FrancophonIA/ELRC3.0 huggingface dataset:
English: • Deliver business activities to a high level of quality, efficiency and consistency in both the human and veterinary areas.
Slovenian: • zagotavljanje poslovnih dejavnosti z visoko stopnjo kakovosti, učinkovitosti in doslednosti, in sicer tako humani kot veterinarski medicini;
English: In addition, the requests from stakeholders will increasingly relate not only to accessing data, but also to interpretation and analyses of those data.
Slovenian: Poleg tega se bodo zahteve deležnikov vse bolj nanašale na razlago in analizo teh podatkov ter ne samo na dostop do njih.
English: Patients, consumers and healthcare professionals demand more and better information to support their decision-making, together with high levels of transparency from industry and regulators.
Slovenian: Bolniki, potrošniki in zdravstveni delavci zahtevajo vse bolj obsežne in kakovostne informacije, da bi jim pomagale pri odločanju, ter visoko raven preglednosti pri industriji in regulativnih organih.
English: In the coming years, the Agency expects a significant increase in its activities, both in terms of volumes (e.g. scientific advice and pharmacovigilance) and in terms of complexity of products, scientific issues and procedures, due to the scientific development.
Slovenian: Agencija pričakuje, da se bodo zaradi znanstvenega razvoja njene dejavnosti v prihodnjih letih znatno povečale, tako z vidika obsega (npr. znanstveno svetovanje in farmakovigilanca) kot z vidika kompleksnosti proizvodov, znanstvenih vprašanj in postopkov.
English: This year, 2015, will be the 20th anniversary of the inauguration of the EMA, and the beginning of not only centralised approval of medicines, but of the whole European medicines network.
Slovenian: Agencija bo v letu 2015 praznovala 20. obletnico svoje ustanovitve, s tem pa tudi začetka ne samo centralizirane odobritve zdravil, pač pa tudi evropske mreže za zdravila kot take.
English: The implementation of the policy on access to clinical data will also be a significant aspect of the Agency's transparency initiatives.
Slovenian: Pomemben vidik pobud agencije za preglednost bo tudi izvajanje politike dostopa do kliničnih podatkov.
English: Transparency of the decision-making process throughout the lifecycle of medicines remains a key driver.
Slovenian: Preglednost postopka odločanja v celotnem življenjskem ciklu zdravil je ključnega pomena.
English: As part of this work, the Agency will continue contributing to the work of the Transatlantic Task Force on Antimicrobial Resistance (TATFAR), which aims to increase levels of communication, coordination and cooperation between the EU and the United States on human and veterinary antimicrobials.
Slovenian: V tem okviru bo še naprej prispevala k delu Čezatlantske skupine za protimikrobno odpornost (TATFAR), ki si prizadeva povečati raven komuniciranja, usklajevanja in sodelovanja med EU in Združenimi državami na področju uporabe protimikrobnih učinkovin v humani in veterinarski medicini.
English: Therefore, the EMA will continue its collaboration with its EU and international partners on a number of initiatives aimed at limiting the development of AMR.
Slovenian: Zato bo s svojimi partnerji iz EU in mednarodnimi partnerji še naprej sodelovala pri številnih pobudah za omejevanje razvoja protimikrobne odpornosti.
English: To address the above scientific and societal trends, the Agency is reinforcing its development support to various stakeholder groups, and has undertaken a number of initiatives to ensure early dialogue to foster drug development and improve regulatory pathways for early patient access to medicines.
Slovenian: Da bi se odzvala na zgoraj navedene znanstvene in družbene trende, agencija krepi svojo razvojno podporo različnim interesnim skupinam in je sprožila več pobud, da bi tako zagotovila čim zgodnejši dialog za pospešitev razvoja zdravil in izboljšanje regulativnih postopkov z namenom omogočiti bolnikom čim prejšnji dostop do zdravil.
English: • Facilitate early stages of medicines development in both the human and veterinary areas.
Slovenian: • olajšanje začetnih faz razvoja zdravil za uporabo v humani in veterinarski medicini;
English: This will affect the way the scientific committees evaluate medicines, and consequently the workload of the Agency, both in its endeavour to support the scientific assessment of the committees and in its role as a key provider of training, technical and methodological guidance for the scientific work.
Slovenian: To bo vplivalo na način, kako znanstveni odbori vrednotijo zdravila, in posledično na delovno obremenitev agencije, tako kar zadeva njeno prizadevanje za podpiranje znanstvenega ocenjevanja odborov kot njeno vlogo ključnega ponudnika usposabljanja ter tehničnih in metodoloških smernic za znanstveno delo.
English: As a result of full implementation of the legislation, the coordinating role of the Agency in the monitoring of all EU medicines, irrespective of their route of authorisation, will increase, and with it the scope of the Agency's responsibilities in the pharmacovigilance field.
Slovenian: S polnim izvajanjem zakonodaje se bo povečala usklajevalna vloga agencije pri spremljanju vseh zdravil EU, ne glede na način njihove odobritve, s tem pa tudi obseg njenih odgovornosti na področju farmakovigilance.
English: The revision of the EU's veterinary medicines legislation, with the aim of significantly simplifying the regulatory requirements, while maintaining a high level of protection of human and animal health, is expected to impact the Agency's activities once the legislation is adopted.
Slovenian: Pričakovati je, da bo sprejetje revidirane zakonodaje EU o zdravilih za uporabo v veterinarski medicini, katere namen je občutno poenostaviti regulativne zahteve, hkrati pa ohraniti visoko raven varovanja zdravja ljudi in živali, vplivalo na dejavnosti agencije.
English: To address these developments, the Agency continues to consolidate and enhance its collaboration with and support to the NCAs through a number of initiatives, including a revised training and competence development programme in cooperation with national authorities, promoting the national experts programme, and prioritising its information technology development programme with projects that support the work, effectiveness and efficiency of the NCAs.
Slovenian: Agencija se teh novih izzivov loteva tako, da s številnimi pobudami še naprej utrjuje in krepi svoje sodelovanje s pristojnimi nacionalnimi organi in podporo le-tem, med drugim s spremenjenim programom usposabljanja in razvijanja sposobnosti v sodelovanju z nacionalnimi organi, spodbujanjem nacionalnega programa za strokovnjake in namenjanjem prednostne vloge programu za razvoj informacijske tehnologije s projekti, ki podpirajo delo, učinkovitost in uspešnost pristojnih nacionalnih organov.
English: The increasing workload will call for higher involvement of the NCAs.
Slovenian: Zaradi naraščajoče delovne obremenitve bo potrebno večje sodelovanje pristojnih nacionalnih organov.
English: At the same time, the face of the pharmaceutical industry is evolving, with an increasing number of small or medium-sized enterprises (SMEs) undertaking the early stages of medicines development.
Slovenian: Hkrati se spreminja struktura farmacevtske industrije, saj se začetnih faz razvoja zdravil vse pogosteje lotevajo mala in srednja podjetja (MSP).
English: Following closely these developments and ensuring availability of the required expertise will therefore be important.
Slovenian: Natančno spremljanje tega razvoja dogodkov in zagotavljanje razpoložljivosti potrebnega strokovnega znanja bosta še naprej na njenem dnevnem redu.
English: • Implement pharmacovigilance legislation and the clinical trials legislation.
Slovenian: • izvajanje zakonodaje o farmakovigilanci in kliničnem preskušanju;
English: As the Agency regulates both human and veterinary medicines, it is well placed to implement the 'One Health' approach and follow its application in tackling the AMR, both in its own work and through collaboration with its European and international partners.
Slovenian: Agencija skrbi za zakonsko ureditev zdravil za uporabo v humani in veterinarski medicini, zato lahko izvaja pristop „eno zdravje“ in spremlja njegovo uporabo v boju proti protimikrobni odpornosti, in sicer tako pri svojem delu kot na podlagi sodelovanja s svojimi evropskimi in mednarodnimi partnerji.
English: The ever-increasing role of information technology in health-related matters, including use of e-health records and databases, mobile communications and social media by consumers and healthcare professionals, also demands that surveillance methods evolve to consider these developments.
Slovenian: Vse večja vloga informacijske tehnologije v zadevah, povezanih z zdravjem, vključno z uporabo evidenc in podatkovnih zbirk e-zdravja, mobilnih komunikacij in družbenih medijev s strani potrošnikov in zdravstvenih delavcev, zahteva tudi spremembo metod spremljanja, ki morajo upoštevati te novosti.
English: As a result, increased focus on ensuring that medicines tested and manufactured outside the EU meet the EU requirements will drive efforts to develop and strengthen collaboration with international partners regarding collaborative inspections, information exchange, capacity building and greater mutual reliance.
Slovenian: Posledično bo vse večja osredotočenost na zagotavljanje, da zdravila, ki so preizkušena in proizvedena zunaj EU, ustrezajo zahtevam EU, spodbudila prizadevanja za razvoj in krepitev sodelovanja z mednarodnimi partnerji, kar zadeva skupne preglede, izmenjavo informacij, krepitev zmogljivosti in večje vzajemno zaupanje.
English: In a continuous effort to meet the demands for increased efficiency of operations, while increasing the level of service the Agency provides, data management has become a key activity in creating an integrated, shared environment that provides a single, accurate, consistent source of data for the Agency, its partners and stakeholders.
Slovenian: Upravljanje podatkov je zaradi nenehnega prizadevanja za izpolnjevanje zahtev po večji učinkovitosti operacij in istočasnega povečevanja ravni storitev, ki jih zagotavlja agencija, postalo ključna dejavnost pri ustvarjanju povezanega skupnega okolja, ki zagotavlja enoten, natančen in dosleden vir podatkov za agencijo ter njene partnerje in deležnike.
English: The coming years will see an increasing need to consider aspects such as patients' values and preferences, the needs of other stakeholders (e.g. health-technology assessment bodies, or HTAs) when planning clinical research programmes and post-authorisation measures, the impact of 'real life' evidence data, and others.
Slovenian: V prihodnjih letih se bo povečevala potreba po upoštevanju vidikov, kot so vrednote in želje bolnikov, potrebe drugih deležnikov (npr. organov za ocenjevanje zdravstvenih tehnologij) pri načrtovanju programov kliničnih raziskav in ukrepov po pridobitvi dovoljenja za promet, učinek podatkov o dokazih iz prakse itd.
English: Therefore, the Agency will continue providing technical support to the EC with respect to discussion in Parliament and Council on their proposal for revision of the veterinary legislation, including on amendments to the framework for authorisation of innovative veterinary medicines, simplification of post-authorisation maintenance of veterinary products, pharmacovigilance and other aspects.
Slovenian: Agencija bo zato Evropski komisiji še naprej zagotavljala tehnično podporo v zvezi z razpravo v Evropskem parlamentu in Svetu glede predloga za revizijo veterinarske zakonodaje, med drugim o predlaganih spremembah okvira za odobritev inovativnih zdravil za uporabo v veterinarski medicini, poenostavitvi ohranjanja proizvodov za uporabo v veterinarski medicini po pridobitvi dovoljenja za promet, farmakovigilanci in drugih vidikih.
English: Growing interdependencies between committees and scientific disciplines in the decision-making further emphasise the need to continuously simplify and align processes, improve quality assurance and quality control, increase robustness of the processes and reach higher efficiency of the evaluation procedures.
Slovenian: Vse večja medsebojna odvisnost odborov in znanstvenih disciplin pri odločanju dodatno poudarja potrebo po nenehnem poenostavljanju in usklajevanju postopkov, izboljševanju zagotavljanja in nadzora kakovosti, povečevanju zanesljivosti procesov in doseganju večje učinkovitosti postopkov vrednotenja.
English: The move towards developing more targeted and individualised medicines, continuous development and use of state-of-the-art knowledge and technologies in drug development, and integration of development and use of medicines and medical devices all contribute to the increasing complexity of the scientific advice and other Agency's activities.
Slovenian: Premik v smeri razvoja bolj ciljno usmerjenih in individualiziranih zdravil, nenehen razvoj in uporaba najsodobnejših znanj in tehnologij pri razvoju zdravil ter povezovanje razvoja in uporabe zdravil in medicinskih pripomočkov skupaj prispevajo k vse večji zapletenosti znanstvenega svetovanja in drugih dejavnosti agencije.
English: The growing need for industry and academia to approach the regulators early in their endeavours increases the role of the Agency in facilitating such contact and ensuring early knowledge sharing.
Slovenian: Zaradi vse večje potrebe po tem, da industrija in akademski krogi do regulativnih organov pristopijo že na začetku svojih prizadevanj, ima agencija vse večjo vlogo pri olajševanju tovrstnega stika in zagotavljanju zgodnje izmenjave znanja.
English: EMA priorities and key influences
Slovenian: Prednostne naloge Evropske agencije za zdravila (EMA) in ključni dejavniki, ki vplivajo nanje
English: Pharmacovigilance and clinical trials legislation
Slovenian: Zakonodaja o farmakovigilanci in kliničnem preskušanju
English: The ever-increasing expectations of patients and healthcare professionals to have medicines available to treat various conditions, in combination with the continuous need for flexible and fast reaction to arising public health threats, highlights the importance of ensuring faster patient access to medicines on the market, while maintaining the quality of scientific assessment.
Slovenian: Vse večja pričakovanja bolnikov in zdravstvenih delavcev glede razpoložljivosti zdravil za zdravljenje različnih bolezenskih stanj ter stalna potreba po prožnem in hitrem odzivanju na pojavljajoče se nevarnosti za javno zdravje izpostavljajo pomen zagotavljanja hitrejšega dostopa bolnikov do zdravil na trgu, pri čemer pa je treba ohraniti kakovost znanstvene ocene.
English: The increasing complexity and globalisation of medicines supply chains will also require improved information exchange and closer, more streamlined cooperation among authorities, to ensure product and data integrity, and continuity of the medicines supply chain.
Slovenian: Zaradi vse večje kompleksnosti in globalizacije dobavnih verig zdravil bosta potrebna tudi boljša izmenjava informacij ter tesnejše in racionalnejše sodelovanje med organi, da se zagotovita neoporečnost proizvodov in podatkov ter neprekinjenost dobavne verige zdravil.
English: This translates into an increasing need for managing and sharing reliable data, in particular to support evidence-based regulatory decision-making grounded on science, improve the use of medicines and satisfy the demands for greater transparency and openness.
Slovenian: Zato bo potreba po upravljanju in izmenjavi zanesljivih podatkov vse večja, zlasti z namenom, da se podpre na znanosti temelječe regulativno odločanje na podlagi dokazov, izboljša uporaba zdravil in zadovoljijo potrebe po večji preglednosti in odprtosti.
English: As the EMA enhances its efforts to share knowledge and information with the NCAs, patients, healthcare professionals, the media and other stakeholders, the demand for data is expected to increase, and the central coordination role of the Agency, combined with improvements in data integration, becomes more important.
Slovenian: S krepitvijo prizadevanj agencije za izmenjavo znanja in informacij s pristojnimi nacionalnimi organi, bolniki, zdravstvenimi delavci, mediji in drugimi deležniki se bo predvidoma povečalo povpraševanje po podatkih, zaradi česar bo postala osrednja usklajevalna vloga agencije, vključno z izboljšavami pri povezovanju podatkov, še pomembnejša.
English: The growing trend for patients and healthcare professionals to use the internet, mobile communications and social media when searching for medicines-related information raises the importance of using these communication channels more widely, to ensure easy, consistent and timely access to authoritative, reliable and understandable information on medicines.
Slovenian: Zaradi vse bolj poudarjenega trenda, da bolniki in zdravstveni delavci pri iskanju informacij o zdravilih uporabljajo internet, mobilne komunikacije in družbene medije, je treba razširiti uporabo teh komunikacijskih kanalov, da se zagotovi preprost, dosleden in pravočasen dostop do verodostojnih, zanesljivih in razumljivih informacij o zdravilih.
English: Factors such as advances in and growing complexity of medicines development, globalisation, the increasing role of social media as an information source, growing expectation for transparency, key legislation changes and continuous striving for increased efficiency, all impact the Agency's work.
Slovenian: Na njeno delo vplivajo številni dejavniki, kot so nova dognanja v razvoju zdravil in njegova vse večja kompleksnost, globalizacija, vse večja vloga družbenih medijev kot vira informacij, vse večja pričakovanja glede preglednosti, bistvene zakonodajne spremembe in nenehno prizadevanje za večjo učinkovitost.
English: Veterinary medicines legislation
Slovenian: Zakonodaja o zdravilih za uporabo v veterinarski medicini
English: Along with SMEs, academia and public-private partnerships are also becoming an increasingly important source of innovation in medicines.
Slovenian: Vse pomembnejši vir inovacij na področju zdravil so poleg MSP tudi akademski krogi in javno-zasebna partnerstva.
English: Organization (WHO), thus highlighting AMR as a global health crisis of similar importance to pandemics of an infectious disease.
Slovenian: Resnost težave priznava tudi Svetovna zdravstvena organizacija (SZO), ki z razvojem svetovnega akcijskega načrta za boj proti protimikrobni odpornosti poudarja, da je protimikrobna odpornost svetovna zdravstvena kriza, ki je po pomembnosti na podobni ravni kot pandemija nalezljive bolezni.
English: substance management service
Slovenian: Namestnik izvršnega direktorja
English: Subtotal AST Total AST SC 6
Slovenian: Namestnik izvršnega direktorja Andreas Pott
English: International non-proprietary name (INN): deltamethrin
Slovenian: Mednarodno nelastniško ime (INN): deltametrin
English: The opinion was converted into a Decision by the European Commission on 24 September 2013.
Slovenian: Mnenje je bilo 24. septembra 2013 spremenjeno v sklep Evropske komisije.
English: The Committee appointed Dr C. Ibrahim as rapporteur and Ms H. Jukes as co-rapporteur.
Slovenian: Odbor je za poročevalca imenoval dr. C Ibrahima, za soporočevalko pa H. Jukes.
English: For the pour-on product 24 concerned Member States are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Slovenian: Za zdravilo v polivu je zadevnih 24 držav članic, in sicer Avstrija, Belgija, Bolgarija, Ciper, Češka republika, Danska, Estonija, Francija, Grčija, Irska, Islandija, Italija, Latvija, Litva, Luksemburg, Madžarska, Nemčija, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Slovenija in Španija.
English: The reference Member State is the United Kingdom for both products.
Slovenian: Referenčna država članica za obe zdravili je Združeno kraljestvo.
English: Written explanations were provided by the applicant on 22 May
Slovenian: Predlagatelj je 22. maja 2013 podal pisna pojasnila.
English: The decentralised procedure started on 19 December 2011.
Slovenian: Decentralizirani postopek se je začel 19. decembra 2011.
English: The referral procedure started on 6 March 2013.
Slovenian: Napotitveni postopek se je začel 6. marca 2013.
English: Potential serious risks were identified during the decentralised procedure by Germany and the Netherlands regarding the environmental safety of the product.
Slovenian: Med decentraliziranim postopkom sta Nemčija in Nizozemska ugotovili možnost resnega tveganja v zvezi z varnostjo zdravila za okolje.
English: On 26 February 2013, the reference Member State, the United Kingdom, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Slovenian: Referenčna država članica, Združeno kraljestvo, je 26. februarja 2013 obvestila Evropsko agencijo za zdravila, da skupina CMD(v) ni dosegla soglasja v zvezi z zdravilom, in zadevo napotila na CVMP skladno s členom 33(4) Direktive 2001/82/ES.
English: These are ‘hybrid' applications according to Art. 13(3) Directive 2001/82/EC, as amended, referring to the reference products Pfizer Pour On Insecticide 1% w/v Cutaneous Solution and Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose registered in the United Kingdom.
Slovenian: To sta vlogi za „hibridna zdravila“ v skladu s členom 13(3) Direktive 2001/82/ES, kakor je bila spremenjena, v zvezi z referenčnima zdraviloma Pfizer insekticid v polivu 1 % w/v dermalna raztopina in insekticid za kožni nanos 1 % w/v večodmerna dermalna raztopina, odobrenima v Združenem kraljestvu.
English: Day 60 of the CMD(v) procedure was on 14 February 2013, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Slovenian: Na šestdeseti dan postopka CMD(v), 14. februarja 2013, zadevne države članice niso dosegle soglasja o zdravilu, zato je bil postopek napoten na odbor CVMP.
English: For the spot-on product Belgium, France, Germany and the Netherlands are involved as concerned Member States.
Slovenian: Za zdravilo za kožni nanos pa so zadevne države članice Belgija, Francija, Nemčija in Nizozemska.
English: Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle contain deltamethrin as active ingredient and is intended for use in cattle and sheep as a topical application for the treatment and prevention of infestations by lice and flies on cattle; ticks, lice, keds and established blowfly strike on sheep and lice and ticks on lambs.
Slovenian: Deltanil 10 mg/ml, raztopina za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopina za kožni nanos za govedo, vsebujeta zdravilno učinkovino deltametrin in sta namenjeni lokalni uporabi pri govedu in ovcah za zdravljenje in preprečevanje napadov uši in muh na govedu, ugrizov klopov, uši, muhe melophagus ovinus in mesarskih muh na ovcah ter klopov in uši pri jagnjetih.
English: Therefore, the Committee adopted by majority a positive opinion on 17 July 2013 recommending the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Slovenian: Odbor je zato 17. julija 2013 z večino sprejel pozitivno mnenje, da priporoča izdajo dovoljenj za promet z zdravili Deltanil 10 mg/ml, raztopina za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopina za kožni nanos za govedo.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures
Slovenian: Ker ti pomisleki na 210. dan postopka še vedno niso bili rešeni, je bila zadeva 17. decembra 2012 v skladu s členom 33(1) Direktive 2001/82/ES napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek − zdravila za uporabo v veterinarski medicini (CMD(v)).