natgillin/translations-raw huggingface dataset:
Final accounts 2005 10 Appropriation/Budget 2006 as of 31 December 2006 Appropriation/Budget 2007 as adopted by the Management Board on 19 December 2006
Zaključni računi 2005. 10 Odobrena proračunska sredstva/proračun za 2006 z dne 31. decembra 2006.
2.8 Medicines for children
2.8 Zdravila za otroke
The Agency expects to complete the remaining internal evaluation work and follow-up with new Member States in the context of the EC-Canada MRA, which will now include Bulgaria and Romania.
Agencija pričakuje dokončanje preostalega notranjega ocenjevanja in spremljanja z novima državama članicama glede sporazuma o medsebojnem priznavanju med ES in Kanado, kar zdaj vključuje Bolgarijo in Romunijo.
Plasma master file (PMF).
Glavni dosje plazme (Plasma master file, PMF).
The Agency expects to receive in 2007 the first variations to similar biological products and first updates of opinions given to medicinal products intended for non-EU markets.
Agencija pričakuje, da bo v letu 2007 prejela prve spremembe biološko podobnih zdravil in prve spremembe mnenj, izdanih za zdravila, ki niso namenjena trgom EU.
A trend seen in scientific advice is the high interest shown by industry, with a significant increase in the number of requests from year to year translating into a high workload and, thus, the need for effective management of procedures.
Gibanje, ki ga je mogoče opaziti na področju znanstvenega svetovanja, je veliko zanimanje industrije, ki se kaže v precejšnjem povečevanju števila vlog iz leta v leto, kar pa pomeni veliko delovno obremenitev in s tem tudi potrebo po učinkovitem upravljanju postopkov.
The EMEA expects that the number of parallel-distribution notifications for 2007 will stabilise at approximately 1,000.
EMEA pričakuje, da se bo število obvestil o vzporedni distribuciji v letu 2007 ustalilo in doseglo približno 1000 obvestil.
5.2 Information technology
5.2 Informacijska tehnologija
The EMEA and the network partners will establish a rolling twoyear work plan for the period 2007-2009 and will take forward a project designed to set up a network of academic centres for the intensive monitoring of targeted medicines.
EMEA in partnerji mreže bodo oblikovali dvoletni krožni delovni načrt za obdobje 2007-2009 ter nadaljevali projekt, namenjen vzpostavitvi mreže akademskih centrov za intenzivno spremljanje ciljnih zdravil.
The Agency provides secretarial support to the Coordination groups for mutual recognition and decentralised procedures (human and veterinary products) (CMD)(h) and CMD(v)), and to their subgroups/working groups, in accordance with the approved rules of procedure.
Sekretariat Agencije daje podporo Usklajevalnima skupinama za postopke medsebojnega priznavanja in za decentralizirane postopke (zdravila za uporabo v humani medicini in zdravila za uporabo v veterinarski medicini) (CMD)(h) in CMD(v)) ter njunim podskupinam/delovnim skupinam, v skladu z odobrenim poslovnikom.
Close collaboration between the EMEA, the European Directorate for the Quality of Medicines and the national authorities in the programme continues to prove invaluable in assuring effective and continued post-marketing surveillance of the quality of medicines.
Tesno sodelovanje med EMEA, Evropskim direktoratom za kakovost zdravil in nacionalnimi organi po tem programu se še naprej kaže kot neprecenljivo pri zagotavljanju učinkovitega in stalnega nadzora kakovosti zdravil po izdaji dovoljenja.
In 2007, the European medicines network will continue its work to address trends relating to the growing complexity and the number of tasks performed at Community level, as well as the advent of novel therapies and technologies.
V letu 2007 bo Evropska mreža zdravil nadaljevala obravnavanje trendov, povezanih z vse večjo zapletenostjo in številčnostjo nalog, ki se izvajajo na ravni Skupnosti, ter tudi delo v zvezi s prihodom novih tehnologij in terapij.
This is a result of recognition and appreciation by potential applicants of improvements to the veterinary scientific advice procedure, as well as growing confidence in the industry through experience with the procedure.
To je posledica dejstva, da morebitni vlagatelji priznavajo in cenijo izboljšave v postopku znanstvenega svetovanja na področju veterine, ter tudi vse večjega zaupanja v industrijo zaradi dobrih izkušenj s postopkom.
A production system is anticipated that will be able to make available sets of controlled terms, subject to the establishment of a formal process for the control of such terms.
Pričakuje se, da bo proizvodni sistem zmožen proizvesti nabore nadzorovanih izrazov v skladu z vzpostavitvijo uradnega postopka za kontrolo takih izrazov.
For product quality defects and other recalls see www.emea.europa.eu/inspections/defectinstructions.html for instructions and contact points.
Za pomanjkljivosti proizvodov in druge preklice pojdite na naslov www.emea.europa.eu/inspections/defectinstructions.html, ki vsebuje navodila in kontaktne osebe.
It will develop, with the Commission and Member States, guidelines for transparency of the paediatric clinical-trials database.
Skupaj s Komisijo in državami članicami bo razvila smernice za preglednost zbirke podatkov o pediatričnih kliničnih preizkušanjih.
In addition to the new tools we have already implemented, we want to work with Member State authorities and academic centres on establishing networks of experts to run intensive drug-monitoring programmes that will actively study the safety of targeted medicines.
Poleg novih orodij, ki smo jih že uvedli, želimo sodelovati z organi držav članic in akademskimi središči ter oblikovati mreže strokovnjakov, ki bodo vodile intenzivne programe spremljanja zdravil in dejavno preučevale varnost ciljno usmerjenih zdravil.
2.4 Establishment of maximum residue limits
2.4 Določitev mejne vrednosti ostankov
− Progress the implementation of the European Risk Management Strategy (ERMS), in close collaboration with the national competent authorities, leading to a more efficient system for supervising the safety of medicinal products;
− nadaljnje izvajanje evropske strategije obvladovanja tveganja v tesnem sodelovanju s pristojnimi nacionalnimi organi, s čemer se bo dosegel učinkovitejši sistem nadzorovanja varnosti zdravil;
301 Evaluations
301 Ocenjevanje
PIM (Product Information Management) (In pilot production)
PIM (upravljanje informacij o proizvodu) (v pilotski izdelavi)
Stimulation of innovation
Spodbujanje inovacij:
In addition to handling notifications, the Agency plans to review and update its guidance on parallel distribution to improve the efficiency of parallel-distribution notification processes, and will publish parallel-distribution notifications issued by the EMEA on its website.
Poleg obravnave obvestil namerava Agencija pregledati in posodobiti svoje smernice o vzporedni distribuciji, da bi izboljšala učinkovitost postopka obveščanja o vzporedni distribuciji, in na svoji spletni strani objaviti obvestila o vzporedni distribuciji, ki jih izda EMEA.
General EU contribution EU contribution for SME policy EU contribution for Paediatrics policy n/a 0.00 2,647 1.71
Prispevek EU za pediatrično politiko n/a 0,00 2.647 1,71
Work will include background upgrading of the underlying infrastructure followed by the delivery of improved systems for importing and exporting sets of data.
Delo bo vključevalo nadgradnjo ozadja osnovne infrastrukture, ki ji bo sledila zagotovitev izboljšanih sistemov za uvažanje in izvažanje naborov podatkov.
The Agency will review its post-authorisation activities during the ongoing process-improvement exercise to further increase efficiency.
Agencija bo pregledala svoje dejavnosti po izdaji dovoljenja v okviru izboljševanja postopkov, ki trenutno poteka, da bi še bolj povečala učinkovitost.
In line with the legislation, development will focus on products authorised using the centralised procedure in this first phase.
V skladu z zakonodajo bo v tej prvi fazi razvoj osredotočen na proizvode, za katere je bilo izdano dovoljenje po centraliziranem postopku.
Agency activities in the information technology area will seek to address the growing requirement to provide and maintain a paperless meeting room environment, high levels of service availability and good quality of IT service.
Pri svojih dejavnostih na področju informacijske tehnologije si bo Agencija prizadevala obravnavati rastoče zahteve po zagotavljanju in vzdrževanju okolja za sestanke brez papirja, visokih ravni razpoložljivosti storitev in dobro kakovost informacijsko-tehnoloških storitev.
This will enable the Agency to ensure the provision of reliable and robust IT services to its staff, delegates and all users of pan-European systems.
To bo Agenciji omogočilo, da bo svojemu osebju, odposlancem in vsem uporabnikom vseevropskih sistemov lahko zagotovila zanesljive in trdne informacijsko-tehnološke storitve.
To step up the provision of veterinary pharmacovigilance information, the Agency plans to increase reporting on pharmacovigilance information to the stakeholders.
Za pospešitev zagotavljanja informacij o veterinarski farmakovigilanci načrtuje Agencija povečanje sporočanja informacij o farmakovigilanci zainteresiranim strankam.
Incentives are provided because such medicines might, for economic reasons, not otherwise be developed.
Takih zdravil zaradi ekonomskih razlogov morda ne bi razvijali, zato so ponujene spodbude.
Medicines agencies have traditionally relied on spontaneous reporting of adverse reactions, and the EMEA EudraVigilance database remains a key tool for this.
Agencije za zdravila se tradicionalno opirajo na spontano poročanje o neželenih učinkih in zbirka podatkov EMEA EudraVigilance ostaja ključno orodje na tem področju.
These projects have been agreed as being EudraNet, EudraVigilance, EudraPharm, electronic submissions, clinical trials and good manufacturing practice databases.
Dogovorjeno je bilo, da ti projekti vključujejo EudraNet, EudraVigilance, EudraPharm, elektronsko pošiljanje vlog, klinična preizkušanja in zbirke podatkov o dobri proizvodni praksi.
The Agency will introduce additional information-technology tools to track applications for veterinary scientific advice, and will measure the level of satisfaction with the new procedure in order to make additional improvements, if needed.
Agencija bo uvedla dodatna orodja informacijske tehnologije za prejemanje vlog za znanstveno svetovanje na področju veterine ter izmerila raven zadovoljstva z novim postopkom, da bi po potrebi izvedla dodatne izboljšave.
The Agency expects that the number of applications in the post-authorisation area of veterinary medicines will remain largely unchanged.
Agencija pričakuje, da bo število vlog na področju dejavnosti po izdaji dovoljenja za veterinarska zdravila ostalo pretežno nespremenjeno.
Annex 4 EMEA contact points Pharmacovigilance and product quality defect reporting
Priloga 4 Kontaktne osebe EMEA Farmakovigilanca in poročanje o pomanjkljivosti izdelkov
Subject to successful conclusion of pilot activities for both new marketing authorisation applications and post-authorisation activities, the system will go into full production during the year.
Ob uspešnemu zaključku pilotskih dejavnosti za nove vloge za dovoljenje za promet in dejavnosti po izdaji dovoljenja za promet bo sistem med letom začel delovati s polno zmogljivostjo.
− Promote the participation of patients and healthcare professionals in the work of the Agency.
− spodbujanje sodelovanja bolnikov in zdravstvenih strokovnjakov pri delu Agencije.
If justified, desktop videoconferencing facilities will be developed and pilot web broadcasts of scientific meetings may be carried out in 2007.
Če bodo upravičene, se bodo razvijale tudi zmogljivosti za namizne videokonference in morda bodo v letu 2007 izvršeni pilotni prenosi znanstvenih sestankov.
Both GMP5 and PMF6 inspections numbers are expected to rise relative to 2006.
Agencija pričakuje, da se bo število inšpekcijskih pregledov na področju GMP5 in PMF6 v primerjavi z letom 2006 povečalo.
As part of the activities, the EMEA will prepare EPAR3 summary updates for line extensions that lead to major changes in the indications or conditions of use.
V okviru teh dejavnosti bo EMEA pripravljala povzetke sprememb EPAR3 za razširitev indikacij, ki pomenijo velike spremembe v indikacijah ali pogojih uporabe.
To better prepare itself and the network for the advent of new therapies and technologies, the Agency will promote early dialogue with sponsors of potential applications for advanced therapies and emerging products and technologies.
Da bi Agencija sebe in mrežo bolje pripravila na prihod novih tehnologij in terapij, bo spodbujala zgodnji dialog s sponzorji morebitnih vlog za napredne terapije ter nove proizvode in tehnologije.
By developing these initiatives, the EMEA aims to promote the appropriate use of medicines and further contribute to patient safety.
Z razvijanjem teh pobud si EMEA prizadeva spodbuditi ustrezno uporabo zdravil in še izboljšati varnost bolnikov.
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.
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.
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.
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.
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.
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.
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.
Za nadaljnjo pospešitev izvajanja revidirane zakonodaje bo uveden postopek za spremljanje dejanskega dajanja na trg zdravil, za katera je izdano dovoljenje.
POST-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Noël Wathion
VREDNOTENJE ZDRAVIL ZA UPORABO V HUMANI MEDICINI PO IZDAJI DOVOLJENJA ZA PROMET Vodja: Noël Wathion
3.1 GMP, GCP, GLP and pharmacovigilance inspections
3.1 Inšpekcijski pregledi GMP, GCP, GLP in farmakovigilance
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.
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.
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.
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.
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.
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.
These procedures include accelerated assessment, conditional marketing authorisation and compassionate use;
Med temi postopki so pospešeno ocenjevanje, pogojno dovoljenje za promet in sočutna uporaba;
Annex 2 EMEA establishment plan 2005-2007
Priloga 2 Načrt delovnih mest EMEA za obdobje 2005-2007
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
− 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.
− 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.
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.
Nenehno bomo presojali prednostno naravo projektov in dejavnosti za prilagoditev povečanemu obsegu dejavnosti ter po potrebi izvedli izboljšave, da bi ohranili visoke standarde.
The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organisation.
EMEA izdaja potrdila o zdravilu v skladu z ureditvami, ki jih je določila Svetovna zdravstvena organizacija.
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.
Rad bi poudaril, da se te dejavnosti lahko izvajajo prek usklajenega delovanja Evropske mreže zdravil in tesnega sodelovanja med EMEA in pristojnimi nacionalnimi organi.
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.
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.
2.7 Arbitration and Community referrals
2.7 Arbitraža in napotitve Skupnosti
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.
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.
With regard to alternative meeting solutions, the Agency will work to extend videoconferencing and broadcasting of meetings to national competent authorities and EMEA experts.
Glede alternativnih rešitev za sestanke si bo Agencija prizadevala povečati uporabo videokonferenc in prenosov sestankov pristojnim nacionalnim organom in strokovnjakom EMEA.
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.
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.
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.
Agencija bo poskrbela za izvajanje in uporabo načrtov za neprekinjenost poslovanja v letu 2007 ter za organizacijo kampanj ozaveščanja o varnosti in zdravju.
In 2007 the Agency plans to develop 20 herbal monographs and make 10 entries into the list of herbal substances, preparations and combinations thereof.
Agencija za leto 2007 načrtuje pripravo 20 monografij rastlin in 10 vnosov na seznam snovi rastlinskega izvora, pripravkov in njihovih kombinacij.
As part of this, we will further promote the participation of patients and healthcare professionals in our activities.
V tem okviru bomo še naprej podpirali sodelovanje bolnikov in zdravstvenih strokovnjakov v naših dejavnostih.
Certificates within the framework of cooperation with the WHO and certificates for SMEs are also expected to increase in 2007.
V letu 2007 se pričakuje tudi povečanje števila potrdil v okviru sodelovanja s Svetovno zdravstveno organizacijo ter potrdil za mala in srednje velika podjetja.
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.
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).