FrancophonIA/ELRC3.0 huggingface dataset:
English: Annex 8 IT projects and operational activities
Slovenian: Priloga 8 Projekti IT in operativne dejavnosti
English: • Greg MARKEY1 (United Kingdom)
Slovenian: • Greg MARKEY1 (Združeno kraljestvo)
English: Legal sector
Slovenian: Sektor za pravne zadeve
English: Requests for GMP inspection increased by 8 % relative to 2003, mainly due to a large number of reinspections which fell due and the impact of inspections in the context of the PMF certification scheme.
Slovenian: Prošnje za inšpekcijske preglede za dobro proizvodno prasko so se povečale za 8 % v primerjavi z letom 2003 predvsem zaradi veliko ponovnih inšpekcijskih pregledov, za katere se je iztekel rok, in vpliva inšpekcijskih pregledov v okviru sistema certificiranja PMF.
English: • Gianmartino BENZI (EMEA representative)
Slovenian: • Gianmartino BENZI (predstavnik EMEA)
English: Pharmacovigilance is a priority area for the Agency and, as a consequence, the EMEA will continue and further strengthen its efforts in order to ensure the safe use of products licensed in accordance with the centralised procedure.
Slovenian: Farmakovigilanca je prednostno področje za Agencijo in EMEA bo zato še naprej krepila svoja prizadevanja za zagotovitev varne uporabe izdelkov, za katere je bilo izdano dovoljenje po centraliziranem postopku.
English: • The CVMP's preparation for enlargement of the European Union proved more than adequate, with the restructuring of the Committee in accordance with the revised pharmaceutical legislation taking place smoothly and without any difficulty.
Slovenian: • Priprava CVMP na širitev Evropske unije se je izkazala za zelo ustrezno, saj se je Odbor nemoteno in brez težav preoblikoval v skladu z revidirano farmacevtsko zakonodajo.
English: Archiving and backup of data
Slovenian: Arhiviranje in varnostno kopiranje podatkov
English: The task of the Committee is to advise the Executive Director on the outcome of audit reports issued by the Court of Auditors, the Internal Audit Service of the European Commission, the IQM/Audit function of the Agency and any other external audit organisation.
Slovenian: Njegova naloga je svetovati izvršnemu direktorju o rezultatih revizijskih poročil, ki jih objavijo Računsko sodišče, Služba za notranjo revizijo Evropske komisije, služba Agencije za integrirano upravljanja kakovosti/revizijo in katera koli druga zunanja revizijska organizacija.
English: 1 Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93.
Slovenian: Uredba Komisije (ES) št. 1085/2003 z dne 3. junija 2003 o pregledu sprememb dovoljenja za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini, ki spadajo v področje Uredbe Sveta (EGS) št. 2309/93.
English: EU institutions and other agencies
Slovenian: Institucije in druge agencije EU
English: To maintain the highest levels of security and confidentiality for all data held on EMEA systems
Slovenian: Ohraniti najvišje ravni varnosti in zaupnosti vseh podatkov, ki se hranijo v sistemih EMEA.
English: Personnel and budget
Slovenian: Kadrovske zadeve in proračun
English: • Lars GRAMSTAD (Norway)
Slovenian: • Lars Gramstad (Norveška)
English: Veterinary immunologicals and vaccines excluded
Slovenian: Izključena veterinarska imunološka zdravila in cepiva
English: An EMEA PAT team was created in January 2004 to review the implications of PAT with a view to ensuring that the European regulatory framework and the authorities are prepared for and adequately equipped to conduct thorough and effective evaluations of PAT-based submissions.
Slovenian: Januarja 2004 je bila oblikovana skupina EMEA PAT, ki naj bi pregledala učinke analitske tehnologije procesa (process analytical technology, PAT) in tako zagotovila, da so evropski regulativni okvir in organi pripravljeni in ustrezno opremljeni za izvajanje temeljitega in učinkovitega vrednotenja vlog, ki temeljijo na PAT.
English: • Patrick SALMON2 (Ireland)
Slovenian: • Patrick SALMON2 (Irska)
English: • A programme of ongoing quality improvements in the scientific and regulatory operations of the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Orphan Medicinal Products (COMP) was put in place and initiated.
Slovenian: • Uveden je bil program za stalne kakovostne izboljšave v znanstvenem in regulativnem delovanju Odbora za zdravila za uporabo v humani medicini (CHMP) in Odbora za zdravila sirote (COMP), ki se je začel tudi izvajati.
English: Helping to bring medicines for rare diseases to the market
Slovenian: Pomoč pri dajanju zdravil za redke bolezni na trg
English: • PAT team a European team of GMP inspectors and quality assessors was established to address matters relating to the implementation of process analytical technology (PAT) by manufacturers, and a training session for assessors and inspectors was organised in September with the support of the Swedish Medical Products Agency.
Slovenian: • Ustanovljena je bila skupina PAT - evropska skupina inšpektorjev in ocenjevalcev kakovosti za dobro proizvodno prakso - za obravnavo zadev v zvezi z izvajanjem analitske tehnologije procesa (process analytical technology, PAT) pri proizvajalcih, v septembru pa je bilo organizirano usposabljanje za ocenjevalce in inšpektorje, ki ga je podprla švedska agencija za zdravila.
English: The CHMP adopted an opinion on a referral under Article 31 regarding paroxetine-containing medicines in April 2004.
Slovenian: CHMP je aprila 2004 sprejel mnenje o predložitvi v skladu s členom 31 glede zdravil z vsebnostjo paroksetina.
English: Visual recording of meetings for archiving and broadcasting purposes was set up using Internet/web-based technology
Slovenian: Uvedeno je bilo vizualno snemanje sestankov za arhiviranje in prenašanje z uporabo internetne/spletne tehnologije.
English: • COMP Working Group with Interested Parties
Slovenian: • Delovna skupina COMP za sodelovanje z zainteresiranimi stranmi
English: Working parties and ad hoc groups
Slovenian: Delovne in ad hoc skupine
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The EMEA is actively engaged in a dialogue with its stakeholders, i.e. patients, healthcare professionals, academia, learned societies and the pharmaceutical industry.
Slovenian: EMEA dejavno sodeluje v dialogu s svojimi interesnimi skupinami, in sicer bolniki, zdravstvenimi strokovnjaki, akademskim krogom, znanstvenimi združenji in farmacevtsko industrijo.
English: Val DIEZ1 (Alternate: José MARTINEZ OLMOS)
Slovenian: Val DIEZ1 (namestnik: José MARTINEZ OLMOS)
English: As in previous years, the scientific support given to the EMEA by the national competent authorities was excellent.
Slovenian: Pristojni nacionalni organi so tako kot v preteklih letih EMEA zagotavljali odlično znanstveno podporo.
English: As part of the confidentiality arrangements with the US FDA, a pilot scheme was launched to give parallel scientific advice.
Slovenian: V okviru dogovora o zaupnosti s FDA ZDA se je začel izvajati pilotni program za vzporedno znanstveno svetovanje.
English: In no case did such reviews lead to a call for changes to the summary of product characteristics (SPC) or product label/leaflet.
Slovenian: 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.
English: Public information on arbitration and referral procedures was made available by the EMEA upon finalisation of the procedures by the European Commission.
Slovenian: EMEA je javnosti predstavila informacije o postopkih arbitraže in predložitve potem, ko je Evropska Komisija zaključila postopke.
English: 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.
Slovenian: 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.
English: 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,
Slovenian: 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,
English: Mariette BACKES-LIES (Alternate: Claude A HEMMER)
Slovenian: Mariette BACKES-LIES (namestnik: Claude A HEMMER)
English: 3.3 Maximum residue limits
Slovenian: 3.3 Mejne vrednosti ostankov
English: 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.
Slovenian: 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.
English: Aginus A W KALIS (Alternate: Pim KAPITEIN)
Slovenian: Aginus A W KALIS (namestnik: Pim KAPITEIN)
English: The total number of requests for protocol assistance (PA) was 35, of which 32 were finalised.
Slovenian: Za pomoč pri protokolu je bilo skupaj prejetih 35 zahtevkov, od katerih jih je bilo 32 dokončno obdelanih.
English: To ensure that the Agency s processing and storage capabilities are aligned to its business workload
Slovenian: Zagotoviti, da so zmogljivosti obdelave in hranjenja podatkov skladne z delovno obremenitvijo Agencije
English: 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.
Slovenian: Po začetnem vrednotenju Odbor za zdravila za uporabo v veterinarski medicini (CVMP) sprejme mnenje, ali se za zdravilo lahko izda dovoljenje za promet.
English: Similarly, the EMEA coordinates pharmacovigilance inspections requested by the scientific committees and inspections of blood establishments within the plasma master file (PMF) certification framework.
Slovenian: Podobno EMEA usklajuje inšpekcijske preglede farmakovigilance, ki jih zahtevajo znanstveni odbori, in inšpekcijske preglede zavodov za kri v okviru certificiranja glavnega dosjeja plazme (PMF).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The COMP adopted 4 negative opinions in 2004.
Slovenian: COMP je v letu 2004 sprejel 4 negativna mnenja.
English: To upgrade the Experts database and make it available to all NCAs
Slovenian: Nadgraditi zbirko podatkov o strokovnjakih in jo dati na voljo vsem pristojnim nacionalnim organom
English: Activities in relation to the key steps of the centralised procedure
Slovenian: Dejavnosti, povezane s ključnimi fazami centraliziranega postopka
English: 3 Veterinary medicines
Slovenian: 3 Veterinarska zdravila
English: The role of this group is to advise the CVMP on specific scientific questions addressed to it.
Slovenian: Njena naloga je svetovati CVMP glede posebnih znanstvenih vprašanj, ki so nanjo naslovljena.
English: By the end of 2004, the following standing working parties supported the work of the CHMP:
Slovenian: Do konca leta 2004 so CHMP pri delu podpirale naslednje stalne delovne skupine:
English: • Rembert ELBERS (Germany)
Slovenian: • Rembert ELBERS (Nemčija)
English: Improvements to consistency of advice provided
Slovenian: Izboljšave glede skladnosti svetovanja
English: Relationships with interested parties continued to flourish in 2004.
Slovenian: Odnosi z zainteresiranimi stranmi so bili tudi v letu 2004 uspešni.
English: In this context, the EMEA signed a contract in order to be supplied with a 50-desk disaster static recovery suite.
Slovenian: V zvezi s tem je EMEA podpisala pogodbo za dobavo nabora za statično obnovitev programske opreme po njeni odpovedi za 50 miz.
English: Achievements
Slovenian: Dosežki
English: The IT development team completed the conception, elaboration and early construction phases of this project with input from the EMEA scientific advice experts
Slovenian: Razvojna skupina IT je dokončala faze idejne zasnove, priprave in začetne izvedbe tega projekta z vložki strokovnjakov EMEA za znanstveno svetovanje.
English: 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.
Slovenian: 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.
English: • George STATHOPOULOS (Greece)
Slovenian: • George STATHOPOULOS (Grčija)
English: 3.1 Scientific advice
Slovenian: 3.1 Znanstveno svetovanje
English: Back-up copies of all EMEA data are held in secure off-site locations.
Slovenian: Varnostne kopije vseh podatkov EMEA se hranijo na varnih lokacijah zunaj Agencije.
English: 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.
Slovenian: 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.
English: • EMEA/CHMP Working Group with Patients Organisations
Slovenian: • Skupina EMEA/CHMP za sodelovanje z organizacijami bolnikov
English: 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.
Slovenian: 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.
English: Guideline on adjuvants in vaccines Released for consultation in March
Slovenian: Guideline on adjuvants in vaccines Predstavljeno za posvetovanje marca 2004
English: The outcome of the consultation exercise was discussed during a workshop held at the EMEA in December 2004.
Slovenian: O rezultatih posvetovanja se je razpravljalo na delavnici, ki jo je EMEA organizirala decembra 2004.
English: 1 Joined from September 2004 meeting.
Slovenian: Pridružen od sestanka v septembru 2004.
English: Press officer:
Slovenian: Tiskovni predstavnik:
English: Biotechnology Quality Pre-clinical Clinical
Slovenian: Biotehnologija Kakovost Predklinični Klinični
English: Referrals concluded
Slovenian: Zaključene predložitve
English: For enquiries concerning VAMF certificates:
Slovenian: Za vprašanja o potrdilih VAMF:
English: • Veijo SAANO (Finland)
Slovenian: • Veijo Saano (Finska)
English: Number of payments received Number of payments made
Slovenian: Število prejetih plačil Število opravljenih plačil
English: A European public assessment report (EPAR) is published once the Commission has adopted a final marketing authorisation decision.
Slovenian: Evropsko javno poročilo o oceni zdravila (EPAR) se objavi, ko Komisija sprejme končno odločitev o izdaji dovoljenja za promet z zdravili.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: EDMS was successfully launched in September 2004 with an integrated helpdesk support service
Slovenian: EDMS se je začel uspešno izvajati septembra 2004 z integrirano storitvijo pomoči uporabnikom.
English: 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.
Slovenian: 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.
English: The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organization.
Slovenian: EMEA izdaja potrdila o zdravilu v skladu z ureditvami, ki jih je določila Svetovna zdravstvena organizacija.
English: The list of these experts is available for examination on request at the EMEA offices.
Slovenian: Njihov seznam je na zahtevo na voljo za pregled v uradih EMEA.
English: In addition, the Agency receives data to address post-authorisation commitments (specific obligations and follow-up measures) for centrally authorised products.
Slovenian: 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.
English: The EMEA offers to hold pre-submission meetings with sponsors who intend to submit an application for orphan designation.
Slovenian: EMEA ponuja možnost, da opravi sestanek pred oddajo vloge s sponzorji, ki nameravajo vložiti vlogo za določitev zdravila sirote.
English: The fund supports new marketing authorisation applications for orphan medicinal products, as well as protocol assistance and post-authorisation activities relating to these medicines.
Slovenian: 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.
English: 1.1 Management Board
Slovenian: 1.1 Upravni odbor
English: • Business continuity: a second data room was established and disaster recovery sites identified
Slovenian: • zveznost poslovanja: uveden je bil prostor za sekundarne podatke (second data room) in opredeljene lokacije za obnovitve programske opreme po njeni odpovedi
English: • Heidrun BOSCH TRABERG (Denmark)
Slovenian: • Heidrun Bosch Traberg (Danska)
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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 %.
English: • Change to the composition of the Management Board, CHMP and CVMP
Slovenian: • spremembo sestave upravnega odbora, CHMP in CVMP;
English: Gloria GARCÍA LORENTE (Spain) Alternate: Adela VELÁZQUEZ
Slovenian: ￭ Gloria GARCÍA LORENTE (Španija) Namestnik: Adela Velázquez
English: The CVMP established the following standing and temporary working parties to assist its scientific assessment activities: Standing working parties
Slovenian: CVMP je ustanovil naslednje stalne in začasne delovne skupine, ki mu pomagajo pri dejavnostih znanstvenega vrednotenja:
English: Number of reimbursed meetings Number of reimbursed delegates
Slovenian: Število srečanj s povrnjenimi stroški Število delegatov s povrnjenimi stroški