FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's policy on the handling of competing interests of scientific experts, including committee members allows the Agency to identify cases where the potential involvement of an expert as a member of a committee, working party or other group or in any other Agency activity needs to be restricted or excluded due to interests in the pharmaceutical industry.
Slovenian: Politika agencije o obravnavanju navzkrižja interesov znanstvenih strokovnjakov, vključno s člani odborov, agenciji omogoča, da opredeli primere, v katerih je treba morebitno vključitev strokovnjaka kot člana odbora, delovne ali druge skupine ali vključitev v katero koli dejavnost agencije omejiti ali izključiti zaradi interesov v farmacevtski industriji.
English: It is based on a closelycoordinated regulatory network of national competent authorities in the Member States of the EEA working together with the EMA and the European Commission.
Slovenian: Temelji na tesno usklajeni regulativni mreži pristojnih nacionalnih organov v državah članicah EGP, ki sodelujejo z agencijo EMA in Evropsko komisijo.
English: • Product information available in all EU languages at the same time.
Slovenian: • informacije o zdravilu so hkrati na voljo v vseh uradnih jezikih EU.
English: − cancer;
Slovenian: − raka,
English: To fulfil its mission, the EMA works closely with national competent authorities in a regulatory network.
Slovenian: Agencija EMA pri izpolnjevanju svojega poslanstva tesno sodeluje s pristojnimi nacionalnimi organi v regulativni mreži.
English: The current revised policy reflects a balanced approach to handling competing interests that aims to effectively restrict the involvement of experts with possible competing interests in the Agency's work while maintaining EMA's ability to access the best available expertise.
Slovenian: Trenutna spremenjena politika odraža uravnotežen pristop k obravnavanju navzkrižja interesov, katerega cilj je učinkovito omejiti vključevanje strokovnjakov z morebitnim navzkrižjem interesov v delo agencije ter agenciji še naprej omogočati dostop do najboljšega razpoložljivega strokovnega znanja.
English: • an executive role, or a lead role in the development of a medicine during previous employment with a pharmaceutical company will result in non-involvement with the concerned company or product during the term of the mandate;
Slovenian: • izvršna ali vodilna vloga pri razvoju zdravila v času prejšnje zaposlitve pri farmacevtski družbi pomeni prepoved sodelovanja z zadevno družbo ali pri zadevnem zdravilu v času trajanja mandata;
English: These European experts serve as members of the Agency's scientific committees, working parties or in assessment teams supporting their members.
Slovenian: Ti evropski strokovnjaki delujejo kot člani znanstvenih odborov in delovnih skupin agencije ali pa v skupinah za ocenjevanje, v katerih zagotavljajo podporo njihovim članom.
English: EMA protects public and animal health in the EU Member States, as well as the countries of the European Economic Area (EEA), by ensuring that all medicines available on the EU market are safe, effective and of high quality.
Slovenian: Agencija EMA varuje javno zdravje in zdravje živali v državah članicah EU in državah Evropskega gospodarskega prostora (EGP) z zagotavljanjem varnosti, učinkovitosti in visoke kakovosti vseh zdravil, ki so na voljo na trgu EU.
English: • Medicines are authorised for all EU citizens at the same time.
Slovenian: • dovoljenja za zdravila se hkrati izdajo za vse državljane EU;
English: The concept enables rapporteurs and co-rapporteurs for EMA's scientific committees to include experts from other Member States in their assessment teams.
Slovenian: To poročevalcem in soporočevalcem znanstvenih odborov agencije EMA omogoča vključevanje strokovnjakov iz drugih držav članic v svoje ocenjevalne skupine.
English: Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the EEA countries Iceland, Liechtenstein and Norway.
Slovenian: Dovoljenje za promet, ki ga Evropska komisija izda po centraliziranem postopku, velja v vseh državah članicah EU in državah EGP, tj. na Islandiji, v Lihtenštajnu in na Norveškem.
English: The Management Board is the European Medicines Agency's integral governance body.
Slovenian: Upravni odbor je osrednji organ upravljanja Evropske agencije za zdravila.
English: • Coordination Group for Mutual Recognition and Decentralised Procedures - Human
Slovenian: • Usklajevalna skupina za postopek z vzajemnim priznavanjem in decentralizirani postopek - v humani medicini;
English: They also underpin important decisions about medicines marketed in Europe, referred to EMA through referral procedures.
Slovenian: Na njih temeljijo tudi pomembne odločitve o zdravilih, ki se tržijo v Evropi in se agenciji EMA predložijo na podlagi napotitvenih postopkov.
English: • to restrict involvement of experts in the assessment of medicines if they plan to take up a job in the pharmaceutical industry in May 2015.
Slovenian: • maja 2015, da bi pri ocenjevanju zdravil omejila vključitev strokovnjakov, ki se nameravajo zaposliti v farmacevtski industriji.
English: • scientific support for advanced-therapy medicines;
Slovenian: • znanstvena podpora za zdravila za napredno zdravljenje;
English: Executive Director
Slovenian: Izvršni direktor
English: EMA's Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products for Veterinary Use (CVMP) carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or not.
Slovenian: Odbor agencije EMA za zdravila za uporabo v humani medicini (CHMP) ali Odbor za zdravila za uporabo v veterinarski medicini (CVMP) opravi znanstveno oceno vloge in izda priporočilo, ali naj se zdravilo da v promet ali ne.
English: Multinational assessment teams
Slovenian: Večnacionalne ocenjevalne skupine
English: EMA's Management Board adopted the current version of the policy and trust of-breach procedure in December 2015.
Slovenian: Upravni odbor agencije EMA je trenutno različico politike in postopek za obravnavo zlorabe zaupanja sprejel decembra 2015.
English: • advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines;
Slovenian: • zdravila za napredno zdravljenje, kot sta gensko zdravljenje in somatsko celično zdravljenje, ali zdravila tkivnega inženirstva;
English: Tthe Management Board revised its rules on how the Agency handles potential competing interests of staff members in October 2016.
Slovenian: Upravni odbor je oktobra 2016 spremenil pravila o tem, kako agencija obravnava morebitno navzkrižje interesov zaposlenih.
English: These are available on the EMA website under Management Board members.
Slovenian: Te izjave so na voljo na spletišču agencije EMA v razdelku Člani upravnega odbora.
English: • National competent authorities (veterinary)
Slovenian: • pristojni nacionalni organi (veterinarska medicina).
English: EMA and its regulatory network partners run a scheme to enable multinational teams to assess applications for human and veterinary medicines.
Slovenian: Agencija EMA in njeni partnerji v regulativni mreži delujejo v shemi, ki omogoča, da večnacionalne skupine ocenjujejo vloge za zdravila za uporabo v humani in veterinarskih medicini.
English: The Agency maintains a public European expert list containing details on all experts who can be involved in EMA work.
Slovenian: Agencija vodi javni seznam evropskih strokovnjakov, ki vsebuje podrobnosti o vseh strokovnjakih, ki jih je mogoče vključiti v njeno delo.
English: The authorisation of clinical trials occurs at Member State level, although the Agency plays a key role in ensuring that the standards of good clinical practice are applied in cooperation with the Member States and manages a database of clinical trials carried out in the EU.
Slovenian: • ocenjuje vlog za odobritev kliničnega preskušanja: klinično preskušanje se odobri na ravni držav članic, čeprav ima agencija ključno vlogo pri zagotavljanju, da se v sodelovanju z državami članicami uporabljajo standardi dobre klinične prakse, in upravlja podatkovno zbirko o kliničnih preskušanjih, izvedenih v EU;
English: What we do
Slovenian: Kaj delamo
English: Agency staff
Slovenian: Osebje agencije
English: The control of the advertising of non-prescription medicines in the EU is primarily conducted on a self-regulatory basis by industry bodies, supported by the statutory role of the national regulatory authorities in the Member States;
Slovenian: • nadzoruje oglaševanja zdravil: nadzor oglaševanja zdravil brez recepta v EU poteka predvsem na samoregulativni podlagi od organov industrije, ki jih podpirajo z zakonom določeni nacionalni regulativni organi v državah članicah;
English: • human medicines containing a new active substance to treat:
Slovenian: • zdravila za uporabo v humani medicini, ki vsebujejo novo učinkovino za zdravljenje:
English: Ensuring the independence of its scientific assessments is a high priority for EMA.
Slovenian: Pomembna prednostna naloga agencije EMA je zagotavljanje neodvisnosti lastnih znanstvenih ocen.
English: The policy on handling competing interests for Management Board members and breach-of-trust procedure aligns with the policy on handling competing interests and breach-of-trust procedure for scientific committee members and experts.
Slovenian: Politika o obravnavanju navzkrižja interesov za člane upravnega odbora in postopek za obravnavo zlorabe zaupanja sta usklajena s politiko o obravnavanju navzkrižja interesov in postopkom za obravnavo zlorabe zaupanja za člane znanstvenih odborov in strokovnjake.
English: EMA has in place a breach-of-trust procedure, which sets out how the Agency deals with incorrect or incomplete DoIs by experts and committee members.
Slovenian: Agencija EMA ima na voljo postopek za obravnavo zlorabe zaupanja, ki določa, kako agencija obravnava nepravilne ali nepopolne izjave o interesih, ki jih predložijo strokovnjaki in člani odborov.
English: It has close ties with the Agency's accounting officer, who is appointed by the Board, and with the internal auditor, who reports to the Board and to the Executive Director on audit findings.
Slovenian: Tesno sodeluje z računovodjo agencije, ki ga tudi imenuje, in notranjim revizorjem, ki o revizijskih ugotovitvah poroča upravnemu odboru in izvršnemu direktorju.
English: The Agency's evaluations of marketing-authorisation applications submitted through the centralised procedure provide the basis for the authorisation of medicines in Europe.
Slovenian: Ocene vlog za izdajo dovoljenja za promet z zdravili, predloženih po centraliziranem postopku, ki jih opravi agencija, so podlaga za izdajo dovoljenja za promet z zdravili v Evropi.
English: • two representatives of the European Parliament;
Slovenian: • dva predstavnika Evropskega parlamenta;
English: • National competent authorities (human)
Slovenian: • pristojni nacionalni organi (humana medicina);
English: EMA brings together scientific experts from across Europe by working closely with the national regulatory authorities in European Union (EU) Member States, in a partnership known as the European medicines regulatory network (For more information, see Chapter 5).
Slovenian: Povezuje znanstvene strokovnjake iz vse Evrope, tako da tesno sodeluje z nacionalnimi regulativnimi organi držav članic Evropske unije (EU) v partnerstvu, ki se imenuje Evropska regulativna mreža za zdravila (dodatne informacije so na voljo v poglavju 5).
English: • to clarify the restrictions if an expert takes up a job in industry and to align the rules on close family members for committee and working party members interests with those for Management Board members in October 2016.
Slovenian: • oktobra 2016, da bi pojasnila omejitve, če se strokovnjak zaposli v industriji, in uskladila pravila glede ožjih družinskih članov pri interesih za člane odborov in delovnih skupin s pravili za člane upravnega odbora.
English: • the oversight of clinical trials;
Slovenian: • nadzorom nad kliničnimi preskušanji;
English: Organisation chart of the European Medicines Agency
Slovenian: Organizacijska shema Evropske agencije za zdravila
English: The Agency screens each expert's declaration of interests (DoI) and assigns each DoI an interest level based on whether the expert has any interests, and whether these are direct or indirect.
Slovenian: Agencija na podlagi preveritve izjave o interesih posameznih strokovnjakov vsaki izjavi določi raven interesa glede na to, ali ima strokovnjak morebitne interese in ali so ti neposredni ali posredni.
English: The European Commission develops EU legislation concerning medicines and the European Parliament together with the Council of the European Union adopt it.
Slovenian: • pripravlja zakonov o zdravilih: Evropska komisija pripravi zakonodajo EU o zdravilih, Evropski parlament in Svet Evropske unije pa jo sprejmeta.
English: Decisions about price and reimbursement take place at the level of each Member State considering the potential role and use of the medicine in the context of the national health system of that country.
Slovenian: • določa cene ali razpoložljivosti zdravil: cena in povračilo se določita na ravni posameznih držav članic, ob upoštevanju morebitne vloge in uporabe zdravila v nacionalnem zdravstvenem sistemu zadevne države.
English: It is based on the ‘About us' section of EMA's corporate website.
Slovenian: Njegova vsebina temelji na razdelku spletišča agencije EMA „O nas“.
English: National authorisation procedures
Slovenian: Nacionalni postopki izdaje dovoljenja
English: EMA has encouraged the formation of multinational assessment teams since 2013 for initial marketing authorisation applications.
Slovenian: Agencija EMA od leta 2013 spodbuja oblikovanje večnacionalnih skupin za ocenjevanje prvotnih vlog za pridobitev dovoljenja za promet z zdravilom.
English: Today, the great majority of new, innovative medicines pass through the centralised authorisation procedure in order to be marketed in the EU.
Slovenian: Danes se za veliko večino novih inovativnih zdravil dovoljenje za promet v EU izda po centraliziranem postopku.
English: • the decentralised procedure, whereby a medicine that has not yet been authorised in the EU
Slovenian: • decentralizirani postopek, po katerem se lahko za zdravilo, za katero v EU še ni bilo izdano dovoljenje, hkrati izda dovoljenje v več državah članicah EU.
English: The network pools resources and expertise in the EU and gives EMA access to thousands of European scientific experts who take part in the regulation of medicines.
Slovenian: Mreža združuje vire in strokovno znanje v EU in agenciji EMA omogoča dostop do več tisoč evropskih znanstvenih strokovnjakov, ki sodelujejo pri zakonski ureditvi zdravil.
English: − auto-immune and other immune dysfunctions;
Slovenian: − avtoimunih bolezni in drugih imunskih pomanjkljivosti,
English: The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
Slovenian: Evropska agencija za zdravila (EMA) je decentralizirana agencija Evropske unije (EU), pristojna za znanstveno vrednotenje, nadzor in spremljanje varnosti zdravil, ki jih farmacevtske družbe razvijejo za uporabo v EU.
English: • one representative of veterinarians' organisations.
Slovenian: • enega predstavnika veterinarskih organizacij.
English: − neurodegenerative diseases;
Slovenian: − nevrodegenerativnih bolezni,
English: The European medicines regulatory network gives EMA access to experts from across the EU, allowing it to bring together the best-available scientific expertise in the EU for the regulation of medicines.
Slovenian: Evropska regulativna mreža za zdravila agenciji EMA zagotavlja dostop do strokovnjakov iz vse EU, kar ji omogoča združevanje najboljšega razpoložljivega strokovnega znanja v EU za zakonsko ureditev zdravil.
English: • two representatives of the European Commission;
Slovenian: • dva predstavnika Evropske komisije;
English: Evaluate applications for marketing authorisation
Slovenian: Ocenjevanje vlog za pridobitev dovoljenja za promet
English: • orphan medicines (medicines for rare diseases);
Slovenian: • zdravila sirote (zdravila za zdravljenje redkih bolezni);
English: Its day-to-day operations are carried out by the EMA staff, based inAmsterdam, overseen by EMA's Executive Director.
Slovenian: Njene vsakodnevne dejavnosti izvaja osebje v Amsterdamu pod nadzorom izvršnega direktorja.
English: • two representatives of patients' organisations;
Slovenian: • dva predstavnika organizacij bolnikov;
English: The European Medicines Agency (EMA) takes care to ensure that its scientific experts, staff and Management Board do not have any financial or other interests that could affect their impartiality.
Slovenian: Evropska agencija za zdravila (EMA) skrbi, da njeni znanstveni strokovnjaki ter zaposlenimi in člani upravnega odbora nimajo finančnih ali drugih interesov, ki bi lahko vplivali na njihovo nepristranskost.
English: Pharmaceutical companies or other medicines developers carry out the research and development of medicines, who then submit the findings and test results for their products to the Agency for evaluation;
Slovenian: • izvaja raziskav ali razvija zdravil: raziskave in razvoj zdravil izvajajo farmacevtske družbe ali drugi razvijalci zdravil, ki nato ugotovitve in rezultate preskušanj svojih izdelkov predložijo agenciji v ovrednotenje;
English: • the mutual-recognition procedure, whereby a marketing authorisation granted in one Member
Slovenian: • postopek z vzajemnim priznavanjem, po katerem se lahko dovoljenje za promet, izdano v eni državi članici, prizna v drugih državah članicah EU;
English: • the nature of the interests declared;
Slovenian: • vrsti prijavljenih interesov;
English: The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
Slovenian: Odgovorna je za znanstveno vrednotenje, nadzor in spremljanje varnosti zdravil, ki jih razvijejo farmacevtske družbe za uporabo v EU.
English: These bodies are composed of European experts made available by national competent authorities of the EU Member States, which work closely with EMA in the European medicines regulatory network.
Slovenian: Te organe sestavljajo evropski strokovnjaki, ki jih dajo na voljo pristojni nacionalni organi držav članic EU in z agencijo EMA tesno sodelujejo v evropski regulativni mreži za zdravila.
English: The Agency takes care to ensure that its scientific experts, staff and Management Board do not have any financial or other interests that could affect their impartiality.
Slovenian: Skrbi za to, da njeni znanstveni strokovnjaki ter zaposleni in člani upravnega odbora nimajo finančnih ali drugih interesov, ki bi lahko vplivali na njihovo nepristranskost.
English: Authorisation of medicines
Slovenian: Izdajanje dovoljenj za zdravila
English: The mission of the EMA is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the EU.
Slovenian: Poslanstvo agencije EMA je krepitev znanstvene odličnosti pri vrednotenju in nadzoru zdravil v skrbi za javno zdravje in zdravje živali v EU.
English: This allows the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.
Slovenian: S tem se imetniku dovoljenja za promet dovoli, da na podlagi enotnega dovoljenja za promet da zdravilo v promet ter na voljo bolnikom in zdravstvenim delavcem v vsej EU.
English: For more information on the IT systems EMA manages together with the EU Member States, see EU Telematics.
Slovenian: Dodatne informacije o sistemih IT, ki jih agencija EMA upravlja skupaj z državami članicami EU, so na voljo v razdelku Telematika EU.
English: These national authorities supply thousands of European experts to take part in EMA's scientific committees, working parties and other groups.
Slovenian: Iz teh nacionalnih organov prihaja na tisoče evropskih strokovnjakov, ki sodelujejo v znanstvenih odborih ter delovnih in drugih skupinah agencije EMA.
English: For more information, see Medical devices.
Slovenian: Za več informacij glejte Medicinski pripomočki.
English: Handling competing interests
Slovenian: Obravnavanje navzkrižja interesov
English: Under the centralised authorisation procedure, pharmaceutical companies submit a single marketingauthorisation application to EMA.
Slovenian: Po centraliziranem postopku izdaje dovoljenja farmacevtske družbe agenciji EMA predložijo enotno vlogo za izdajo dovoljenja za promet.
English: Medical devices are regulated by national competent authorities in Europe.
Slovenian: • ocenjuje medicinskih pripomočkov: medicinske pripomočke urejajo nacionalni pristojni organi v Evropi.
English: • orphan designation of medicines for rare diseases;
Slovenian: • določitev zdravil sirot za redke bolezni;
English: For more information, see Health-technology-assessment bodies;
Slovenian: Več informacij je na voljo v razdelku Organi za ocenjevanje zdravstvene tehnologije;
English: Patents having effect in most European countries may be obtained either nationally, via national patent offices, or via a centralised process at the European Patent Office;
Slovenian: • nadzoruje farmacevtskih patentov in nima informacij o njih: patenti, ki veljajo v večini evropskih držav, se lahko pridobijo na nacionalni ravni, pri nacionalnih patentnih uradih ali po centraliziranem postopku pri Evropskem patentnem uradu;
English: The legal decision to grant, suspend or revoke a marketing authorisation for any medicine falls under the remit of the European Commission for centrally authorised products, and the national competent authorities of the EU Member States for nationally authorised products.
Slovenian: • izdaja dovoljenj za promet z zdravili: za odločitve o izdaji, začasnem preklicu ali preklicu dovoljenja za promet za katero koli zdravilo je za zdravila, odobrena po centralnem postopku, pristojna Evropska komisija , pristojni nacionalni organi držav članic EU pa so pristojni za zdravila, odobrena na nacionalni ravni.
English: Healthcare professionals can provide individual patients advice on medical conditions, treatments or side effects with a medicine;
Slovenian: • daje zdravniške nasvete: individualne nasvete bolnikom o zdravstvenih stanjih, zdravljenju ali neželenih učinkih zdravil lahko dajejo zdravstveni delavci;
English: − viral diseases.
Slovenian: − virusnih bolezni;
English: Management Board members
Slovenian: Člani upravnega odbora
English: • one representative of doctors' organisations;
Slovenian: • enega predstavnika zdravniških organizacij;
English: For more information see Pharmacovigilance.
Slovenian: Več informacij je na voljo v razdelku Farmakovigilanca.
English: Scope of the centralised authorisation procedure
Slovenian: Področje uporabe centraliziranega postopka izdaje dovoljenja
English: Pooling expertise
Slovenian: Združevanje strokovnega znanja
English: EMA's European public assessment reports describe the scientific basis for EMA's recommendations on all centrally authorised medicines.
Slovenian: V svojih evropskih javnih poročilih o oceni zdravil opiše znanstveno podlago za svoja priporočila o zdravilih, odobrenih po centralnem postopku.
English: EMA also publishes a large amount of information in lay language about its work and about medicines.
Slovenian: Veliko informacij o svojem delu in zdravilih objavi tudi v poljudnem jeziku.
English: • suspected side effects reported with medicines;
Slovenian: • domnevnimi neželenimi učinki zdravil;
English: • veterinary medicines for use as growth or yield enhancers.
Slovenian: • zdravila, ki se uporabljajo kot pospeševalci rasti ali izplena v veterinarski medicini.
English: Management Board
Slovenian: Upravni odbor
English: About us
Slovenian: O nas
English: Centralised authorisation procedure
Slovenian: Centralizirani postopek izdaje dovoljenja
English: For more information see:
Slovenian: Več informacij je na voljo v razdelku: