FrancophonIA/ELRC3.0 huggingface dataset:
English: The authorisation of herbal medicines (i.e. medicinal plants or parts thereof, or medicinal preparations containing these) in the European Union usually takes place in accordance with the national procedures of individual countries.
Slovenian: Odobritev zdravil rastlinskega izvora (tj. zdravilnih rastlin ali njihovih delov ali njih vsebujočih zdravilnih pripravkov) v Evropski uniji ponavadi poteka skladno z nacionalnimi postopki v posameznih državah.
English: two new mock-up vaccines that can be adapted for use in an influenza pandemic.
Slovenian: Dve novi modelni cepivi, ki se lahko prilagodijo proti pandemiji gripe.
English: Collectively, these partner organisations provide the best-available scientific expertise to ensure a sound regulatory system for medicines in Europe.
Slovenian: Te partnerske organizacije skupaj zagotavljajo najboljšo možno znanstveno strokovno znanje za zagotavljanje dobrega regulativnega sistema za zdravila v Evropi.
English: It is from within this network that the Agency sources most of the experts that serve as members of its scientific committees, working parties and related groups.
Slovenian: Znotraj te mreže Agencija pridobi večino svojih strokovnjakov, ki sodelujejo v njenih znanstvenih odborih, delovnih skupinah in povezanih skupinah.
English: received 5 requests for scientific advice relating to veterinary medicines.
Slovenian: prejela 5 zahtevkov za znanstveno svetovanje v zvezi z zdravili za uporabo v veterinarski medicini.
English: The main initiative undertaken in 2008 within the framework of this strategy was the introduction of an early notification system for improved communication between European regulatory authorities, as well as with the US Food and Drug Administration, on envisaged regulatory action to be taken in response to (emerging) safety issues.
Slovenian: Glavna pobuda, opravljena v letu 2008 v okviru te strategije, je bila uvedba zgodnjega sistema prijavljanja za izboljšanje komunikacije med evropskimi regulativnimi organi ter tudi Uradom za živila in zdravila iz ZDA glede predvidenih regulativnih ukrepov, ki naj bi se izvedli kot odziv na (porajajoča se) varnostna vprašanja.
English: Medicines regulators around the world share the same objective of establishing adequate procedures for the development, testing, authorisation and monitoring of medicines, in the interest of protecting the populations they represent.
Slovenian: Regulativni organi za zdravila po vsem svetu imajo isti cilj vzpostavljanje ustreznih postopkov za razvoj, preskušanje, odobritev in spremljanje zdravil z namenom zaščite ljudi, ki jih zastopajo.
English: Roughly half of these applications related to type-I variations (minor changes) and half to type-II variations (major changes).
Slovenian: Približno polovica teh vlog se je nanašala na spremembe tipa I (manjše spremembe), druga polovica pa na spremembe tipa II (večje spremembe).
English: a series of exchanges of information with the medicines authorities of the USA, Canada and Japan, within the framework of confidentiality arrangements signed between the EU and these countries;
Slovenian: niz izmenjav informacij z organi, pristojnimi za zdravila, v ZDA, Kanadi in na Japonskem, v okviru dogovorov o zaupnosti, ki so podpisani med EU in omenjenimi državami;
English: The CHMP will process these applications within 210 days, as stipulated in EU legislation, and adopt opinions in each case as to whether or not it recommends that a marketing authorisation should be granted.
Slovenian: CHMP bo obdelal te vloge v 210 dneh, kakor določa zakonodaja EU, in v vsakem primeru sprejel mnenje o priporočilu odobritve dovoljenja ali zavrnitvi le-tega.
English: The EU offers pharmaceutical companies incentives to develop such medicines, so that patients suffering from rare diseases may benefit from a similar quality of medical treatment as other patients.
Slovenian: EU nudi farmacevtskim družbam spodbude za razvoj takšnih zdravil, tako da so lahko bolniki, ki imajo redke bolezni, deležni zdravljenja podobne kakovosti kot drugi bolniki.
English: 8 Maximum residue limit: the maximum acceptable concentration of the residue of a medicine in a food product obtained from a treated animal.
Slovenian: Najvišje mejne vrednosti ostankov: najvišja sprejemljiva koncentracija ostankov zdravila v živilu, ki se pridobi iz zdravljene živali.
English: Supervising the development of medicines for children
Slovenian: Nadzor razvoja zdravil za otroke
English: A CHMP opinion is a recommendation to the European Commission on whether or not it should grant a Community marketing authorisation (or licence) that allows the medicine concerned to be placed on the market in all 30 European Economic Area countries (the 27 European Union Member States, plus Iceland, Liechtenstein and Norway).
Slovenian: Mnenje CHMP je priporočilo Evropski komisiji, da odobri ali zavrne dovoljenje (ali licenco) Skupnosti za promet z zdravilom, ki omogoča dajanje zdravila v promet v vseh 30 državah Evropskega gospodarskega prostora (27 držav članic Evropske unije ter Islandija, Lihtenštajn in Norveška).
English: The European Risk Management Strategy is a strategy developed by the Agency and its partners in the European regulatory network for medicines.
Slovenian: Evropsko strategijo obvladovanja tveganja je Agencija pripravila s svojimi partnerji v evropski regulativni mreži za zdravila.
English: Minor changes require only that a notification be sent to the Agency for validation.
Slovenian: Manjše spremembe zahtevajo le obveščanje Agencije, da jih potrdi.
English: Of the 66 medicines to receive a positive opinion from the CHMP in 2008, those that are of particular note include:
Slovenian: Od 66 zdravil, ki so prejela pozitivno mnenje CHMP v letu 2008, je treba posebej izpostaviti naslednje:
English: improving resource-planning, notably by providing regular estimates of resources required for forthcoming applications for regulatory procedures;
Slovenian: izboljšanje načrtovanja virov, zlasti s pripravo rednih ocen virov, ki so potrebni za prihodnje vloge za regulativne postopke;
English: In 2008, the Agency reviewed 391 such reports relating to medicines for human use and 91 relating to veterinary medicines.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Revenue and staffing figures
Slovenian: Prihodki in zaposleni
English: improving competence-development, notably by providing a series of training sessions for experts and assessors on a range of specialised topics.
Slovenian: izboljšanje razvijanja usposobljenosti, zlasti s pripravo niza usposabljanj za strokovnjake in presojevalce o številnih specializiranih temah.
English: adopted 5 entries to the ‘Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products'5.
Slovenian: sprejel 5 vnosov v „Seznam rastlinskih snovi Skupnosti, njihovih pripravkov in kombinacij za uporabo v tradicionalnih zdravilih rastlinskega izvora“5.
English: 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.
Slovenian: 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.
English: 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;
Slovenian: izboljšanje organizacije sej v Agenciji, zlasti izboljšanje razpoložljivosti video- in telekonferenčne opreme, kar zmanjša potrebo po potovanjih strokovnjakov na različne lokacije Agencije;
English: adopted 129 positive and 4 negative opinions on PIP applications, and 8 positive opinions on modification of agreed PIPs;
Slovenian: sprejel 129 pozitivnih in 4 negativna mnenja o vlogah za PIP ter 8 pozitivnih mnenj o spremembah dogovorjenih načrtov pediatričnih raziskav;
English: almost two thirds of orphan designations were for medicines to treat conditions affecting children.
Slovenian: bilo skoraj dve tretjini določitev zdravil sirot za zdravila, ki se uporabljajo za zdravljenje bolezni otrok.
English: 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;
Slovenian: 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:
English: It is intended for use in patients who do not respond well to, or cannot tolerate, conventional arthritis treatments.
Slovenian: Namenjeno je uporabi pri bolnikih, ki se ne odzivajo dobro na običajna zdravljenja artritisa ali jih ne prenašajo.
English: Providing scientific advice to support the development of medicines
Slovenian: Zagotavljanje znanstvenega svetovanje v podporo razvoja zdravil
English: 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.
Slovenian: 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.
English: ‘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.
Slovenian: 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.
English: In 2008, the SME Office:
Slovenian: V letu 2008 je urad za mala in srednje velika podjetja:
English: 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.
Slovenian: 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“.
English: Public-health benefits of medicines recommended for authorisation in 2008
Slovenian: Koristi zdravil, priporočenih za odobritev v letu 2008, za javno zdravje
English: 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.
Slovenian: CHMP sprejema mnenja po strogem ocenjevanju znanstvenih podatkov, ki so jih predložile farmacevtske družbe v podporo svojim vlogam za odobritev zdravil.
English: 119 orphan-designation applications were submitted to the Agency;
Slovenian: bilo Agenciji predloženih 119 vlog za določitev zdravila sirote;
English: The medicine concerned was an anti-obesity medicine.
Slovenian: Zadevno zdravilo je bilo zdravilo proti debelosti.
English: processed 337 applications for qualification or renewal of SME status;
Slovenian: obdelal 337 vlog za izpolnjevanje statusa malih in srednje velikih podjetij ali obnovitev tega statusa;
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Reporting in EudraVigilance Veterinary
Slovenian: Poročanje v sistemu EudraVigilance Veterinary
English: 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;
Slovenian: 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;
English: 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.
Slovenian: 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.
English: The COMP's opinion is forwarded to the European Commission, which takes the final decision on orphan designation.
Slovenian: Mnenje Odbora za zdravila sirote se pošlje Evropski komisiji, ki sprejme končno odločitev o določitvi zdravila sirote.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: An equivalent system, called EudraVigilance Veterinary, exists to receive reports of adverse reactions occurring through the use of authorised veterinary medicines.
Slovenian: Enakovreden sistem, imenovan EudraVigilance Veterinary, obstaja za prejemanje poročil o neželenih učinkih, ki se pojavljajo pri uporabi odobrenih veterinarskih zdravil.
English: Three of these applications concerned generic versions of previously authorised medicines.
Slovenian: Tri od teh vlog so zadevale generične različice že odobrenih zdravil.
English: published a revised and updated version of its SME User Guide on the Agency's website;
Slovenian: na spletišču Agencije objavil popravljeno in posodobljeno različico Uporabniškega priročnika za mala in srednje velika podjetja;
English: A further 308 reports related to adverse reactions occurring in humans following exposure to veterinary medicines.
Slovenian: Dodatnih 308 poročil se je nanašalo na neželene učinke pri ljudeh po izpostavitvi veterinarskim zdravilom.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Modelni cepivi nista namenjeni izdelavi, temveč lahko bistveno pospešita postopek odobritve „pravih“ cepiv po identifikaciji pandemičnega seva.
English: conducted 5 compliance-checks as part of the validation process for marketing-authorisation applications;
Slovenian: opravil 5 preverjanj skladnosti kot del validacijskega postopka vlog za odobritev dovoljenja za promet z zdravilom;
English: 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.
Slovenian: 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.
English: Activities carried out in 2008 to provide greater transparency of documents and data controlled by the Agency included:
Slovenian: Dejavnosti za zagotovitev večje preglednosti dokumentov in podatkov, ki jih obvladuje Agencija, so bile v letu 2008:
English: 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.).
Slovenian: 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.).
English: It can be used with other anticancer medicines after the cancer has been removed by surgery.
Slovenian: Lahko se uporablja z drugimi zdravili proti raku po odstranitvi rakavega tkiva s kirurškim posegom.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: All 13 procedures resulted in a positive opinion being adopted by the Agency's Committee for Medicinal Products for Veterinary Use (CVMP).
Slovenian: Vseh 13 postopkov se je končalo s pozitivnim mnenjem, ki ga je sprejel Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
English: This will allow doctors a wider scope when prescribing these medicines to patients, which benefits patients by extending the treatment options available to them;
Slovenian: To omogoča zdravnikom več možnosti pri predpisovanju teh zdravil bolnikom, kar koristi bolnikom, saj se povečajo možnosti zdravljenja, ki so jim na voljo;
English: 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.
Slovenian: 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.
English: National origins of Agency staff
Slovenian: Narodnost osebja Agencije
English: Twenty-three applications were withdrawn by applicants before completion of the evaluation procedure.
Slovenian: Vlagatelji so umaknili 23 vlog pred zaključkom postopka ocenjevanja.
English: 31 were type-II variation procedures that resulted in positive opinions from the CHMP on the extension of indication of authorised medicines.
Slovenian: je bilo 31 postopkov spremembe tipa II, ki so se končali s pozitivnim mnenjem CHMP o razširitvi indikacije odobrenega zdravila.
English: Reviewing periodic safety update reports for human and veterinary medicines
Slovenian: Pregled periodičnih poročil o varnosti zdravil za uporabo v humani in veterinarski medicini
English: 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.
Slovenian: 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.
English: Post-authorisation procedures finalised
Slovenian: Zaključeni postopki po izdaji dovoljenja