natgillin/translations-raw huggingface dataset:
Following a comprehensive review of the EU's pharmaceutical legislative framework, which started in July 2001, the new European pharmaceutical legislation was published in the Official Journal of the European Union on 30 April 2004.
Po temeljiti reviziji farmacevtskega zakonodajnega okvira EU, ki se je začela julija 2001, je bila nova evropska farmacevtska zakonodaja objavljena v Uradnem listu Evropske unije 30. aprila 2004.
Overall, substantial progress was made on implementing the telematics strategy during the year, with projects being delivered in line with expectations.
Na splošno je bil v letu 2004 dosežen precejšen napredek pri izvajanju telematske strategije, pri čemer so se projekti izvajali v skladu s pričakovanji.
Much effort was devoted in 2004 to the establishment of a long-term vision and implementation strategy for the Agency.
V letu 2004 je bilo veliko truda vloženega v določitev dolgoročne vizije in izvedbene strategije za Agencijo.
This initiative started in 2002, and the Agency is now preparing summaries for medicinal products designated in previous years.
Ta pobuda se je začela izvajati leta 2002, Agencija pa zdaj pripravlja povzetke za zdravila, določena za zdravila sirote v prejšnjih letih.
The Agency assists delegates with logistics and practical arrangements.
Agencija pomaga delegatom pri logistiki in praktičnih rešitvah.
• Implementation of the new EMEA Financial Regulation, with revision of procedures
• izvajanje nove finančne uredbe EMEA z revizijo postopkov
New Member States took part in the testing part of the programme from May 2004 onwards, as samples of certain products had already been taken from the market prior to accession.
Nove države članice so od maja 2004 sodelovale v programu na področju preizkušanja, ker so bili vzorci nekaterih izdelkov že vzeti na trgu pred pristopom.
After the EU enlargement on 1 May 2004, the CVMP met for the first time with members from the new Member States.
Po širitvi EU 1. maja 2004 se je CVMP prvič sestal s člani iz novih držav članic.
Previous annual reports and other reference documents are available from the EMEA website:
Prejšnja letna poročila in drugi referenčni dokumenti so na voljo na spletnem naslovu EMEA:
Adopted by the Management Board on 10 March 2005
Sprejel upravni odbor dne 10. marca 2005
These two groups contribute to the harmonisation of inspection-related procedures across the EU and develop guidance documents.
Ti skupini prispevata k usklajevanju z inšpekcijskimi pregledi povezanih postopkov po vsej EU in razvijanju usmeritvenih dokumentov.
The ultimate objective of the Road Map exercise is to ensure that, building on the achievements of its first 10 years, the EMEA adequately prepares the ground for further success in the future.
Končni cilj izvajanja usmeritvenega načrta je zagotoviti, da EMEA na podlagi dosežkov v svojih prvih 10 letih pripravi ustrezno podlago za naslednje uspehe v prihodnosti.
The IT development team provided a new version of the Experts database in 2004
Razvojna skupina IT je v letu 2004 zagotovila novo različico zbirke podatkov o strokovnjakih
5 EU telematics strategy
5 Telematska strategija EU
The Agency ensures full compliance with all regulatory and quality requirements in the areas of document and records management.
Agencija zagotavlja popolno upoštevanje vseh regulativnih in kakovostnih zahtev na področju upravljanja dokumentov in poročil.
Not in operation.
Se ne izvaja.
Positive Withdrawn prior to opinion Negative
Pozitivna Umaknitev pred mnenjem Negativna
In light of this, the EMEA created a new Sector for Medical Information.
Glede na to je EMEA oblikovala nov sektor za informacije o zdravilih.
This was the first time that such dialogue had occurred for a veterinary scientific advice procedure.
To je bilo prvo tako sodelovanje v postopku veterinarskega znanstvenega svetovanja.
These vaccines contain no adjuvant and should result in less injection-site reactions in vaccinated cats
Ta cepiva ne vsebujejo adjuvansov in bi morala imeti manj reakcij na mestu cepljenja pri mačkah.
All procedures were completed within the legal timelines, with summaries of opinion published at the same time as the opinions.
Vsi postopki so bili dokončani v zakonskih rokih, povzetki mnenj pa objavljeni skupaj z mnenji.
With the additional national competent authorities of the new Member States and a larger number of European experts, the EMEA is now required to operate in and manage an increasingly complex system.
Glede na dodatne pristojne nacionalne organe novih držav članic in večje število evropskih strokovnjakov se od EMEA zdaj zahteva, da deluje v vse bolj zapletenem sistemu in ga obvladuje.
Old substances are those which were on the market prior to the entry into force of Regulation (EEC) No 2377/90 and for which there are still some outstanding issues to address.
Stare učinkovine so tiste, ki so bile na trgu preden je začela veljati Uredba (EGS) št. 2377/90 in pri katerih so še vedno odprta nekatera vprašanja.
Time to opinion Time to decision
Čas do sprejetja mnenja Čas do sprejetja odločitve
The fee reduction policy applicable to designated orphan medicinal products during 2004 remained unchanged since 2002 and was as follows:
Politika zniževanja pristojbin za zdravila, določena za zdravila sirote, je v letu 2004 ostala nespremenjena od leta 2002 in je zajemala:
The PAT team held 5 meetings in 2004 and established contacts with 3 pharmaceutical companies.
Skupina PAT je imela v letu 2004 pet sestankov in je navezala stike s tremi farmacevtskimi podjetji.
Considerable effort was made to prepare for the significant changes associated with the new legislation, which will come into full effect on 20 November 2005.
Veliko naporov je bilo vloženih v priprave na pomembne spremembe, povezane z novo zakonodajo, ki bo v celoti začela veljati 20. novembra 2005.
The Agency continually strives to improve the structures and procedures of the scientific evaluation of medicinal products.
Agencija si nenehno prizadeva, da bi izboljšala svoje strukture in postopke znanstvenega vrednotenja zdravil.
This was to enable a more phased approach and address potential public health concerns.
Namen tega procesa je omogočiti bolj postopen prehod in obravnavo potencialnih vprašanj javnega zdravja.
• Adopted new financial regulation and implementing rules for the Agency
• sprejetje nove finančne uredbe in izvedbenih predpisov za Agencijo
controlling the safety of medicines for humans and animals, in particular through a pharmacovigilance network and the establishment of safe limits for residues in food-producing animals,
nadziranjem varnosti zdravil za ljudi in živali, predvsem z mrežo farmakovigilance in določitvijo varnih mejnih vrednosti ostankov v živalih, namenjenih proizvodnji hrane,
This allows innovations of the pharmaceutical industry to reach healthcare services and patients in the EU market faster than before.
Tako lahko inovacije v farmacevtski industriji hitreje kot prej dosežejo zdravstvene službe in bolnike na trgu EU.
• Likewise, the total number of variation applications exceeded the forecast figure, although a significant increase in the number of major variations had been expected, following the entry into force in 2003 of the new Regulation on variations1, which altered the categorisation of some variations.
• Podobno je skupno število vlog za spremembe kljub pričakovanemu precejšnjemu povečanju števila glavnih sprememb preseglo predviden obseg po tem, ko je v letu 2003 začela veljati nova Uredba o spremembah1, ki je spremenila kategorizacijo nekaterih sprememb.
The implementation plan for the confidentiality arrangement, detailing the information and documents the two agencies will exchange and the process for monitoring the implementation of the plan itself, was published in October 2004.
Izvedbeni načrt za dogovor o zaupnosti, ki podrobno določa informacije in dokumente za izmenjavo med agencijama ter spremljanje izvedbe samega načrta, je bil objavljen oktobra 2004.
Impact of scientific advice (n=48) on proportion of approvals over time
Učinek znanstvenega svetovanja (n=48) na delež odobritev v času
The EMEA provides companies with scientific advice on specific questions relating to the quality, safety or efficacy of their medicinal products.
EMEA podjetjem zagotavlja znanstveno svetovanje glede posebnih vprašanj, povezanih s kakovostjo, varnostjo ali učinkovitostjo njihovih zdravil.
• The Meeting Management System (MMS) was upgraded, including a new range of services.
• Izpopolnjen je bil sistem vodenja sestankov (Meeting Management System, MMS), ki vključuje nov sklop storitev.
A revised template was introduced to facilitate the collection of relevant data.
Uveden je bil revidiran vzorec, ki naj bi olajšal zbiranje ustreznih podatkov.
Medical conditions affecting children only Medical conditions affecting both children and adults Medical conditions affecting adults only
Zdravstvena stanja, ki prizadanejo samo otroke Zdravstvena stanja, ki prizadanejo otroke in odrasle Zdravstvena stanja, ki prizadanejo samo odrasle
Support was provided through scientific and regulatory training for committee members, experts and assessors.
Podpora se je izvajala z znanstvenim in regulativnim usposabljanjem članov odborov, strokovnjakov in ocenjevalcev.
International partners
Mednarodni partnerji
The new version of the database was made available to all national competent authorities.
Dostop do nove različice zbirke podatkov je bil omogočen vsem pristojnim nacionalnim organom.
This number is 31 % higher than the figure for 2003, and 27.5 % higher than the forecast number of 40.
To je 31 % več kot v letu 2003 in za 27,5 % presega predvidenih 40 vlog.
Annex 6 National competent authority partners
Priloga 6 Pristojni nacionalni organi kot partnerji
Authorities in developing countries can rely on centralised assessments to support marketing in their countries, thus facilitating access to these medicines and avoiding the need for costly and duplicative assessment work.
Organi v državah v razvoju se lahko zanesejo na centralizirane ocene, ki podpirajo trženje v njihovih državah, kar omogoča lažji dostop do teh zdravil in odpravlja potrebo po dragem in dvojnem ocenjevanju.
The composition of the CHMP was announced on 1 June 2004, following the conclusion of a Management Board consultation procedure.
Sestava CHMP je bila objavljena 1. junija 2004 po zaključku posvetovalnega postopka upravnega odbora.
Collecting, processing and analysing data in one repository is one of the prerequisites for efficiently supporting the pharmacovigilance activities and risk management strategy of the EU.
Zbiranje, obdelava in analiza podatkov v eni bazi je eden od prvih pogojev za učinkovito podpiranje dejavnosti farmakovigilance in strategije obvladovanja tveganja EU.
The evaluation process serves to ensure that medicinal products reaching the EU marketplace have a favourable risk/benefit balance for patients.
S postopkom vrednotenja se zagotovi, da imajo zdravila, ki dosežejo trg EU, ugodno razmerje med tveganji in koristmi za bolnike.
From 1 May 2004, the 10 new EU Member States were able to participate at the VMRFG meetings as full members of the group.
Od 1. maja 2004 lahko 10 novih držav članic EU sodeluje na sestankih VMRFG kot polnopravne članice skupine.
Bilateral relations with non-EU competent authorities also continued in 2004, in particular with regard to the implementation of the EU-US FDA confidentiality arrangements signed by the European Commission, EMEA and FDA in September 2003.
Dvostranski odnosi s pristojnimi organi, ki niso iz EU, so se nadaljevali tudi v letu 2004, zlasti glede izvedbe dogovorov o zaupnosti med EU in FDA ZDA, ki so jih podpisale Evropska komisija EMEA in FDA septembra 2003.
The primary institutional partner of the EMEA is the European Commission, in particular the Directorate-General for Enterprise and Industry.
Glavni institucionalni partner EMEA je Evropska komisija, zlasti Generalni direktorat za podjetništvo in industrijo.
Following an exchange of views with IFAH-Europe in 2004, the procedure and guidance for prospective applicants to request scientific advice has been considerably amended, which appears to be resulting in more applications.
Po izmenjavi stališč z IFAH-Evropa leta 2004 so bili postopek in navodila za možne vlagatelje zahtevkov za znanstveno svetovanje precej spremenjeni in zdi se, da ima to za posledico več zahtevkov.
A new policy and procedure on the handling of conflicts of interests of scientific committee members and experts was adopted in March 2004.
Marca 2004 so bili sprejeti nova politika in postopki glede obravnave navzkrižja interesov članov znanstvenih odborov in strokovnjakov.
The EU special contribution in 2004 amounted to 4 million, most of which contributed towards reduced fees for marketing authorisation applications and for protocol assistance.
Poseben prispevek EU je v letu 2004 znašal 4 milijone EUR, večina tega zneska pa je prispevala k znižanju pristojbin za vloge za dovoljenja za promet z zdravili in za pomoč pri protokolu.
An EU special contribution the orphan medicinal products fund is provided to create incentives for sponsors intending to develop such medicinal products, which otherwise might not be developed.
Poseben prispevek EU - sklad za zdravila sirote - ustvarja spodbude za sponzorje, da bi razvili taka zdravila, ki se sicer morda ne bi razvila.
There were no negative opinions and 1 application was withdrawn prior to opinion.
Negativnih mnenj ni bilo, 1 vloga pa je bila umaknjena pred sprejetjem mnenja.
Meeting reimbursements increased by 38 % due to EU enlargement with a corresponding increase in the recording of new third parties.
Nadomestila za sestanke so se zaradi širitve EU povečala za 38 %, kar ustreza povečanju v vpisu novih tretjih strani.
• Refurbishment of parts of the EMEA offices to accommodate new staff, telematics projects, and delegates and experts from the new Member States
• prenova delov pisarn EMEA za sprejem novega osebja, telematskih projektov ter delegatov in strokovnjakov iz novih držav članic
As a consequence of the new legislation, the Scientific Advice Working Group became a standing working party of the CHMP in May 2004.
Zaradi nove zakonodaje je Delovna skupina za znanstveno svetovanje postala stalna delovna skupina v CHMP maja 2004.
The European system offers two routes for authorisation of medicinal products.
Evropski sistem ponuja dva postopka za izdajo dovoljenja za promet z zdravili.
Apart from the MRAs with Canada and the US, as of 1 May 2004, all MRAs now apply in all 25 Member States.
Poleg sporazumov s Kanado in ZDA od 1. maja 2004 vsi sporazumi veljajo v vseh 25 državah članicah.
The centralised procedure is compulsory for medicinal products derived from biotechnology and is available at the request of companies for other innovative new products.
Centraliziran postopek je obvezen za zdravila, pridobljena z biotehnologijo, in je na voljo podjetjem na njihovo zahtevo za druga inovativna nova zdravila.
The Management Board met for the first time in its new configuration on 24 May 2004 at an extraordinary meeting.
Upravni odbor se je v novi sestavi prvič sestal 24. maja 2004 na izrednem zasedanju.
• Two exercises ultimately aimed at enabling the automatic transfer of data between competent authorities and EU Telematiics systems were initiated
• začeli sta se izvajati dve nalogi, katerih končni cilj je bil omogočiti samodejen prenos podatkov med pristojnimi organi in sistemi telematike EU
Caitríona Fisher chaired the meetings during the Irish EU presidency and Truus Janse-de Hoog chaired the meetings during the Dutch EU presidency.
Caitríona Fisher je predsedoval na zasedanjih med irskim predsedstvom EU, Truus Janse-de Hoog pa med nizozemskim predsedstvom.
European experts list
Seznam evropskih strokovnjakov
This Committee will provide the Member States and the European institutions with the bestpossible scientific opinion on questions relating to herbal medicinal products.
Odbor bo državam članicam in evropskim institucijam posredoval najboljše možno znanstveno mnenje o vprašanjih, povezanih z zeliščnimi zdravili.
The year 2004 was the Agency s tenth year of operations.
Leto 2004 je bilo deseto leto delovanja Agencije.
The EMEA operates in partnership with the national competent authorities for human and veterinary medicinal products in the Member States and the EEA-EFTA countries Iceland, Liechtenstein and Norway.
EMEA deluje v partnerstvu s pristojnimi nacionalnimi organi za zdravila za humano in veterinarsko uporabo v državah članicah in državah EGP-EFTA: Islandijo, Lihtenštajnom in Norveško.
In order to protect public and animal health, it may become necessary to implement urgent measures such as the recall of one or more batches of a medicinal product during its marketing period.
Zaradi zaščite zdravja ljudi in živali se lahko izkaže, da je treba izvesti nujne ukrepe, kot je umik ene ali več serij zdravil med obdobjem njihovega trženja.
Implementation of the plan, which also considered the impact of the EU enlargement in May 2004 and the need to prepare for future revisions of pharmaceutical legislation, started in early 2004.
Načrt, ki je upošteval tudi učinek širitve EU maja 2004 in potrebo po pripravi na prihodnje revizije farmacevtske zakonodaje, se je začel izvajati v začetku leta 2004.
The CHMP reviewed its guidance on comparability of medicinal products and focused on new guidelines specifically addressing biosimilar products.
CHMP je pregledal svoje smernice o primerljivosti zdravil in se osredotočil na nove smernice, ki posebej obravnavajo biološko podobne izdelke.
The Agency carried out sampling and testing activities as planned.
Agencija je opravila dejavnosti vzorčenja in preizkušanja po načrtih.
A selection of corporate projects in 2004:
Izbor podjetniških projektov v letu 2004:
In 2004, the provision of scientific advice and protocol assistance was up by approximately 25 % in comparison to 2003.
V letu 2004 se je zagotavljanje znanstvenega svetovanja in pomoči pri protokolu povečalo za približno 25 % v primerjavi z letom 2003.
This was due partly to the increased number of meetings and partly to the reimbursement of meeting expenses for representatives from the new Member States.
Razlog za to sta bila večje število sestankov in povračilo stroškov za srečanja predstavnikom iz novih držav članic.
• The Experts database, comprising more than 3 500 European experts, was upgraded.
• Dopolnjena je bila zbirka podatkov o strokovnjakih, ki zajema več kot 3500 evropskih strokovnjakov.
The MRFG also, on request, provides procedural and regulatory advice and develops general guidance papers, which it publishes on the MRFG website.
MRFG na zahtevo opravlja tudi postopkovno in regulativno svetovanje ter razvija splošne usmeritvene dokumente in jih objavlja na spletni strani MRFG.
The first meeting of the new Committee, which for the first time included representatives from the 10 new EU Member States as full members, took place from 1 3 June 2004.
Prvi sestanek novega odbora, v katerem so bili prvič tudi predstavniki iz 10 novih polnopravnih držav članic EU, je potekal od 1. do 3. junija 2004.
The code provides specific guidance on conflicts of interests and the declaration of those interests, on confidentiality and discretion, and on good administrative practices.
Kodeks določa posebne smernice glede navzkrižij interesov in izjave o takih interesih, zaupnosti in diskretnosti ter dobre upravne praske.
In addition, regulatory and procedural guidance is provided to the CHMP, HMPC and COMP, and to their related working parties and ad hoc groups.
Poleg tega se regulativne in postopkovne smernice zagotavljajo tudi CHMP, HMPC in COMP ter njihovim povezanim delovnim in ad hoc skupinam.
Many of these projects were big and involved development and deployment through collaboration with the EMEA Human and Veterinary Units.
Mnogo teh projektov je bilo velikih in je zajemalo razvoj in napotitve prek sodelovanja z enotami EMEA za humano in veterinarsko medicino.
It is essential to improve EMEA coordination on the collection and evaluation of adverse effects data for medicinal products.
Nujno je treba izboljšati uskladitev EMEA pri zbiranju in vrednotenju podatkov o škodljivih učinkih zdravil.
Denmark 3.57 % Estonia 0.77 % Finland 2.04 % France
Danska 3.57 % Estonija 0.77 % Finska
Flugestone acetate and norgestomet were placed in Annex III of Regulation (EEC) No 2377/90 in 2003, with provisional MRLs expiring in 2008.
Flugeston acetat in norgestomet sta bila v letu 2003 vključena v Prilogo III k Uredbi (EGS) št. 2377/90, začasni MRL-ji zanju pa potečejo leta 2008.
Following the entry into force of parts of the new pharmaceutical legislation in May 2004, the Committee for Medicinal Products for Human Use (CHMP) replaced the Committee for Proprietary Medicinal Products (CPMP).
Po uveljavitvi delov nove farmacevtske zakonodaje maja 2004 je Odbor za zdravila za uporabo v humani medicini (CHMP) zamenjal Odbor za lastniška zdravila (CPMP).
The EMEA continued its interaction with the European Parliament, in particular with the Committee on the Environment, Public Health and Food Safety.
EMEA je še naprej sodelovala z Evropskim parlamentom, zlasti z Odborom za okolje, javno zdravje in varno hrano.
The Management Board met 5 times in 2004:
V letu 2004 se je upravni odbor sestal petkrat:
In 2004, annual reports of the sampling and testing results were produced for the first time, starting with the 2003 programme.
V letu 2004 so bila prvič izdelana letna poročila o rezultatih vzorčenja in preizkušanja, ki se začenjajo s programom za leto
Two national competent authorities and 21 pharmaceutical companies implemented the electronic transmission of ICSRs during 2004.
Dva pristojna nacionalna organa in 21 farmacevtskih podjetij so uvedli elektronski prenos ICSR-jev v letu 2004.
In this context, I would like to draw attention to an important issue in the Road Map, which will further improve the interests of EU citizens and patients by means of medicines control: the reinforcement of pharmacovigilance coordination.
V zvezi s tem bi rad opozoril na pomemben vidik usmeritvenega načrta, ki bo z nadzorom zdravil še izboljšal interese državljanov EU in bolnikov, in sicer na okrepitev uskladitve farmakovigilance.
The contributions that industry associations are making to this technology platform will help to find solutions to clear bottlenecks during the development of new medicines.
Prispevki industrijskih združenj k tej tehnološki platformi bodo pomagali pri iskanju rešitev za odpravo ozkih grl med razvijanjem novih zdravil.
This exercise was conducted in a most transparent manner, with the recommendations being discussed and finalised at a workshop in which all organisations that had commented were invited to participate.
Postopek je bil opravljen zelo pregledno, tako da so se priporočila obravnavala in dokončno oblikovala na delavnici, na katero so bile povabljene vse organizacije, ki so dale pripombe.
Average number of days for centralised procedures
Povprečno število dni za centralizirane postopke
The quality and safety of products derived from human plasma rely both on the source plasma material and the further manufacturing processes.
Kakovost in varnost izdelkov, pridobljenih iz človeške plazme, sta odvisni od vira materiala plazme in nadaljnjih proizvodnih procesov.
Once an opinion has been given, the Agency posts a summary of opinion on its website.
Po izdaji mnenja Agencija objavi povzetek mnenja na svoji spletni strani.
Part 4 of the dossier, regarding efficacy, has been identified as the area where quality of the dossier could be further improved; it is the part of the dossier which results in most questions to the applicant at day 120 of the procedure.
Del 4 dokumentacije v zvezi z učinkovitostjo je področje, na katerem bi se kakovost dokumentacije lahko še izboljšala; zaradi tega dela dokumentacije se zastavi največ vprašanj vlagatelju na 120. dan postopka.
I would like to begin by thanking the EMEA staff and scientific committees and working group members for the results achieved in 2004 in very challenging circumstances and at a time of many changes.
Najprej bi se rad zahvalil osebju EMEA ter članom znanstvenih odborov in delovnih skupin za rezultate, dosežene v letu 2004, ki je bilo polno izzivov in sprememb.