not apply to services in the field of long-term care whose purpose is to support people in need of assistance in carrying out routine, everyday tasks.
V stališču Sveta na prvi obravnavi v zvezi s področjem uporabe predlagane direktive je pojasnjeno, da se ta direktiva ne uporablja za storitve na področju dolgoročne oskrbe, katere namen je zagotavljati podporo ljudem, ki potrebujejo pomoč pri opravljanju običajnih vsakdanjih opravil.
With regard to the scope of the proposed Regulation on the common authorisation procedure, the common position (Article 1) clarifies that this does not apply to smoke flavourings falling within the Regulation (EC) No 2065/2003 of the European Parliament and of the Council.
Glede na področje uporabe predlagane uredbe o skupnem postopku odobritve, skupno stališče (člen 1) pojasnjuje, da se ta ne uporablja za arome dima, ki spadajo v področje uporabe Uredbe (ES) št. 2065/2003 Evropskega parlamenta in Sveta.
With regard to the secretariat-general's preparations in respect of support facilities for new members, Mr Osborn felt it would be useful for the Task Force set up within the administration for this purpose to be able to draw on the advice and experience of one or two existing members as to the practical difficulties with which new arrivals might be faced.
OSBORN je razpravljal o pripravah generalnega sekretariata na sprejem novih članov in dejal, da bi bilo koristno, če bi projektna skupina, ustanovljena v ta namen v okviru uprave, glede praktičnih težav, s katerimi bi se lahko soočili novinci, lahko uporabila nasvete in izkušnje nekaterih članov.
With regard to the security and protection of personal data, the EESC considers that transfer "…by any other appropriate means …" in the event of technical failure of electronic means is not entirely suitable.
Glede varnosti in varstva osebnih podatkov državljanov EESO meni, da prenos podatkov "z uporabo drugih ustreznih sredstev" v primeru tehnične okvare elektronskih instrumentov za pošiljanje ni najustreznejša rešitev.
with regard to the security of the European GNSS programmes, and without prejudice to the provisions of Articles 13 and 14 of Regulation (EC) No 683/2008 of the European Parliament and the Council, it shall perform:
v zvezi z varnostjo evropskih programov GNSS ter brez poseganja v člena 13 in 14 Uredbe (ES) št. 683/2008 Evropskega parlamenta in Sveta zagotavlja naslednje:
With regard to the segmentation of this market, the production of fruit juice from concentrate is predominant as compared to juice produced directly (respectively 87.6% and 12.4%).
Glede na segmentacijo tega trga prevladuje proizvodnja sadnih sokov iz koncentrata v primerjavi s sokovi, ki se proizvedejo neposredno (87,6 % in 12,4 %).
With regard to the service of pilotage, Member States may submit the granting of the authorisation referred to in Article 7 to particularly strict criteria relating to maritime safety and public service requirements.
Kar zadeva pilotažne storitve, lahko države članice podvržejo izdajo dovoljenja iz člena 7 strogim merilom, povezanim s pomorsko varnostjo in obveznostmi iz opravljanja javnih storitev.
With regard to the settlement of disputes, this proposal for a Regulation provides for the setting‑up of independent bodies.
V zvezi z reševanjem sporov ta predlog Uredbe predvideva ustanovitev neodvisnih teles.
With regard to the shareholders´ vote, there are differences with regard to the object of the vote and whether the vote is binding or not, while it appears that there are differences with regard to the follow-up which is given to a negative advisory vote.
V zvezi z glasovanjem delničarjev so razlike glede predmeta glasovanja in glede vprašanja, ali je glasovanje zavezujoče ali ne, hkrati pa se zdi, da so razlike glede nadaljnjega ukrepanja v primeru negativnega posvetovalnega glasovanja.
With regard to the sharing economy in its different forms, the EU has not clearly laid out its principles on abuse of dominant positions and how this can be reconciled with the objective of a "social market economy", considering that a growing proportion of the workers concerned find themselves to be de facto outside the law in terms of labour rights.
EU v zvezi z različnimi oblikami ekonomije delitve nima jasnega načelnega stališča glede zlorabe prevladujočega položaja in združljivosti teh oblik s ciljem „socialnega tržnega gospodarstva“, čeprav je vse večji delež zadevne delovne sile dejansko izvzet iz določb delovnega prava.
With regard to the significance of ICT for the innovation system, member states should consider how to better use the ERDF to accelerate achievement of the EU 2020 objectives for broadband access including total coverage, making use of the different technologies (fibre, adsl, wireless, satellite) available to suit the diverse geographical needs and challenges of different regions across the EU.
IKT ima pomembno vlogo v inovacijskih sistemih, zato bi morale države članice razmisliti, kako bolje uporabiti ESRR za pospešitev doseganja ciljev strategije Evropa 2020 glede širokopasovnega dostopa, vključno s celotno pokritostjo, in pri tem uporabiti različne razpoložljive tehnologije (vlakna, adsl, brezžična povezava, satelitska povezava), da zadovoljijo raznovrstne geografske potrebe in izzive različnih regij EU.
with regard to the single payment scheme the total amount of complementary national direct aid which may be granted by a new Member State in respect of a given year shall be limited by a specific financial envelope.
glede sheme enotnega plačila se skupni znesek nacionalne neposredne pomoči, ki jo lahko nova članica odobri za določeno leto, omeji za določeni finančni okvir.
with regard to the single payment scheme, detailed rules relating in particular to the establishment of national reserve, the transfer of entitlements, the definition of permanent crops, permanent pastures, and grassland, the options provided for in Chapters 2 and 3 of Title III and the integration of coupled payments provided for in Chapter 4 of Title III;
glede sheme enotnega plačila, podrobna pravila, povezana zlasti z vzpostavitvijo nacionalne rezerve, prenosom pravic, opredelitvijo trajnih nasadov, trajnih pašnikov in travnikov, možnostmi, predvidenimi v poglavjih 2 in 3 naslova III, in vključevanje vezanih plačil, predvidenih v poglavju 4 naslova III;
With regard to the Single Resolution Board, it is vitally important for its members to have the greatest possible independence and expertise and for democratic scrutiny of its decisions to be built in.
V zvezi z enotnim odborom za reševanje je najpomembnejše zagotoviti čim večjo neodvisnost in strokovnost njegovih članov ter predvideti demokratični nadzor nad njihovimi odločitvami.
With regard to the social impacts the assessments conclude that the programme will deliver employment benefits, by strengthening the sectors' capacity and supporting SMEs and their adaptation to the digital shift.
Sklep ocen glede socialnih učinkov je ta, da bo program prinesel koristi za zaposlovanje, s tem da bo okrepil sposobnost sektorjev in podpiral MSP ter njihovo prilagajanje digitalnemu premiku.
With regard to the social integration and re-integration of minors and young offenders, any future Community policies will also have to take account of the role of trade union and employers' organisations and their specific channels for dialogue when mapping out paths towards the socio-occupational integration and re-integration of socially-excluded minors.
Pri oblikovanju načinov integracije in socialno-poklicnega vključevanja mladoletnikov, izključenih iz družbe – proces, ki ga v točki 1.1 tega mnenja uvrščamo v tretji steber – bodo morale prihodnje politike Skupnosti upoštevati tudi organizacije sindikatov in delodajalcev in njihove posebne načine ustvarjanja dialoga.
With regard to the social situation, there is, despite laudable progress over the last few years, still work to be done, e.g. in tackling labour market problems.
Glede socialnih razmer so kljub velikemu napredku v zadnjih letih potrebna dodatna prizadevanja, na primer pri reševanju težav na trgu dela.
With regard to the specific issue of assisting spouses and life partners, the provisions adopted by the Council will entitle them to social protection in their own name, regardless of the type of system and any entitlement to 'derived' social protection (through of the self-employed worker).
Glede specifičnega vprašanja zakoncev, ki pomagajo samozaposlenim osebam, in življenjskih partnerjev bi s strani Sveta sprejeta določba tem osebam omogočila pravico dostopa do socialne zaščite v njihovem lastnem imenu, ne glede na vrsto sistema in upravičenost do morebitne „izpeljane“ zaščite (prek samozaposlenega delavca).
With regard to the spectrum released by switch-off of analogue terrestrial television, Member States’ spectrum plans should be flexible enough to allow the introduction of other electronic communications services, in addition to digital broadcasting services.
V zvezi s spektrom, ki bo na voljo z ukinitvijo analogne prizemne televizije, bi moralo biti načrtovanje spektra držav članic dovolj prožno, da poleg digitalnih radiofuznih storitev omogoči uvedbo drugih elektronskih komunikacijskih storitev.
With regard to the SSA, the upper limit established in Article 12(3) of Regulation (EC) No 1405/2006 on the basis of the historical implementation in 2001-03, does represent a constraint, however.
Vendar zgornja meja, ki je v členu 12(3) Uredbe št. 1405/2006 določena na podlagi pretekle izvedbe v obdobju 2001–2003, pri posebnem režimu preskrbe povzroča določeno togost.
With regard to the staff of the Agency, the Director shall exercise the powers provided for in Article 25(3).
V zvezi z zaposlenimi v Agenciji direktor izvaja pristojnosti iz člena 25(3).
With regard to the staff of the Authority, the Director shall exercise the powers provided for in Article 49(3).
V zvezi z zaposlenimi v organu direktor izvaja pristojnosti iz člena 49(3).
With regard to the state of play concerning ratification of the Convention on the accession of new Member States to the Arbitration Convention12, the ratification process has been finalised in 2009.
Postopek ratifikacije Konvencije o pristopu novih držav članic h Konvenciji o arbitraži12 je bil zaključen leta 2009.
With regard to the stated objectives, a central European Competent Authority (option 3) appears to be a very effective solution.
Glede na navedene cilje se zdi osrednji evropski pristojni organ (možnost 3) zelo učinkovita rešitev.
With regard to the strand on Prevention, Preparedness and Consequence Management, preparatory action is about to be taken under a pilot project on fight against terrorism.
Na področju preprečevanja, pripravljenosti in obvladovanja posledic naj bi bil pripravljalni ukrep sprejet v okviru pilotnega projekta za boj proti terorizmu.
With regard to the Structural Funds, measures to help women in the agricultural (EAGGF) and fisheries (FIFG) sectors should be stepped up and linked to environmental protection, another area in which Community gender-linked policies are rather weak.
v okviru strukturnih skladov je treba okrepiti ukrepe v prid ženskam na področju kmetijstva (Evropski kmetijski usmerjevalni in jamstveni sklad - EKUJS) in ribištva (Finančni instrument za usmerjanje ribištva – FIUR) in ju morda povezati z zaščito okolja in s področji, kjer so politike Skupnosti pomanjkljive s stališča vprašanj enakosti spolov;
With regard to the Structural Funds, measures to help women in the agricultural (EAGGF) and fisheries (FIFG) sectors should be stepped up and possibly linked to environmental protection, another area in which Community gender-linked policies are rather weak.
v okviru strukturnih skladov je treba okrepiti ukrepe v prid ženskam na področju kmetijstva (Evropski kmetijski usmerjevalni in jamstveni sklad - EKUJS) in ribištva (Finančni instrument za usmerjanje ribištva – FIUR) in ju morda povezati z zaščito okolja in s področji, kjer so politike Skupnosti pomanjkljive s stališča vprašanj enakosti spolov;
With regard to the substances listed in Annex III, the Commission shall seek additional information, taking into account recent scientific data from all possible sources, and keep the measures applied under regular review with a view to timely presentation to the European Parliament and to the Council of any necessary proposals.”
V zvezi s snovmi iz Priloge III bo Komisija prav tako zbrala dodatne informacije, ob upoštevanju najnovejših znanstvenih podatkov iz vseh mogočih virov, in uporabljene ukrepe redno pregledovala, da bo Evropskemu parlamentu in Svetu lahko pravočasno predložila kakršne koli potrebne predloge.“
With regard to the substantive provisions, the Commission accepts amendments 53 to 69 as they improve the Common Position by strengthening:
Glede vsebinskih določb Komisija sprejema predloge sprememb od 53 do 69, ker izboljšujejo skupno stališče:
With regard to the substantive provisions, the Commission accepts the following amendments:
Glede vsebinskih določb Komisija sprejme naslednje spremembe:
With regard to the synthetic training devices referred to in Article 8c(1), the Agency shall:
Agencija v zvezi s simulacijskimi napravami za usposabljanje iz člena 8c(1):
With regard to the systems set up by Member States to fulfill the requirements of Commission Regulation (EC) n°1386/2002 on the management and control systems, progress was achieved in 2004, although some difficulties were identified in 2003 in Greece, Spain and Portugal and communicated to the national authorities in the framework of the partnerships.
Pri sistemih, ki so jih države članice vzpostavile za izpolnjevanje zahtev Uredbe Komisije (ES) št. 1386/2002 glede sistemov upravljanja in nadzora pomoči, je bil leta 2004 dosežen napredek, čeprav so bile leta 2003 opažene nekatere težave v Grčiji, Španiji in na Portugalskem in bile sporočene nacionalnim organom v okviru partnerstva.
With regard to the systems set up by the ten new Member States to fulfill the requirements of Commission Regulation (EC) n°1386/2002, desk reviews were completed in the period January-March 2005 enabling the Commission to gain assurance on the set-up of the systems.
V zvezi s sistemi, ki jih je vzpostavilo deset novih držav članic, da se izpolnijo zahteve Uredbe Komisije (ES) št. 1386/2002, so bili pisni pregledi končani v obdobju med januarjem in marcem 2005, kar je Komisiji omogočilo pridobitev zagotovila o vzpostavitvi sistemov.
With regard to the target date 2010, preparatory work is under way in the Ministry of Finance and Magyar Nemzeti Bank (Central Bank of Hungary).
Ob upoštevanju leta 2010 kot ciljnega datuma so se začela pripravljalna dela na Ministrstvu za finance in v Centralni banki Madžarske (Magyar Nemzeti Bank).
With regard to the tasks of the Agency and the national competent authorities related to certification, oversight and enforcement under this Regulation, the Commission shall be empowered to adopt delegated acts in accordance with Article 117 in order to lay down detailed rules concerning:
V zvezi z nalogami Agencije in pristojnih nacionalnih organov, ki se nanašajo na certificiranje, nadzor in izvrševanje v skladu s to uredbo, se Komisija pooblasti za sprejemanje delegiranih aktov v skladu s členom 117, s katerimi določi podrobna pravila v zvezi s/z:
With regard to the text of Rule 12(4), the RP Panel agreed to the rapporteur's text.
Kar zadeva besedilo člena 12(4), je komisija za poslovnik izrazila strinjanje z besedilom, ki ga je predlagal poročevalec.
With regard to the themes of projects, their embedding in the local and regional context, and to the composition of stakeholders there are important synergies with other Union programmes, namely in the areas of employment, social affairs and equal opportunities, education, youth and culture, justice, and regional policy.
Pri temah projektov, njihovem vključevanju v lokalni in regionalni okvir in sestavi zainteresiranih strani obstajajo pomembne sinergije z drugimi programi Unije, in sicer na področju zaposlovanja, socialnih zadev in enakih možnosti, izobraževanja, mladih in kulture, pravosodja in regionalne politike.