natgillin/translations-raw huggingface dataset:
The EMEA received the first requests for SME status following the entry into force of the SME Regulation, and processed them.
EMEA je po začetku veljavnosti Uredbe MSP prejela in obdelala prve zahtevke za status MSP.
facilitating innovation and stimulating research, hence contributing to the competitiveness of EU-based pharmaceutical industry, and mobilising and coordinating scientific resources from throughout the EU to provide high-quality evaluation of medicinal products, to advise on research and development programmes, to perform inspections for ensuring fundamental GxP1 provisions are consistently achieved, and to provide useful and clear information to users and healthcare professionals.
pospeševanjem inovacij in spodbujanjem raziskav, s čimer prispeva h konkurenčnosti farmacevtske industrije EU, ter zbiranjem in usklajevanjem znanstvenih virov iz vse EU zaradi zagotovitve visoke kakovosti vrednotenja zdravil, izvajanja inšpekcijskih pregledov za zagotavljanje doslednega izvajanja temeljnih določb GXP ter zagotovitve uporabnih in jasnih informacij uporabnikom in zdravstvenemu osebju.
The Regulation also gives the EMEA important new responsibilities, in particular for the provision of better information about medicines to patients, consumers and healthcare professionals, and for strengthening the provision of scientific advice to companies.
Uredba prav tako prinaša pomembne nove odgovornosti za EMEA, zlasti zagotavljanje boljših informacij o zdravilih bolnikom, potrošnikom in zdravstvenemu osebju, in krepitev zagotavljanja znanstvenega svetovanja podjetjem.
Good progress was made with the implementation of EudraVigilance in 2005, with 23 national competent authorities and 105 marketing authorisation holders reporting electronically to the EudraVigilance Post-Authorisation Module (EVPM).
Pri izvajanju EudraVigilance je bil v letu 2005 dosežen dober napredek, pri čemer je 23 nacionalnih pristojnih organov in 105 imetnikov dovoljenj za promet z zdravilom elektronsko poročalo v modul EudraVigilance po izdaji dovoljenja (EudraVigilance Post-Authorisation Module - EVPM).
Risk management plans
Načrti za obvladovanje tveganja
Designations were for products covering a wide range of therapeutic areas, but the largest number of them related to products for the treatment of cancer.
Določitve so se nanašale na izdelke, ki so pokrivali široko vrsto terapevtskih področij, vendar je bilo največ določitev povezanih z izdelki za zdravljenje raka.
3.1.3 Initial evaluation
3.1.3 Začetno vrednotenje
The EMEA's Mission Statement is, in the context of a continuing globalisation, to protect and promote public and animal health by developing efficient and transparent procedures to allow rapid access by users to safe and effective innovative medicines and to generic and non-prescription medicines through a single European marketing authorisation,
Glede na nenehno globalizacijo je poslanstvo EMEA varovati in pospeševati zdravje ljudi in živali z razvojem učinkovitih in preglednih postopkov, ki uporabnikom omogočajo hiter dostop do varnih in učinkovitih inovativnih zdravil ter do generičnih zdravil in zdravil brez recepta z enotnim evropskim dovoljenjem za promet,
3.2.2 Initial evaluation
3.2.2 Začetno vrednotenje
Initiation of a safety review for dermatological medicinal products containing tacrolimus or pimecrolimus, following concerns of potential cancer risks for patients
začetkom presoje varnosti za dermatološka zdravila, ki vsebujejo takrolimus ali pimekrolimus, zaradi pomislekov o možnih tveganjih za nastanek raka;
This included drawing up guidelines for the new procedures, as well as contributing to the update of existing guidance documents, for both human and veterinary medicines, such as the good manufacturing practice (GMP) guide and the Notice to Applicants.
To je vključevalo pripravo smernic za nove postopke in prispevanje k posodabljanju obstoječih usmeritvenih dokumentov za zdravila za uporabo v humani in veterinarski medicini, kot so smernice dobre proizvodne prakse in obvestila vlagateljem.
Question-and-answer documents were prepared systematically for all major safety issues involving centrally authorised products.
Sistematično so bili pripravljeni dokumenti z vprašanji in odgovori za vsa pomembnejša vprašanja o varnosti v zvezi z izdelki, za katere je bilo izdano dovoljenje po centraliziranem postopku.
Orphan medicinal product procedures 2003 - 2005
Postopki za zdravila sirote v obdobju 2003-2005
4 SAFETY OF MEDICINES
4 VARNOST ZDRAVIL
Opinions in 2005 The CHMP adopted 24 positive opinions and 1 negative opinion in 2005 on products intended for the European market.
Mnenja v letu 2005 Odbor za zdravila za uporabo v humani medicini (CHMP) je v letu 2005 sprejel 24 pozitivnih mnenj in 1 negativno mnenje v zvezi z izdelki, namenjenimi evropskemu trgu.
The number of applications for variations to marketing authorisations increased once again in 2005.
V letu 2005 se je ponovno povečalo število vlog za spremembe dovoljenj za promet z zdravilom.
Adverse reactions in human beings following exposure to a veterinary medicinal product were reported in 49 cases during 2005, none of which resulted in fatality.
V letu 2005 se je o neželenih učinkih pri ljudeh zaradi izpostavljenosti veterinarskim zdravilom poročalo v 49 primerih, od katerih se ni noben končal s smrtnim izidom.
While the Agency devoted great energy in 2005 to setting up these and other initiatives under its extended mandate, it also focused on improving its core scientific activities, particularly in the area of pharmacovigilance, which resulted in more efficient and effective practices for safeguarding the quality, safety and efficacy of authorised medicinal products.
Čeprav je Agencija v letu 2005 večino svojega časa in energije posvetila tem in še nekaterim drugim pobudam, se je ukvarjala tudi z izboljševanjem svojih osrednjih znanstvenih dejavnosti, še zlasti na področju farmakovigilance, zaradi česar so postopki za ohranjanje kakovosti, varnosti in učinkovitosti odobrenih zdravil še uspešnejši in učinkovitejši.
Biotechnology medicines
biotehnološkimi zdravili;
New applications for veterinary medicines received/forecast (Input)
Prejete/predvidene nove vloge za veterinarska zdravila (vhodni podatek)
Working through the EMEA/CHMP Working Group with Patients' and Consumers' Organisations (the Agency's platform for interaction with patients and consumers), a set of recommendations was published in March 2005 relating to: transparency and dissemination of information; product information; pharmacovigilance; and interaction between the EMEA and patients' organisations.
V sodelovanju EMEA/delovne skupine CHMP z organizacijami bolnikov in potrošnikov (platforma Agencije za sodelovanje z bolniki in potrošniki) je bil marca 2005 objavljen sklop priporočil, ki so se nanašala na preglednost in obveščanje, informacije o izdelkih, farmakovigilanco in sodelovanje med
Another initiative aimed in particular at encouraging the development of medicines for minor species in the important livestock sector is the extrapolation of MRLs from major to minor species.
Še ena pobuda, ki je usmerjena zlasti na spodbujanje razvoja zdravil za manj pomembne vrste v pomembnem sektorju za živino, je ekstrapolacija najvišjih mejnih vrednoti ostankov za pomembnejše živalske vrste na manj pogoste živalske vrste.
The EMEA received 65 quality-defect reports concerning human medicinal products and 3 qualitydefect reports for veterinary medicinal products.
EMEA je prejela 65 poročil o pomanjkljivi kakovosti pri zdravilih za uporabo v humani medicini in 3 poročila o pomanjkljivostih pri zdravilih za uporabo v veterinarski medicini.
There was a substantial increase in the number of requests for scientific advice and protocol assistance in 2005 - up 60% on the number received in 2004.
Veliko povečanje zahtevkov za znanstveno svetovanje V letu 2005 se je število zahtevkov za znanstveno svetovanje in pomoč pri protokolu močno povečalo, in sicer za 60 % v primerjavi s številom zahtevkov, prejetih v letu 2004.
A think-tank group was established to consider innovative methods for drug development and to assess hurdles that may be encountered by pharmaceutical companies researching or developing such methods.
Ustanovljena je bila ustvarjalna skupina za obravnavanje inovativnih načinov razvoja zdravil in oceno ovir, s katerimi se srečujejo farmacevtska podjetja, ki raziskujejo ali razvijajo takšne načine.
The EMEA coordinated and managed requests for 98 good manufacturing practice (GMP) and plasma master file inspections, 14 good clinical practice (GCP) and pharmacovigilance inspections, and 2 good laboratory practice (GLP) inspections during 2005, representing a total increase of 23% relative to 2004.
EMEA je v letu 2005 uskladila in vodila prošnje za 98 inšpekcijskih pregledov dobre proizvodne prakse in glavnega dosjeja plazme, 14 inšpekcijskih pregledov dobre klinične prakse in farmakovigilance ter 2 inšpekcijska pregleda dobre laboratorijske prakse, kar je skupaj predstavljalo 23-odstotno relativno povečanje v primerjavi z letom 2004.
Conclusion of the safety review of the selective serotonin reuptake inhibitor (SSRI) class of antidepressants
zaključkom presoje varnosti razreda antidepresivov SSRI (selektivni zaviralci ponovnega privzema serotonina);
3.2 Medicines for veterinary use 3.2.1 Scientific advice
3.2 Zdravila za uporabo v veterinarski medicini 3.2.1 Znanstveno svetovanje
The Agency released the ‘EMEA pandemic influenza crisis management plan for the evaluation and maintenance of pandemic influenza vaccines and antivirals' for consultation in 2005.
Agencija je objavila "načrt kriznega upravljanja pandemije influence za ovrednotenje in ohranitev cepiv in protivirusnih zdravil za pandemijo influence EMEA" za namene posvetovanj v letu 2005.
There were also new indications in the area of diabetes, cardiovascular, neurodegenerative and rheumatoid diseases.
Nove terapevtske indikacije so se nanašale tudi na področje sladkorne bolezni ter kardiovaskularnih, nevrodegenerativnih in revmatoidnih bolezni.
These include risk-management plans, the collection of specific pharmacovigilance data from targeted groups of patients, and new possibilities for pharmacovigilance inspections and inspection of active substances.
Ta vključujejo načrte za obvladovanje tveganja, zbiranje farmakovigilančnih podatkov v ciljnih skupinah bolnikov ter nove možnosti za inšpekcijske preglede farmakovigilance in inšpekcijske preglede zdravilnih učinkovin.
PIM enables the management and exchange of product information (summary of product characteristics, package leaflet and labelling) by all parties involved in the evaluation process for the centralised procedure.
Upravljanje informacij o izdelkih omogoča upravljanje in izmenjavo informacij o izdelkih (povzetka glavnih značilnosti zdravila, navodil za uporabo in označevanja) vsem strankam, vključenim v vrednotenje za centraliziran postopek.
There was a similar increase in the number of finalised post-authorisation procedures, particularly those for type-II variations.
Podobno se je povečalo število dokončno obdelanih postopkov po izdaji dovoljenja za promet z zdravilom, zlasti postopkov za spremembe tipa II.
As part of the revised pharmaceutical legislation, all new applications for marketing authorisation and applications for major changes to existing authorisations must be accompanied by a risk management plan.
V skladu z revidirano farmacevtsko zakonodajo morajo biti vse nove vloge za izdajo dovoljenja za promet z zdravilom in vloge za večje spremembe obstoječih dovoljenj za promet z zdravilom opremljene z načrtom za obvladovanje tveganja.
A new Medical Information sector became fully operational in September 2005 and assumed responsibilities for interaction with patients' and healthcare professionals' organisations and for activities associated with the provision of productrelated information.
Septembra 2005 je začel v celoti delovati novi sektor za zdravstvene informacije, ki je prevzel odgovornost za sodelovanje z organizacijami bolnikov in zdravstvenih strokovnjakov ter za dejavnosti, povezane z zagotavljanjem informacij o zdravilih.
Results requiring further investigation were found in 8 of the 39 products.
Pri 8 od 39 izdelkov so rezultati pokazali, da so potrebne dodatne preiskave.
New indications: A total of 28 extensions of indications were introduced, a large number of which related to new treatment options for previously approved medicines in the area of cancer.
Nove terapevtske indikacije: uvedenih je bilo skupaj 28 razširitev terapevtskih indikacij, od katerih se jih je veliko število nanašalo na nove možnosti zdravljenja s predhodno odobrenimi zdravili za zdravljenje raka.
Of these, 14 applications were for immunologicals, and concerned quality changes; 7 were for pharmaceuticals, with 4 concerning clinical changes and 3 concerning quality changes.
Od tega je bilo 14 vlog za imunološka zdravila, ki so zadevale spremembe kakovosti; 7 vlog je bilo za farmacevtske izdelke, od tega so se 4 nanašale na klinične spremembe, 3 pa na spremembe kakovosti.
It enables the Agency to strike the right balance between encouraging research and development of new medicines and strengthening their surveillance, giving patients access to much-needed new, safe and innovative medicines.
Agenciji omogoča vzpostavitev ustreznega ravnotežja med spodbujanjem raziskav ter razvojem novih zdravil in krepitvijo nadzora nad njimi, pri čemer zagotavlja bolnikom dostop do prepotrebnih, varnih in inovativnih zdravil.
The EMEA has a major role, reinforced by the new pharmaceutical legislation, in the provision of information to patients and healthcare professionals.
EMEA ima pomembno vlogo, ki jo je dodatno okrepila nova farmacevtska zakonodaja, pri zagotavljanju informacij bolnikom in zdravstvenim strokovnjakom.
As a result, the Agency was immediately able to embrace its new responsibilities and begin offering an extended range of services in support of European efforts to bring innovative new medicines to the market.
Tako se je bila sposobna nemudoma lotiti novih odgovornosti in je lahko takoj pričela nuditi večje število storitev, s katerimi podpira Evropsko unijo pri uvajanju novih, izpopolnjenih zdravil na trg.
Personnel management
Upravljanje kadrov
Strengthening the quality-assurance system of scientific assessments by adopting a procedure for pilot peer reviews during the initial assessment phase of marketing authorisation applications
krepitvijo sistema zagotavljanja kakovosti znanstvenega vrednotenja s sprejetjem postopka za pilotne medsebojne presoje med začetno fazo vrednotenja vlog za izdajo dovoljenj za promet z zdravilom;
Advanced therapies
Napredna zdravljenja
Improving veterinary pharmacovigilance
Izboljšanje veterinarske farmakovigilance
The new legislation gives the Agency new tools, aimed at fostering innovative medicines and therapies and providing for faster access of patients to medicines.
Nova zakonodaja Agenciji daje nova orodja, ki so namenjena spodbujanju inovativnih zdravil in zdravljenj ter zagotavljanju hitrejšega dostopa bolnikov do zdravil.
Type-I variations Type-II variations Extensions
Spremembe tipa I Spremembe tipa II Razširitve indikacij
The number of adverse drug reaction (ADR) reports for centrally authorised medicinal products received by the EMEA in 2005 was significantly greater than in previous years.
Število poročil o neželenih učinkih zdravil za zdravila, za katera so bila izdana dovoljenja po centraliziranem postopku, ki jih je EMEA prejela v letu 2005, je bilo precej večje kot v predhodnih letih.
Variations in 2005
Spremembe v letu 2005
The CHMP also made a commitment to accelerate the scientific evaluation of applications for scientific advice and for marketing authorisation relating to core dossiers for pandemic-influenza vaccines.
CHMP se je zavezal, da bo spodbujal znanstveno vrednotenje za vloge za znanstveno svetovanje in izdajo dovoljenja za promet z zdravilom, ki se nanašajo na temeljno dokumentacijo za cepiva za pandemijo influence.
Two out of the 22 recalls were classified as ‘Class 1' recalls, i.e. relating to defects, which are potentially life-threatening or could cause serious risks to health.
Dva od 22 umikov sta bila razvrščena kot umika "1. razreda", tj. umiki, ki se nanašajo na pomanjkljivosti, ki so lahko smrtno nevarne ali bi lahko povzročile nastanek resnih tveganj za zdravje.
Supporting applicants in the development of new therapeutic approaches and technologies
podporo vlagateljem pri razvoju novih terapevtskih pristopov in tehnologij;
New therapies
Nove terapije
The Agency dealt with a number of major safety issues in 2005, involving both centrally and noncentrally authorised medicines for human use, including:
Agencija je v letu 2005 obravnavala številna pomembna vprašanja o varnosti, ki so vključevala zdravila za uporabo v humani medicini, za katera je bilo izdano dovoljenje po centraliziranem in decentraliziranem postopku, vključno z:
The Regulation introduces, under specific conditions, new accelerated assessment and conditional marketing authorisation procedures, which help to ensure that patients have timely access to innovative medicines.
Uredba pod posebnimi pogoji uvaja nove postopke pospešenega vrednotenja in izdaje pogojnih dovoljenj za promet z zdravilom, ki omogočajo, da imajo bolniki pravočasen dostop do inovativnih zdravil.
EMEA supports applicants in the development of new therapeutic approaches and technologies.
EMEA podpira vlagatelje pri razvoju novih terapevtskih pristopov in tehnologij.
These include accelerated assessment, conditional marketing authorisation, and opinions on compassionate use of medicines.
Orodja vključujejo hitrejše ocenjevanje, izdajo pogojnih dovoljenj za promet z zdravilom in mnenja o sočutni uporabi zdravil.
In 2005, the EMEA received a total of 354 expedited spontaneous reports of suspected serious adverse reactions to centrally authorised veterinary medicines in animals or humans.
V letu 2005 je EMEA prejela skupaj 354 pospešenih spontanih poročil o sumih na resne neželene učinke pri živalih ali ljudeh v zvezi z veterinarskimi zdravili, za katera so bila izdana dovoljenja po centraliziranem postopku.
The Agency received 41 applications for initial marketing authorisation in 2005: 15 of these were applications for designated orphan medicinal products.
Agencija je prejela 41 vlog za izdajo začetnih dovoljenj za promet z zdravilom v letu 2005, od tega se je 15 vlog nanašalo na zdravila, določena za zdravila sirote.
Six recalls were ‘Class 2' recalls, i.e. relating to defects which could cause illness or mistreatment.
Šest umikov je bilo razvrščenih kot umiki "2. razreda", tj. umiki, ki se nanašajo na pomanjkljivosti, ki lahko povzročijo nastanek bolezni ali zlorabo.
Conditional fee exemption where scientific advice is followed and a marketing-authorisation application is not successful
pogojno oprostitev pristojbin, če so bili upoštevani znanstveni nasveti in če vloga za izdajo dovoljenja za promet z zdravilom ni bila uspešna;
Ensuring adequacy of environmental risk assessment by developing guidance to help applicants prepare the environmental risk assessment part of marketing-authorisation applications for veterinary medicines.
zagotavljanjem primernosti ocene tveganja za okolje z razvijanjem smernic za pomoč vlagateljem pri pripravi tistega dela vloge za izdajo dovoljenj za promet za veterinarska zdravila, ki se nanaša na oceno tveganja za okolje.
Good progress with EudraVigilance Veterinary
Dober napredek v zvezi z EudraVigilance za veterinarstvo
Some of the recommendations were implemented in 2005, including one for new product-information templates which allow better information to be provided for patients and which are tested for readability.
Nekatera priporočila so se začela izvajati v letu 2005, vključno s priporočilom za nove predloge za informacije o zdravilih, ki omogočajo, da se bolnikom zagotavljajo boljše informacije, in so bile preizkušene glede razumljivosti besedila.
Assistance with translations of the product-information documents submitted in the application for a marketing authorisation.
pomoč pri prevajanju dokumentov, ki vsebujejo informacije o proizvodu, ki jih je treba predložiti v vlogi za izdajo dovoljenja za promet z zdravilom.
Five applications for extension or modification of MRLs were submitted in 2005.
V letu 2005 je bilo predloženih pet vlog za razširitev ali spremembo najvišjih mejnih vrednosti ostankov.
Safety review of non-steroidal anti-inflammatory drugs (NSAIDs)
presojo varnosti nesteroidnih protivnetnih zdravil (NSAID);
A total of 41 type-I variation applications were received, relating to 14 type-IA and 27 type-IB variations.
Prejetih je bilo skupno 41 vlog za spremembo tipa I, od katerih se jih je 14 nanašalo na spremembo tipa IA in 27 na spremembo tipa IB.
In the area of veterinary medicines, the Agency is responsible for all medicinal products derived from biotechnology or intended primarily for use as performance enhancers to promote growth of or to increase yield from treated animals.
Na področju veterinarskih zdravil je Agencija odgovorna za vsa zdravila, ki so biotehnološko pridobljena ali namenjena zlasti spodbujanju rasti rejnih živali ali njihovega donosa.
3.2.4 Post-authorisation activities
3.2.4 Dejavnosti po izdaji dovoljenja
None of these concerned out-of-specification results.
Nobena preiskava ni pokazala neskladnosti s specifikacijami.
The medicines involved are an antiviral for the prevention of influenza, an antibacterial for a range of infections, an anti-epileptic and a product used in the treatment of leukaemia.
Zadevna zdravila vključujejo protivirusno zdravilo za preprečevanje influence, antibakterijsko zdravilo za širšo vrsto okužb, antiepileptik in zdravilo za zdravljenje levkemije.
The CVMP continued to extrapolate MRLs upon requests from companies in 2005 for substances important for therapy in minor species.
CVMP je v letu 2005 nadaljeval z ekstrapolacijo najvišjih mejnih vrednoti ostankov na zahtevo podjetij za snovi, ki so pomembne za zdravljenje pri manj pogostih vrstah.
The CHMP also gave its first scientific opinions in the context of cooperation with the World Health Organization (WHO) on medicines intended exclusively for use in countries outside of the EU.
CHMP je predložil tudi svoja prva znanstvena mnenja v okviru sodelovanja s Svetovno zdravstveno organizacijo (WHO) za zdravila, namenjena izključno uporabi v državah zunaj EU.
3.1.4 Post-authorisation activities
3.1.4 Dejavnosti po izdaji dovoljenja
Also introduced by the new legislation is a new procedure, which enables the CHMP to give scientific opinions in the context of cooperation with the World Health Organization (WHO) for medicinal products used in markets outside of the European Union.
Nova zakonodaja je uvedla tudi postopek, ki CHMP omogoča, da podaja znanstvena mnenja v okviru sodelovanja s Svetovno zdravstveno organizacijo (WHO) za zdravila, ki se uporabljajo na trgih zunaj Evropske unije.
The Committee released for public consultation draft entries to the ‘Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products' for Valerian root and Linseed.
Odbor je za namene javnega posvetovanja objavil osnutek vpisov na "seznam rastlinskih snovi Skupnosti, njihovih pripravkov in kombinacij za uporabo v tradicionalnih zdravilih rastlinskega izvora" za baldrijanovo korenino in laneno seme.
The EMEA put in place procedures to reinforce detection of pharmacovigilance signals for centrally authorised products during 2005, allowing the Agency to take appropriate action earlier.
EMEA je v letu 2005 uvedla postopke za okrepitev odkrivanja signalov farmakovigilance za izdelke, za katere so bila izdana dovoljenja po centraliziranem postopku, kar je Agenciji omogočilo, da hitreje sprejme ustrezne ukrepe.
Meeting four times in 2005, the EMEA Management Board:
Upravni odbor EMEA Na štirih zasedanjih v letu 2005 je upravni odbor EMEA: