FrancophonIA/ELRC3.0 huggingface dataset:
English: The report shows that the Agency's performance with regard to the growing core business remained at a high standard, despite the fact that significant resources were dedicated to pandemic work throughout the year.
Slovenian: Składno s poročilom je uspešnost agencije, kar zadeva razvijajočo se osnovno dejavnost, ostala na visoki ravni, čeprav so bila med letom precejšnja sredstva namenjena delu v zvezi s pandemijo.
English: Prof. Lawrence Phillips of the London School of Economics led the sessions.
Slovenian: Predaval je prof. Lawrence Phillips z London School of Economics.
English: Mr Dalli had extensive meetings with key staff of the Agency, and also outlined his priorities and replied to the questions of staff members.
Slovenian: Imel je izčrpne sestanke s ključnim osebjem agencije, na kratko je tudi predstavil svoje prednostne naloge in odgovoril na vprašanja osebja.
English: There is also a correlation between compliance with scientific advice and positive outcomes.
Slovenian: Obstaja tudi povezava med upoštevanjem znanstvenih nasvetov in ugodno rešenimi vlogami.
English: • Capabilities & limitations of human judgement presentation.
Slovenian: • Predstavitev sposobnosti in omejitev človeške presoje.
English: Board members raised concerns about the process by which DG Sanco has apparently decided to give the mandate for vigilance of cells and tissues to ECDC.
Slovenian: Člani odbora so izrazili zaskrbljenost glede postopka, s katerim se je GD SANCO menda odločil, da bo mandat za stalni nadzor celic in tkiv podelil ECDC.
English: Revised Management Board consultation procedure for CHMP and CVMP nominations
Slovenian: Spremenjeni posvetovalni postopek upravnega odbora za imenovanje v CHMP in CVMP
English: The Commission also stated that any deficit in the EU contribution compared to the request should not lead to cuts in the telematics expenditure intended for the implementation of the proposed legislation.
Slovenian: Komisija je še navedla, da prispevek EU, ki je manjši od zahtevanega, ne sme biti vzrok za zmanjšanje izdatkov za telematiko, namenjenih za izvajanje predlagane zakonodaje.
English: The Chair invited members to volunteer as topic coordinators for the assessment of the Executive Director's annual activity report 2009.
Slovenian: Predsednik je pozval člane, naj se prostovoljno javijo za tematske koordinatorje za oceno letnega poročila o dejavnostih izvršnega direktorja za leto 2009.
English: The Commission will write to the Chair to confirm specific dates for the shortlist of candidates to enable the Board to plan for an extraordinary meeting.
Slovenian: Komisija bo pisala predsedniku, naj potrdi posebne datume za ožji seznam kandidatov, da bo Odbor lahko načrtoval izredno sejo.
English: This topic links to the Agency's work on the methodology for the assessment of benefit/risk balance of medicinal products.
Slovenian: Ta tema je povezana z delom agencije na področju metodologije za oceno razmerja med koristmi in tveganji pri zdravilih.
English: The conference will address the topics raised in the evaluation and will also be an opportunity to discuss key issues proposed in the Agency's draft road map to 2015.
Slovenian: Na konferenci se bodo obravnavale teme iz ocene, razpravljalo se bo lahko tudi o ključnih vprašanjih, predlaganih v osnutku časovnega načrta agencije do leta 2015.
English: Committee on Herbal Medicinal Products: update from the Chair
Slovenian: Odbor za zdravila rastlinskega izvora: najnovejše informacije od predsednika
English: The Board also requested that the Agency send for information copies of scientific articles that are written by the Agency's staff.
Slovenian: Odbor je še zahteval, naj agencija naroči informativne izvode znanstvenih člankov, ki jih piše njeno osebje.
English: The adequacy of available genotoxicity data should be judged on a case-by-case basis and the request for new data should be made when there is a specific concern for safety.
Slovenian: Ustreznost dostopnih podatkov o genotoksičnosti je treba presojati za vsak primer posebej, v primeru posebne zaskrbljenosti zaradi varnosti pa je treba zahtevati nove podatke.
English: For new active substances the negative outcome rate last year was 40%.
Slovenian: Pri novih zdravilnih učinkovinah je bilo lansko leto zavrnjenih 40 % vlog.
English: The Board also noted that issues exist in the area of the registration of traditional herbal medicinal products which can lead to products being marketed under another classification, e.g. food supplements.
Slovenian: Odbor je še opozoril na težave na področju registracije tradicionalnih zdravil rastlinskega izvora, zaradi katerih se lahko zdravila dajo v promet v okviru druge klasifikacije, npr. prehranskih dopolnil.
English: The Board proposed to develop a harmonised approach for use by all Member States after the expiry of the transitional period.
Slovenian: Predlagal je, naj vse države članice po izteku prehodnega obdobja pripravijo usklajen pristop za uporabo.
English: The draft budget also includes resource needs for the implementation of the future pharmacovigilance and counterfeit medicines legislation, which were challenged by the Commission as being higher than estimated.
Slovenian: Predlog proračuna vključuje tudi potrebna sredstva za izvajanje prihodnje zakonodaje o farmakovigilanci in ponarejenih zdravilih, ki jim je Komisija nasprotovala, ker da so višja od ocenjenih.
English: A number of issues were raised, relating to the availability of genotoxicity data by Member States, distribution of rapporteurships among Member States, and the impact of the strict requirements of the conflicts-of-interest policy on the availability of scientific expertise.
Slovenian: Obravnavana so bila mnoga vprašanja, npr. glede dostopnosti podatkov o genotoksičnosti držav članic, razdelitve poročanja med države članice in vpliva strogih zahtev politike za obvladovanje navzkrižij interesov, ki velja za dostopnost znanstvenega strokovnega znanja.
English: The adopted preliminary work programme will be further modified in the course of 2010 to take into account the outcome of the evaluation of the Agency and its Road Map to 2015.
Slovenian: Sprejet predhodni delovni program bo še spremenjen v letu 2010, pri čemer bosta upoštevana izid ocene agencije in njen časovni načrt do leta 2015.
English: The amendments may concern the reduction of fee income due to revised inflation rate, possible use of part of the surplus from 2008, increase in orphan medicinal products budget, financing ICT expenditure, and consultancy services aimed to identify options for future accommodation for the Agency.
Slovenian: Spremembe se bodo lahko nanašale na zmanjšanje dohodka od pristojbin zaradi popravljene stopnje inflacije, mogočo uporabo dela presežka iz leta 2008, povečanje proračuna za zdravila za sirote, financiranje izdatkov za IKT in svetovalne storitve za opredelitev možnosti za prihodnji sedež agencije.
English: The Board also commented that the quality of dossiers may be a significant factor, and it is likely that a number of the products that received a negative opinion could have been approved if the dossiers had been of a higher standard.
Slovenian: Odbor je še pripomnil, da je lahko pomemben dejavnik kakovost vlog in da je verjetno, da bi bila lahko številna zdravila, za katera je bilo sprejeto negativno mnenje, odobrena, če bi bile vloge kakovostnejše.
English: The Board discussed the need to enhance the number of list entries, but noted the hurdles posed by the unavailability of genotoxicity data.
Slovenian: Odbor je razpravljal o potrebnem povečanju števila vnosov na seznamu, vendar je opozoril na ovire zaradi nedostopnosti podatkov o genotoksičnosti.
English: With regard to EPARs, the Board suggested that work should continue to promote them in the medical and scientific community, as these documents contain very valuable information about the evaluation of medicines and the decision-making process.
Slovenian: Odbor je glede EPAR predlagal, naj se nadaljuje njihovo promoviranje v zdravniški in znanstveni skupnosti, saj vsebujejo zelo dragocene informacije o oceni zdravil in postopku sprejemanja odločitev.
English: [EMA/MB/3790/2010] The agenda was adopted.
Slovenian: [EMA/MB/3790/2010] Dnevni red je bil sprejet.
English: European Commission Isabel de la Mata Georgette Lalis
Slovenian: Isabel de la Mata, Georgette Lalis
English: • Extending & improving judgement presentation.
Slovenian: • Predstavitev o širjenju in izboljšanju presoje.
English: The Management Board welcomed the presentation of the Chair of the Committee on Herbal Medicinal Products.
Slovenian: Upravni odbor je pozdravil predstavitev predsednika Odbora za zdravila rastlinskega izvora.
English: The revised implementing rules will enter into force on 1 April 2010.
Slovenian: Spremenjena izvedbena pravila bodo začela veljati 1. aprila 2010.
English: Meeting of the chairs of the management boards of EU agencies
Slovenian: Sestanek predsednikov upravnih odborov agencij EU
English: The Committee watched presentations by the chairs of the telematics implementation groups.
Slovenian: Odbor je gledal predstavitve predsednikov izvedbenih skupin za telematiko.
English: The Executive Director will write to members of the Board before June concerning the appointment of a Chair.
Slovenian: Izvršni direktor bo članom Odbora glede imenovanja predsednika pisal pred junijem.
English: The revised rules will enter into force on 1 April 2010.
Slovenian: Spremenjena pravila bodo začela veljati 1. aprila 2010.
English: [EMA/MB/183091/2010] The Management Board adopted the amendments to the reimbursement rules for delegates, whereby an allowance, corresponding to 35% of the maximum cost of a hotel night (€60 for London), is introduced to provide financial support to delegates where no accommodation invoices can be provided.
Slovenian: [EMA/MB/183091/2010] Upravni odbor je sprejel spremembe pravil o nadomestilih za delegate, pri čemer se uvaja nadomestilo v višini 35 % najvišjih stroškov za prenočitev v hotelu (60 EUR za London), da se zagotovi finančna podpora delegatom, če ne morejo predložiti računa o nastanitvi.
English: − [EMA/78873/2010] Survey 2009 for medicinal products for human use;
Slovenian: [EMA/78873/2010] Raziskava o zdravilih za uporabo v humani medicini za leto 2009;
English: The Management Board supported the conversion of these contract agent posts to temporary agent posts as essential in the Agency's efforts to recruit and retain scientific and highly specialised expertise.
Slovenian: Upravni odbor je podprl pretvorbo delovnih mest za pogodbene uslužbence v delovna mesta za začasne uslužbence kot ključni ukrep pri prizadevanjih agencije za zaposlovanje in ohranitev osebja z znanstvenim in visokospecializiranim strokovnim znanjem.
English: The Board also stressed that Member States continued to have reservations as to the ability to record time on an ongoing basis.
Slovenian: Odbor je še poudaril, da imajo države članice še vedno dvome glede tega, ali lahko vsakič evidentirajo porabljeni čas.
English: Held in London on 17-18 March 2010
Slovenian: V Londonu, 17. in 18. marca 2010
English: The Committee discussed the overall governance arrangements of the telematics programme.
Slovenian: Razpravljal je o splošni ureditvi vodenja programa telematike.
English: Draft work programme and budget 2011
Slovenian: Predlog delovnega programa in proračuna za leto 2011
English: The Board had an opportunity to test the website during the break.
Slovenian: Odbor jo je med odmorom lahko preskusil.
English: The Chair also informed the Board that the Chair of the Audit Advisory Committee is preparing a reflection paper for the Board, which will set out options for the future of the Committee.
Slovenian: Predsednik je Odbor obvestil tudi o tem, da predsednik Odbora za presojo in svetovanje pripravlja študijo za Odbor, v kateri bodo predstavljene možnosti za prihodnost Odbora za presojo in svetovanje.
English: The amendments concern the adjustment of fees to inflation (increase by 1%), establishing reduced fees for applications for marketing authorisation for multi-strain dossiers, adapting the fees for extensions of marketing authorisations and clarifying reporting requirements for national competent authorities.
Slovenian: Spremembe zadevajo prilagoditev pristojbin inflaciji (povečanje za 1 %), določitev znižanih pristojbin za vloge za pridobitev dovoljenja za promet z zdravilom za vloge za več sevov, prilagoditev pristojbin za razširitve dovoljenj za promet z zdravilom in pojasnitev zahtev za poročanje nacionalnim pristojnim organom.
English: Minutes of the 66th meeting of the Management Board
Slovenian: Zapisnik 66. seje upravnega odbora
English: Preliminary draft budget 2011 (PDB)
Slovenian: Predhodni predlog proračuna za leto 2011 (PDB)
English: Rannveig Gunnarsdóttir (Iceland)
Slovenian: Rannveig Gunnarsdóttir (Islandija),
English: [EMA/MB/806136/2009] The Management Board adopted the minutes with the following changes under point 12 (payment system to Member States): The Board clarified that only those countries which participated in the pilot demonstrated ability to identify hourly rates for services provided and to record time spent on centralised applications.
Slovenian: [EMA/MB/806136/2009] Upravni odbor je sprejel zapisnik z naslednjimi spremembami pod točko 12 (sistem plačil državam članicam): Odbor je pojasnil, da so samo države, ki so sodelovale v poskusnem projektu, pokazale, da lahko opredelijo urne postavke za opravljene storitve in evidentirajo čas, porabljen za vloge za pridobitev dovoljenja za promet z zdravilom po centraliziranem postopku.
English: [EMA/MB/6505/2010; EMA/MB/68936/201; EMA/MB/125880/2010] The Management Board adopted the preliminary work programme, preliminary draft budget (PDB) and draft staff policy plan for 2011.
Slovenian: [EMA/MB/6505/2010; EMA/MB/68936/201; EMA/MB/125880/2010] Upravni odbor je sprejel predhodni delovni program, predhodni predlog proračuna (PDB) in predlog načrta kadrovske politike za leto 2011.
English: It was emphasised that there should be the right balance between the interests of patients and of industry.
Slovenian: Poudaril je še, da morajo biti interesi bolnikov in industrije v pravilnem ravnotežju.
English: Evaluation of the Agency by the European Commission
Slovenian: Ocena agencije, ki jo je naročila Evropska komisija
English: Preliminary work programme 2011
Slovenian: Predhodni delovni program za leto 2011
English: 26 April 2010 EMA/MB/194352/2010
Slovenian: 26. aprila 2010 EMA/440615/2011
English: a) Update
Slovenian: a) Najnovejše informacije
English: The change took place on 1 March 2010.
Slovenian: SANCO; sprememba se je zgodila 1. marca 2010;
English: Minutes from the 65th meeting, held on 10 December 2009
Slovenian: Zapisnik s 65. seje, ki je potekala 10. decembra 2009
English: Revised delegate reimbursement rules
Slovenian: Spremenjena pravila o nadomestilih za delegate
English: • Action plan for herbal medicines 2010-2011 presentation.
Slovenian: • Predstavitev Akcijskega načrta za zdravila rastlinskega izvora za leti 2010 in 2011.
English: The following colleagues put their names forward to assist in this task: Chair, Austria, Estonia, Ireland,
Slovenian: Naslednji kolegi so se javili, da bodo pomagali pri tej nalogi: predsednik, Avstrija, Estonija, Irska, Nemčija, Španija, Nizozemska in Mike O'Donovan.
English: [EMA/MB/75924/2010] A written procedure will be launched in April or May to amend the budget 2010.
Slovenian: [EMA/MB/75924/2010] Aprila ali maja se bo začel pisni postopek za spremembo proračuna za leto 2010.
English: • [EMA/MB/84539/2010] Outcome of written procedures during the period from 21 November 2009
Slovenian: • [EMA/MB/84539/2010] Rezultat pisnih postopkov v obdobju od 21. novembra 2009 do
English: [EMA/MB/142837/2010] The Management Board endorsed an action plan for herbal medicinal products.
Slovenian: [EMA/MB/142837/2010] Upravni odbor je potrdil akcijski načrt za zdravila rastlinskega izvora.
English: • [EMA/61092/2010] Update report on the Agency's implementation of the EU telematics strategy.
Slovenian: • [EMA/61092/2010] Dopolnjeno poročilo o telematski strategiji EU, ki jo izvaja agencija.
English: Action plan for herbal medicines for 2010-2011
Slovenian: Akcijski načrt za zdravila rastlinskega izvora za leti 2010 in 2011
English: The Commission representative stated that the Agency's justification for the request to convert these posts was inappropriate, taking into account the Staff Regulations.
Slovenian: Predstavnik Komisije je navedel, da agencija glede na kadrovske predpise ni ustrezno utemeljila zahteve za pretvorbo teh delovnih mest.
English: b) Terms of reference
Slovenian: b) Poslovnik
English: Data indicate that small companies suffer higher rates of negative outcomes.
Slovenian: Podatki kažejo, da se zavrne več vlog malih podjetij.
English: [EMA/MB/818152/2009] The Management Board adopted the amendments to the Fee Regulation implementing rules.
Slovenian: [EMA/MB/818152/2009] Upravni odbor je sprejel spremembe izvedbenih pravil o pristojbinah.
English: [EMA/MB/69923/2010] The Management Board adopted the Agency's annual report 2009.
Slovenian: [EMA/MB/69923/2010] Upravni odbor je sprejel letno poročilo agencije za leto 2009.
English: Timely engagement between regulators and industry is needed to assure that more products pass the regulatory assessment.
Slovenian: Za zagotovitev, da bo več zdravil odobrenih na podlagi ocene regulativnih organov, je potrebno pravočasno sodelovanje regulativnih organov in industrije.
English: European Food Safety Agency (EFSA) in the area of health claims for food containing herbal ingredients.
Slovenian: • odzvati se na vse zahteve Komisije po okrepljenem sodelovanju med agencijo EMA in Evropsko agencijo za varnost hrane (EFSA) na področju zdravstvenih trditev za hrano, ki vsebuje rastlinske sestavine.
English: Report from the Heads of Medicines Agencies The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including:
Slovenian: Člani upravnega odbora so se seznanili s posodobljenim poročilom vodij agencij za zdravila o več temah, vključno s/z:
English: th meeting of the Management Board, held in London, 17-18 March 2010
Slovenian: Seznam udeležencev 66. seje upravnega odbora, ki je potekala v Londonu 17. in 18. marca 2010
English: • [EMA/MB/121058/2010] Minutes from the first MBTC meeting, held on 9 December 2009, adopted on 9 February 2010.
Slovenian: • [EMA/MB/121058/2010] Zapisnik prve seje MBTC, ki je potekala 9. decembra 2009, sprejet
English: − [EMA/MB/117221/2010] Note on veterinary products.
Slovenian: [EMA/MB/117221/2010] Obvestilo o zdravilih za uporabo v veterinarski medicini.
English: • [EMEA/MB/115301/2010] Annual report 2009 of the Agency's Internal Audit.
Slovenian: • [EMEA/MB/115301/2010] Letno poročilo za leto 2009 Službe za notranjo revizijo agencije.
English: • [EMEA/MB/115245/2010] Annual report 2009 of the Agency's Audit Advisory Committee.
Slovenian: • [EMEA/MB/115245/2010] Letno poročilo za leto 2009 Odbora za presojo in svetovanje agencije.
English: [EMA/MB/64422/2010] The Management Board adopted the terms of reference of the Management Board Telematics Committee.
Slovenian: [EMA/MB/64422/2010] Upravni odbor je sprejel poslovnik Odbora upravnega odbora za telematiko.
English: With respect to the selection procedure for the appointment of the Agency's new Executive Director, the Commission expects to produce a shortlist of candidates before the summer or in early September.
Slovenian: Komisija pred poletjem ali v začetku septembra pričakuje ožji seznam kandidatov v zvezi z izbirnim postopkom za imenovanje novega izvršnega direktorja agencije.
English: Gro Ramsten Wesenberg (Norway) Brigitte Batliner (Liechtenstein)
Slovenian: Gro Ramsten Wesenberg (Norveška),
English: Highlights
Slovenian: Poudarki
English: Term of office of the Chair of the Board
Slovenian: Mandat predsednika Odbora
English: 1 Directive 2004/24/EC of 31 March 2004.
Slovenian: • delom projektne skupine HMA za izboljšanje veterinarske zakonodaje; 1 Direktiva 2004/24/ES z dne 31 marca 2004.
English: Björn Lemmer
Slovenian: Giuseppe Nisticó, Björn Lemmer
English: Sanco.
Slovenian: Ciper
English: [EMA/MB/281553/2007Rev.2] The Management Board adopted the revised procedure.
Slovenian: [EMA/MB/281553/2007Spr.
English: Date of first authorisation: 14 September 1998 Date of latest renewal: 14 September 2008
Slovenian: Datum prve odobritve: 14. september 1998 Datum zadnjega podaljšanja: 14. september 2008
English: If you have problems with your heart.
Slovenian: Če imate težave s srcem.
English: The maximum recommended dosing frequency is once per day.
Slovenian: Največja priporočena pogostnost odmerjanja je enkrat na dan.
English: It is not possible to determine whether these events were directly related to VIAGRA.
Slovenian: Ni mogoče ugotoviti ali so bili ti dogodki neposredno povezani z zdravilom VIAGRA.
English: • Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000 people)
Slovenian: • Dolgotrajna in včasih boleča erekcija - to se zgodi redko (pojavi se lahko pri največ 1 od 1000 bolnikov)
English: If you have recently had a stroke or a heart attack, or if you have low blood pressure.
Slovenian: Če ste nedavno doživeli možgansko kap ali srčni infarkt ali če imate nizek krvni tlak.
English: You should not take VIAGRA more than once a day.
Slovenian: Zdravila VIAGRA ne smete uporabiti več kot enkrat na dan.
English: If you are taking riociguat.
Slovenian: Če jemljete riociguat.
English: In clinical trials sildenafil was administered to more than 8000 patients aged 19-87.
Slovenian: V kliničnih preskušanjih je sildenafil dobivalo več kot 8000 bolnikov, starih od 19 do 87 let.
English: Orodispersible tablets can be taken with or without water.
Slovenian: Orodisperzibilne tablete se lahko jemlje z ali brez vode.
English: If you have a deformity of your penis or Peyronie's Disease.
Slovenian: Če imate deformacijo spolnega uda ali Peyroniejevo bolezen.
English: • A sudden decrease or loss of vision - this occurs rarely
Slovenian: • Nenadno poslabšanje ali izguba vida - to se zgodi redko
English: Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of VIAGRA without sexual activity.
Slovenian: Za številne dogodke je bilo opisano, da so se zgodili med ali kmalu po spolnem odnosu, nekateri pa so se pojavili kmalu po uporabi zdravila VIAGRA, brez spolne dejavnosti.
English: The amount of time VIAGRA takes to work varies from person to person, but it normally takes between half an hour and one hour.
Slovenian: Čas, potreben za začetek delovanja zdravila VIAGRA, se od posameznika do posameznika razlikuje, a ponavadi traja od pol ure do ene ure.
English: The European Medicines Agency has waived the obligation to submit the results of studies with VIAGRA in all subsets of the paediatric population for the treatment of erectile dysfunction.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij za zdravilo VIAGRA za vse podskupine pediatrične populacije za zdravljenje erektilne disfunkcije.
English: If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
Slovenian: Če imate določene redke dedne očesne bolezni (npr. retinitis pigmentosa).
English: The safety profile of VIAGRA is based on 9,570 patients in 74 double-blind placebo-controlled clinical studies.
Slovenian: Varnostni profil zdravila VIAGRA temelji na 9570 bolnikih v 74 dvojno slepih s placebom nadzorovanih kliničnih študijah.
English: In order for VIAGRA to be effective, sexual stimulation is required.
Slovenian: Da bi bilo zdravilo VIAGRA učinkovito, je potrebna spolna stimulacija.
English: If you take more VIAGRA than you should:
Slovenian: Če ste vzeli večji odmerek zdravila VIAGRA, kot bi smeli:
English: If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Če ste alergični na sildenafil ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: VIAGRA with food and drink and alcohol
Slovenian: Zdravilo VIAGRA skupaj s hrano, pijačo in alkoholom