FrancophonIA/ELRC3.0 huggingface dataset:
English: Blister pack (14, 56 or 100) and perforated unit dose blister pack (100) for 225 mg hard capsules
Slovenian: Pretisni omot (14, 56 in 100) in perforirani enoodmerni pretisni omot (100) za 225 mg trde kapsule
English: Pregabalin Pfizer 300 mg hard capsules Pregabalin
Slovenian: Pregabalin Pfizer 300 mg trde kapsule pregabalin
English: Carton of blister pack (14, 56 or 100) and perforated unit dose blister pack (100) for 225 mg hard capsules
Slovenian: Škatla s pretisnim omotom (14, 56 in 100) in perforiranim enoodmernim pretisnim omotom (100) za 225 mg trde kapsule
English: Pregabalin Pfizer 150 mg hard capsules Pregabalin
Slovenian: Pregabalin Pfizer 150 mg trde kapsule pregabalin
English: Pregabalin Pfizer 50 mg hard capsules Pregabalin
Slovenian: Pregabalin Pfizer 50 mg trde kapsule pregabalin
English: Pregabalin Pfizer 25 mg hard capsules Pregabalin
Slovenian: Pregabalin Pfizer 25 mg trde kapsule pregabalin
English: Pregabalin Pfizer 50 mg hard capsules PVC/Aluminium blisters containing 14, 21, 56, 84, or 100 hard capsules.
Slovenian: PVC/aluminijski pretisni omoti s 14, 21, 56, 84 ali 100 trdimi kapsulami.
English: Carton of blister pack (14, 56, 100, and 112) and perforated unit dose blister pack (100) for 75 mg hard capsules
Slovenian: Škatla s pretisnim omotom (14, 56, 100 in 112) in perforiranim enoodmernim pretisnim omotom (100) za 75 mg trde kapsule
English: Psychiatric disorders Common
Slovenian: Redki dezinhibicija
English: Pregabalin Pfizer 100 mg hard capsules PVC/Aluminium blisters containing 21, 84, or 100 hard capsules.
Slovenian: PVC/aluminijski pretisni omoti z 21, 84 ali 100 trdimi kapsulami.
English: Blister pack (14, 56, 100 or 112) and perforated unit dose blister pack (100) for 75 mg hard capsules
Slovenian: Pretisni omot (14, 56, 100 in 112) in perforirani enoodmerni pretisni omot (100) za 75 mg trde kapsule
English: • Sore throat.
Slovenian: • vneto žrelo
English: It is advised not to drink alcohol while taking Pregabalin Pfizer.
Slovenian: Če jemljete zdravilo Pregabalin Pfizer, odsvetujemo pitje alkohola.
English: In addition, Pregabalin Pfizer is available in an HDPE bottle containing 200 capsules for the 25 mg, 75 mg, 150 mg and 300 mg strengths.
Slovenian: Poleg tega je zdravilo Pregabalin Pfizer v jakostih 25 mg, 75 mg, 150 mg in 300 mg na voljo v plastenki iz polietilena visoke gostote z 200 kapsulami.
English: Pregabalin Pfizer 150 mg hard capsules PVC/Aluminium blisters containing 14, 56, 100, or 112 hard capsules.
Slovenian: PVC/aluminijski pretisni omoti s 14, 56, 100 ali 112 trdimi kapsulami.
English: Some of the objectives of the action plan include:
Slovenian: Nekateri cilji akcijskega načrta so:
English: The agreement on an option may be needed as early as this autumn.
Slovenian: Sporazum o eni od možnosti je morda potreben že to jesen.
English: Commissioner John Dalli visited the Agency on 5 March 2010.
Slovenian: Komisar John Dalli je 5. marca 2010 obiskal agencijo.
English: The discussion is foreseen for the October meeting.
Slovenian: Razprava je predvidena za oktobrsko sejo.
English: Other members were invited to join.
Slovenian: Drugi člani so bili pozvani, naj se jim pridružijo.
English: The two-day meeting started on 17 March with a presentation on decision making.
Slovenian: Dvodnevna seja se je začela 17. marca s predstavitvijo o sprejemanju odločitev.
English: Fourteen of the new posts are requested due to increased workload and/or new activities.
Slovenian: Štirinajst novih delovnih mest se zahteva zaradi večje delovne obremenitve in/ali novih dejavnosti.
English: to 25 February 2010.
Slovenian: 25. februarja 2010.
English: This provision is in line with reimbursement rules of other EU institutions.
Slovenian: Ta določba je skladna s pravili o nadomestilih drugih institucij EU.
English: Additional information was provided in a written report.
Slovenian: Dodatne informacije so na voljo v pisnem poročilu.
English: The report will be sent to the topic coordinators by the end of April.
Slovenian: Poročilo bo tematskim koordinatorjem poslano do konca aprila.
English: This cooperation was a prerequisite for the successful response to the threat.
Slovenian: To sodelovanje je pogoj za uspešen odziv na nevarnost.
English: The group plans to meet twice a year.
Slovenian: Skupina načrtuje dva sestanka na leto.
English: A number of suggestions for future developments in the field were provided.
Slovenian: Podani so bili številni predlogi za prihodnji razvoj dogodkov na tem področju.
English: The above trends underline the importance of the operation of policies that support small and mediumsized enterprises.
Slovenian: Zgornje težnje poudarjajo pomen delovanja politik, ki podpirajo mala in srednje velika podjetja.
English: A joint conference organised by the European Commission and the Agency will take place on 30 June 2010.
Slovenian: Skupna konferenca Evropske komisije in agencije bo potekala 30. junija 2010.
English: All newly requested staff posts are financed through fee revenue.
Slovenian: Vsa na novo zahtevana delovna mesta se financirajo s prihodki od pristojbin.
English: The Agency's partners and stakeholders will be invited to participate.
Slovenian: Partnerji agencije in zainteresirane strani bodo povabljeni k sodelovanju.
English: Although the Commission confirmed that the decision had already been taken, the Board called for further debate on this matter.
Slovenian: Čeprav je Komisija potrdila, da je bila odločitev že sprejeta, je Odbor pozval k nadaljnji razpravi o tem vprašanju.
English: A number of countries chose not to participate in the pilot.
Slovenian: Številne države so se odločile, da ne bodo sodelovale v poskusnem projektu.
English: New website of the Agency
Slovenian: Nova spletna stran agencije
English: • collecting information on the uptake of the traditional use registration scheme in Member States;
Slovenian: • zbrati informacije o koriščenju sheme za registracijo tradicionalne uporabe v državah članicah;
English: The H1N1 pandemic continues to affect Africa, and EU vaccine stock is being exported to affected countries.
Slovenian: Pandemija H1N1 še vedno pretresa Afriko in zaloga cepiva EU se izvaža v prizadete države.
English: The group will examine in greater detail the requirement put forward by the Court of Auditors.
Slovenian: Skupina bo podrobneje proučila zahtevo Računskega sodišča.
English: • HMPC presentation.
Slovenian: • Predstavitev HMPC.
English: • Future revision of the transparency directive, with a view to promoting competitiveness of industry and innovation.
Slovenian: • prihodnjo spremembo direktive o preglednosti, da se spodbuja konkurenčnost industrije in inovacij;
English: • Performance of the Agency's scientific procedures:
Slovenian: • Izvajanje znanstvenih postopkov agencije:
English: When available, the options will be presented to the Management Board.
Slovenian: Ko bodo možnosti na voljo, bodo predstavljene upravnemu odboru.
English: The Board noted that the topic coordinators will continue reflecting on the payment system.
Slovenian: Odbor je omenil, da bodo tematski koordinatorji še naprej razmišljali o sistemu plačil.
English: The budget represents an increase of €20.7 million (10.5%) over the 2010 budget.
Slovenian: Proračun je za 20,7 milijona EUR (10,5 %) večji od proračuna za leto 2010.
English: The Agency delivered opinions within legislative timelines and achieved the majority of set targets.
Slovenian: Agencija je predložila mnenja v zakonskih rokih in dosegla večino zastavljenih ciljev.
English: Members stressed that a very short lead time from identification of the threat to the start of vaccination was only possible due to cooperation of regulators and industry.
Slovenian: Člani so poudarili, da je zelo kratek čas od opredelitve nevarnosti do začetka cepljenja mogoč samo zaradi sodelovanja med regulativnimi organi in industrijo.
English: • implementation of the e-submissions system across the EU and the future workshop on this topic;
Slovenian: • izvajanjem sistema e-predložitev v EU in prihodnjo delavnico o tej temi;
English: Information on the use of vaccines in those countries will add to the pool of knowledge on the safety and effectiveness of these vaccines.
Slovenian: Informacije o uporabi cepiv v teh državah bodo razširile vedenje o varnosti in učinkovitosti teh cepiv.
English: Depending on the outcome, the European Commission and the European Parliament will be informed about a preferred option.
Slovenian: Evropska komisija in Evropski parlament bosta odvisno od izida obveščena o prednostni možnosti.
English: • Note on the outcome of the selection procedure for patients'/consumers' representatives to participate as observers in the PhVWP.
Slovenian: • Obvestilo o rezultatu izbirnega postopka za predstavnike bolnikov/potrošnikov, ki bodo kot opazovalci sodelovali v skupini PhVWP.
English: A few deviations occurred, notably in the field of herbal medicinal products.
Slovenian: Bila so nekatera odstopanja, zlasti na področju zdravil rastlinskega izvora.
English: The budget includes estimated fee revenue of €163 million and a requested Community contribution of €47.1 million, which the Commission representative indicated was beyond the current EU financial perspectives.
Slovenian: Proračun vključuje ocenjene prihodke iz pristojbin v višini 163 milijonov EUR in zahtevan prispevek Skupnosti v višini 47,1 milijona EUR, za katerega je predstavnik Komisije navedel, da je višji od zdajšnjih finančnih obetov EU.
English: The Board thanked the topic coordinators (Chair, Austria and the Netherlands) for their contribution in preparing these documents.
Slovenian: Odbor se je zahvalil tematskim koordinatorjem (predsedniku, Avstriji in Nizozemski) za njihov prispevek pri pripravi teh dokumentov.
English: The Board noted that the evaluation of the Agency commissioned by the European Commission and carried out by Ernst & Young has been completed.
Slovenian: Odbor je opozoril, da je ocena agencije, ki jo je naročila Evropska komisija in izvedlo podjetje Ernst & Young, končana.
English: • Benchmarking of European Medicines Agencies (BEMA).
Slovenian: • primerjalno analizo evropskih agencij za zdravila (BEMA).
English: The PDB for 2011 totals €218.9 million, in line with the work programme.
Slovenian: PDB za leto 2011 znaša 218,9 milijona EUR in je skladen z delovnim programom.
English: The MBTC and Heads of Medicines Agencies telematics group will work to ensure optimum collaboration.
Slovenian: MBTC in skupina za telematiko vodij agencij za zdravila si bosta prizadevala za čim boljše sodelovanje.
English: Preparation for a written procedure on adoption of amending budget No 1/2010
Slovenian: Priprava na pisni postopek za sprejetje spremembe proračuna št. 1/2010
English: As a consequence, the number of contract agents will decrease by 35 in 2011 compared to 2010.
Slovenian: Zato se bo število pogodbenih uslužbencev leta 2011 v primerjavi z letom 2010 zmanjšalo za 35.
English: Visit of the Commissioner for Health and Consumer Policy
Slovenian: Obisk komisarja za zdravje in varstvo potrošnikov
English: In this respect, the Board welcomed the Norwegian model, where the agency has involved universities in producing draft monographs.
Slovenian: Odbor je v zvezi s tem pozdravil norveški model, v okviru katerega je agencija v pripravo osnutkov monografij vključila univerze.
English: • Completion of the evaluation of the Agency and the upcoming conference on the report; the Board asked to see the report before its publication.
Slovenian: • zaključkom ocene agencije in bližnjo konferenco o poročilu; Odbor je zahteval, naj se mu poročilo predloži, preden bo objavljeno;
English: A common statement by the Heads of Medicines Agencies could help to communicate with national parliaments and bodies in light of the ongoing debate on national strategies applied during the crisis.
Slovenian: Skupna izjava vodij agencij za zdravila bi lahko olajšala sporazumevanje z nacionalnimi parlamenti in organi glede na zdajšnjo razpravo o nacionalnih strategijah, ki se uporabljajo v krizi.
English: Mr Dalli stressed that patients' interests are at the heart of his and our work.
Slovenian: Poudaril je, da so interesi bolnikov v središču njegovega in našega dela.
English: The members will have three weeks to draft an analysis and assessment, which will be submitted to the Management Board for adoption around 20 May 2010.
Slovenian: Člani bodo imeli tri tedne časa za pripravo osnutka analize in ocene, ki ju bodo upravnemu odboru predložili v sprejetje okrog 20. maja 2010.
English: The proportion of new marketing authorisation applications for human medicines with negative outcomes increased to 33% last year, compared to 20-25% in previous years.
Slovenian: Delež novih vlog za pridobitev dovoljenja za promet z zdravilom za uporabo v humani medicini z negativnim izidom se je lansko leto povečal na 33 % v primerjavi s prejšnjimi leti, ko je znašal 20-25 %.
English: The amendments clarify, among others, that the procedure does not apply to re-nominations of members/alternates for which the Management Board was already consulted.
Slovenian: Skladno s spremembami je med drugim jasno, da postopek ne velja za vnovična imenovanja članov/nadomestnih članov, o katerih je upravni odbor že izrazil mnenje.
English: • Visits of Commissioner Dalli to EMA and EFSA.
Slovenian: • obiski komisarja Dallija v agencijah EMA in EFSA;
English: It was pointed out that the term of office of the current Chair of the Management Board will expire in June.
Slovenian: Opozorjeno je bilo, da se bo mandat zdajšnjemu predsedniku upravnega odbora iztekel junija.
English: Members considered that the decision should take into account the fact that cells and tissues can be raw materials for medicinal products.
Slovenian: Člani so menili, da bi bilo treba pri odločitvi upoštevati, da so celice in tkiva lahko surovine za zdravila.
English: The Board asked to accelerate the procedure to enable members to consider candidates in June.
Slovenian: Odbor je zahteval pospešitev postopka, da se članom omogoči, da junija razmišljajo o kandidatih.
English: • improving the output of the Committee;
Slovenian: • izboljšati učinek Odbora;
English: Amendments to fees payable to the European Medicines Agency and other measures
Slovenian: Spremembe pristojbin, ki se plačujejo Evropski agenciji za zdravila, in drugih ukrepov
English: A representative of the European Commission will attend the next meeting to outline details of the recent evaluation of EU agencies and the Commission's response.
Slovenian: Naslednjega sestanka se bo udeležil predstavnik Evropske komisije, ki bo na kratko predstavil podrobnosti nedavne ocene agencij EU in odziv Komisije.
English: The action plan will now be discussed at the Heads of Medicines Agencies in April.
Slovenian: O akcijskem načrtu bodo aprila razpravljali vodje agencij za zdravila.
English: It will review the existing governance structures and consider alternative arrangements to optimise the governance of the programme.
Slovenian: Proučil bo zdajšnje strukture vodenja in razmislil o alternativni ureditvi, da bi optimiziral vodenje programa.
English: • Progress on the pharmaceutical package (legislative proposals on pharmacovigilance, falsified medicines and the proposal on provision of information to patients).
Slovenian: • napredkom pri farmacevtskem paketu (zakonodajnimi predlogi o farmakovigilanci, ponarejenih zdravilih in predlogu za zagotavljanje informacij bolnikom);
English: The Agency will also start preparing for the implementation of legislation on pharmacovigilance and falsified medicines.
Slovenian: Agencija se bo tudi začela pripravljati na izvajanje zakonodaje o farmakovigilanci in ponarejenih zdravilih.
English: The Board expressed its support for the vaccination strategies adapted by Member States in the wake of a potentially severe pandemic threat.
Slovenian: Odbor je izrazil podporo strategijam cepljenja, ki so jih prilagodile države članice zaradi morebitne hude nevarnosti pandemije.
English: The Commissioner was satisfied with the work of the Agency, including achievements in the area of communication and the involvement of patients and healthcare professionals.
Slovenian: Komisar je bil zadovoljen z delom agencije, vključno z dosežki na področju komunikacij ter sodelovanjem bolnikov in zdravstvenih delavcev.
English: 8bis.
Slovenian: 8a.
English: The PDB includes an increase of 48 posts in the establishment plan, to a maximum number of 615 temporary agents.
Slovenian: PDB vključuje povečanje za 48 delovnih mest, določeno v kadrovskem načrtu, pri čemer naj bi bilo največje število začasnih uslužbencev 615.
English: The operations of the Agency and its work programme are shaped by various trends in the scientific and business environment of the Agency, including globalisation, scientific progress, and growing demand for openness and communication with stakeholders.
Slovenian: Dejavnosti agencije in njen delovni program oblikujejo različne težnje v znanstvenem in poslovnem okolju agencije, vključno z globalizacijo, znanstvenim napredkom in čedalje večjo potrebo po odprtosti in komunikaciji z zainteresiranimi stranmi.
English: The Board noted that a number of non-EU countries used EU authorisation to grant authorisation of pandemic vaccines in their own countries.
Slovenian: Odbor je opozoril, da so številne države nečlanice EU uporabile dovoljenje EU za izdajo dovoljenja za pandemska cepiva v svojih državah.
English: This is particularly true for areas where targets are self-set, as for example in the area of European public assessment reports (EPARs), where a number of self-set targets are not achieved due to circumstances outside of the Agency's reach.
Slovenian: To še zlasti velja za področja, na katerih so cilji samozastavljeni, kot na primer na področju evropskih javnih poročil o oceni zdravila (EPAR), pri katerih številni samozastavljeni cilji niso doseženi zaradi okoliščin, na katere agencija ne more vplivati.
English: The Executive Director and the Board thanked the staff of the Agency and the national authorities for their deep commitment and highly effective performance in the face of this public-health threat.
Slovenian: Izvršni direktor in Odbor sta se zahvalila osebju agencije in nacionalnim organom za njihovo globoko predanost in zelo učinkovito delovanje ob tej nevarnosti za javno zdravje.
English: In the meantime, the network needs to continue developing a coherent approach to the provision of information to patients and healthcare professionals across the EU.
Slovenian: Medtem mora mreža še naprej razvijati jasen pristop za zagotavljanje informacij bolnikom in zdravstvenim delavcem v EU.
English: The impact of the recent legislation on variations should be seen in 2010 and will need to be taken into account in 2011.
Slovenian: Vpliv nedavno sprejete zakonodaje o spremembah bi moral biti opazen v letu 2010 in ga bo treba upoštevati leta 2011.
English: • progress with the HMA/EMA training strategy;
Slovenian: • napredkom pri strategiji usposabljanja HMA/EMA;
English: • Agenda point 8bis_Amendment of the reimbursement rules for delegates.
Slovenian: • Točka 8a dnevnega reda Sprememba pravil o nadomestilih za delegate.
English: The Board suggested looking at the adequacy of some of the key performance indicators.
Slovenian: Odbor je predlagal, naj se preveri, ali so nekateri ključni kazalniki uspešnosti ustrezni.
English: Specifically, the sessions presented how to extend human capabilities in decision making and also demonstrated case studies where models were applied to extend and improve human judgement.
Slovenian: Še zlasti je bilo na predavanjih predstavljeno, kako razširiti človeške sposobnosti pri sprejemanju odločitev, predstavljene pa so bile tudi študije primerov, pri katerih so bili uporabljeni modeli za razširitev in izboljšanje človeške presoje.
English: The first meeting of chairs of the management boards of EU agencies took place to share best practices and discuss common issues and challenges.
Slovenian: Namen prvega sestanka predsednikov upravnih odborov agencij EU je bil izmenjati najboljšo prakso ter razpravljati o skupnih vprašanjih in izzivih.
English: • Creation of a task force on corporate social responsibility of the pharmaceutical industry.
Slovenian: • oblikovanjem projektne skupine za družbeno odgovornost podjetij v farmacevtski industriji.
English: Concern was expressed that the decision was taken prematurely, without due examination of the issue and discussion with all stakeholders.
Slovenian: Odločitev je bila po njihovem mnenju sprejeta prezgodaj, brez potrebne presoje vprašanja in razprave z vsemi zainteresiranimi stranmi.
English: Draft agenda for 18 March 2010 meeting
Slovenian: Osnutek dnevnega reda za sejo dne 18. marca 2010
English: The Agency will now work to identify lessons learned from the pandemic situation to identify improvements for future situations of this nature.
Slovenian: Agencija se bo zdaj lotila opredeljevanja lekcij, naučenih na podlagi pandemije, da bi opredelila izboljšanja za take primere v prihodnosti.
English: Expiry of the building lease in 2014
Slovenian: Iztek najemne pogodbe za zgradbo leta 2014
English: The new website of the Agency, which is under development, was demonstrated to the Management Board.
Slovenian: Nova spletna stran agencije, ki še nastaja, je bila predstavljena upravnemu odboru.
English: With regard to output of the Committee, the members also regretted that Member States do not have adequate resources to allow additional support for the work of the Committee.
Slovenian: Člani so glede učinka Odbora obžalovali tudi, da države članice nimajo ustreznih sredstev, da bi omogočile dodatno podporo njegovemu delu.
English: Following the discussion of the Management Board at the December meeting about the gap between workload and the number of temporary agents, the Agency requested 34 posts to replace existing contract agent positions with temporary agent positions.
Slovenian: Agencija je po razpravi upravnega odbora na decembrski seji o razliki med delovno obremenitvijo in številom začasnih uslužbencev zahtevala 34 delovnih mest, s katerimi bi nadomestila zdajšnja delovna mesta za pogodbene uslužbence z delovnimi mesti za začasne uslužbence.
English: If needed, the Court of Auditors will be contacted for further clarification.
Slovenian: Po potrebi bo za dodatna pojasnila navezala stik z njim.
English: Annual report 2009
Slovenian: Letno poročilo za leto 2009
English: The Agency began to identify options for a future location of the Agency in London, once its current lease expires in 2014.
Slovenian: Agencija je začela iskati možnosti za svoj prihodnji sedež v Londonu, ko se ji bo leta 2014 iztekla zdajšnja najemna pogodba.
English: The priorities for 2011 are consistent with previous years and the Road Map to 2010.
Slovenian: Prednostne naloge za leto 2011 so enake kot prejšnja leta in skladne s časovnim načrtom do leta 2010.
English: The Board was concerned that few applications are submitted to national competent authorities in many Member States in light of the approaching deadline for registration of herbal medicinal products in Member States (April 2011)1.
Slovenian: Odbor je bil zaskrbljen, ker je bilo nacionalnim pristojnim organom v številnih državah članicah glede na bližajoči se rok za registracijo zdravil rastlinskega izvora v državah članicah (april 2011)1 predloženih malo vlog.
English: A number of additional changes were made to the minutes as part of the written procedure which preceded this adoption.
Slovenian: V pisnem postopku pred tem sprejetjem so bile opravljene številne dodatne spremembe zapisnika.
English: The Board also stressed that the Agency's guidance relating to new and emerging therapies is highly important in the light of scientific development.
Slovenian: Odbor je še poudaril, da so navodila agencije glede novih in nastajajočih zdravljenj zelo pomembna glede na znanstveni razvoj.
English: • The move of the Pharmaceutical Unit F2 (and Unit F3, cosmetics and medical devices) to DG
Slovenian: • prehodom farmacevtskih enot F2 in F3 (kozmetični izdelki in medicinski pripomočki) pod GD