natgillin/translations-raw huggingface dataset:
[This sentence below should be adapted to National requirements] Make sure you read the patient guide that you will receive from your doctor.
Poskrbite, da boste prebrali vodnik za bolnice, ki vam ga bo izročil zdravnik.
• Ask your doctor about taking folic acid when trying for a baby.
• Če želite zanositi, se z zdravnikom posvetujte o jemanju folne kisline.
Your doctor will discuss the Annual Risk Acknowledgement Form and will ask you to sign it and keep it. You will also receive a Patient Card from your pharmacist to remind you of valproate risks in pregnancy.
Od farmacevta boste prejeli tudi opozorilno kartico za bolnice kot opozorilo na tveganja uporabe valproata med nosečnostjo.
Ask your doctor about taking folic acid when planning to have a baby.
Ko načrtujete nosečnost, se z zdravnikom posvetujte o jemanju folne kisline.
• Schedule an urgent appointment with your doctor if you are pregnant or think you might be pregnant.
• Če načrtujete nosečnost ali če ste noseči, se takoj posvetujte z zdravnikom.
Schedule an urgent appointment with your doctor if you want to become pregnant or if you think you are pregnant.
Če želite zanositi ali menite, da ste noseči, se dogovorite za nujen pregled pri zdravniku.
See section 4.
Glejte poglavje
2 Communication from the Commission to the European Parliament and the Council.
1 Sporočilo Komisije Evropskemu parlamentu in Svetu.
Several new tasks have started only in 2015 or are still to commence.
Nekatere od novih nalog so se začele šele leta 2015 oziroma se sploh še niso začele.
Hence, transparency is one of the Agency's top priorities.
Zato je preglednost ena izmed prednostnih nalog agencije.
Timely access to promising medicines
Pravočasen dostop do obetavnih zdravil
Improving the quality and efficiency of regulatory work
Izboljšanje kakovosti in učinkovitosti regulativnega dela
The Agency sees stable, increasing trends in these activities.
Agencija opaža stabilen in naraščajoč trend teh dejavnosti.
Until then, the Agency will focus on ensuring that the existing legal framework is used as effectively as possible and carry out the necessary preparations for the entry into effect of the revised legislation.
Do takrat se bo agencija osredotočala na zagotavljanje čim učinkovitejše uporabe obstoječega zakonodajnega okvira in izvajala potrebne priprave za začetek veljavnosti revidirane zakonodaje.
At the same time, legislative changes are expanding the responsibilities of medicines regulators in Europe.
Hkrati zakonodajne spremembe širijo dolžnosti regulativnih organov za zdravila v Evropi.
Addressing public-health priorities
Obravnava prednostnih nalog za javno zdravje
Programming of human and financial resources for decentralised agencies 2014-2020; http://ec.europa.eu/budget/library/biblio/documents/fin_fwk1420/COM_2013_519_en.pdf
Načrtovanje človeških in finančnih virov za decentralizirane agencije v obdobju 2014-2020; http://ec.europa.eu/budget/library/biblio/documents/fin_fwk1420/COM_2013_519_en.pdf.
Alongside old problems such as antimicrobial resistance, new diseases and issues emerge.
Poleg starih problemov, kot je protimikrobna odpornost, se porajajo nove bolezni in nova vprašanja.
This is particularly important with continued economic pressures on the Member States, and regulatory authorities being required to cut costs while delivering their responsibilities.
To je še zlasti pomembno zaradi stalnega gospodarskega pritiska na države članice in zahtev, ki jih prejemajo regulativni organi, naj zmanjšajo stroške in hkrati opravijo svoje dolžnosti.
The availability of sustainable, high-quality scientific and regulatory expertise will be a critical success factor in addressing the progress in regulatory science.
Razpoložljivost vzdržnega, visokokakovostnega znanstvenega in regulativnega znanja bo ključni dejavnik uspeha pri obravnavanju napredka v regulativni znanosti.
Among these are the introduction of single assessment for nationally authorised products (PSUSA) in 2015, the upcoming implementation of public hearings, and management of signals submitted by the pharmaceutical industry from 2017.
Med njimi so uvedba enotne presoje za nacionalno odobrena zdravila (PSUSA) leta 2015, prihajajoče izvajanje javnih zaslišanj in upravljanje signalov, ki jih predloži farmacevtska industrija, leta 2017.
The network has access to thousands of experts from Member States across Europe, allowing it to source the best possible expertise for the regulation of medicines in the European Union (EU).
Mreža ima dostop do tisočih strokovnjakov iz vseh držav članic, kar ji omogoča razpolaganje z najboljšim možnim strokovnim znanjem za zakonsko ureditev zdravil v Evropski uniji (EU).
The EMA, like other EU agencies, is required to reduce the number of posts by 10% during 2014-20202.
Tako kot druge agencije v EU mora tudi EMA v obdobju 2014-20201 zmanjšati število delovnih mest za 10 %.
The Agency expects that the volume of PSUSAs will continue to increase over the next few years.
Agencija pričakuje, da se bo obseg PSUSA v naslednjih nekaj letih še povečeval.
The Clinical Trials Regulation (EU) 536/2014 was published in May 2014, and requires the Agency, in collaboration with the European Commission (EC) and Member States, to develop the systems necessary for its implementation.
Uredba o kliničnem preskušanju (EU) 536/2014, ki je bila objavljena maja 2014, od agencije zahteva, da v sodelovanju z Evropsko komisijo in državami članicami razvija sisteme, potrebne za njeno izvajanje.
The Agency will implement its geriatric strategy, identify priority research areas in paediatrics and engage in a number of activities related to dementia and Alzheimer's disease.
Agencija bo izvajala svojo geriatrično strategijo, določila bo prednostna področja raziskav v pediatriji in se vključila v številne dejavnosti, povezane z demenco in Alzheimerjevo boleznijo.
The European medicines regulatory network is based on a network of around 50 human and veterinary medicines regulatory authorities ('national competent authorities', or NCAs) from the 31 European Economic Area Member States, together with the European Medicines Agency (EMA).
Evropska regulativna mreža za zdravila temelji na mreži, ki jo tvori približno 50 regulativnih organov za zdravila za uporabo v humani in veterinarski medicini (pristojnih nacionalnih organov) iz 31 držav Evropskega gospodarskega prostora, skupaj z Evropsko agencijo za zdravila (EMA).
The Agency is a demand-driven organisation.
Agencija je organizacija, odvisna od povpraševanja.
Ensuring the adequate availability of a wide range of high-quality, safe and effective veterinary medicines remains the highest priority for regulators within the European Union.
Zagotavljanje ustrezne razpoložljivosti širokega spektra visokokakovostnih, varnih in učinkovitih zdravil za uporabo v veterinarski medicini ostaja prednostna naloga regulativnih organov v Evropski uniji.
The Agency will also continue its work to facilitate the development of medicines for rare diseases and identify areas in need of further research.
Prav tako bo nadaljevala svoje delo pri spodbujanju razvoja zdravil za redke bolezni in določila področja, na katerih so potrebne nadaljnje raziskave.
The Agency operates in a constantly changing and evolving environment.
Okolje delovanja agencije se nenehno spreminja in razvija.
Scientific advancement and changing scene of medicines development
Znanstveni napredek in spreminjajoče se dogajanje pri razvoju zdravil
This means the environment trends, workload forecasts and implementation of a number objectives and activities described in this programming document will also impact the national authorities and their work, as well as require their input and support.
To pomeni, da bodo okoljski trendi, napovedi delovne obremenitve ter uresničevanje oziroma izvajanje številnih ciljev in dejavnosti, ki so opisane v tem delovnem programu, vplivali tudi na nacionalne organe in njihovo delo ter zahtevali njihov doprinos in podporo.
Patients, consumers and healthcare professionals demand high levels of transparency and more and better information to support their decision-making.
Bolniki, potrošniki in zdravstveni delavci zahtevajo visoko raven preglednosti ter vse obsežnejše in boljše informacije, ki bi jim pomagale pri odločanju.
Stakeholder involvement and transparency
Vključevanje deležnikov in preglednost
Antimicrobial resistance (AMR) is a growing issue for both humans and animals.
Protimikrobna odpornost je pri ljudeh in živalih vse večji problem.
The European Commission has proposed ambitious changes to the legal framework for veterinary medicines, designed to ensure that legislation is adapted over the next few years to the particular needs of the veterinary domain where this is needed.
Evropska komisija je predlagala ambiciozne spremembe zakonodajnega okvira za zdravila za uporabo v veterinarski medicini, s katerimi naj bi se v naslednjih nekaj letih zakonodaja prilagodila tako, da bo ustrezala posebnim potrebam na veterinarskem področju, kjer bo potrebno.
5 July 2016
8. februar 2016
Once the necessary systems are developed and the Regulation comes into application, the Agency will be tasked with maintaining these systems and providing support to stakeholders.
Ko bodo potrebni sistemi razviti in se bo uredba začela uporabljati, bo naloga agencije, da te sisteme vzdržuje in zagotavlja podporo deležnikom.
The Agency will continue improving internal processes and implementing its process-performance management system to further increase efficiencies and optimise operations.
Agencija bo še naprej izboljševala notranje procese in izvajala sistem za upravljanje uspešnosti procesov, s čimer bo še bolj povečala učinkovitost in optimizirala operacije.
Efficiency is the key to sustainable delivery of regulatory activities and to coping with increasing responsibilities, volumes and complexity of procedures and activities.
Učinkovitost je ključnega pomena za vzdržno izvedbo regulativnih dejavnosti in za soočanje z naraščajočim številom odgovornosti, obsegom in kompleksnostjo postopkov in dejavnosti.
Societal trends, including an aging population, polypharmacy and comorbidity, and new and redefined diseases such as dementia, will become more of a public-health burden.
Družbeni trendi, vključno s starajočo se populacijo, polifarmacijo in soobolevnostjo, ter nove in na novo opredeljene bolezni, kot je demenca, bodo postale večje breme za javno zdravje.
All aspects of the work of the Agency, from the initial evaluation through to post-authorisation monitoring, are becoming subject to more intense scrutiny by stakeholders and the community as a whole.
Vsi vidiki dela agencije, od začetnega ocenjevanja do spremljanja po pridobitvi dovoljenja za promet, so pod vedno bolj skrbnim drobnogledom deležnikov in skupnosti kot celote.
In the global arena, regulators worldwide are also increasingly recognising the potential and need to create synergies, avoid duplications and use global regulatory resources more effectively.
V globalnem smislu regulativni organi po vsem svetu prav tako čedalje bolj prepoznavajo potencial in potrebo po ustvarjanju sinergij, izogibanju podvajanj in učinkovitejši uporabi globalnih regulativnih virov.
EMA/92499/2016 Rev. 11 Executive Director
EMA/171294/2016 Izvršni direktor
Scientific-advice requests and follow-up shows positive trends over the last years.
Tudi trend prošenj za znanstveno svetovanje in trend nadaljevalnih ukrepov sta v zadnjih letih pozitivna.
The globalisation of pharmaceutical activities results in an increasing number of manufacturing and clinical-trial activities being conducted outside the EU.
Zaradi globalizacije farmacevtskih dejavnosti čedalje več proizvodnje in kliničnih preskušanj poteka zunaj EU.
The Agency will also be improving its public-health-crisis-response mechanisms, building on the past experience of pandemic influenza and the work on Ebola.
Poleg tega bo izboljševala svoje mehanizme odzivanja na krizne razmere na področju javnega zdravja, pri čemer se bo opirala na pretekle izkušnje s pandemijo gripe in delo v zvezi z ebolo.
EMA priority areas and key influences
Prednostna področja Evropske agencije za zdravila (EMA) in ključni dejavniki, ki vplivajo nanje
The discussions leading to the revision of the EU veterinary medicines legislation are expected to continue in the next years, with the legislation becoming applicable no sooner than 2019.
Razprave o reviziji zakonodaje EU o zdravilih za uporabo v veterinarski medicini se bodo predvidoma v naslednjih letih nadaljevale, pri čemer zakonodaja ne bo začela veljati pred letom 2019.
Novel therapies that were previously seen only in the human domain are starting to make their way into veterinary medicine, and the Agency will need to harness the expertise of the network to develop or adapt regulatory requirements to make the European market attractive for this type of product.
Nove terapije, ki so bile prej na voljo samo na področju zdravil za uporabo v humani medicini, so si začele utirati pot tudi v veterinarsko medicino, agencija pa bo morala izkoristiti strokovno znanje znotraj mreže za razvoj ali prilagoditev regulativnih zahtev, tako da bo evropski trg postal zanimiv za tovrstne izdelke.
Therefore, strengthening capacity and capability development across the network through the Network Training Centre, supporting the work of the innovation network, and enriching expertise through outreach to academia will remain an important part of the Agency's agenda.
Zato krepitev zmogljivosti in razvoj zmožnosti v okviru mreže prek Mrežnega centra za usposabljanje, podpiranje dela inovacijske mreže in bogatitev znanja prek sodelovanja z akademskimi krogi ostajajo pomemben del programa agencije.
Reinforcing the support to SMEs to facilitate navigation of the EU regulatory system and simplifying the Agency's approaches, making them more open, flexible and easier to navigate, will be key to ensuring more prospective medicines reach patients in such an environment.
Krepitev podpore malim in srednje velikim podjetjem, da se bodo laže znašli v regulativnem sistemu EU, in poenostavljanje pristopov agencije, da s tem postanejo bolj odprti, prožni in enostavnejši, bo ključnega pomena za zagotavljanje, da v takšnem okolju bolnike doseže več potencialnih zdravil.
With regard to standards in veterinary medicines, a particular focus will be on fostering the VICH Outreach programme, which aims to extend uptake of VICH guidelines to countries with less developed regulatory systems.
V zvezi s standardi zdravil za uporabo v veterinarski medicini bo poudarek predvsem na spodbujanju programa za ozaveščanje VICH, ki je namenjen širjenju sprejemanja smernic VICH v državah z manj razvitimi regulativnimi sistemi.
Advancements in science and technology are redefining the scientific basis of disease, expanding the possibilities for medicines development and use, and increasing demands on regulatory advice and assessment.
Napredek v znanosti in tehnologiji na novo opredeljuje znanstveno podlago bolezni, širi možnosti za razvoj in uporabo zdravil ter povečuje potrebe za regulativno svetovanje in presojo.
Work will continue on facilitating access to the market for products for minor use in major species or for use in minor species (MUMS), providing fee reductions for those products considered of most benefit to animal or public health.
Nadaljevalo se bo delo na področju lažje dostopnosti trga za zdravila za manjšo uporabo pri pomembnejših vrstah ali za uporabo pri manj pomembnih vrstah, pri čemer se bodo znižale pristojbine za izdelke, ki naj bi najbolj koristili zdravju živali ali javnemu zdravju.
Efforts to combat AMR will remain high on the Agency's agenda and will include providing the necessary support to the European Commission action plan, to the transatlantic and WHO initiatives, adopting the 'one health' approach, developing or updating relevant guidelines (including paediatric aspects) and balancing the need to assure the continued availability of antimicrobials in veterinary medicines with the need to minimise the risk to man from their use in animals.
Prizadevanja za boj proti protimikrobni odpornosti ostajajo visoko na lestvici prednostnih nalog agencije, vključevala pa bodo zagotavljanje potrebne podpore akcijskemu načrtu Evropske komisije, čezatlantskim pobudam in pobudam SZO, sprejetje pristopa „eno zdravje“, razvijanje ali posodabljanje ustreznih smernic (vključno s pediatričnimi vidiki) in uravnovešenje potrebe po zagotavljanju nenehne razpoložljivosti protimikrobnih zdravil za uporabo v veterinarski medicini in potrebe po zmanjševanju tveganja za človeka zaradi njihove uporabe pri živalih.
Hence, the main focus areas of the Agency in this respect will include improving utilisation of existing regulatory tools, such as conditional marketing authorisation and accelerated assessment procedures, looking at ways to optimise development pathways and implementing the new priority medicines scheme (PRIME).
Zato se bo agencija v tem smislu najbolj osredotočala na izboljšanje uporabe obstoječih regulativnih orodij, kot so pogojno dovoljenje za promet z zdravilom in pospešeni postopki presoje, iskanje načinov za optimizacijo razvojnih poti in uvajanje nove sheme prednostnih zdravil (PRIME).
In 2016, the Agency will start providing early and enhanced scientific and regulatory support to medicine developers through the priority medicines scheme (PRIME).
Leta 2016 bo agencija razvijalcem zdravil prek sheme prednostnih zdravil (PRIME) začela zagotavljati zgodnjo in okrepljeno znanstveno in regulativno podporo.
Finally, particular attention will be given to tackling the challenges that exist in bringing new vaccines to market and in ensuring that authorised vaccines are available to deal rapidly with incursions of exotic disease, the risk of which has increased substantially in recent years.
Končno bo posebna pozornost namenjena reševanju izzivov pri uvajanju novih cepiv na trg in zagotavljanju, da so na voljo odobrena cepiva za hiter odziv na vdor eksotičnih bolezni.
As part of supporting the work of the NCAs, the Agency will deliver telematics systems, both to implement legal requirements and help achieve operational excellence, facilitate capacity-building through the Network Training Centre, and support work-sharing in various domains.
Kot del podpore nalogam pristojnih nacionalnih organov bo agencija priskrbela telematične sisteme za izvajanje pravnih zahtev in pomoč pri doseganju operativne odličnosti, lažje vzpostavljanje zmogljivosti prek Mrežnega centra za usposabljanje in podporo delitvi dela na različnih področjih.
To deliver on its responsibilities, the EMA works closely with the NCAs.
Da bi lahko izpolnjevala svoje dolžnosti, agencija tesno sodeluje s pristojnimi nacionalnimi organi.
The Agency is finalising implementation of the pharmacovigilance legislation in 2016-2017.
Agencija v obdobju 2016-2017 zaključuje z uvajanjem zakonodaje o farmakovigilanci.
To address shortages and ensure availability of authorised medicines, the Agency will continue promoting proactive risk-management by manufacturers and marketing-authorisation holders, and instil controls to ensure product quality and supply continuity.
Da bi se odzvala na pomanjkanje in zagotovila razpoložljivost odobrenih zdravil, bo agencija še naprej spodbujala proaktivno obvladovanje tveganj pri izdelovalcih in imetnikih dovoljenja za promet z zdravili ter uveljavljala nadzor za zagotavljanje kakovosti izdelkov in neprekinjene dobave.
This, coupled with the complexity of international supply chains, presents challenges to ensure adherence to the required clinical-trial and manufacturing standards, to ensure data integrity, and to manage the risks of supply chain and counterfeit operations.
Skupaj s kompleksnostjo mednarodnih dobavnih verig to ustvarja izziv za zagotavljanje skladnosti z zahtevanimi standardi za klinična preskušanja in proizvodnjo, zagotavljanje neoporečnosti podatkov in obvladovanje tveganj v dobavni verigi in pri ponarejanju.
Developments in the pharmaceutical industry and the number of medicinal products on the market strongly influence the volumes of pre-authorisation activities, initial marketing applications and related activities in the post-authorisation stage.
Razvojni dosežki v farmacevtski industriji in število zdravil na trgu močno vplivajo na obseg dejavnosti pred odobritvijo, osnovnih vlog za dovoljenje za promet z zdravilom in sorodnih dejavnosti v fazi po izdaji dovoljenja za promet z zdravilom.
Committee for Medicinal Products for Veterinary Use
Zdravila za uporabo v veterinarski medicini
Emerging new technologies, personalised medicines, new advanced therapies, combination and borderline products all contribute to the increasing complexity of medicines.
Nastajajoče nove tehnologije, zdravila po meri posameznika, novi napredni načini zdravljenja, kombinirani in mejni izdelki prispevajo k naraščajoči kompleksnosti zdravil.
This includes development and implementation of frameworks for stakeholder interaction, capturing patient values and preferences in benefit-risk assessment of medicines, implementing public hearings, conducting surveys to better understand and be able to meet stakeholder needs and expectations, and continued cooperation with other EU agencies in the areas of common interest.
To vključuje razvoj in izvajanje okvirov za interakcijo z deležniki, zajemanje vrednot in želja bolnikov pri ocenjevanju razmerja med tveganji in koristmi zdravil, izvajanje javnih zaslišanj, opravljanje anket, s katerimi lahko bolje razumemo potrebe in pričakovanja deležnikov in jih izpolnimo, ter stalno sodelovanje z drugimi agencijami v EU na področjih skupnega interesa.
With a multitude of stakeholders involved from the early stages of development through to patients accessing and using the medicines, the Agency continuously works to interact with and involve stakeholders in the regulatory processes in the best ways possible.
Ker so v obdobje od zgodnje faze razvoja do trenutka, ko bolniki prejmejo in uporabljajo zdravila, vključeni številni deležniki, je agencija z njimi v stalnem stiku in jih na najboljše možne načine vključuje v regulativni proces.
The ever-increasing expectations of patients and healthcare professionals to have promising medicines available at the earliest appropriate opportunity, in combination with the continuous need for flexible and fast reaction to arising public-health threats, requires exploring flexible licencing pathways and a lifespan approach to medicines.
Zaradi vse večjih pričakovanj bolnikov in zdravstvenih delavcev glede čim prejšnje razpoložljivosti obetavnih zdravil ter stalne potrebe po prožnem in hitrem odzivanju na pojavljajoče se nevarnosti za javno zdravje je treba raziskati prožne poti izdajanja dovoljenj in vseživljenjski pristop do zdravil.
Structure of the work programme 2016
Uvod k delovnemu programu agencije za leto 2016
Here, the Agency continues its collaboration with non-EU competent authorities and regulators to increase reliance on each other's inspection and assessment activities, develop exchanges of information on products throughout their lifecycle, cooperate on activities in particular areas of interest, and build capacity and capability of regulators in countries with less developed systems.
Na tem področju agencija nadaljuje sodelovanje s pristojnimi organi in regulativnimi organi zunaj EU, da bi povečala medsebojno zaupanje v inšpekcijske preglede in ocenjevanje, razvila izmenjavo informacij o izdelkih v njihovem celotnem življenjskem ciklu, sodelovala pri dejavnostih na posebnih interesnih področjih ter vzpostavljala zmogljivost in zmožnost regulativnih organov v državah z manj razvitimi sistemi.
At the same time, the face of the pharmaceutical industry is evolving, with an increasing number of small or medium-sized enterprises (SMEs) undertaking the early stages of medicines development.
Hkrati se spreminja struktura farmacevtske industrije, saj se začetnih faz razvoja zdravil vse pogosteje lotevajo mala in srednje velika podjetja (MSP).