natgillin/translations-raw huggingface dataset:
In 2004, the EMEA received 6 new applications for new MRLs.
V letu 2004 je EMEA prejela 6 novih vlog za nove MRL-je.
ECD will be used by many applications that require directory information, starting first of all with MMS Phase III
ECD bo uporabljalo mnogo aplikacij, ki potrebujejo informacije iz imenika, prva pa bo MMS faza III.
Horizontal telematics services
Horizontalne telematske storitve
The Sector also completed a system healthcheck to finalise relevant aspects of configuration, operational support and delivery of services.
Sektor je opravil tudi "zdravstveni pregled sistema", da bi dokončno oblikoval pomembne vidike konfiguracije, operativne podpore in izvajanja storitev.
An overarching guideline on the general principle was issued for consultation in November 2004, along with concept papers on the requirements for different types of products.
Novembra 2004 so bile za posvetovanje objavljene skupne smernice o splošnem načelu skupaj z idejnimi dokumenti o zahtevah za različne vrste izdelkov.
This includes activities relating to pharmacovigilance information (periodic safety update reports), follow-up measures, specific obligations, annual re-assessments (annual reports) and renewal applications.
Sem sodijo dejavnosti, ki se nanašajo na informacije o farmakovigilanci (periodiočno dopolnjena poročila o varnosti), nadaljnji ukrepi, posebne obveznosti, vsakoletne ponovne ocene (letna poročila) in vloge za podaljšanje.
In view of the growing use of electronic documents, their publication on the Internet, new legislation on access to documents, the role of the Agency as a medicinal information provider, and requirements for document and records management under ISO 9000, the Agency has refocused its activities on the entire lifecycle of documents and, consequently, has adapted its approach to records management.
Glede na naraščanje uporabe elektronskih dokumentov, njihovo objavljanje na internetu, novo zakonodajo o dostopu do dokumentov, vlogo Agencije pri zagotavljanju medicinskih informacij in zahteve po upravljanju dokumentov in poročil v skladu z ISO 9000 je Agencija preusmerila svoje dejavnosti na celotni življenjski ciklus dokumentacije in zato prilagodila tudi svoj pristop k vodenju poročil.
This has been addressed by the Road Map, in which proposals have been made concerning the future cooperation of the network.
S tem vprašanjem se ukvarja usmeritveni načrt, ki vsebuje predloge glede prihodnjega sodelovanja v mreži.
The scope was to explore the possibility of developing a parallel scientific advice procedure, where the two agencies would evaluate advice requests within the same timelines and discuss them together.
Namen je bil preučiti možnosti za razvoj vzporednega postopka znanstvenega svetovanja, tako da bi obe agenciji pregledali zahtevke za svetovanje v enakih rokih in o njih skupaj razpravljali.
This should facilitate the future introduction of risk management plans as foreseen in the new Community legislation and compliance with the ICH E2E concept of pharmacovigilance planning.
To naj bi olajšalo uvedbo načrtov za obvladovanje tveganja v prihodnosti, kot jih predvideva zakonodaja Skupnosti, in skladnost s konceptom načrtovanja farmakovigilance ICH E2E.
On 1 May 2004, the new Regulations and Rules applicable to officials and other servants of the European Communities entered into force.
Novi "Predpisi in pravila za uradnike in druge uslužbence Evropskih skupnosti" so začeli veljati 1. maja 2004.
Prior to May 2004, the new Member States participated voluntarily in simplified mutual recognition procedures under the Collaboration Agreement between Veterinary Drug Registration Institutions (CAVDRI) of European Union Associated Countries.
Pred majem 2004 so nove države članice prostovoljno sodelovale v poenostavljenih postopkih medsebojnega priznavanja v skladu s Sporazumom o sodelovanju med institucijami za registracijo veterinarskih zdravil (Collaboration Agreement between Veterinary Drug Registration Institutions, CAVDRI) pridruženih držav Evropske unije.
The number of new applications for the mutual recognition procedure in 2004 increased compared to 2003.
V letu 2004 se je število novih vlog za postopek medsebojnega priznavanja povečalo v primerjavi z letom 2003.
This, together with the automatic extension of European Commission decisions granting marketing authorisations for medicinal products to the 10 new Member States on the date of accession, and the implicit requirement that product information be available in all official languages of the European Union, increased the volume of translation work substantially.
Zaradi tega in avtomatične razširitve odločitev Evropske komisije o dodelitvi dovoljenj za promet z zdravili na 10 novih držav članic z dnem pristopa ter implicitne zahteve, da so informacije o izdelku na voljo v vseh uradnih jezikih Evropske unije, se je znatno povečal obseg prevajalskega dela.
Two Infodays took place, in June and December 2004, held together with Industry.
Junija in decembra 2004 sta bila skupaj z industrijo organizirana dva informativna dneva.
3.4 Availability of medicines for minor use and minor species
3.4 Razpoložljivost zdravil manj pogoste uporabe in za manj pogoste vrste
With a view to ensuring the quality and consistency of regulatory practices, a benchmarking exercise based on ISO 9004:2000 was started in 2004, involving the EMEA and national competent authorities.
Zaradi zagotavljnja kakovosti in doslednosti regulativnih praks se je v letu 2004 začela izvajati primerjalna analiza na podlagi ISO 9004:2000, v katero so bili vključeni EMEA in pristojni nacionalni organi.
Centrally within the EMEA and between EMEA and NCAs all aspects of security services and communications have been implemented.
Centralno znotraj EMEA ter med EMEA in pristojnimi nacionalnimi organi so se izvedli vsi vidiki varnostnih storitev in komunikacij.
A further 40 % increase in the number of travel and hotel bookings for reimbursed delegates occurred, as well as a 20 % increase in hotel booking requirements for non-reimbursed delegates.
Poleg tega se je za 40 % povečalo število rezervacij za potovanja in hotele za delegate, ki se jim povrnejo stroški, za 20 % pa zahteve po rezervacijah hotelov za delegate, ki se jim ne povrnejo stroški.
Management and internal control systems are part of EMEA corporate governance and are consolidated in an integrated management system at the EMEA.
Sistem upravljanja in sistem notranje kontrole sta sestavna dela podjetniškega upravljanja EMEA in sta povezana v integriran sistem upravljanja v EMEA.
It also ensures the Agency s risk management and liaises with the European Commission s Internal Audit Service.
Zagotavlja tudi obvladovanje tveganja za Agencijo in se povezuje s Službo za notranjo revizijo Evropske komisije.
Whereas 12 type-II variations had been forecast, the EMEA actually received 16, of which 12 concerned pharmaceuticals and 4 concerned vaccines.
Čeprav je bilo predvidenih 12 sprememb tipa II, jih je EMEA dejansko prejela 16, od tega 12 za farmacevtske izdelke in 4 za cepiva.
2004 was a very successful year for the IT sector from both operational and project-delivery points of view.
Leto 2004 je bilo za sektor IT zelo uspešno z operativnega vidika in z vidika izvajanja projektov.
MRLs established for cattle were extrapolated for three substances; in one case to goats, in a second case to sheep and in a third case to all mammalian species.
MRL-ji, določeni za govedo, so bili ekstrapolirani za tri učinkovine, in sicer v prvem primeru na koze, v drugem primeru na ovce in v tretjem primeru na vse vrste sesalcev.
An observer for the veterinary authority of one EEA-EFTA state participated in plenary sessions.
Na plenarnih zasedanjih je sodeloval opazovalec za veterinarski organ ene države EGP-EFTA.
A hepatitis A and B vaccine had its use extended to children aged 1 to 5 years.
Razširila se je uporaba cepiva proti hepatitisu A in B na otroke od 1 do 5 let starosti.
• EudraVigilance in the veterinary sector for electronic reporting of adverse reactions became fully operational on 1 January 2005.
• EudraVigilance v veterini za elektronsko poročanje o neželenih učinkih je začela v celoti delovati 1. januarja 2005.
The enlargement of the European Union to 25 Member States on 1 May 2004 and the entry into force of the new pharmaceutical legislation, which introduced a fourth scientific committee and new scientific groups, led to a considerable increase in the number of meetings organised, in the number of meeting days, and in the number of delegates to be reimbursed.
Zaradi širitve Evropske unije na 25 držav članic s 1. majem 2004 in nove farmacevtske zakonodaje, ki uvaja četrti znanstveni odbor in nove znanstvene skupine, se je znatno povečalo število organiziranih srečanj, število dni srečanj in število delegatov, ki jim je treba povrniti stroške.
Two informal meetings were held in 2004: one in Cork, in May, under the Irish presidency, and one in Rotterdam, in November, under the Dutch presidency.
V letu 2004 sta bila opravljena dva neformalna sestanka, in sicer maja pod irskim predsedstvom v Corku in novembra pod nizozemskim predsedstvom v Rotterdamu.
Approximately 3 500 European experts are used by the EMEA in its scientific evaluation work.
Pri svojih dejavnostih znanstvenega vrednotenja EMEA uporablja približno 3500 evropskih strokovnjakov.
The CVMP took an average of 210 days for assessment of those new applications which received a Commission decision in 2004.
CVMP je potreboval povprečno 210 dni za ovrednotenje novih vlog, za katere je Komisija sprejela odločitev v letu 2004.
Three Article 6(12) referrals were withdrawn.
Tri napotitve v skladu s členom 6(12) so bile umaknjene.
This cooperation follows a new legal provision of Article 59 of Regulation (EC) No 726/2004, which lays down provisions to avoid conflicts between scientific opinions of different Community bodies.
To sodelovanje je skladno z novim predpisom v skladu s členom 59 Uredbe (ES) št. 726/2004, kjer so določeni predpisi, ki naj bi preprečili navzkrižja v znanstvenih mnenjih različnih organov Skupnosti.
The EMEA compensates the national competent authorities for the provision of scientific services.
EMEA plačuje pristojne nacionalne organe za zagotavljanje znanstvenih storitev.
Although the implementation rate at the level of Member States and pharmaceutical industry has remained low, the EMEA took several initiatives in 2004 to stimulate electronic reporting of individual case safety reports (ICSRs).
Čeprav je izvedbena stopnja na ravni držav članic in farmacevtske industrije ostala nizka, je EMEA v letu 2004 sprejela več pobud, da bi spodbudila elektronsko oddajanje varnostnih poročil o posameznih primerih (individual case safety report, ICSR).
Having implemented 2 large data storage arrays in the new EMEA data centre, IT has ensured that the Agency s processing and storage capabilities are aligned to its workload for the next 5 years
Z uvedbo 2 velikih polj za shranjevanje podatkov v novem podatkovnem centru EMEA je IT zagotovila, da so zmogljivosti obdelave in hranjenja podatkov skladne z delovno obremenitvijo Agencije v naslednjih 5 letih.
• Revision 4 of the Guideline on the acceptability of invented names for human medicinal products processed through the centralised procedure (CPMP/328/98, Rev 4) was released for external consultation in September 2004.
• Četrta revizija "Smernic o sprejemljivosti izmišljenih imen zdravil za humano uporabo, ki se obravnavajo po centraliziranem postopku" (CPMP/328/98, Rev 4) je bila predstavljena za javno posvetovanje septembra 2004.
Out of the overall requests for scientific advice received in 2004, 23 related to the field of cancer, 7 to the field of diabetes, 4 to the field of neurodegenerative diseases and 1 to the field of HIV/AIDS.
Od vseh zahtevkov za znanstveno svetovanje, prejetih v letu 2004, se jih je 23 nanašalo na področje raka, 7 na področje sladkorne bolezni, 4 na področje nevrodegenerativnih bolezni in 1 na področje HIV/AIDS.
In addition, the EMEA participated in the eleventh International Conference of Drug Regulatory Authorities (ICDRA), in Madrid.
Poleg tega je EMEA sodelovala na enajsti mednarodni konferenci regulativnih organov za zdravila (ICDRA) v Madridu.
2004 saw the first cooperation with the European Food Safety Authority (EFSA), involving the establishment of maximum residue limits for Lasalocid sodium (coccidiostat) for chicken and game birds, which was also evaluated in 2004 by EFSA for approval as a feed additive.
V letu 2004 je prvič potekalo sodelovanje z Evropskim uradom za varnost živil in prehrane (EFSA), ki je zajemalo določitev mejnih vrednosti ostankov lasalocid natrija (kokcidiostatik) za piščance in pernato divjad, ki ga je v letu 2004 ocenila tudi EFSA zaradi njegove odobritve kot krmnega dodatka.
Actions have focused on revision and strengthening of the quality assurance system, establishing clear roles and tasks for the working parties, and revising the policy on the handling of conflicts of interests.
Ukrepi so usmerjeni v revizijo in okrepitev sistema zagotavljanja kakovosti, določitev jasnih vlog in nalog za delovne skupine ter revizijo politike ravnanja pri navzkrižjih interesov.
In addition, following the finalisation of the USR, it is common for the company concerned to inform healthcare professionals by means of a Dear Doctor letter in all EU countries where the medicine is marketed.
Poleg tega je po zaključku postopka USR običajno, da zadevno podjetje s pismom v obliki "Spoštovani zdravnik" obvesti zdravstvene strokovnjake v vseh državah EU, kjer se zdravilo trži.
• Creation of scientific advisory groups to assist the committees in their work
• oblikovanje znanstveno svetovalnih skupin, ki naj bi pomagale odborom pri njihovem delu;
A further outcome of the review on transparency policy measures was the development of a Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework .
Še en rezultat revizije ukrepov politike transparentnosti je bil razvoj "Postopka za smernice Evropske unije in povezane dokumente v farmacevtskem zakonodajnem okviru".
EudraVigilance is the EU s data processing network and management system for monitoring adverse drug reactions.
EudraVigilance je mreža EU za obdelavo podatkov in sistem upravljanja za spremljanje neželenih učinkov zdravil.
• Reinforced role for the Agency in the provision of scientific advice to companies
• okrepljena vloga Agencije pri zagotavljanju znanstvenega svetovanja podjetjem;
• The total number of new applications for marketing authorisation received in 2004 was higher than initially planned, particularly for those concerning non-orphan products.
• Vseh novih zahtevkov za dovoljenje za promet z zdravili, prejetih v letu 2004, je bilo več, kot je bilo načrtovano v začetku, zlasti za izdelke, ki niso zdravila sirote.
A wide range of changes are possible to alter or improve the medicinal product.
Lahko se opravi vrsta sprememb, katerih namen je spremeniti ali izboljšati zdravilo.
Products placed on the market in one Member State can be marketed in any other part of the Community by a parallel distributor independent of the marketing authorisation holder.
Izdelke, dane na trg v eni državi članici, lahko v katerem koli drugem delu Skupnosti trži "vzporedni distributer", neodvisen od imetnika dovoljenja za promet z zdravilom.
In addition to its ongoing work with the Commission services in 2004, the EMEA cooperated with other EU agencies, most notably the European Food Safety Authority (EFSA) and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA).
Poleg stalnega sodelovanja s službami Komisije je EMEA v letu 2004 sodelovala tudi z drugimi agencijami EU, zlasti Evropskim uradom za varnost živil in prehrane (EFSA) in Evropskim centrom za spremljanje drog in zasvojenosti z drogami (EMCDDA).
Existing healthcare databases in Member States should also be used for pharmacovigilance purposes.
Za farmakovigilanco bi bilo treba uporabiti tudi obstoječe zbirke podatkov iz sistemov zdravstvenega varstva v državah članicah.
The implementation of new Community legislation in October 2003 split type-I variations into typeIA and type-IB variations, and also converted about 25 % of the former quality-related type-I variations into type-II variations.
Z uvedbo nove zakonodaje Skupnosti oktobra 2003 so se spremembe tipa I razdelile na spremembe tipa IA in tipa IB, okoli 25 % prejšnjih sprememb tipa I glede kakovosti pa se je preoblikovalo v spremembe tipa II.
The Management Board adopted the EMEA quality policy in March 2004, with a revision in June 2004.
Upravni odbor je sprejel politiko kakovosti EMEA marca 2004 in jo revidiral junija 2004.
The HMPC met twice in 2004 and set up temporary working groups to review and update available guidance that was adopted by the Herbal Medicinal Products Working Party (HMPWP) between 1997 and 2004, and to identify the need for additional guidance in the quality, safety and efficacy fields or on organisational matters.
HMPC se je v letu 2004 sestal dvakrat in ustanovil začasne delovne skupine za revizijo in posodobitev razpoložljivih smernic, ki jih je sprejela Delovna skupina za zeliščna zdravila (HMPWP) med letoma 1997 in 2004, in za opredelitev potrebe po dodatnih smernicah na področjih kakovosti, varnosti in učinkovitosti ali organizacije.
The IT sector provides reliable and robust IT services to EMEA staff, delegates and all users of panEuropean systems.
Sektor IT zagotavlja zanesljive in močne storitve IT za osebje EMEA, delegate in vse uporabnike vseevropskih sistemov.
The group is made up of delegates from the EU, Iceland and Norway, and meets at the EMEA to coordinate Member States positions on topics relating to the mutual recognition procedure (MRP).
Skupino sestavljajo delegati iz EU, Islandije in Norveške, ki na zasedanjih na EMEA usklajujejo stališča držav članic glede tem, povezanih s postopkom medsebojnega priznavanja.
The business objects reporting tool was also installed so that standard financial reports on asset purchases and depreciation could be produced.
Nameščeno je bilo tudi orodje za poročanje Business Objects, s katerim se lahko pripravijo standardna finančna poročila o nakupih premoženja in amortizaciji.
Parts of the Agency were refurbished in 2004.
V letu 2004 je bilo prenovljenih nekaj delov Agencije.
SWP contribution
Prispevek SWP
In line with the procedure, the results were provided to the (co-)rapporteurs to consider and subsequently to make recommendations for follow-up actions, i.e. specific investigation, inspections or variations.
V skladu s postopkom so bili rezultati posredovani (so)poročevalcem, ki naj bi jih preučili in kasneje dali priporočila za nadaljnje ukrepe, in sicer posebne preiskave, inšpekcijske preglede ali spremembe.
The EMEA received a total of 19 type-I variation applications (14 type-IA and 5 type-IB) less than half of the original 40 forecast.
EMEA je prejela skupaj 19 vlog za spremembe tipa I (14 za tip IA in 5 za tip IB), kar je manj kot polovica od predvidenih 40 vlog.
• Environmental Risk Assessment
• Ocena tveganja za okolje
The impact of scientific advice on the outcome of the scientific evaluation at the marketing authorisation stage has been assessed.
Ocenjen je bil učinek znanstvenega svetovanja na rezultat znanstvenega vrednotenja v fazi izdajanja dovoljenja za promet z zdravili.
This document was released for the purpose of transparency and has no legal force with respect to Directive 2001/83/EC.
Ta dokument je bil predstavljen zaradi preglednosti in ni pravno zavezujoč v zvezi z Direktivo 2001/83/ES.
• A range of vaccines for cats, containing live and inactivated components in various valency combinations, allowing veterinarians to adapt the vaccination programme to the needs of individual cats, for active immunisation of:
• vrsto cepiv za mačke z vsebnostjo živih in inaktiviziranih sestavin v različnih valentnih kombinacijah, ki veterinarjem omogočajo, da program cepljenja prilagodijo potrebam posameznih mačk, za aktivno imunizacijo naslednjih bolezni:
As a joint effort, a revised mandate of the Pharmacovigilance Working Party was agreed upon.
Skupaj so sklenili dogovor o revidiranih pooblastilih Delovne skupine za farmakovigilanco.
A procurement plan for the whole Agency was compiled, providing a framework for tenders launched over the course of the year.
Sestavljen je bil načrt javnih naročil za celotno Agencijo, ki je zagotavljal okvir za izvedbo razpisov v celem letu.
The Agency consulted with its stakeholders on a number of issues during 2004.
Agencija se je v letu 2004 s svojimi interesnimi skupinami posvetovala o številnih vprašanjih.
Management changes in 2004 included the implementation of an integrated management policy for the Agency, the extension of internal audits to include the functioning of the scientific committees, and the establishment of an Audit Advisory Committee.
Pri upravljanju so spremembe v letu 2004 zajemale izvedbo politike integriranega upravljanja Agencije, razširitev notranjih revizij na delovanje znanstvenih odborov in ustanovitev Posvetovalnega odbora za revizije.
Final appropriations for the 2003 budget.
Končna proračunska sredstva za leto 2003.
• The Agencys processes in relation to human medicines were further improved as a consequence of successful implementation of several short-term improvements, mainly stemming from the audit of the former CPMP conducted in 2003.
• Postopki Agencije v zvezi z zdravili za uporabo v humani medicini so bili izboljšani zaradi uspešne izvedbe več kratkoročnih izboljšav, ki izhajajo zlasti iz revizije nekdanjega Odbora za lastniška zdravila (CPMP), opravljene v letu 2003.
On average, the COMP reached an opinion within 69 days and the Commission adopted a decision within 32 days.
COMP je sprejel mnenje v povprečno 69 dneh, Komisija pa je sprejela odločitev v povprečno 32 dneh.
The internal structures of the EMEA were reorganised in 2004 with the creation of three horizontal services reporting to the Executive Director: an Executive Support Sector, a Legal Affairs Sector and the formalisation of the Integrated Quality Management/Internal Audit Function (see above).
V letu 2004 so bile organizirane notranje strukture EMEA z oblikovanjem treh horizontalnih služb, ki poročajo izvršnemu direktorju: sektor za izvršno podporo, sektor za pravne zadeve in uradno oblikovanje službe za integrirano upravljanje kakovosti/notranje pregledovanje (glej zgoraj).
In addition, a special web-based tool designed to support electronic reporting by small and mediumsized enterprises and non-commercial sponsors of clinical trials was released in 2004.
Poleg tega se je v letu 2004 začelo uporabljati posebno spletno orodje, ki naj bi podpiralo elektronsko poročanje malih in srednje velikih podjetij ter nekomercialnih sponzorjev o kliničnih preizkušanjih.
It includes the work of the Agency s Management Board, its partnership with national competent authorities and European institutions, and other general aspects of the EMEA, including transparency and the Agency s international activities.
Predstavljeno je delo upravnega odbora Agencije, partnerstvo s pristojnimi nacionalnimi organi in evropskimi institucijami ter drugi splošni vidiki EMEA, vključno s preglednostjo in mednarodnimi dejavnostmi Agencije.
• Johannes PETRUS HOOGLAND (Netherlands) (vice-chairman)
• Johannes PETRUS HOOGLAND (Nizozemska) (podpredsednik)
Interaction with stakeholders especially patients organisations was extensive during 2004.
Sodelovanje z interesnimi skupinami, zlasti organizacijami bolnikov, je bilo v letu 2004 zelo dejavno.
The HMPWP continued its work in 2004 until the inauguration of the HMPC in September 2004.
HMPWP je v letu 2004 nadaljevala svoje delo do ustanovitve HMPC septembra 2004.
Meetings and other activities
Srečanja in druge dejavnosti
In 2004, several marketing authorisations were extended in order to provide more treatment options for children.
V letu 2004 je bilo razširjenih več dovoljenj za promet z zdravili z namenom, da se zagotovi več možnosti zdravljenja za otroke.