natgillin/translations-raw huggingface dataset:
The guideline on summary of product characteristics was revised in order to introduce new requirements in accordance with the new Paediatric Regulation.
Smernica o povzetku značilnosti izdelka je bila spremenjena, tako da so v njej uvedene nove zahteve v skladu z novo Uredbo o pediatriji.
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.
Pomemben kazalnik dejavnosti agencije EMEA med katerim koli letom je število vlog, ki jih prejme, in postopkov za začetna dovoljenja za promet z zdravili.
Strengthening EudraVigilance to support proactive pharmacovigilance in the EU
Krepitev sistema EudraVigilance za podpiranje proaktivne farmakovigilance v EU
Definition and implementation of EU Telematics controlled terms continued.
Določanje in uveljavljanje sistema telematsko nadzorovanih pogojev EU se je nadaljevalo.
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.
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.
However, work on the interim DataWarehouse solution for EudraVigilance Human had severe impact on work in this area.
Vendar pa je delo pri začasni rešitvi podatkovnega skladišča za sistem EudraVigilance Human resno vplivalo na delo na tem področju.
Thirty-seven of the 92 requests were refused.
Od 92 zahtevkov jih je bilo 37 zavrnjenih.
The number of reports received was almost double the number of reports received in 2006.
Število prejetih poročil je bilo skoraj dvakrat tolikšno kot število prejetih poročil v letu 2006.
Activities in the area of supporting innovation and improving access to medicines yielded some very positive results in 2007.
Dejavnosti na področju podpore inovacijam in izboljševanja dostopnosti zdravil so v letu 2007 prinesle nekaj zelo spodbudnih rezultatov.
The summaries of activities presented here reflect the excellent performance of all EMEA staff and national competent authority experts.
Povzetki dejavnosti, predstavljeni tukaj, odražajo izvrstno delo celotnega osebja agencije EMEA in strokovnjakov nacionalnih pristojnih organov.
• We support research and innovation to stimulate the development of better medicines.
• Podpiramo raziskave in inovativnost za spodbujanje razvoja boljših zdravil.
However, it should not be the first choice of non-steroidal anti-inflammatory drug (NSAID) treatment in these conditions (Article 31 procedure).
Kljub temu ne sme biti prva izbira pri zdravljenju teh bolezni z nesteroidnimi protivnetnimi zdravili (NSAID) (postopek iz člena 31).
In this context, the CVMP adopted a positive opinion for an H7 avian-influenza vaccine.
Zato je CVMP sprejel pozitivno mnenje za cepivo proti aviarni influenci H7.
With the legal and regulatory framework for similar biological medicines now firmly established, 10 applications for these were received in 2007.
Pravni in regulativni okvir za podobna biološka zdravila je zdaj trdno določen, in tako smo v letu 2007 prejeli 10 vlog za taka zdravila.
Experts participate in the work of the EMEA as members of the scientific committees, working parties, scientific advisory groups or related groups.
Strokovnjaki sodelujejo pri delu agencije EMEA kot člani znanstvenih odborov, delovnih skupin, znanstvenih svetovalnih skupin ali povezanih skupin.
Ninety-five percent of requests for access to documents were processed within the established timelines.
95 odstotkov zahtevkov za dostop do dokumentov je bilo obravnavanih v določenem časovnem okviru.
Implementation of new procedures to facilitate early dialogue with sponsors resulted in an increased number of requests for regulatory eligibility and briefing meetings.
Izvajanje novih postopkov za spodbujanje zgodnjega dialoga s sponzorji je prineslo povečano število zahtevkov za regulativno upravičenost in informativne sestanke.
• publishes impartial and comprehensible information about medicines and their use;
• objavlja nepristranske in razumljive podatke o zdravilih in njihovi uporabi;
The meeting considered the major challenges facing the development of new medicines and the continuing availability of existing ones.
Na srečanju so razpravljali o glavnih izzivih pri razvoju novih zdravil in stalni razpoložljivosti obstoječih zdravil.
6 EMEA BUDGET AND STAFF
6 PRORAČUN IN OSEBJE AGENCIJE EMEA
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.
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.
2.7 Arbitration and Community referrals Number of referrals submitted to the EMEA continued to rise
2.7 Arbitraža in napotitve Skupnosti Število napotitev, predloženih agenciji EMEA, se je še naprej povečevalo
The average time required for the assessment, post-opinion and decision phases of the centralised procedure remained approximately at the 2006 level.
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.
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.
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.
1.1 Implementation of the legislation on medicines for children
1.1 Izvajanje zakonodaje o zdravilih za otroke
A total of €4.89 million from the EU special contribution was used to grant fee reductions for orphan medicines in 2007.
Skupno 4,89 milijona EUR od posebnega prispevka EU je bilo v letu 2007 uporabljenih za odobritev znižanja pristojbin za zdravila sirote.
• 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.
• 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.
Medicines to treat cancer still dominate
Zdravila za zdravljenje raka še vedno prevladujejo
The electronic exchange of pharmacovigilance information within the EU is improving, as are active surveillance, harmonisation and risk management.
Elektronska izmenjava podatkov o farmakovigilanci v EU se izboljšuje, enako pa velja tudi za aktivni nadzor, usklajevanje in obvladovanje tveganja.
More procedures finalised, in shorter time
Večje število postopkov je bilo dokončno obdelanih v krajšem času
• We communicate in an open, transparent manner with all of our partners, stakeholders and colleagues.
• Z vsemi našimi partnerji, zainteresiranimi stranmi in kolegi komuniciramo odprto in pregledno.
My role as Chair of the Management Board commenced in June 2007, following my election by the members.
Vlogo predsednika upravnega odbora sem začel opravljati junija 2007, ko so me člani odbora izvolili na to mesto.
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.
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.
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.
Neposredni cilj številnih ključnih dejavnosti Agencije je olajševanje inovacij in raziskav ter tako podpiranje ciljev programa lizbonske strategije.
Altogether, 5 referrals were carried out under this procedure.
Skupaj je bilo v skladu s tem postopkom izvedenih pet napotitev.
Thirty-one requests for classification were received.
Prejetih je bilo 31 zahtevkov za razvrstitev.
The EMEA coordinated the post-opinion linguistic review for 76 new applications and line extensions.
Agencija EMEA je usklajevala jezikovno pregledovanje po izdaji mnenja za 76 novih vlog in razširitev linij.
European Review System (Installation)
Evropski sistem za presojanje (namestitev)
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.
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.
The EMEA continued to invest in the professional development of staff.
Agencija EMEA je še naprej vlagala v poklicno usposabljanje osebja.
In 2007, 212 companies requested SME status, and 172 requests were approved.
V letu 2007 je 212 podjetij zaprosilo za status MSP in od tega je bilo 172 prošenj odobrenih.
This should lead to improved use of the EudraVigilance database in the overall conduct of pharmacovigilance at EU level.
To bi moralo voditi k boljši uporabi zbirke podatkov sistema EudraVigilance pri celotnem upravljanju farmakovigilance na ravni EU.
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.
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.
The first pilot was released in September.
Prvi pilotni sistem je bil izdan septembra.
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.
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.
This brought the total number of companies with assigned SME status to 246 at the end of 2007.
S tem se je število podjetij s podeljenim statusom MSP do konca leta 2007 povečalo na 246.
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.
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.
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.
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.
Other areas of cooperation included the development of telematics and discussion on common resource and competence planning.
Med drugimi področji sodelovanja sta bila razvoj telematike in razprava o skupnem načrtovanju virov in kompetenc.
• recommends safe limits for residues of veterinary medicines used in food-producing animals, for the establishment of maximum residue limits by the European Commission;
• 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;
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.
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.
Pharmacovigilance in the veterinary sector in the EU continues to undergo changes triggered by the revised pharmaceuticals legislation introduced in 2004.
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.
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.
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.
European risk-management strategy (ERMS) for medicines for human use: further progress made
Evropska strategija obvladovanja tveganja (ERMS) za zdravila za uporabo v humani medicini: dosežen je bil nadaljnji napredek
The first version of EudraGMP was launched in April 2007, and version 1.1 was released into production in December 2007.
Prva različica sistema EudraGMP je bila izdana aprila 2007, ustvarjanje različice 1.1 pa se je začelo decembra 2007.
Legal role
Pravna vloga
The number of national competent authorities and pharmaceutical companies reporting electronically to EudraVigilance (the EU database on adverse drug reactions) increased in 2007.
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.
These corresponded to 85 applications with an average of 2 to 4 indications per application.
Te so ustrezale 85 vlogam, v katerih so bile v povprečju od dve do štiri indikacije na vlogo.
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.
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.
Audioconferencing was introduced for some meetings, reducing the need for experts to travel to the EMEA.
Pri nekaterih sestankih so bile uvedene avdiokonference, kar je zmanjšalo potrebo po tem, da strokovnjaki potujejo na sedež agencije EMEA.
Periodic safety update reports (PSURs)
Z zadnjimi podatki dopolnjena redna poročila o varnosti (PSUR)
The full annual report for 2007 was adopted by the Management Board on 6 March 2008, and is available on the EMEA website:
Celotno letno poročilo za leto 2007 je upravni odbor sprejel 6. marca 2008 in je na voljo na spletni strani Evropske agencije za zdravila:
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.
Evropska mreža zdravil je partnerstvo več kot 40 regulativnih organov za zdravila v Evropski uniji (EU) in je temelj uspeha agencije EMEA.
Nine out of the 36 finalised referral procedures related to safety concerns.
Devet od 36 končanih postopkov napotitve se je nanašalo na varnostni vidik.
EMEA/197729/2008/EN/FINAL
EMEA/421613/2008/SL/KONČNA
Bulgarian, Romanian and (following the expiry of the derogation) Maltese were successfully included in the translations framework.
V prevode so bile uspešno vključene bolgarščina, romunščina in (po preteku odstopanja) malteščina.
Free scientific advice for minor uses and minor species
Brezplačno znanstveno svetovanje za manjšo uporabo in manj pomembne živalske vrste
Risk-management plans (RMPs) are submitted as part of a new application or an application involving a significant change in the marketing authorisation.
Načrti za obvladovanje tveganja (RMP) se predložijo kot del nove vloge ali vloge, ki vključuje znatno spremembo dovoljenja za promet z zdravilom.
The Agency also organised a number of training sessions for assessors from national competent authorities.
Agencija je tudi priredila več usposabljanj za ocenjevalce iz nacionalnih pristojnih organov.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Širok obseg izvedenih dejavnosti na področjih farmakovigilance in ohranitve je omogočil proaktivnejši pristop k varnosti zdravil in je tako prispeval k varovanju javnega zdravja.
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.
Agencija je nacionalnim pristojnim organom plačala skupno 53,6 milijona EUR za zagotavljanje storitev pri vrednotenju zdravil za uporabo v humani in veterinarski medicini.
Seven out of the total number of 65 opinions adopted were negative, recommending that the marketing authorisation for these medicines be refused.
Sedem od skupaj 65 sprejetih mnenj je bilo negativnih in je priporočalo zavrnitev dovoljenja za promet s temi zdravili.
• We make independent recommendations based on scientific evidence, using state-of-the-art knowledge and expertise in our field.
• Izdajamo neodvisna priporočila, ki temeljijo na znanstvenih dokazih, pri čemer uporabljamo najnovejše strokovno znanje na našem področju.
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.
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.
Nine applications were withdrawn prior to opinion.
Devet vlog je bilo umaknjenih pred sprejetjem mnenja.
FOREWORD BY THE CHAIR OF THE MANAGEMENT BOARD
PREDGOVOR PREDSEDNIKA UPRAVNEGA ODBORA
The first SME workshop was held on 2 February 2007.
Prva delavnica za MSP je bila 2. februarja 2007.
The CHMP concluded that piroxicam should no longer be used for treatment of short-term painful and inflammatory conditions.
CHMP se je odločil, da piroksama ni več dovoljeno uporabljati za zdravljenje kratkoročnih bolečin in vnetij.
• provides scientific advice and incentives to stimulate the development and improve the availability of innovative new medicines;
• ponuja znanstveno svetovanje in spodbude, da spodbuja razvoj in izboljša dostopnost inovativnih novih zdravil;
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.
Slednja je glede na čedalje večjo zahtevnost postopkov vrednotenja ter pojav naprednih terapij in drugih novih tehnologij na medicinskem področju še posebno potrebna.
Summary of the thirteenth annual report of the EMEA
Povzetek trinajstega letnega poročila agencije EMEA
Detection of pharmacovigilance signals
Odkrivanje signalov farmakovigilance
The SME User Guide was updated in 2007 to reflect the experience gained during the course of 2006.
Navodila za uporabnike za MSP so bila leta 2007 posodobljena, tako da posredujejo izkušnje, pridobljene leta 2006.
Specific criteria for veterinary medicines require further development.
Natančna merila za zdravila za uporabo v veterinarski medicini je treba še naprej razvijati.
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.
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.
The PDCO held its first meeting on 4-5 July 2007.
PDCO je prvič zasedal 4. in 5. julija 2007.
The number of staff employed at the EMEA was 441, in addition to which there were 124 seconded national experts and contract agents.
Agencija EMEA je zaposlovala 441 ljudi, poleg tega je pri Agenciji delalo 124 začasno dodeljenih nacionalnih strokovnjakov in pogodbenih uslužbencev.
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.
Časovni okviri, ki so bili določeni v postopkih, so bili preseženi zaradi velikega števila zahtevkov za obvestila, zaostankov iz prejšnjih let in pomanjkanja virov.
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.
CVMP je končal vrednotenje in izdal mnenja o treh postopkih napotitve, začetih v letu 2007, in sedmih postopkih napotitve, začetih v letu 2006.
• 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;
• 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;
Promoting access to vaccines against major epizootic diseases of domestic livestock
Spodbujanje dostopa do cepiv proti težkim kužnim boleznim domačih rejnih živali