natgillin/translations-raw huggingface dataset:
Typically, this is done to benefit from price differentials.
Praviloma se to izvaja zato, da se lahko izkoristijo ugodnosti zaradi razlik v ceni.
Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect not more than five in 10 000 people in the European Union.
Zdravila sirote so namenjena za ugotavljanje, preprečevanje ali zdravljenje življenjsko nevarnih ali kronično izčrpavajočih zdravstvenih stanj, ki v Evropski skupnosti ne prizadenejo več kot pet od 10.000 ljudi.
Title IV of the new Regulation entered into force on 20 May 2004.
Naslov IV nove uredbe je začel veljati 20. maja 2004.
The EMEA ensures efficient support for the meetings it organises, providing facilities and services, and constantly improves the resources available.
EMEA zagotavlja učinkovito podporo srečanjem, ki jih organizira, zagotavlja zmogljivosti in storitve ter stalno izboljšuje razpoložljive vire.
The time taken by companies to answer questions relating to deficiencies in their applications (referred to as clock stop ) increased.
Podaljšal se je čas, ki ga potrebujejo podjetja, da odgovorijo na vprašanja v zvezi s pomanjkljivostmi v njihovih vlogah (tako imenovana "zaustavitev časa").
Special attention was paid to improving communication between the stakeholders and to increasing transparency and understanding.
Posebna pozornost je bila posvečena izboljšanju komuniciranja med interesnimi skupinami ter povečanju preglednosti in razumevanja.
A total of 87 requests were received and 77 were finalised.
Prejetih je bilo skupaj 87 zahtevkov, 77 pa jih je bilo dokončno obdelanih.
The new legislative framework consists of:
Nov zakonodajni okvir zajema:
New regulatory framework
Nov regulativni okvir
This represents a 40 % increase in activity when compared to 2003, and indicates that companies developing medicines for rare diseases have a high level of interest in receiving support and advice during the research and development phase.
To je 40-odstotno povečanje dejavnosti v primerjavi z letom 2003 in kaže, da je pri podjetjih, ki razvijajo zdravila za redke bolezni, prisoten velik interes za prejemanje podpore in svetovanja med fazo raziskav in razvoja.
The accounts sector maintains the accounts, makes payments and collects revenue in accordance with the procedures laid down in the Financial Regulation.
Računovodski sektor vodi račune, opravlja plačila in zbira prihodke v skladu s postopki iz finančne uredbe.
A total of 5 925 delegate visits were reimbursed, leading to a 47 % increase in expenditure in 2004.
Stroški so bili povrnjeni za skupaj 5925 obiskov delegatov, zaradi česar so se odhodki v letu 2004 povečali za 47 %.
The existing procedures were updated to take account of the consequences of the EU enlargement and the revision of the pharmaceutical legislation.
Obstoječi postopki so bili posodobljeni tako, da upoštevajo posledice širitve EU in revizijo farmacevtske zakonodaje.
To achieve 99.5 % availability for all IT services supporting the corporate activities of the EMEA
Doseči 99,5-odstotno razpoložljivost vseh storitev IT za podporo podjetniških dejavnosti EMEA
Cooperation with EFSA
Sodelovanje z EFSA
Of the medicinal products having received a positive opinion, some were more notable in terms of therapeutic progress:
Pri zdravilih, za katera so bila izdana pozitivna mnenja, so bila nekatera še posebej pomembna z vidika napredka v zdravljenju:
The majority (>90 %) of results received show that the products were of high quality and complied with their authorised specifications.
Večina (> 90 %) pridobljenih rezultatov kaže, da so izdelki visoke kakovosti in skladni s specifikacijami, ki so odobrene zanje.
Two informal meetings were held in 2004, in Dublin and Scheveningen.
V letu 2002 sta bila opravljena dva neformalna sestanka v Dublinu in Scheveningenu.
The work for final MRLs for these two substances is well underway and is likely to be completed in 2005.
Dela za končno določitev MRL-jev za ti dve učinkovini potekajo in bodo verjetno dokončana v letu 2005.
Elements of the new legislation which came into force in 2004 include:
Elementi nove zakonodaje, ki so začeli veljati v letu 2004, zajemajo:
There were also regular bilateral meetings between the EMEA and the secretaries of various interested parties.
Potekali so redni dvostranski sestanki med EMEA in sekretariati različnih zainteresiranih strani.
1.7 Corporate governance - Integrated management system
1.7 Podjetniško upravljanje - integrirani sistem upravljanja
Surpluses in one budget year are returned to the Commission, where they are earmarked to compensate for shortfalls in fee income in following budget years.
Presežki iz enega proračunskega leta se vrnejo Komisiji, kjer se namensko rezervirajo za izravnavo primanjkljajev v prihodkih iz pristojbin v naslednjih proračunskih letih.
In 2004, the VMRFG provided answers to a wide range of questions from both Member States and Industry on a number of different regulatory issues.
V letu 2004 je VMRFG pripravil odgovore na številna vprašanja, ki so jih predstavile države članice in industrija glede vrste različnih regulativnih vprašanj.
This is the highest number of positive opinions adopted in any year since orphan medicinal product legislation was implemented in 2000.
To je najvišje število pozitivnih mnenj, sprejetih v katerem koli letu, odkar je bila leta 2000 uvedena zakonodaja v zvezi z zdravili sirotami.
I am pleased to report that the integration of the 10 new Member States into the European regulatory network was successful beyond all expectations thanks to excellent preparatory work conducted in the years leading up to the EU enlargement.
Z veseljem ugotavljam, da je uspeh vključitve 10 novih držav članic v evropsko regulativno mrežo presegel vsa pričakovanja, za kar se lahko zahvalimo odličnim pripravam, opravljenim v letih pred širitvijo EU.
# Denotes an orphan medicinal product designated under Regulation (EC) No 121/2000.
# Označuje zdravilo siroto, določeno v skladu z Uredbo (ES) št. 121/2000.
• Revised the rules on public access to EMEA documents 16 December 2004
• revizija predpisov o javnem dostopu do dokumentov EMEA 16. december 2004
By the end of 2004, almost 10 % of the total of 335 EMEA staff members were nationals of one of the 10 new Member States.
Do konca leta 2004 je bilo skoraj 10 % od skupaj 335 članov osebja EMEA iz ene od 10 novih držav članic.
In 2004, 2 referrals were received; no arbitration was submitted.
V letu 2004 sta bili prejeti dve predložitvi, predložena pa ni bila nobena arbitraža.
The new legislation introduced a simplified registration procedure for traditional herbal medicinal products.
Nova zakonodaja je uvedla poenostavljen postopek registracije za tradicionalna zeliščna zdravila.
The number of SUSARs received electronically was 7 984, of which 3 746 were from EU sources and 4 238 from outside the EU.
V elektronski obliki je bilo prejetih 7.984 SUSAR-jev, od katerih jih je bilo 3.746 iz virov EU in 4.238 iz virov zunaj EU.
The Agency finalised 340 notifications of change.
Zaključila je tudi 340 obvestil o spremembi.
These experts and the EMEA secretariat will continue work in these and other new areas, such as cell therapy and tissue engineering, in 2005.
Ti strokovnjaki in sekretariat EMEA bodo v letu 2005 nadaljevali delo na teh in drugih novih področjih, kot sta celično zdravljenje in inženiring tkiv.
There were no referral procedures under Articles 36 or 37.
V skladu s členoma 36 in 37 ni bilo nobenih postopkov predložitve.
In 2004, total compensation was 32 233 000 about one third of the Agencys total budget.
V letu 2004 so plačila skupaj znašala 32.233.000 EUR, kar je približno tretjina celotnega proračuna Agencije.
In 2004, the EMEA validated 402 initial parallel distribution notifications and finalised 373 initial notifications.
V letu 2004 je EMEA potrdila 402 začetni obvestili o vzporedni distribuciji in zaključila 373 začetnih obvestil.
The authorities make scientific resources available in the form of a network of more than 3 500 European experts who assist the Agency in the performance of its scientific tasks.
Organi omogočajo dostop do znanstvenih virov v obliki mreže več kot 3500 evropskih strokovnjakov, ki Agenciji pomagajo pri opravljanju njenih znanstvenih nalog.
The enlargement of the European Union made it necessary to implement the Specific Mechanism in the existing notification procedure.
Prvič, zaradi širitve Evropske unije je bilo treba uvesti poseben mehanizem v obstoječi postopek obveščanja.
The ICDRA promotes worldwide collaboration between regulatory authorities for medicinal products.
ICDRA spodbuja sodelovanje med regulativnimi organi za zdravila po vsem svetu.
Annex 12 Guidelines and working documents in 2004
Priloga 12 Smernice in delovni dokumenti v letu 2004
It manages efficiently the cash resources of the Agency, maintains the Agency s relationship with its banks, and provides accurate and timely financial information to management.
Učinkovito upravlja z gotovinskimi viri Agencije, vzdržuje odnose Agencije z njenimi bankami in zagotavlja točne in pravočasne finančne informacije vodstvu.
Every Member State now has one member on the Board.
Zdaj ima vsaka država članica v odboru enega člana.
No scientific advice (n=171)
Brez znanstvenega svetovanja (n=171)
Implementation of 3-tier architecture with appropriate security and interface to Internet services for internal and remote services
Uvedba triplastne strukture z ustrezno varnostjo in vmesnikom za internet za interne in oddaljene storitve
The Executive Support Sector addresses, in particular, the need for improved relations with external partners and the provision of support for the Agency s management activities.
Sektor za izvršno podporo se ukvarja zlasti s potrebo po izboljšanih odnosih z zunanjimi partnerji in zagotavljanjem podpore pri dejavnostih upravljanja Agencije.
Legislative provisions implementing special measures for innovative medicines, technologies and therapies will help to provide more rapid access to medicines without compromising the safety of patients.
Zakonodajni predpisi za izvajanje posebnih ukrepov za inovativna zdravila, tehnologije in terapije bodo omogočili hitrejši dostop do zdravil, ne da bi to ogrozilo varnost bolnikov.
In 2004, the EMEA also published guidance for parallel distributors.
V letu 2004 je EMEA objavila tudi smernice za vzporedne distributerje.
The new Member State authorities were connected to the EudraVigilance Gateway and are actively involved in the joint implementation activities at Community level.
Organi novih držav članic so se povezali v EudraVigilance Gateway in dejavno sodelujejo v skupnih izvedbenih dejavnostih na ravni Skupnosti.
Where the original national authorisation cannot be recognised, the points in dispute are submitted to the EMEA for arbitration.
Kadar se izvorno nacionalno dovoljenje za promet ne more priznati, se sporne točke predložijo EMEA v arbitražo.
Annual reports for 32 products were prepared in 2004, each of which is prepared in cooperation with a rapporteur and co-rapporteur, and adopted by the CVMP.
V letu 2004 so bila pripravljena letna poročila za 32 izdelkov; vsako poročilo se pripravi v sodelovanju s poročevalcem in soporočevalcem, sprejme pa ga CVMP.
In 2004, the Agency began to implement a series of transparency policy measures adopted by the Management Board in October 2003.
V letu 2004 je Agencija začela izvajati vrsto ukrepov politike preglednosti, ki jih je upravni odbor sprejel oktobra 2003.
• User requirements for the database were drawn up in line with additional requirements resulting from the terms of Regulation (EC) No 726/2004, G10 recommendations and Council conclusions
• zahteve uporabnikov zbirke podatkov so bile sestavljene v skladu z dodatnimi zahtevami, ki izhajajo iz določb Uredbe (ES) št. 726/2004, priporočili G10 in sklepi Sveta
The workload relating to medicinal products for veterinary use fell somewhat in comparison to 2003 but was, nonetheless, also substantial.
Delovna obremenitev pri zdravilih za veterinarsko uporabo je nekoliko upadla v primerjavi z letom 2003, vendar je bila kljub temu precejšnja.
In addition to the members appointed by the European Commission and the European Parliament, the new Board will also have representatives from doctors and patients organisations.
Poleg članov, ki jih imenujeta Evropska komisija in Evropski parlament, bodo v novem odboru tudi predstavniki iz organizacij zdravnikov in bolnikov.
A commitment was made in 2003 to implement a large number of projects in 2004.
V letu 2003 je bila sprejeta zaveza o izvedbi veliko projektov v letu 2004.
A comprehensive upgrade to the MMS was delivered both on time and within budget.
Celovita nadgradnja MMS je bila opravljena pravočasno in v okviru proračuna.
One product was not renewed and, therefore, its marketing authorisation expired in 2004.
En izdelek ni bil podaljšan in zato je njegovo dovoljenje za promet v letu 2004 poteklo.
The procedure will be revised based on experience gained from the pilot phase in time for the introduction of the new Community legislation in November 2005.
Postopek bo pregledan na podlagi izkušenj, pridobljenih v pilotni fazi, v primernem času pred uvedbo nove zakonodaje Skupnosti novembra 2005.
• Major work was undertaken in 2004 in relation to the further development and implementation of the EudraVigilance project.
• V letu 2004 so se začela izvajati pomembna dela v zvezi z nadaljnjim razvojem in izvajanjem projekta EudraVigilance.
At the beginning of 2004 there were 3 old substances remaining for which MRLs had not been entirely completed: altrenogest, flugestone acetate and norgestomet.
V začetku leta 2004 so ostale še 3 "stare" učinkovine, za katere MRL-ji še niso bili popolnoma dokončani: altrenogest, flugeston acetat in norgestomet.
To implement one common and standard directory of all parties involved in the EU pharmaceutical regulatory process
Uvesti skupni in standardni imenik vseh strank, ki sodelujejo v farmacevtskem regulativnem procesu EU
To take over the final stages of the EDMS pre-production application, prepare it for the move into operation and operate the application when in production
Prevzeti zadnje faze uporabe EDMS pred proizvodnjo, jo pripraviti za prehod v delovanje in izvajati aplikacijo, ko bo v proizvodnji
• Integration of delegates from the new Member States
• vključevanje delegatov iz novih držav članic
The paper was released for external consultation in September 2004 and aims at putting in place a transparent process for the development, consultation, finalisation and implementation of pharmaceutical guidelines.
Ta dokument je bil predstavljen za zunanje posvetovanje septembra 2004, njegov namen pa je uvesti pregleden postopek za razvoj, posvetovanje, dokončno oblikovanje in izvedbo farmacevtskih smernic.
Greater level of satisfaction with the quality of dossiers
Večje zadovoljstvo s kakovostjo dokumentacije
1 EMEA in the European system
1 EMEA v evropskem sistemu
Altrenogest received a positive opinion to establish final MRLs in June 2004.
Za altrenogest je bilo sprejeto pozitivno mnenje za določitev končnih MRL-jev junija 2004.
Recommendations and advice provided include general public-health issues relating to veterinary medicinal products.
Priporočila in svetovanje zajemajo splošna vprašanja javnega zdravja, povezana z veterinarskimi zdravili.
• Implementation of new and modified accounting practices in line with the reform of the Commission
• izvajanje novega in spremenjenega računovodskega sistema v skladu z reformo Komisije
• The new EU Member States were successfully integrated in the scientific committees dealing with medicines for human use and in the activities of the Agency.
• Nove države članice EU so se uspešno vključile v znanstvene odbore, ki se ukvarjajo z zdravili za uporabo v humani medicini, in v dejavnosti Agencije.
The other sections of the guideline were reviewed in 2004 and it is expected that the European Commission will publish an amended version in the first quarter of 2005.
Drugi oddelki smernic so bili revidirani v letu 2004 in Evropska komisija naj bi objavila spremenjeno različico v prvem četrtletju leta 2005.
Transparent and public rules of conduct reinforce the Agency s reliability in the eyes of the general public.
Pregledna in javna pravila ravnanja krepijo ugled Agencije v očeh javnosti.
A key part of the plan is a pilot programme under which companies can request parallel scientific advice from the two agencies.
Ključni del načrta je pilotni program, v skladu s katerim lahko podjetja zaprosijo za vzporedno znanstveno svetovanje obeh agencij.
First contacts were established during 2004 with the new European Centre for Disease Prevention and Control (ECDC).
V letu 2004 je navezala prve stike z novim Evropskim centrom za preprečevanje in nadzor bolezni (ECDC).
• EudraNet II in operation by May 2004
• EudraNet II je delovala do maja 2004
Overall performance for the year was very good, with regulatory timelines being met in almost all areas of activity.
Splošna uspešnost v letu 2003 je bila zelo dobra, predpisani roki pa so bili doseženi na skoraj vseh področjih dejavnosti.
Such substances are evolving partly through the development of new products, while others are old molecules for which no MRLs had previously been established or which had previously not been used as veterinary medicines.
Take učinkovine se razvijajo delno z razvojem novih izdelkov, pri nekaterih pa gre za stare učinkovine, za katere pred tem ni bilo določenih MRL-jev ali ki se prej niso uporabljale kot veterinarska zdravila.
The parallel distribution activity was marked by two major changes in 2004:
V letu 2004 sta dejavnost vzporedne distribucije zaznamovali dve pomembni spremembi:
For half of the applications, the clock stop was over 200 days, while for others it was shorter in a number of cases, as short as 50 or 60 days.
Pri polovici vlog je bila zaustavitev časa daljša od 200 dni, pri drugih pa je bila krajša - večkrat le 50 ali 60 dni.
The volume of the third parties database grew significantly in 2004, with over 1 000 parties added.
Obseg zbirke podatkov tretjih strani se je v letu 2004 znatno povečal, saj je bilo dodanih več kot 1000 tretjih strani.
18 174 reports were received from EU sources and 46 012 were from outside the EU.
Iz virov v EU je bilo prejetih 18.174, iz virov zunaj EU pa 46.012 poročil.
• Two standards for electronic information exchange (the EU Module 1 Specification and the Application Form Specification) were adopted
• sprejeta sta bila dva standarda za elektronsko izmenjavo informacij (specifikacija EU Modul 1 in specifikacija obrazca za vlogo)
Good relations were maintained with Industry, academia and other stakeholders, while cooperation with and support from the European Commission and Parliament were also extremely good.
Nadaljevali so se dobri odnosi z industrijo, akademskim svetom in drugimi interesnimi skupinami, izredno uspešna pa sta bila tudi sodelovanje in podpora Evropske komisije in Parlamenta.
Two working parties and one ad hoc group assist the Committee:
Odboru pomagajo dve delovni skupini in ena ad hoc skupina:
The Committee adopted its key position paper in June 2004 setting out to further define the problem and offering solutions to try and resolve matters from a regulatory perspective.
Odbor je junija 2004 sprejel ključni dokument o stališču, v katerem je izrazil svoj namen nadaljnje opredelitve problema in ponudil rešitve, s katerimi bi se lahko vprašanja rešila z regulativnega vidika.
• Cancer (5 new products)
• rak (5 novih izdelkov)
The control framework of the Agency changed significantly with the adoption of the new EMEA quality policy and new internal control standards.
Kontrolni okvir Agencije se je precej spremenil s sprejetjem nove politike kakovosti EMEA in novih standardov notranje kontrole.
As a result of the enlargement and the increased number of documents being posted on the EMEA website, the number of external requests for information increased by 50 % over the previous year.
Zaradi širitve in večjega števila dokumentov, objavljenih na spletni strani EMEA, se je število zunanjih zahtevkov za informacije povečalo za 50 % v primerjavi z letom poprej.
The Board heard regular progress reports on the EU telematics strategy.
Odbor je obravnaval redna poročila o napredku glede telematske strategije EU.
All working documents adopted by the HMPWP are listed in Annex 12.
Vsi delovni dokumenti, ki jih je sprejela HMPWP, so navedeni v Prilogi 12.
• In 2004, the CHMP/EMEA initiated a revision of the European Commission Summary of Product Characteristics (SPC) Guideline, and agreement on sections 4.1 and 5.1 was reached.
• V letu 2004 sta CHMP/EMEA začela revizijo Smernic Evropske komisije o povzetku glavnih značilnosti zdravila (Summary of Product Characteristics, SPC) in doseženo je bilo soglasje glede oddelkov 4.1 in 5.1.
Sterile medicinal products and some biological medicinal products are excluded from the scope.
Iz področja uporabe so izključena sterilna zdravila in nekatera biološka zdravila.
The new sector is responsible for the provision of information that is easily understandable and accessible for patients and healthcare professionals.
Ta sektor je odgovoren za zagotavljanje informacij, ki so lahko razumljive in dostopne bolnikom in zdravstvenim strokovnjakom.
A 99.5 % availability of IT services was achieved and key projects were delivered on time and within budget.
Dosežena je bila 99,5-odstotna razpoložljivost storitev IT, najpomembnejši projekti pa so bili izvedeni pravočasno in v okviru proračuna.
The constant monitoring of the safety of medicines after authorisation ( pharmacovigilance ) is an important part of the work of the national competent authorities and the EMEA.
Stalno spremljanje varnosti zdravil po izdaji dovoljenja za promet ("farmakovigilanca") je pomemben element dela pristojnih nacionalnih organov in EMEA.
The engaged involvement and intensive cooperation of so many partners, stakeholders and other interested parties contributed greatly to the success of the Agency s operations in 2004.
Prizadevno vključevanje in intenzivno sodelovanje številnih partnerjev, interesnih skupin in drugih zainteresiranih strani sta veliko prispevala k uspešnosti poslovanja Agencije v letu 2004.
Preparations started for the full application of all provisions by 20 November 2005.
Začele so se priprave, da bi se vse določbe do 20. novembra 2005 začele v celoti uporabljati.
As the Agency prepares to receive applications in relation to emerging therapies and new technologies, a new regulatory framework needs to be developed.
Ker se Agencija pripravlja na sprejem vlog v zvezi z novimi terapijami in tehnologijami, je treba razviti nov regulativni okvir.
A system of activity-based budgeting was developed, with details included in the budget reports to the Management Board and to the budgetary authority.
Razvit je bil sistem upravljanja proračuna po dejavnostih, katerega podrobnosti so vključene v proračunska poročila za upravni odbor in proračunski organ.
A major step towards improving the quality of the EU regulatory network as a whole was the agreement between the heads of regulatory agencies to introduce an EU benchmarking system.
Pomemben korak k izboljšanju kakovosti celotne regulativne mreže EU je bil sporazum med vodji regulativnih agencij o uvedbi sistema EU za primerjalne analize.
The Committee re-elected Dr Daniel Brasseur as chairman and Dr Eric Abadie as vicechairman.
Odbor je ponovno izvolil dr. Daniela Brasseura kot predsednika in dr. Erica Abadiea kot podpredsednika.
1.5 Transparency and communication
1.5 Preglednost in obveščanje
And while the growth of the European network to 28 EEA-EFTA countries, 42 national competent authorities and a pool of over 3 500 national experts certainly placed increased pressure on the EMEA in its role as coordinator, the Agency was able to cope without any major difficulty.
Čeprav je širitev evropske mreže na 28 držav EGP-EFTA, 42 pristojnih nacionalnih organov in več kot 3500 nacionalnih strokovnjakov zagotovo povečala pritisk na EMEA kot koordinatorja, je Agencija nove razmere obvladovala brez večjih težav.
The main achievements are described briefly in the table below.
Glavni dosežki so na kratko opisani v naslednji tabeli: