natgillin/translations-raw huggingface dataset:
To prepare a strategy for establishing a pan-European paediatric-research network, the EMEA met with existing networks in the EU.
Za pripravo strategije za vzpostavitev vseevropske mreže za pediatrične raziskave se je EMEA sestala z obstoječimi mrežami v EU.
1.7 Tackling antimicrobial resistance
1.7 Obravnavanje protimikrobne odpornosti
However, 2 products were found not to comply with their authorised specifications.
Ugotovljeno je bila, da dva izdelka nista bila skladna s svojimi specifikacijami.
All initial evaluations were carried out within the 210-day regulatory time limit.
Vsa začetna vrednotenja so bila opravljena v 210-dnevnem regulativnem roku.
In one case, this resulted in the recall of a batch of the product.
V enem primeru je to povzročilo umik serije izdelka.
The EMEA Management Board met four times in 2006, under chairman Hannes Wahlroos, from Finland, and vice-chairman Jytte Lyngvig, from Denmark.
Upravni odbor EMEA je leta 2006 zasedal štirikrat, predsedoval mu je Hannes Wahlroos iz Finske, podpredsednica pa je bila Jytte Lyngvig iz Danske.
The good progress observed in 2005 with EudraVigilance continued in 2006.
Dober napredek, opažen leta 2005 pri izvajanju EudraVigilance, se je leta 2006 nadaljeval.
of Regulation (EC) No 726/2004
Uredbe (ES) št. 726/2004
An analysis of all defects reported during 2005 was completed and published.
Zaključena in objavljena je bila analiza vseh pomanjkljivosti, prijavljenih leta 2005.
1.4 European medicines network Sharing expertise and competence-development in the network
1.4 Evropska mreža zdravil Izmenjava strokovnega znanja in izkušenj ter razvoj pristojnosti znotraj mreže
Efforts to improve transparency of regulatory activity
Prizadevanja za izboljšanje preglednosti regulativne dejavnosti
In addition, the Agency made a successful start with the SME Office, which provides assistance to small and medium-sized enterprises involved in the development of medicines in Europe.
Poleg tega je pri Agenciji uspešno začel delovati Urad za mala in srednje velika podjetja, ki zagotavlja pomoč malim in srednje velikim podjetjem, ki se ukvarjajo z razvojem zdravil v Evropi.
The Agency also attended meetings with the European Commission Directorate-General for Research to prepare the funding of research on off-patent medicines.
Agencija se je udeležila tudi srečanj z Generalnim direktoratom za raziskave Evropske komisije za pripravo financiranja raziskav o zdravilih brez patenta.
The CHMP concluded that these medicinal products continue to offer effective protection against hepatitis B, but recommended some changes to the prescribing information.
CHMP je sklenil, da ta zdravila še naprej zagotavljajo učinkovito zaščito pred hepatitisom B, vendar je priporočil nekaj sprememb glede informacij pri predpisovanju;
The concept of risk-management plans (RMPs) was fully implemented in 2006 as part of the new legislative provisions of Regulation (EC) No 726/2004.
Koncept načrtov za obvladovanje tveganja je bil kot del novih zakonskih določb Uredbe (ES) št. 726/2004 leta 2006 izveden v celoti.
The Agency managed to further reduce the average processing time for designation procedures to 57 days - the shortest average time since the start of the procedure, in the year 2000.
Agenciji je uspelo dodatno skrajšati povprečen čas obdelave postopkov določanja na 57 dni, kar je najkrajši povprečni čas od začetka postopka v letu 2000.
Product defects and deviations
Pomanjkljivosti in odstopanja pri proizvodih
There were 25 applications relating to the more complex type-II variations.
Petindvajset vlog se je nanašalo na kompleksnejše spremembe tipa II.
EMEA/88802/2007/EN/FINAL
EMEA/230199/2007/SL/KONČ.
EU contribution and fee revenue (€ million), 1995-2006
Prispevek EU in prihodki iz pristojbin (milijon EUR), 1995-2006
These recommendations are to be included in the risk-management plans of all pandemic-influenza vaccines.
Ta priporočila bodo vključena v načrte za obvladovanje tveganja vseh cepiv proti pandemiji influence.
The Audit Advisory Committee, whose external members were selected by tender, is reinforcing the integrated management and internal-audit system.
Svetovalni odbor za proračun, katerega zunanji člani so bili izbrani na razpisu, krepi integriran sistem upravljanja in notranje revizije.
Work is required to implement extended search, technical structuring of the content, incorporation of data from national competent authorities, and a multilingual approach.
Potrebno je delo za izvajanje razširjenega iskanja, tehničnega strukturiranja vsebine, vključevanja podatkov od nacionalnih pristojnih organov in večjezičnega pristopa;
At the end of 2006, EudraVigilance contained a total of 677,976 individual-case-safety reports (ICSRs), corresponding to 409,138 individual cases.
Na koncu letu 2006 je EudraVigilance vsebovala skupaj 677.976 varnostnih poročil o posameznih primerih (individual case safety reports - ICSR), kar ustreza 409.138 posameznim primerom.
The new framework helps to manage an increasing workload and the new legal requirements in relation to medicines for human use.
Novi okvir pomaga obvladovati vse večjo delovno obremenitev in izvajati nove zakonske zahteve v zvezi z zdravili za uporabo v humani medicini.
Despite the operational challenges and increased workload this entailed, the Agency was able to achieve all the main objectives it had set itself for the year, and once more delivered good performance results across the entire spectrum of its activities.
Čeprav je to prineslo operativne izzive in večjo delovno obremenitev, je Agencija dosegla vse glavne cilje, ki si jih je zastavila za zadevno leto, in ponovno dosegla dobre rezultate na vseh področjih svojega delovanja.
The Agency is part of the Steering Council of the European Technology Platform for Global Animal Health and assisted in finalising its Strategic Research Agenda aimed at promoting access to the market for innovative products for animal health, including those for limited markets.
Agencija je del usmerjevalnega odbora Evropske tehnološke platforme za globalno zdravje živali in je pomagala pri dokončanju njegove agende strateškega raziskovanja, katere cilj je spodbujanje dostopa na trg za inovativne proizvode za zdravje živali, vključno s proizvodi za omejene trge.
Thanks to the newly streamlined procedure, the SAWP was able to complete these scientific-advice procedures more quickly than in previous years.
Delovna skupina za znanstveno svetovanje (SAWP) je zaradi nedavno racionaliziranega postopka zaključila zadevne postopke znanstvenega svetovanja hitreje kot v prejšnjih letih.
Most of those not reviewed related to active substances whose safety profile was well known.
Večina načrtov, ki niso bili preučeni, se je nanašala na zdravilne učinkovine, katerih varnostni profil je bil dobro znan.
The Agency's policy on fee reductions for orphan medicines was amended in 2006 to take into account the increasing number of fee-reduction requests being received.
Politika Agencije o znižanjih pristojbin za zdravila sirote je bila spremenjena leta 2006, da bi se upoštevalo naraščajoče število prejetih zahtevkov za znižanje pristojbine.
The EMEA has worked hard in 2006 to prepare the ground for ensuring the smooth implementation of this new piece of legislation.
EMEA se je v letu 2006 trudila pripraviti podlago za zagotovitev gladkega izvajanja tega novega dela zakonodaje.
And 2006 was indeed a year with plenty to report on.
Leto 2006 je bilo dejansko leto, v katerem se je zgodilo veliko takega, o čemer je mogoče poročati.
As in previous years, there were more positive opinions on orphan designation for cancer treatments than in any other therapeutic area.
Kot v prejšnjih letih je bilo sprejetih več pozitivnih mnenj o določitvi zdravil sirot za zdravljenje raka kot na katerem koli drugem terapevtskem področju.
Eight applications were withdrawn by applicants before an opinion could be adopted.
Osem vlog so vlagatelji umaknili, preden je bilo sprejeto mnenje.
These focused on improving the safety of medicines, increasing the availability of new medicines, and enhancing scientific competence within the network.
Ukrepi so bili osredotočeni na izboljšanje varnosti zdravil, povečanje razpoložljivosti novih zdravil in krepitev znanstvenih pristojnosti znotraj mreže.
This included a review of results from: risk-management, internal and external audits; self-assessments related to internal control standards; self-assessments as part of the Benchmarking of European Medicines Agencies (BEMA); the environmental analysis 2006; and the 2006 staffmotivation survey.
To je vključevalo pregled rezultatov iz: obvladovanja tveganja, notranjih in zunanjih revizij, samoocen, povezanih s standardi notranjega nadzora, samoocen kot delov primerjalnih analiz evropskih agencij za zdravila (Benchmarking of European Medicines Agencies - BEMA), okoljske analize za leto 2006 in raziskave o motivaciji zaposlenih iz leta 2006.
Developing an action plan for better harmonisation and work-sharing between authorities in the European Surveillance Strategy (ESS) for veterinary medicines.
razvoj akcijskega načrta za boljšo usklajenost in delitev dela med organi oblasti v evropski strategiji nadzorovanja (European Surveillance Strategy - ESS) za veterinarska zdravila;
This overview is intended to support the Commission with the preparation of its report to the European Parliament and to the Council concerning the application of the relevant legislative provisions relating to traditional herbal medicinal products.
Ta pregled je namenjen zagotavljanju podpore Komisiji pri pripravi njenega poročila Evropskemu parlamentu in Svetu glede uporabe ustreznih zakonskih določb, povezanih s tradicionalnimi zdravili rastlinskega izvora.
PIM (Product Information Management - a process that supports the electronic exchange of product information between applicants and the EMEA, as well as the review of this information).
PIM (upravljanje informacij o izdelkih - proces, ki podpira elektronsko izmenjavo informacij o izdelkih med vlagatelji in EMEA ter ponovno preučevanje teh informacij).
A total of €6.7 million was granted to fund fee reductions for orphan medicines in 2006, primarily from the EU special contribution.
V letu 2006 je bilo dodeljenih skupaj 6,7 milijona EUR za financiranje znižanj pristojbin za zdravila sirote, predvsem iz posebnega prispevka EU.
They provides for the extension of marketing authorisations granted by one Member State to one or more other Member States identified by the applicant.
Postopka predvidevata razširitev dovoljenj za promet z zdravilom, ki jih izda ena država članica, na eno ali več drugih držav članic, ki jih določi vlagatelj.
The investigations revealed some regulatory and scientific discrepancies, which were mainly addressed through amendment of the testing documentation by the Marketing-authorisation holders concerned.
Preiskave so odkrile nekatere regulativne in znanstvene neskladnosti, ki so bile pretežno razrešene s spremembo dokumentov preizkušanja s strani zadevnih imetnikov dovoljenj za promet z zdravilom.
Finally, the EMEA was an important contributor for the development of strategic research agendas for both human and veterinary medicinal products within the 7th Framework Programme, the EU's chief instrument for funding scientific research and technological development over the period 2007 to
Nazadnje, EMEA je pomembno prispevala k razvoju strateških razvojnih agend za zdravila za uporabo v humani in veterinarski medicini v okviru Sedmega okvirnega programa, glavnega instrumenta EU za financiranje znanstvenih raziskav in tehnološkega razvoja v obdobju od 2007 do 2013.
A further improvement was also registered in the average clock-stop time required by applicant companies.
Nadaljnji napredek je bil viden tudi pri povprečnih zaustavitvah časa, ki so jih zahtevali vlagatelji.
Work continued on improving the operation of the sampling-and-testing programme.
Nadaljevalo se je delo za izboljšanje delovanja programa vzorčenja in preizkušanja.
Project status at the end of 2006
Status projektov na koncu leta 2006
The Agency reviewed 80% of the RMPs submitted as part of new applications.
Agencija je preučila 80 % načrtov za obvladovanje tveganja, ki so bili predloženi kot del novih vlog.
New indications broaden scope of existing medicines
Nove terapevtske indikacije razširjajo obseg obstoječih zdravil
The presence of representatives from patients', doctors' and veterinarians' organisations, who joined the Board in September 2005, has added a new dimension to how the Board operates, and their experience and expertise has made an invaluable contribution to the Board's functioning.
Prisotnost predstavnikov organizacij bolnikov, zdravnikov in veterinarjev, ki so se upravnemu odboru pridružili septembra 2005, je dodala novo razsežnost delu upravnega odbora, njihove izkušnje in strokovno znanje pa so dragoceno pripomogle k delovanju tega odbora.
Warnings and contra-indications were added for the classes of medicinal products (class labelling) below:
Dodana so bila opozorila in kontraindikacije za spodaj navedene razrede zdravil (označevanje razreda):
EudraNet (secure communication between stakeholders in the European Medicines Regulatory Network).
EudraNet (varno komuniciranje med zainteresiranimi stranmi v evropski regulativni mreži za zdravila).
This was due to the frequent update of the Annexes to the Community marketing authorisations of parallel-distributed products and to other changes proposed by parallel distributors (e.g. addition of countries of origin).
To je bila posledica pogostega posodabljanja prilog k dovoljenjem Skupnosti za promet z izdelki, ki se vzporedno distribuirajo, in drugih sprememb, ki jih predlagajo vzporedni distributerji (npr. dodatek držav izvora).
Almost forty organisations representing patients and consumers answered the Agency's call in 2006 for expressions of interest in becoming involved in EMEA activities, of which 16 met the EMEA eligibility criteria and were placed on a public list on the Agency's website, which will be updated regularly.
Skoraj štirideset organizacij, ki predstavljajo bolnike in potrošnike, je odgovorilo na poziv Agencije iz leta 2006 za izraz interesa za sodelovanje v dejavnostih EMEA, od katerih jih je 16 izpolnjevalo merila ustreznosti EMEA in so tako bile vpisane na javni seznam na spletni strani Agencije, ki se bo redno posodabljal.
1.3 Information and communication
1.3 Zagotavljanje informacij in obveščanje
In order to review the experience gained with risk-management plans to date, and to introduce further improvements, a Review and Learning Project was set up, involving the EMEA, CHMP, PhVWP and CMD(h).
Za preučitev izkušenj, ki so bile do sedaj pridobljene iz načrtov za obvladovanja tveganja, in za uvedbo dodatnih izboljšav je bil oblikovan revizijski in učni projekt, v katerem sodelujejo EMEA, CHMP, PhVWP in CMD(h).
This was the first full year of operation of the new pharmaceutical legislation introduced in the European Union in November 2005, under which the EMEA assumed new responsibilities and saw the scope of its tasks greatly extended.
V tem letu se je prvič celo leto izvajala nova farmacevtska zakonodaja, uvedena v Evropski uniji novembra 2005, v skladu s katero je EMEA prevzela nove odgovornosti, močno pa se je povečal tudi obseg njenih nalog.
Questionand-answer documents are now systematically published to give relevant information at the time of withdrawal or refusal of applications.
Dokumenti z vprašanji in odgovori se zdaj sistematično objavljajo tako, da so ustrezne informacije zagotovljene ob umiku ali zavrnitvi vlog.
New dossiers concerning generics and novel aspects of pharmaceutical development
Novi dosjeji v zvezi z generičnimi in novimi vidiki farmacevtskega razvoja
We also contributed towards stimulating research and development of new medicines through our involvement in the Innovative Medicines Initiative and the European Technology Platform for Global Animal Health, but in particular through the dedicated support provided to small and medium-sized companies by our SME Office, which, in its first year of operation, generated even greater interest than had been expected.
K spodbujanju raziskav in razvoja novih zdravil smo prispevali tudi z vključenostjo v pobudo za inovativna zdravila in evropske tehnološke platforme za globalno zdravje živali, še zlasti pa s specializirano podporo, ki jo malim in srednje velikim podjetjem zagotavlja naš Urad za mala in srednje velika podjetja, ki je v prvem letu svojega delovanja zbudil celo večji interes, kot je bilo pričakovano.
The CVMP completed the assessment and issued opinions in 4 referral procedures, 3 of which started in 2006 and 1 in 2005.
CVMP je zaključil ocenjevanje in izdal mnenja v štirih postopkih napotitve, od katerih so se tri začeli leta 2006, eden pa leta 2005.
At the conclusion of the scientific evaluation, undertaken in 210 days within the Agency, the opinion of the scientific committee is transmitted to the European Commission to be transformed into a single market authorisation valid throughout the whole European Union.
Na koncu znanstvenega vrednotenja, ki ga Agencija opravi v 210 dneh, se mnenje znanstvenega odbora sporoči Evropski komisiji in ta izda enotno dovoljenje za promet z zdravilom, veljavno po vsej Evropski uniji.
This covers a large number of projects, which are essentially designed to increase efficiency of the European medicines network, to provide better information to patients and users of medicinal products, and to contribute to the safe and effective use of these products.
Ta zajema veliko število projektov, oblikovanih predvsem za povečanje učinkovitosti Evropske mreže zdravil, zagotavljanje boljših informacij bolnikom in uporabnikom zdravil ter prispevanje k varni in učinkoviti uporabi teh izdelkov.
In February 2006, the Agency began publishing summaries of European public assessment reports (EPARs) that are specially written to be understandable by patients and members of the general public.
Februarja 2006 je Agencija začela izdajati povzetke evropskih javnih poročil o oceni zdravila (EPAR), ki so posebej napisana tako, da jih lahko razumejo bolniki in člani širše javnosti.
The increasing importance of the Agency's role in the provision of high-quality information to patients and healthcare professionals led to a number of initiatives in the area of information and communication in 2006, as briefly outlined below.
Vse večji pomen Agencije pri zagotavljanju visokokakovostnih informacij bolnikom in zdravstvenim delavcem je privedel do številnih pobud na področju zagotavljanja informacij in obveščanja v letu 2006, ki so na kratko opisane v nadaljevanju.
Developing efficient and transparent procedures to allow rapid access by users to safe and effective innovative medicines and to generic and non-prescription medicines through a single European marketing authorisation.
razvojem učinkovitih in preglednih postopkov, ki uporabnikom omogočajo hiter dostop do varnih in učinkovitih inovativnih zdravil ter do generičnih zdravil in zdravil brez recepta z enotnim evropskim dovoljenjem za promet;
The approval of biosimilar products places Europe at the forefront of medicines regulation in this area and represents an important contribution to public health in the EU.
Odobritev biološko podobnih izdelkov uvršča Evropo v ospredje na področju regulacije zdravil in je pomemben prispevek k javnemu zdravju v EU.
The majority of new indications related to medicinal products approved for the treatment of various forms of cancer.
Večina novih terapevtskih indikacij se je nanašala na zdravila, odobrena za zdravljenje različnih oblik raka.
More than half of orphan-designated medicines are for treatment of children
Več kot polovica zdravil, določenih za zdravila sirote, je namenjena zdravljenju otrok
Further progress with EudraVigilance
Nadaljnji napredek pri EudraVigilance
The EMEA and national competent authorities of the EU Member States carried out a number of actions aimed at strengthening the European medicines network - one of the Executive Director's priorities for 2006.
EMEA in nacionalni pristojni organi držav članic EU so izvedli vrsto ukrepov, namenjenih krepitvi Evropske mreže zdravil, ki je bila ena izmed prednostnih nalog izvršnega direktorja v letu 2006.
of Commission Regulation (EC) No 1084/2003
Uredbe Komisije (ES) št. 1084/2003
1.1 Improving the safety of medicines
1.1 Izboljšanje varnosti zdravil
The centralised procedure is compulsory for all medicinal products for human and animal use derived from biotechnology processes.
Centralizirani postopek je obvezen za vsa zdravila za uporabo v humani in veterinarski medicini, pridobljena z biotehnološkimi postopki.
The EMEA and national competent authorities made further progress with the European RiskManagement Strategy for human medicines, particularly in the areas highlighted below.
EMEA in nacionalni pristojni organi so dosegli nadaljnji napredek pri evropski strategiji obvladovanja tveganja za zdravila za uporabo v humani medicini, zlasti na področjih, ki so navedena v nadaljevanju.
Revenue and expenditure in 2006
Prihodki in odhodki v letu 2006
The main change to the policy concerned a re-focusing of incentives on support for protocol assistance and other pre-authorisation assistance.
Glavna sprememba politike se je nanašala na preusmeritev glavne pozornosti pobud na podporo pomoči pri protokolu in druge pomoči pred izdajo dovoljenja.
* The 36-day EMEA post-opinion phase in 2006 accounts for the Agency's processing time as well as the time required by applicants and Member States to carry out their post-opinion translation checks.
* 36-dnevna faza po sprejetju mnenja EMEA v letu 2006 predstavlja čas obdelave Agencije in čas, ki ga vlagatelji in države članice potrebujejo za izvedbo preverjanj prevoda po sprejetju mnenja.
These led to authorisations under exceptional circumstances and are subject to specific obligations and follow-up measures, including enhanced pharmacovigilance measures, to ensure the safe use of these products.
Te so pripeljale do izdaje dovoljenj v izjemnih okoliščinah, cepivi pa sta predmet posebnih obveznosti in dodatnih ukrepov, vključno z okrepljenimi ukrepi farmakovigilance za zagotovitev varne uporabe teh izdelkov;
By the end of the year, 161 sponsors of clinical trials being conducted in the European Economic Area were reporting suspected unexpected serious adverse reactions to the EudraVigilance Clinical Trial Module (EVCTM).
Do konca leta 2006 je 161 sponzorjev, ki so izvajali klinična preizkušanja znotraj evropskega gospodarskega prostora (EGP), poročalo o sumih na resne nepričakovane neželene učinke v modul kliničnih preizkušanj EudraVigilance (EudraVigilance Clinical Trial Module - EVCTM).
Four additional members were appointed to the Scientific Advice Working Party (SAWP), and its meetings were extended to three days, allowing more meetings to be held with applicant companies for discussions.
v delovno skupino za znanstveno svetovanje (Scientific Advice Working Party - SAWP) so bili imenovani štirje dodatni člani, sestanki te delovne skupine pa so bili podaljšani na tri dni, kar omogoča več razprav z družbami vlagateljicami;
This prompt action, together with accelerated decision-making procedures by the European Commission, enabled authorised vaccines of high quality to be made available for use across the EU at a time of increased risk of avian-influenza occurrence in the autumn of 2006.
Tovrstno pospešeno ukrepanje je skupaj s pospešenim postopkom odločanja Evropske komisije omogočilo, da so bila med povečanim tveganjem za pojav aviarne influence jeseni leta 2006 na voljo odobrena visokokakovostna cepiva v EU.
Much effort was placed on competence-development in 2006.
V letu 2006 je bilo veliko prizadevanj posvečenih razvoju pristojnosti.
To date, a total of 53,642 ICSRs, corresponding to 26,997 individual cases, have been transmitted to EVCTM.
Do sedaj je bilo v modul EVCTM posredovanih skupaj 53.642 ICSR-jev, kar ustreza 26.997 posameznim primerom.
For the third consecutive year, more than one hundred applications were received for the designation of orphan medicinal products: a total of 104 applications were submitted.
Že tretje leto zapored je bilo prejetih več kot sto vlog za določitev zdravila kot zdravila sirote: skupaj so bile predložene 104 vloge.