FrancophonIA/ELRC3.0 huggingface dataset:
English: The Innovation Task Force (ITF) - an EMEA multidisciplinary group that includes scientific, regulatory and legal competences - held 18 briefing meetings with companies developing medicines in the area of emerging therapies and new technologies.
Slovenian: Projektna skupina za inovacije (ITF) - multidisciplinarna skupina agencije EMEA s pristojnostmi na znanstvenem, regulativnem in pravnem področju - je organizirala 18 informativnih sestankov s podjetji, ki razvijajo zdravila na področju nastajajočih terapij in novih tehnologij.
English: I would like to express my deep gratitude, and that of the entire network, to Hannes for his important contribution, which is greatly appreciated.
Slovenian: Profesorju Hannesu bi se rad iskreno zahvalil, tako v svojem imenu kot v imenu celotne mreže, za njegov pomembni prispevek, ki ga vsi zelo cenimo.
English: The EMEA received applications for PIPs and full or partial waivers relating to 202 indications.
Slovenian: EMEA je prejela vloge za načrte pediatričnih raziskav in popolne ali delne opustitve, ki se nanašajo na 202 indikaciji.
English: The new paediatric legislation was successfully implemented, and a new scientific committee was established to oversee the performance of new tasks for the Agency and for the network.
Slovenian: Nova zakonodaja o pediatriji je bila uspešno uvedena, ustanovljen pa je bil tudi nov znanstveni odbor, da bo za Agencijo in mrežo nadzoroval izvajanje novih nalog.
English: A draft was published for a threemonth public consultation in December 2007.
Slovenian: Osnutek je bil decembra 2007 objavljen za namene trimesečnega javnega posvetovanja.
English: The number of marketing-authorisation applications for orphan-designated medicines was lower than in 2006, but close to the 7-year average since the introduction of orphan legislation.
Slovenian: Število vlog za izdajo dovoljenj za promet z zdravilom za zdravila, določena kot zdravila sirote, je bilo manjše kot v letu 2006, vendar je bilo blizu sedemletnemu povprečju od uvedbe zakonodaje o zdravilih sirotah.
English: Opinions adopted in 2007
Slovenian: Mnenja, sprejeta v letu 2007
English: European Technology Platform for Global Animal Health
Slovenian: Evropska tehnološka platforma za globalno zdravje živali
English: Recognising that micro, small and medium-sized enterprises (SMEs) are often a motor for innovation - particularly in the field of new technologies and emerging therapies - the Agency's SME Office continued to implement the EMEA's policy to support them.
Slovenian: Ker se zavedamo, da so mikro, mala in srednje velika podjetja (MSP) pogosto gonilna sila inovacij (zlasti v novih tehnologijah in terapijah), je Urad za MSP Agencije nadaljeval izvajanje politike agencije EMEA, ki je usmerjena v podpiranje MSP.
English: The Agency amended its policy on fee reductions for orphan medicines in 2007 to continue to focus on incentives to support protocol assistance, marketing-authorisation applications and other preauthorisation activities, and to support SMEs in the first year after granting of a marketing authorisation.
Slovenian: Agencija je v letu 2007 spremenila svojo politiko znižanja pristojbin za zdravila sirote, da se je lahko še naprej osredotočala na spodbude za podpiranje pomoči pri protokolu, dejavnosti, povezane z vlogami za izdajo dovoljenj za promet z zdravilom, in druge dejavnosti pred izdajo dovoljenj za promet, ter podpiranje MSP v prvem letu po podelitvi dovoljenja za promet z zdravilom.
English: The Agency participated in the preparation of the action plan, released in August 2007, for implementation of the Strategic Research Agenda.
Slovenian: Agencija je sodelovala pri pripravi akcijskega načrta za izvajanje strateških raziskovalnih programov, ki je bil objavljen avgusta 2007.
English: Principal activities Working with the Member States and the European Commission as partners in a European medicines network, the European Medicines Agency:
Slovenian: S partnerskim sodelovanjem z državami članicami in Evropsko komisijo v Evropski mreži zdravil Evropska agencija za zdravila:
English: In 2007, the Agency received 90 such applications relating to medicines for human use and 15 for veterinary medicines.
Slovenian: V letu 2007 je Agencija prejela 90 vlog, ki so se nanašale na zdravila za uporabo v humani medicini, in 15 za veterinarska zdravila.
English: The network gives the EMEA access to a pool of more than 4,000 experts, allowing the Agency to source the best-available scientific expertise for regulating medicines in the EU.
Slovenian: Mreža zagotavlja agenciji EMEA dostop do bazena z več kot 4000 strokovnjaki, kar Agenciji omogoča, da pri urejanju področja zdravil v EU uporablja najboljše strokovno znanje, ki je na voljo.
English: The transition from observer status to full participation in the European medicines network and in the work of the Agency was facilitated as a result of careful preparations in the run-up to these countries' accession to the EU.
Slovenian: Prehod iz statusa opazovalk do polnopravnega sodelovanja v Evropski mreži zdravil in pri delu Agencije so olajšale skrbne priprave pred pridružitvijo teh držav EU.
English: With a view to participating in educational programmes for regulatory scientists, in conjunction with academia and the national competent authorities, the EMEA contributed to the initiative started by Italy for a European school for regulatory assessment of medicines.
Slovenian: Da bodo regulativni znanstveniki sodelovali v izobraževalnih programih v sodelovanju z akademiki in nacionalnimi pristojnimi organi, je agencija EMEA prispevala k pobudi, ki jo začela Italija, za evropsko šolo za regulativno vrednotenje zdravil.
English: Continuing high priority was given to the authorisation of vaccines against avian influenza in chickens, because control of the disease in chickens reduces the likelihood of a pandemic developing through transfer of the virus from birds to man.
Slovenian: Neprekinjena velika prednost se je še naprej dajala izdaji dovoljenj za promet s cepivi proti aviarni influenci pri piščancih, saj nadzor nad boleznijo pri piščancih zmanjšuje verjetnost razvoja pandemije zaradi prenosa virusa s ptic na človeka.
English: There was a marked improvement in the average clock-stop time required by applicant companies.
Slovenian: Opažen je bil znaten napredek pri povprečnem času zamrznitve teka roka, ki so ga potrebovala podjetja, ki so oddala vloge.
English: 4 INSPECTIONS
Slovenian: 4 INŠPEKCIJSKI PREGLEDI
English: Certificates within the framework of cooperation with the World Health Organization and certificates for SMEs also increased.
Slovenian: Povečalo se je tudi število potrdil na podlagi sodelovanja s Svetovno zdravstveno organizacijo (WHO) ter potrdil za mala in srednja podjetja.
English: This conference brought together all major stakeholders in animal health, including industry, academia, international animal-health organisations, and regulators from around the world.
Slovenian: Na tej konferenci so se srečale vse pomembnejše zainteresirane strani s področja zdravja živali, vključno s predstavniki industrije, akademiki, mednarodnimi organizacijami za zdravje živali in upravnimi organi z vsega sveta.
English: Overall, these figures are consistent with a trend towards the introduction of immunological methods of control for disease problems in food-producing animals and an emphasis on companion-animal medicines in the field of veterinary pharmaceuticals.
Slovenian: Na splošno se te številke skladajo s težnjo po uvajanju imunoloških metod nadzora bolezni pri živalih, namenjenih za proizvodnjo hrane, ter poudarkom na zdravilih za hišne živali na področju veterinarskih farmacevtskih zdravil.
English: Further, advanced networkmanagement and performance services were implemented.
Slovenian: Uvedene so bile tudi napredne storitve za upravljanje in delovanje omrežja.
English: The total number of new applications - 90 - was higher than in any other year.
Slovenian: Skupno število novih vlog (90) je bilo večje kot katero koli leto poprej.
English: The small number of new MRL applications is of concern as it clearly shows that very few new molecules are being introduced onto the veterinary market for livestock species.
Slovenian: Majhno število novih vlog za najvišje mejne vrednosti ostankov je skrb zbujajoče, saj jasno kaže, da se na veterinarski trg za živino uvaja zelo malo novih molekul.
English: The lack of uptake of extension applications is possibly related to the fact that many extensions that are of interest to companies have already been undertaken by the CVMP as free-of-charge extrapolations over recent years, as part of the CVMP's efforts to facilitate authorisation of medicines for minor uses and minor species.
Slovenian: Vzrok, zakaj se število vlog za razširitev ne povečuje, je mogoče povezan z dejstvom, da je veliko razširitev, ki so zanimiva za podjetja, že izvedel CVMP v obliki brezplačnih interpolacij v preteklih letih kot del prizadevanj CVMP, da olajša podeljevanje dovoljenj za promet z zdravili za manjšo uporabo in manj pomembne živalske vrste.
English: The Agency prepared a EudraVigilance action plan, which was subsequently adopted by the Heads of Medicines Agencies and the EMEA Management Board, to address implementation problems relating to the quality of submitted data and legal reporting deadlines.
Slovenian: Agencija je pripravila akcijski načrt EudraVigilance, ki so ga pozneje sprejeli vodje agencij za zdravila in upravni odbor agencije EMEA za obravnavanje težav pri izvajanju v zvezi s kakovostjo predloženih podatkov in zakonitimi roki za poročanje.
English: For their hard work and dedication throughout the year, I express my deep gratitude to all members of the EMEA staff, as well as to all the experts and colleagues of the Member State national competent authorities and our partners at the European Commission and European Parliament who have contributed greatly to another successful year for the EMEA.
Slovenian: Globoko sem hvaležen vsem članom osebja agencije EMEA za njihovo trdo delo in predanost skozi vse leto, vsem strokovnjakom in kolegom iz nacionalnih pristojnih organov držav članic ter našim partnerjem v Evropski komisiji in Evropskem parlamentu, ki so zelo veliko prispevali k še enemu uspešnemu letu za agencijo EMEA.
English: Within the existing network, the EMEA worked closely with Member State national competent authorities on activities intended to improve the efficiency of the use of available resources and to secure the long-term availability of appropriate scientific expertise.
Slovenian: Znotraj obstoječe mreže je EMEA z nacionalnimi pristojnimi organi držav članic tesno sodelovala pri dejavnostih, za katere je predvideno, da bodo izboljšale učinkovitost uporabe obstoječih virov in zagotovile dolgoročno dostopnost ustreznega strokovnega znanja.
English: Four positive opinions related to the extension of existing MRLs to other species.
Slovenian: Štiri pozitivna mnenja so se nanašala na razširitev veljavnih mejnih vrednosti ostankov na druge živalske vrste.
English: This year also saw Bulgaria and Romania welcomed into the EU family of nations, and they were quickly integrated into the work of the EMEA as full members of the European medicines network, while preparatory work to integrate Croatia and Turkey was also conducted in advance of these countries' possible accession to the EU.
Slovenian: Letos sta se evropski družini narodov pridružili še Bolgarija in Romunija ter bili hitro vključeni v delo agencije EMEA kot polnopravni članici Evropske mreže zdravil, medtem ko smo izvajali tudi pripravljalna dela za vključitev Hrvaške in Turčije pred njuno morebitno pridružitvijo EU.
English: The European Medicines Agency is the European Union body responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products.
Slovenian: Evropska agencija za zdravila je organ Evropske unije, odgovoren za usklajevanje obstoječih znanstvenih virov, ki so jih dale na razpolago države članice za vrednotenje, nadzor in farmakovigilanco zdravil.
English: As in previous years, cancer treatment was the most-represented therapeutic area for which the COMP adopted positive orphan-designation opinions.
Slovenian: Enako kot v prejšnjih letih je zdravljenje raka najpogosteje zastopano terapevtsko področje, za katero je COMP sprejel pozitivna mnenja o določitvi zdravila kot zdravila sirote.
English: The EMEA participated in the planning process at the level of the Heads of Medicines Agencies.
Slovenian: Agencija EMEA je pri postopku načrtovanja sodelovala na ravni vodij nacionalnih agencij za zdravila.
English: A total of 762 suspected signals concerning 139 intensively monitored medicines, and 349 suspected signals concerning 162 routinely monitored medicines, were identified.
Slovenian: Skupaj je bilo prepoznanih 762 sumov signalov v zvezi s 139 intenzivno spremljanimi zdravili in 349 prepoznanih sumov signalov v zvezi s 162 rutinsko spremljanimi zdravili.
English: Compliance by Member States with the translation-checking process was very good overall, in both pre-authorisation and post-authorisation phases.
Slovenian: Države članice so pri postopku pregledovanja prevodov na splošno zelo dobro izpolnjevale pogoje, in sicer tako pred izdajo dovoljenja za promet kot tudi po njej.
English: Two positive opinions were adopted for medicines that were reviewed under accelerated assessment (Isentress and Soliris).
Slovenian: Sprejeti sta bili dve pozitivni mnenji za zdravili, ki sta bili pregledani po postopku pospešenega vrednotenja (Isentress in Soliris).
English: Reviews were undertaken in the context of a peerreview process within the CHMP.
Slovenian: Presoje so bile izvedene na podlagi postopka medsebojne presoje znotraj CHMP.
English: The number of good clinical practice (GCP) and pharmacovigilance inspections in 2007 was more than twice the number in 2006.
Slovenian: Število inšpekcijskih pregledov dobre klinične prakse (GCP) in farmakovigilance je bilo v letu 2007 več kot dvakrat večje kot v letu 2006.
English: As a result of this, the Agency held regular contacts with relevant learned societies, particularly those involved in the areas of cardiology, diabetes, central nervous system and oncology.
Slovenian: Rezultat tega je bil, da je Agencija vzdrževala redne stike s pomembnimi znanstvenimi združenji, še posebej tistimi, ki delujejo na področjih kardiologije, daibetesa, centralnega živčnega sistema in onkologije.
English: Key activities in this area during 2007 included the systematic publication of assessment reports for withdrawn or refused marketing-authorisation applications, the publication of press releases and question-and-answer documents providing information in cases where there were safety concerns with medicines, and the provision of product-related information in all EU languages.
Slovenian: Ključne dejavnosti na tem področju v letu 2007 so vključevale sistematično objavljanje poročil o vrednotenju za umaknjene ali zavrnjene vloge za dovoljenje za promet z zdravilom, objavljanje sporočil za javnost in dokumentov z vprašanji in odgovori, ki ponujajo informacije v primerih, v katerih so obstajali pomisleki o varnosti zdravila, ter zagotavljanje podatkov, povezanih z izdelkom, v vseh jezikih EU.
English: Contributing to the Innovative Medicines Initiative
Slovenian: Prispevek k pobudi za inovativna zdravila
English: A medicine belonging to a new class of antiretrovirals (CCR5 inhibitors).
Slovenian: • Zdravilo, ki spada v novi razred antiretrovirusnih zdravil (zaviralcev CCR5).
English: Resources in the network are scarce, and work began on developing planning processes for improved use and efficiency of the available resources.
Slovenian: Sredstva v mreži so skopa, in tako smo začeli razvijati postopke za načrtovanje, ki bodo omogočali boljšo uporabo in učinkovitost sredstev, ki so na voljo.
English: Assessment of new applications by the CVMP took an average of 200 days.
Slovenian: CVMP je za vrednotenje novih vlog v povprečju porabil 200 dni.
English: • provides independent, science-based recommendations on the quality, safety and efficacy of medicines, and on more general issues relevant to public and animal health that involve medicines;
Slovenian: • zagotavlja neodvisna, znanstveno podprta priporočila o kakovosti, varnosti in učinkovitosti zdravil ter splošnejših zadevah, ki so pomembne za zdravje ljudi in živali ter so povezane z zdravili;
English: The average time required to finalise procedures for provision of scientific advice in 2007 was 48 days, which is a reduction from the average time of 55 days in 2006.
Slovenian: Povprečni čas, potreben za končanje postopkov za zagotavljanje znanstvenega svetovanja, v letu 2007 je bil 48 dni, kar je manj v primerjavi z letom 2006, ko je bil ta čas povprečno 55 dni.
English: A mock-up pandemic vaccine is not intended for stockpiling, but can be used to speed up the availability of a final vaccine in the event of a pandemic, once the pandemic strain has been identified.
Slovenian: Modelno cepivo ni namenjeno za ustvarjanje zalog, temveč se lahko uporabi za pospeševanje dosegljivosti končnega cepiva v primeru pandemije, ko je pandemični sev prepoznan;
English: All applications for new MRLs and for extension or modification of MRLs were processed within the 120-day legal timeframe.
Slovenian: Vse vloge za nove mejne vrednosti ostankov in razširitev ali spremembo mejnih vrednosti ostankov so bile obravnavane v 120-dnevnem zakonskem roku.
English: All 7 immunological applications were indicated for food-producing animals: 2 for poultry, 2 for pigs, 1 for cattle, 1 for both cattle and sheep, and 1 for horses.
Slovenian: Vseh sedem imunoloških vlog je imelo indikacije za živali, namenjene za proizvodnjo hrane: dve za perutnino, dve za prašiče, ena za govedo in ovce ter ena za konje.
English: Global Animal Health Conference
Slovenian: Konferenca o globalnem zdravju živali
English: The final report, titled ‘Innovative Drug Development Approaches', focused on identifying scientific bottlenecks and emerging science in the development of medicines - both in industry's research and development and in the academic environment - and on generating recommendations for future EMEA actions.
Slovenian: Končno poročilo z naslovom „Innovative Drug Development Approaches“ (inovativni pristopi k razvoju zdravil) se osredotoča na prepoznavanje ozkih grl pri znanstvenem delu in znanstvenih dognanj, ki se pojavljajo pri razvoju zdravil - tako pri raziskavah in razvoju v industriji kot v akademskem okolju - ter na sestavljanje priporočil za prihodnje ukrepe agencije EMEA.
English: Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
Slovenian: Seznam rastlinskih snovi Skupnosti, njihovih pripravkov in kombinacij za uporabo v tradicionalnih zdravilih rastlinskega izvora
English: This is an increase of 18% compared to 2006.
Slovenian: Glede na leto 2006 to pomeni 18-odstotno povečanje.
English: Stimulating availability of veterinary medicines for limited markets
Slovenian: Spodbujanje dostopnosti zdravil za uporabo v veterinarski medicini za omejene trge
English: The CVMP recommended a marketing authorisation under exceptional circumstances for 2 medicines.
Slovenian: CVMP je priporočil izdajo dovoljenja za promet z zdravilom v izjemnih okoliščinah za dve zdravili.
English: The development of a framework of interaction between the EMEA and healthcare professionals was started in 2007.
Slovenian: Razvoj okvira za sodelovanje med agencijo EMEA in zdravstvenim osebjem se je začel v letu 2007.
English: Two mock-up pandemic-influenza vaccines intended for the prevention of influenza during an officially declared pandemic situation.
Slovenian: • Dve modelni cepivi proti pandemični gripi, namenjeni za preprečevanje gripe med uradno razglašeno pandemijo.
English: This causes vasodilation (widening of the blood vessels), so that the blood pressure drops and the potential risk of damage caused by high blood pressure can be reduced.
Slovenian: To povzroči vazodilacijo (širjenje krvnih žil), zaradi česar se zniža krvni tlak in zmanjša morebitna nevarnost poškodb zaradi visokega krvnega tlaka;
English: The EMEA received 63,393 reports concerning investigational medicines, i.e. adverse drug reactions observed during clinical trials.
Slovenian: Agencija EMEA je prejela 63 393 poročil v zvezi s preskusnimi zdravili, tj. poročil o neželenih učinkih zdravila, ki so bili opaženi med kliničnim preskušanjem.
English: However, the number of initial applications by active substance, i.e. without double applications, was 19% lower than in
Slovenian: Vendar pa je bilo število začetnih vlog po zdravilnih učinkovinah, tj. brez dvojnih vlog, za 19 % manjše kot v letu 2006.
English: I am very pleased to introduce the EMEA annual report for 2007.
Slovenian: Z zadovoljstvom vam predstavljam letno poročilo agencije EMEA za leto 2007.
English: Porcine circovirus is involved in the aetiology of porcine multisystemic wasting syndrome (PMWS), which is considered one of the most significant challenges facing the pig industry in the EU, and the authorisation of these products should assist with control of this disease;
Slovenian: Prašičji cirkovirus je vključen v etiologijo multisistemskega sindroma hiranja pri prašičih (PMWS), ki se šteje za enega največjih izzivov, s katerim se srečuje prašičereja v EU, izdaja dovoljenja za ta izdelka pa bi morala pripomoči k omejevanju te bolezni;
English: Forty medicines were tested as part of the 2007 programme.
Slovenian: Na podlagi programa je bilo v letu 2007 preskušenih 40 zdravil.
English: Cancer again the main therapeutic area represented
Slovenian: Rak je znova glavno zastopano terapevtsko področje
English: 2.8 Herbal medicines Community herbal monographs
Slovenian: 2.8 Zdravila rastlinskega izvora Rastlinske monografije Skupnosti
English: The Committee for Medicinal Products for Veterinary Use (CVMP) produced internal reflection papers on the criteria to be used for defining a ‘limited market' and on the procedure whereby the Committee formally classifies a medicine as indicated for a limited market.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je pripravil notranje preučitvene dokumente o merilih, ki se bodo uporabljala za opredelitev „omejenega trga“, in postopku, s katerim Odbor uradno opredeli zdravilo kot zdravilo za omejeni trg.
English: One application was received for a scientific opinion on medicinal products intended for non-EU markets.
Slovenian: Prejeli smo tudi eno vlogo za znanstveno mnenje o zdravilu, ki je namenjeno za trge zunaj EU.
English: Five concerned medicines for companion animals, principally dogs, and the other 3 concerned medicines indicated for pigs, cattle and rabbits.
Slovenian: Pet od teh zdravil je bilo namenjenih hišnim živalim, predvsem psom, preostala tri zdravila pa so imele indikacije za prašiče, govedo in zajce.
English: The Agency held a number of workshops and conferences to address critical scientific areas, involving academia, regulatory authorities and, where appropriate, pharmaceutical industry.
Slovenian: Agencija je organizirala več delavnic in konferenc za obravnavanje najpomembnejših znanstvenih področij, na katerih so bili vključeni akademiki, regulativni organi, in kadar je bilo primerno, farmacevtska industrija.
English: Work remained to be done in respect of a small number of NCAs.
Slovenian: Pri manjšemu številu nacionalnih pristojnih organov je ostalo še nekaj dela.
English: Quantitative signal-detection methodologies were included in EVDAS and new functionality facilitating the review of signals was added to EudraVigilance.
Slovenian: V EVDAS so bile vključene metodologije za kvantitativno zaznavanje signalov, zbirki EudraVigilancepa je bila dodana nova funkcija, ki olajšuje pregledovanje signalov.
English: Two negative opinions were adopted, recommending the refusal of applications for an extension of indication.
Slovenian: Sprejeti sta bili dve mnenji, ki sta priporočali zavrnitev vlog za razširitev terapevtskih indikacij.