FrancophonIA/ELRC3.0 huggingface dataset:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dasselta.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Dasselta, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Because Dasselta is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Dasselta generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Dasselta is a ‘generic medicine'.
Slovenian: Zdravilo Dasselta je „generično zdravilo“.
English: Dasselta is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Slovenian: Zdravilo Dasselta se uporablja za lajšanje simptomov alergijskega rinitisa (vnetja nosne votline, ki ga povzroči alergija, na primer seneni nahod ali alergija na pršice) ali urtikarije (bolezni kože, ki jo povzroča alergija in katere simptomi vključujejo srbenje in izpuščaje).
English: Dasselta is a medicine containing the active substance desloratadine.
Slovenian: Dasselta je zdravilo, ki vsebuje zdravilno učinkovino desloratadin.
English: Because Dasselta is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius.
Slovenian: Ker je zdravilo Dassleta generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Aerius.
English: The CHMP concluded that, in accordance with EU requirements, Dasselta has been shown to have comparable quality and to be bioequivalent to Aerius.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Dasselta primerljivo raven kakovosti kot zdravilo Aerius ter da mu je biološko enakovredno.
English: The Committee recommended that Dasselta be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Dasselta odobri dovoljenje za promet.
English: What is Dasselta used for?
Slovenian: Za kaj se zdravilo Dasselta uporablja?
English: Why has Dasselta been approved?
Slovenian: Zakaj je bilo zdravilo Dasselta odobreno?
English: What is Dasselta?
Slovenian: Kaj je zdravilo Dasselta?
English: How has Dasselta been studied?
Slovenian: Kako je bilo zdravilo Dasselta raziskano?
English: It works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself.
Slovenian: Zdravilna učinkovina zdravila Dasselta, desloratadin, je antihistaminik, ki deluje kot zaviralec receptorjev, na katere se običajno veže histamin tj. snov v telesu, ki povzroča alergijske simptome.
English: How is Dasselta used?
Slovenian: Kako se zdravilo Dasselta uporablja?
English: The selection and appointment process usually takes approximately 12 months.
Slovenian: Postopek izbora in imenovanja po navadi traja približno 12 mesecev.
English: The analysis and assessment will be sent to the budgetary authority and the Court of Auditors.
Slovenian: Analiza in ocena se bosta poslali proračunskemu organu in Računskemu sodišču.
English: Stakeholders' expectations should be managed appropriately.
Slovenian: Treba je ustrezno obvladovati pričakovanja zainteresiranih strani.
English: The appointment process can be done by a written procedure.
Slovenian: Postopek imenovanja je mogoče opraviti s pisnim postopkom.
English: Members recognised that the Member States have different legislation and interpretation with regards to transparency and information.
Slovenian: Člani so priznali, da imajo države članice različno zakonodajo in tolmačenje v zvezi s preglednostjo in informacijami.
English: The European Commission indicated that it will propose to reduce this request by € 9 million.
Slovenian: Evropska komisija je napovedala, da bo predlagala zmanjšanje višine tega zahtevka za 9 milijonov EUR.
English: The document also includes provisions regarding performance indicators and quality assurance.
Slovenian: Dokument vključuje tudi določbe v zvezi s kazalniki uspešnosti in zagotavljanjem kakovosti.
English: The Agency is preparing proposals on how to manage this increase in workload (some referrals are very large, complex and include some 300-800 products).
Slovenian: Agencija pripravlja predloge, kako obvladati to povečanje delovne obremenitve (nekatere napotitve so zelo obsežne in zapletene ter vključujejo od 300 do 800 proizvodov).
English: Staffing issue Closed session.
Slovenian: Kadrovsko vprašanje Zaprta seja.
English: Declaration of conflicts of interest
Slovenian: Izjava o navzkrižjih interesov
English: Measures for the implementation of the policy will be reflected annually in the Agency's work programme.
Slovenian: Ukrepi za izvajanje politike bodo vsako leto izraženi v delovnem programu Agencije.
English: This may impact on the Committee's ability to conduct its normal work.
Slovenian: To lahko vpliva na sposobnost odbora za opravljanje običajnega dela.
English: Also, further reflection is needed as to the type of support, information and overall added benefit such a network will provide.
Slovenian: Poleg tega je potreben nadaljnji razmislek o vrsti podpore, informacijah in splošnih koristih, ki jih bo zagotavljala taka mreža.
English: The amended rules will be published on the Agency's website.
Slovenian: Spremenjena pravila bodo objavljena na spletni strani Agencije.
English: The permissible level of conflicts of interests of rapporteurs and co-rapporteurs should remain at the present level (level 1).
Slovenian: Dovoljena stopnja navzkrižij interesov poročevalcev in soporočevalcev mora ostati na sedanji stopnji (stopnji 1).
English: The Annual Activity Report 2008 and the Analysis and assessment of the Annual Activity Report 2008
Slovenian: Letno poročilo o dejavnostih za leto 2008 ter analiza in ocena letnega poročila o dejavnostih za leto 2008
English: Amendments to the Fee implementing rules
Slovenian: Spremembe izvedbenih pravil o pristojbinah
English: Simplification of the contractual arrangements between the EMEA and the National Competent Authorities of the Member States: development of a cooperation agreement
Slovenian: Poenostavitev pogodbenih ureditev med agencijo EMEA in nacionalnimi pristojnimi organi držav članic: razvoj sporazuma o sodelovanju
English: Johannes Löwer (HMA Group)*
Slovenian: Johannes Löwer (skupina HMA)*
English: The members welcomed the significant work done in the area to date.
Slovenian: Člani so pozdravili prizadevanja, ki so bila doslej dosežena na tem področju.
English: The rules will be submitted for adoption after a positive opinion of the European Commission.
Slovenian: Pravila bodo predložena v sprejetje po prejetem pozitivnem mnenju Evropske komisije.
English: The procedures are not remunerated, which also impacts on national competent authorities' ability to volunteer for the work.
Slovenian: Postopki se ne plačujejo, kar prav tako vpliva na sposobnost nacionalnih pristojnih organov, da prostovoljno prevzamejo delo.
English: The Commission will aim to publish a vacancy announcement before the summer break 2009.
Slovenian: Komisija namerava objaviti prosto delovno mesto pred poletnimi počitnicami 2009.
English: These changes would ensure that a future policy would not limit the availability of the best expertise for robust decision making.
Slovenian: S temi spremembami bi se zagotovilo, da prihodnja politika ne bo omejevala razpoložljivosti najboljšega strokovnega znanja in izkušenj za trdno odločanje.
English: A revised version will be resubmitted for adoption in October and the signature of the contracts is expected by the end of the year.
Slovenian: Revidirana različica bo oktobra ponovno predložena v sprejetje, pogodbe pa bodo po pričakovanjih podpisane do konca leta.
English: The members stressed that the policy should be implemented in a stepwise approach, taking into account available resources.
Slovenian: Člani so poudarili, da je treba politiko izvajati na podlagi postopnega pristopa ob upoštevanju razpoložljivih virov.
English: The Management Board is invited to send additional written comments to the EMEA by the end of July.
Slovenian: Upravni odbor je bil pozvan, naj agenciji EMEA do konca julija pošlje dodatne pisne pripombe.
English: The retention of surplus (reserve) is important to provide stability to the Agency in case of reduction in the fee revenue, particularly in the light of risk factors mentioned above.
Slovenian: Ohranitev presežka (rezerve) je pomembna za zagotavljanje stabilnosti Agencije v primeru manjših prihodkov iz pristojbin, zlasti zaradi zgoraj navedenih dejavnikov tveganja.
English: For 2010, the EMEA requested a European Commission contribution of € 45 million for the conduct of public health-related activities.
Slovenian: Agencija EMEA je za leto 2010 vložila zahtevek za prispevek Evropske komisije v višini 45 milijonov EUR za izvajanje dejavnosti v zvezi z javnim zdravjem.
English: The presented proposal takes into account Management Board comments.
Slovenian: V predstavljenem predlogu so upoštevane pripombe upravnega odbora.
English: 1 October 2009
Slovenian: 1. oktobra 2009
English: The revisions concern applications made under Article 29 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use.
Slovenian: Spremembe se nanašajo na vloge, predložene na podlagi člena 29 Uredbe (ES) št. 1901/2006 Evropskega parlamenta in Sveta o zdravilih za pediatrično uporabo.
English: The Commission's Vice-President Margot Wallström leads the inter-institutional working group in which the EU agencies are represented.
Slovenian: Podpredsednica Evropske komisije Margot Wallström vodi medinstitucionalno delovno skupino, v kateri so zastopane agencije EU.
English: The Board also considered that the nomination of a candidate can take place before June 2010 in a two-day meeting.
Slovenian: Upravni odbor je menil, da bi lahko imenovanje kandidata potekalo na dvodnevni seji pred junijem 2010.
English: The Management Board wished to be engaged in the process and the discussions, and be involved more closely during the third stage.
Slovenian: Upravni odbor želi sodelovati v tem postopku in razpravah ter se tesneje vključiti v tretjo fazo dela.
English: London, 11 June 2009
Slovenian: London, 11. junija 2009
English: The benefit/risk evaluation of vaccines needs to be conducted taking into account the infectivity and virulence potential of the virus.
Slovenian: Treba je opraviti presojo koristi in tveganj cepiv ob upoštevanju možnosti nalezljivosti in virulentnosti virusa.
English: On the other side, care should be taken to avoid micromanagement of agencies and avoid creating a single model for all agencies that would take away flexibility when implementing tasks under their responsibility.
Slovenian: Po drugi strani je treba poskrbeti za preprečevanje mikroupravljanja agencij in vzpostavitve enotnega modela za vse agencije, saj bi to agencijam odvzelo prožnost pri izvajanju nalog v njihovi pristojnosti.
English: The members discussed that it is important to reach an agreement among the stakeholders of what constitutes commercially confidential information.
Slovenian: Člani so razpravljali, da je treba med zainteresiranimi stranmi doseči soglasje, kaj so poslovno zaupne informacije.
English: Paediatric investigation plans
Slovenian: Načrti pediatričnih raziskav
English: Budget 2010 update
Slovenian: Posodobljene informacije v zvezi s proračunom za leto 2010
English: A similar extension was approved for Relenza by the Member States.
Slovenian: Države članice so podobno podaljšanje odobrile za zdravilo Relenza.
English: An operational task force for the implementation of the transparency policy will be considered.
Slovenian: Obravnavalo se bo oblikovanje operativne projektne skupine za izvajanje politike preglednosti.
English: The experience shows that the current low level of permissible conflicts of interests restricts the involvement of valuable scientific expertise, which impacts on the work of the scientific committees.
Slovenian: Izkušnje kažejo, da sedanja nizka stopnja dovoljenih navzkrižij interesov omejuje izkoriščanje dragocenega znanstvenega strokovnega znanja in izkušenj, kar vpliva na delo znanstvenih odborov.
English: This agenda item will be further discussed at the October meeting.
Slovenian: O tej točki dnevnega reda se bo nadalje razpravljalo na oktobrski seji.
English: The Executive Director thanked the members of the Committee for Medicinal Products for Human Use and vaccine working party for their work in the field.
Slovenian: Izvršni direktor se je zahvalil članom Odbora za zdravila za uporabo v humani medicini in delovni skupini za cepiva za njihovo delo na tem področju.
English: This becomes an emerging risk for the financing of the Agency in the light of the likely negative financial impact of the revised variations regulation, uncertainty of the impact of a new payment system to Member States and the current economic climate.
Slovenian: To je nastajajoče tveganje za financiranje Agencije zaradi po vsej verjetnosti negativnega finančnega učinka revidirane uredbe o spremembah, negotovosti glede učinka novega plačilnega sistema za države članice in sedanjih gospodarskih razmer.
English: A proposal taking into account the Board's views will be submitted in December 2009.
Slovenian: Predlog, v katerem bodo upoštevana stališča upravnega odbora, bo predložen decembra 2009.
English: The group intends to work in three stages: draft the statements in consultation with the agencies under some 35 topics; consider the experience under those topics; make proposals for the future.
Slovenian: Skupina namerava delovati v treh fazah: v posvetovanju z agencijami pripraviti izjave v zvezi s približno 35 temami, obravnavati izkušnje v zvezi z zadevnimi temami in pripraviti predloge za prihodnost.
English: The proposed rules transpose the rules that are applied in the European Commission for secondment of their staff to organisations outside the EU.
Slovenian: Predlagana pravila prenašajo pravila, ki se uporabljajo pri Evropski komisiji za dodelitev njenega osebja organizacijam zunaj EU.
English: Resource requirements of the CVMP
Slovenian: Zahteve v zvezi z viri odbora CVMP
English: The Board noted the progress made in the previous year, major developments in the management and control systems and conclusions of audits.
Slovenian: Upravni odbor se je seznanil z napredkom, doseženim v lanskem letu, pomembnimi spremembami upravljavskega in kontrolnega sistema ter sklepi revizij.
English: Specifically, the scientific committee reviewed scientific information and recommended extending the shelf life of Tamiflu from 5 to 7 years; it also provided an opinion on the use of antiviral medicine Tamiflu in children under one year and in pregnant and breastfeeding women.
Slovenian: Natančneje, znanstveni odbor je proučil znanstvene informacije in priporočil podaljšanje roka uporabnosti zdravila Tamiflu s 5 na 7 let; poleg tega je predložil mnenje o uporabi protivirusnega zdravila Tamiflu pri otrocih, mlajših od enega leta, nosečnicah in doječih ženskah.
English: The FDA colleague will join the EMEA in June.
Slovenian: Član urada FDA se bo agenciji EMEA pridružil junija.
English: As discussed above, in addition there is a proposal at the Commission to cancel the earmarked revenue from the 2008 surplus.
Slovenian: Kot je bilo navedeno že zgoraj, Komisija predlaga tudi ukinitev namenskega prihodka iz presežka v letu 2008.
English: Mr Johannes Löwer's invitation as an observer is extended to all future meetings of the Management Board.
Slovenian: Povabilo Johannesu Löwerju kot opazovalcu velja za vse prihodnje seje upravnega odbora.
English: The members invited the Agency to elaborate more on the mandate and role of the coordinating group of the proposed network, the composition of this group and expected competencies of members.
Slovenian: Člani so Agencijo pozvali, naj natančno opredeli pristojnosti in vlogo usklajevalne skupine predlagane mreže, sestavo te skupine in pričakovane kompetence članov.
English: Developing the European Medical Information network
Slovenian: Razvoj evropske mreže zdravstvenih informacij
English: Participants at the sixty-third meeting of the Management Board London, 11 June 2009
Slovenian: Udeleženci triinšestdesete seje upravnega odbora London, 11. junija 2009
English: The Management Board welcomed the results of the Agency's operations in 2008 and the strong contribution of the EMEA to EU-wide efforts in support of making high-quality, safe and effective medicines available for use in human and animal populations.
Slovenian: Upravni odbor je pozdravil rezultate dejavnosti Agencije v letu 2008 in velik prispevek agencije EMEA k prizadevanjem EU v podporo omogočanju razpoložljivosti visokokakovostnih, varnih in učinkovitih zdravil za uporabo v humani in veterinarski medicini.
English: A consequence analysis, including resource needs, will follow this proposal.
Slovenian: Temu predlogu bo sledila analiza posledic, vključno s potrebami po virih.
English: Currently, the Agency is in dialogue with manufacturers of vaccines and with European and international regulators to discuss scientific and regulatory issues in order to facilitate the availability of vaccines for use in an influenza pandemic situation.
Slovenian: Agencija je vzpostavila dialog s proizvajalci cepiv ter evropskimi in mednarodnimi regulatorji za razpravo o znanstvenih in regulativnih vprašanjih, kar bo olajšalo razpoložljivost cepiv za uporabo v pandemijah gripe.
English: The Management Board was informed that the court of first instance dismissed a company's application in relation to suspension of the Agency's decision and the adoption of interim measures.
Slovenian: Upravni odbor je bil obveščen, da je sodišče prve stopnje zavrnilo pritožbo nekega podjetja v zvezi z začasno razveljavitvijo odločbe Agencije in sprejetjem začasnih ukrepov.
English: The proposals aim to create visual identity for the Agency, to further promote its recognition and reputation.
Slovenian: Cilj predlogov je oblikovati vizualno podobo Agencije, ki bo dodatno krepila njeno prepoznavnost in ugled.
English: The members noted the update report from the European Commission on a range of topics, including: work on novel influenza and the Council's conclusions regarding strategy for vaccine development; pharmaceutical package and good progress with pharmacovigilance and anticounterfeiting proposals, as well as Member States' concerns over the proposal for drug information provisions.
Slovenian: Člani so se seznanili s posodobljenim poročilom Evropske komisije o različnih temah, vključno z: delom v zvezi z novo gripo in sklepi Sveta o strategiji za razvoj cepiva, farmacevtskim svežnjem in dobrim napredkom v zvezi s predlogi o farmakovigilanci in boju proti ponarejanju zdravil, ter pomisleki držav članic o predlogu določb glede informacij o zdravilih.
English: The Executive Director announced the appointment of Edit Weidlich as head of the Agency's internal audit and Fergus Sweeney as head of the Agency's inspections sector.
Slovenian: Izvršni direktor je napovedal imenovanje Edit Weidlich za vodjo službe za notranjo revizijo Agencije in Fergusa Sweeneya za vodjo inšpekcijskega sektorja Agencije.
English: In addition, the members enquired whether it would be useful to determine the level of conflicts of interest of new nominees during the nomination procedure, raising potential issues with the nominating authority.
Slovenian: Poleg tega je člane zanimalo, ali bi bilo koristno opredeliti stopnjo navzkrižij interesov novih kandidatov med postopkom imenovanja, kar je problematika, ki bi jo mogoče lahko obravnaval organ za imenovanja.
English: The Management Board is involved in 4 stages of the process: the provision of the opinion on the vacancy notice, nomination of an observer to a pre-selection committee at the European Commission, nomination of a director from a shortlist proposed by the European Commission, and appointment of the director after the nominee's presentation at a committee of the European Parliament (in the case of the EMEA - the concerned committee is the Committee on Environment, Public Health and Food Safety).
Slovenian: Upravni odbor je vključen v štiri faze tega postopka: predložitev mnenja o objavi prostega delovnega mesta, imenovanje opazovalca v predizbirno komisijo pri Evropski komisiji, imenovanje direktorja iz ožjega seznama kandidatov, ki ga predlaga Evropska komisija, in imenovanje direktorja po predstavitvi, ki jo kandidat opravi v ustreznem odboru Evropskega parlamenta (v primeru agencije EMEA je to Odbor za okolje, javno zdravje in varnost hrane).
English: The rules follow those of the European Commission with derogation regarding the calculation of the duration of the mission for departure and arrival times from London stations and airports.
Slovenian: Ta pravila temeljijo na pravilih Evropske komisije, od katerih se razlikujejo glede izračuna trajanja misije za čas odhoda in prihoda iz londonskih postaj in letališč.
English: The Management Board considered that it is feasible to increase the level of allowable conflicts of interests, but this needs to be matched with increased transparency to assure the public that opinions and decisions will continue to be reached with utmost independence.
Slovenian: Upravni odbor je menil, da je mogoče povečati stopnjo dopustnih navzkrižij interesov, vendar bo treba hkrati povečati preglednost in javnosti tako zagotoviti, da se mnenja in odločitve še naprej sprejemajo popolnoma neodvisno.
English: The comments received at the meeting will be incorporated and the policy will be published for public consultation.
Slovenian: Pripombe, prejete na seji, se bodo upoštevale, objavljena pa bo tudi politika za namene javnega posvetovanja.
English: The Management Board noted the developments in the budgetary procedure for 2010.
Slovenian: Upravni odbor se je seznanil s spremembami proračunskega postopka za leto 2010.
English: The proposals, including scheduling of referrals in line with the ability of the Committee to manage them, will be submitted to the Management Board and the Heads of Medicines Agencies.
Slovenian: Predlogi, vključno s časovnim razporejanjem napotitev v skladu s sposobnostjo Odbora, da jih upravlja, se bodo nato predložili upravnemu odboru in vodjem agencij za zdravila.
English: The Management Board heard an update on the Agency's work in the field of novel swine influenza (so called A/H1N1).
Slovenian: Upravni odbor se je seznanil z delom Agencije na področju nove prašičje gripe (tako imenovane gripe A/H1N1).
English: The Board discussed that it is important to understand that EU agencies differ in their roles, the sectors they operate in and the stakeholders they are accountable for.
Slovenian: Upravni odbor je poudaril, da je treba upoštevati, da se agencije EU razlikujejo glede na svojo vlogo, sektorje, v katerih delujejo, in zainteresirane strani, za katere so pristojne.
English: The Management Board will also be informed of the 35 statements once all the findings have been consolidated.
Slovenian: Upravni odbor bo po združitvi vseh ugotovitev obveščen tudi o 35 izjavah.
English: The Chair invited the members to submit their expression of interests to participate as observers in the preselection committee.
Slovenian: Predsedujoči je člane pozval, naj predložijo prijavo interesa za sodelovanje v vlogi opazovalca v predizbirni komisiji.