FrancophonIA/ELRC3.0 huggingface dataset:
English: Reviewing the efficiency of the Agency's operations is particularly important at this time, as it faces challenges resulting from the increased complexity and volume of its activities, from its wider scope of responsibilities, from the heightened expectations of its stakeholders, from challenges posed by the advent of new and more complex technologies, and from the continuing globalisation of the pharmaceutical sector.
Slovenian: Pregled učinkovitosti delovanja Agencije je v tem trenutku še posebej pomemben, saj se Agencija spopada z izzivi, ki izhajajo iz vedno večje zahtevnosti in količine njenih dejavnosti, iz vedno večjega obsega odgovornosti, iz povečanih pričakovanj zainteresiranih strani, iz izzivov, ki jih predstavlja prihod novih in bolj zapletenih tehnologij, in nadaljnje globalizacije farmacevtskega sektorja.
English: The year 2006 is the first year of full operation of the revised pharmaceutical legislation.
Slovenian: Leto 2006 je prvo leto, ko se je spremenjena farmacevtska zakonodaja začela polno izvajati.
English: The Agency plans to undertake a major refurbishment project to increase meeting facilities for the Agency's scientific committees and working groups, following entry into force of the new legislation.
Slovenian: Agencija namerava uvesti večji projekt obnove, tako da bi pridobila prostore za sestanke znanstvenih odborov in delovnih skupin Agencije po začetku veljavnosti nove zakonodaje.
English: The Agency is committed to full implementation of the EMEA integrated quality-management system and internal control standards.
Slovenian: Agencija je zavezana, da bo v celoti izvajala integriran sistem EMEA za vodenje kakovosti in standarde notranje kontrole.
English: EU institutions, agencies and European and international partners
Slovenian: Institucije, agencije ter evropski in mednarodni partnerji EU
English: Where necessary, action will be taken to further refine procedures as a result of experience gained and the growing number of applications.
Slovenian: Po potrebi se bodo sprejeli ukrepi za dodatno dodelavo postopkov na podlagi pridobljenih izkušenj in vse večjega števila vlog.
English: Integrated quality management and audit
Slovenian: Integrirano upravljanje kakovosti in pregledo vanje
English: The improved procedures will allow smoother operation of the process, and will be fully integrated into the Agency's working practices in 2006.
Slovenian: Izboljšani postopki bodo prispevali k temu, da bodo postopki potekali bolj gladko, in v delovne postopke Agencije bodo popolnoma vključeni v letu 2006.
English: The Agency will make every effort to enhance cooperation between European partners on all activities relating to medicines, particularly those which contribute to the safety of patients in Europe and to the availability of new, effective and safe medicines.
Slovenian: Agencija si bo z vsemi sredstvi prizadevala okrepiti sodelovanje med evropskimi partnerji pri vseh dejavnostih, povezanih z zdravili, zlasti tistih, ki prispevajo k varnosti bolnikov v Evropi in dostopnosti novih, učinkovitih in varnih zdravil.
English: The EMEA will contribute to international harmonisation discussions on quality systems and implementation of quality risk-management and pharmaceutical development.
Slovenian: EMEA bo prispevala k mednarodnim razpravam o harmonizaciji sistemov kakovosti ter izvedbi kakovostnega obvladovanja tveganja in razvoju farmacije.
English: It is projected that the number of applications for scientific advice and protocol assistance (for designated orphan medicinal products) received in 2006 will be twice as high as in 2004; in particular, the ratio of scientific-advice requests relating to products for new therapies and technologies is expected to rise.
Slovenian: Predvideva se, da bo število vlog za znanstveno svetovanje in pomoč pri protokolu (za določena zdravila sirote), ki bodo prispele v letu 2004, za dvakrat presegalo število iz leta 2004; pričakuje se zlasti povečanje deleža zahtevkov za znanstveno svetovanje za izdelke, povezane z novimi terapijami in tehnologijami.
English: In 2006, the Agency will be in a position to consolidate the integrated management measures implemented over the years.
Slovenian: Leta 2006 bo lahko Agencija povezala ukrepe integriranega upravljanja, ki so se izvajali v preteklih letih.
English: The Agency expects that all national competent authorities will be reporting electronically to the EudraVigilance system by the end of 2006, which is reflected in the forecast increase of electronic reports in the chart below.
Slovenian: Agencija od vseh nacionalnih pristojnih organov pričakuje, da bodo do konca leta 2006 začeli pošiljati elektronska poročila v sistem EudraVigilance, kar je razvidno iz napovedi o povečanju števila poročil v elektronski obliki v spodnjem grafikonu.
English: Provision of support and incentives to SMEs developing medicinal products;
Slovenian: zagotavljanje podpore in spodbud malim in srednje velikim podjetjem, ki razvijajo zdravila;
English: The main priorities for 2006 are: continued development and modification of systems to implement the new legislation; reliable operation of the EU telematics systems and related services; and continued analysis and development of the EU telematics IT projects.
Slovenian: Glavne prednostne naloge za leto 2006 so: nadaljevanje razvoja in spreminjanja sistemov za izvedbo nove zakonodaje; zanesljivo delovanje telematskih sistemov EU in povezanih storitev ter stalna analiza in razvoj projektov IT na področju telematike EU.
English: In order to support innovation and research that leads to improved availability of medicines - and to promote access to them - the Agency will conduct a range of activities and implement a variety of tools, as follows:
Slovenian: Za podporo inovacijam in raziskavam, ki vodijo k večji dostopnosti zdravil - in za spodbujene dostopa do njih - bo Agencija opravila vrsto dejavnosti in uporabila vrsto orodij, kot je opisano spodaj:
English: Once completed, the database will be a further source of authoritative information about medicines for patients, healthcare professionals and regulators.
Slovenian: Ko bo ta zbirka podatkov dokončana, bo dodatni vir verodostojnih informacij o zdravilih za bolnike, zdravstvene strokovnjake in zakonodajalce.
English: The Agency will also continue its work with the World Health Organization, Codex Alimentarius and OIE.
Slovenian: Agencija bo tudi nadaljevala sodelovanje s Svetovno zdravstveno organizacijo, Codexom Alimentariusom in Mednarodnim uradom za živalske kužne bolezni (OIE).
English: In the area of veterinary medicines:
Slovenian: Na področju veterinarskih zdravil:
English: This comes in response to heightened public awareness and a subsequent demand for the re-use of information.
Slovenian: Tako se bo odzvala na večjo javno ozaveščenost in posledične zahteve po vnovični uporabi informacij.
English: Increase openness and transparency of activities to underline the good corporate governance of the Agency and allow interested parties to closely monitor its activities.
Slovenian: večja odprtost in preglednost dejavnosti, da se poudari dobro podjetniško upravljanje Agencije in zainteresiranim stranem omogoči natančno spremljanje njenih dejavnosti.
English: Two to three new upgrade versions of the main EudraVigilance application (7.1, 7.2, 7.3) will be released in the course of 2006.
Slovenian: V letu 2006 bosta izdani dve od treh posodobljenih različic glavnega uporabniškega programa EudraVigilance (7.1, 7.2, 7.3).
English: By the end of the year, advanced query facilities will be provided.
Slovenian: Do konca leta bodo zagotovljene napredne možnosti za poizvedovanje.
English: Activities in terms of the number of applications for designation are expected to stabilise at the 2005 level, although the outcome of the European Commission's report on orphan medicinal products regulation in early 2006 will be decisive for long-term trends and the potential evolution of the orphan policy at Community level.
Slovenian: Pričakovati je, da se bodo dejavnosti v zvezi s številom vlog za določitev umirile na ravni iz leta 2005, čeprav bo izid poročila Evropske komisije o uredbi o zdravilih sirotah v začetku leta 2006 odločilno vplival na dolgoročna gibanja in usmeritve politike zdravil sirot na ravni Skupnosti.
English: The Agency's work in the infrastructure area is directly linked to the increased number of meetings, visitors to the Agency, telecommunications activities and staff.
Slovenian: Delo Agencije na področju infrastrukture je neposredno povezano z večjim številom sestankov, obiskov na Agenciji, telekomunikacijskih dejavnosti in zaposlenih.
English: Finally, the policies concerning public access to the data included in EudraVigilance will be defined, taking into account the protection of individual and commercially confidential data.
Slovenian: Končno se bo opredelila tudi politika javnega dostopa do podatkov v sistemu EudraVigilance, pri čemer se bo upoštevala zaščita posameznih in poslovno zaupnih podatkov.
English: To this end, the Agency will: conduct self-assessment activities as part of the EU benchmarking system, alongside its European partners; review the level of implementation of the internal control standards; conduct annual management-review activities; assess its achievements in the area of risk management; and assess the impact of improvements following audits.
Slovenian: V ta namen bo Agencija: skupaj z evropskimi partnerji izvajala dejavnosti samoocenjevanja v okviru sistema EU za primerjalne analize; pregledala stopnjo izvajanja standardov notranje kontrole; izvajala dejavnosti letnega pregleda upravljanja; ocenila svoje dosežke na področju obvladovanja tveganja in ocenila vpliv izboljšav po revizijah.
English: Close cooperation between all members of the European medicines network is paramount to the successful functioning of the network, to its ability to provide safe and effective medicines to patients within optimal timelines, and to the creation of a regulatory environment that is effective and stimulates research and innovation.
Slovenian: Tesno sodelovanje med vsemi člani Evropske mreže zdravil je najpomembnejše za uspešno delovanje mreže, njeno sposobnost zagotavljanja varnih in učinkovitih zdravil bolnikom v optimalnem času ter vzpostavitev regulativnega okolja, ki je učinkovito in spodbuja raziskave in inovacije.
English: Taking into account further changes of the Agency's regulatory and legal environment, the Agency will develop a strategy for any future expansion and reorganisation of its offices.
Slovenian: Agencija bo ob upoštevanju nadaljnjih sprememb njenega regulativnega in zakonodajnega okolja razvila strategijo za vse prihodnje širitve in spremembe prostorov.
English: The Agency may also need to implement the changeover to the newly created “europa.eu” domain for websites and e-mail addresses to meet the requirement of the European Parliament and Council Regulation.
Slovenian: Agencija bo verjetno morala izvesti tudi prehod na novo domeno "europa.eu" za spletne strani in elektronske naslove ter tako izpolniti zahtevo Evropskega parlamenta in Uredbe Sveta.
English: For more details about the mandates, composition and other information on the EMEA Scientific Committees, Scientific Advisory Groups and Working Parties please refer to the Agency's website at: www.emea.eu.int
Slovenian: Za podrobnejše informacije o nalogah in pooblastilih ter sestavi znanstvenih odborov, znanstvenih svetovalnih skupin in delovnih skupin EMEA in druge informacije o njih, prosimo, obiščite spletno stran Agencije na naslovu: www.emea.eu.int
English: In 2005, the Agency adapted its scientificadvice and protocol-assistance procedures to meet the requirements of the new legislation, resulting in reduced timelines, extended scope, greater involvement of experts, and increased added value of the advice.
Slovenian: Leta 2005 je Agencija prilagodila svoje postopke znanstvenega svetovanja in pomoči pri protokolu zahtevam nove zakonodaje ter tako skrajšala roke, razširila področje uporabe, intenzivneje vključila strokovnjake in povečala dodano vrednost svetovanja.
English: The Agency will continue to work on rationalisation of the process and will follow up on the removal of the legalisation step formerly performed by the European Commission.
Slovenian: Agencija si bo še naprej prizadevala za racionalizacijo postopka in bo spremljala odpravo zakonodajne stopnje, za katero je bila doslej zadolžena Evropska komisija.
English: The provision of scientific advice is one of the most important ways in which the Agency can support innovation and research: analysis of the impact of scientific advice provided by the Agency shows that the procedure significantly increases the chances of obtaining a marketing authorisation.
Slovenian: Eden najpomembnejših načinov, kako Agencija lahko podpira inovacije in raziskave, je zagotavljanje znanstvenega svetovanja: analiza vpliva znanstvenega svetovanja, ki jo je izdelala Agencija, kaže, da ta proces bistveno povečuje možnosti za pridobitev dovoljenja za promet.
English: The Agency expects an increase in the number of applications for marketing authorisation.
Slovenian: Agencija pričakuje, da se bo povečalo število vlog za dovoljenje za promet.
English: The year 2006 is the first full year of operation of the Coordination Groups for Mutual-Recognition and Decentralised Procedures (CMDs) established by the new Community legislation.
Slovenian: Leta 2006 bodo prvič vse leto delovale skupine za usklajevanje za postopke vzajemnega priznavanja in decentralizirane postopke (CMD), ki so ustanovljene v skladu z novo zakonodajo Skupnosti.
English: Transparency, communication and provision of information to patients, healthcare professionals and users of medicines
Slovenian: Preglednost, obveščanje in zagotavljanje informacij bolnikom, zdravstvenim strokovnjakom in uporabnikom zdravil
English: Greater openness and provision of information relating to medicinal products submitted to the Agency for evaluation, both before and after the granting of a marketing authorisation;
Slovenian: večja odprtost in zagotavljanje informacij v zvezi z zdravili, predloženimi Agenciji za vrednotenje, pred dodelitvijo dovoljenja za promet in po njej;
English: The Agency will conduct exercises and continually test its business-continuity plan, to ensure its proper functioning.
Slovenian: Agencija bo izvajala vaje in stalno preizkušala svoj načrt zveznosti poslovanja ter tako zagotavljala njegovo pravilno delovanje.
English: Continue efforts to increase the availability of veterinary medicines, particularly for minor species and minor uses;
Slovenian: nadaljnja prizadevanja za povečanje dostopnosti veterinarskih zdravil, zlasti za manj pomembne vrste in uporabnike;
English: The Agency expects an increase in the number of extension or modification applications for maximum residue limits (MRLs) in 2006.
Slovenian: Agencija v letu 2006 pričakuje povečanje števila vlog za razširitev ali spremembo mejnih vrednosti ostankov (MVO).
English: The Agency expects to receive a total of 59 initial applications (including ones for generic, biologically similar and compassionate-use products, and products intended for non-EU markets), which is a 44% increase on the previous year;
Slovenian: Agencija pričakuje, da bo skupno dobila 59 začetnih vlog (vključno z zdravili za generično, biološko podobno in sočutno uporabo ter zdravili, ki niso namenjena za trge EU), kar pomeni povečanje za 73 % glede na predhodno leto;
English: Provide support to SMEs to contribute towards the promotion of innovation and research in this sector;
Slovenian: podpora malim in srednje velikim podjetjem, kar bi prispevalo k spodbujanju inovacij in raziskav v tem sektorju;
English: In addition, the Agency will collaborate fully and work with the Member States' veterinary regulatory authorities in the European Surveillance System to foster a joint approach to optimising efficiency in EU veterinary pharmacovigilance for all medicinal products authorised in the Community.
Slovenian: Poleg tega bo Agencija polno sodelovala in delala skupaj z veterinarskimi regulativnimi organi držav članic v evropskem sistemu nadzora, s čimer bo spodbujala skupni pristop k povečevanju učinkovitosti v veterinarski farmakovigilanci EU za vsa zdravila, ki imajo dovoljenje za promet v Skupnosti.
English: In view of significant technological developments in the field of medicines, the European medicines network will focus its attention in 2006 on ensuring the long-term availability of competences to respond to the emergence of new therapies and technologies.
Slovenian: Ob upoštevanju pomembnega tehnološkega razvoja na področju zdravil se bo Evropska mreža zdravil v letu 2006 posvetila zagotavljanju dolgoročne dostopnosti pristojnosti, s katerimi se bo lahko odzivala na nove terapije in tehnologije.
English: Appropriation/Budget 2005 as of 31 December 2005.
Slovenian: Proračunska sredstva/proračun 2005 od 30. novembra 2005.
English: The full work programme 2006 in English can be found on the Agency's website: www.emea.eu.int
Slovenian: Celoten delovni program 2006 v angleškem jeziku je na voljo na spletni strani Agencije: www.emea.eu.int
English: The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organisation.
Slovenian: EMEA izdaja potrdila o zdravilu v skladu z dogovori, ki jih je določila Svetovna zdravstvena organizacija.
English: In the area of medicines for human use, the Agency will focus on fully integrating the new legislative requirements relating to pharmacovigilance into its processes, alongside further development and implementation of the European risk-management strategy.
Slovenian: Na področju zdravil za uporabo v humani medicini se bo Agencija posvetila polni vključitvi zakonodajnih zahtev v zvezi s farmakovigilanco v svoje postopke, pri čemer bo dodatno razvijala in uresničevala evropsko strategijo obvladovanja tveganja.
English: This is due mainly to the widened scope of the centralised procedure, new support available to companies considering applications for limited markets and/or for regional diseases and more generic applications expected as the data exclusivity period expires for centralised veterinary authorisations;
Slovenian: To je predvsem posledica razširjenega področja uporabe centraliziranega postopka, nove podpore, ki je na voljo podjetjem, ki preučujejo vloge za omejene trge in/ali regionalne bolezni, in pričakovanega povečanja števila generičnih vlog, ker se za centralizirana veterinarska dovoljenja izteka obdobje izključne pravice do uporabe podatkov;
English: EXECUTIVE DIRECTOR EXECUTIVE DIRECTOR Thomas Lönngren Thomas Lönngren
Slovenian: IZVRŠNI DIREKTOR EXECUTIVE DIRECTOR Thomas Lönngren Thomas Lönngren
English: To ensure it manages the greater scope and complexity of its activities in the most efficient and effective way, the Agency will continue to develop its integrated quality-management system, with particular focus on optimising processes and on effective use of resources.
Slovenian: Da bi zagotovila kar najbolj uspešno in učinkovito upravljanje večjega obsega in zahtevnosti svojih aktivnosti, bo Agencija še naprej razvijala svoj integrirani sistem vodenja kakovosti, s posebnim poudarkom na optimizaciji procesov in učinkoviti uporabi virov.
English: Pre-accession activities in view of the next wave of EU enlargement, in 2007, will include operation of the pre-accession linguistic review process (PALC II) and CADREAC procedures, as well as participation in the PHARE multi-beneficiary programme, to facilitate the integration of Bulgarian and Romanian regulatory authorities in the work of the Agency.
Slovenian: Predpristopne dejavnosti z vidika naslednjega vala širitve EU leta 2007 bodo zajemale delovanje procesa predpristopne jezikovne verzije (PALC II) in postopke CADREAC ter sodelovanje v večnamenskem programu PHARE, da bi tako pospešili vključitev bolgarskih in romunskih regulativnih organov v delo Agencije.
English: Furthermore, in order to identify safety signals, the EMEA will have to provide assistance to Member States on the import of product-related data and analysis of pharmacovigilance data.
Slovenian: Poleg tega bo morala EMEA, če hoče prepoznati varnostna opozorila, pomagati državam članicam pri uvozu podatkov, povezanih z zdravili, in analizi podatkov o farmakovigilanci.
English: Management Board meetings
Slovenian: Sestanki upravnega odbora
English: Improving transparency, communication and provision of information;
Slovenian: izboljšanje preglednosti, obveščanja in zagotavljanja informacij;
English: The EMEA will liaise with EU medicines-enforcement officers on their work to investigate the incidence of counterfeit medicines.
Slovenian: EMEA bo navezala stike z uradniki EU na področju zakonodaje za zdravila pri njihovem preiskovanju pogostosti ponarejenih zdravil.
English: The Agency will also continue to support implementation of the clinical trials directive and will further develop relevant procedures and guidelines, and support the operation and further development of the clinical trials database.
Slovenian: Agencija bo tudi še naprej podpirala izvajanje direktive o kliničnem preizkušanju in razvijala ustrezne postopke in smernice ter podpirala delovanje in nadaljnji razvoj zbirke podatkov o kliničnih preizkusih.
English: Sampling and testing
Slovenian: Vzorčenje in preizkušanje
English: Close collaboration between the EMEA, the European Directorate for the Quality of Medicines and the national authorities in this programme continues to prove invaluable in assuring effective and continued post-marketing surveillance of the quality of medicines.
Slovenian: Tesno sodelovanje med EMEA, Evropskim direktoratom za kakovost zdravil in nacionalnimi organi po tem programu se še naprej kaže kot neprecenljivo pri zagotavljanju učinkovitega in stalnega nadzora kakovosti zdravil po izdaji dovoljenja.
English: Measures include the provision of free, high-quality scientific advice to companies developing orphan medicines or veterinary medicines intended for use in minor animal species.
Slovenian: Ukrepi vključujejo zagotavljanje brezplačnega in visoko kakovostnega znanstvenega svetovanja podjetjem, ki razvijajo zdravila sirote in veterinarska zdravila za uporabo pri manj pomembnih živalskih vrstah.
English: The Agency will also see the establishment of a new audit-advisory committee, following an open tender in 2005.
Slovenian: Agencija bo ustanovila tudi nov Posvetovalni odbor za revizije na podlagi javnega razpisa leta 2005.
English: Infrastructure services Accounting
Slovenian: Infrastrukturne storitve Računovodstvo
English: Following the full switch to electronic reporting of adverse drug reactions (ADRs) to veterinary medicines for all Member States in 2005, a number of activities relating to further training and the provision of assistance to Member States and industry will be required.
Slovenian: Po popolnem prehodu na elektronsko poročanje o neželenih učinkih veterinarskih zdravil v vseh državah članicah v letu 2005 se zahteva vrsta dejavnosti v zvezi z dodatnim usposabljanjem in zagotavljanjem pomoči državam članicam in industriji.
English: Similarly, the provision of certificates free of charge to small and medium-sized enterprises will be accommodated.
Slovenian: Podobno bo sprejeto podeljevanje potrdil malim in srednje velikim podjetjem brez plačila pristojbine.
English: During the year, the Agency will complete its implementation of legislative and procedural requirements in the area of good manufacturing practice (GMP) for active substances and certain excipients.
Slovenian: Agencija bo med letom dokončno uresničila zakonodajne in postopkovne zahteve na področju dobre proizvodne prakse za aktivne snovi in določene pomožne snovi.