natgillin/translations-raw huggingface dataset:
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.
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.
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.
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.
New medicinal products (non-orphan)
Nova zdravila (ne zdravila sirote)
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;
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;
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.
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.
The Agency will also prepare for the development of additional tools, including a scientificmemory database and a scientific-advice database.
Agencija se bo tudi pripravila na razvoj dodatnih orodij, vključno z zbirkama podatkov znanstvenega pomnilnika in znanstvenega svetovanja.
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.
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.
In 2006, the EMEA expects to receive the first applications for generic medicines through the centralised procedure.
EMEA pričakuje, da bo v letu 2006 dobila prve vloge za generična zdravila po centraliziranem postopku.
Availability of medicines and innovation
Dostopnost zdravil in inovacije
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.
Inovacije in stalni napredek v smislu izdelave in kontrolnih metod bo pospeševala skupina PAT (Process Analytical Technology).
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.
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.
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.
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.
The most appropriate involvement of specialised expertise in the various processes will have to be carefully considered during such revision.
Pri takem pregledovanju bo treba natančno preučiti najustreznejši način vključevanja specializiranega strokovnega znanja v različne postopke.
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.
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.
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.
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.
POST-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Noël Wathion
POSTEVALUATION OF MEDICINES FOR HUMAN USE Head: Noël Wathion
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.
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.
Supporting innovation and research, in particular by providing support to SMEs and by discussing challenges relating to new technologies and therapies with key parties;
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;
Good clinical practice (including pharmacovigilance) GMP (including PMF)
Dobra laboratorijska praksa Dobra klinična praksa (vključno s farmakovigilanco) Dobra proizvodna praksa (vključno s PMF)
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
21 Odhodki za obdelavo podatkov 22 Premično premoženje in s tem povezani stroški 23/25 Drugi dohodki za poslovanje 24 Poštnine in obveščanje
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.
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.
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.
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.
To that effect, the EMEA will investigate translation memory, with the attendant requirement for the development of a translation-terminology database.
Zato bo EMEA preučila pomnilnik prevodov in pri tem poskušala razviti zbirko podatkov prevajalske terminologije.
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;
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;
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.
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.
CHAPTER 4 EU TELEMATICS STRATEGY CHAPTER 5 SUPPORT ACTIVITIES
POGLAVJE 4 TELEMATSKA STRATEGIJA EU POGLAVJE 5 PODPORNE DEJAVNOSTI
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.
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.
As part of the Agency's mission to provide information to interested parties, the Agency will work to improve the quality of translations.
Agencija si bo v okviru svojega poslanstva za zagotavljanje informacij zainteresiranim stranem prizadevala izboljšati kakovost prevodov.
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.
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.
Contributing towards stimulating the innovation and research of medicines in the EU, to allow faster access to new therapies and technologies;
prispevek k spodbujanju inovacij in raziskav zdravil v EU, s čimer bi izboljšali dostop do novih terapij in tehnologij;
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.
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.
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.
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.
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.
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.
Protocol-assistance and follow-up requests Scientific-advice and follow-up requests
Zahtevki za pomoč pri protokolu in spremljanje Zahtevki za znanstveno svetovanje in spremljanje
The sampling and testing programme for centrally authorised products will continue in 2006, using the expertise of the EEA's network of official medicines-control laboratories, enabling the quality of medicinal products on the market in the EEA to be controlled.
Program vzorčenja in preizkušanja za zdravila, odobrena po centraliziranem postopku, se bo nadaljeval v letu 2006 z uporabo strokovnega znanja mreže EGP uradnih laboratorijev za nadzor zdravil, ki omogočajo nadzor kakovosti zdravil na trgu EGP.
The regulatory and scientific consistency of scientific committees (CHMP and CVMP) opinions and assessment reports, and their quality, will be further improved.
Dodatno se bosta izboljšali regulativna in znanstvena skladnost ter kakovost mnenj in poročil o oceni odborov (CHMP in CVMP).
Revenue and expenditure overview 2004-2006
Pregled prihodkov in odhodkov za obdobje 2004-2006
Total grade D Total Staff
Stopnja D skupaj Osebje skupaj
Meetings at the EMEA
Sestanki v EMEA
As an important element of the harmonised approach to the scientific assessment of herbal medicinal products in the EU, the Committee on Herbal Medicinal Products (HMPC) will pay particular attention in 2006 to establishing Community herbal monographs, as well as to preparing entries to the draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
Odbor za zdravila rastlinskega izvora (HMPC) bo leta 2006 v okviru usklajenega pristopa k znanstvenemu ocenjevanju zdravil rastlinskega izvora v EU posvetil posebno pozornost pripravi monografij rastlin Skupnosti ter pripravi vnosov v osnutek seznama snovi rastlinskega izvora, pripravkov in njihovih kombinacij za uporabo v tradicionalnih zdravilih rastlinskega izvora.
The Agency is continuing the development of the scientific-memory database for centrally authorised veterinary medicines.
Agencija še naprej razvija svojo zbirko podatkov znanstvenega pomnilnika za veterinarska zdravila, odobrena po centraliziranem postopku.
The priorities for the Agency's IT activity relate to the continued provision of quality services in corporate IT, meetings-management and conferences, and electronic document-management and publishing.
Prednostna področja na področju informacijske tehnologije Agencije so povezana s stalnim zagotavljanjem kakovostnih storitev na področju podjetniške informacijske tehnologije, vodenjem sestankov in konferenc ter vodenjem in objavljanjem elektronske dokumentacije.
Subject to the outcome of the analysis of business processes, the EMEA will accept electroniconly submissions of applications for marketing authorisations in the eCTD format towards the end of the year.
EMEA bo enkrat konec leta glede na analizo poslovnih procesov sprejela samo elektronsko pošiljanje vlog za dovoljenje za promet v formatu eCTD.
Given this significant growth in activity, the Agency will develop its meetings-management system to make online booking facilities available to delegates, thereby increasing the efficiency and effectiveness of this process.
Ker se je število dejavnosti precej povečalo, bo Agencija razvila svoj sistem vodenja sestankov, po katerem bodo delegati lahko opravili rezervacije prek spleta, s čimer se bo povečala učinkovitost in uspešnost njenih postopkov.
In addition, the Agency will encourage marketing-authorisation holders to request pre-submission meetings to streamline the submission and review of line-extension and variation applications, thus facilitating the availability of new indications and pharmaceutical forms.
Poleg tega bo Agencija spodbujala imetnike dovoljenj za promet, naj zahtevajo sestanke pred oddajo vloge, na katerih bi poenostavili oddajo vloge ter pregledali vloge za razširitev terapevtskih indikacij in spremembe, s čimer bi poenostavili razpoložljivost novih indikacij in farmacevtskih oblik.
Work to develop EMEA interaction with top-quality experts from national authorities, academia, learned societies and industry on challenges relating to new technologies;
prizadevanje za razvoj vzajemnega delovanja EMEA in vrhunskih znanstvenikov nacionalnih organov, akademskih krogov, znanstvenih združenj in industrije glede izzivov, povezanih z novimi tehnologijami;
Development of corporate applications will concentrate on the completion of phase III of the Meetings Management System (end of March), the continuing update of the corporate product database and tracking system SIAMED to include provisions of the new medicines legislation, and its migration to a different technical platform, and further work on a number of smaller systems such as the contracts database.
Razvoj podjetniških uporabniških programov se bo osredotočal na dokončanje tretje faze sistema vodenja sestankov (konec marca), stalno posodabljanje zbirke podatkov o podjetniških izdelkih in sistem iskanja SIAMED, tako da bo vključil določbe nove zakonodaje o zdravilih in prehod na novo tehnološko platformo ter nadaljnje delo na vrsti podobnih sistemov, kot je zbirka podatkov o pogodbah.
The Agency will advance the work on the new database for GMP certificates and manufacturing authorisations, and will complete the construction of an EU telematics data centre with high availability, high scalability and good performance.
Agencija bo izboljšala delo na novi zbirki podatkov za potrdila o dobri proizvodni praksi in dovoljenjih za izdelavo ter dokončno zgradila telematski podatkovni center z visoko stopnjo razpoložljivosti, obvladljivosti in učinkovitosti.
Meetings at the EMEA Document management and publishing
Sestanki v EMEA Upravljanje dokumentov in objave
Managing the Agency
Upravljanje Agencije
Number of reimbursed delegates
Število delegatov s povrnjenimi stroški
For enquiries concerning PMF certificates
Za vprašanja o potrdilih PMF
Chapter 1 EMEA in the European system
Poglavje 1 EMEA v evropskem sistemu
It will also roll out the first production version of the EU-wide database on manufacturing authorisations and GMP certificates.
Objavila bo tudi prvo delovno različico zbirke podatkov za vso EU o dovoljenjih za izdelavo in potrdilih o dobri proizvodni praksi.
Annex 4 Management Board and scientific committee meeting dates in 2006
Priloga 4 Datumi sestankov upravnega odbora in znanstvenega odbora v letu 2006
Strengthen cooperation on pharmacovigilance, scientific advice, support to SMEs and the provision of information;
Evropska mreža zdravil krepitev sodelovanja na področju farmakovigilance, znanstvenega sodelovanja, podpore malim in srednje velikim podjetjem in zagotavljanja informacij;
These include acceleratedassessment, conditional-marketing-authorisation and compassionate-use procedures, and the provision of scientific opinions on medicinal products intended for non-EU markets (in cooperation with the WHO).
Sem se prištevajo postopki za pospešeno oceno, pogojno izdajo dovoljenja za promet in sočutno uporabo ter zagotavljanje znanstvenih mnenj o zdravilih, ki niso namenjena na trge EU (v sodelovanju z WHO).
Certificate requests
Zahtevki za potrdila
Coordination groups for mutual-recognition and decentralised procedures (human and veterinary products)
Skupine za usklajevanje za postopke vzajemnega priznavanja in decentralizirane postopke (zdravila za uporabo v humani medicini in veterinarska zdravila)
Thursday 28 September
Četrtek, 28. septembra
Post-authorisation activities
Dejavnosti po izdaji dovoljenja
• on the Internet at www.emea.eu.int
• na internetu na www.emea.eu.int
Operation of new regulatory procedures, including accelerated-assessment, conditionalmarketing-authorisation and compassionate-use procedures;
delovanje novih regulativnih postopkov, vključno s postopki za pospešeno oceno, pogojno izdajo dovoljenja za promet in sočutno uporabo;
The RMP identifies known and potential risks with the medicinal product so that risk-minimisation measures and other pharmacovigilance activities can be implemented proactively to protect public health.
Načrt za obvladovanje tveganja opredeljuje znana in potencialna tveganja zdravila, tako da je mogoče v skrbi za varovanje javnega zdravja izvesti ukrepe za zmanjšanje tveganja in druge dejavnosti na področju farmakovigilance.
MRL ext./mod.
Vloge za razš./spre.
The suite of business intelligence and statistical tools within EudraVigilance will enable safety data relating to products on the market and under development in Europe to be monitored, analysed and acted upon in an increasingly sophisticated manner; an interim data warehouse and business intelligence solution for medicinal products for human use will be made available to all EU/EEA regulators in March 2006.
Nabor orodij za poslovno inteligenco in statističnih orodij v okviru sistema EudraVigilance bo omogočil vedno bolj dodelano spremljanje varnostnih podatkov o izdelkih, ki so v Evropi že na trgu in ki se šele razvijajo, njihovo analizo in odzivanje nanje; pilotsko podatkovno skladišče in rešitev poslovne inteligence za zdravila za uporabo v humani medicini bodo na voljo vsem zakonodajalcem EU/EGS marca 2006.
Management Board and scientific committee meeting dates in 2006 EMEA contact points
Datumi sestankov upravnega odbora in znanstvenega odbora v letu 2006 Kontaktne osebe EMEA