FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency also contributed to the availability of a number of new medicines on the market, including new chemical entities and similar biological and generic medicines.
Slovenian: Agencija je prispevala tudi k dostopnosti številnih novih zdravil na trgu, vključno z novimi kemijskimi entitetami ter podobnimi biološkimi in generičnimi zdravili.
English: Further development of interaction with healthcare professionals, patients and consumers
Slovenian: Nadaljnji razvoj sodelovanja z zdravstvenim osebjem, bolniki in potrošniki
English: It is a great honour to be appointed to this post and I look forward to working with the members and all partners to advance the important work we undertake on behalf of citizens.
Slovenian: V veliko čast mi je, da sem bil imenovan na to mesto, in zelo se veselim, da bomo s člani in vsemi partnerji nadaljevali pomembno delo, ki ga opravljamo v imenu državljanov.
English: In addition, feedback from the Member States indicated good quality overall of the translations provided by the pharmaceutical industry.
Slovenian: Poleg tega so povratne informacije držav članice kazale na splošno dobro kakovost prevodov, ki jih je zagotovila farmacevtska industrija.
English: In collaboration with IFAH-Global, the EMEA hosted a Global Animal Health Conference on 15-16 November 2007.
Slovenian: V sodelovanju z organizacijo IFAH-Global je agencija EMEA gostila konferenco o globalnem zdravju živali, ki je bila 15. in 16. novembra 2007.
English: 1.5 Transparency, communication and provision of information
Slovenian: 1.5 Preglednost, obveščanje in zagotavljanje informacij
English: The first joint meeting with patients and healthcare professionals was held on 1 June 2007.
Slovenian: Prvi skupni sestanek z bolniki in zdravstvenim osebjem je bil 1. junija 2007.
English: • We value the contribution of our partners and stakeholders to our work.
Slovenian: • Spoštujemo prispevek naših partnerjev in zainteresiranih strani pri našem delu.
English: Twenty-nine internal and external recruitment procedures were carried out.
Slovenian: Izvedenih je bilo 29 notranjih in zunanjih postopkov za zaposlovanje.
English: In addition, the EMEA systematically updated EPAR summaries relating to major variations.
Slovenian: Poleg tega je agencija EMEA sistematično posodabljala povzetke EPAR, ki se nanašajo na večje spremembe.
English: The EMEA had adopted a decision on 4 of the 10 opinions by the end of 2007.
Slovenian: EMEA je do konca leta 2007 sprejela sklepe o štirih od desetih mnenj.
English: They were transmitted to the European Commission for approval.
Slovenian: Vpisa sta bila poslana v odobritev Evropski komisiji.
English: Sixty-seven percent of the Agency's revenue came from fee income.
Slovenian: 67 % prihodkov Agencije so pomenili prihodki od pristojbin.
English: At this stage, there is no suggestion that there is a general trend for decreasing activity in this area, but the level of activity will continue to be monitored.
Slovenian: Za zdaj nič ne kaže na splošne smernice zmanjševanja dejavnosti na tem področju, vendar pa bomo stopnjo dejavnosti spremljali še naprej.
English: 1 PRIORITIES IN 2007
Slovenian: 1 PREDNOSTNE NALOGE V LETU 2007
English: Three of the referrals were made under Article 33 and 3 were made under Article 35 of Directive 2001/82/EC.
Slovenian: Tri napotitve so bile izvedene v skladu s členom 33, tri pa v skladu s členom 35 Direktive 2001/82/ES.
English: Improving the safety of medicines for human and veterinary use was once again one of the Agency's top priorities.
Slovenian: Izboljšanje varnosti zdravil za uporabo v humani in veterinarski medicini je bila znova ena od najpomembnejših nalog Agencije.
English: In 2007, the Agency's activities in relation to transparency and communication concentrated on consolidating existing activities.
Slovenian: V letu 2007 so se dejavnosti Agencije v zvezi s preglednostjo in obveščanjem osredotočale na krepitev sedanjih dejavnosti.
English: Seven meetings were held in total.
Slovenian: Skupno je imel sedem sestankov.
English: The Agency strengthened its internal handling of requests for access to documents.
Slovenian: Agencija je okrepila notranjo obravnavo zahtev za dostop do dokumentov.
English: The EMEA provided guidance and training for SMEs.
Slovenian: Agencija EMEA je zagotavljala smernice in usposabljanje za MSP.
English: EudraVigilance Veterinary became the main reporting tool used by national competent authorities.
Slovenian: EudraVigilance za veterinarstvo je postal glavno orodje za poročanje, ki ga uporabljajo nacionalni pristojni organi.
English: 1.3 Stimulation of innovation
Slovenian: 1.3 Spodbujanje inovacij
English: Time required for centralised procedure remains low
Slovenian: Čas, ki je potreben za centralizirani postopek, ostaja kratek
English: A new referral procedure - the procedure following Article 107(2) of Directive 2001/83/EC as amended - was used for the first time in 2007.
Slovenian: Novi postopek napotitve - postopek v skladu s členom 107(2) Direktive 2001/83/ES, kakor je bila spremenjena - je bil prvič uporabljen v letu 2007.
English: Contra-indications, warnings and precautions for use
Slovenian: Kontraindikacije, opozorila in previdnostni ukrepi za uporabo
English: SME Office: supporting innovation among Europe's SMEs
Slovenian: Urad za MSP: podpora inovacijam pri evropskih MSP
English: In addition to preliminary specification work for the next major upgrade, technical upgrades were implemented on the system.
Slovenian: Poleg predhodnega načrtovanja za naslednjo večjo nadgradnjo so bile v sistemu izvedene tehnične nadgradnje.
English: Concept of risk-management plans firmly established
Slovenian: Zasnova načrta za obvladovanje tveganja je trdno določena
English: 3.1 Scientific advice Level of activity in relation to scientific advice lower than expected
Slovenian: 3.1 Znanstveno svetovanje Stopnja dejavnosti v zvezi z znanstvenim svetovanjem nižja od pričakovane
English: I would like to thank the members of all the scientific committees and working parties for their hard work, and also to thank the staff of the European Commission for their ongoing support.
Slovenian: Zahvalil bi se še vsem članom znanstvenih odborov in delovnih skupin za njihovo trdo delo ter tudi osebju Evropske komisije za njegovo nenehno podporo.
English: The EMEA experienced yet another year of increases in all of its areas of activity.
Slovenian: Za agencijo EMEA je bilo to še eno leto porasta na vseh področjih njene dejavnosti.
English: Two good laboratory practice (GLP) (non-clinical) inspections were carried out.
Slovenian: Izvedena sta bila dva inšpekcijska pregleda dobre laboratorijske prakse (neklinična).
English: 4.3 Sampling and testing
Slovenian: 4.3 Vzorčenje in preskušanje
English: 2007 was the fifth year of implementation of the EU telematics projects by the Agency.
Slovenian: Leto 2007 je bilo peto leto, odkar Agencija izvaja telematske projekte EU.
English: 5 EU TELEMATICS STRATEGY
Slovenian: 5 TELEMATSKA STRATEGIJA EU
English: • involves representatives of patients, healthcare professionals and other stakeholders in its work, to facilitate dialogue on issues of common interest;
Slovenian: • v svoje delo vključuje predstavnike bolnikov, zdravstvenih strokovnjakov in drugih zainteresiranih strani, da olajša dialog o temah, ki so v skupnem interesu;
English: • We promote the well-being, motivation and ongoing professional development of every member of the Agency.
Slovenian: • Spodbujamo dobrobit, motivacijo in nenehno strokovno izpopolnjevanje vsakega člana Agencije.
English: The EMEA reviewed 92% of the risk-management plans submitted as part of new applications.
Slovenian: EMEA je pregledala 92 % načrtov za obvladovanje tveganja, ki so bili predloženi kot del nove vloge.
English: EU enlargement
Slovenian: Širitev EU
English: The Agency received entirely new responsibilities with the entry into force of Regulation (EC) No 1901/2006 on medicinal products for paediatric use (the Paediatric Regulation) on 26 January 2007.
Slovenian: Agencija je dobila popolnoma nove odgovornosti, ko je začela veljati Uredba (ES) št. 1901/2006 o zdravilih za pediatrično uporabo (Uredba o pediatriji) 26. januarja 2007.
English: This increase from 183 days in 2006 arose due to fewer accelerated procedures being completed in 2007.
Slovenian: To povečanje glede na 183 dni v letu 2006 je nastalo zaradi manjšega števila končanih postopkov pospešenega vrednotenja v letu 2007.
English: This plan now gives the required predictability to future development of EVV that is necessary for national competent authorities to commit the necessary resources to ensure its full and timely implementation.
Slovenian: Ta načrt zdaj daje potrebno predvidljivost prihodnjemu razvoju EVV, ki je potrebna, da lahko nacionalni pristojni organi dodelijo potrebna sredstva za zagotovitev njegovega popolnega in pravočasnega izvajanja.
English: Inspections agencies that are not part of the national medicines agencies were added into the EudraNet.
Slovenian: Agencije za inšpekcijske preglede, ki niso del nacionalnih agencij za zdravila, so bile dodane v omrežje EudraNet.
English: The EMEA also supported the Commission in its work to develop the new Regulation on Advanced Therapies, which was published in December 2007 and which will usher in further new responsibilities for the Agency in 2008.
Slovenian: EMEA je tudi podpirala Komisijo pri njenem delu za razvoj nove Uredbe o naprednih terapijah, ki je bila objavljena decembra 2007 in ki uvaja nove odgovornosti za Agencijo v letu 2008.
English: EudraPharm was updated in 2007.
Slovenian: Sistem EudraPharm je bil posodobljen v letu 2007.
English: Sponsors may request advice on whether their product can be classed as a medicinal product, thus being eligible for EMEA procedures.
Slovenian: Sponzorji lahko zaprosijo za nasvet, ali je njihove izdelke mogoče opredeliti kot medicinske izdelke, da tako postanejo upravičenci za postopke agencije EMEA.
English: Six of these were class-1 recalls, compared with 2 during all of 2006.
Slovenian: Šest od teh umikov je bilo 1. razreda v primerjavi z dvema v vsem letu 2006.
English: In 2007, the Agency received 7 requests for scientific advice (16 were forecast).
Slovenian: V letu 2007 je Agencija prejela sedem zahtevkov za znanstveno svetovanje (pričakovanih jih je bilo 16).
English: As of December 2007, however, no referrals regarding herbal medicines had been received.
Slovenian: Vendar pa od decembra 2007 ni bila prejeta nobena napotitev v zvezi z zdravili rastlinskega izvora.
English: INTRODUCTION BY THE EXECUTIVE DIRECTOR
Slovenian: UVOD IZVRŠNEGA DIREKTORJA
English: It is believed this results from, among other factors, the Agency's efforts to promote awareness of expedited reporting.
Slovenian: Menimo, da je to med drugim posledica prizadevanj Agencije, da spodbuja zavest o pospešenem poročanju.
English: The guideline on summary of product characteristics was revised in order to introduce new requirements in accordance with the new Paediatric Regulation.
Slovenian: Smernica o povzetku značilnosti izdelka je bila spremenjena, tako da so v njej uvedene nove zahteve v skladu z novo Uredbo o pediatriji.
English: An important indicator of the EMEA's activity during any year is the number of applications it receives and processes for the initial marketing authorisation of medicines.
Slovenian: Pomemben kazalnik dejavnosti agencije EMEA med katerim koli letom je število vlog, ki jih prejme, in postopkov za začetna dovoljenja za promet z zdravili.
English: Strengthening EudraVigilance to support proactive pharmacovigilance in the EU
Slovenian: Krepitev sistema EudraVigilance za podpiranje proaktivne farmakovigilance v EU
English: Definition and implementation of EU Telematics controlled terms continued.
Slovenian: Določanje in uveljavljanje sistema telematsko nadzorovanih pogojev EU se je nadaljevalo.
English: The HMPC status report on the progress made in relation to the implementation of the Directive since its entry into force, which had been forwarded to the European Commission for the preparation of its draft communication, was published on the EMEA website.
Slovenian: Poročilo HMPC o doseženem napredku v zvezi z izvajanjem Direktive od začetka njene veljavnosti, ki je bilo posredovano Evropski komisiji za pripravo osnutka sporočila, je bilo objavljeno na spletni strani agencije EMEA.
English: However, work on the interim DataWarehouse solution for EudraVigilance Human had severe impact on work in this area.
Slovenian: Vendar pa je delo pri začasni rešitvi podatkovnega skladišča za sistem EudraVigilance Human resno vplivalo na delo na tem področju.
English: Thirty-seven of the 92 requests were refused.
Slovenian: Od 92 zahtevkov jih je bilo 37 zavrnjenih.
English: The number of reports received was almost double the number of reports received in 2006.
Slovenian: Število prejetih poročil je bilo skoraj dvakrat tolikšno kot število prejetih poročil v letu 2006.
English: Activities in the area of supporting innovation and improving access to medicines yielded some very positive results in 2007.
Slovenian: Dejavnosti na področju podpore inovacijam in izboljševanja dostopnosti zdravil so v letu 2007 prinesle nekaj zelo spodbudnih rezultatov.
English: The summaries of activities presented here reflect the excellent performance of all EMEA staff and national competent authority experts.
Slovenian: Povzetki dejavnosti, predstavljeni tukaj, odražajo izvrstno delo celotnega osebja agencije EMEA in strokovnjakov nacionalnih pristojnih organov.
English: • We support research and innovation to stimulate the development of better medicines.
Slovenian: • Podpiramo raziskave in inovativnost za spodbujanje razvoja boljših zdravil.
English: However, it should not be the first choice of non-steroidal anti-inflammatory drug (NSAID) treatment in these conditions (Article 31 procedure).
Slovenian: Kljub temu ne sme biti prva izbira pri zdravljenju teh bolezni z nesteroidnimi protivnetnimi zdravili (NSAID) (postopek iz člena 31).
English: In this context, the CVMP adopted a positive opinion for an H7 avian-influenza vaccine.
Slovenian: Zato je CVMP sprejel pozitivno mnenje za cepivo proti aviarni influenci H7.
English: With the legal and regulatory framework for similar biological medicines now firmly established, 10 applications for these were received in 2007.
Slovenian: Pravni in regulativni okvir za podobna biološka zdravila je zdaj trdno določen, in tako smo v letu 2007 prejeli 10 vlog za taka zdravila.
English: Experts participate in the work of the EMEA as members of the scientific committees, working parties, scientific advisory groups or related groups.
Slovenian: Strokovnjaki sodelujejo pri delu agencije EMEA kot člani znanstvenih odborov, delovnih skupin, znanstvenih svetovalnih skupin ali povezanih skupin.
English: Ninety-five percent of requests for access to documents were processed within the established timelines.
Slovenian: 95 odstotkov zahtevkov za dostop do dokumentov je bilo obravnavanih v določenem časovnem okviru.
English: Implementation of new procedures to facilitate early dialogue with sponsors resulted in an increased number of requests for regulatory eligibility and briefing meetings.
Slovenian: Izvajanje novih postopkov za spodbujanje zgodnjega dialoga s sponzorji je prineslo povečano število zahtevkov za regulativno upravičenost in informativne sestanke.
English: • publishes impartial and comprehensible information about medicines and their use;
Slovenian: • objavlja nepristranske in razumljive podatke o zdravilih in njihovi uporabi;
English: The meeting considered the major challenges facing the development of new medicines and the continuing availability of existing ones.
Slovenian: Na srečanju so razpravljali o glavnih izzivih pri razvoju novih zdravil in stalni razpoložljivosti obstoječih zdravil.
English: 6 EMEA BUDGET AND STAFF
Slovenian: 6 PRORAČUN IN OSEBJE AGENCIJE EMEA
English: Discussions with the European Commission resulted in the inclusion of the topic ‘Relative safety of NSAIDs' in the 2007 work programme for the health theme of the 7th Framework Programme.
Slovenian: Rezultat razprav z Evropsko komisijo je bila vključitev teme „Relativna varnost nesteroidnih protivnetnih zdravil (NSAID)“ v delovni program za leto 2007 kot zdravstvena tema 7. okvirnega programa.
English: 2.7 Arbitration and Community referrals Number of referrals submitted to the EMEA continued to rise
Slovenian: 2.7 Arbitraža in napotitve Skupnosti Število napotitev, predloženih agenciji EMEA, se je še naprej povečevalo
English: The average time required for the assessment, post-opinion and decision phases of the centralised procedure remained approximately at the 2006 level.
Slovenian: Povprečni čas, ki je potreben za vrednotenje, stopnjo po izdaji mnenja in stopnjo odločitve pri centraliziranem postopku, je ostal približno enak kot v letu 2006.
English: On an organisational level, the EMEA conducted elections of chairs and vice-chairs for four of its scientific committees, including the new Paediatric Committee, and of a new chair for its Management Board.
Slovenian: Na organizacijski ravni je EMEA izvedla volitve predsednikov in podpredsednikov za štiri od svojih znanstvenih odborov, vključno z novim Odborom za pediatrijo, in volitve novega predsednika upravnega odbora.
English: 1.1 Implementation of the legislation on medicines for children
Slovenian: 1.1 Izvajanje zakonodaje o zdravilih za otroke
English: A total of €4.89 million from the EU special contribution was used to grant fee reductions for orphan medicines in 2007.
Slovenian: Skupno 4,89 milijona EUR od posebnega prispevka EU je bilo v letu 2007 uporabljenih za odobritev znižanja pristojbin za zdravila sirote.
English: • develops best practice for medicines evaluation and supervision in Europe, and contributes alongside the Member States and the European Commission to the harmonisation of regulatory standards at the international level.
Slovenian: • razvija najboljšo prakso za vrednotenje zdravil in nadzor nad njimi v Evropi ter skupaj z državami članicami in Evropsko komisijo prispeva k usklajevanju regulativnih standardov na mednarodni ravni.
English: Medicines to treat cancer still dominate
Slovenian: Zdravila za zdravljenje raka še vedno prevladujejo
English: The electronic exchange of pharmacovigilance information within the EU is improving, as are active surveillance, harmonisation and risk management.
Slovenian: Elektronska izmenjava podatkov o farmakovigilanci v EU se izboljšuje, enako pa velja tudi za aktivni nadzor, usklajevanje in obvladovanje tveganja.
English: More procedures finalised, in shorter time
Slovenian: Večje število postopkov je bilo dokončno obdelanih v krajšem času
English: • We communicate in an open, transparent manner with all of our partners, stakeholders and colleagues.
Slovenian: • Z vsemi našimi partnerji, zainteresiranimi stranmi in kolegi komuniciramo odprto in pregledno.
English: My role as Chair of the Management Board commenced in June 2007, following my election by the members.
Slovenian: Vlogo predsednika upravnega odbora sem začel opravljati junija 2007, ko so me člani odbora izvolili na to mesto.
English: Throughout 2007, the EMEA worked in close cooperation with others in the European medicines network, in particular in the area of risk-management, which is so fundamental to our consumerprotection role.
Slovenian: Skozi vse leto 2007 je EMEA tesno sodelovala z drugimi člani Evropske mreže zdravil, še posebej na področju upravljanja tveganj, ki je temeljnega pomena za našo vlogo pri varstvu potrošnika.
English: A number of the Agency's core business activities are directly aimed at facilitating innovation and research, and as such, supporting the objectives of the Lisbon agenda.
Slovenian: Neposredni cilj številnih ključnih dejavnosti Agencije je olajševanje inovacij in raziskav ter tako podpiranje ciljev programa lizbonske strategije.
English: Altogether, 5 referrals were carried out under this procedure.
Slovenian: Skupaj je bilo v skladu s tem postopkom izvedenih pet napotitev.
English: Thirty-one requests for classification were received.
Slovenian: Prejetih je bilo 31 zahtevkov za razvrstitev.
English: The EMEA coordinated the post-opinion linguistic review for 76 new applications and line extensions.
Slovenian: Agencija EMEA je usklajevala jezikovno pregledovanje po izdaji mnenja za 76 novih vlog in razširitev linij.
English: European Review System (Installation)
Slovenian: Evropski sistem za presojanje (namestitev)
English: This reflects an increase in the number of routine inspection requests, in line with the policy on GCP inspections adopted in 2006, as well as an increasing focus on inspections in countries where there is little European experience.
Slovenian: To odraža povečano število zahtevkov za rutinski inšpekcijski pregled v skladu s politiko o inšpekcijskih pregledih dobre klinične prakse, sprejeto v letu 2006, in tudi čedalje večji poudarek na inšpekcijskih pregledih v državah, v katerih je evropskih izkušenj malo.
English: The EMEA continued to invest in the professional development of staff.
Slovenian: Agencija EMEA je še naprej vlagala v poklicno usposabljanje osebja.
English: In 2007, 212 companies requested SME status, and 172 requests were approved.
Slovenian: V letu 2007 je 212 podjetij zaprosilo za status MSP in od tega je bilo 172 prošenj odobrenih.
English: This should lead to improved use of the EudraVigilance database in the overall conduct of pharmacovigilance at EU level.
Slovenian: To bi moralo voditi k boljši uporabi zbirke podatkov sistema EudraVigilance pri celotnem upravljanju farmakovigilance na ravni EU.
English: The initial success of the EMEA's SME Office seen in 2006 was reconfirmed this year, with Europe's smaller innovative companies demonstrating a keen interest in the dedicated support on offer to them from the EMEA.
Slovenian: Začetni uspehi Urada za MSP Agencije v letu 2006 so se letos znova potrdili, saj so evropska manjša inovativna podjetja pokazala veliko zanimanje za podporo, ki jim jo ponuja EMEA.
English: The first pilot was released in September.
Slovenian: Prvi pilotni sistem je bil izdan septembra.
English: Applications for these 2 vaccines were evaluated on an accelerated timetable, taking into account the epidemiological situation within the EU and the contribution of the Agency to pandemic preparedness.
Slovenian: Vlogi za ti dve cepivi sta bili ovrednoteni po pospešenem urniku, ker smo upoštevali epidemiološke razmere v EU in prispevek Agencije k pripravljenosti na pandemijo.
English: This brought the total number of companies with assigned SME status to 246 at the end of 2007.
Slovenian: S tem se je število podjetij s podeljenim statusom MSP do konca leta 2007 povečalo na 246.
English: Daniel Brasseur, former Chair of the Committee for Medicinal Products for Human Use (CHMP) and of the former Paediatric Working Party, was elected Chair; Gérard Pons was elected Vice-chair.
Slovenian: Daniel Brasseur, prejšnji predsednik Odbora za zdravila za uporabo v humani medicini (CHMP) in predhodne delovne skupine za pediatrijo, je bil izvoljen za predsednika, za podpredsednika pa je bil izvoljen Gérard Pons.
English: Only a few reports were submitted electronically by marketing-authorisation holders, due to the majority of large veterinary pharmaceutical companies still being in the implementation and testing phase.
Slovenian: Imetniki dovoljenj za promet z zdravili so elektronsko predložili le nekaj poročil, saj je večina velikih veterinarskih farmacevtskih podjetij še vedno na stopnji uvajanja in preskušanja.
English: Other areas of cooperation included the development of telematics and discussion on common resource and competence planning.
Slovenian: Med drugimi področji sodelovanja sta bila razvoj telematike in razprava o skupnem načrtovanju virov in kompetenc.
English: • recommends safe limits for residues of veterinary medicines used in food-producing animals, for the establishment of maximum residue limits by the European Commission;
Slovenian: • predlaga varne mejne vrednosti ostankov veterinarskih zdravil, ki se uporabljajo pri živalih, namenjenih za proizvodnjo hrane, na podlagi katerih Evropska komisija določi najvišje mejne vrednosti ostankov;