natgillin/translations-raw huggingface dataset:
5.3 Sampling and testing 
5.3 Vzorčenje in preizkušanje
Finally, in view of the next phase of EU enlargement, the EMEA completed preparations for pre-accession linguistic check activities for Bulgaria and Romania, to be launched in January 2006. 
Končno, v luči nove faze širitve EU je EMEA zaključila priprave za predpristopne dejavnosti jezikovnega preverjanja za Bolgarijo in Romunijo, ki se bodo začele januarja 2006.
In years to come, the EMEA will need further top-quality expertise and will be increasingly reliant on the Member States and their authorities to offer this. 
V prihodnjih letih bo EMEA potrebovala dodatno vrhunsko strokovno znanje in izkušnje ter se bo za zagotovitev tega vse bolj zanašala na države članice in njihove organe.
2 IMPLEMENTATION OF THE ROAD MAP 
2 IZVAJANJE USMERITVENEGA NAČRTA ("ROAD MAP")
13 EU TELEMATICS STRATEGY AND INFORMATION TECHNOLOGY 
13 TELEMATSKA STRATEGIJA EU IN INFORMACIJSKA TEHNOLOGIJA
The results presented in this Annual Report prove that the EMEA ably faced up to its many challenges in 2005. 
Rezultati, predstavljeni v tem letnem poročilu, dokazujejo, da se je EMEA primerno spoprijela s številnimi izzivi v letu 2005.
The 11th year of operation of the European Medicines Agency (EMEA) was eventful. 
Enajsto leto delovanja Evropske agencije za zdravila (EMEA) je bilo polno dogodkov.
A number of meetings were held with companies ahead of possible future applications. 
Pred možnimi prihodnjimi uporabami so bili organizirani številni sestanki s podjetji.
Electronic reporting of adverse reactions is now mandatory. 
Elektronsko poročanje o neželenih učinkih je sedaj obvezno.
The list was submitted to the Commission in May 2005 to serve as basis for a list of essential substances, which is provided for by the new legislation . 
Seznam je bil predložen Komisiji maja 2005 in bo podlaga za seznam bistvenih snovi, ki ga določa nova zakonodaja.
The Agency contributed to the development of a proposed regulation on advanced therapies. 
Agencija je prispevala k razvoju predlagane uredbe o naprednih zdravljenjih.
A further 15 applications were withdrawn prior to opinion. 
Nadaljnjih 15 vlog je bilo umaknjenih, preden je bilo mnenje sprejeto.
The extrapolations are carried out without specific applications or payment of fees, provided the criteria detailed in the relevant CVMP guideline are met, thus ensuring consumer safety. 
Ekstrapolacije se izvajajo brez posebnih vlog ali plačila pristojbin, če so izpolnjena merila iz ustreznih smernic CVMP in je tako zagotovljena varnost potrošnika.
Strengthening interaction with patients' and consumers' organisations 
krepitvijo sodelovanja z organizacijami bolnikov in potrošnikov;
14 MANAGING THE AGENCY 
14 UPRAVLJANJE AGENCIJE
It began with celebrations to mark an important milestone in the history of the EMEA: its tenth anniversary. 
Začelo se je s praznovanjem v čast pomembnemu mejniku v zgodovini Agencije: njeni deseti obletnici.
While the majority of these concerned new pharmaceutical forms, 2 concerned new target species. 
Medtem ko se jih je večina nanašala na nove farmacevtske oblike, sta 2 zadevali nove ciljne vrste.
This development will greatly enhance the ability of the EMEA to evaluate the safety of medicines. 
Ta razvoj bo bistveno okrepil sposobnost EMEA za vrednotenje varnosti zdravil.
The year 2005 was the first full year of operation of the Committee on Herbal Medicinal Products (HMPC), following its inaugural meeting in September 2004. 
Leto 2005 je bilo prvo polno leto delovanja Odbora za zdravila rastlinskega izvora (HMPC) po njegovem ustanovitvenem zasedanju septembra 2004.
In 2005, the Agency discussed implementation plans for electronic reporting with major partners in the veterinary pharmaceutical industry. 
V letu 2005 je Agencija razpravljala o izvedbenih načrtih za elektronsko poročanje s pomembnejšimi partnerji v veterinarski farmacevtski industriji.
A total of 34,352 ICSRs relating to SUSARs were received. 
Prejetih je bilo skupaj 34.352 ICSR-jev, ki so se nanašali na SUSAR-je.
The strategy includes earlier and more frequent involvement of experts particularly on rare diseases and new therapies. 
Strategija vključuje zgodnejše in pogostejše vključevanje strokovnjakov, zlasti v zvezi z redkimi boleznimi in novimi zdravljenji.
Thomas Lönngren was unanimously appointed by the Management Board to serve in this demanding post for another five-year period, from 2006 to 2010. 
Upravni odbor je soglasno imenoval Thomasa Lönngrena na to zahtevno delovno mesto za nadaljnje petletno obdobje, od leta 2006 do leta 2010.
5 INSPECTIONS 
5 INŠPEKCIJSKI NADZOR
Strengthening the EU pharmacovigilance system to make the best use of the scientific resources and expertise available at EU level. 
krepitvijo sistema farmakovigilance EU za čim boljšo uporabo znanstvenih virov in strokovnega znanja ter izkušenj, ki so na razpolago na ravni EU.
This policy put in place a framework for the checking of translations of product information by the national competent authorities, and set up a financial compensation scheme. 
Ta politika je vzpostavila okvir za preverjanje prevodov informacij o izdelkih s strani pristojnih nacionalnih organov in oblikovala program finančnih nadomestil.
A reflection paper to highlight patients' benefits in this new area was issued. 
Objavljen je bil preučitveni dokument za izpostavitev koristi za bolnike na tem novem področju.
New medicinal products (non-orphan) Orphan medicinal products Similar biological products 
Nova zdravila (ki niso zdravila sirote) Zdravila sirote Biološko podobni izdelki
The Agency was given responsibility for implementing the EU telematics strategy agreed by the European Commission, Member States and the EMEA. 
Agenciji je bila zaupana odgovornost za izvajanje telematske strategije EU, o kateri so se dogovorile Evropska komisija, države članice in EMEA.
At the same time, it provides new tools for strengthened protection of public health. 
Uredba hkrati zagotavlja nova orodja za okrepljeno varstvo javnega zdravja.
Electronic reporting into the EudraVigilance database became mandatory in November 2005. 
Elektronsko poročanje v zbirko podatkov EudraVigilance je postalo obvezno novembra 2005.
The information updates published on the EMEA website relating to these issues have been acclaimed as extremely useful. 
Posodobljene informacije o teh vprašanjih, ki se objavljajo na spletni strani EMEA, so bile ocenjene kot zelo uporabne.
In addition, I would like to thank the Member States' competent authorities, which, together with the EMEA, form the core regulatory network for medicinal products. 
Poleg tega se želim zahvaliti pristojnim organom držav članic, ki skupaj z EMEA sestavljajo temeljni regulativni okvir za zdravila.
The EMEA will be involved in the issues of relative effectiveness and provision of information to patients. 
EMEA bo sodelovala pri vprašanjih relativne učinkovitosti in zagotavljanja informacij bolnikom.
To further improve the management of translations, the Management Board adopted a revised EMEA translation policy in September 2005. 
Za nadaljnje izboljšanje upravljanja prevodov je upravni odbor septembra 2005 sprejel revidirano prevajalsko politiko EMEA.
Pandemic influenza preparedness 
Pripravljenost na pandemijo influence
Following the entry into force of new ‘Regulations and Rules applicable to officials and other servants of the European Communities', the EMEA prepared a series of implementing rules for adoption by the Management Board. 
Po začetku veljavnosti novih "predpisov in pravil za uradnike in druge uslužbence Evropskih skupnosti" je EMEA pripravila vrsto izvedbenih pravil, ki jih sprejme upravni odbor.
This led to a doubling of parallel distribution notifications submitted to the EMEA in 2005. 
To je pripeljalo do podvojitve števila obvestil o vzporedni distribuciji, predloženih EMEA v letu 2005.
The overall volume of pre- and post-authorisation applications received was high, but the Agency was able to handle its tasks successfully. 
Skupno število prejetih vlog pred in po izdaji dovoljenja za promet je bilo visoko, vendar je Agencija zmogla uspešno opraviti svoje naloge.
The group will provide progress reports to the EMEA Management Board and to the group of heads of national medicines agencies. 
Skupina bo poslala poročila o napredku upravnemu odboru EMEA in skupini vodij nacionalnih agencij za zdravila.
The Agency also developed guidelines and concept papers designed to improve the consistency of safety data assessments. 
Agencija je razvila tudi smernice in konceptualne dokumente za izboljšanje skladnosti presoj podatkov o varnosti.
Together with this key document, a further 6 draft guidelines on specific types of products were released for consultation in the first half of the year. 
Skupaj s tem ključnim dokumentom je bilo v prvi polovici leta za namene posvetovanja objavljenih 6 osnutkov smernic o posebnih vrstah izdelkov.
The Management Board has been closely following the progress of the European innovation and technology platform, especially in the area of veterinary medicines. 
Upravni odbor budno spremlja napredek evropske platforme za inovacije in tehnologijo, zlasti na področju veterinarskih zdravil.
The number of issued certificates continued to increase, and certificate number 100,000 was issued (for an AIDS product) in August 2005. 
Število izdanih potrdil še naprej narašča, avgusta 2005 pa je bilo izdano potrdilo številka 100.000 (za izdelek za AIDS).
In 2005 this included the annual management review, which aims to ensure that management tools are effective and suitable in relation to the Agency's needs, and a self-assessment carried out in the context of the EU benchmarking system in order to improve the EMEA management system. 
V letu 2005 je to vključevalo letni pregled upravljanja, katerega cilj je zagotoviti, da so orodja upravljanja učinkovita in primerna za potrebe Agencije, ter samoocenjevanje, ki je bilo opravljeno v okviru sistema primerjalnih analiz EU za izboljšanje sistema upravljanja EMEA.
Strengthening the Agency's interaction with European industry associations representing the innovative, generic and self-medication industries 
krepitvijo sodelovanja Agencije z evropskimi panožnimi združenji, ki zastopajo inovativno in generično industrijo in industrijo samozdravil;
5.2 Product defects and deviations 
5.2 Pomanjkljivosti in odstopanja pri proizvodih
I am particularly grateful for the excellent participation of our partners from the new Member States, in what was the first full year of operation in a European Union of 25 nations. 
Posebno zahvalo sem dolžan našim partnerjem iz novih držav članic za njihovo izjemno sodelovanje pri dejavnostih Agencije v prvem celem letu, ko Evropsko unijo sestavlja 25 narodov.
The first submission of a core dossier was made in December 2005, and discussions on a number of other submissions were under way at the year's end. 
Prva predložitev temeljne dokumentacije je bila opravljena decembra 2005, na koncu leta pa so potekale razprave o številnih drugih predložitvah.
In addition, 67 sponsors conducting clinical trials within the European Economic Area (EEA) were reporting suspected unexpected serious adverse reactions (SUSARs) to the EudraVigilance Clinical Trial Module (EVCTM). 
Poleg tega je 67 sponzorjev, ki so izvajali klinična preizkušanja znotraj evropskega gospodarskega prostora (EGP), poročalo o sumih na resne nepričakovane neželene učinke (suspected unexpected serious adverse reactions - SUSAR) v modul kliničnih preizkušanj EudraVigilance (EudraVigilance Clinical Trial Module - EVCTM).
An action plan to further progress the European risk management strategy (ERMS) was published in May 2005, covering a number of key aspects including: 
Maja 2005 je bil objavljen akcijski načrt za nadaljnji razvoj evropske strategije obvladovanja tveganja (ERMS), ki zajema številne ključne vidike, vključno z:
To address the specific needs of smaller companies, an additional, simple electronic reporting form was developed for use at Member State level by smaller marketing authorisation holders. 
Za obravnavanje posebnih potreb manjših podjetij je bil razvit dodaten enostaven elektronski obrazec za poročanje, ki ga bodo na ravni držav članic uporabljali manjši imetniki dovoljenj za promet z zdravilom.
Improvements to scientific and other business practices helped the Agency to deliver very good performance results for the year. 
Izboljšave v znanstveni in poslovni praksi so pripomogle k temu, da se Agencija v tem letu lahko pohvali z zelo dobrimi rezultati.
An important step forward was made in improving the usability of data relating to the safety of medicines. 
Pomemben korak naprej je bil narejen v zvezi z izboljšanjem uporabnosti podatkov, ki se nanašajo na varnost zdravil.
By the end of 2005, the majority of EU Member States were reporting electronically to the EudraVigilance Veterinary database, launched in October 2004; the remaining Member States are set to follow suit shortly. 
Do konca leta 2005 je večina držav članic EU elektronsko poročala v zbirko veterinarskih podatkov EudraVigilance, ki je bila vzpostavljena oktobra 2004; preostale države članice naj bi tej praksi sledile v kratkem.
The training profiles aim for a continuous system of competence development and help to identify outstanding training needs. 
Namen profilov usposabljanja je ustaljen sistem razvoja pristojnosti in pomoč pri opredelitvi izjemnih potreb po usposabljanju.
The majority of results show that the products were of high quality and complied with their specifications. 
Večina rezultatov kaže, da je bila kakovost izdelkov boljša in da so bili izdelki skladni s svojimi specifikacijami.
A new strategy for providing scientific advice 
Nova strategija zagotavljanja znanstvenega svetovanja
The plans will allow the proactive implementation of risk minimisation measures and other pharmacovigilance activities. 
Načrti bodo omogočili proaktivno izvajanje ukrepov za zmanjšanje tveganja in drugih dejavnosti farmakovigilance.
Scientific advice activities increased significantly in 2005: 10 requests for scientific advice were received. 
Dejavnosti znanstvenega svetovanja so se v letu 2005 bistveno povečale: prejetih je bilo 10 zahtevkov za znanstveno svetovanje.
The implementation of the new pharmaceutical legislation was a success thanks to the joint efforts of the EMEA, its scientific committees and their working parties, the national competent authorities and 
Izvajanje nove farmacevtske zakonodaje je bilo uspešno zaradi skupnih prizadevanj EMEA, njenih znanstvenih odborov in njihovih delovnih skupin, nacionalnih pristojnih organov, Evropske komisije
The incentives offered by the SME Regulation apply equally to the human and veterinary sectors, and include: 
Spodbude, ki jih zagotavlja Uredba MSP, se nanašajo na sektorje za humano in veterinarsko medicino ter vključujejo:
Other 
a
In addition to its own internal activities, the EMEA also cooperated in 2005 with the European Commission Directorate-General for Research in the context of the ‘Innovative Medicines Initiative' of the 7th Framework Programme for research, technological development and demonstration activities (2007-2013). 
Poleg svojih notranjih dejavnosti je EMEA v letu 2005 sodelovala z Generalnim direktoratom za raziskave Evropske komisije v okviru "pobude za inovativna zdravila" 7. okvirnega programa za raziskave, tehnološki razvoj in predstavitvene dejavnosti (2007-2013).
The Agency made good progress with national competent authorities in further developing and implementing the 2003 European risk management strategy (ERMS) that looks at how to better identify and manage safety issues. 
Agencija je dosegla dober napredek v sodelovanju s pristojnimi nacionalnimi organi pri nadaljnjem razvoju in izvajanju evropske strategije obvladovanja tveganja (European risk management strategyERMS) iz leta 2003, ki obravnava načine za boljšo opredelitev in obvladovanje vprašanj varnosti.
Work began in 2005 on implementing this new provision, which will require plans to identify any known or potential risks associated with the medicinal product concerned. 
V letu 2005 se je začelo delo v zvezi z izvajanjem te nove določbe, ki bo zahtevala načrte za opredelitev vseh znanih in možnih tveganj, povezanih z zadevnim zdravilom.
All of these achievements in 2005 would not have been possible without the dedicated cooperation and support the Agency received from the European Parliament, the European Commission, the national medicines authorities and all of the Agency's partners throughout Europe, all of whom I thank for their invaluable help. 
Vsi ti dosežki v letu 2005 pa ne bili možni brez naklonjenega sodelovanja in podpore, ki jo je Agencija dobivala od Evropskega parlamenta, Evropske komisije, nacionalnih organov, pristojnih za zdravila, ter vseh partnerjev širom po Evropi.
In addition, there were 74 type-II variations relating to special warnings and precautions for use. 
Poleg tega se je 74 sprememb tipa II nanašalo na posebna opozorila in previdnostne ukrepe za uporabo.
The majority of applications concerned medicinal products for single, companion-animal species (dogs or cats only); 1 was for dogs, cats and horses; 1 was for use in food-producing animals (pigs). 
Večina vlog je zadevala zdravila za eno samo hišno živalsko vrsto (samo pse ali mačke); 1 vloga je bila za pse, mačke in konje; 1 je bila vložena za uporabo pri živalih, namenjenih proizvodnji hrane (prašiče).
the introduction of new measures to accelerate the assessment of medicines that are of critical importance to public health. 
uvajanje novih ukrepov za pospeševanje ocenjevanja zdravil, ki so izjemnega pomena za javno zdravje.
Of these 24 products, 3 are designated orphan medicinal products. 
Od teh 24 izdelkov so 3 zdravila določena za zdravila sirote.
At the end of 2005, the European Commission set up the Pharmaceutical Forum, a discussion platform for topics like pricing and reimbursement of medicines, relative effectiveness of medicinal products and drug information in Europe. 
Konec leta 2005 je Evropska komisija ustanovila farmacevtski forum, platformo za razpravljanje o temah, kot so oblikovanje cen in povračilo stroškov zdravil, relativna učinkovitost zdravil in informacije o drogah v Evropi.
Initiatives in the areas of risk detection, risk assessment, risk minimisation and risk communication 
pobudami na področju odkrivanja tveganj, ocene tveganj, zmanjšanja tveganj in obveščanja o tveganjih;
Of these, 305 reports related to suspected adverse reactions in animals, with a single report relating to one or more animals. 
Od tega se je 305 poročil nanašalo na sume na neželene učinke pri živalih, pri čemer je eno samo poročilo zadevalo eno ali več živali.
The EMEA will assume an active role in precautionary measures against pandemic influenza. 
EMEA bo prevzela dejavno vlogo na področju previdnostnih ukrepov za preprečevanje pandemije influence.
Working together with the CHMP, Scientific Advice Working Party and interested parties, the Executive Director proposed a new strategy and procedure, for which a 2-month public consultation exercise was launched in September 2005. 
V sodelovanju s CHMP, delovno skupino za znanstveno svetovanje in zainteresiranimi stranmi, je izvršni direktor predlagal novo strategijo in postopek, za katera se je septembra 2005 začelo dvomesečno javno posvetovanje.
The first production version the Community database for medicinal products was delivered in line with the planned specifications and made available to regulatory authorities. 
Prva proizvodna različica zbirke podatkov Skupnosti za zdravila je bila zagotovljena v skladu z načrtovanimi specifikacijami in dana na razpolago regulativnim organom.
The Agency established a EudraVigilance Steering Committee, which defines policies of implementation and access to EudraVigilance, and a EudraVigilance Expert Working Group, addressing all practical and operational aspects of implementation involving all stakeholders. 
Agencija je ustanovila usmerjevalni odbor EudraVigilance, ki določa politiko izvajanja in dostop do EudraVigilance, ter strokovno delovno skupino EudraVigilance, ki obravnava vse praktične in operativne vidike izvajanja in vključuje vse zainteresirane strani.
Developing a European Risk Management Strategy (ERMS) for safer medicines 
razvojem evropske strategije obvladovanja tveganja (European Risk Management StrategyERMS) za varnejša zdravila;
the implementation of procedures for greater (and in some cases free) provision of early-stage scientific advice to companies developing ‘breakthrough' medicines; 
izvajanje postopkov za obširnejše (in v nekaterih primerih brezplačno) zagotavljanje znanstvenega svetovanja že v začetnih fazah podjetjem, ki razvijajo 'revolucionarna' zdravila;
Because of this unexpected important increase in workload, delays in the procedure were encountered during 2005, but, due to a temporary increase in staff and improved efficiency of the process, the delays were partially reduced by the end of the year. 
Zaradi tega nepričakovanega pomembnega povečanja delovne obremenitve je v letu 2005 prihajalo do zamud pri postopkih, vendar so bile te zamude do konca leta delno zmanjšane zaradi začasnega povečanja števila osebja in izboljšane učinkovitosti procesa.
A number of important actions were carried out, aimed at improving electronic reporting of post-authorisation safety information, improving the exchange of safety information within the EU, and ensuring adequate surveillance and harmonised action. 
Izvedeni so bili številni pomembni ukrepi, katerih cilj je bil izboljšanje elektronskega poročanja informacij o varnosti po izdaji dovoljenja, izboljšanje izmenjave informacij o varnosti znotraj EU ter zagotavljanje ustreznega nadzora in usklajenih ukrepov.
An important new task of the revised legislation is the provision of assistance to small and mediumsized enterprises (SMEs) involved in the development of pharmaceuticals in the European Union. 
Pomembna naloga revidirane zakonodaje je zagotavljanje pomoči malim in srednje velikim podjetjem (MSP), ki so vključena v razvoj farmacevtskih izdelkov v Evropski uniji.
Herbal medicinal products entered into the Community list fulfil certain criteria, such as having been in medicinal use for a sufficiently long time, and are considered not to be harmful under normal conditions of use. 
Zdravila rastlinskega izvora, ki so vključena v seznam Skupnosti, izpolnjujejo določene kriterije, na primer, da so se dovolj dolgo uporabljala v zdravstvene namene in da niso škodljiva pod normalnimi pogoji uporabe.
Road Map actions implemented during 2005 related to: 
Ukrepi iz usmeritvenega načrta, ki so se izvajali v letu 2005, so bili povezani s:
Extensions of use for children: 4 products had their use extended to include the treatment of children. 
Razširitve uporabe za vključitev populacij otrok: 4 izdelkom se je razširila uporaba z namenom vključitve zdravljenja otrok.
Preparatory work for implementation of the future regulation on medicinal products for paediatric use was initiated in conjunction with the CHMP Paediatric Working Party. 
Začelo se je pripravljalno delo za izvajanje prihodnje uredbe o zdravilih za pediatrično uporabo v povezavi z delovno skupino za pediatrijo CHMP.
Good progress with EudraVigilance 
Dober napredek v zvezi z EudraVigilance
It significantly extends the scope of the centralised procedure for medicines for human use, giving the Agency responsibility for the evaluation and supervision of: 
Uredba bistveno razširja obseg centraliziranega postopka za zdravila za uporabo v humani medicini in Agenciji nalaga odgovornost za vrednotenje in nadzor nad:
A survey of SMEs was carried out in 2005 to understand their specific needs and expectations, and a first meeting with SME stakeholder organisations was held to discuss the results. 
V letu 2005 je bila opravljena raziskava malih in srednje velikih podjetij za pridobitev vpogleda v njihove posebne potrebe in pričakovanja, organiziran pa je bil tudi prvi sestanek z zainteresiranimi organizacijami malih in srednje velikih podjetij, na katerem se je razpravljalo o rezultatih raziskave.