FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Poleg tega si bo HMPC še naprej prizadeval za posodabljanje smernic glede vsebine vlog za registracijo tradicionalne medicinske uporabe zdravil rastlinskega izvora.
English: This document provides a summary of the Agency's work programme 2006, adopted by the Management Board on 15 December 2005.
Slovenian: Ta dokument je povzetek delovnega programa Agencije za leto 2006, ki ga je upravni odbor sprejel dne 15. decembra 2005.
English: 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.
Slovenian: 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.
English: Existing facilities and services for videoconferencing over the Internet will be extended and improved.
Slovenian: Razširili in izboljšali bodo zdajšnje zmožnosti in storitve za izvedbo videokonferenc prek interneta.
English: 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.
Slovenian: 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.
English: Changes in the legislation now make it possible to submit applications for the authorisation of non-prescription medicines through the centralised route.
Slovenian: Zaradi zakonodajnih sprememb je zdaj mogoče predložiti vloge za dovoljenje zdravil, ki se ne izdajajo na recept, po centraliziranem postopku.
English: 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).
Slovenian: 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).
English: The Agency will implement a number of adopted guidelines relating to similar biological (biosimilar) medicinal products, and will consolidate procedures for generic medicines.
Slovenian: Agencija bo uresničila vrsto spremenjenih smernic za biološko podobna zdravila in bo utrdila postopke za generična zdravila.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Novi koncept načrtov za obvladovanje tveganja, ki ga prinaša nova zakonodaja, bo zahteval ustrezno vrednotenje, na stopnjah pred izdajo dovoljenja in po njem.
English: 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.
Slovenian: Leta 2006 se bo izvajala motivacija osebja, ovrednotil pa se bo tudi vpliv ukrepov, ki so bili rezultat izvajanja motivacije leta 2005.
English: The Agency expects the number of inspections to remain stable in 2006.
Slovenian: Agencija pričakuje, da se število inšpekcijskih pregledov v letu 2006 ne bo spreminjalo.
English: 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;
Slovenian: 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;
English: 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;
Slovenian: 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;
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: The Agency will also establish a framework and tools for evaluation of referral and arbitration procedures relating to traditional herbal medicinal products.
Slovenian: Agencija bo vzpostavila tudi okvir in orodja za ocenjevanje postopkov predložitve in arbitraže, povezanih s tradicionalnimi zdravili rastlinskega izvora.
English: 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).
Slovenian: 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.
English: In addition to summaries of opinions, European public assessment reports (EPARs) and information on arbitrations and referrals, the Agency will now provide information on the withdrawal by applicants of applications prior to opinion and will produce summaries of EPARs written in a manner that is more understandable to the public.
Slovenian: Poleg povzetkov mnenj, evropskih javnih poročil o oceni in obveščanja o arbitražah in predložitvah Agencija po novem zagotavljala informacije o umiku vlog pred izdajo mnenja in pripravlja povzetke evropskih javnih poročil o oceni na način, ki je javnosti bolj razumljiv.
English: In 2006, the Agency will work with its partners to implement a new strategy for the testing of medicinal products, to accommodate a more risk-based approach to the selection of products for inclusion in annual testing programmes.
Slovenian: Leta 2006 si bo Agencija s partnerji prizadevala uresničiti novo strategijo preizkušanja zdravil, pri kateri se uporablja pristop izbire izdelkov za vključitev v letne programe preizkušanja, ki bolj temelji na tveganju.
English: New medicinal products (non-orphan)
Slovenian: Nova zdravila (ne zdravila sirote)
English: Provision of free scientific advice to companies developing veterinary medicines for minor uses and minors species, as well as developing and implementing - in collaboration with Member State competent authorities - related guidelines, thus facilitating availability of such medicines;
Slovenian: zagotavljanje brezplačnega znanstvenega svetovanja podjetjem, ki razvijajo veterinarska zdravila za manj pomembne uporabnike in vrste in ki razvijajo in izvajajo - v sodelovanju s pristojnimi organi držav članic - povezane smernice, kar pospešuje dostopnost takšnih zdravil;
English: In addition to the maintenance and operational support of corporate and EU telematics applications - and the development of new EU telematics projects - the Agency's efforts and resources in the IT area will be applied to the operation, support, maintenance and development of a number of corporate and business-continuity projects.
Slovenian: Poleg vzdrževanja in operativne podpore podjetniškim in telematskim uporabniškim programom EU - in razvoja novih telematskih projektov EU - bo Agencija svoja prizadevanja in sredstva na področju informacijske tehnologije namenjala za delovanje, podporo, vzdrževanje in razvoj vrste podjetniških projektov in projektov za zveznost poslovanja.
English: The Agency will also prepare for the development of additional tools, including a scientificmemory database and a scientific-advice database.
Slovenian: Agencija se bo tudi pripravila na razvoj dodatnih orodij, vključno z zbirkama podatkov znanstvenega pomnilnika in znanstvenega svetovanja.
English: The Agency's continuing cooperation at the European level will include work with the EU institutions on the handling of pandemic threats, a project on innovative human and veterinary medicines for Europe (technology platforms), and activities relating to the forthcoming regulations on medicinal products for paediatric use and on advanced therapies.
Slovenian: Tekoče sodelovanje Agencije na evropski ravni bo zajemalo delo z institucijami EU na področju obvladovanja groženj epidemije, projekt o inovativnih zdravilih za uporabo v humani medicini in veterinarskih zdravilih za Evropo (tehnološke platforme) in dejavnosti, povezane s prihajajočimi predpisi glede zdravil za pediatrično uporabo in glede naprednih terapij.
English: In 2006, the EMEA expects to receive the first applications for generic medicines through the centralised procedure.
Slovenian: EMEA pričakuje, da bo v letu 2006 dobila prve vloge za generična zdravila po centraliziranem postopku.
English: Availability of medicines and innovation
Slovenian: Dostopnost zdravil in inovacije
English: Innovation and continual improvement in the context of manufacturing and control methods will be facilitated through the work of the Process Analytical Technology (PAT) team.
Slovenian: Inovacije in stalni napredek v smislu izdelave in kontrolnih metod bo pospeševala skupina PAT (Process Analytical Technology).
English: Further development of the European risk-management strategy will target the implementation of the new legislation, complementary implementation initiatives (in the fields of risk detection, risk assessment, risk minimisation and risk communication, and in insufficiently developed fields of pharmacovigilance such as paediatrics and vaccines) and further strengthening of the EU pharmacovigilance system.
Slovenian: Nadaljnji razvoj evropske strategije obvladovanja tveganja bo usmerjen v uresničevanje nove zakonodaje, dodatne pobude za uresničevanje (na področjih zaznavanja tveganja, ocene tveganja, zmanjševanja tveganja in obveščanja o tveganju ter na nezadostno razvitih področjih farmakovigilance, kot so zdravila v pediatriji in cepiva) in dodatno krepitev sistema farmakovigilance EU.
English: The Agency will continue upgrading its electronic document management system, as this forms the bedrock for effective publishing of core business information to the Web interface, and will undertake the necessary development of records management (including retention policies) and mail registration.
Slovenian: Agencija bo še naprej dopolnjevala svoj sistem elektronskega vodenja dokumentacije, saj je to podlaga za učinkovito objavljanje osnovnih poslovnih informacij na spletnem vmesniku, in bo začela razvijati sistem vodenja poročil (vključno s politikami hranjenja) in registriranja pošte.
English: The most appropriate involvement of specialised expertise in the various processes will have to be carefully considered during such revision.
Slovenian: Pri takem pregledovanju bo treba natančno preučiti najustreznejši način vključevanja specializiranega strokovnega znanja v različne postopke.
English: Provision of regulatory input and advice to the European Commission's DG Research on innovation and technology platforms for human and veterinary medicines, aimed at supporting innovation and facilitating the availability of medicines.
Slovenian: zagotavljanje regulativnega prispevka in svetovanja Generalnemu direktoratu Evropske komisije za raziskave o inovacijah in tehnoloških platformah za zdravila za uporabo v humani medicini in veterinarska zdravila, da bi tako podpirali inovacije in spodbujali dostopnost zdravil.
English: Taking into account the change in the legislation regarding automatic referrals and the development of lists of medicinal products for which a harmonised summary of product characteristics (SPC) should be drawn up, an increase in arbitrations/referrals for both human and veterinary medicines is expected.
Slovenian: Ob upoštevanju spremembe zakonodaje o samodejnih predložitvah in priprave seznamov zdravil, za katera je treba izdelati usklajeni Povzetek o glavnih značilnostih zdravila, se pričakuje povečanje števila arbitraž/predložitev za zdravila za uporabo v humani medicini in veterinarska zdravila.
English: POST-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Noël Wathion
Slovenian: POSTEVALUATION OF MEDICINES FOR HUMAN USE Head: Noël Wathion
English: Existing procedures (such as the CHMP handling of safety concerns for centrally processed applications) will be revised to effectively incorporate the concept of RMPs in the evaluation process.
Slovenian: Obstoječi postopki se bodo pregledali (na primer, kako CHMP obravnava varnostna vprašanja pri vlogah, obdelanih po centraliziranem postopku), tako da se bo koncept načrtov obvladovanja tveganja učinkovito vključil v postopek ocenjevanja.
English: Supporting innovation and research, in particular by providing support to SMEs and by discussing challenges relating to new technologies and therapies with key parties;
Slovenian: podpiranje inovacij in raziskav, zlasti s podporo malim in srednje velikim podjetjem in z razpravami s ključnimi partnerji o izzivih, ki jih prinašajo nove tehnologije in terapije;
English: Good clinical practice (including pharmacovigilance) GMP (including PMF)
Slovenian: Dobra laboratorijska praksa Dobra klinična praksa (vključno s farmakovigilanco) Dobra proizvodna praksa (vključno s PMF)
English: 20 Investment in immovable property, renting of building and associated costs 21 Expenditure on data processing 22 Movable property and associated costs 23/25 Other administrative expenditure 24 Postage and communications
Slovenian: 21 Odhodki za obdelavo podatkov 22 Premično premoženje in s tem povezani stroški 23/25 Drugi dohodki za poslovanje 24 Poštnine in obveščanje
English: The Agency will progress its work on IP telephony, web-streaming, video-streaming and other audiovisual-meetings systems, to support the Agency's objectives in the area of meetingsmanagement.
Slovenian: Agencija bo nadaljevala delo na področju telefonije IP, neprekinjenega pretoka po spletu in drugih sistemov avdiovizualnih konferenc za podporo ciljev Agencije na področju vodenja sestankov.
English: The Agency will continue its work to fully implement recent Community legislation on herbal medicinal products and to provide Member States and EU institutions with the best-possible scientific opinion on questions relating to herbal medicinal products.
Slovenian: Agencija si bo še naprej prizadevala polno uresničiti najnovejšo zakonodajo Skupnosti o zdravilih rastlinskega izvora in zagotoviti državam članicam in ustanovam EU najboljše znanstveno svetovanje pri vprašanjih, povezanih z zdravili rastlinskega izvora.
English: To that effect, the EMEA will investigate translation memory, with the attendant requirement for the development of a translation-terminology database.
Slovenian: Zato bo EMEA preučila pomnilnik prevodov in pri tem poskušala razviti zbirko podatkov prevajalske terminologije.
English: Further implementation of the orphan-medicines policy, whereby developers of designated orphan medicinal products - often derived from new technologies - enjoy reduced fees or fee waivers for a number of Agency procedures, thus stimulating the development of these products and increasing patients' access to them;
Slovenian: nadaljnji razvoj politike na področju zdravil sirot, pri čemer so razvijalci določenih zdravil sirot - pogosto izpeljanih iz novih tehnologij - upravičeni do znižanih pristojbin oziroma opustitve pristojbine za številne postopke Agencije, kar spodbuja razvoj teh izdelkov in povečuje dostop bolnikov do teh zdravil;
English: To carry out its mission relating to protection and promotion of public health, the Agency will draw on the best-available expertise in the EU and EEA-EFTA Member States to assess medicines, to provide high-quality scientific advice, to evaluate safety profiles of medicines and to develop important guidance documents.
Slovenian: Agencija bo pri uresničevanju svojega poslanstva, povezanega z zaščito in spodbujanjem javnega zdravja, črpala iz najboljšega razpoložljivega strokovnega znanja in izkušenj v EU in državah članicah EGP-EFTA ter tako ocenjevala zdravila, zagotavljala visoko kakovostno znanstveno svetovanje, vrednotila varnostne lastnosti zdravil in pripravljala pomembne usmeritvene dokumente.
English: CHAPTER 4 EU TELEMATICS STRATEGY CHAPTER 5 SUPPORT ACTIVITIES
Slovenian: POGLAVJE 4 TELEMATSKA STRATEGIJA EU POGLAVJE 5 PODPORNE DEJAVNOSTI
English: The Agency will provide secretarial support to the CMDs and their working parties, whose responsibilities will include: preparation and distribution of documents; provision of lists of positions taken on similar issues; follow-up to meetings; facilitation of liaison with other scientific working groups and with interested parties; assistance on preparation of annual reports; specific activities assigned to the CMDs under their work programmes; assistance in providing regulatory and legal support to CMD activities; coordination of the 60-days procedure for discussion in case of disagreement between Member States in mutual-recognition or decentralised procedures; and preparation of the list of medicinal products for which a harmonised SPC should be drawn up.
Slovenian: Agencija bo zagotavljala tajniško podporo skupinam CMD in njihovim delovnim skupinam, katerih dolžnosti bodo zajemale: pripravo in razdeljevanje dokumentov; zagotavljanje seznamov stališč do podobnih vprašanj; nadaljnja zasedanja; zagotavljanje povezav z drugimi znanstvenimi delovnimi skupinami in zainteresiranimi stranmi; pomoč pri pripravi letnih poročil; posebne dejavnosti, dodeljene skupinam CMD v skladu z njihovimi delovnimi programi; pomoč pri zagotavljanju regulativne in zakonske pomoči pri dejavnostih skupin CMD; usklajevanje 60dnevnega postopka za obravnavo v primeru nesporazumov med državami članicami pri postopkih vzajemnega sodelovanja ali decentraliziranih postopkih ter pripravo seznama zdravil, za katera je treba pripraviti usklajeni Povzetek glavnih značilnosti zdravila.
English: As part of the Agency's mission to provide information to interested parties, the Agency will work to improve the quality of translations.
Slovenian: Agencija si bo v okviru svojega poslanstva za zagotavljanje informacij zainteresiranim stranem prizadevala izboljšati kakovost prevodov.
English: The Agency will also offer substantial support to small and mediumsized enterprises (SMEs) through its new SME Office, and will work with academia, learned societies and industry on issues relating to new technologies.
Slovenian: Agencija bo prek svojega novega urada za mala in srednje velika podjetja zagotovila tudi pomembno podporo malim in srednje velikim podjetjem in bo sodelovala z akademskimi sveti, znanstvenimi združenji in industrijo glede vprašanj v zvezi z novimi tehnologijami.
English: Contributing towards stimulating the innovation and research of medicines in the EU, to allow faster access to new therapies and technologies;
Slovenian: prispevek k spodbujanju inovacij in raziskav zdravil v EU, s čimer bi izboljšali dostop do novih terapij in tehnologij;
English: The Agency's inspection-related working parties will: harmonise inspection procedures and processes, in particular those relating to inspections of active substances and to pharmacovigilance; develop guidelines in light of the requirements of Community legislation on clinical trials and blood; and continue to work on GMP guidelines on products used as gene and cell therapies.
Slovenian: Delovne skupine Agencije, povezane z inšpekcijskim nadzorom, bodo: usklajevale inšpekcijske postopke in procese, zlasti tiste, ki se nanašajo na inšpekcijske preglede aktivnih snovi in farmakovigilanco; razvijale smernice v duhu zahtev zakonodaje Skupnosti o kliničnih preizkusih in krvi ter nadaljevale delo na smernicah dobre proizvodne prakse pri izdelkih, ki se uporabljajo za gensko in celično zdravljenje.
English: Cooperation between the EMEA and the US Food and Drug Administration will continue in the context of the EU-USA confidentiality arrangements, with primary focus on the parallel scientificadvice process and the exchange of safety-related information.
Slovenian: Sodelovanje med EMEA in FDA ZDA se bo nadaljevalo v okviru dogovorov o zaupnosti med EU in ZDA, pri čemer se bo največ pozornosti posvetilo vzporednemu znanstvenemu svetovanju in izmenjavi informacij, povezanih z varnostjo.
English: As part of this approach, the EMEA and national competent authorities have implemented the EU Benchmarking System, with its regular cycle of self-assessment activities and peer-review visits.
Slovenian: EMEA in nacionalni pristojni organi so v okviru tega pristopa začeli izvajati sistem EU za primerjalne analize z rednim ciklusom dejavnosti samoocenjevanja in medsebojnih pregledov.
English: Protocol-assistance and follow-up requests Scientific-advice and follow-up requests
Slovenian: Zahtevki za pomoč pri protokolu in spremljanje Zahtevki za znanstveno svetovanje in spremljanje