FrancophonIA/ELRC3.0 huggingface dataset:
English: Continue to support the European Commission in implementing its ‘Better Regulation' initiative in the field of pharmaceutical legislation.
Slovenian: Še naprej podpirati Evropsko komisiji pri izvajanju njene pobude „bolje oblikovanih predpisov“ na področju farmacevtske zakonodaje;
English: This may contribute to a higher number of applications for such products.
Slovenian: To bo morda prispevalo k večjemu številu vlog za taka zdravila.
English: The Agency hopes that these discussions will result in reduced duplication of international inspections and contribute to the efficient use of inspection resources.
Slovenian: Agencija upa, da bodo te razprave pripeljale do manjšega podvojevanja mednarodnih inšpekcijskih pregledov in s tem prispevale k učinkoviti izrabi inšpekcijskih sredstev.
English: A number of activities are underway with this goal in mind.
Slovenian: Za spoštovanje tega cilja se odvijajo številne dejavnosti.
English: As seen in the graph below, the level of generic medicines is expected to increase gradually.
Slovenian: Kot je razvidno s spodnjega grafa, se pričakuje postopna rast ravni generičnih zdravil.
English: This will provide much-needed regulatory tools for improving the availability of innovative medicines in Europe.
Slovenian: To bo omogočilo nujno potrebno regulativno orodje za izboljšavo dostopnosti inovativnih zdravil v Evropi.
English: The Agency and the Member States will continue their collaboration on the implementation of the European Surveillance Strategy.
Slovenian: Agencija in države članice bodo še naprej sodelovale pri izvajanju evropske strategije nadzora (European Surveillance Strategy).
English: Excluding the six additional posts for paediatrics legislation as per decision of the Management Board (EMEA/MB/244582/2007).
Slovenian: 1 Brez šestih dodatnih mest za zakonodajo o pediatriji po odločitvi upravnega odbora (EMEA/MB/244582/2007).
English: The Agency forecasts that the number of requests for access will increase by around 68% to 155 requests (a single request may encompass hundreds of documents).
Slovenian: Agencija predvideva, da se bo število zahtevkov za dostop povečalo za približno 68 % na 155 zahtevkov (posamezni zahtevek lahko vsebuje več sto dokumentov).
English: This situation is expected to continue for 2008.
Slovenian: Pričakuje se, da se bodo leta 2008 enake razmere nadaljevale.
English: The Agency will implement further changes in its internal control system in order to make the system more efficient and effective.
Slovenian: Agencija bo uvedla nadaljnje spremembe v svojem sistemu notranjega nadzora, da bi postal bolj smotrn in učinkovit.
English: In this context, the remaining evaluation work in Bulgaria and Romania is expected to be completed as part of the MRA between the European Commission and Canada.
Slovenian: Na podlagi tega se pričakuje, da bo preostalo ocenjevalno delo v Bolgariji in Romuniji dokončano kot del sporazuma o vzajemnem priznavanju med Evropsko komisijo in Kanado.
English: The Agency's full work programme for 2008, which was adopted by the Management Board on 13 December 2007, can be found on the Agency's website: www.emea.europa.eu
Slovenian: Celoten delovni program Agencije za leto 2008, ki ga je upravni odbor sprejel 13. decembra 2007, je na voljo na spletni strani Agencije www.emea.europa.eu.
English: Another area of the Agency's international work will relate to clinical trials and inspections.
Slovenian: Drugo področje mednarodnega dela Agencije se bo nanašalo na klinična preskušanja in inšpekcijske preglede.
English: A detailed graph showing the number of applications split into product types can be found in the full version of the work programme, section 2.3.
Slovenian: Podroben graf, ki prikazuje število vlog, razdeljenih na vrste izdelkov, je na voljo v poglavju 2.3 celotne različice delovnega programa.
English: In 2008, the Agency will continue its existing international activities and will aim to expand international collaboration.
Slovenian: V letu 2008 bo Agencija nadaljevala svoje sedanje mednarodne dejavnosti s ciljem, da mednarodno sodelovanje še razširi.
English: Head: Hans-Georg Wagner
Slovenian: Vodja: Hans-Georg Wagner
English: In order to ensure that the Agency is able to operate key processes in case of a disaster or an unforeseen event of any kind, the Agency has developed a business-continuity plan.
Slovenian: Za zagotovitev, da bo lahko Agencija opravljala ključne procese v primeru naravne nesreče ali kakršnega koli nepredvidenega dogodka, je razvila načrt neprekinjenega poslovanja.
English: This provides the information necessary for the Agency to introduce needed improvements.
Slovenian: To bo Agenciji zagotovilo potrebne informacije za uvedbo potrebnih izboljšav.
English: This ensures that the products actually on the market continue to meet public- and animal-health requirements.
Slovenian: To zagotavlja, da zdravila, ki so že na trgu, še naprej izpolnjujejo zahteve glede javnega zdravja in zdravja živali.
English: PRIORITIES AND KEY OBJECTIVES FOR 2008
Slovenian: Prednostne naloge in glavni cilji za leto 2008 so:
English: The Agency anticipates that the number of delegates coming to the Agency in 2008 will increase by 8% (to 8,400) and the number of meetings by 12% compared to 2007.
Slovenian: Agencija pričakuje, da se bo število delegatov, ki bodo leta 2008 prišli v Agencijo, povečalo za 8 % (na 8,.400), število sej pa za 12 % v primerjavi z letom 2007.
English: Work is progressing in this area and additional proposals on how to tackle this issue will be considered in the revised Road Map which the EMEA will develop to steer the Agency's course from 2010 to 2013.
Slovenian: Na tem področju delo napreduje, dodatni predlogi, kako se lotiti te zadeve, pa bodo podani v revidiranem usmeritvenem načrtu, ki ga bo EMEA razvila, da usmeri svojo pot od leta 2010 do 2013.
English: Some of the challenges posed by the environment in which the Agency and its partners - the national competent authorities - operate relate to the increasing demand on scientific resources.
Slovenian: Nekateri izzivi, ki izvirajo iz okolja, v katerem delujejo Agencija in njeni partnerji (nacionalni odgovorni organi), zadevajo povečano povpraševanje po znanstvenih virih.
English: Increasing globalisation of the regulatory environment for medicines means that the EMEA needs to extend its activities in the international arena.
Slovenian: Vedno večja globalizacija regulativnega okolja za zdravila pomeni, da mora EMEA razširiti svoje dejavnosti ne mednarodnem področju.
English: Significant attention will be given to microbicides and to tropical, neglected, communicable and new emerging diseases.
Slovenian: Posebno pozornost bo Agencija posvetila mikrobicidom ter tropskim, zapostavljenim, nalezljivim in novim nastajajočim boleznim.
English: Maintain ongoing international cooperation in human and veterinary fields and explore possibilities for extending cooperation to other non-EU countries on important public-health matters.
Slovenian: Vzdrževati stalno mednarodno sodelovanje na področju humane in veterinarske medicine ter raziskati možnosti širitve sodelovanja na druge države zunaj EU glede pomembnih zadev na področju javnega zdravja;
English: Implementation of the plan will allow the Agency, the Member States and the veterinary pharmaceutical industry to improve and streamline the electronic exchange of pharmacovigilance information.
Slovenian: Izvajanje načrta bo omogočilo Agenciji, državam članicam in veterinarski farmacevtski industriji izboljšanje in racionaliziranje elektronske izmenjave informacij o farmakovigilanci.
English: This area of activity has experienced strong growth over the years, but it remains difficult to forecast the volume of arbitrations and referrals.
Slovenian: To področje dejavnosti se je v zadnjih letih zelo povečalo, vendar je še vedno težko napovedati število arbitraž in napotitev.
English: On top of this, there is the increasing complexity of activities stemming from advances in pharmaceutical research and development techniques.
Slovenian: Poleg tega pa se povečuje kompleksnost dejavnosti, kar izvira iz napredka v farmacevtskih tehnikah raziskav in razvoja.
English: The list of these European experts is available for examination on request at the EMEA offices.
Slovenian: Seznam teh evropskih strokovnjakov je na zahtevo na voljo v uradih agencije EMEA.
English: Head: Andreas Pott
Slovenian: Vodja: Andreas Pott
English: In 2008, the Agency expects that standards for the quality of the network will be agreed and that the Coordinating Group for the network of existing networks will be set up.
Slovenian: Agencija pričakuje, da bodo v letu 2008 uvedeni dogovorjeni standardi za kakovost mreže in da bo ustanovljena usklajevalna skupina za mrežo obstoječih mrež.
English: As a response to this requirement, the Agency is developing the EudraVigilance Access Policy, which it plans to finalise in 2008.
Slovenian: Kot odgovor na to zahtevo Agencija razvija politiko dostopa do sistema EudraVigilance in jo namerava v letu 2008 tudi dokončati.
English: The workload of the Agency continues to increase steadily, as a result of new regulatory initiatives and increasing activity in existing core areas of responsibility.
Slovenian: Delovna obremenitev Agencije se stalno povečuje zaradi novih regulativnih pobud ter povečanja dejavnosti na obstoječih glavnih področjih odgovornosti.
English: Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting a small number of patients in the European Union.
Slovenian: Zdravila sirote so namenjena diagnosticiranju, preprečevanju ali zdravljenju smrtno nevarnih ali kronično izčrpavajočih bolezni, ki prizadenejo majhno število bolnikov v Evropski uniji.
English: The European Union has launched a number of initiatives that aim to help researchers overcome certain bottlenecks in the development of medicines.
Slovenian: Evropska unija je sprožila številne pobude, da bi znanstvenikom pomagala premostiti določene ovire pri razvoju zdravil.
English: EUROPEAN UNION INSTITUTIONS
Slovenian: INSTITUCIJE EVROPSKE UNIJE
English: The Agency's Road Map contains a number of strategic objectives in the field of transparency and provision of information.
Slovenian: Usmeritveni načrt Agencije vsebuje številne strateške cilje na področju preglednosti in zagotavljanja informacij.
English: As part of its corporate governance, the Agency seeks feedback from its stakeholders about their experience with the Agency and its procedures.
Slovenian: Agencija si kot del upravljanja želi povratne informacije svojih zainteresiranih strani o njihovih izkušnjah z Agencijo in njenimi postopki.
English: The Agency will step up its interactions with international organisations and increase its contribution to scientific and regulatory discussions at the international level.
Slovenian: Agencija bo okrepila svoje odnose z mednarodnimi organizacijami in povečala svoj doprinos k znanstvenim in zakonodajnim razpravam na mednarodni ravni.
English: The Agency is continuing its consolidation of existing practices and implementation of additional ones.
Slovenian: Agencija nadaljuje združevanje svojih obstoječih postopkov in izvajanje dodatnih.
English: Advanced therapies and other emerging therapies and new technologies
Slovenian: 3.3 Napredne terapije in druge nastajajoče terapije ter nove tehnologije
English: The Agency will also contribute to the implementation of the Clinical Trials Directive.
Slovenian: Agencija bo prispevala tudi k izvajanju direktive o kliničnih preskušanjih.
English: The number of initial notifications received in 2008 is expected to be comparable to that for 2007.
Slovenian: Pričakuje se, da bo število začetnih obvestil, prejetih v letu 2008, primerljivo s številom v letu 2007.
English: Consequently, the area of advanced therapies will present a big area of change for the Agency in 2008 and 2009.
Slovenian: Posledično bo na področju naprednih terapij veliko sprememb za Agencijo v letih 2008 in 2009.
English: This is due to the growing volume of core tasks of the Agency and of its partners in the network, and to the addition of new tasks vested by new legislation (e.g. the implementation of the new paediatric legislation in 2007 and the new legislation on advanced therapies in 2008).
Slovenian: Razlog za to je v vedno večjem številu osnovnih nalog Agencije in njenih partnerjev v mreži in dodajanju novih nalog zaradi novih zakonodaj (npr. izvajanje nove zakonodaje o pediatriji v letu 2007 in nove zakonodaje o naprednih terapijah v letu 2008).
English: INTRODUCTION BY THE EXECUTIVE DIRECTOR
Slovenian: Uvod izvršnega direktorja
English: Consequently, the number of new veterinary pharmaceutical medicines for food-producing animals will remain at a low level.
Slovenian: Posledično bo število novih zdravil za uporabo v veterinarski medicini, namenjenih živalim za proizvodnjo živil, ostalo majhno.
English: These measures will familiarise the national competent authorities with the work performed by the EMEA's scientific committees and their working parties.
Slovenian: Ti ukrepi bodo nacionalnim pristojnim organom dali vpogled v delo, ki ga izvajajo znanstveni odbori EMEA ter njihove delovne skupine.
English: This will help the Agency to clarify areas of concern to some parts of the industry that were identified in the IFAH Benchmarking survey conducted in 2006.
Slovenian: To bo Agenciji omogočilo, da industriji razjasni nekatere skrb zbujajoče vidike, ki so bili ugotovljeni v anketi primerjalne analize IFAH, izvedene v letu 2006.
English: Payable initial notifications Total initial notifications Notifications of a change
Slovenian: Plačljiva začetna obvestila Obvestila o spremembi
English: A wide range of documents are published by the EMEA, including press releases, general information documents, annual reports and work programmes.
Slovenian: Agencija EMEA objavlja širok razpon dokumentov, vključno s sporočili za javnost, splošnimi informativnimi dokumenti, letnimi poročili in delovnimi programi.
English: More and more clinical trials are conducted in countries outside the EU.
Slovenian: Vse več kliničnih preskušanj se izvaja v državah zunaj EU.
English: The primary focus in 2008 will be the development of general principles, standards, quality assurance and transparency-related aspects, which subsequently will be applied across the network of these centres.
Slovenian: Glavni poudarek v letu 2008 bo razvoj splošnih načel, standardov, zagotavljanja kakovosti in vidikov preglednosti, ki se bodo nato uvajali po vsej mreži centrov.
English: Similarly, since the offer by the EMEA to extend MRLs to other species without a fee (by way of extrapolation, provided the scientific criteria are met) was not taken up in 2007, only a small number of such requests for extrapolation are expected in 2008.
Slovenian: Čeprav ponudba agencije EMEA, da MVO brezplačno razširi tudi na druge vrste (z ekstrapolacijo, če so izpolnjeni znanstveni pogoji), leta 2007 ni bila sprejeta, se leta 2008 pričakuje le malo takih zahtevkov za ekstrapolacijo.
English: Improve the conduct of the Agency's core activities
Slovenian: Izboljšati opravljanje glavnih dejavnosti Agencije
English: 2 Appropriation/Budget 2006 as per final accounts.
Slovenian: Odobrena proračunska sredstva/proračun za leto 2006 kot v zaključnih računih.
English: The measures include providing free scientific advice as well as administrative and financial assistance similar to that given to SMEs.
Slovenian: Med te ukrepe spada nudenje brezplačnih znanstvenih nasvetov ter administrativne in finančne pomoči, podobno kot pri malih in srednje velikih podjetjih.
English: The number of arbitrations and referrals remains difficult to predict, but the increasing trend since the introduction of the new legislation is expected to continue.
Slovenian: Število arbitraž in napotitev je še vedno težko napovedati, pričakovati pa je, da se bodo nadaljevale smernice rasti, ki so se začele z uvedbo nove zakonodaje.
English: The EMEA will also work in the field of environmental risk assessment and will provide support to programmes aimed at reducing animal testing.
Slovenian: EMEA bo delovala tudi na področju ocene okoljskega tveganja ter nudila pomoč programom, katerih cilj je zmanjšati število preizkusov na živalih.
English: Depending on the outcome, the projects may have an impact on certain aspects of how the Agency evaluates and supervises medicines and delivers its services to its stakeholders.
Slovenian: Glede na končni izid bodo projekti morda vplivali na to, kako Agencija ocenjuje in nadzoruje zdravila ter zagotavlja storitve svojim zainteresiranim stranem.
English: In 2008, the Agency, in addition to its core activities in the area of parallel distribution, will verify compliance with the mandatory notification procedure by parallel distributors.
Slovenian: V letu 2008 bo Agencija poleg svojih glavnih dejavnosti na področju vzporedne distribucije preverjala, ali vzporedni distributerji spoštujejo obvezni postopek obveščanja.
English: This trend is in line with the number of innovative reference products reaching the end of the 10-year period of data exclusivity.
Slovenian: To gibanje je skladno s številnimi inovativnimi referenčnimi zdravili, katerih 10-letno obdobje ekskluzivnosti podatkov se izteka.
English: As part of these initiatives, the EMEA plans to increase transparency in the field of non-product-related activities.
Slovenian: Kot del teh pobud namerava EMEA povečati preglednost na področju dejavnosti, ki niso povezane z zdravili.
English: The anticipated increase is partly due to the fact that many of the arbitrations relating to applications for generic products also lead to simultaneous Community-interest referrals, as this represents the only way that Member States can address issues relating to safety and efficacy that arise during the procedure.
Slovenian: Pričakovano povečanje je delno pripisano dejstvu, da veliko arbitraž, povezanih z vlogami za generična zdravila, vodi tudi do sočasnih napotitev v interesu Skupnosti, kajti samo tako lahko države članice obravnavajo vprašanja varnosti in učinkovitosti, ki se pojavijo med postopkom.
English: A number of related guidelines will be further developed and support will be provided to the European Commission to follow up on the 2007 conference on implementation of clinical trials legislation.
Slovenian: Nadaljnje bo razvila številne sorodne smernice in nudila pomoč Evropski komisiji, da bo nadgradila konferenco iz leta 2007 o izvajanju zakonodaje o kliničnih preskušanjih.
English: General EU contribution EU contribution for SME policy EU contribution for paediatrics policy EU contribution for IT Telematics strategy Special EU contribution for orphan medicinal products
Slovenian: Prispevek EU za pediatrično politiko Prispevek EU za telematsko strategijo IT Posebni prispevek EU za zdravila sirote Prispevek iz EGP
English: The EMEA will continue to work on a new transitional programme IPA (instrument for pre-accession) for supporting the participation of Croatia, Turkey and the Former Yugoslav Republic of Macedonia as observers in meetings, training courses, and workshops planned by the EMEA.
Slovenian: EMEA bo nadaljevala delo na novem prehodnem programu IPA (predpristopni instrument) za podporo sodelovanju Hrvaške, Turčije in Makedonije kot opazovalk na sejah, usposabljanjih in delavnicah, ki jih načrtuje EMEA.
English: 4 Appropriation/Draft Budget 2008 as adopted by the Management Board on 13 December 2007.
Slovenian: Odobrena proračunska sredstva/predlog proračuna za leto 2008, kot ga je sprejel upravni odbor 13. decembra 2007.
English: This is due to the fact that more products are authorised and subsequently more variations are submitted.
Slovenian: To gre pripisati dejstvu, da je odobrenih vse več zdravil, in posledično je predloženih več sprememb.
English: Scientific advice and protocol assistance are key areas of activity for the Agency, in particular with respect to fostering new innovative technologies and therapies and as a means to facilitate and improve earlier availability of medicinal products.
Slovenian: Znanstveno svetovanje in pomoč pri protokolu sta ključni področji dejavnosti Agencije, zlasti z namenom spodbujanja novih inovativnih tehnologij in terapij ter kot način, da se omogoči in izboljša zgodnja dostopnost zdravil.
English: These will include links between specific therapies such as gene, cell-therapy and tissue-engineered products, and nanomedicines.
Slovenian: Te bodo vključevale povezave med posameznimi terapijami, kot so genska terapija, celična terapija in izdelki, pridobljeni iz človeških tkiv, ter nanozdravila.
English: Another type of advice relates to the assessment of dossier requirements in relation to products for limited markets.
Slovenian: Druga vrsta svetovanja zadeva oceno zahtev za dosje v zvezi z zdravili za omejene trge.
English: In addition, the operation of the scientific committees' working parties will be reviewed in order to evaluate whether it may be possible to rationalise the use of resources from the national competent authorities.
Slovenian: Hkrati bo Agencija preučila delovanje delovnih skupin znanstvenih odborov, da bi ocenila, če je mogoče racionalizirati uporabo virov nacionalnih pristojnih organov.
English: Reinforce the Agency's interaction with patients and healthcare professionals, building on the initiatives undertaken in 2006 and 2007 and taking due account of satisfaction surveys.
Slovenian: Okrepiti stike Agencije z bolniki in zdravstvenimi delavci, nadgrajevati pobude, sprejete leta 2006 in 2007, in upoštevati ankete o zadovoljstvu.
English: Elements affecting the environment include the adoption of new EU legislation in the field of pharmaceuticals, challenges faced by researchers in the development of new therapies, globalisation of the regulatory environment and steady intensification of work within the Agency's existing areas of responsibility.
Slovenian: Med elemente, ki vplivajo na to okolje, sodijo sprejetje nove EU zakonodaje na področju farmacevtskih izdelkov, izzivi, s katerimi se soočajo raziskovalci pri razvijanju novih terapij, globalizacija regulativnega okolja in vse bolj intenzivne dejavnosti znotraj obstoječih področij odgovornosti Agencije.
English: In addition to ongoing activities in this field, the Agency will review how to expand its scientific-advice database with information on scientific advice given by national competent authorities.
Slovenian: Poleg tekočih dejavnosti na tem področju bo Agencija ocenila, kako dopolniti svojo podatkovno bazo o znanstvenem svetovanju s podatki o znanstvenem svetovanju, ki ga izvajajo pristojni nacionalni organi.
English: The authorities will also be involved in the EU telematics programme.
Slovenian: Pristojni organi bodo vključeni tudi v telematski program EU.
English: The Agency will discuss worksharing and cooperation on all types of inspections with its international partners, as part of efforts to address the increasing demand for international collaboration in this area and to avoid duplication of effort and resources.
Slovenian: Agencija se bo s svojimi mednarodnimi partnerji dogovarjala glede delitve dela in sodelovanja pri vseh vrstah inšpekcijskih pregledov, kar bo del prizadevanj, da bi ji uspelo zadovoljiti vse večje povpraševanje po mednarodnem sodelovanju na tem področju ter bi se izognila podvojevanju truda in vloženih sredstev.
English: In 2008, the Agency will continue its work to tackle major public- and animal-health threats, including the development of antimicrobial resistance, pandemic influenza, avian influenza and other epizootic diseases such as bluetongue.
Slovenian: V letu 2008 bo Agencija nadaljevala svoje delo na področju boja proti večjim nevarnostim, ki pretijo javnemu zdravju in zdravju živali, vključno z razvojem antimikrobne rezistence, pandemijo gripe, ptičjo gripo in drugimi epizootskimi boleznimi, kot je bolezen modrikastega jezika.
English: Referrals concerning new indications, new pharmaceutical forms or new routes of administration relating to paediatric use are a new legislative tool.
Slovenian: Napotitve, ki zadevajo nove indikacije, nove farmacevtske oblike in nove poti uporabe v pediatriji, so novo regulativno orodje.