natgillin/translations-raw huggingface dataset:
For the European Parliament
Uredba Sveta (ES) št. 974/98 z dne 3. maja 1998 o uvedbi eura (UL L 139, 11.5.1998, str. 1).
The President
Uredba Sveta (ES) št. 1338/2001 z dne 28. junija 2001 o določitvi ukrepov, potrebnih za zaščito eura pred ponarejanjem (UL L 181, 4.7.2001, str. 6).
For the Council
Uredba Sveta (ES) št. 1339/2001 z dne 28. junija 2001 o razširitvi učinkov Uredbe (ES) št. 1338/2001 o določitvi potrebnih ukrepov za zaščito eura pred ponarejanjem na tiste države članice, ki eura niso sprejele za svojo enotno valuto (UL L 181, 4.7.2001, str. 11).
OJ C 179, 25.6.2013, p. 9.
Št. 2623, str. 372 – Serija pogodb Lige narodov 1931.
OJ C 271, 19.9.2013, p. 42.
Okvirni sklep Sveta 2000/383/PNZ z dne 29. maja 2000 o povečanju zaščite s kaznimi in drugimi sankcijami za ponarejanje v zvezi z uvedbo eura (UL L 140, 14.6.2000, str. 1).
Position of the European Parliament of 16 April 2014 (not yet published in the Official Journal) and decision of the Council of 6 May 2014.
instrumentov, predmetov, računalniških programov in podatkov ter katerih koli drugih sredstev, posebej prirejenih za ponarejanje ali spreminjanje valute, ali
Council Regulation (EC) No 974/98 of 3 May 1998 on the introduction of the euro (OJ L 139, 11.5.1998, p. 1).
pristojnosti za sprejemanje odločitev v imenu pravne osebe, ali
Council Regulation (EC) No 1338/2001 of 28 June 2001 laying down measures necessary for the protection of the euro against counterfeiting (OJ L 181, 4.7.2001, p. 6).
kaznivo dejanje v celoti ali delno storjeno na njenem ozemlju, ali
Council Regulation (EC) No 1339/2001 of 28 June 2001 extending the effects of Regulation (EC) No 1338/2001 laying down measures necessary for the protection of the euro against counterfeiting to those Member States which have not adopted the euro as their single currency (OJ L 181, 4.7.2001, p. 11).
je storilec kaznivega dejanja na ozemlju te države članice in ni izročen ali
instruments, articles, computer programs and data, and any other means peculiarly adapted for the counterfeiting or altering of currency; or
Izvedbena uredba Komisije (EU) št. 535/2014
an authority to take decisions on behalf of the legal person; or
z dne 20. maja 2014
the offence is committed in whole or in part within its territory; or
o določitvi standardnih uvoznih vrednosti za določitev uvozne cene za nekatere vrste sadja in zelenjave
the offender is in the territory of that Member State and is not extradited; or
EVROPSKA KOMISIJA JE –
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 23 May 2016.
ob upoštevanju Pogodbe o delovanju Evropske unije,
This Directive supplements the provisions and facilitates the application of the Geneva Convention by the Member States.
SPREJELA NASLEDNJO UREDBO:
To that end, it is important that the Member States are parties to the Geneva Convention.
Standardne uvozne vrednosti iz člena 136 Izvedbene uredbe (EU) št. 543/2011 so določene v Prilogi k tej uredbi.
The International Convention for the Suppression of Counterfeiting Currency signed at Geneva on 20 April 1929 and its Protocol (the ‘Geneva Convention’) [7] lays down rules to effectively prevent, prosecute and punish the offence of counterfeiting currency.
Ta uredba začne veljati na dan objave v Uradnem listu Evropske unije.
In particular, it aims at ensuring that severe criminal penalties and other sanctions can be imposed for offences of counterfeiting currency.
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
All contracting parties to the Geneva Convention have to apply the principle of non-discrimination to currencies other than their domestic currency.
V Bruslju, 20. maja 2014
Commission Implementing Regulation (EU) No 535/2014
Za Komisijo
of 20 May 2014
V imenu predsednika
establishing the standard import values for determining the entry price of certain fruit and vegetables
Generalni direktor za kmetijstvo in razvoj podeželja
THE EUROPEAN COMMISSION,
UL L 299, 16.11.2007, str. 1.
Having regard to the Treaty on the Functioning of the European Union,
UL L 157, 15.6.2011, str. 1.
Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) [1],
PRILOGA
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors [2], and in particular Article 136(1) thereof,
Standardne uvozne vrednosti za določitev uvozne cene za nekatere vrste sadja in zelenjave
Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.
Oznaka KN
The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data.
Oznaka tretje države [1]
Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,
Standardna uvozna vrednost
HAS ADOPTED THIS REGULATION:
Nomenklatura držav, določena v Uredbi Komisije (ES) št. 1833/2006 (UL L 354, 14.12.2006, str. 19).
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Oznaka „ZZ“ predstavlja „druga porekla“.
Regulation (EU) No 536/2014 of the European Parliament and of the Council
Uredba (EU) št. 536/2014 Evropskega parlamenta in Sveta
on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
o kliničnem preskušanju zdravil za uporabo v humani medicini in razveljavitvi Direktive 2001/20/ES
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168(4)(c) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije ter zlasti člena 114 in člena 168(4)(c) Pogodbe,
In a clinical trial the rights, safety, dignity and well-being of subjects should be protected and the data generated should be reliable and robust.
Pri kliničnem preskušanju bi bilo treba zagotoviti varnost, dostojanstvo in dobro počutje udeležencev in zaščititi njihove pravice, pridobljeni podatki pa bi morali biti zanesljivi in ponovljivi.
The interests of the subjects should always take priority over all other interests.
Interesi udeležencev bi morali vedno prevladati nad ostalimi interesi.
In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation.
Zaradi zagotavljanja neodvisnega nadzora nad upoštevanjem teh načel bi morala biti za klinično preskušanje potrebna predhodna odobritev.
The existing definition of a clinical trial as contained in Directive 2001/20/EC of the European Parliament and of the Council [3] should be clarified.
Obstoječo opredelitev kliničnega preskušanja iz Direktive 2001/20/ES Evropskega parlamenta in Sveta [3] bi bilo treba razjasniti.
For that purpose, the concept of clinical trial should be more precisely defined by introducing the broader concept of ‘clinical study’ of which the clinical trial is a category.
Zato bi bilo treba pojem kliničnega preskušanja natančneje opredeliti z uvedbo širšega pojma „klinična študija“, saj je klinično preskušanje ena od njenih zvrsti.
That category should be defined on the basis of specific criteria.
Navedeno zvrst bi bilo treba opredeliti na podlagi posebnih meril.
This approach takes due account of international guidelines, and is in line with the Union law governing medicinal products, which builds on the dichotomy of ‘clinical trial’ and ‘non-interventional study’.
Ta pristop upošteva mednarodne smernice in je v skladu s pravom Unije o zdravilih, ki temelji na razlikovanju med „kliničnim preskušanjem“ in „neintervencijsko študijo“.
Directive 2001/20/EC aims to simplify and harmonise the administrative provisions governing clinical trials in the Union.
Cilj Direktive 2001/20/ES je bil poenostavitev in uskladitev upravnih določb, ki urejajo klinična preskušanja v Uniji.
However, experience shows that a harmonised approach to the regulation of clinical trials has only been partly achieved.
Vendar pa izkušnje kažejo, da je bil harmoniziran pristop k ureditvi kliničnih preskušanj le delno dosežen.
This makes it in particular difficult to perform a given clinical trial in several Member States.
Zaradi tega je zlasti težko izvesti klinično preskušanje v nekaterih državah članicah.
Scientific development, however, suggests that future clinical trials will target more specific patient populations, such as subgroups identified through genomic information.
Na podlagi razvoja znanosti pa je mogoče sklepati, da bodo klinična preskušanja v prihodnosti usmerjena na točno določene skupine pacientov, ki bodo na primer izbrani zaradi svojega genskega zapisa.
In order to include a sufficient number of patients for such clinical trials it may be necessary to involve many, or all, Member States.
Zaradi zagotavljanja zadostnega števila udeležencev za takšna klinična preskušanja bo morda nujno vključiti večino ali vse države članice.
The new procedures for the authorisation of clinical trials should stimulate the inclusion of as many Member States as possible.
Z novimi postopki za odobritev kliničnih preskušanj bi se morala spodbujati vključitev čim več držav članic.
Therefore, in order to simplify the procedures for the submission of an application dossier for the authorisation of a clinical trial, the multiple submission of largely identical information should be avoided and replaced by the submission of one application dossier to all the Member States concerned through a single submission portal.
Zato bi bilo treba zaradi poenostavitve postopkov predložitve dosjeja vloge za odobritev kliničnega preskušanja odpraviti večkratno predložitev večinoma istih informacij in bi namesto tega zadostovala predložitev enega dosjeja vloge vsem zadevnim državam članicam prek enotnega portala.
Given that clinical trials carried out in a single Member State are equally important to European clinical research, the application dossier for such clinical trials should also be submitted through that single portal.
Ker so klinična preskušanja, izvedena v eni sami državi članici, za evropske klinične raziskave prav tako pomembna, bi bilo treba dosje vloge za taka klinična preskušanja predložiti prek tega enotnega portala.
As regards Directive 2001/20/EC, experience also indicates that the legal form of a Regulation would present advantages for sponsors and investigators, for example in the context of clinical trials taking place in more than one Member State, since they will be able to rely on its provisions directly, but also in the context of safety reporting and labelling of investigational medicinal products.
V zvezi z Direktivo 2001/20/ES izkušnje tudi kažejo, da bi pravna oblika uredbe imela prednosti za sponzorje in raziskovalce, ki se bodo, na primer pri kliničnih preskušanjih, ki potekajo v več kot eni državi članici, lahko neposredno zanesli na njene določbe, temveč tudi za varnostna poročila in označevanje zdravil v preskušanju.
Divergences of approach among different Member States will be therefore kept to a minimum.
Razlike med pristopi posameznih držav članic bodo na ta način kolikor je mogoče majhne.
The Member States concerned should cooperate in assessing a request for authorisation of a clinical trial.
Zadevne države članice bi morale sodelovati pri ocenjevanju zahtev za odobritev kliničnega preskušanja.
This cooperation should not include aspects of an intrinsically national nature, such as informed consent.
To sodelovanje ne bi smelo vključevati značilno nacionalnih vidikov, kot je na primer prostovoljna privolitev po poučitvi.
In order to avoid administrative delays for starting a clinical trial, the procedure to be used should be flexible and efficient, without compromising patient safety or public health.
Da bi se preprečile upravne zamude pri začetku kliničnega preskušanja, bi moral biti postopek, ki se uporabi, prilagodljiv in učinkovit, ne da bi bila ogrožena varnost pacientov ali javno zdravje.
The timelines for assessing an application dossier for clinical trials should be sufficient to assess the file while, at the same time, ensuring quick access to new, innovative treatments and ensuring that the Union remains an attractive place for conducting clinical trials.
Roki za oceno dosjeja vloge za klinična preskušanja bi morali biti dovolj dolgi, da se oceni dokumentacija, hkrati pa bi tudi morali omogočati hiter dostop do novih in inovativnih postopkov zdravljenja ter ohraniti zanimanje za izvajanje kliničnih preskušanj v Uniji.
Against this background, Directive 2001/20/EC introduced the concept of tacit authorisation.
Zaradi tega je Direktiva 2001/20/ES uvedla koncept tihe odobritve.
This concept should be maintained in order to ensure that timelines are adhered to.
Ta koncept bi bilo treba ohraniti, da se zagotovi upoštevanje rokov.
In the event of a public health crisis, Member States should have the possibility to assess and authorise a clinical trial application swiftly.
V primeru kriznih razmer na področju javnega zdravja bi morale države članice imeti možnost hitro oceniti in odobriti vlogo za klinično preskušanje.
No minimal timelines for approval should therefore be established.
Zato se minimalnih rokov za odobritev ne bi smelo določiti.
Clinical trials for the development of orphan medicinal products as defined in Regulation (EC) No 141/2000 of the European Parliament and of the Council [4] and of medicinal products addressed to subjects affected by severe, debilitating and often life-threatening diseases affecting no more than one person in 50000 in the Union (ultra-rare diseases) should be fostered.
Spodbujati bi bilo treba klinično preskušanje za razvoj zdravil sirot, kot so opredeljena v Uredbi (ES) št. 141/2000 Evropskega parlamenta in Sveta [4], in zdravil, namenjenih za osebe, ki trpijo zaradi resnih, izčrpavajočih in pogosto življenjsko nevarnih bolezni, ki v Uniji prizadenejo manj kot eno osebo na 50000 (zelo redke bolezni).
Member States should efficiently assess all clinical trials applications within the given timelines.
Države članice bi morale učinkovito oceniti vse vloge za klinična preskušanja v danem časovnem okviru.
A rapid yet in-depth assessment is of particular importance for clinical trials concerning medical conditions which are severely debilitating and/or life threatening and for which therapeutic options are limited or non-existent, as in the case of rare and ultra-rare diseases.
Hitra, a poglobljena ocena je zlasti pomembna za klinična preskušanja, povezana z zdravstvenimi stanji, ki so močno izčrpavajoča in/ali življenjsko nevarna in za katera so možnosti zdravljenja omejene ali jih ni, na primer redke ali zelo redke bolezni.
The risk to subject safety in a clinical trial mainly stems from two sources: the investigational medicinal product and the intervention.
Tveganje za varnost udeležencev v kliničnem preskušanju v glavnem izhaja iz dveh virov: zdravila v preskušanju in intervencije.
Many clinical trials, however, pose only a minimal additional risk to subject safety compared to normal clinical practice.
Vendar pa je pri mnogih kliničnih preskušanjih dodatno tveganje za varnost udeležencev v primerjavi z običajno klinično prakso minimalno.
This is particularly the case where the investigational medicinal product is covered by a marketing authorisation, that is the quality, safety and efficacy has already been assessed in the course of the marketing authorisation procedure" or, if that product is not used in accordance with the terms of the marketing authorisation, that use is evidence- based and supported by published scientific evidence on the safety and efficacy of that product, and the intervention poses only very limited additional risk to the subject compared to normal clinical practice.
To še zlasti velja za zdravilo v preskušanju z dovoljenjem za promet, kar pomeni, da so bile kakovost, varnost in učinkovitost že ocenjene v postopku za pridobitev dovoljenja za promet, ali, če se to zdravilo ne uporablja v skladu s pogoji iz dovoljenja za promet, uporaba temelji na dokazih in je podprta z objavljenimi znanstvenimi dokazi glede varnosti in učinkovitosti tega zdravila in intervencija pomeni le zelo omejeno dodatno tveganje za udeleženca v primerjavi z običajno klinično prakso.
Those low-intervention clinical trials are often of crucial importance for assessing standard treatments and diagnoses, thereby optimising the use of medicinal products and thus contributing to a high level of public health.
Klinična preskušanja z minimalno intervencijo so pogosto izredno pomembna za ocenjevanje standardnih postopkov zdravljenja in diagnosticiranja, ker se tako optimizira uporaba zdravila, kar prispeva k višji ravni javnega zdravja.
Those clinical trials should be subject to less stringent rules, as regards monitoring, requirements for the contents of the master file and traceability of investigational medicinal products.
Za ta klinična preskušanja bi morala veljati manj stroga pravila glede spremljanja, glede zahtev za vsebino glavne dokumentacije in glede sledljivosti zdravil v preskušanju.
In order to ensure subject safety they should however be subject to the same application procedure as any other clinical trial.
Da bi zagotovili varnost udeležencev, bi moral zanje veljati enak postopek vlaganja vlog kot za vsako drugo klinično preskušanje.
The published scientific evidence supporting the safety and efficacy of an investigational medicinal product not used in accordance with the terms of the marketing authorisation could include high quality data published in scientific journal articles, as well as national, regional or institutional treatment protocols, health technology assessment reports or other appropriate evidence.
Objavljeni znanstveni dokazi v podporo varnosti in učinkovitosti zdravila v preskušanju, ki se ne uporablja v skladu s pogoji dovoljenja za promet, bi lahko vključevali zelo kakovostne podatke, objavljene v člankih znanstvenih revij, pa tudi nacionalne, regionalne ali institucionalne protokole zdravljenja, poročila o oceni zdravstvenih tehnologij ali druge ustrezne dokaze.
The Recommendation of the Organisation for Economic Cooperation and Development (OECD) Council on the Governance of Clinical Trials of 10 December 2012 introduced different risk categories for clinical trials.
S priporočilom Sveta Organizacije za gospodarsko sodelovanje in razvoj (OECD) o upravljanju kliničnih preskušanj z dne 10. decembra 2012 so bile uvedene različne kategorije tveganja za klinična preskušanja.
Those categories are compatible with the categories of clinical trials defined in this Regulation as the OECD Categories A and B(1) correspond to the definition of a low-intervention clinical trial as set out in this Regulation, and the OECD Categories B(2) and C correspond to the definition of a clinical trial as set out in this Regulation.
Te kategorije so združljive s kategorijami kliničnih preskušanj, opredeljenih v tej uredbi, saj kategoriji A in B(1) OECD ustrezata opredelitvi kliničnega preskušanja z minimalno intervencijo iz te uredbe, kategoriji B(2) in C OECD pa opredelitvi kliničnega preskušanja iz te uredbe.
The assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits (relevance) and the risk and inconvenience for the subject.
Pri oceni vloge za klinično preskušanje bi bilo treba upoštevati zlasti pričakovane koristi pri zdravljenju in za javno zdravje („relevantnost“) ter tveganje in neprijetnost za udeleženca.
In respect of the relevance, various aspects should be taken into account, including whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment of medicinal products and the authorisation of their placing on the market and whether surrogate end-points, when they are used, are justified.
V zvezi z relevantnostjo bi bilo treba upoštevati različne vidike, tudi to, ali so klinično preskušanje priporočili ali zahtevali regulatorni organi, pristojni za ocenjevanje zdravil in izdajo dovoljenj za njihovo dajanje v promet ter ali so nadomestne opazovane spremenljivke ob koncu preskušanja, kadar se uporabljajo, upravičene.
Unless otherwise justified in the protocol, the subjects participating in a clinical trial should represent the population groups, for example gender and age groups, that are likely to use the medicinal product investigated in the clinical trial.
Če ni v protokolu drugačne utemeljitve, bi morali udeleženci, ki sodelujejo pri kliničnem preskušanju, predstavljati skupine prebivalstva, na primer spolne in starostne skupine, ki bi najverjetneje uporabljale zdravilo, ki je v postopku kliničnega preskušanja.
In order to improve treatments available for vulnerable groups such as frail or older people, people suffering from multiple chronic conditions, and people affected by mental health disorders, medicinal products which are likely to be of significant clinical value should be fully and appropriately studied for their effects in these specific groups, including as regards requirements related to their specific characteristics and the protection of the health and well-being of subjects belonging to these groups.
Zaradi izboljšanja zdravljenja, ki je na voljo ranljivim skupinam, kot so občutljivejši ali starejši, ljudje s številnimi kroničnimi obolenji in ljudje z duševnimi motnjami, bi bilo treba učinke zdravil, ki bi lahko imela znatno klinično vrednost, v celoti in ustrezno preučiti pri teh posebnih skupinah, vključno glede zahtev, povezanih z njihovimi posebnimi lastnostmi ter varstvom zdravja in dobrega počutja udeležencev, ki pripadajo tem skupinam.
The authorisation procedure should provide for the possibility to extend the timelines for the assessment in order to allow the sponsor to address questions or comments raised during the assessment of the application dossier.
Postopek odobritve bi moral omogočati podaljšanje obdobja ocenjevanja, s čimer bi se sponzorju omogočilo, da odgovori na vprašanja ali pripombe, ki so se pojavile pri ocenjevanju dosjeja vloge.
Moreover, it should be ensured that, within the extension period, there is always sufficient time for assessing the additional information submitted.
Poleg tega bi bilo treba zagotoviti, da je v podaljšanem obdobju še vedno dovolj časa za oceno dodatnih predloženih informacij.
The authorisation to conduct a clinical trial should address all aspects of subject protection and data reliability and robustness.
Pri odobritvi izvedbe kliničnega preskušanja bi bilo treba upoštevati vse vidike zaščite udeležencev ter zanesljivost in ponovljivost podatkov.
That authorisation should therefore be contained in a single administrative decision by the Member State concerned.
Za to odobritev bi zato morala zadoščati ena sama upravna odločba zadevne države članice.
It should be left to the Member State concerned to determine the appropriate body or bodies to be involved in the assessment of the application to conduct a clinical trial and to organise the involvement of ethics committees within the timelines for the authorisation of that clinical trial as set out in this Regulation.
Zadevna država članica bi morala določiti ustrezen organ ali organe, ki bodo sodelovali pri oceni vloge za izvajanje kliničnega preskušanja, ter v obdobju za odobritev tega kliničnega preskušanja, kot ga določa ta uredba, organizirati vključitev odborov za etična vprašanja.
Such decisions are a matter of internal organisation for each Member State.
Take odločitve so stvar notranje organizacije vsake države članice.