FrancophonIA/ELRC3.0 huggingface dataset:
English: The EMEA receives safety reports and product-quality-defect reports from within the EU and outside concerning centrally authorised medicinal products, and coordinates action relating to the safety and quality of medicinal products.
Slovenian: EMEA prejema varnostna poročila in poročila o pomanjkljivosti izdelkov za zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku v Evropski uniji in zunaj nje, ter usklajuje ukrepe, ki se nanašajo na varnost in kakovost zdravil.
English: The Agency expects that the number of variations and line extensions in the veterinary field will also increase in accordance with the increased number of products that will be on the market.
Slovenian: Agencija pričakuje, da se bo število sprememb in razširitev indikacij v veterinarski medicini tudi povečalo skladno z večjim številom zdravil na trgu.
English: This includes the publication of agendas and minutes of meetings of the Management Board, as well as of information from various EMEA committees on non-product-related issues; and providing access to the EudraVigilance database and to information on paediatric clinical trials (EU telematics project), in line with agreed access policies.
Slovenian: To vključuje objavljanje dnevnega reda in zapisnikov sej upravnega odbora in informacij različnih odborov EMEA o zadevah, ki niso povezane z zdravili, ter omogočanje dostopa do podatkovne baze EudraVigilance in do informacij o kliničnih preskušanjih v pediatriji (EU telematski projekt), skladno z dogovorjeno politiko o dostopu.
English: Improve the transparency of EMEA activities; provide access to EudraVigilance data, information on clinical trials, data held in EudraGMP and EMEA documents in general, in line with agreed access policies.
Slovenian: Izboljšati preglednost dejavnosti agencije EMEA; omogočiti dostop do podatkov EudraVigilance, podatkov o kliničnih preskušanjih, podatkov v dokumentih EudraGMP in dokumentih EMEA na splošno, skladno z dogovorjeno politiko dostopa;
English: Consolidate and enhance activities relating to medicinal products for paediatric use, building on the experience gained in the first year of operation of new procedures; commence work on the implementation of the strategy for the network of paediatric research.
Slovenian: Utrditi in okrepiti dejavnosti, ki zadevajo zdravila za uporabo v pediatriji, nadgrajevati izkušnje iz prvega leta delovanja novih postopkov; začeti projekt izvajanja strategije za mrežo raziskav v pediatriji;
English: On the other hand, it is expected that marketing-authorisation holders will make more voluntary use of the summary of product characteristics (SPC) harmonisation procedure to streamline the harmonisation of product information and optimise post-approval maintenance of their products across the EU.
Slovenian: Na drugi strani pa se pričakuje, da bodo imetniki dovoljenj za promet z zdravili prostovoljno dejavneje uporabljali usklajevalni postopek za povzetek glavnih značilnosti zdravila (SPC), da bi po vsej EU racionalizirali usklajevanje informacij o zdravilih in vzdrževanje zdravil po izdaji dovoljenja za promet.
English: The Agency's Management Board has introduced a set of measures to support the availability of medicinal products for veterinary use.
Slovenian: Upravni odbor Agencije je uvedel ukrepe za podporo dostopnosti zdravil za uporabo v veterinarski medicini.
English: The Agency contributes to the facilitation of innovation and availability of medicines through a number of its scientific activities, such as implementation of the orphan medicinal products policy, scientific advice, and management of accelerated assessment procedures, among others.
Slovenian: Agencija prispeva k spodbujanju inovacij informacij in dostopnosti zdravil s svojimi številnimi znanstvenimi dejavnostmi, kot so med drugim izvajanje politike zdravil sirot, znanstveno svetovanje in upravljanje postopkov za pospešeno ocenjevanje.
English: The constant monitoring of the safety of medicines after authorisation (‘pharmacovigilance') is an important part of the work of the national competent authorities and the EMEA.
Slovenian: Farmakovigilanca in poročanje o pomanjkljivosti izdelkov Stalno spremljanje varnosti zdravil po izdaji dovoljenja za promet („farmakovigilanca“) je pomemben element dela pristojnih nacionalnih organov in agencije EMEA.
English: In addition, the Agency is an active participant in EU-level initiatives, including the Innovative Medicines Initiative, European Technology Platform for Global Animal Health and the 7th Framework Programme.
Slovenian: Poleg tega Agencija dejavno sodeluje v pobudah na ravni EU, vključno s pobudo za inovativna zdravila, evropsko tehnološko platformo za globalno zdravje živali ter 7. okvirnim programom.
English: POST-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Noël Wathion
Slovenian: VREDNOTENJE ZDRAVIL ZA UPORABO V HUMANI MEICINI PO IZDRAJI DOVOLJENJA ZA PROMET Vodja: Noël Wathion
English: In order to help the pharmaceutical industry improve the quality of their submissions, the Agency will identify common application difficulties encountered by the industry and will provide necessary feedback.
Slovenian: Da bi Agencija farmacevtski industriji pomagala pri izboljševanju kakovosti njenih vlog, bo opredelila splošne težave, s katerimi se srečuje industrija pri vlogah, ter dala potrebne povratne informacije.
English: Transparency, provision of information and interaction with patients and healthcare professionals
Slovenian: 1.2 Preglednost, zagotavljanje informacij ter sodelovanje z bolniki in zdravstvenimi delavci
English: IT systems will be updated or newly developed to support the core activities.
Slovenian: Agencija bo posodobila ali pa na novo razvila sisteme informacijske tehnologije, da bodo v oporo glavnim dejavnostim.
English: Appropriation/Budget 2007 as of 31 December 2007.
Slovenian: 3 Odobrena proračunska sredstva/proračun za leto 2007 z dne 31. decembra 2007.
English: These initiatives include the establishment of procedures for the provision of advice on biomarkers and development of guidance for advanced-therapy medicinal products.
Slovenian: Med te pobude spadajo vzpostavitev postopkov za svetovanje glede bioloških označevalcev in razvoj smernic za zdravila za napredne terapije.
English: The Agency expects that these measures will contribute to the number of requests for scientific advice in 2008 reaching 20.
Slovenian: Agencija pričakuje, da bodo ti ukrepi prispevali k temu, da bo v letu 2008 z za znanstveno svetovanje 20.
English: Support for innovation and availability of medicines
Slovenian: 1.3 Podpora inovacijam in dostopnost zdravil
English: This will be done through the implementation of a new process to streamline preparation of CVMP assessment reports and the creation and updating of European public assessment reports (EPARs).
Slovenian: To se bo doseglo z izvajanjem novega postopka za racionalizacijo priprav poročil o oceni CVMP ter s pripravo in posodobitvijo evropskih javnih poročil o oceni zdravila (EPAR).
English: The Agency expects a continuation of the long-term trend for a gradual increase in the number of applications for marketing authorisation of veterinary medicinal products.
Slovenian: Agencija pričakuje nadaljevanje dolgoročnih smernic počasne rasti števila vlog za izdajo dovoljenja za promet z zdravili za uporabo v veterinarski medicini.
English: In preparation for the entry into force of the new legislation, the Agency will establish a new, sixth, scientific committee in 2008, and will develop the necessary procedures for the assessment of advanced-therapy medicinal products.
Slovenian: Za pripravo na začetek veljavnosti nove zakonodaje bo Agencija v letu 2008 uvedla nov, šesti znanstveni odbor in razvila potrebne postopke za oceno zdravil za napredne terapije.
English: This approach will assist with the provision of reliable and robust IT services to staff, delegates and all users of pan-European systems.
Slovenian: Ta pristop bo Agenciji omogočil, da bo svojemu osebju, odposlancem in vsem uporabnikom vseevropskih sistemov lahko zagotovila zanesljive in trdne informacijsko-tehnološke storitve..
English: Continue implementation of the EMEA Road Map and contribute to the implementation of the Heads of Medicines Agencies strategy paper; commence preparation of the EMEA Road Map
Slovenian: Nadaljevati izvajanje usmeritvenega načrta EMEA in prispevati k izvajanju strateškega dokumenta vodij agencij za zdravila; začeti pripravo usmeritvenega načrta EMEA za obdobje
English: Cooperation with the US FDA also covers paediatric medicinal products.
Slovenian: Sodelovanje z ameriškim uradom FDA zajema tudi zdravila za uporabo v pediatriji.
English: Develop and implement the EMEA communications strategy and information-related aspects of the EMEA Road Map in order to adapt the current EMEA information practices and improve the provision of information to all stakeholders.
Slovenian: Razviti in izvajati komunikacijsko strategijo EMEA in z informacijami povezane vidike usmeritvenega načrta EMEA, da se prilagodijo trenutni informacijski postopki EMEA ter se izboljša zagotavljanje informacij vsem ciljnim skupinam;
English: Enhance collaboration with the Heads of Medicines Agencies and national competent authorities, thereby contributing to the network of excellence, in particular through initiatives in the fields of safety of medicines, resource planning, competence development, the medical information network,
Slovenian: Razširiti sodelovanje z vodji agencij za zdravila in nacionalnimi pristojnimi organi in s tem prispevati k mreži odličnosti, zlasti s pobudami na področju varnosti zdravil, načrtovanja virov,
English: Annex 1 EMEA structure
Slovenian: Priloga 1 Organizacijska shema agencije EMEA
English: Integrated management at the Agency
Slovenian: 1.7 Integrirano upravljanje Agencije
English: The variety of scientific-advice requests will also increase, from advice on products subject to the centralised procedure, to alternative clinical-trial design, to programmes for products intended for non-EU markets.
Slovenian: Večja bo tudi raznolikost vlog za znanstveno svetovanje, od nasvetov o zdravilih, za katera velja centralizirani postopek, do alternativnih oblik izvajanja kliničnega preskušanja in programov za zdravila, namenjena za trge zunaj EU.
English: Following receipt of the first applications for paediatric investigation plans (PIPs) and waivers during 2007 - the first year of implementation of the regulation on paediatric medicines - the number of applications is expected to be maintained during 2008, with around 400 clinical indications in new PIP and paediatric-waiver applications.
Slovenian: Po prejemu prvih vlog za načrte pediatričnih raziskav (PIP) in sisteme opustitev v letu 2007, prvem letu izvajanja uredbe o zdravilih v pediatriji, se pričakuje, da bo tudi v letu 2008 število vlog ostalo na enaki ravni, kar pomeni približno 400 kliničnih indikacij v novih vlogah za načrte pediatričnih raziskav in pediatrične sisteme opustitev.
English: Measures include the provision of free scientific advice to veterinary companies developing medicines for minor uses or minor species.
Slovenian: Med ukrepi so zagotavljanje brezplačnega znanstvenega svetovanja veterinarskim podjetjem, ki razvijajo zdravila za manj pomembne indikacije ali vrste.
English: To assure high quality standards for the assessment of risk-management plans for paediatric medicines, the Agency will extend the existing peer-review system to the field of paediatric medicines.
Slovenian: Da bi Agencija zagotovila visokokakovostne standarde za oceno načrtov za obvladovanje tveganja pri zdravilih za uporabo v pediatriji, bo svoj sedanji sistem medsebojnih pregledov stanovskih strokovnjakov razširila tudi na področje zdravil za uporabo v pediatriji.
English: The Agency will continue to contribute to these efforts, in particular through its support to the Innovative Medicines Initiative, the 7th Framework Programme and the European Technology Platform for Global Animal Health.
Slovenian: Agencija bo še naprej delovala na tem področju, zlasti s svojo podporo pobudi za inovativna zdravila, 7. okvirnemu programu in evropski tehnološki platformi za globalno zdravje živali.
English: The EMEA will work throughout the year to prepare for its entry into force, by setting up a sixth scientific committee - the Committee for Advanced Therapies - and by introducing the necessary procedures for evaluating advanced-therapy medicines.
Slovenian: Agencija EMEA se bo celo leto pripravljala na začetek veljavnosti uredbe z ustanovitvijo šestega znanstvenega odbora (Odbora za napredne terapije) in z uvedbo potrebnih postopkov za vrednotenje zdravil za napredne terapije.
English: In addition, the Agency will work to implement initiatives proposed by the EMEA/CHMP Think-Tank on innovative drug development, will continue its support to small and medium-sized enterprises, and will undertake projects to assess the impact and consistency of the Agency's scientific opinions.
Slovenian: Hkrati bo Agencija izvajala pobude, ki jih bodo predlagale ustvarjalne enote EMEA/CHMP, za razvoj inovativnih zdravil, nadaljevala svojo podporo malim in srednje velikim podjetjem ter razvijala projekte za oceno vpliva in usklajenosti znanstvenih mnenj Agencije.
English: The Community database of manufacturing authorisations and GMP certificates, EudraGMP, will be expanded to contain a module with negative inspection outcomes (EU telematics project).
Slovenian: EudraGMP, podatkovna baza Skupnosti o dovoljenjih za proizvodnjo in potrdilih GMP, bo še razširjena in bo vsebovala modul z negativnimi rezultati inšpekcijskih pregledov (telematski projekt EU).
English: This will also include development of guidance documents for applicants.
Slovenian: Med naloge spada tudi razvoj navodil za predlagatelje.
English: The Agency plans to have 42 centrally authorised products verified for quality and compliance with authorised specifications.
Slovenian: Agencija namerava preizkusiti 42 zdravil, za katera je bilo izdano dovoljenje po centraliziranem postopku, da preveri njihovo kakovost in oceni spoštovanje odobrenih določb.
English: Collaboration with Member States in the area of medicines for children will also cover information on off-label paediatric use of medicines in Member States, and the implementation of a strategy for the exchange of paediatric information.
Slovenian: V sodelovanje z državami članicami na področju zdravil za otroke spadajo tudi informacije o uporabi zdravil, ki ni v skladu z odobrenimi indikacijami, v pediatriji v državah članicah in izvajanje strategije za izmenjavo informacij v pediatriji.
English: The quality of centrally authorised medicinal products placed on the market is supervised through the sampling and testing programme.
Slovenian: Kakovost zdravil, za katera je bilo izdano dovoljenje za promet po centraliziranem postopku, se na trgu nadzoruje s programom vzorčenja in preskušanja.
English: The Agency's work with its international partners will intensify, particularly in the context of the continued implementation of confidentiality arrangements with the US Food and Drug Administration (FDA), and implementation of the recently signed arrangements with the Japanese and Canadian health authorities.
Slovenian: Sodelovanje Agencije z mednarodnimi partnerji se bo še okrepilo, zlasti v okviru nadaljnjega izvajanja dogovorov o zaupnosti z ameriškim Uradom za zdravila in živila (FDA) in izvajanja nedavno podpisanega dogovora z japonskimi in kanadskimi zdravstvenimi organi.
English: In addition, the Agency plans to provide public access to information on paediatric clinical trials by the end of 2008, to create further transparency in this area (EU telematics project).
Slovenian: Hkrati namerava Agencija do konca leta 2008 omogočiti javni dostop do informacij o pediatričnih kliničnih preskušanjih (telematski projekt EU) za nadaljnje ustvarjanje preglednosti na področju pediatričnih kliničnih preskušanj.
English: Annex 2 EMEA establishment plan 2006-2008
Slovenian: Priloga 2 Načrt delovnih mest agencije EMEA za obdobje 2006-2008
English: As for human medicinal products, the Agency will carry out preparatory work to provide access to EudraVigilance Veterinary data by the professional community and the general public.
Slovenian: Kot v primeru zdravil za uporabo v humani medicini bo Agencija opravljala pripravljalno delo za omogočanje dostopa do podatkov veterinarskega sistema EudraVigilance za strokovne kroge in splošno javnost.
English: The Agency will support the European Commission in any necessary follow-up to the report.
Slovenian: Agencija bo Komisijo podprla, če bo potrebna kakršna koli dopolnitev.
English: GCP and pharmacovigilance inspections are expected to rise relative to previous years, taking into account the GCP policy on increasing numbers of routine inspections and increasing pharmacovigilance activity, as well as the need for greater supervision of the conduct and ethical standards of clinical trials performed outside the EU.
Slovenian: Pričakuje se, da bodo inšpekcijski pregledi dobre klinične prakse (GCP) in farmakovigilance številčnejši kot v prejšnjih letih, kar temelji na politiki dobre klinične prakse glede povečanja števila rutinskih inšpekcijskih pregledov in povečane dejavnosti na področju farmakovigilance ter tudi na potrebi po večjem nadzoru etičnih standardov in načina izvajanja kliničnih preskušanj zunaj EU.
English: The primary responsibility for implementation lies with the Agency, under the auspices of the telematics management structure.
Slovenian: Agencija ima glavno vlogo pri izvajanju pod okriljem telematske upravljalne sheme.
English: EMEA IN THE EUROPEAN MEDICINES NETWORK
Slovenian: EMEA v Evropski mreži zdravil
English: This will continue to be done as part of the review process for initial marketing authorisations and will be reflected in the European public assessment reports (EPARs).
Slovenian: To se bo še naprej izvajalo kot del postopka pregleda za izdajo začetnega dovoljenja za promet z zdravilom in bo razvidno v evropskih javnih poročilih o oceni zdravil (EPAR).
English: PDCO Paediatric Committee
Slovenian: PDCO Odbor za pediatrijo
English: The EMEA PMF/VAMF-certification process is an assessment of the PMF/VAMF-application dossier.
Slovenian: Certifikacijski postopek agencije EMEA za PMF/VAMF je ocena dokumentacije za vlogo za PMF/VAMF.
English: Permanent posts
Slovenian: Stalna delovna mesta
English: The Agency's interaction and engagement with patients and healthcare professionals will continue.
Slovenian: Agencija bo še naprej vzdrževala stike z bolniki in zdravstvenimi delavci.
English: For enquiries concerning VAMF certificates
Slovenian: Za vprašanja v zvezi s potrdili VAMF
English: However, the Agency expects that the number of referrals due to differences in opinion at Member State level in the framework of mutual-recognition procedures will be similar to that of 2007.
Slovenian: Agencija kljub temu pričakuje, da bo zaradi razlik v mnenjih med državami članicami glede postopkov vzajemnega priznavanja število napotitev primerljivo s številom v letu 2007.
English: Review and further strengthen collaboration with the FDA in the context of the EU/US FDA confidentiality arrangements; implement the EU/Japanese Health Authorities and EU/Health Canada confidentiality arrangements.
Slovenian: Preučiti in nadalje okrepiti sodelovanje z Uradom za zdravila in živila (FDA) v okviru dogovorov o zaupnosti med EU in ameriškim uradom FDA; izvajati dogovore o zaupnosti med EU in japonskimi zdravstvenimi organi ter EU in Ministrstvom za zdravje iz Kanade;
English: Improve the methodology for determining benefit-risk balance of both human and veterinary medicinal products in order to improve predictability and consistency of the Agency's scientific opinions; place more emphasis on benefit-risk issues in the post-authorisation phase.
Slovenian: Izboljšava metodologije za določanje ravnovesja med koristmi in tveganji pri zdravilih za uporabo v humani in veterinarski medicini, da bi se izboljšala predvidljivost in skladnost znanstvenih mnenj Agencije; večji poudarek na vidike koristi in tveganj pri zdravilih v fazi po pridobitvi dovoljenja za promet;
English: transparency, communication, paediatric medicines and the benchmarking of European medicines agencies (BEMA).
Slovenian: razvijanja sposobnosti, mreže zdravstvenih informacij, preglednosti, komunikacije, zdravil za uporabo v pediatriji ter primerjalno analizo evropskih agencij za zdravila (BEMA);
English: The Agency also plans to work with the US FDA to implement the process for parallel designation of orphan medicinal products.
Slovenian: Hkrati namerava Agencija sodelovati z Uradom za živila in zdravila (FDA) iz ZDA pri izvajanju postopka vzporednega določanja zdravil sirot.
English: In the area of initial evaluation of medicines, the Agency will work to improve the content and presentation of information in the assessment report of the Committee for Medicinal Products for Human Use and in the EPARs.
Slovenian: Na področju začetne ocene zdravil se bo Agencija trudila izboljšati vsebino in predstavitev informacij v poročilu o oceni, ki ga izda Odbor za zdravila za uporabo v humani medicini, in javnih poročilih (EPAR).
English: These certify the marketing-authorisation and good-manufacturing status of medicinal products in the EU and are intended for use in support of marketing-authorisation applications in, and export to, non-EU countries.
Slovenian: Ta potrjujejo izdajo dovoljenja za promet in dober proizvodni status zdravil v EU, uporabljajo pa se kot spremni dokumenti k vlogam za izdajo dovoljenj za promet v državah, ki niso članice EU, in za izvoz v te države.
English: Foster transparency, communication and provision of information
Slovenian: Pospeševati preglednost, obveščanje in zagotavljanje informacij
English: This takes into account the increasing number of authorised products requiring reinspection, increasing numbers of variations, the impact of generic applications, and new requirements for GMP for active substances.
Slovenian: To pričakovanje temelji na večjem številu izdelkov z dovoljenjem za promet, za katere je potreben ponovni pregled, na večjem številu sprememb, vplivu generičnih vlog in novih zahtevah za dobro proizvodno prakso pri zdravilnih učinkovinah.
English: Continue to apply a proactive approach to safety of medicines throughout their lifecycle, through initiatives undertaken in the context of the European Risk-Management Strategy (ERMS), in particular by implementing the ENCePP (European Network of Centres of Pharmacovigilance and Pharmacoepidemiology) project, by further developing EudraVigilance as a cornerstone of the EU Pharmacovigilance System, and by further improving the concept of risk-management plans for medicines for human use.
Slovenian: Nadaljnji proaktivni pristop k varnosti zdravil skozi njihov življenjski cikel, s pobudami v okviru Evropske strategije obvladovanja tveganja (ERMS), zlasti z izvajanjem projekta Evropske mreže centrov za farmakovigilanco in farmakoepidemiologijo, z nadaljnjim razvojem sistema EudraVigilance kot temelja sistema farmakovigilance EU in z nadaljnjo izboljšavo koncepta načrtov za obvladovanje tveganja pri uporabi zdravil v humani medicini;
English: This trend, coupled with the requirements of legislation that aims to improve the availability of medicines for children, increases the need for the Agency to ensure that due care is given to ethical standards in clinical trials performed in non-EU countries.
Slovenian: Ta trend, skupaj z zakonodajnimi zahtevami, katerih namen je izboljšati dostopnost zdravil za otroke, še povečujejo potrebo, da Agencija zagotovi upoštevanje etičnih načel pri kliničnih preskušanjih zunaj EU.