natgillin/translations-raw huggingface dataset:
Following this, a new career structure was implemented, as were changes to grading and allowances etc., which are being applied to existing staff and new recruits.
Na podlagi tega so se začeli izvajati nov sistem poklicnega napredovanja ter spremembe v razvrščanju in dodatkih itd., ki veljajo za obstoječe osebje in nove zaposlene.
4.3 Sampling and testing
4.3 Vzorčenje in preizkušanje
6.2 Information technology at the EMEA
6.2 Informacijska tehnologija v EMEA
The new EMEA Financial Regulation was implemented with the agreement of the European Commission, the favourable opinion of the Court of Auditors and approval of the EMEA Management Board.
Nova finančna uredba EMEA je bila izvedena s soglasjem Evropske komisije, pozitivnim mnenjem Računskega sodišča in odobritvijo upravnega odbora EMEA.
The agreement covers medicinal products for human use only.
Sporazum zajema le zdravila za uporabo v humani medicini.
To maintain the MMS and implement a range of new services in MMS Phase III
Vzdrževati MMS in uvesti vrsto novih stortiev v MMS fazi III
The EMEA cooperates closely with other scientific and regulatory institutions and agencies in the public health arena at European Union level.
EMEA tesno sodeluje z drugimi znanstvenimi in regulativnimi institucijami in agencijami na področju javnega zdravja na ravni Evropske unije.
Information on the high rate of virological failure and emergence of resistance at an early stage with some triple combinations was added to relevant product information.
Informacije o visoki stopnji virološke odpovedi in pojava rezistence v zgodnji fazi z nekaterimi trojnimi kombinacijami so bile dodane ustreznim podatkom o izdelku.
Involving its partners and stakeholders in this consultation process allowed the EMEA to achieve a broad consensus on the best way forward for the Agency in an operating environment characterised by significant political, institutional, legislative and scientific developments.
EMEA je z vključitvijo svojih partnerjev in interesnih skupin v ta proces posvetovanja dosegla široko soglasje o najboljšem načinu nadaljnjega dela Agencije v dejavnem okolju, ki ga je zaznamovalo pomembno politično, institucionalno, zakonodajno in znanstveno dogajanje.
It will help to harmonise procedures and provisions concerning herbal medicinal products laid down in the Member States and help to further integrate herbal medicinal products in the European regulatory framework.
Pomagal bo uskladiti postopke in predpise v zvezi z zeliščnimi zdravili, določene v državah članicah, in še bolj vključiti zeliščna zdravila v evropski regulativni okvir.
The aim of this benchmarking system is to contribute to the development of a world-class regulatory system for medicinal products, based on a network of agencies operating to best-practice standards.
Cilj tega sistema primerjalne analize je prispevati k razvoju svetovno priznanega regulativnega sistema za zdravila na podlagi mreže agencij, ki delujejo v skladu s standardi najboljše prakse.
• Implementation of an improved activity-based budgeting database and budgetary planning
• izvajanje izboljšane proračunske zbirke podatkov, utemeljene na dejavnostih, in proračunskega načrtovanja
In accordance with the EMEA Financial Regulation, the Agency is required to publish an analysis and assessment of its annual activity report together with its annual report.
Agencija mora v skladu s finančno uredbo EMEA skupaj s svojim letnim poročilom objaviti analizo in oceno letnega poročila o dejavnostih.
The purpose of the EMEA certificates of medicinal products scheme is to support the work of health authorities outside the European Union, in particular in developing countries.
Namen sistema potrdil EMEA za zdravila je podpirati delo zdravstvenih organov zunaj Evropske unije, zlasti v državah v razvoju.
In this context, the CVMP, its processes, records and working practices were audited in October 2004.
V tem okviru je bila oktobra 2004 opravljena revizija CVMP, njegovih postopkov, dokumentacije in delovnih praks.
The main achievements in 2004 included:
Glavni dosežki v letu 2004 so bili:
The EU enlargement, new scientific committee and new responsibilities of the EMEA arising from the parts of the new legislation that entered into force in 2004 generated a huge increase in the number of delegates and visitors coming to the Agency.
Širitev EU, nov znanstveni odbor in nove odgovornosti EMEA, izhajajoči iz delov nove zakonodaje, ki so začeli veljati v letu 2004, so močno povečali število delegatov in obiskovalcev, ki prihajajo v Agencijo.
1.6 EU institutions, agencies and international partners
1.6 Institucije, agencije in mednarodni partnerji EU
European Public Assessment Reports are published as soon as possible after receipt of the respective Commission Decision in line with the procedure for human medicines.
Evropska javna poročila o oceni se objavijo čim prej po prejemu ustrezne odločitve Komisije v skladu s postopkom za zdravila za uporabo v humani medicini.
This is a 36 % increase compared to the previous year.
To je 36 % več kot v prejšnjem letu.
This indicates that there were fewer premature applications.
To kaže na manj prenagljenih vlog.
In 2004, the regulatory time for proceeding through the centralised procedure remained stable, at an average of 288 days, including 187 days for assessment.
V letu 2004 je regulativni čas za izvedbo centraliziranega postopka ostal enak, in sicer je povprečno trajal 288 dni, vključno z 187 dnevi za vrednotenje.
Predictions for 2005-2006 indicate a relatively stable level of applications.
Po predvidevanjih naj bi bilo število vlog v letih 2005−2006 relativno stabilno.
The European Union telematics strategy for pharmaceuticals is agreed between Member States, the EMEA and the European Commission, and aims to increase efficiency, enhance transparency and provide support for the procedures set out in European legislation.
O telematski strategiji Evropske unije za farmacevtske izdelke se dogovorijo države članice, EMEA in Evropska komisija, njen cilj pa je povečati učinkovitost in preglednost ter zagotoviti podporo za postopke, določene v evropski zakonodaji.
Secondly, a new legislative tool entered into force allowing the EMEA, in cooperation with the World Health Organization (WHO), to assess medicines for third-world countries.
Drugič, začelo je veljati novo zakonodajno orodje, ki EMEA omogoča, da v sodelovanju s Svetovno zdravstveno organizacijo (WHO) vrednoti zdravila za države tretjega sveta.
Number of visitors
Število obiskovalcev
Periodic safety update reports
Periodično dopolnjena poročila o varnosti
The EMEA coordinated and chaired meetings of the Costing Group.
EMEA je usklajevala in vodila sestanke skupine za stroške.
The CVMP agreed to set a harmonised withdrawal period, which is now adopted throughout the Community.
CVMP se je strinjal glede določitve usklajene karence, ki je zdaj sprejeta po vsej Skupnosti.
Topics included risk management strategies, pharmacovigilance and the implementation of the European telematics strategy.
Obravnavane teme so zajemale strategije obvladovanja tveganja, farmakovigilanco in izvajanje evropske telematske strategije.
CVMP rapporteurs, co-rapporteurs and EMEA project managers reported (in the joint EMEA/IFAHEurope survey on the centralised procedure) a much greater level of satisfaction with the quality of dossiers submitted than was reported in the previous survey, in which the outcome had already been regarded as very positive.
Poročevalci in soporočevalci CVMP ter projektni vodje EMEA so poročali (v skupni raziskavi EMEA/IFAH-Evropa o centraliziranem postopku) o precej večjem zadovoljstvu s kakovostjo predložene dokumentacije, kot je bilo to ocenjeno v preteklem poročilu, ki pa je tudi navajalo zelo pozitivne rezultate.
To prepare for these changes, the notification procedure was changed to take into account feedback received from parallel distributors.
Zaradi priprave na te spremembe je bil postopek obveščanja spremenjen tako, da se upoštevajo povratne informacije, prejete od vzporednih distributerjev.
The PSUR records all adverse drug reactions reported worldwide during a defined time interval, together with all other emerging information relevant to safety, including proposals for safety-related action, where necessary.
V PSUR so zabeleženi vsi neželeni učinki zdravil, prijavljeni po vsem svetu v določenem časovnem presledku, ter vse druge informacije, ki se pojavijo glede varnosti, vključno s predlogi za ukrepe v zvezi z varnostjo, kadar je treba.
Summary reports are published on the EMEA website within 14 days of publication in the Official Journal of a Commission Regulation amending the Annexes to Council Regulation (EEC) No 2377/90.
Povzetki poročil se objavijo na spletni strani EMEA v 14 dneh od objave Uredbe Komisije o spremembi prilog k Uredbi Sveta (EGS) št. 2377/90 v Uradnem listu.
Support to sponsors
Podpora sponzorjem
This is a shortfall of 3 in comparison with the forecast of 10 MRL applications, and means the number remains at the same level as in 2003.
To je 3 manj v primerjavi s predvidenimi 10 vlogami za MRL, kar pomeni, da je število ostalo na enaki ravni kot v letu 2003.
• The steady increase in the number of requests for scientific advice and protocol assistance reflects the efforts of the EMEA to encourage the systematic use of these procedures.
• Stalno naraščanje števila zahtevkov za znanstveno svetovanje in pomoč pri protokolu kaže prizadevanja EMEA, da bi spodbudila dosledno uporabo teh postopkov.
6.1 Administration
6.1 Administracija
Registration through the centralised procedure will be mandatory for these therapeutic areas from the end of 2005.
Od konca leta 2005 bo za ta terapevtska področja obvezna prijava prek centraliziranega postopka.
Chapter 1 sets out the activities of the EMEA within the European system.
Poglavje 1 obravnava dejavnosti EMEA v evropskem sistemu.
MRAs with Australia, New Zealand, Switzerland, Canada and Japan are currently operational, but with slightly different provisions as to scope and applicability.
Trenutno se izvajajo sporazumi za medsebojno priznavanje z Avstralijo, Novo Zelandijo, Kanado in Japonsko, ki pa imajo nekoliko drugačne določbe glede področja uporabe in veljavnosti.
Companies submitted 8 new applications for veterinary medicines in 2004, of which 4 were for immunologicals and 4 were for pharmaceuticals, including 1 generic.
Podjetja so v letu 2004 vložila 8 novih vlog za veterinarska zdravila, od katerih so bile štiri za imunološka zdravila in 4 za farmacevtske izdelke, vključno z 1 generičnim.
The CVMP took an average of 108 days for assessment of new MRLs.
CVMP je za vrednotenje novih MRL-jev potreboval povprečno 108 dni.
The collection and exchange of such information between marketing authorisation holders, sponsors of clinical trials and regulators allows rapid and appropriate responses to be made in order to afford the best protection to users of medicinal products.
Zbiranje in izmenjava takih informacij med imetniki dovoljenj za promet, sponzorji kliničnih preizkusov in zakonodajalci omogoča hiter in ustrezen odziv, s katerim naj bi se dosegla najboljša zaščita uporabnikov zdravil.
The new COMP members brought new expertise to the Committee in the areas of paediatrics, genetics and oncology.
Novi člani COMP so Odboru prispevali novo strokovno znanje na področju pediatrije, genetike in onkologije.
At an extraordinary meeting in December 2004, the CHMP concluded, on the basis of the available evidence, that there are public health concerns in relation to the safe use of these medicinal products in children and adolescents with depression, anxiety and related conditions, irrespective of the therapeutic indication.
CHMP je na izrednem zasedanju decembra 2004 na podlagi razpoložljivih dokazov sklenil, da so prisotna varnostna vprašanja glede javnega zdravja v zvezi z varno uporabo teh zdravil pri otrocih in mladostnikih z depresijo, strahom in podobnimi stanji ne glede na terapevtske indikacije.
In addition, the sector constantly introduces new services and improvements to the infrastructure as required from business and users alike, taking into account prevailing technological trends to ensure that infrastructure and facilities are moving with the times.
Poleg tega sektor stalno uvaja nove storitve in izboljšave v infrastrukturi, ki jih zahtevajo podjetja ali uporabniki, ob upoštevanju prevladujočih tehnoloških trendov, da bi zagotovil razvoj infrastrukture in opreme v skladu s splošnim napredkom.
1.4 European medicines network
1.4 Evropska mreža zdravil
A training tender was concluded which put framework contracts in place for future training needs.
Opravljen je bil razpis za usposabljanje, s katerim so bile pripravljene okvirne pogodbe za prihodnje potrebe po usposabljanju.
After a one-year period of implementation, changes have been introduced to the pilot procedure for follow-up of test results to streamline the reporting structures.
Po enem letu izvajanja so bile v pilotnem postopku opravljene spremembe glede naknadnih ukrepov pri rezultatih preizkušanja, da bi se racionalizirale strukture poročanja.
Recruitment planning was put in place so that units can better plan recruitment needs and to enable more efficient organisation of selection procedures.
Uvedeno je bilo zaposlitveno načrtovanje, da bi lahko enote bolje načrtovale potrebe po novih kadrih in da bi se učinkoviteje organizirali postopki izbire.
In 2004, the Board approved the revised rules on access to EMEA documents and the EMEA Code of Conduct, which are binding on all who participate in the work of the Agency.
V letu 2004 je odbor odobril revidirane predpise o dostopu do dokumentov EMEA in Kodeks ravnanja EMEA, ki so zavezujoči za vse sodelujoče pri delu Agencije.
EMEA general information service:
Služba EMEA za splošne informacije:
The revised EudraVigilance Veterinary test system was available from early September 2004, with the production system becoming available on 18 October 2004 well before 1 January 2005, the date for implementation of electronic reporting agreed with the Member States Heads of Veterinary Regulatory Authorities.
Revidiran sistem preizkušanja EudraVigilance za veterino je bil na voljo od začetka septembra 2004, sistem proizvodnje pa je bil dostopen od 18. oktobra 2004, kar je dovolj zgodaj pred 1. januarjem 2005, ko naj bi se uvedlo elektronsko poročanje, o katerem je bil sklenjen dogovor z vodji veterinarskih regulativnih organov držav članic.
Firstly, the conclusion and implementation of a confidentiality arrangement with the US Food and Drug Administration (FDA) creates enhanced cooperation between the two agencies, particularly on the provision of parallel scientific advice to companies developing new medicines.
Prvič, sklenitev in izvedba dogovora o zaupnosti z Upravo ZDA za hrano in zdravila (FDA) sta okrepili sodelovanje med agencijama, zlasti pri zagotavljanju vzporednega znanstvenega svetovanja podjetjem, ki razvijajo nova zdravila.
In 2004, work continued towards establishing common costing methodologies for calculating the cost of scientific services provided by the national competent authorities to the EMEA.
V letu 2004 so se nadaljevala prizadevanja za določitev skupnih metodologij za izračun stroškov znanstvenih storitev, ki jih EMEA zagotavljajo pristojni nacionalni organi.
Version 2.1.1 adopted in July 2004
Različica 2.1.1 sprejeta julija 2004
The average duration of the procedures was 86 days in 2004.
Postopki so v letu 2004 povprečno trajali 86 dni.
Greater collaboration with non-EU authorities and increased dialogue with health organisations, academia and learned societies should facilitate a consistent regulatory approach for new technologies.
Tesnejše sodelovanje z organi, ki niso iz EU, in okrepljen dialog z zdravstvenimi organizacijami, akademskim krogom in znanstvenimi združenji naj bi omogočila skladen regulativni pristop glede novih tehnologij.
Arbitration procedures are initiated because of disagreement between Member States in the framework of the mutual recognition procedure (Article 33 of Directive 2001/82/EC).
Arbitražni postopki se uvedejo zaradi spora med državami članicami v okviru postopka medsebojnega priznavanja (člen 33 Direktive 2001/82/ES).
Following this, the EMEA decided to expedite the review of COX-2 inhibitors in the context of the ongoing procedure.
Na podlagi tega je EMEA sklenila pospešiti revizijo inhibitorjev COX-2 v okviru postopka, ki trenutno poteka.
Blood and blood-forming organs
Kri in organi za tvorbo krvi
This means that the collection, testing, storage and transportation of human plasma are major factors in the quality assurance of the manufacture of plasma-derived products.
To pomeni, da so zbiranje, testiranje, shranjevanje in prevoz človeške plazme pomembni dejavniki zagotavljanja kakovosti pri proizvodnji izdelkov iz plazme.
Integration of the new EU Member States
Vključitev novih držav članic EU
The operational and technical work of the EMEA is reported in Chapter 2 on medicines for human use, Chapter 3 on veterinary medicines and Chapter 4 on inspection activities.
Operativne in tehnične dejavnosti EMEA so predstavljene v poglavju 2 o zdravilih za uporabo v humani medicini, poglavju 3 o veterinarskih zdravilih in poglavju 4 o dejavnostih inšpekcijskega nadzora.
Operational since 29 May 2004
Izvaja se od 29. maja 2004
• A test implementation of an eCTD review system across the EU regulatory community for pharmaceuticals resulted in a decision to extend the requirements-gathering phase by a further 12 months
• rezultat poskusnega izvajanja sistema revizije eCTD po vsej regulativni skupnosti EU za farmacevtske izdelke je bila odločitev, da se faza zbiranja zahtev podaljša za 12 mesecev
It provides for the extension of marketing authorisations granted by one Member State to one or more other Member States identified by the applicant.
Ta postopek predvideva razširitev dovoljenj za promet z zdravili, ki jih izda ena država članica, na eno ali več drugih držav članic, ki jih določi vlagatelj.
Sampling from the market in different countries is carried out by national inspectorates and testing is performed by Official Medicines Control Laboratories coordinated through the EDQM (European Directorate for the Quality of Medicines).
Vzorčenje na trgu v različnih državah izvajajo nacionalni inšpektorati, preizkušanje pa izvajajo uradni laboratoriji za nadzor zdravil, ki jih usklajuje EDQM (Evropski direktorat za kakovost zdravil).
Product defects and deviations
Pomanjkljivosti in odstopanja pri izdelkih
• The contract for building the Product Information Management (PIM) system was placed following completion of a specification exercise
• pogodba za izgradnjo sistema upravljanja informacij o izdelkih (Product Information Management, PIM) je bila sklenjena po zaključku specifikacij
Following the positive outcome of this initial trial, a formal pilot phase will be starting in January 2005, as outlined in the document jointly agreed during the EMEA and FDA bilateral meeting on 17 September 2004.
Po uspešnih rezultatih tega začetnega preizkusa se bo januarja 2005 začela izvajati formalna pilotna faza, kot je opisana v dokumentu, o katerem sta se EMEA in FDA dogovorili na dvostranskem sestanku 17. septembra 2004.
EMEA guidelines in 2004
Smernice EMEA v letu 2004
The Board discussed matters relating to the new pharmaceutical legislation and its impact on the role and operations of the Agency, as well as the European Medicines Agency Road Map to 2010 longterm strategy.
Odbor je razpravljal o vprašanjih, povezanih z novo farmacevtsko zakonodajo in njenim vplivom na vlogo in delovanje Agencije, ter o dolgoročni strategiji "Usmeritvenega načrta Evropske agencije za zdravila do leta 2010".
The EU s revised pharmaceutical legislation and the expansion of the total number of Member States to 25 brought about changes to the composition of the Management Board.
Spremenjena farmacevtska zakonodaja EU in povečanje števila držav članic na skupaj 25 držav sta spremenili sestavo upravnega odbora.
The Committee now has one member from each of the 25 EU Member States and one member each from Iceland and Norway.
Odbor ima zdaj po enega člana iz vsake od 25 držav članic EU in po enega člana iz Islandije in Norveške.
In June 2003, the European pharmaceutical law introduced a legal framework for marketing authorisations for products similar to biological products that were already authorised so-called biosimilar products.
Junija 2003 je evropska farmacevtska zakonodaja uvedla pravni okvir za dovoljenja za promet z zdravili za tako imenovane biološko podobne izdelke, to je izdelke, ki so biološko podobni izdelkom, za katere je že izdano dovoljenje za promet.
The other referral concerned the veterinary medicinal product Micotil 300 (tilmicosin).
Druga predložitev je bila v zvezi z veterinarskim zdravilom Micotil 300 (tilmikozin).
The new EU pharmaceutical legislation gives the Agency a greater mandate for the provision of information to patients and healthcare professionals.
Nova farmacevtska zakonodaja EU Agenciji daje več pooblastil za zagotavljanje informacij bolnikom in zdravstvenim strokovnjakom.
The CVMP adopted 10 positive opinions for veterinary medicines, including 8 vaccines.
CVMP je sprejel 10 pozitivnih mnenj za veterinarska zdravila, ki zajemajo 8 cepiv.
Mutual recognition agreements (MRAs) between the European Community (EC) and partner (third) countries include specific annexes regarding medicinal products and GMP.
Sporazumi o medsebojnem priznavanju (mutual recognition agreements, MRA) med Evropsko skupnostjo (ES) in partnerskimi (tretjimi) državami zajemajo posebna dopolnila o zdravilih in dobri proizvodni praksi.
The code ensures that a consistent standard of professional conduct applies to all parties associated with the EMEA s work and responsibilities.
Kodeks zagotavlja, da standard poklicnega ravnanja velja dosledno za vse strani, ki so povezane z delom in odgovornostmi EMEA.
There has been an increase in the number of applications during each of the past five years.
Število vlog se je povečalo v vsakem od preteklih pet let.
• Change to the name of the Agency: The EMEA changed its official title from European Agency for the Evaluation of Medicinal Products to European Medicines Agency
• spremembo imena agencije: EMEA je spremenila svoj uradni naziv iz "Evropska agencija za vrednotenje zdravil" v "Evropska agencija za zdravila";
• The first steps in the review of the sampling and testing programme were agreed, including revised objectives for the programme, principles for new testing arrangements, and greater transparency measures.
• Dogovorjeni so bili prvi ukrepi za revizijo programa vzorčenja in preizkušanja vključno z revizijo ciljev programa, načeli za nove ureditve preizkušanja in ukrepi za večjo preglednost.
• Implementation of the new staff regulations
• izvajanje novih kadrovskih predpisov
Final appropriations for the 2004 budget.
Končna proračunska sredstva za leto 2004.
The resulting long-term strategy is one that takes a realistic view of the challenges facing the Agency and the EU regulatory system as a whole, while offering viable proposals as to how those challenges can be met.
Na tej podlagi oblikovana dolgoročna strategija ima stvaren odnos do izzivov, s katerimi se srečujeta Agencija in tudi celoten regulativni sistem EU, hkrati pa za njihovo izpolnitev ponuja izvedljive predloge.
3.9 Management and organisation of the CVMP
3.9 Upravljanje in organizacija CVMP
Every holder of a manufacturing authorisation is required to implement an effective procedure for the recall of defective products.
Vsak imetnik dovoljenja za promet mora izvesti učinkovit postopek za umik pomanjkljivih izdelkov.
In some cases where the applicant has been unable to address these questions and the dossier was heading for a negative opinion, this has led to the withdrawal of the application.
V nekaterih primerih, ko vlagatelj ni mogel obravnavati teh vprašanj in je kazalo, da bo za dokumentacijo sprejeto negativno mnenje, je bila vloga umaknjena.
Scientific advice (n=48)
Znanstveno svetovanje (n=48)
The EMEA participated in all meetings of the Heads of Medicines Agencies organised during the Irish and Dutch EU presidencies in 2004.
EMEA se je udeležila vseh sestankov vodij agencij za zdravila, ki so bili organizirani med irskim in nizozemskim predsedstvom v letu 2004.