FrancophonIA/ELRC3.0 huggingface dataset:
English: A status report on the progress of the implementation plan for the framework of interaction with patients and consumers was presented to the Patients' and Consumers' Working Party (PCWP) during its December 2007 meeting.
Slovenian: Poročilo o napredku izvedbenega načrta za okvir sodelovanja z bolniki in potrošniki je bilo predstavljeno delovni skupini bolnikov in potrošnikov (PCWP) na njenem sestanku decembra 2007.
English: Pharmacovigilance in the veterinary sector in the EU continues to undergo changes triggered by the revised pharmaceuticals legislation introduced in 2004.
Slovenian: Področje farmakovigilance v veterinarskem sektorju v EU se še naprej spreminja, kar je povzročila spremenjena zakonodaja o farmacevtskih izdelkih, ki je začela veljati leta 2004.
English: Guiding principles
Slovenian: Vodilna načela
English: The CVMP endorsed a set of proposals for measures that could be provided by the EMEA to assist companies with the submission of applications through the centralised procedure relating to limited markets, in line with the requirements of Article 79 of Regulation 726/2004.
Slovenian: CVPM je potrdil skupino predlogov za ukrepe, ki bi jih agencija EMEA lahko zagotovila za pomoč podjetjem pri predložitvi vlog po centraliziranem postopku za omejene trge v skladu z zahtevami iz člena 79 Uredbe št. 726/2004.
English: European risk-management strategy (ERMS) for medicines for human use: further progress made
Slovenian: Evropska strategija obvladovanja tveganja (ERMS) za zdravila za uporabo v humani medicini: dosežen je bil nadaljnji napredek
English: The first version of EudraGMP was launched in April 2007, and version 1.1 was released into production in December 2007.
Slovenian: Prva različica sistema EudraGMP je bila izdana aprila 2007, ustvarjanje različice 1.1 pa se je začelo decembra 2007.
English: Legal role
Slovenian: Pravna vloga
English: The number of national competent authorities and pharmaceutical companies reporting electronically to EudraVigilance (the EU database on adverse drug reactions) increased in 2007.
Slovenian: Število nacionalnih pristojnih organov in farmacevtskih podjetij, ki elektronsko poročajo v sistem EudraVigilance (zbirka podatkov EU o neželenih učinkih zdravil), se je v letu 2007 povečalo.
English: These corresponded to 85 applications with an average of 2 to 4 indications per application.
Slovenian: Te so ustrezale 85 vlogam, v katerih so bile v povprečju od dve do štiri indikacije na vlogo.
English: A total of 125 applications were received for the designation of orphan medicines - the fourth consecutive year in which more than one hundred such applications have been submitted.
Slovenian: Za določitev zdravil sirot je bilo prejetih skupno 125 vlog; to je bilo že četrto zaporedno leto, v katerem je bilo predloženih več kot sto takih vlog.
English: Audioconferencing was introduced for some meetings, reducing the need for experts to travel to the EMEA.
Slovenian: Pri nekaterih sestankih so bile uvedene avdiokonference, kar je zmanjšalo potrebo po tem, da strokovnjaki potujejo na sedež agencije EMEA.
English: Periodic safety update reports (PSURs)
Slovenian: Z zadnjimi podatki dopolnjena redna poročila o varnosti (PSUR)
English: The full annual report for 2007 was adopted by the Management Board on 6 March 2008, and is available on the EMEA website:
Slovenian: Celotno letno poročilo za leto 2007 je upravni odbor sprejel 6. marca 2008 in je na voljo na spletni strani Evropske agencije za zdravila:
English: The European medicines network - a partnership of more than 40 medicines regulatory authorities in the European Union (EU) - is the basis of the EMEA's success.
Slovenian: Evropska mreža zdravil je partnerstvo več kot 40 regulativnih organov za zdravila v Evropski uniji (EU) in je temelj uspeha agencije EMEA.
English: Nine out of the 36 finalised referral procedures related to safety concerns.
Slovenian: Devet od 36 končanih postopkov napotitve se je nanašalo na varnostni vidik.
English: EMEA/197729/2008/EN/FINAL
Slovenian: EMEA/421613/2008/SL/KONČNA
English: Bulgarian, Romanian and (following the expiry of the derogation) Maltese were successfully included in the translations framework.
Slovenian: V prevode so bile uspešno vključene bolgarščina, romunščina in (po preteku odstopanja) malteščina.
English: Free scientific advice for minor uses and minor species
Slovenian: Brezplačno znanstveno svetovanje za manjšo uporabo in manj pomembne živalske vrste
English: Risk-management plans (RMPs) are submitted as part of a new application or an application involving a significant change in the marketing authorisation.
Slovenian: Načrti za obvladovanje tveganja (RMP) se predložijo kot del nove vloge ali vloge, ki vključuje znatno spremembo dovoljenja za promet z zdravilom.
English: The Agency also organised a number of training sessions for assessors from national competent authorities.
Slovenian: Agencija je tudi priredila več usposabljanj za ocenjevalce iz nacionalnih pristojnih organov.
English: The number of training days taken by EMEA staff was up by almost 30% on the previous year, reaching a total of 4,166 days.
Slovenian: Število dni, ki jih je osebje agencije EMEA porabilo za usposabljanje, se je povečalo za skoraj 30 % v primerjavi s prejšnjim letom in je znašalo 4166 dni.
English: In August 2007, the HMPC provided comments on the draft communication from the Commission to the Council and the European Parliament released for consultation in May 2007 on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC (introduced by Directive 2004/24/EC) on specific provisions applicable to traditional herbal medicinal products.
Slovenian: V avgustu 2007 je HMPC podal pripombe k osnutku sporočila Komisije Svetu in Evropskemu parlamentu o izkušnjah, pridobljenih pri uporabi določb iz poglavja 2a Direktive 2001/83/ES (ki jo je uvedla Direktiva 2004/24/ES), objavljenega za namene posvetovanja maja 2007 o posebnih določbah, ki se uporabljajo za tradicionalna zdravila rastlinskega izvora.
English: In view of the possible accession of Croatia and Turkey, the Agency organised a conference in each of these countries to prepare the groundwork for their potential future integration into the European medicines network.
Slovenian: Zaradi morebitne pridružitve Hrvaške in Turčije je Agencija organizirala konferenco v obeh državah, da pripravi temelje za njuno morebitno prihodnjo vključitev v Evropsko mrežo zdravil.
English: The EMEA started an exercise to improve the organisation of working parties, aimed at achieving more efficient meetings and a better distribution of tasks among members of the scientific committees and their working parties.
Slovenian: Agencija EMEA je začela vajo za izboljšanje organiziranosti delovnih skupin, namenjeno doseganju učinkovitejših sestankov in boljše porazdelitve nalog med člani znanstvenih odborov in njihovih delovnih skupin.
English: The wide range of activities undertaken in the field of pharmacovigilance and maintenance have allowed a more proactive approach to safety of medicines to be taken, thus contributing to the protection of public health.
Slovenian: Širok obseg izvedenih dejavnosti na področjih farmakovigilance in ohranitve je omogočil proaktivnejši pristop k varnosti zdravil in je tako prispeval k varovanju javnega zdravja.
English: The Agency paid a total of €53.6 million to the national competent authorities for the provision of services in the evaluation of medicines for human and veterinary use.
Slovenian: Agencija je nacionalnim pristojnim organom plačala skupno 53,6 milijona EUR za zagotavljanje storitev pri vrednotenju zdravil za uporabo v humani in veterinarski medicini.
English: Seven out of the total number of 65 opinions adopted were negative, recommending that the marketing authorisation for these medicines be refused.
Slovenian: Sedem od skupaj 65 sprejetih mnenj je bilo negativnih in je priporočalo zavrnitev dovoljenja za promet s temi zdravili.
English: • We make independent recommendations based on scientific evidence, using state-of-the-art knowledge and expertise in our field.
Slovenian: • Izdajamo neodvisna priporočila, ki temeljijo na znanstvenih dokazih, pri čemer uporabljamo najnovejše strokovno znanje na našem področju.
English: I am pleased to report that the European Medicines Agency once again made a strong contribution to EU-wide efforts in support of making high-quality, safe and effective medicines available for use in human and animal populations.
Slovenian: Z veseljem sporočam, da je Evropska agencija za zdravila znova močno prispevala k prizadevanjem v vsej EU za podpiranje dostopnosti visokokakovostnih, varnih in učinkovitih zdravil, dostopnih za uporabo v človeški in živalski populaciji.
English: Nine applications were withdrawn prior to opinion.
Slovenian: Devet vlog je bilo umaknjenih pred sprejetjem mnenja.
English: FOREWORD BY THE CHAIR OF THE MANAGEMENT BOARD
Slovenian: PREDGOVOR PREDSEDNIKA UPRAVNEGA ODBORA
English: The first SME workshop was held on 2 February 2007.
Slovenian: Prva delavnica za MSP je bila 2. februarja 2007.
English: The CHMP concluded that piroxicam should no longer be used for treatment of short-term painful and inflammatory conditions.
Slovenian: CHMP se je odločil, da piroksama ni več dovoljeno uporabljati za zdravljenje kratkoročnih bolečin in vnetij.
English: • provides scientific advice and incentives to stimulate the development and improve the availability of innovative new medicines;
Slovenian: • ponuja znanstveno svetovanje in spodbude, da spodbuja razvoj in izboljša dostopnost inovativnih novih zdravil;
English: This latter is particularly necessary given the increasing complexity of evaluation procedures and the advent of advanced therapies and other new technologies in the medical domain.
Slovenian: Slednja je glede na čedalje večjo zahtevnost postopkov vrednotenja ter pojav naprednih terapij in drugih novih tehnologij na medicinskem področju še posebno potrebna.
English: Summary of the thirteenth annual report of the EMEA
Slovenian: Povzetek trinajstega letnega poročila agencije EMEA
English: Detection of pharmacovigilance signals
Slovenian: Odkrivanje signalov farmakovigilance
English: The SME User Guide was updated in 2007 to reflect the experience gained during the course of 2006.
Slovenian: Navodila za uporabnike za MSP so bila leta 2007 posodobljena, tako da posredujejo izkušnje, pridobljene leta 2006.
English: Specific criteria for veterinary medicines require further development.
Slovenian: Natančna merila za zdravila za uporabo v veterinarski medicini je treba še naprej razvijati.
English: The Agency organised a highly successful conference with a wide range of stakeholders who examined the operation of the Clinical Trials Directive after three years of practical experience, and published a report on the feedback provided.
Slovenian: Agencija je organizirala nadvse uspešno konferenco z veliko različnimi zainteresiranimi stranmi, ki so preučile izvajanje direktive o kliničnem preskušanju po treh letih praktičnih izkušenj, in objavila poročilo o povratnih informacijah, ki so jih podale zainteresirane strani.
English: The PDCO held its first meeting on 4-5 July 2007.
Slovenian: PDCO je prvič zasedal 4. in 5. julija 2007.
English: The number of staff employed at the EMEA was 441, in addition to which there were 124 seconded national experts and contract agents.
Slovenian: Agencija EMEA je zaposlovala 441 ljudi, poleg tega je pri Agenciji delalo 124 začasno dodeljenih nacionalnih strokovnjakov in pogodbenih uslužbencev.
English: The timelines set out in the procedures were not adhered to, due to the high number of notification requests received, a backlog from previous years and a lack of resources.
Slovenian: Časovni okviri, ki so bili določeni v postopkih, so bili preseženi zaradi velikega števila zahtevkov za obvestila, zaostankov iz prejšnjih let in pomanjkanja virov.
English: The CVMP completed the assessment and issued opinions on 3 of the referral procedures started in 2007 and on 7 of the referral procedures started in 2006.
Slovenian: CVMP je končal vrednotenje in izdal mnenja o treh postopkih napotitve, začetih v letu 2007, in sedmih postopkih napotitve, začetih v letu 2006.
English: • applies efficient and transparent evaluation procedures to help bring new medicines to the market by means of a single, EU-wide marketing authorisation granted by the European Commission;
Slovenian: • uporablja učinkovite in pregledne postopke vrednotenja, da pripomore k uvedbi novih zdravil na trg z enotnim dovoljenjem za promet z zdravilom, ki velja za celotno EU in ga podeli Evropska komisija;
English: Promoting access to vaccines against major epizootic diseases of domestic livestock
Slovenian: Spodbujanje dostopa do cepiv proti težkim kužnim boleznim domačih rejnih živali
English: The EMEA continued to support the development of medicines for rare diseases and to provide highquality scientific advice to companies developing medicines.
Slovenian: Agencija EMEA je še naprej podpirala razvoj zdravil za redke bolezni in ponujala visokokakovostno znanstveno svetovanje podjetjem, ki razvijajo zdravila.
English: 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.
Slovenian: 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.
English: 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.).
Slovenian: 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.).
English: An antidote medicinal product used for treating cyanide poisoning.
Slovenian: • Protistrup, ki se uporablja pri zastrupitvi s cianidom.
English: A medicine with a chemical structure resembling that of thalidomide.
Slovenian: • Zdravilo s kemično strukturo, ki je podobna kemični strukturi talidomida.
English: I would like to express my gratitude to the Executive Director and all EMEA staff for their commitment and excellent contribution during the year.
Slovenian: Zahvaljujem se izvršnemu direktorju in vsemu osebju agencije EMEA za njihovo predanost in izvrstno delo med letom.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 3.6 Arbitration and Community referrals Procedures started in 2007
Slovenian: 3.6 Arbitraža in napotitve Skupnosti Postopki, začeti v letu 2007
English: • implements measures for continuously supervising the quality, safety and efficacy of authorised medicines to ensure that their benefits outweigh their risks;
Slovenian: • 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;
English: Forty-nine percent of orphan medicines designated in 2007 were for conditions affecting children, including 4% intended exclusively for paediatric use.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Good manufacturing practice (GMP) inspection numbers - including inspections in the context of plasma master files (PMFs) - showed a 32% increase compared with 2006 (110).
Slovenian: 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).
English: They form part of the overall response of the European regulatory network to the lack of availability of veterinary medicines.
Slovenian: Ti predlogi so sestavni del splošnega odgovora evropske regulativne mreže na slabo dostopnost zdravil za uporabo v veterinarski medicini.
English: 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.
Slovenian: 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).
English: According to revised EU legislation, Member States can initiate referrals regarding herbal medicines.
Slovenian: V skladu s spremenjeno zakonodajo EU lahko države članice predložijo napotitve z zvezi z zdravili rastlinskega izvora.
English: • We adhere to high standards of professional and personal integrity.
Slovenian: • Ravnamo se po visokih standardih strokovne in osebne poštenosti.
English: 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.
Slovenian: 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.
English: The CHMP adopted 41 opinions for new indications, providing additional treatment options for patients.
Slovenian: CHMP je sprejel 41 mnenj za nove terapevtske indikacije in tako zagotovil dodatne možnosti zdravljenja bolnikov.
English: Further improvements in relation to provision of information on medicines
Slovenian: Nadaljnje izboljšave v zvezi z omogočanjem informacij o zdravilih
English: Extensions of indications broaden scope of existing medicines
Slovenian: Razširitve terapevtskih indikacij širijo obseg obstoječih zdravil
English: Principles and processes for advanced education exchanges between regulatory authorities, academia and, where appropriate, industry were established.
Slovenian: Določena so bila načela in postopki za napredno izmenjavo znanja med regulativnimi organi, akademiki, in kadar je primerno, industrijo.
English: 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)).
Slovenian: 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)).
English: 2 vaccines against avian influenza in poultry, mainly chickens.
Slovenian: • dve cepivi proti aviarni influenci pri perutnini, predvsem piščancih.
English: 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.
Slovenian: 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.
English: Two opinions were adopted following accelerated assessment of the application.
Slovenian: Dve mnenji sta bili sprejeti po postopku pospešenega vrednotenja vloge.
English: 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.
Slovenian: 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.
English: It is designed to support signal-detection and the assessment of adverse-drug-reaction reports.
Slovenian: Zasnovano je tako, da podpira zaznavanje signalov in ocenjevanje poročil o neželenih učinkih zdravil.
English: 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.
Slovenian: 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.
English: The first phase of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) project was concluded, resulting in the establishment of an inventory.
Slovenian: Prva stopnja projekta Evropske mreže centrov za farmakoepidemiologijo in farmakovigilanco (ENCePP) je bila končana, njen rezultat pa je sestava popisa.
English: The CHMP concluded more than 100 type-II variations relating to special warnings and precautions for use, including:
Slovenian: CHMP je sprejel odločbe za več kot 100 sprememb tipa II, ki se nanašajo na posebna opozorila in previdnostne ukrepe za uporabo, vključno z:
English: 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;
Slovenian: 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;