natgillin/translations-raw huggingface dataset:
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.
The majority of recalls (14) were classified as ‘Class 3' recalls, which are not associated with serious public health hazards.
Večina umikov (14) je bila razvrščena kot umiki "3. razreda", ki niso povezani z resnimi nevarnostmi za zdravje ljudi.
Strengthened procedures for detection of pharmacovigilance signals
Okrepljeni postopki za odkrivanje signalov farmakovigilance
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 ter sta povezana v integriran sistem upravljanja v EMEA.
The strategy aims to contribute to better protection and promotion of public and animal health, to improve the regulatory environment for medicinal products, and to stimulate innovation, research and development in the EU.
Cilj strategije je prispevati k boljši zaščiti in spodbujanju zdravja ljudi in živali, izboljšati regulativno okolje za zdravila in spodbujati inovacije, raziskave in razvoj v EU.
Fee reductions for scientific advice, inspections and (for veterinary medicines) establishment of maximum residue limits
znižanja pristojbin za znanstveno svetovanje, inšpekcijske preglede in (za veterinarska zdravila) opredelitev mejnih vrednosti ostankov;
The first production version of the product information management (PIM) review system for regulatory authorities and the first production version of the PIM light-authoring tool for applicants were ready, enabling formal delivery very early in 2006.
Pripravljeni sta bili prva proizvodna različica presoje sistema upravljanja informacij o izdelkih (product information management - PIM) za regulativne organe in prva proizvodna različica orodja Light-Authoring PIM za vlagatelje, kar je omogočilo uradno dostavo že zelo zgodaj v letu 2006.
The Committee for Orphan Medicinal Products (COMP) adopted 88 positive opinions on designation of orphan medicines in 2005 - the highest number since the entry into force of EU legislation on orphan medicines (Regulation (EC) No 141/2000) in 2000.
Odbor za zdravila sirote (COMP) je v letu 2005 sprejel 88 pozitivnih mnenj o določitvi zdravila kot zdravila sirote - to je najvišje število pozitivnih mnenj, sprejetih od začetka veljavnosti EU zakonodaje v zvezi z zdravili sirotami (Uredba (ES) št. 141/2000) leta 2000.
This European approach uses a ‘core dossier' that allows the completion of the evaluation and approval of an application based on a mock-up vaccine (with an influenza virus strain similar to the pandemic strain) before the outbreak of a pandemic.
Ta evropski pristop uporablja "temeljno dokumentacijo", ki omogoča vrednotenje in odobritev vloge na podlagi modela cepiva (s sevom virusa influence, ki je podoben pandemičnemu sevu) pred izbruhom pandemije.
One application was withdrawn prior to opinion.
Ena vloga je bila umaknjena pred sprejetjem mnenja.
Taking into account the greater scientific role of the Agency, stemming from the revised EU pharmaceutical legislation and the Road Map, the Agency started the implementation of training profiles for all EMEA staff.
Ob upoštevanju večje znanstvene vloge Agencije, ki izhaja iz revidirane farmacevtske zakonodaje EU in usmeritvenega načrta, je Agencija začela izvajati profile usposabljanja za vse osebje EMEA.
The Agency is involved in the steering group of the platform, and there are therefore good opportunities to influence and improve the development and availability of veterinary medicines.
Agencija sodeluje v usmerjevalni skupini platforme, zato ima veliko možnosti za vplivanje in krepitev razvoja in razpoložljivosti veterinarskih zdravil.
Pharmacovigilance in the veterinary sector was a top priority for the EMEA in 2005.
Farmakovigilanca v veterinarskem sektorju je bila najpomembnejša prednostna naloga EMEA v letu 2005.
The Agency made continuous improvements to its processes and interfaces with partners in the European network and ensures the logistics of the benchmarking of medicines agencies of 28 EU/EEA countries.
Agencija je izvedla številne izboljšave svojih procesov in vmesnikov s partnerji v evropski mreži ter zagotavljala logistiko za primerjalne analize agencij za zdravila za 28 držav članic EU/EGP.
In the beginning of 2005, the Agency published its long-term strategy, the ‘European Medicines Agency Road Map to 2010: Preparing the Ground for the Future'.
EMEA je na začetku leta 2005 objavila svojo dolgoročno strategijo z naslovom "Usmeritveni načrt Evropske agencije za zdravila do leta 2010: Priprava podlage za prihodnost".
In addition, the Committee gave 3 opinions for the extrapolation of existing MRLs to further species, in line with its policy on availability of veterinary medicines.
Poleg tega je Odbor predložil 3 mnenja za ekstrapolacijo obstoječih najvišjih mejnih vrednosti ostankov na dodatne vrste v skladu s svojo politiko o razpoložljivosti veterinarskih zdravil.
In the event of a pandemic, the actual influenza strain is submitted as a variation to the core dossier.
V primeru pandemije se dejanski sev influence predloži kot sprememba temeljne dokumentacije.
The new groups are set up under the revised EU pharmaceutical legislation to examine any question relating to the marketing of a medicinal product for human or veterinary use in two or more Member States, in accordance with the mutual recognition procedure (MRP) or the new decentralised procedure (DCP).
Novi skupini sta bili ustanovljeni v skladu z revidirano farmacevtsko zakonodajo EU za preučevanje vprašanj, povezanih s trženjem zdravil za humano in veterinarsko uporabo v dveh ali več državah članicah, v skladu s postopkom medsebojnega priznavanja ali novim decentraliziranim postopkom.
A total of 880 suspected signals, concerning 87 products, were detected and investigated.
Odkrilo in preučilo se je skupaj 880 sumov signalov, ki so zadevali 87 izdelkov.
The revised EU pharmaceutical legislation gives the Agency a greater mandate to provide scientific advice, and gives the Executive Director direct responsibility for establishing efficient structures for its provision - particularly with regard to advice for the development of new therapies.
Revidirana farmacevtska zakonodaja EU Agenciji daje več pooblastil za zagotavljanje znanstvenega svetovanja in izvršnemu direktorju nalaga odgovornost za vzpostavitev učinkovitih struktur za njegovo zagotavljanje - zlasti glede svetovanja za razvoj novih zdravljenj.
Following a period of external consultation with stakeholders, the Agency finalised and published a procedure for the development of pharmaceutical guidelines and related documents, proposing a consistent and transparent approach to their development, consultation and publication.
Po končanem obdobju javnih posvetovanj z zainteresiranimi stranmi je Agencija dokončna oblikovala in objavila postopek za razvoj farmacevtskih smernic in povezanih dokumentov ter predlagala skladen in pregleden pristop k njihovemu razvoju, zadevnem posvetovanju in objavi.
A class-labelling procedure was also conducted in relation to the use of epoetins in cancer patients, and another one in relation to dental, periodontal and psychiatric disorders possibly associated with the use of peginterferon alfa.
Eden izmed postopkov označevanja razreda je bil izveden tudi v zvezi z uporabo epoetinov pri bolnikih z rakom in drugi pa v zvezi z dentalnimi, parodontalnimi in psihiatričnimi motnjami, ki so verjetno povezane z uporabo peginterferona alfa.
The investigations revealed some regulatory and scientific discrepancies, which were mainly addressed through amendment of the testing documentation by the marketing authorisation holders concerned.
Preiskave so odkrile nekatere regulativne in znanstvene neskladnosti, ki so bile pretežno razrešene s spremembo dokumentov preizkušanja s strani zadevnih imetnikov dovoljenj za promet z zdravilom.
Contributions were made to the Innovative Medicines Initiative (IMI), the development of the European Technology Platform on Global Animal Health (ETPGAH), and the establishment of priorities for rare diseases.
Agencija je prispevala k pobudi za inovativna zdravila, k razvoju evropske tehnološke platforme za globalno zdravje živali (European Technology Platform on global Animal Health - ETPGAH) in določitvi prednostnih nalog za redke bolezni.
An important aspect of information and communication is the provision of safety-related information to patients and healthcare professionals.
Pomemben vidik obveščanja in komuniciranja je zagotavljanje informacij o varnosti bolnikom in zdravstvenim strokovnjakom.
Safety reviews
Presoje varnosti
In November 2005, the MRFG was replaced by the ‘Coordination Group for Mutual Recognition and Decentralised Procedures-Human', or ‘CMD(h)' and the VMRFG was replaced by the ‘Coordination Group for Mutual Recognition and Decentralised Procedures-Veterinary', or ‘CMD(v)'.
Novembra 2005 je bila MRFG nadomeščena z "Usklajevalno skupino za postopek medsebojnega priznavanja in decentralizirani postopek - humana medicina" ali "CMD(h)", VMRFG pa je bila nadomeščena z "Usklajevalno skupino za postopek medsebojnega priznavanja in decentralizirani postopek - veterinarska medicina" ali "CMD(v)".
the successful launch of the Agency's SME Office, which provides specific assistance to the smaller companies that are so often at the cutting edge of medicinal technologies development;
uspešen začetek Urada za MSP Agencije, ki nudi posebno pomoč manjšim podjetjem, ki so pogosto tista, ki se ukvarjajo z razvojem vrhunske medicinske tehnologije;
By the end of the year, the majority of the Member States' authorities were submitting their adverse drug reaction reports electronically to the Agency.
Do konca leta je večina organov držav članic Agenciji po elektronski poti pošiljala poročila o neželenih učinkih zdravil.
Broader advice e.g. on non-product related issues will now be offered, and, in parallel, workshops and think-tank meetings will create opportunities for increased awareness and dialogue with specific experts.
Na voljo bo širše svetovanje, npr. o vprašanjih, ki niso povezana z izdelki, medtem ko bodo delavnice in ustvarjalni sestanki hkrati zagotavljali možnosti za večjo ozaveščenost in dialog s posebnimi strokovnjaki.
As anticipated, 2005 was quite an extraordinary year for the European Medicines Agency.
Leto 2005 je bilo po vseh pričakovanjih izredno leto za Evropsko agencijo za zdravila.
During 2005, the Agency provided guidance in preparation for the entry into force of the revised legislation.
V letu 2005 je Agencija med pripravami na začetek veljavnosti revidirane zakonodaje zagotavljala vse potrebne smernice.
Suspension of a centrally authorised hexavalent vaccine due to concerns over the level of longterm protection offered by one of its components
začasno izključitvijo heksavalentnega cepiva, za katerega je bilo izdano dovoljenje po centraliziranem postopku, zaradi pomislekov o ravni dolgoročne zaščite, ki jo zagotavlja ena od njegovih sestavin;