FrancophonIA/ELRC3.0 huggingface dataset:
English: By developing these initiatives, the EMEA aims to promote the appropriate use of medicines and further contribute to patient safety.
Slovenian: Z razvijanjem teh pobud si EMEA prizadeva spodbuditi ustrezno uporabo zdravil in še izboljšati varnost bolnikov.
English: If the Agency is to continue to deliver on its commitment to high-quality results in all core areas, it must also be supported by a corresponding increase in finances, human resources and allocated national experts.
Slovenian: Če želi Agencija še naprej dosegati kakovostne rezultate na vseh najpomembnejših področjih, je treba ustrezno povečati tudi finančna sredstva, človeške vire in število dodeljenih nacionalnih strokovnjakov.
English: The office aims to facilitate communication with SMEs through dedicated personnel within the agency who will respond to practical or procedural enquiries, monitor applications, and organise workshops and training sessions for SMEs.
Slovenian: Namen urada je olajšati komunikacijo z malimi in srednje velikimi podjetji prek specializiranega osebja na Agenciji, ki bo odgovarjalo na praktične ali postopkovne poizvedbe, spremljalo vloge ter organiziralo delavnice in usposabljanja za mala in srednje velika podjetja.
English: To respond to these changes, the Agency will improve its electronic document management system (EDMS), which is important for effective publishing of core business information to the web interface.
Slovenian: V odgovor na te izzive bo Agencija izboljšala svoj sistem elektronskega vodenja dokumentacije (EDMS), kar je pomembno za učinkovito objavljanje ključnih poslovnih informacij na spletnem vmesniku.
English: To further advance the implementation of the revised legislation, the procedure for monitoring the actual placing on the market of authorised products will be implemented.
Slovenian: Za nadaljnjo pospešitev izvajanja revidirane zakonodaje bo uveden postopek za spremljanje dejanskega dajanja na trg zdravil, za katera je izdano dovoljenje.
English: POST-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Noël Wathion
Slovenian: VREDNOTENJE ZDRAVIL ZA UPORABO V HUMANI MEDICINI PO IZDAJI DOVOLJENJA ZA PROMET Vodja: Noël Wathion
English: 3.1 GMP, GCP, GLP and pharmacovigilance inspections
Slovenian: 3.1 Inšpekcijski pregledi GMP, GCP, GLP in farmakovigilance
English: A number of related guidelines will be implemented, and expert fora for the investigation of new sources and methods for intensive monitoring of the paediatric use of medicines will be established.
Slovenian: Izvajale se bodo številne s tem povezane smernice in ustanovljeni bodo strokovni forumi za raziskovanje novih virov in metod za intenzivno spremljanje uporabe zdravil v pediatriji.
English: The Agency expects that a total of 13 arbitrations/referrals will be submitted to the CVMP in 2007three more than in 2006 - including twelve referrals following mutual recognition and decentralised procedures.
Slovenian: Agencija pričakuje, da bo v letu 2007 Odboru za zdravila za uporabo v veterinarski medicini (CVMP) predloženih skupaj 13 arbitraž/napotitev - tri več kot leta 2006 - vključno z dvanajstimi napotitvami po postopku medsebojnega priznavanja in decentraliziranem postopku.
English: In order to ensure that scientific issues are fully discussed prior to submission, and thus to avoid premature applications in the veterinary area, the Agency will hold pre-submission meetings involving the rapporteur, corapporteur and necessary experts.
Slovenian: Da bi Agencija zagotovila, da se znanstvena vprašanja pred oddajo vloge v celoti preučijo in da se tako izogne prezgodnjim vlogam na področju veterine, bo organizirala sestanke pred oddajo vloge, na katerih bodo navzoči poročevalec, soporočevalec in potrebni strokovnjaki.
English: These procedures include accelerated assessment, conditional marketing authorisation and compassionate use;
Slovenian: Med temi postopki so pospešeno ocenjevanje, pogojno dovoljenje za promet in sočutna uporaba;
English: Annex 2 EMEA establishment plan 2005-2007
Slovenian: Priloga 2 Načrt delovnih mest EMEA za obdobje 2005-2007
English: The Agency establishes maximum residue limits (MRLs) for pharmacologically active substances used in veterinary medicinal products, to provide for the safe use of foodstuffs of animal origin, including meat, fish, milk, eggs and honey.
Slovenian: Agencija določa mejne vrednosti ostankov (MVO) za farmakološko zdravilne učinkovine, ki se uporabljajo v veterinarskih zdravilih, da bi tako zagotovila varno uporabo živil živalskega izvora, vključno z mesom, ribami, mlekom, jajci in medom.
English: Regular releases throughout the year are foreseen, putting into place reporting against the requested pre-defined queries for pharmacovigilance (in respect of both human and veterinary products).
Slovenian: Predvidene so redne sprostitve v uporabo prek leta, ki uveljavljajo poročanje po zahtevanih vnaprej opredeljenih poizvedbah glede farmakovigilance (glede zdravil za humano uporabo in veterinarskih zdravil).
English: Maintenance activities relating to post-authorisation commitments (specific obligations, follow-up measures), renewal applications and annual reassessments are expected to continue at last year's rate.
Slovenian: Pričakuje se, da bodo vzdrževalne dejavnosti, povezane z obveznostmi po izdaji dovoljenja (posebne obveznosti, ukrepi spremljanja), prošnjami za podaljšanje in letnimi ponovnimi ocenami, še naprej potekale vsaj enkrat letno.
English: The Agency will continue its work in respect of, and maintain readiness for, a potential influenza pandemic, including through training and simulation activities and measures to promote the authorisation through the centralised procedure of safe and effective vaccines for control of avian influenza in birds.
Slovenian: Agencija bo nadaljevala svoje delo in ohranila pripravljenost na morebitno pandemijo gripe, vključno z usposabljanjem, simulacijami dejavnosti in ukrepi za spodbujanje izdajanja dovoljenj po centraliziranem postopku za varna in učinkovita cepiva za nadzor ptičje gripe.
English: However, the achievement of these targets is critically dependent on the availability of adequate bibliographic data and on resources made available at NCA level to support their review.
Slovenian: Vendar pa je doseganje teh ciljev močno odvisno od razpoložljivosti ustreznih bibliografskih podatkov in virov, ki so za njihov pregled na voljo na ravni pristojnih nacionalnih organov.
English: − Support further initiatives, once identified, to facilitate greater availability of veterinary medicines, particularly through measures to assist companies submitting applications for veterinary medicines which have limited markets or which are intended for diseases with regional distribution.
Slovenian: − podpora nadaljnjim pobudam, ko so le-te enkrat opredeljene, da se omogoči večja dostopnost zdravil za uporabo v veterinarski medicini, zlasti z ukrepi za pomoč podjetjem pri predložitvi vlog za taka zdravila, ki imajo omejen trg ali ki so namenjena regionalno porazdeljenim boleznim.
English: It will continuously assess the prioritisation of projects and activities to accommodate a considerably increased volume of activity, and effect improvements where necessary to ensure that high standards are maintained.
Slovenian: Nenehno bomo presojali prednostno naravo projektov in dejavnosti za prilagoditev povečanemu obsegu dejavnosti ter po potrebi izvedli izboljšave, da bi ohranili visoke standarde.
English: The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organisation.
Slovenian: EMEA izdaja potrdila o zdravilu v skladu z ureditvami, ki jih je določila Svetovna zdravstvena organizacija.
English: I would like to emphasise that these activities are only possible through the harmonious functioning of the European medicines network, with the EMEA and the national competent authorities working side by side.
Slovenian: Rad bi poudaril, da se te dejavnosti lahko izvajajo prek usklajenega delovanja Evropske mreže zdravil in tesnega sodelovanja med EMEA in pristojnimi nacionalnimi organi.
English: In addition to four outsourced contracts (switchboard/reception; audiovisual technicians; security guarding; and catering), the Agency will consider outsourcing reprographics and ancillary services in 2007.
Slovenian: Poleg štirih pogodb z zunanjimi izvajalci (telefonska centrala/recepcija, avdiovizualni tehniki, varovanje ter priprava in dostava hrane) bo Agencija v letu 2007 razmislila o pogodbah z zunanjimi izvajalci za reprografiko in pomožne storitve.
English: 2.7 Arbitration and Community referrals
Slovenian: 2.7 Arbitraža in napotitve Skupnosti
English: In addition to evaluation of applications for MRLs, the Agency will provide assistance to the Commission with the review of Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of MRLs for veterinary medicinal products in foodstuffs of animal origin.
Slovenian: Agencija bo poleg ocene vlog za MVO zagotovila tudi podporo Komisiji pri reviziji Uredbe (EGS) št. 2377/90 o določitvi postopka Skupnosti za določanje najvišjih mejnih vrednosti ostankov zdravil za uporabo v veterinarski medicini v živilih živalskega izvora.
English: With regard to alternative meeting solutions, the Agency will work to extend videoconferencing and broadcasting of meetings to national competent authorities and EMEA experts.
Slovenian: Glede alternativnih rešitev za sestanke si bo Agencija prizadevala povečati uporabo videokonferenc in prenosov sestankov pristojnim nacionalnim organom in strokovnjakom EMEA.
English: The Agency will continue its support for the implementation of directives on GCP and will further work on the preparation of guidelines and Community procedures associated with implementation of GMP-related aspects of the new legislation.
Slovenian: Agencija bo še naprej podpirala izvajanje direktiv o GCP ter si prizadevala za pripravo smernic in postopkov Skupnosti, ki so povezani z izvajanjem vidikov nove zakonodaje, povezanih z GMP.
English: The Agency will attend to the implementation and exercising of business-continuity plans in 2007, as well as to the organisation of health and safety awareness campaigns.
Slovenian: Agencija bo poskrbela za izvajanje in uporabo načrtov za neprekinjenost poslovanja v letu 2007 ter za organizacijo kampanj ozaveščanja o varnosti in zdravju.
English: In 2007 the Agency plans to develop 20 herbal monographs and make 10 entries into the list of herbal substances, preparations and combinations thereof.
Slovenian: Agencija za leto 2007 načrtuje pripravo 20 monografij rastlin in 10 vnosov na seznam snovi rastlinskega izvora, pripravkov in njihovih kombinacij.
English: As part of this, we will further promote the participation of patients and healthcare professionals in our activities.
Slovenian: V tem okviru bomo še naprej podpirali sodelovanje bolnikov in zdravstvenih strokovnjakov v naših dejavnostih.
English: Certificates within the framework of cooperation with the WHO and certificates for SMEs are also expected to increase in 2007.
Slovenian: V letu 2007 se pričakuje tudi povečanje števila potrdil v okviru sodelovanja s Svetovno zdravstveno organizacijo ter potrdil za mala in srednje velika podjetja.
English: To ensure high quality of IT projects, the Agency will progress the deployment of best-practice support processes based on the IT Infrastructure Library (ITIL) service management.
Slovenian: Zaradi zagotavljanja visoke kakovosti projektov informacijske tehnologije bo Agencija še naprej razvijala postopke podpore najboljši praksi, ki temeljijo na upravljanju storitev Knjižnice infrastrukture informacijske tehnologije (ITIL).
English: Despite initiatives taken by the CVMP1 to facilitate the authorisation of products for minor uses and minor species, the number of associated extensions and modifications has remained stable over the last years - a situation likely to continue in 2007, with 5 applications being predicted.
Slovenian: Kljub pobudam CVMP1, s katerimi je ta želel poenostaviti izdajanje dovoljenj za zdravila za manj pomembne uporabe in vrste, se število povezanih razširitev in sprememb mejnih vrednosti ostankov v zadnjih letih ni spremenilo - tako bo verjetno ostalo tudi v letu 2007, v katerem se pričakuje 5 vlog.
English: Work will continue on strengthening the quality and the regulatory and scientific consistency of CHMP2 opinions and assessment reports in the post authorisation phase, building on improvements introduced in 2006.
Slovenian: Nadaljevale se bodo dejavnosti v zvezi s krepitvijo kakovosti ter regulativne in znanstvene skladnosti mnenj in poročil o oceni CHMP2 v fazi po izdaji dovoljenja, pri čemer se bo gradilo na izboljšavah, ki so bile uvedene v letu 2006.
English: The Agency will also update interested parties on the operations of the HMPC, with particular emphasis on prioritisation of herbal substances identified for list entry/monograph development.
Slovenian: Agencija bo še naprej obveščala zainteresirane stranke o dejavnostih HMPC, poseben poudarek pa bo na prednostni opredelitvi snovi rastlinskega izvora, določenih za vnos v seznam/razvoj monografije.
English: 20 Investment in immovable property, renting of building and asset costs
Slovenian: 20 Naložbe v nepremičnine, najemi objektov in s tem povezani stroški
English: To respond to the increasing number of meetings, and to improve the meetings-organisation workflow and procedures, the Agency will focus on two aspects: streamlining the management of meetings and providing alternative meeting solutions.
Slovenian: Zaradi vedno večjega števila sestankov in izboljšanja pretoka dela in postopkov pri organizaciji sestankov se bo Agencija osredotočila na dva vidika: racionalizacijo upravljanja sestankov in zagotavljanje alternativnih rešitev za sestanke.
English: * With the implementation of the mandatory electronic reporting of ICSRs and the EudraVigilance Data Warehouse and Analysis System, a new method has been developed to present the number of ICSRs received/expected over time.
Slovenian: * Z uresničitvijo obveznega elektronskega sporočanja varnostnih poročil o posameznih primerih (ICSR) ter sistema za shranjevanje in analizo podatkov EudraVigilance je bila razvita nova metoda za predstavljanje števila varnostnih poročil o posameznih primerih, prejetih/pričakovanih v določenem času.
English: − Further maintain and improve measures for facilitating innovation and research, and thus increasing availability of medicines, in particular through: continuous support for the orphan medicinal products policy; the provision of scientific advice; support for micro, small and medium-sized enterprises; research into the impact and consistency of the Agency's decision making;
Slovenian: − ohranjanje in nadaljnje izboljševanje ukrepov za spodbujanje inovacij in raziskav ter s tem povečanje dostopnosti zdravil, zlasti v smislu stalne podpore politiki za zdravila sirote; zagotavljanja znanstvenega svetovanja; podpore za mikro, mala in srednje velika podjetja; raziskav vpliva in skladnosti odločanja Agencije;
English: Important areas of interaction with the European Commission on public-health issues will include: work associated with the legislation and initiatives relating to advanced therapies; support on the updating and further development of the Notice to Applicants; work within the framework of the public-private partnership aimed at providing quality information to patients; and assistance in revision of legislation governing variations to marketing authorisations.
Slovenian: Med pomembnimi področji sodelovanja z Evropsko komisijo o vprašanjih javnega zdravja bodo: delo, povezano z zakonodajo in pobudami, povezanimi z naprednimi terapijami; podpora pri posodabljanju in nadaljnjem razvoju Obvestila vlagateljem (Notice to Applicants); delo v okviru javno-zasebnega partnerstva za zagotavljanje kakovostnih informacij bolnikom; pomoč pri reviziji zakonodaje, ki ureja spremembe dovoljenj za promet.
English: The EMEA will continue ongoing activities in areas including: EU programme to reduce animal testing and develop modern approaches to safety assessment of medicines, minimisation of the occurrence of antimicrobial resistance, and environmental risk-assessment for medicinal products.
Slovenian: EMEA bo nadaljevala dejavnosti, ki potekajo na naslednjih področjih: program EU za zmanjšanje preizkusov na živalih in razvoj sodobnih pristopov k ocenjevanju varnosti zdravil; zmanjševanje pojava antimikrobne rezistence; ocena okoljskega tveganja zdravil.
English: Earlier and improved availability of medicines
Slovenian: Zgodnja in izboljšana dostopnost zdravil:
English: The EMEA will continue its initiatives aimed at improving the availability of veterinary medicines for minor uses and minor species.
Slovenian: EMEA bo nadaljevala svoje pobude, katerih cilj je izboljšati dostopnost veterinarskih zdravil za manj pomembne uporabnike in vrste.
English: The Agency will focus its initiatives in the following areas: implementation of transparency and communication provisions relating to medicines for paediatric use and paediatric clinical trials; improving the provision of information on scientific non-product related issues; completion of the implementation of the legislation on access to documents; provision of access to information on adverse drug reactions contained in the EMEA EudraVigilance database; and provision of product-related information in the new Community languages, Bulgarian and Romanian, and, following expiry of the derogation, in Maltese.
Slovenian: Svoje pobude bo usmerila na naslednja področja: izvajanje določb o preglednosti in obveščanju v zvezi z zdravili za pediatrično uporabo in pediatričnimi kliničnimi preizkušanji; izboljšanje zagotavljanja informacij o znanstvenih vprašanjih, ki se ne nanašajo na zdravilo; dokončanje izvajanja zakonodaje o dostopnosti dokumentov; zagotavljanje dostopa do informacij o neželenih učinkih zdravil, vsebovanih v zbirki podatkov EMEA EudraVigilance; zagotavljanje z zdravili povezanih podatkov v novih jezikih Skupnosti, bolgarščini in romunščini ter, po poteku prehodnega obdobja odloga, tudi v malteškem jeziku.
English: 303 Studies and consultants 304 Publications
Slovenian: 303 Študije in svetovalci
English: 1.4 Emerging therapies and new technologies
Slovenian: 1.4 Nove terapije in tehnologije
English: This is an important new mandate for the EMEA, giving the Agency a significant role in stimulating the availability of safe and effective medicines for children.
Slovenian: To je pomembna nova naloga za Agencijo, saj je ta dobila pomembno vlogo v spodbujanju dostopnosti varnih in učinkovitih zdravil za otroke.
English: The Agency estimates around 400 requests or applications relating to paediatric activities (such as paediatric investigation plans, waivers and scientific advice) will be received in the first year of activity.
Slovenian: Agencija pričakuje, da bo v prvem letu delovanja prejela okrog 400 zahtevkov ali vlog v zvezi s pediatričnimi dejavnostmi (kot so načrti pediatričnih raziskav, opustitve in znanstveno svetovanje).
English: It is expected that over 70 centrally authorised veterinary products will be available by 2007.
Slovenian: Pričakuje se, da bo do leta 2007 na voljo več kot 70 proizvodov z dovoljenjem, izdanim po centraliziranem postopku.
English: To address these trends, the EMEA, together with the national competent authorities, will work to strengthen the network of excellence and will cooperate to further develop resource-planning and work-sharing practices.
Slovenian: EMEA bo, z namenom obravnave teh trendov, skupaj s pristojnimi nacionalnimi organi okrepila mrežo odličnosti ter s sodelovanjem še bolj razvila prakso načrtovanja virov in delitve dela.
English: − Continue to apply a proactive approach to safety of medicines by initiating early assessment of the safety prior to authorisation, by monitoring implementation of risk-management plans after marketing authorisation, and by supervising the updating of such plans throughout the lifecycle of the product;
Slovenian: − nadaljnji proaktivni pristop k varnosti zdravil z izvajanjem zgodnjega ocenjevanja varnosti pred izdajo dovoljenja, spremljanjem izvajanja načrtov za obvladovanje tveganj po izdaji dovoljenja in nadzorovanjem posodabljanja takih načrtov skozi življenjski cikel zdravila;
English: Requests should be sent in writing to the EMEA or to
Slovenian: Pisne zahtevke pošljite na naslov EMEA ali na
English: A renomination of the majority of the CHMP, CVMP and HMPC members will take place in May 2007, following completion of their three-year term.
Slovenian: Maja 2007 bo po koncu triletnega mandata potekal ponoven izbor večine članov CHMP, CVMP in HMPC.
English: EU telematics strategy
Slovenian: Telematska strategija EU
English: Additional efforts will focus on addressing the impact of legal and procedural requirements on various inspection areas, on integration of certain ICH concepts (quality risk-management, design space, etc.) in assessment and inspection areas, and on analysis of GMP, PMF inspection and quality-defect findings in previous years.
Slovenian: Dodatna prizadevanja bodo usmerjena v obravnavanje vpliva pravnih in postopkovnih zahtev na različna področja inšpekcijskih pregledov, v povezovanje določenih konceptov Mednarodne konference o usklajevanju (ICH) (obvladovanje tveganj na področju kakovosti, načrtovalski prostor (design space) itd.) pri oceni in na področjih inšpekcijskih pregledov ter v analizo GMP, inšpekcijskih pregledov PMF in ugotovitev o pomanjkljivi kakovosti iz prejšnjih let.
English: − Implement the new regulation on medicinal products for paediatric use, including the establishment of a new Paediatric Committee, delivering opinions and decisions on paediatric investigation plans and waivers, and providing information on paediatric clinical trials.
Slovenian: − izvajanje nove uredbe o zdravilih za pediatrično uporabo, vključno z ustanovitvijo novega Odbora za pediatrijo, izdajanje mnenj in odločitev o načrtih pediatričnih raziskav in opustitvah ter zagotavljanje informacij o pediatričnih kliničnih preizkušanjih.
English: The Agency expects to complete the implementation of the full scope of the GMP Annex with EC-Japan MRA and maintenance arrangements.
Slovenian: Agencija pričakuje dokončno uresničitev celotnega obsega priloge o GMP sporazuma o medsebojnem priznavanju med ES in Japonsko ter vzdrževalnih ureditev.
English: 14 Socio-medical infrastructure 15 Exchange of civil servants and experts 16 Social welfare
Slovenian: 11 Aktivno zaposleno osebje 13 Stroški službenih potovanj 14 Socialno-zdravstvena infrastruktura 15 Izmenjava javnih uslužbencev in strokovnjakov 16 Socialno varstvo
English: The Agency will take part in the work of the Pharmaceutical Forum, and will continue the development of the EudraPharm database, containing information about centrally authorised products.
Slovenian: Agencija bo sodelovala pri delu Farmacevtskega foruma in nadaljevala razvoj zbirke podatkov EudraPharm, ki vsebuje podatke o zdravilih, odobrenih po centraliziranem postopku.
English: It will continue to implement the policy on micro, small and medium-sized enterprises (SMEs), which are often innovative companies working in the field of new technologies and emerging therapies; will continue to provide high-quality scientific advice to companies developing medicinal products; will support the development of orphan medicinal products; and will actively participate in the Innovative Medicines Initiative.
Slovenian: Še naprej bo izvajala politiko v zvezi z mikro, malimi in srednje velikimi podjetji (MSP), ki so pogosto inovativna na področju novih tehnologij in terapij, zagotavljala bo visoko kakovost znanstvenega svetovanja podjetjem, ki razvijajo zdravila, podpirala bo razvoj zdravil sirot in dejavno sodelovala v pobudi za inovativna zdravila (Innovative Medicines Initiative).
English: 7 Good clinical practice (GCP).
Slovenian: 7 Dobra klinična praksa (Good clinical practice, GCP).