natgillin/translations-raw huggingface dataset:
Increase openness and transparency of activities to underline the good corporate governance of the Agency and allow interested parties to closely monitor its activities.
večja odprtost in preglednost dejavnosti, da se poudari dobro podjetniško upravljanje Agencije in zainteresiranim stranem omogoči natančno spremljanje njenih dejavnosti.
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.
V letu 2006 bosta izdani dve od treh posodobljenih različic glavnega uporabniškega programa EudraVigilance (7.1, 7.2, 7.3).
By the end of the year, advanced query facilities will be provided.
Do konca leta bodo zagotovljene napredne možnosti za poizvedovanje.
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.
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.
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.
Delo Agencije na področju infrastrukture je neposredno povezano z večjim številom sestankov, obiskov na Agenciji, telekomunikacijskih dejavnosti in zaposlenih.
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.
Končno se bo opredelila tudi politika javnega dostopa do podatkov v sistemu EudraVigilance, pri čemer se bo upoštevala zaščita posameznih in poslovno zaupnih podatkov.
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.
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.
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.
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.
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.
Agencija bo ob upoštevanju nadaljnjih sprememb njenega regulativnega in zakonodajnega okolja razvila strategijo za vse prihodnje širitve in spremembe prostorov.
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.
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.
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
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
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.
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.
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.
Agencija si bo še naprej prizadevala za racionalizacijo postopka in bo spremljala odpravo zakonodajne stopnje, za katero je bila doslej zadolžena Evropska komisija.
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.
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.
The Agency expects an increase in the number of applications for marketing authorisation.
Agencija pričakuje, da se bo povečalo število vlog za dovoljenje za promet.
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.
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.
Transparency, communication and provision of information to patients, healthcare professionals and users of medicines
Preglednost, obveščanje in zagotavljanje informacij bolnikom, zdravstvenim strokovnjakom in uporabnikom zdravil
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;
večja odprtost in zagotavljanje informacij v zvezi z zdravili, predloženimi Agenciji za vrednotenje, pred dodelitvijo dovoljenja za promet in po njej;
The Agency will conduct exercises and continually test its business-continuity plan, to ensure its proper functioning.
Agencija bo izvajala vaje in stalno preizkušala svoj načrt zveznosti poslovanja ter tako zagotavljala njegovo pravilno delovanje.
Continue efforts to increase the availability of veterinary medicines, particularly for minor species and minor uses;
nadaljnja prizadevanja za povečanje dostopnosti veterinarskih zdravil, zlasti za manj pomembne vrste in uporabnike;
The Agency expects an increase in the number of extension or modification applications for maximum residue limits (MRLs) in 2006.
Agencija v letu 2006 pričakuje povečanje števila vlog za razširitev ali spremembo mejnih vrednosti ostankov (MVO).
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;
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;
Provide support to SMEs to contribute towards the promotion of innovation and research in this sector;
podpora malim in srednje velikim podjetjem, kar bi prispevalo k spodbujanju inovacij in raziskav v tem sektorju;
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.
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.
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.
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.
Appropriation/Budget 2005 as of 31 December 2005.
Proračunska sredstva/proračun 2005 od 30. novembra 2005.
The full work programme 2006 in English can be found on the Agency's website: www.emea.eu.int
Celoten delovni program 2006 v angleškem jeziku je na voljo na spletni strani Agencije: www.emea.eu.int
The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organisation.
EMEA izdaja potrdila o zdravilu v skladu z dogovori, ki jih je določila Svetovna zdravstvena organizacija.
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.
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.
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;
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;
EXECUTIVE DIRECTOR EXECUTIVE DIRECTOR Thomas Lönngren Thomas Lönngren
IZVRŠNI DIREKTOR EXECUTIVE DIRECTOR Thomas Lönngren Thomas Lönngren
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.
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.
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.
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.
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.
Poleg tega bo morala EMEA, če hoče prepoznati varnostna opozorila, pomagati državam članicam pri uvozu podatkov, povezanih z zdravili, in analizi podatkov o farmakovigilanci.
Management Board meetings
Sestanki upravnega odbora
Improving transparency, communication and provision of information;
izboljšanje preglednosti, obveščanja in zagotavljanja informacij;
The EMEA will liaise with EU medicines-enforcement officers on their work to investigate the incidence of counterfeit medicines.
EMEA bo navezala stike z uradniki EU na področju zakonodaje za zdravila pri njihovem preiskovanju pogostosti ponarejenih zdravil.
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.
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.
Sampling and testing
Vzorčenje in preizkušanje
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.
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.
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.
Ukrepi vključujejo zagotavljanje brezplačnega in visoko kakovostnega znanstvenega svetovanja podjetjem, ki razvijajo zdravila sirote in veterinarska zdravila za uporabo pri manj pomembnih živalskih vrstah.
The Agency will also see the establishment of a new audit-advisory committee, following an open tender in 2005.
Agencija bo ustanovila tudi nov Posvetovalni odbor za revizije na podlagi javnega razpisa leta 2005.
Infrastructure services Accounting
Infrastrukturne storitve Računovodstvo
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.
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.
Similarly, the provision of certificates free of charge to small and medium-sized enterprises will be accommodated.
Podobno bo sprejeto podeljevanje potrdil malim in srednje velikim podjetjem brez plačila pristojbine.
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.
Agencija bo med letom dokončno uresničila zakonodajne in postopkovne zahteve na področju dobre proizvodne prakse za aktivne snovi in določene pomožne snovi.
Taking into account the level of the orphanmedicinal-products fund (requested amount of EUR 5,900,000) and recommendations of the Committee for Orphan Medicinal Products (COMP), the Agency proposes fee reductions that will provide maximum possible incentives during the development and marketing-authorisation phases of orphan medicines.
Agencija ob upoštevanju proračuna za zdravila sirote (zahtevani znesek 5.900.000 EUR) in priporočila Odbora za zdravila sirote (COMP) predlaga znižanje pristojbin, s katerim bi zagotovili največ pobud med stopnjami razvoja in pridobivanja dovoljenja za promet za zdravila sirote.
In addition, the HMPC will continue its work on updating the guidance for the content of applications to register the traditional medicinal use of herbal medicinal products.
Poleg tega si bo HMPC še naprej prizadeval za posodabljanje smernic glede vsebine vlog za registracijo tradicionalne medicinske uporabe zdravil rastlinskega izvora.
This document provides a summary of the Agency's work programme 2006, adopted by the Management Board on 15 December 2005.
Ta dokument je povzetek delovnega programa Agencije za leto 2006, ki ga je upravni odbor sprejel dne 15. decembra 2005.
Further development of the EudraVigilance system (comprising an electronic database and dataprocessing network for adverse drug reactions) is paramount to the successful implementation of the strategy and will, therefore, remain at the top of the Agency's agenda in the field of safety of medicines.
Nadaljnji razvoj sistema EudraVigilance (sestavljenega iz elektronske zbirke podatkov in mreže za obdelavo podatkov o neželenih učinkih zdravila) je bistvenega pomena za uspešno izvedbo strategije in bo tako ostal na vrhu programa Agencije za področje varnosti zdravil.
Existing facilities and services for videoconferencing over the Internet will be extended and improved.
Razširili in izboljšali bodo zdajšnje zmožnosti in storitve za izvedbo videokonferenc prek interneta.
With regard to the area of personnel-management, the Agency will work to implement the staff regulations and a new competence-development policy, and will direct professional-training management towards a continuous system of competence development, taking account of the greater scientific orientation of the Agency.
Kar zadeva območje kadrovskega vodenja, bo Agencija skušala izvajati kadrovske predpise in novo politiko razvoja pristojnosti ter usmerjala vodenje strokovnega usposabljanja k neprekinjenemu sistemu razvijanja pristojnosti, ob upoštevanju povečane znanstvene vloge Agencije.
Changes in the legislation now make it possible to submit applications for the authorisation of non-prescription medicines through the centralised route.
Zaradi zakonodajnih sprememb je zdaj mogoče predložiti vloge za dovoljenje zdravil, ki se ne izdajajo na recept, po centraliziranem postopku.
Both EudraCT (the clinical-trials database) and EudraGMP (the database of GMP certificates and manufacturing authorisations) will provide EU regulators a single source of information for these domains for the whole of the European Union; two new versions of EudraCT will be released during 2006 (3.0.0 in April 2006, 4.0.0 in June 2006).
Tako EudraCT (zbirka podatkov o kliničnih preizkušanjih) in EudraGMP (zbirka podatkov o potrdilih o dobri proizvodni praksi in dovoljenjih za izdelavo) bosta zakonodajalcem EU ponujali en sam vir informacij na teh področjih za celotno Evropsko unijo; v letu 2006 bosta objavljeni dve novi različici EudraCT (3.0.0 marca, 4.0.0 junija 2006).
The Agency will implement a number of adopted guidelines relating to similar biological (biosimilar) medicinal products, and will consolidate procedures for generic medicines.
Agencija bo uresničila vrsto spremenjenih smernic za biološko podobna zdravila in bo utrdila postopke za generična zdravila.
The Agency will fully embrace its responsibility to assess four classes of medicines for which authorisation must now be sought through the centralised procedure: those for HIV/AIDS, cancer, diabetes and neurodegenerative disorder.
Agencija bo prevzela polno odgovornost za oceno štirih razredov zdravil, za katera je zdaj treba pridobiti dovoljenje po centraliziranem postopku: zdravil za HIV/aids, raka, sladkorno bolezen in nevrodegenerativne bolezni.
The novel concept of risk-management plans (RMPs) introduced by the new legislation will require adequate evaluation, both in the pre- and post-authorisation phases.
Novi koncept načrtov za obvladovanje tveganja, ki ga prinaša nova zakonodaja, bo zahteval ustrezno vrednotenje, na stopnjah pred izdajo dovoljenja in po njem.
A staff-motivation exercise will be conducted in 2006, and the impact of actions developed as an outcome of the 2005 exercise will be evaluated.
Leta 2006 se bo izvajala motivacija osebja, ovrednotil pa se bo tudi vpliv ukrepov, ki so bili rezultat izvajanja motivacije leta 2005.
The Agency expects the number of inspections to remain stable in 2006.
Agencija pričakuje, da se število inšpekcijskih pregledov v letu 2006 ne bo spreminjalo.
Commencement of discussions with academia, learned societies, industry and other parties on challenges relating to new technologies and therapies, plus implementation of practical proposals stemming from these fora, as part of the Agency's efforts to foster research into new technologies and rare diseases;
začetek razprav z akademskimi krogi, znanstvenimi združenji, industrijo in drugimi stranmi o izzivih v zvezi z novimi tehnologijami in terapijami ter uresničevanje praktičnih predlogov, ki izhajajo iz teh forumov v okviru prizadevanj Agencije za spodbujanje raziskav novih tehnologij in redkih bolezni;
In addition to continuous improvement and revision of procedures, the Agency plans to strengthen cooperation with its pool of partners who can provide specialised knowledge and expertise, and to increase the size of that pool;
Agencija namerava poleg stalnega napredka in pregledovanja postopkov okrepiti sodelovanje s skupino partnerjev, ki ji lahko zagotavljajo specializirano strokovno znanje in izkušnje, ter povečati obseg te skupine;
Owing to the new legislation, the Agency expects to receive the first authorisation applications for generic medicines this year, and will assume full responsibility for evaluating medicines intended for the treatment of HIV/AIDS, cancer, diabetes and neurodegenerative disorders, which must now be authorised through the centralised procedure.
Zaradi nove zakonodaje Agencija pričakuje, da bo letos prejela prve vloge za izdajo dovoljenj za generična zdravila in bo prevzela polno odgovornost za vrednotenje zdravil, namenjenih za zdravljenje HIV/aidsa, raka, diabetesa in degenerativnih motenj živčnega sistema, ki jih je sedaj treba odobriti po centraliziranem postopku.
An important legislative change requires applicants to include an RMP in their application, to be evaluated by the Committee for Medicinal Products for Human Use (CHMP).
Pomembna zakonodajna sprememba od vlagateljev zahteva, da svoji vlogi priložijo načrt za obvladovanje tveganja, ki ga oceni Odbor za zdravila za uporabo v humani medicini (CHMP).
The Agency will also establish a framework and tools for evaluation of referral and arbitration procedures relating to traditional herbal medicinal products.
Agencija bo vzpostavila tudi okvir in orodja za ocenjevanje postopkov predložitve in arbitraže, povezanih s tradicionalnimi zdravili rastlinskega izvora.
A significant increase (64%) in validated parallel-distribution notifications was observed in 2005, due to the implementation of Community legislation on parallel distribution (mandatory EMEA notification procedure).
Leta 2005 je bilo zaradi začetka veljavnosti zakonodaje Skupnosti o vzporedni distribuciji (obvezen postopek obveščanja EMEA) opaziti pomembno povečanje (64 %) potrjenih obvestil o vzporedni distribuciji.