natgillin/translations-raw huggingface dataset:
Referrals concerning new indications, new pharmaceutical forms or new routes of administration relating to paediatric use are a new legislative tool. 
Napotitve, ki zadevajo nove indikacije, nove farmacevtske oblike in nove poti uporabe v pediatriji, so novo regulativno orodje.
In 2008, the Agency plans to consolidate the outcomes of its two-year process-improvement exercise and will continue to implement measures to optimise key processes, improve cost-effectiveness of the Agency's operations, and achieve higher satisfaction for the Agency's stakeholders. 
V letu 2008 namerava Agencija združiti rezultate dveletnega izboljševanja postopkov in nadalje izvajati ukrepe za racionalizacijo ključnih procesov, izboljšanje stroškovne učinkovitosti njenega delovanja in dosego večjega zadovoljstva njenih zainteresiranih straneh.
It is anticipated that the majority of referrals will continue to relate to arbitrations that are due to differences in opinion at the Member State level within the framework of the mutual-recognition or decentralised procedures. 
Pričakovati je tudi, da bo večina napotitev še naprej zadevala arbitraže zaradi razlik v mnenjih na ravni držav članic v okviru postopka vzajemnega priznavanja ali decentraliziranega postopka.
The number of clinical trials conducted in countries outside the EU is increasing. 
Število kliničnih preskušanj v državah zunaj EU narašča.
Senior medical officer 
Visoki zdravstveni uradnik
In the area of information technology, the Agency and its partners will work to increase the use of various IT tools that support collaboration. 
Na področju informacijske tehnologije bo Agencija s svojimi partnerji povečala uporabo različnih orodij informacijske tehnologije, ki podpirajo sodelovanje.
In addition, a number of inspections to support plasma-file certification are planned, contributing to about 15% of the total number. 
Poleg tega je načrtovanih več inšpekcijskih pregledov za potrditev dokazil o plazemskih dosjejih, kar je 15 % vseh pregledov.
Conduct an assessment of the impact and consistency of the Agency's scientific opinions. 
Izvajati oceno vpliva in skladnosti znanstvenih mnenj Agencije.
The Agency will also maintain and further strengthen dialogue with all stakeholders through joint workshops with the European Commission on both the regulatory and scientific aspects of advanced therapy medicinal products. 
Agencija bo tudi vzdrževala in še naprej krepila dialog z vsemi zainteresiranimi stranmi na skupnih delavnicah z Evropsko komisijo o regulativnih in znanstvenih vidikih zdravil za napredne terapije.
Improve liaison with the World Health Organization and developing countries' regulatory authorities for the effective use of opinions on medicinal products intended for non-EU markets. 
Izboljšati povezavo s Svetovno zdravstveno organizacijo in upravnimi organi držav v razvoju za učinkovito uporabo mnenj o zdravilih, namenjenih trgom zunaj EU;
Over 4,000 experts are used by the EMEA in its scientific evaluation work. 
Agencija EMEA pri svojem znanstvenem ocenjevalnem delu sodeluje z več kot 4.000 strokovnjaki.
This activity is strengthened through the peer review of assessment reports, which also includes the review of risk-management plans. 
To dejavnost krepijo tudi medsebojni pregledi stanovskih strokovnjakov, s katerimi se pregledajo poročila ocen, ki vključujejo tudi pregled načrtov za obvladovanje tveganja.
As part of the task of implementing the paediatric legislation, the Agency will begin to implement the strategy on the network of paediatric research. 
Kot del naloge izvajanja pediatrične zakonodaje bo Agencija začela izvajanje strategije o mreži raziskav v pediatriji.
The Agency will participate in the work relating to studies on off-patent medicinal products used in children, studies on the safety of medicines, and projects on rare diseases. 
Agencija bo sodelovala pri delu, ki zadeva študije zdravil za otroke brez patenta, študije o varnosti zdravil in projekte o redkih boleznih.
Summary of the work programme for the European Medicines Agency 
Povzetek delovnega programa Evropske agencije za zdravila
With this in mind, the EMEA will conduct a few pilot projects related to benefit-risk assessment, risk communication and scientific memory. 
V skladu s tem bo EMEA izvedla nekaj pilotnih projektov, povezanih analizo tveganja in koristi, sporočanjem tveganja ter znanstvenim spominom.
This requirement contributes to the Agency's initiatives in the area of transparency and provision of information. 
Ta zahteva prispeva k pobudam Agencije glede preglednosti in posredovanja informacij.
Once implemented, the advice given will facilitate certain aspects of the conduct of clinical trials and may potentially contribute to earlier availability of novel medicines. 
Ko se bo začel postopek izvajati, bodo nasveti olajšali nekatere vidike kliničnega preskušanja in morda prispevali k zgodnejši dostopnosti novih zdravil.
In addition to their participation in the work of certain EMEA committees and working parties, patients' representatives will continue to be involved in the review of documents developed for patients and the general public. 
Predstavniki bolnikov bodo poleg sodelovanja pri delu določenih odborov in delovnih skupin EMEA še naprej vključeni v pregled dokumentov, pripravljenih za bolnike in splošno javnost.
This includes implementation across all the committees of the electronic system for managing meeting documents and wider implementation of video- and teleconferencing facilities. 
To vključuje uporabo elektronskega sistema za upravljanje z gradivi za seje v vseh odborih ter širšo uporabo video in telekonferenčne opreme.
Implement the new legislation on advanced-therapy medicinal products and establish a new Committee for Advanced Therapies. 
Izvajati novo zakonodajo o zdravilih za napredne terapije in ustanoviti nov odbor za napredne terapije;
The office aims to facilitate communication with SMEs through dedicated personnel within the Agency who will respond to practical or procedural enquiries, monitor applications, and organise workshops and training sessions for SMEs. 
Namen urada je olajšati komunikacijo z malimi in srednje velikimi podjetji s specializiranim osebjem na Agenciji, ki bo odgovarjalo na praktične ali postopkovne poizvedbe, spremljalo vloge ter organiziralo delavnice in usposabljanja za mala in srednje velika podjetja.
Integrated quality management and audit 
Integrirano upravljanje kakovosti in revizija
Care will be taken to ensure that a new system, if introduced, will promote cooperation and exchange of resources in the network. 
Če bo nov sistem vpeljan, bo posebna pozornost namenjena temu, da bo ta sistem spodbujal sodelovanje in izmenjavo sredstev znotraj mreže.
The Agency's focus in 2008 in the area of variations will be on the establishment of a new procedure for variations of generic and similar biological medicinal products in order to allow the implementation of changes to the product information subsequent to changes to the reference product, hence ensuring consistency. 
Agencija se bo na področju sprememb v letu 2008 osredotočila na uvajanje novega postopka za spremembe generičnih in biološko podobnih zdravil, da bi omogočila izvajanje sprememb v informacijah o zdravilih po spremembi referenčnih zdravil in s tem zagotovila skladnost.
Based on the initial experience during 2007, there is a clear trend for an increase in referral procedures in the context of the suspension or revocation of marketing authorisations as a result of the evaluation of pharmacovigilance data. 
Na podlagi začetnih izkušenj iz leta 2007 je mogoče videti jasne smernice rasti števila napotitvenih postopkov v okviru umika ali preklica dovoljenja za promet kot posledice ovrednotenja podatkov o farmakovigilanci.
The Agency also expects to receive some referrals relating to harmonisation within the Community of the conditions of authorisation of already authorised products, to Community interests, and to other safety-related issues. 
Agencija pričakuje, da bo prejela tudi nekaj napotitev v zvezi z usklajevanjem pogojev dovoljenj za že odobrena zdravila znotraj Skupnosti ter v zvezi z interesi Skupnosti in drugimi vprašanji, povezanimi z varnostjo.
The EMEA plans to set up a new procedure for advice on biomarkers. 
Agencija EMEA namerava uvesti nov postopek za svetovanje o bioloških označevalcih.
The legislation requires the Agency to provide access to EudraVigilance data by its stakeholders. 
Zakonodaja zahteva, da Agencija svojim zainteresiranim stranem omogoči dostop do podatkov sistema EudraVigilance.
Sampling and testing 
2.7 Vzorčenje in preskušanje
Another large area of activity will relate to the provision of support to small and medium-sized enterprises (SMEs) developing medicines for human and veterinary use. 
Nadaljnje obsežno področje dejavnosti bo zadevalo zagotavljanje podpore malim in srednje velikim podjetjem, ki razvijajo zdravila za uporabo v humani in veterinarski medicini.
The Agency will develop the next phase of the EudraPharm database (EU telematics projects), introducing multilingual navigation and content, advanced search capability and better-structured product information. 
Agencija bo razvila naslednjo fazo podatkovne baze EudraPharm (EU telematski projekt) in predstavila večjezikovno navigacijo in vsebino, napredne možnosti iskanja ter bolje zasnovane informacije o izdelkih.
Among these, the Agency will participate in discussions regarding Ayurvedic and traditional Chinese medicines. 
Tako bo Agencija sodelovala v razpravah o ajurvedskih in tradicionalnih kitajskih zdravilih.
In order to review and improve the process for producing Community herbal monographs and entries to the aforementioned list, the EMEA will explore the possibility of involving academia alongside the resources made available by the European medicines network. 
Da bi EMEA pregledala in izboljšala postopek oblikovanja monografij rastlin Skupnosti in vnosov v omenjeni seznam, bo preučila možnosti vključevanja akademikov poleg virov, ki jih omogoča Evropska mreža zdravil.
The graph below demonstrates that this activity has experienced strong growth over the years. 
V spodnjem grafu je prikazano, da se je v preteklih letih ta dejavnost zelo povečala.
The number of extensions has remained low over recent years, despite the initiatives taken by the CVMP to facilitate the authorisation of products for minor uses and minor species. 
Število razširitev je v zadnjih letih ostalo majhno, kljub pobudam, ki jih je dal CVMP za lažje izdajanje dovoljenj za promet z zdravili za manj pomembne uporabe in vrste.
In order to address the pressures on scientific resources, the Agency and its partners will work to ensure long-term availability of top-quality scientific expertise (through establishment of an inventory of available expertise, and through various training and competence-development activities) and to develop further the common workload-planning practices. 
V odgovor na pritiske na znanstvene vire bodo Agencija in njeni partnerji delali na tem, da zagotovijo dolgoročno dostopnost najkakovostnejšega znanstvenega strokovnega znanja (z uvedbo popisa obstoječih strokovnih znanj in z različnimi usposabljanji ter dejavnostmi za razvijanje znanja) ter nadalje razvijejo splošno prakso načrtovanja delovne obremenitve.
GMP inspection numbers will continue their steep growth, with a further 30% increase expected compared to 2007. 
Število inšpekcijskih pregledov dobre proizvodne prakse (GMP) se bo še naprej strmo povečevalo, v primerjavi z letom 2007 pričakujemo nadaljnjo 30-odstotno rast.
The EMEA/CHMP working group with healthcare professionals' organisations will finalise recommendations that will improve these interactions. 
Delovna skupina EMEA/CHMP bo s sodelovanjem z organizacijami zdravstvenih delavcev dokončno oblikovala predloge, ki bodo te stike še izboljšali.
Focus on the international issues related to inspections, in particular with regard to avoiding where possible the duplication of inspections internationally; ensure consistency of standards for manufacture of active substances and finished products, and consistency of ethical standards for the conduct of clinical trials outside the EU. 
Osredotočiti se na mednarodne zadeve glede inšpekcijskih pregledov, zlasti glede preprečevanja podvojevanja inšpekcijskih pregledov na mednarodni ravni, kadar je to mogoče; zagotoviti skladnost standardov za izdelavo zdravilnih učinkovin in končnih izdelkov ter skladnost etičnih standardov za izvajanje kliničnih preskušanj zunaj EU;
The strategy helps the partners to optimise the efficiency in the EU regulatory network for veterinary pharmacovigilance of all medicinal products authorised in the Community. 
Omenjena strategija omogoča partnerjem racionaliziranje učinkovitosti v regulativni mreži EU za farmakovigilanco za vsa zdravila z dovoljenjem v Skupnosti.
The Agency and its partners in the European medicines network must ensure that they have the scientific resources necessary to address these challenges, both in the short term and further into the future. 
Agencija in njeni partnerji v Evropski mreži zdravil si morajo kratkoročno in dolgoročno zagotoviti znanstvena sredstva za te izzive.
The Management Board plans to review the system of remuneration for provision of scientific services to the EMEA in order to improve compliance with existing legislation. 
Upravni odbor namerava preučiti sistem plačila za zagotavljanje znanstvenih storitev EMEA, da bi zagotovili večje upoštevanje obstoječe zakonodaje.
In the field of inspections, the EMEA will actively participate in the international discussions on worksharing and cooperation on all types of inspections with the FDA and WHO. 
Na področju inšpekcijskih pregledov bo EMEA aktivno sodelovala v mednarodnih razpravah o delitvi dela ter sodelovanju z uradom FDA in SZO pri vseh vrstah pregledov.
EXECUTIVE DIRECTOR Thomas Lönngren 
IZVRŠNI DIREKTOR Thomas Lönngren
Also important in 2008 will be a focus on initiatives to improve the monitoring of risks of medicines, facilitate the availability of medicines for human and veterinary use, and strengthen transparency, communication and provision of information to stakeholders, in particular patients and healthcare professionals. 
V letu 2008 bo pomembna naloga tudi osredotočenje na pobude za izboljšanje spremljanja tveganj pri zdravilih, za omogočanje dostopa do zdravil za uporabo v humani in veterinarski medicini ter za okrepitev preglednosti, poročanja in zagotavljanja informacij ciljnim skupinam, zlasti bolnikom in zdravstvenim delavcem.
The Agency will carry out activities to assess the impact and consistency of its scientific opinions. 
Agencija bo izvajala dejavnosti ocenjevanja vpliva in skladnosti svojih znanstvenih mnenj.
The main focus in this area will be the further strengthening of the quality and consistency of assessment of postauthorisation applications, in particular, extensions. 
Glavni poudarek na tem področju bo nadaljnje izboljševanje kakovosti in skladnosti ocenjevanja vlog po izdaji dovoljenja za promet, predvsem kar zadeva razširitve.
The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organization. 
Agencija EMEA izdaja potrdila o zdravilu v skladu z ureditvami, ki jih je določila Svetovna zdravstvena organizacija.
This will in turn increase access to essential postauthorisation information and will better equip the network for safeguarding public and animal health. 
To bo povečalo dostop do pomembnih informacij po izdaji dovoljenja za promet in bo mrežo bolje opremilo za varovanje zdravja ljudi in živali.
In the area of information technology, the Agency will progress the deployment of best-practice-support processes based on the IT Infrastructure Library (ITIL) service management. 
Na področju informacijske tehnologije bo Agencija pospešila uvedbo postopkov podpore najboljšim praksam, ki temeljijo na upravljanju storitev Knjižnice infrastrukture informacijske tehnologije (ITIL).
The main factors influencing the Agency's activities in the area of pharmacovigilance relate to the implementation of the paediatric and advanced therapy legislation. 
Glavni dejavniki, ki vplivajo na dejavnosti Agencije na področju farmakovigilance, so povezani z izvajanjem zakonodaje o pediatriji in zakonodaje o naprednih terapijah.
This work is carried out in the face of increasing volume and complexity of activities. 
To delo bo izvajala kljub zvečanemu številu in kompleksnosti dejavnosti.
The Agency, in accordance with a WHO scheme, issues certificates of medicinal products to support the work of health authorities outside the European Union, in particular in developing countries. 
V skladu s shemo SZO izdaja Agencija potrdila o zdravilih v podporo dela zdravstvenih organov zunaj Evropske unije, zlasti v državah v razvoju.
The Agency will continue to provide administrative and financial support to these enterprises and will facilitate electronic reporting by SMEs of adverse-drug-reaction data through the EudraVigilance system. 
Agencija bo še naprej nudila administrativno in finančno podporo tem podjetjem in omogočala njihovo elektronsko poročanje o neželenih učinkih zdravil prek sistema EudraVigilance.
Within the animal-health industry, priorities are expected to remain directed predominantly towards the small-animal and immunologicals sectors of the market. 
Znotraj sektorja za zdravje živali bodo prednostne naloge ostale usmerjene predvsem v tržne sektorje za male živali in imunološke izdelke.
The Agency will then continue to elaborate data-analysis and signal-detection tools that will enhance the Agency's surveillance role within the regulatory network of the European Union. 
Agencija bo nato nadaljevala izpopolnjevanje orodij za obdelavo podatkov in prepoznavanje signalov, ki bodo okrepili njeno nadzorno vlogo znotraj regulativne mreže Evropske unije.
Work in this area will continue and the next phase of business-continuity solutions, including IT aspects, will be implemented. 
Delo na tem področju se bo nadaljevalo in Agencija bo izvajala naslednjo fazo rešitev na področju neprekinjenega poslovanja, vključno z informacijsko-tehnološkimi vidiki.
This will include building on its successful collaboration with the US Food and Drug Administration (FDA) as a model for co-operation with the Japanese and Canadian authorities. 
To vključuje bogatenje njenega uspešnega sodelovanja z Uradom za živila in zdravila (FDA) iz ZDA kot modela za sodelovanje z japonskimi in kanadskimi pristojnimi organi.
The Agency will advance projects such as EU Telematics Controlled Terms and Product Information Management (PIM), together with a number of other systems mentioned in the relevant sections of this work programme. 
Agencija bo razvijala projekte, kot sta telematsko nadzorovani izrazi EU (EU Telematics Controlled Terms) in Upravljanje s produktnimi informacijami (Product Information management, PMI), ter številne druge sisteme, ki so navedeni v odgovarjajočih poglavjih tega delovnega programa.
In the field of information provision, the Agency will consolidate related activities into the EMEA programme on provision of information. 
Na področju zagotavljanja informacij bo Agencija združila sorodne dejavnosti v program EMEA o zagotavljanju informacij.
Meeting management and conferences 
Upravljanje srečanj in konference
In addition, such medicines benefit from market exclusivity. 
Poleg tega pa tržna ekskluzivnost ugodno vpliva na taka zdravila.
The EMEA shall continue to ensure that necessary risk-minimisation measures have been put in place prior to the granting of marketing authorisations for medicinal products. 
Agencija EMEA bo še naprej zagotavljala, da so nujni ukrepi za zmanjševanje tveganja opravljeni pred izdajo dovoljenja za promet z zdravili.
As described earlier, the Agency will also ensure that due account is taken of ethical standards in clinical trials performed in non-EU countries, as part of the assessment of post-authorisation applications. 
Kot je že opisano, bo Agencija skrbela za upoštevanje etičnih standardov pri kliničnih preskušanjih, ki se izvajajo v državah zunaj EU, in to bo del njene ocene vlog po izdaji dovoljenja za promet.
PRE-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Patrick Le Courtois 
VREDNOTENJE ZDRAVIL ZA UPORABO V HUMANI MEDICINI PRED IZDAJO DOVOLJENJA ZA PROMET Vodja: Patrick Le Courtois
As part of this initiative, the Agency will launch a revised survey with IFAH-Europe of its procedures for authorisation of veterinary medicinal products. 
Kot del te pobude bo Agencija z IFAH-Europe začela revidirano anketo o njenih postopkih za izdajo dovoljenj za promet z zdravili za uporabo v veterinarski medicini.
In order to ensure high-quality assessment of the new types of applications, the Agency will review the scientific expertise available in the Agency and its committees and, if needed, will seek complementary expertise/experience in close collaboration with Member States. 
Da bi Agencija zagotovila visokokakovostni postopek za ocenjevanje novih vrst vlog, bo preučila znanstveno znanje in izkušnje v Agenciji in njenih odborih ter po potrebi dodajala znanje/izkušnje v tesnem sodelovanju z državami članicami.
This work is carried out in the context of the confidentiality arrangements with the US FDA. 
To sodelovanje se bo odvijalo na podlagi dogovora o zaupnosti z uradom FDA iz ZDA.
The EMEA decided to review existing practices and to introduce necessary changes to improve the efficiency and effectiveness of the document- and information-management processes. 
Odločila se je, da preuči dosedanje načine dela in uvede potrebne spremembe za povečanje smotrnosti in učinkovitosti postopkov upravljanja z dokumenti in informacijami.
While last year the Agency focused its efforts on implementing the Paediatric Regulation, the dominant regulatory issue in 2008 will be the implementation of a new regulation on advanced-therapy medicinal products. 
Medtem ko se je Agencija lansko leto posvetila izvajanju pediatrične uredbe, bo glavna regulativna dejavnost v letu 2008 izvajanje nove uredbe o zdravilih za napredno zdravljenje.
Total grade AD AST 11 
Stopnja AD skupaj AST 11
The number of procedures is difficult to predict and the impact on the workload of the CHMP and EMEA secretariat will be carefully monitored. 
Težko je predvideti število postopkov, vpliv na delovno obremenitev Odbora za zdravila za uporabo v humani medicini (CHMP) ter sekretariata agencije EMEA pa bo skrbno nadzorovan.
The Agency anticipates that the number of requests for scientific advice and protocol assistance will continue to increase in 2008. 
Agencija pričakuje, da se bo število vlog za znanstveno svetovanje in pomoč pri protokolu v letu 2008 še povečalo.
The EMEA receives safety reports and product-quality-defect reports from within the EU and outside concerning centrally authorised medicinal products, and coordinates action relating to the safety and quality of medicinal products. 
EMEA prejema varnostna poročila in poročila o pomanjkljivosti izdelkov za zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku v Evropski uniji in zunaj nje, ter usklajuje ukrepe, ki se nanašajo na varnost in kakovost zdravil.
The Agency expects that the number of variations and line extensions in the veterinary field will also increase in accordance with the increased number of products that will be on the market. 
Agencija pričakuje, da se bo število sprememb in razširitev indikacij v veterinarski medicini tudi povečalo skladno z večjim številom zdravil na trgu.
This includes the publication of agendas and minutes of meetings of the Management Board, as well as of information from various EMEA committees on non-product-related issues; and providing access to the EudraVigilance database and to information on paediatric clinical trials (EU telematics project), in line with agreed access policies. 
To vključuje objavljanje dnevnega reda in zapisnikov sej upravnega odbora in informacij različnih odborov EMEA o zadevah, ki niso povezane z zdravili, ter omogočanje dostopa do podatkovne baze EudraVigilance in do informacij o kliničnih preskušanjih v pediatriji (EU telematski projekt), skladno z dogovorjeno politiko o dostopu.