natgillin/translations-raw huggingface dataset:
Minor changes require only that a notification be sent to the Agency for validation.
Manjše spremembe zahtevajo le obveščanje Agencije, da jih potrdi.
Of the 66 medicines to receive a positive opinion from the CHMP in 2008, those that are of particular note include:
Od 66 zdravil, ki so prejela pozitivno mnenje CHMP v letu 2008, je treba posebej izpostaviti naslednje:
improving resource-planning, notably by providing regular estimates of resources required for forthcoming applications for regulatory procedures;
izboljšanje načrtovanja virov, zlasti s pripravo rednih ocen virov, ki so potrebni za prihodnje vloge za regulativne postopke;
In 2008, the Agency reviewed 391 such reports relating to medicines for human use and 91 relating to veterinary medicines.
V letu 2008 je Agencija pregledala 391 takih poročil v zvezi z zdravili za uporabo v humani medicini in 91 poročil v zvezi z veterinarskimi zdravili.
The EudraVigilance reporting system, which is managed by the European Medicines Agency, allows the safety of authorised medicines to be monitored continuously, so that appropriate regulatory action, such as the suspension of a marketing authorisation, can be taken rapidly whenever there is a risk to public health.
Sistem poročanja EudraVigilance, ki ga upravlja Evropska agencija za zdravila, omogoča stalno spremljanje varnosti odobrenih zdravil, tako da se lahko hitro sprejmejo ustrezni regulativni ukrepi, kot je zadržanje dovoljenja za promet, vedno ko obstaja tveganje za javno zdravje.
Revenue and staffing figures
Prihodki in zaposleni
improving competence-development, notably by providing a series of training sessions for experts and assessors on a range of specialised topics.
izboljšanje razvijanja usposobljenosti, zlasti s pripravo niza usposabljanj za strokovnjake in presojevalce o številnih specializiranih temah.
adopted 5 entries to the ‘Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products'5.
sprejel 5 vnosov v „Seznam rastlinskih snovi Skupnosti, njihovih pripravkov in kombinacij za uporabo v tradicionalnih zdravilih rastlinskega izvora“5.
preparing for the future provision of access to certain data contained in EudraCT - the EU's database of clinical-trial information - and preparing an implementation plan for adapting information-technology systems to allow for such access.
priprave za prihodnje zagotavljanje dostopa do določenih podatkov v sistemu EudraCT, zbirke podatkov EU o kliničnih preskušanjih, in priprava načrta uresničevanja prilagoditve sistemov informacijske tehnologije, ki bodo omogočili ta dostop.
improving the organisation of meetings at the Agency, notably by improving the availability of video- and teleconferencing facilities, thus reducing the need for experts to travel to the Agency's premises;
izboljšanje organizacije sej v Agenciji, zlasti izboljšanje razpoložljivosti video- in telekonferenčne opreme, kar zmanjša potrebo po potovanjih strokovnjakov na različne lokacije Agencije;
adopted 129 positive and 4 negative opinions on PIP applications, and 8 positive opinions on modification of agreed PIPs;
sprejel 129 pozitivnih in 4 negativna mnenja o vlogah za PIP ter 8 pozitivnih mnenj o spremembah dogovorjenih načrtov pediatričnih raziskav;
almost two thirds of orphan designations were for medicines to treat conditions affecting children.
bilo skoraj dve tretjini določitev zdravil sirot za zdravila, ki se uporabljajo za zdravljenje bolezni otrok.
participation in a series of projects being run by the World Health Organization, notably the ‘Make medicines child size' programme aimed at addressing the need for improved availability of safe medicines for children;
sodelovanje v nizu projektov, ki jih vodi Svetovna zdravstvena organizacija, zlasti v programu „Zdravila po meri otrok“, katerega cilj je usmeriti pozornost na potrebo po izboljšanju razpoložljivosti varnih zdravil za otroke:
It is intended for use in patients who do not respond well to, or cannot tolerate, conventional arthritis treatments.
Namenjeno je uporabi pri bolnikih, ki se ne odzivajo dobro na običajna zdravljenja artritisa ali jih ne prenašajo.
Providing scientific advice to support the development of medicines
Zagotavljanje znanstvenega svetovanje v podporo razvoja zdravil
For major changes, the marketing-authorisation holder is usually obliged to submit new data for evaluation by the CHMP and adoption of an opinion on the acceptability of the proposed change.
Pri večjih spremembah mora imetnik dovoljenja za promet z zdravili ponavadi predložiti nove podatke za oceno s strani CHMP ter sprejem mnenja o sprejemljivosti predlagane spremembe.
‘Orphan' medicines are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect not more than five in 10,000 persons in the European Union.
Zdravila „sirote“ so namenjena diagnosticiranju, preprečevanju ali zdravljenju smrtno nevarnih ali kronično izčrpavajočih bolezni, ki prizadenejo do pet na 10.000 oseb v Evropski uniji.
In 2008, the SME Office:
V letu 2008 je urad za mala in srednje velika podjetja:
However, set against a background of continuing globalisation of the pharmaceutical sector, further rapid advances in medical science and the unrelenting pace of regulatory activity in the medicines network of the European Union (EU), it was by no means a ‘dull' year for the Agency.
Vendar zaradi nadaljevanja globalizacije farmacevtskega sektorja, dodatnega hitrega napredka v medicini in neizprosno hitrega poteka regulativnih dejavnosti v mreži zdravil v Evropski uniji (EU) to leto za Agencijo gotovo ni bilo „dolgočasno“.
Public-health benefits of medicines recommended for authorisation in 2008
Koristi zdravil, priporočenih za odobritev v letu 2008, za javno zdravje
The CHMP adopts opinions after a rigorous evaluation of the scientific data submitted by pharmaceutical companies in support of their applications for approval of their medicinal products.
CHMP sprejema mnenja po strogem ocenjevanju znanstvenih podatkov, ki so jih predložile farmacevtske družbe v podporo svojim vlogam za odobritev zdravil.
119 orphan-designation applications were submitted to the Agency;
bilo Agenciji predloženih 119 vlog za določitev zdravila sirote;
The medicine concerned was an anti-obesity medicine.
Zadevno zdravilo je bilo zdravilo proti debelosti.
processed 337 applications for qualification or renewal of SME status;
obdelal 337 vlog za izpolnjevanje statusa malih in srednje velikih podjetij ali obnovitev tega statusa;
The Agency devoted considerable effort in 2008 to setting up its sixth scientific committee - the Committee for Advanced Therapies (CAT) - and putting in place all relevant procedures and personnel ahead of the Committee's inaugural meeting in January 2009.
Agencija je v letu 2008 posvetila veliko naporov ustanovitvi šestega znanstvenega odbora, Odbora za napredno zdravljenje, in vzpostavitvi vseh zadevnih postopkov ter osebja pred inavguralno sejo Odbora januarja 2009.
Closer to home, the Agency continued to work with its EU institutional partners and the national regulatory authorities of the Member States to stimulate innovation in the pharmaceutical sector, strengthen the safety-monitoring of medicines, exchange expertise on a wide range of issues, and forge close relations to build the best possible regulatory system for Europe.
V domačem okolju pa je Agencija še naprej sodelovala s svojimi institucionalnimi partnerji in nacionalnimi regulativnimi organi držav članic pri spodbujanju inovacij v farmacevtskem sektorju, krepitvi nadzora varnosti zdravil, izmenjavi strokovnega znanja s širokega področja ter oblikovanju tesnih povezav za izgradnjo najboljšega možnega regulativnega sistema za Evropo.
Reporting in EudraVigilance Veterinary
Poročanje v sistemu EudraVigilance Veterinary
an ongoing programme of activities designed to help the regulatory authorities of Croatia, Turkey and the former Yugoslav Republic of Macedonia prepare for integration into the European medicines network upon the eventual accession of these countries to the EU;
stalni program dejavnosti za pomoč regulativnim organom na Hrvaškem, v Turčiji in Makedoniji pri pripravi za integracijo v Evropsko mrežo zdravil ob morebitni pridružitvi teh držav v EU;
This section provides an overview of the main activities of the European Medicines Agency in 2008, listed according to priority areas the Agency set itself in its work programme for the year.
V tem razdelku je pregled glavnih dejavnosti Evropske agencije za zdravila v letu 2008, te pa so razvrščene po prednostnih področjih, ki si jih je Agencija zastavila v delovnem programu za to leto.
The COMP's opinion is forwarded to the European Commission, which takes the final decision on orphan designation.
Mnenje Odbora za zdravila sirote se pošlje Evropski komisiji, ki sprejme končno odločitev o določitvi zdravila sirote.
The majority of positive CHMP opinions adopted in 2008 related to cancer medicines, followed by antiinfectives and medicines for the treatment of neurological and central-nervous-system conditions.
Večina pozitivnih mnenj CHMP, ki so bila sprejeta v letu 2008, se je nanašala na zdravila za raka, sledijo zdravila proti okužbam in zdravila za zdravljenje bolezni živčevja in centralnega živčnega sistema.
It assesses the quality, safety and efficacy of the medicine concerned, and adopts a positive opinion if it is satisfied that the data submitted demonstrate that the medicine's benefits outweigh any risks associated with its use.
Odbor ovrednoti kakovost, varnost in učinkovitost zadevnih zdravil ter sprejme pozitivno mnenje, če predloženi podatki dokazujejo, da so koristi zdravila večje od tveganja, ki je povezano z njegovo uporabo.
The total number of people employed by the Agency at the end of 2008, including regular staff plus contract agents, visiting experts, interims and trainees, was 624, or some 14% more than the 547 employed in 2007.
Skupno število zaposlenih v Agenciji konec leta 2008, vključno z rednim osebjem, pogodbeniki, gostujočimi strokovnjaki, začasno zaposlenimi in pripravniki, je bilo 624, kar je približno za 14 % več kot v letu 2007, ko je bilo zaposlenih 547 oseb.
An equivalent system, called EudraVigilance Veterinary, exists to receive reports of adverse reactions occurring through the use of authorised veterinary medicines.
Enakovreden sistem, imenovan EudraVigilance Veterinary, obstaja za prejemanje poročil o neželenih učinkih, ki se pojavljajo pri uporabi odobrenih veterinarskih zdravil.
Three of these applications concerned generic versions of previously authorised medicines.
Tri od teh vlog so zadevale generične različice že odobrenih zdravil.
published a revised and updated version of its SME User Guide on the Agency's website;
na spletišču Agencije objavil popravljeno in posodobljeno različico Uporabniškega priročnika za mala in srednje velika podjetja;
A further 308 reports related to adverse reactions occurring in humans following exposure to veterinary medicines.
Dodatnih 308 poročil se je nanašalo na neželene učinke pri ljudeh po izpostavitvi veterinarskim zdravilom.
As pharmaceutical development and clinical trials of medicines move increasingly beyond the traditional spheres of Europe and North America, regulators are becoming more keenly aware of the need for international cooperation on ensuring that safe and ethical practices are being used for the development and testing of medicinal products in all parts of the world.
Frmacevtski razvoj in klinična preskušanja zdravil pa vse pogosteje potekajo izven tradicionalnega okolja Evrope in Severne Amerike, zato se regulativni organi vse bolj zavedajo potrebe po mednarodnem sodelovanju, s katerim bi zagotovili uporabo varnih in etičnih praks pri razvoju in preskušanju zdravil po celem svetu.
These mock-ups are not themselves intended for production, but can be used to greatly speed up the authorisation procedure for ‘real' vaccines once the strain of the virus causing the pandemic has been identified.
Modelni cepivi nista namenjeni izdelavi, temveč lahko bistveno pospešita postopek odobritve „pravih“ cepiv po identifikaciji pandemičnega seva.
conducted 5 compliance-checks as part of the validation process for marketing-authorisation applications;
opravil 5 preverjanj skladnosti kot del validacijskega postopka vlog za odobritev dovoljenja za promet z zdravilom;
A dedicated SME Office within the Agency provides support to SMEs on these and related issues, to help them maximise the benefits available to them, and thus contributes towards stimulating innovation of new medicines and improving their availability to patients.
Specializirani urad za mala in srednje velika podjetja v Agenciji tem zagotavlja podporo pri takšnih in sorodnih vprašanjih, pomaga kar najbolj izkoristiti koristne razpoložljive možnosti, in s tem prispeva k spodbujanju inovacij novih zdravil in izboljšanju njihove dostopnosti bolnikom.
Activities carried out in 2008 to provide greater transparency of documents and data controlled by the Agency included:
Dejavnosti za zagotovitev večje preglednosti dokumentov in podatkov, ki jih obvladuje Agencija, so bile v letu 2008:
A total of 1,943 reports of adverse reactions in animals were recorded in EudraVigilance Veterinary in 2008, of which 1,712 related to reactions in companion animals (971 in dogs and 704 in cats) and 231 in food-producing animals (cows, pigs, etc.).
V sistemu EudraVigilance za veterino je bilo v letu 2008 ugotovljenih skupno 1 934 poročil o neželenih učinkih pri živalih, od katerih se je 1 712 poročil nanašalo na reakcije pri hišnih živalih (971 pri psih in 704 pri mačkah) ter 231 pri živalih, namenjenih proizvodnji hrane (kravah, prašičih itn.).
It can be used with other anticancer medicines after the cancer has been removed by surgery.
Lahko se uporablja z drugimi zdravili proti raku po odstranitvi rakavega tkiva s kirurškim posegom.
These reports compile all known safety data relating to the use of the medicine concerned, including information that becomes available through additional trials conducted after the medicine has been authorised.
Ta poročila vsebujejo vse znane varnostne podatke v zvezi z uporabo zadevnega zdravila, vključno s podatki, ki postanejo dostopni v dodatnih preskušanjih po odobritvi zdravila.
The Paediatric Committee adopts decisions on certain classes of medicines for which no PIP needs to be established, such as medicines intended to treat conditions that do not affect children or adolescents (e.g. Parkinson's disease).
Odbor za pediatrijo sprejme odločitve o določenih skupinah zdravil, za katere niso potrebni načrti pediatričnih raziskav, kot so zdravila za zdravljenje bolezni, ki se ne pojavljajo pri otrocih in mladostnikih (npr. Parkinsonova bolezen).
Its aim is to put in place measures that allow the early detection, assessment, minimisation and communication of risks associated with medicines throughout their lifecycle.
Njen cilj je uvedba ukrepov, ki omogočajo zgodnje odkrivanje, vrednotenje, čim večje zmanjšanje tveganja in prenos informacij o tveganju, povezanem z zdravili v njihovem celotnem življenjskem ciklu.
All 13 procedures resulted in a positive opinion being adopted by the Agency's Committee for Medicinal Products for Veterinary Use (CVMP).
Vseh 13 postopkov se je končalo s pozitivnim mnenjem, ki ga je sprejel Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
This will allow doctors a wider scope when prescribing these medicines to patients, which benefits patients by extending the treatment options available to them;
To omogoča zdravnikom več možnosti pri predpisovanju teh zdravil bolnikom, kar koristi bolnikom, saj se povečajo možnosti zdravljenja, ki so jim na voljo;
The Agency engages in an intensive annual programme of activities with its regulatory and scientific partners across Europe, and with their counterparts on other continents, to contribute towards these global efforts for better and safer medicines.
Agencija ima intenziven letni program dejavnosti s svojimi regulativnimi in znanstvenimi partnerji v Evropi ter njej enakovrednimi organi na drugih celinah z namenom prispevati k tem globalnim naporom za boljša in varnejša zdravila.
National origins of Agency staff
Narodnost osebja Agencije
Twenty-three applications were withdrawn by applicants before completion of the evaluation procedure.
Vlagatelji so umaknili 23 vlog pred zaključkom postopka ocenjevanja.
31 were type-II variation procedures that resulted in positive opinions from the CHMP on the extension of indication of authorised medicines.
je bilo 31 postopkov spremembe tipa II, ki so se končali s pozitivnim mnenjem CHMP o razširitvi indikacije odobrenega zdravila.
Reviewing periodic safety update reports for human and veterinary medicines
Pregled periodičnih poročil o varnosti zdravil za uporabo v humani in veterinarski medicini
In recognition of this, special provisions have been made in EU legislation to offer financial incentives for such companies, including the reduction or deferment of fees payable to the Agency for regulatory procedures such as marketingauthorisation applications or, for veterinary medicines, the establishment of maximum residue limits8.
V priznanje temu so v zakonodaji EU posebna določila za ponujanje finančnih spodbud tem podjetjem, vključno z zmanjšanjem ali odlogom pristojbin, ki se plačajo Agenciji za regulativne postopke, kot so vloge za izdajo dovoljenja za promet z zdravilom ali določitev najvišjih mejnih vrednosti ostankov za zdravila za uporabo v veterinarski medicini8.
Post-authorisation procedures finalised
Zaključeni postopki po izdaji dovoljenja
‘Post-authorisation procedures' relate to the processing of applications received from marketingauthorisation holders (licensees) who wish to make changes to their authorised medicines, or who are obliged to do so (for example, to include new safety warnings in the prescribing information).
„Postopki po izdaji dovoljenja za promet“ se nanašajo na obdelavo vlog, prejetih od imetnikov dovoljenj za promet z zdravili (imetnikov licence), ki želijo spremeniti odobreno zdravilo ali morajo to storiti (na primer zaradi vključitve novih varnostnih opozoril v informacije za predpisovanje zdravila).
The Agency devoted much effort during the year to preparing for the entry into force of the EU's new Advanced Therapies Regulation - a piece of legislation that will greatly strengthen regulatory procedures relating to medicines at the cutting edge of medical science.
Agencija si je med letom posvetila močno prizadevala za pripravo uvedbe nove zakonodaje EU o zdravilih za napredno zdravljenje - delu zakonodaje za močno okrepitev regulativnih postopkov v zvezi z zdravili, ki so rezultat visoko razvite medicinske znanosti.
the first vaccine for adults against Japanese encephalitis, a disease transmitted by mosquitoes that causes inflammation of the brain and which can lead to long-term disability or death.
Prvo cepivo za odrasle proti japonskemu encefalitisu, bolezni, ki jo prenašajo komarji in povzroča vnetje možganov, kar povzroči dolgotrajno invalidnost ali smrt.
over 100 were type-II variation procedures that resulted in new information, including safety warnings or precautions, being added to the prescribing information for authorised medicines, thereby helping to reduce the risk of misuse or unwanted side-effects associated with the use of these medicines;
je bilo več kot 100 postopkov spremembe tipa II, ki so se končali z dodatkom novih informacij (vključno varnostnih opozoril in previdnostnih ukrepov) v informacije za predpisovanje odobrenih zdravil, kar pripomore k zmanjšanju tveganja napačne uporabe ali neželenih učinkov, ki so povezani z uporabo zadevnih zdravil;
In 2008, the HMPC: finalised 17 Community herbal monographs4 for traditional and well-established herbal medicines;
V letu 2008 je HMPC: dokončal 17 monografij rastlin Skupnosti4 za tradicionalna in dobro uveljavljena zdravila rastlinskega izvora;
Assessing applications for orphan designation
Vrednotenje vlog za določitev zdravila sirote
the first pre-pandemic vaccine for use in adults against the H5N1 subtype of the influenza-A virus, which may cause avian influenza in humans.
Prvo predpandemično cepivo za uporabo pri odraslih proti virusu influence A podtipa H5N1, ki lahko povzroči ptičjo gripo pri človeku.
7 Centrally authorised medicines are ones that have been simultaneously approved in all EEA countries, through procedures operated by the European Medicines Agency, whereas non-centrally authorised medicines have been approved separately by one or more EEA countries.
Zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku, so tista, ki so bila sočasno odobrena v vseh državah EGP v postopkih, ki jih je vodila Evropska agencija za zdravila, zdravila, za katera ni bilo izdano dovoljenje po centraliziranem postopku, pa so bila ločeno odobrena v eni ali več državah EGP.
The year 2008 was one of consolidation and steady progress for the European Medicines Agency (EMEA), rather than one of major leaps and bounds.
Leto 2008 je bilo za Evropsko agencijo za zdravila (EMEA) leto utrjevanja in preudarnega napredka, in ne leto velikih korakov in mejnikov.
a new compound in an existing class of antiretroviral medicines that can be used to treat adults infected with HIV-1 (the virus that causes AIDS) in whom treatment with other medicines in the same class has been unsuccessful.
Nova spojina iz obstoječe skupine protiretrovirusnih zdravil, ki se lahko uporablja za zdravljenje odraslih bolnikov, okuženih z virusom HIV-1 (virusom, ki povzroča AIDS), pri katerih je bilo zdravljenje z drugimi zdravili iz iste skupine neuspešno.
One further application was withdrawn by the applicant before completion of the evaluation procedure.
Eno vlogo pa je vlagatelj umaknil pred zaključkom postopka ocenjevanja.
As part of its ongoing efforts to strengthen the efficiency of the network, the Agency focused in 2008 on:
Agencija se je v svojih prizadevanjih za krepitev učinkovitosti mreže v letu 2008 osredotočila na:
CAP EEA reports CAP non-EEA reports non-CAP EEA reports non-CAP non-EEA reports
Poročila za CAP iz EGP Poročila za CAP izven EGP Poročila za neCAP iz EGP Poročila za neCAP izven EGP
At any stage in their development of a medicine, a company can request scientific advice on how best to conduct the various trials and studies that are necessary to demonstrate the quality, safety and efficacy of their product, and thus improve their chances of obtaining a marketing authorisation for it.
Podjetje lahko na vsaki stopnji razvoja zdravila prosi za znanstveno svetovanje o najboljšem načinu izvedbe različnih preskušanj in študij, ki so potrebne za dokaz kakovosti, varnosti in učinkovitosti zdravila, ter s tem poveča možnosti odobritve dovoljenja za promet z zdravilom.
Evaluating medicines for human use Record number of positive opinions adopted for new human medicines
Vrednotenje zdravil za uporabo v humani medicini Rekordno število sprejetih pozitivnih mnenj za nova zdravila za uporabo v humani medicini
made 1 positive recommendation on extending the use of a medicine authorised for use in adults to use in children, based on clinical-trial data generated in accordance with an agreed PIP.
izdal 1 pozitivno priporočilo o razširitvi uporabe zdravila, ki je odobreno za uporabo pri odraslih, na uporabo pri otrocih zaradi rezultatov kliničnih preskušanj, ki so bili pridobljeni skladno z dogovorjenim načrtom pediatričnih raziskav.
The establishment of the CAT was stipulated in the EU's Advanced Therapies Regulation9 - a new and important piece of legislation that introduces special procedures for the evaluation and authorisation of ‘advanced therapy medicinal products' - medicines derived from gene therapy, somatic cell therapy or tissue engineering - which offer groundbreaking treatment options for patients.
Ustanovitev Odbora za napredno zdravljenje določa Uredba EU o naprednem zdravljenju9, nov in pomemben del zakonodaje, ki uvaja posebne postopke za oceno in odobritev „zdravil za napredno zdravljenje“ - zdravil, pridobljenih z gensko terapijo, terapijo s somatskimi celicami ali tkivnim inženirstvom -, ki bolnikom omogočajo najnovejše možnosti zdravljenja.
Four were line-extension applications.
Štiri vloge so bile za razširitev indikacij.