natgillin/translations-raw huggingface dataset:
The EMEA continued to support the development of medicines for rare diseases and to provide highquality scientific advice to companies developing medicines.
Agencija EMEA je še naprej podpirala razvoj zdravil za redke bolezni in ponujala visokokakovostno znanstveno svetovanje podjetjem, ki razvijajo zdravila.
With the foundation of this new legislative framework and the EMEA's operation of it, children across Europe will begin to benefit from medicines that are developed with their specific needs and best interests at heart.
Z ustanovitvijo tega novega pravnega okvira, ki ga upravlja EMEA, bodo otroci po vsej Evropi začeli uživati koristi zdravil, ki se z najboljšimi nameni razvijajo zanje ob upoštevanju njihovih posebnih potreb.
High performance of EudraNet was achieved both in terms of system availability and quality of management, development and operation of EudraNet applications (EudraNet II, EudraLink, ECD, Experts Database, etc.).
Visoka učinkovitost omrežja EudraNet je bila dosežena tako v smislu dostopnosti sistema kot kakovosti upravljanja, razvoja in delovanja programov sistema EudraNet (EudraNet II, EudraLink, ECD, Experts Database itd.).
An antidote medicinal product used for treating cyanide poisoning.
• Protistrup, ki se uporablja pri zastrupitvi s cianidom.
A medicine with a chemical structure resembling that of thalidomide.
• Zdravilo s kemično strukturo, ki je podobna kemični strukturi talidomida.
I would like to express my gratitude to the Executive Director and all EMEA staff for their commitment and excellent contribution during the year.
Zahvaljujem se izvršnemu direktorju in vsemu osebju agencije EMEA za njihovo predanost in izvrstno delo med letom.
With the support of the national competent authorities the Agency succeeded in establishing the Paediatric Committee (PDCO) - the Agency's fifth scientific committee - and putting in place the necessary procedures for the assessment of paediatric investigation plans (PIPs) and waiver applications.
S podporo nacionalnih pristojnih organov je Agenciji uspelo ustanoviti Odbor za pediatrijo (PDCO) - peti znanstveni odbor Agencije - in uvesti potrebne postopke za vrednotenje načrtov pediatričnih raziskav (PIP) in vlog za opustitev.
Considerable effort was made, together with the national competent authorities for medicines in the EU Member States, to apply a proactive approach to the safety of medicines, with particular emphasis on the establishment of an intensive drug-monitoring system.
Skupaj z nacionalnimi pristojnimi organi za zdravila v državah članicah smo vložili veliko truda, da smo uporabili proaktiven pristop k varnosti zdravil, poseben poudarek pa je bil na ustanovitvi intenzivnega sistema za spremljanje zdravil.
3.6 Arbitration and Community referrals Procedures started in 2007
3.6 Arbitraža in napotitve Skupnosti Postopki, začeti v letu 2007
• implements measures for continuously supervising the quality, safety and efficacy of authorised medicines to ensure that their benefits outweigh their risks;
• izvaja ukrepe za nenehen nadzor nad kakovostjo, varnostjo in učinkovitostjo zdravil, za katera so bila izdana dovoljenja, za zagotovitev, da njihova korist prevlada nad tveganji;
Forty-nine percent of orphan medicines designated in 2007 were for conditions affecting children, including 4% intended exclusively for paediatric use.
49 % zdravil sirot, ki so bila tako določena v letu 2007, je bilo namenjenih za zdravljenje bolezni, ki prizadenejo otroke, vključno s 4 % zdravil, ki so namenjena izključno za uporabo v pediatriji.
Perhaps the most tangible and significant achievement of 2007 was the Agency's successful introduction of new procedures and creation of a new scientific committee dedicated to implementing the EU's Paediatric Regulation, which came into force on 26 January 2007.
Najbrž najvidnejši in najpomembnejši dosežek v letu 2007 je bil, da je Agencija uspešno uvedla nove postopke in ustanovila nov znanstveni odbor, ki se ukvarja z izvajanjem Uredbe EU o zdravilih za pediatrično uporabo, ki je začela veljati 26. januarja 2007.
The Paediatric Committee - the Agency's fifth scientific committee - was launched with great enthusiasm in July of this year, and immediately began to elaborate scientific and procedural arrangements for the assessment of paediatric investigation plans and related regulatory instruments.
Odbor za pediatrijo - peti znanstveni odbor Agencije - je bil z velikim zanosom ustanovljen julija letos ter je nemudoma začel pripravljati znanstvene in proceduralne sporazume za oceno načrtov pediatričnih študij in s tem povezanih regulativnih instrumentov.
Good manufacturing practice (GMP) inspection numbers - including inspections in the context of plasma master files (PMFs) - showed a 32% increase compared with 2006 (110).
Število inšpekcijskih pregledov dobre proizvodne prakse (GMP) - vključno z inšpekcijskimi pregledi na podlagi glavnih dosjejev plazme (plasma master file, PMF) - kaže 32-odstotno povečanje v primerjavi z letom 2006 (110).
They form part of the overall response of the European regulatory network to the lack of availability of veterinary medicines.
Ti predlogi so sestavni del splošnega odgovora evropske regulativne mreže na slabo dostopnost zdravil za uporabo v veterinarski medicini.
The numbers of initial parallel-distribution notifications and notifications of change exceeded the expected numbers, with 1,937 initial notifications (8% more than forecast) and 3,518 notifications of change (45% more than forecast) being received.
Število začetnih obvestil o vzporedni distribuciji in število obvestil o spremembi sta presegli pričakovanja; prejeli smo 1937 začetnih obvestil (8 % več, kot je bilo pričakovano) in 3518 obvestil o spremembi (45 % več, kot je bilo pričakovano).
According to revised EU legislation, Member States can initiate referrals regarding herbal medicines.
V skladu s spremenjeno zakonodajo EU lahko države članice predložijo napotitve z zvezi z zdravili rastlinskega izvora.
• We adhere to high standards of professional and personal integrity.
• Ravnamo se po visokih standardih strokovne in osebne poštenosti.
Services provided by the SME Office included processing of requests for fee reduction or deferral, requests for administrative assistance - more than three times the initially forecasted requests were received - and translation support for product information.
Storitve, ki jih je zagotavljal Urad za MSP, so vključevale obdelavo zahtevkov za znižanje ali odlog pristojbin, zahtevkov za upravno pomoč - prejetih je bilo trikrat toliko zahtevkov, kot je bilo predvideno na začetku - ter prevajalsko podporo za informacije o zdravilih.
The CHMP adopted 41 opinions for new indications, providing additional treatment options for patients.
CHMP je sprejel 41 mnenj za nove terapevtske indikacije in tako zagotovil dodatne možnosti zdravljenja bolnikov.
Further improvements in relation to provision of information on medicines
Nadaljnje izboljšave v zvezi z omogočanjem informacij o zdravilih
Extensions of indications broaden scope of existing medicines
Razširitve terapevtskih indikacij širijo obseg obstoječih zdravil
Principles and processes for advanced education exchanges between regulatory authorities, academia and, where appropriate, industry were established.
Določena so bila načela in postopki za napredno izmenjavo znanja med regulativnimi organi, akademiki, in kadar je primerno, industrijo.
Guidance for the assessment of user-testing results by the CHMP was prepared and adopted in agreement with the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMD(h)).
Smernica CHMP za vrednotenje rezultatov uporabniškega preskušanja je bila pripravljena in sprejeta v soglasju z Usklajevalno skupino za postopek medsebojnega priznavanja in decentralizirani postopekhumana medicina (CMD(h)).
2 vaccines against avian influenza in poultry, mainly chickens.
• dve cepivi proti aviarni influenci pri perutnini, predvsem piščancih.
During the year, a refined action plan was established for veterinary medicines under the European Surveillance Strategy, which now includes priorities for promotion of adverse-reaction reporting, implementation of electronic reporting of these reactions, data analysis, and worksharing between Member States.
Med letom je bil v okviru evropske strategije nadzorovanja sprejet izpopolnjen akcijski načrt za veterinarska zdravila, ki zdaj vključuje prednostne naloge za spodbujanje poročanja o neželenih učinkih, uvajanje elektronskega poročanja o teh učinkih, analizo podatkov in delitev dela med državami članicami.
Two opinions were adopted following accelerated assessment of the application.
Dve mnenji sta bili sprejeti po postopku pospešenega vrednotenja vloge.
The majority of these companies are developing medicines for human use, 9 are developing medicines for veterinary use, 8 are developing medicines both for human and veterinary use, and 19 are regulatory consultants.
Večina teh podjetij razvija zdravila za uporabo v humani medicini, devet podjetij razvija zdravila za uporabo v veterinarski medicini, osem jih razvija zdravila za uporabo v humani in veterinarski medicini, 19 podjetij pa opravlja storitve regulativnega svetovanja.
It is designed to support signal-detection and the assessment of adverse-drug-reaction reports.
Zasnovano je tako, da podpira zaznavanje signalov in ocenjevanje poročil o neželenih učinkih zdravil.
One hundred and thirty-three reports received related to food-producing animals (mainly cattle, pigs and horses), following treatment of 17,459 animals, of which 4,428 showed suspected adverse reactions.
133 prejetih poročil se je nanašalo na živali, namenjene za proizvodnjo hrane (predvsem govedo, prašiči in konji), po zdravljenju 17 459 živali, od tega je pri 4428 živalih obstajal sum neželenih učinkov.
The first phase of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) project was concluded, resulting in the establishment of an inventory.
Prva stopnja projekta Evropske mreže centrov za farmakoepidemiologijo in farmakovigilanco (ENCePP) je bila končana, njen rezultat pa je sestava popisa.
The CHMP concluded more than 100 type-II variations relating to special warnings and precautions for use, including:
CHMP je sprejel odločbe za več kot 100 sprememb tipa II, ki se nanašajo na posebna opozorila in previdnostne ukrepe za uporabo, vključno z:
The vaccines were authorised under exceptional circumstances and are subject to specific obligations and follow-up measures, including enhanced pharmacovigilance measures, to ensure the safe use of the products;
Za cepivi sta bili izdani dovoljenji za promet z zdravilom v izjemnih okoliščinah in bodo zanju veljali posebne obveznosti in nadaljnji ukrepi, vključno z razširjenimi ukrepi farmakovigilance, da se zagotovi varna uporabo izdelkov;
The Innovation Task Force (ITF) - an EMEA multidisciplinary group that includes scientific, regulatory and legal competences - held 18 briefing meetings with companies developing medicines in the area of emerging therapies and new technologies.
Projektna skupina za inovacije (ITF) - multidisciplinarna skupina agencije EMEA s pristojnostmi na znanstvenem, regulativnem in pravnem področju - je organizirala 18 informativnih sestankov s podjetji, ki razvijajo zdravila na področju nastajajočih terapij in novih tehnologij.
I would like to express my deep gratitude, and that of the entire network, to Hannes for his important contribution, which is greatly appreciated.
Profesorju Hannesu bi se rad iskreno zahvalil, tako v svojem imenu kot v imenu celotne mreže, za njegov pomembni prispevek, ki ga vsi zelo cenimo.
The EMEA received applications for PIPs and full or partial waivers relating to 202 indications.
EMEA je prejela vloge za načrte pediatričnih raziskav in popolne ali delne opustitve, ki se nanašajo na 202 indikaciji.
The new paediatric legislation was successfully implemented, and a new scientific committee was established to oversee the performance of new tasks for the Agency and for the network.
Nova zakonodaja o pediatriji je bila uspešno uvedena, ustanovljen pa je bil tudi nov znanstveni odbor, da bo za Agencijo in mrežo nadzoroval izvajanje novih nalog.
A draft was published for a threemonth public consultation in December 2007.
Osnutek je bil decembra 2007 objavljen za namene trimesečnega javnega posvetovanja.
The number of marketing-authorisation applications for orphan-designated medicines was lower than in 2006, but close to the 7-year average since the introduction of orphan legislation.
Število vlog za izdajo dovoljenj za promet z zdravilom za zdravila, določena kot zdravila sirote, je bilo manjše kot v letu 2006, vendar je bilo blizu sedemletnemu povprečju od uvedbe zakonodaje o zdravilih sirotah.
Opinions adopted in 2007
Mnenja, sprejeta v letu 2007
European Technology Platform for Global Animal Health
Evropska tehnološka platforma za globalno zdravje živali
Recognising that micro, small and medium-sized enterprises (SMEs) are often a motor for innovation - particularly in the field of new technologies and emerging therapies - the Agency's SME Office continued to implement the EMEA's policy to support them.
Ker se zavedamo, da so mikro, mala in srednje velika podjetja (MSP) pogosto gonilna sila inovacij (zlasti v novih tehnologijah in terapijah), je Urad za MSP Agencije nadaljeval izvajanje politike agencije EMEA, ki je usmerjena v podpiranje MSP.
The Agency amended its policy on fee reductions for orphan medicines in 2007 to continue to focus on incentives to support protocol assistance, marketing-authorisation applications and other preauthorisation activities, and to support SMEs in the first year after granting of a marketing authorisation.
Agencija je v letu 2007 spremenila svojo politiko znižanja pristojbin za zdravila sirote, da se je lahko še naprej osredotočala na spodbude za podpiranje pomoči pri protokolu, dejavnosti, povezane z vlogami za izdajo dovoljenj za promet z zdravilom, in druge dejavnosti pred izdajo dovoljenj za promet, ter podpiranje MSP v prvem letu po podelitvi dovoljenja za promet z zdravilom.
The Agency participated in the preparation of the action plan, released in August 2007, for implementation of the Strategic Research Agenda.
Agencija je sodelovala pri pripravi akcijskega načrta za izvajanje strateških raziskovalnih programov, ki je bil objavljen avgusta 2007.
Principal activities Working with the Member States and the European Commission as partners in a European medicines network, the European Medicines Agency:
S partnerskim sodelovanjem z državami članicami in Evropsko komisijo v Evropski mreži zdravil Evropska agencija za zdravila:
In 2007, the Agency received 90 such applications relating to medicines for human use and 15 for veterinary medicines.
V letu 2007 je Agencija prejela 90 vlog, ki so se nanašale na zdravila za uporabo v humani medicini, in 15 za veterinarska zdravila.
The network gives the EMEA access to a pool of more than 4,000 experts, allowing the Agency to source the best-available scientific expertise for regulating medicines in the EU.
Mreža zagotavlja agenciji EMEA dostop do bazena z več kot 4000 strokovnjaki, kar Agenciji omogoča, da pri urejanju področja zdravil v EU uporablja najboljše strokovno znanje, ki je na voljo.
The transition from observer status to full participation in the European medicines network and in the work of the Agency was facilitated as a result of careful preparations in the run-up to these countries' accession to the EU.
Prehod iz statusa opazovalk do polnopravnega sodelovanja v Evropski mreži zdravil in pri delu Agencije so olajšale skrbne priprave pred pridružitvijo teh držav EU.
With a view to participating in educational programmes for regulatory scientists, in conjunction with academia and the national competent authorities, the EMEA contributed to the initiative started by Italy for a European school for regulatory assessment of medicines.
Da bodo regulativni znanstveniki sodelovali v izobraževalnih programih v sodelovanju z akademiki in nacionalnimi pristojnimi organi, je agencija EMEA prispevala k pobudi, ki jo začela Italija, za evropsko šolo za regulativno vrednotenje zdravil.
Continuing high priority was given to the authorisation of vaccines against avian influenza in chickens, because control of the disease in chickens reduces the likelihood of a pandemic developing through transfer of the virus from birds to man.
Neprekinjena velika prednost se je še naprej dajala izdaji dovoljenj za promet s cepivi proti aviarni influenci pri piščancih, saj nadzor nad boleznijo pri piščancih zmanjšuje verjetnost razvoja pandemije zaradi prenosa virusa s ptic na človeka.
There was a marked improvement in the average clock-stop time required by applicant companies.
Opažen je bil znaten napredek pri povprečnem času zamrznitve teka roka, ki so ga potrebovala podjetja, ki so oddala vloge.
4 INSPECTIONS
4 INŠPEKCIJSKI PREGLEDI
Certificates within the framework of cooperation with the World Health Organization and certificates for SMEs also increased.
Povečalo se je tudi število potrdil na podlagi sodelovanja s Svetovno zdravstveno organizacijo (WHO) ter potrdil za mala in srednja podjetja.
This conference brought together all major stakeholders in animal health, including industry, academia, international animal-health organisations, and regulators from around the world.
Na tej konferenci so se srečale vse pomembnejše zainteresirane strani s področja zdravja živali, vključno s predstavniki industrije, akademiki, mednarodnimi organizacijami za zdravje živali in upravnimi organi z vsega sveta.
Overall, these figures are consistent with a trend towards the introduction of immunological methods of control for disease problems in food-producing animals and an emphasis on companion-animal medicines in the field of veterinary pharmaceuticals.
Na splošno se te številke skladajo s težnjo po uvajanju imunoloških metod nadzora bolezni pri živalih, namenjenih za proizvodnjo hrane, ter poudarkom na zdravilih za hišne živali na področju veterinarskih farmacevtskih zdravil.
Further, advanced networkmanagement and performance services were implemented.
Uvedene so bile tudi napredne storitve za upravljanje in delovanje omrežja.
The total number of new applications - 90 - was higher than in any other year.
Skupno število novih vlog (90) je bilo večje kot katero koli leto poprej.
The small number of new MRL applications is of concern as it clearly shows that very few new molecules are being introduced onto the veterinary market for livestock species.
Majhno število novih vlog za najvišje mejne vrednosti ostankov je skrb zbujajoče, saj jasno kaže, da se na veterinarski trg za živino uvaja zelo malo novih molekul.
The lack of uptake of extension applications is possibly related to the fact that many extensions that are of interest to companies have already been undertaken by the CVMP as free-of-charge extrapolations over recent years, as part of the CVMP's efforts to facilitate authorisation of medicines for minor uses and minor species.
Vzrok, zakaj se število vlog za razširitev ne povečuje, je mogoče povezan z dejstvom, da je veliko razširitev, ki so zanimiva za podjetja, že izvedel CVMP v obliki brezplačnih interpolacij v preteklih letih kot del prizadevanj CVMP, da olajša podeljevanje dovoljenj za promet z zdravili za manjšo uporabo in manj pomembne živalske vrste.
The Agency prepared a EudraVigilance action plan, which was subsequently adopted by the Heads of Medicines Agencies and the EMEA Management Board, to address implementation problems relating to the quality of submitted data and legal reporting deadlines.
Agencija je pripravila akcijski načrt EudraVigilance, ki so ga pozneje sprejeli vodje agencij za zdravila in upravni odbor agencije EMEA za obravnavanje težav pri izvajanju v zvezi s kakovostjo predloženih podatkov in zakonitimi roki za poročanje.
For their hard work and dedication throughout the year, I express my deep gratitude to all members of the EMEA staff, as well as to all the experts and colleagues of the Member State national competent authorities and our partners at the European Commission and European Parliament who have contributed greatly to another successful year for the EMEA.
Globoko sem hvaležen vsem članom osebja agencije EMEA za njihovo trdo delo in predanost skozi vse leto, vsem strokovnjakom in kolegom iz nacionalnih pristojnih organov držav članic ter našim partnerjem v Evropski komisiji in Evropskem parlamentu, ki so zelo veliko prispevali k še enemu uspešnemu letu za agencijo EMEA.
Within the existing network, the EMEA worked closely with Member State national competent authorities on activities intended to improve the efficiency of the use of available resources and to secure the long-term availability of appropriate scientific expertise.
Znotraj obstoječe mreže je EMEA z nacionalnimi pristojnimi organi držav članic tesno sodelovala pri dejavnostih, za katere je predvideno, da bodo izboljšale učinkovitost uporabe obstoječih virov in zagotovile dolgoročno dostopnost ustreznega strokovnega znanja.
Four positive opinions related to the extension of existing MRLs to other species.
Štiri pozitivna mnenja so se nanašala na razširitev veljavnih mejnih vrednosti ostankov na druge živalske vrste.
This year also saw Bulgaria and Romania welcomed into the EU family of nations, and they were quickly integrated into the work of the EMEA as full members of the European medicines network, while preparatory work to integrate Croatia and Turkey was also conducted in advance of these countries' possible accession to the EU.
Letos sta se evropski družini narodov pridružili še Bolgarija in Romunija ter bili hitro vključeni v delo agencije EMEA kot polnopravni članici Evropske mreže zdravil, medtem ko smo izvajali tudi pripravljalna dela za vključitev Hrvaške in Turčije pred njuno morebitno pridružitvijo EU.
The European Medicines Agency is the European Union body responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products.
Evropska agencija za zdravila je organ Evropske unije, odgovoren za usklajevanje obstoječih znanstvenih virov, ki so jih dale na razpolago države članice za vrednotenje, nadzor in farmakovigilanco zdravil.
As in previous years, cancer treatment was the most-represented therapeutic area for which the COMP adopted positive orphan-designation opinions.
Enako kot v prejšnjih letih je zdravljenje raka najpogosteje zastopano terapevtsko področje, za katero je COMP sprejel pozitivna mnenja o določitvi zdravila kot zdravila sirote.
The EMEA participated in the planning process at the level of the Heads of Medicines Agencies.
Agencija EMEA je pri postopku načrtovanja sodelovala na ravni vodij nacionalnih agencij za zdravila.
A total of 762 suspected signals concerning 139 intensively monitored medicines, and 349 suspected signals concerning 162 routinely monitored medicines, were identified.
Skupaj je bilo prepoznanih 762 sumov signalov v zvezi s 139 intenzivno spremljanimi zdravili in 349 prepoznanih sumov signalov v zvezi s 162 rutinsko spremljanimi zdravili.
Compliance by Member States with the translation-checking process was very good overall, in both pre-authorisation and post-authorisation phases.
Države članice so pri postopku pregledovanja prevodov na splošno zelo dobro izpolnjevale pogoje, in sicer tako pred izdajo dovoljenja za promet kot tudi po njej.
Two positive opinions were adopted for medicines that were reviewed under accelerated assessment (Isentress and Soliris).
Sprejeti sta bili dve pozitivni mnenji za zdravili, ki sta bili pregledani po postopku pospešenega vrednotenja (Isentress in Soliris).
Reviews were undertaken in the context of a peerreview process within the CHMP.
Presoje so bile izvedene na podlagi postopka medsebojne presoje znotraj CHMP.
The number of good clinical practice (GCP) and pharmacovigilance inspections in 2007 was more than twice the number in 2006.
Število inšpekcijskih pregledov dobre klinične prakse (GCP) in farmakovigilance je bilo v letu 2007 več kot dvakrat večje kot v letu 2006.