natgillin/translations-raw huggingface dataset:
facilitating innovation and stimulating research, hence contributing to the competitiveness of EU-based pharmaceutical industry, and mobilising and coordinating scientific resources from throughout the EU to provide high-quality evaluation of medicinal products, to advise on research and development programmes, to perform inspections for ensuring fundamental GXP provisions are consistently achieved, and to provide useful and clear information to users and healthcare professionals.
pospeševanjem inovacij in spodbujanjem raziskav, s čimer prispeva h konkurenčnosti farmacevtske industrije EU, ter zbiranjem in usklajevanjem znanstvenih virov iz vse EU zaradi zagotovitve visoke kakovosti vrednotenja zdravil, izvajanja inšpekcijskih pregledov za zagotavljanje doslednega izvajanja temeljnih določb GXP ter zagotovitve uporabnih in jasnih informacij uporabnikom in zdravstvenemu osebju.
Following the implementation of Title IV of Regulation (EC) No 726/2004, the mandates of the new CHMP working parties were updated to include an increased supportive role for the assessment of new applications, in accordance with the new pharmaceutical legislation.
Po uveljavitvi naslova IV Uredbe (ES) št. 726/2004 so bila v skladu z novo farmacevtsko zakonodajo pooblastila novih delovnih skupin CHMP posodobljena tako, da so zajemala večjo podporno vlogo pri vrednotenju novih vlog.
The EMEA is actively engaged in a dialogue with its stakeholders, i.e. patients, healthcare professionals, academia, learned societies and the pharmaceutical industry.
EMEA dejavno sodeluje v dialogu s svojimi interesnimi skupinami, in sicer bolniki, zdravstvenimi strokovnjaki, akademskim krogom, znanstvenimi združenji in farmacevtsko industrijo.
Val DIEZ1 (Alternate: José MARTINEZ OLMOS)
Val DIEZ1 (namestnik: José MARTINEZ OLMOS)
As in previous years, the scientific support given to the EMEA by the national competent authorities was excellent.
Pristojni nacionalni organi so tako kot v preteklih letih EMEA zagotavljali odlično znanstveno podporo.
As part of the confidentiality arrangements with the US FDA, a pilot scheme was launched to give parallel scientific advice.
V okviru dogovora o zaupnosti s FDA ZDA se je začel izvajati pilotni program za vzporedno znanstveno svetovanje.
In no case did such reviews lead to a call for changes to the summary of product characteristics (SPC) or product label/leaflet.
Take revizije v nobenem primeru niso pokazale potrebe po spremembah povzetka glavnih značilnosti zdravila (summary of product characteristics, SPC) ali etikete oziroma navodil za uporabo izdelka.
Public information on arbitration and referral procedures was made available by the EMEA upon finalisation of the procedures by the European Commission.
EMEA je javnosti predstavila informacije o postopkih arbitraže in predložitve potem, ko je Evropska Komisija zaključila postopke.
The objectives of the sampling and testing programme, derived from the legal requirements, are to supervise the quality of centrally authorised medicinal products placed on the market and to check compliance of these with their authorised specifications.
Cilji programa vzorčenja in preizkušanja, ki izhajajo iz zakonskih zahtev, so nadzorovati kakovost zdravil, za katera je bilo izdano dovoljenje po centraliziranem postopku in ki so v prometu, ter preveriti njihovo skladnost s specifikacijami, ki so zanje odobrene.
The EMEA s Mission Statement is, in the context of a continuing globalisation, to protect and promote public and animal health by 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,
Glede na nenehno globalizacijo je poslanstvo EMEA varovati in pospeševati zdravje ljudi in živali z 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,
Mariette BACKES-LIES (Alternate: Claude A HEMMER)
Mariette BACKES-LIES (namestnik: Claude A HEMMER)
3.3 Maximum residue limits
3.3 Mejne vrednosti ostankov
In 2004, the EMEA and the CVMP, together with the Heads of Medicines Agencies Veterinary, started the European surveillance strategy an initiative intended to foster collaboration and support between Member States on the conduct of good pharmacovigilance practices.
V letu 2004 sta EMEA in CVMP skupaj z vodji agencij za zdravila za uporabo v veterinarski medicini začela izvajati evropsko strategijo nadzorovanja, ki naj bi spodbudila sodelovanje in medsebojno podporo med državami članicami pri izvajanju dobre prakse v farmakovigilanci.
Aginus A W KALIS (Alternate: Pim KAPITEIN)
Aginus A W KALIS (namestnik: Pim KAPITEIN)
The total number of requests for protocol assistance (PA) was 35, of which 32 were finalised.
Za pomoč pri protokolu je bilo skupaj prejetih 35 zahtevkov, od katerih jih je bilo 32 dokončno obdelanih.
To ensure that the Agency s processing and storage capabilities are aligned to its business workload
Zagotoviti, da so zmogljivosti obdelave in hranjenja podatkov skladne z delovno obremenitvijo Agencije
Following this initial evaluation, the Committee for Medicinal Products for Veterinary Use (CVMP) adopts an opinion on whether the product should receive a marketing authorisation.
Po začetnem vrednotenju Odbor za zdravila za uporabo v veterinarski medicini (CVMP) sprejme mnenje, ali se za zdravilo lahko izda dovoljenje za promet.
Similarly, the EMEA coordinates pharmacovigilance inspections requested by the scientific committees and inspections of blood establishments within the plasma master file (PMF) certification framework.
Podobno EMEA usklajuje inšpekcijske preglede farmakovigilance, ki jih zahtevajo znanstveni odbori, in inšpekcijske preglede zavodov za kri v okviru certificiranja glavnega dosjeja plazme (PMF).
The first steps towards implementation of the confidentiality arrangements with the FDA took place in the second half of 2004 and included both routine exchanges of information on inspections performed and ad hoc exchanges on a number of inspection-related issues.
V drugi polovici leta 2004 so se izvedli prvi ukrepi za izvedbo dogovorov o zaupnosti s FDA, ki so zajemali rutinsko izmenjavo informacij o opravljenih inšpekcijskih pregledih in tudi ad hoc izmenjave informacij o vrsti vprašanj v zvezi z inšpekcijskimi pregledi.
In 2004, the duration of the overall designation process, from validation by the EMEA through to Commission Decision, averaged 101 days; well within the 120-day legislative timeframe.
V letu 2004 je celoten proces določitve od potrditve s strani EMEA do odločbe Komisije trajal povprečno 101 dan, kar je znotraj 120-dnevnega z zakonodajo določenega časovnega okvira.
The COMP adopted 4 negative opinions in 2004.
COMP je v letu 2004 sprejel 4 negativna mnenja.
To upgrade the Experts database and make it available to all NCAs
Nadgraditi zbirko podatkov o strokovnjakih in jo dati na voljo vsem pristojnim nacionalnim organom
Activities in relation to the key steps of the centralised procedure
Dejavnosti, povezane s ključnimi fazami centraliziranega postopka
3 Veterinary medicines
3 Veterinarska zdravila
The role of this group is to advise the CVMP on specific scientific questions addressed to it.
Njena naloga je svetovati CVMP glede posebnih znanstvenih vprašanj, ki so nanjo naslovljena.
By the end of 2004, the following standing working parties supported the work of the CHMP:
Do konca leta 2004 so CHMP pri delu podpirale naslednje stalne delovne skupine:
• Rembert ELBERS (Germany)
• Rembert ELBERS (Nemčija)
Improvements to consistency of advice provided
Izboljšave glede skladnosti svetovanja
Relationships with interested parties continued to flourish in 2004.
Odnosi z zainteresiranimi stranmi so bili tudi v letu 2004 uspešni.
In this context, the EMEA signed a contract in order to be supplied with a 50-desk disaster static recovery suite.
V zvezi s tem je EMEA podpisala pogodbo za dobavo nabora za statično obnovitev programske opreme po njeni odpovedi za 50 miz.
The IT development team completed the conception, elaboration and early construction phases of this project with input from the EMEA scientific advice experts
Razvojna skupina IT je dokončala faze idejne zasnove, priprave in začetne izvedbe tega projekta z vložki strokovnjakov EMEA za znanstveno svetovanje.
By implementing the detailed actions set out in the Road Map beginning in 2005 the Agency will be working to maintain and further strengthen its position as a regulatory authority that is publichealth oriented, science-driven, transparent in the way it operates, and committed to applying good administrative practices.
Agencija si bo z izvajanjem (ki ga bo začela v letu 2005) podrobnih ukrepov, določenih v usmeritvenem načrtu, prizadevala za ohranjanje in še dodatno krepitev njenega položaja regulativnega organa, ki je usmerjen v javno zdravje, deluje na podlagi znanja, posluje pregledno in je predan uporabi dobre upravne prakse.
• George STATHOPOULOS (Greece)
• George STATHOPOULOS (Grčija)
3.1 Scientific advice
3.1 Znanstveno svetovanje
Back-up copies of all EMEA data are held in secure off-site locations.
Varnostne kopije vseh podatkov EMEA se hranijo na varnih lokacijah zunaj Agencije.
EMEA certificates are issued by the EMEA, on behalf of the European Commission, to confirm the marketing authorisation status of either products authorised by the European Commission through the centralised procedure or products for which a centralised application has been submitted to EMEA.
Potrdila EMEA izda EMEA v imenu Evropske komisije, da bi potrdila status dovoljenja za promet za izdelke, za katere je Evropska komisija izdala dovoljenje po centraliziranem postopku, ali izdelke, za katere je oddana vloga na EMEA za centralizirani postopek.
• EMEA/CHMP Working Group with Patients Organisations
• Skupina EMEA/CHMP za sodelovanje z organizacijami bolnikov
A new working party was created in 2004, following the entry into force of Title IV of Regulation (EC) No 726/2004: the Scientific Advice Working Party, responsible for all requests for scientific advice relating to product development.
V letu 2004 je bila po uveljavitvi naslova IV Uredbe (ES) št. 726/2004 ustanovljena nova delovna skupina: Delovna skupina za znanstveno svetovanje, ki je odgovorna za vse zahtevke za znanstveno svetovanje v zvezi z razvojem zdravil.
Guideline on adjuvants in vaccines Released for consultation in March
Guideline on adjuvants in vaccines Predstavljeno za posvetovanje marca 2004
The outcome of the consultation exercise was discussed during a workshop held at the EMEA in December 2004.
O rezultatih posvetovanja se je razpravljalo na delavnici, ki jo je EMEA organizirala decembra 2004.
1 Joined from September 2004 meeting.
Pridružen od sestanka v septembru 2004.
Press officer:
Tiskovni predstavnik:
Biotechnology Quality Pre-clinical Clinical
Biotehnologija Kakovost Predklinični Klinični
Referrals concluded
Zaključene predložitve
For enquiries concerning VAMF certificates:
Za vprašanja o potrdilih VAMF:
• Veijo SAANO (Finland)
• Veijo Saano (Finska)
Number of payments received Number of payments made
Število prejetih plačil Število opravljenih plačil
A European public assessment report (EPAR) is published once the Commission has adopted a final marketing authorisation decision.
Evropsko javno poročilo o oceni zdravila (EPAR) se objavi, ko Komisija sprejme končno odločitev o izdaji dovoljenja za promet z zdravili.
Pharmacovigilance is a priority area for the EMEA, and its activities in this field include collecting and reviewing adverse drug reaction reports and periodic safety update reports, managing electronic collection and reporting systems, and issuing safety recommendations to healthcare professionals.
Farmakovigilanca je za EMEA prednostno področje, njene dejavnosti na tem področju pa zajemajo zbiranje in preučevanje poročil o neželenih učinkih zdravil in periodično dopolnjenih poročil o varnosti, vodenje elektronskega zbiranja in sistemov poročanja ter dajanje priporočil zdravstvenim strokovnjakom o varnosti.
The CVMP adopted its Guideline on harmonising the approach to causality assessment for adverse reactions in order to ensure greater consistency throughout the EU in reporting adverse events by all parties involved.
CVMP je sprejel "Smernice o uskladitvi pristopa k ocenjevanju vzročnosti neželenih učinkov", da bi zagotovil večjo skladnost med vključenimi stranmi po vsej EU pri poročanju o neželenih učinkih.
EDMS was successfully launched in September 2004 with an integrated helpdesk support service
EDMS se je začel uspešno izvajati septembra 2004 z integrirano storitvijo pomoči uporabnikom.
Pharmacovigilance for veterinary medicines has continued to be a very high priority for the veterinary secretariat, which seeks to drive forward initiatives for optimising adverse event reporting and risk management of medicinal products in the post-authorisation phase.
Farmakovigilanca za veterinarska zdravila je bila še naprej prednostna naloga za veterinarski sekretariat, ki si prizadeva nadaljevati pobude za optimiziranje poročanja o neželenih učinkih in obvladovanja tveganja zdravil v fazi po izdaji dovoljenja za promet.
The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organization.
EMEA izdaja potrdila o zdravilu v skladu z ureditvami, ki jih je določila Svetovna zdravstvena organizacija.
The list of these experts is available for examination on request at the EMEA offices.
Njihov seznam je na zahtevo na voljo za pregled v uradih EMEA.
In addition, the Agency receives data to address post-authorisation commitments (specific obligations and follow-up measures) for centrally authorised products.
Poleg tega Agencija prejme podatke glede obveznosti po izdaji dovoljenja za promet (posebne obveznosti in nadaljnji ukrepi) za zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku.
The EMEA offers to hold pre-submission meetings with sponsors who intend to submit an application for orphan designation.
EMEA ponuja možnost, da opravi sestanek pred oddajo vloge s sponzorji, ki nameravajo vložiti vlogo za določitev zdravila sirote.
The fund supports new marketing authorisation applications for orphan medicinal products, as well as protocol assistance and post-authorisation activities relating to these medicines.
Sklad podpira nove vloge za dovoljenja za promet za zdravila sirote ter tudi pomoč pri protokolu in dejavnosti po izdaji dovoljenja za promet v zvezi s temi zdravili.
1.1 Management Board
1.1 Upravni odbor
• Business continuity: a second data room was established and disaster recovery sites identified
• zveznost poslovanja: uveden je bil prostor za sekundarne podatke (second data room) in opredeljene lokacije za obnovitve programske opreme po njeni odpovedi
• Heidrun BOSCH TRABERG (Denmark)
• Heidrun Bosch Traberg (Danska)
Referral procedures under Article 18 of Regulation (EEC) No 2309/93 are initiated in cases where there is a safety concern relating to a centrally authorised product.
Postopki predložitve v skladu s členom18 Uredbe (EGS) št. 2309/93 se uvedejo pri varnostnih vprašanjih glede zdravila, za katero je bilo izdano dovoljenje po centraliziranem postopku.
The number of meetings and meeting days increased by 24 % compared to the previous year, including extraordinary Management Board and CHMP meetings in May and September respectively, as well as new Committee on Herbal Medicinal Products (HMPC) meetings from September 2004 onwards.
Število srečanj in dni srečanj, vključno z izrednimi zasedanji upravnega odbora v maju in CHMP v septembru ter sestanki novega Odbora za zeliščna zdravila (HMPC) od septembra 2004, se je v primerjavi letom poprej povečalo za 24 %.
• Change to the composition of the Management Board, CHMP and CVMP
• spremembo sestave upravnega odbora, CHMP in CVMP;
Gloria GARCÍA LORENTE (Spain) Alternate: Adela VELÁZQUEZ
￭ Gloria GARCÍA LORENTE (Španija) Namestnik: Adela Velázquez
The CVMP established the following standing and temporary working parties to assist its scientific assessment activities: Standing working parties
CVMP je ustanovil naslednje stalne in začasne delovne skupine, ki mu pomagajo pri dejavnostih znanstvenega vrednotenja:
Number of reimbursed meetings Number of reimbursed delegates
Število srečanj s povrnjenimi stroški Število delegatov s povrnjenimi stroški
Often, such guidelines are developed as a result of the EU s cooperation with Japan, the US and other international partners on the harmonisation of regulatory requirements for medicinal products, particularly through the International Conference on Harmonisation (ICH), and thus reflect a harmonised approach.
Take smernice se pogosto razvijejo na podlagi sodelovanja EU z Japonsko, ZDA in drugimi mednarodnimi partnerji za uskladitev regulativnih zahtev za zdravila, zlasti prek Mednarodne konference o usklajevanju (ICH), in zato odsevajo usklajen pristop.
Under evaluation in 2004*
Vrednotenih v letu 2004*
126 annual reports were reviewed and reported to the COMP in 2004.
V letu 2004 je bilo pregledanih in COMP posredovanih 126 poročil.
The dedicated range of services provided to EMEA staff, delegates and users of EU telematics systems from the applications themselves to the three levels of helpdesk support services ensure these systems are in line with the Agency s operating requirements
Vrsta storitev, ki se zagotavljajo osebju EMEA, delegatom in uporabnikom telematskih sistemov EU, od samih aplikacij do treh ravni storitev pomoči uporabnikom, zagotavlja skladnost teh sistemov z obratovalnimi zahtevami Agencije.
Members European Parliament
Člani Evropski parlament
Referral procedures under Article 30 of Directive 2001/83/EC are mainly initiated in order to obtain harmonisation within the Community of the conditions of authorisation for products already authorised by the Member States.
Postopki predložitve v skladu s členom 30 Direktive 2001/83/ES se uvedejo predvsem, da se v Skupnosti uskladijo pogoji za izdajo dovoljenj za zdravila, za katera so države članice že izdale dovoljenja.
Ninety-four mutual recognition procedures were completed in 2004.
V letu 2004 je bilo dokončanih 94 postopkov priznanja.
The mandate and work plan for the new group were published.
Objavljena so bila njena pooblastila in načrt dela.
The EMEA started the implementation of the newly established procedure for the handling of safety concerns in relation to centrally processed applications in April 2004, with a pilot phase based on selected medicines undergoing evaluation for marketing authorisation.
EMEA je aprila 2004 začela izvajati na novo uveden postopek za obvladovanje varnostnih vprašanj v zvezi z vlogami, ki se obdelujejo po centraliziranem postopku, katerega pilotna faza temelji na izbranih zdravilih, za katera se opravlja vrednotenje za namene izdaje dovoljenja za promet.
In April, the EMEA released for public consultation a discussion paper entitled The European Medicines Agency Road Map to 2010: Preparing the Ground for the Future .
EMEA je aprila za javno posvetovanje predstavila posvetovalni dokument z naslovom "Usmeritveni načrt Evropske agencije za zdravila do leta 2010: Priprava podlage za prihodnost".
• A new vaccine (the only one available) for active immunisation of dogs against Babesia canis and Babesia rossi to reduce severity of clinical signs associated with acute babesiosis and the anaemia that ensues following a heterologous challenge infection
• novo cepivo (edino, ki je na voljo) za aktivno imunizacijo psov proti Babesia canis in Babesia rossi za zmanjšanje resnosti kliničnih znakov, povezanih z babeziozo in anemijo, ki sta posledica heterologne infekcije;
This was developed in direct consultation with the EMEA s Conferences Sector and radically improved their ability to arrange all EMEA meetings and conferences
Razvita je bila v neposrednem posvetovanju s sektorjem EMEA za konference in je temeljito izboljšala njihove možnosti za vodenje vseh sestankov in konferenc EMEA.
The programme of internal audits continued in 2004, including audits of the Committee for Medicinal Products for Human Use, the Committee for Medicinal Products for Veterinary Use and the Committee on Orphan Medicinal Products.
V letu 2004 se je nadaljeval program notranjih revizij, ki je zajemal revizije Odbora za zdravila za uporabo v humani medicini, Odbora za zdravila za uporabo v veterinarski medicini in Odbora za zdravila sirote.
World Health Organization http://www.who.int
Svetovna zdravstvena organizacija http://www.who.int
• Initiatives to acquaint and train assessors and other regulatory staff with new environmental safety testing requirements were begun.
• Sprožene so bile pobude, da se ocenjevalci in drugo zakonodajno osebje seznanijo in usposobijo na področju novih zahtev za preverjanje okoljske varnosti.
In addition, the EMEA was pleased to support the launch of the IFAH-Europe Good Veterinary Pharmacovigilance Practice Guide, produced by Industry to encourage further advances in the consistent reporting of ADRs throughout the Community.
EMEA je tudi z veseljem podprla začetek izvajanja Smernic dobre prakse za veterinarsko farmakovigilanco IFAH-Evropa, ki jih je pripravila panoga, da bi spodbudila nadaljnji napredek pri skladnem poročanju o neželenih učinkih zdravil po vsej Skupnosti.
• The EMEA risk management strategy was further developed, in particular through the implementation of a newly established procedure for the handling of safety concerns, both pre- and post-authorisation, for centrally processed applications.
• Strategija EMEA za obvladovanje tveganja se je še naprej razvijala, zlasti z izvajanjem na novo uvedenega postopka za obvladovanje vprašanj glede varnosti pred izdajo dovoljenja za promet in po njej za vloge, ki se obravnavajo po centraliziranem postopku.
It remains challenging to accurately predict the number of applications to be received, despite forecasts supplied by Industry, as there is, unfortunately, little intelligence available in the veterinary sector regarding new products in the development pipeline.
Kljub napovedim, ki jih posreduje industrija, je še vedno težko natančno predvideti število vlog, ki bodo prejete, in na žalost je v veterini na voljo malo informacij o novih proizvodih, ki se razvijajo.
• Arthur ISSEYEGH (Cyprus) Alternate: Panayiota KOKKINOU
• Arthur ISSEYEGH (Ciper) Namestnik: Panayiota KOKKINOU
Tamás L PAÁL (Alternate: Beatrix HORVÁTH)
Tamás L PAÁL (namestnik: Beatrix HORVÁTH)
The three-month consultation period that followed generated feedback from some 65 contributors, including EU institutions, national health authorities, patients groups, professional healthcare organisations, pharmaceutical companies, trade associations, academics and other interested parties.
V posvetovalnem obdobju naslednjih treh mesecev se je s povratnimi informacijami odzvalo približno 65 strank, vključno z institucijami EU, nacionalnimi zdravstvenimi organi, skupinami bolnikov, poklicnimi zdravstvenimi organizacijami, farmacevtskimi podjetji, trgovskimi združenji, akademskim krogom in drugimi zainteresiranimi stranmi.
The EMEA component of the EudraVigilance project proceeded as planned in 2004.
V letu 2004 so dejavnosti EMEA v zvezi s projektom EudraVigilance potekale po načrtih.
No applications were received for VAMFs.
Za VAMF-je ni bila prejeta nobena vloga.
An inventory accounting system was implemented and all data, including tangible and intangible assets, were uploaded to the system.
Uveden je bil sistem računovodskega vodenja premoženja, v katerega so bili vpisani vsi podatki, vključno z opredmetenimi in neopredmetenimi sredstvi.
If so, the CHMP adopts a positive opinion that is reflected in a European Public Assessment Report and makes a recommendation to the European Commission that a marketing authorisation be granted for that product.
Če so te zahteve izpolnjene, CHMP sprejme pozitivno mnenje, ki je prikazano v evropskem javnem poročilu o oceni zdravila, in Evropski komisiji pošlje priporočilo, da se izda dovoljenje za promet za to zdravilo.