FrancophonIA/ELRC3.0 huggingface dataset:
English: A gradual shift from chemical to biological products, and from general to more specialised types of medicines, has also been observed, as has an increase in the number of applications from small and medium-sized enterprises.
Slovenian: Opažen je bil tudi postopen premik od kemičnih k biološkim zdravilom in od splošnih k bolj specializiranim vrstam zdravil ter večje število vlog malih in srednje velikih podjetij.
English: The group is currently working on a set of documents, including one on the role of the chairs of management boards, to set out best practice in the area.
Slovenian: Skupina trenutno pripravlja sklop dokumentov, vključno z dokumentom, ki bo urejal vlogo predsednikov upravnih odborov, s čimer želi oblikovati najboljšo prakso na tem področju.
English: This increase is mainly due to the increase in requested EU contribution to finance the implementation of the pharmacovigilance legislation in 2012, as well as an increase in fee income due to the expected increases in workload.
Slovenian: To povečanje je predvsem posledica prošnje za povečanje prispevkov EU za financiranje izvajanja zakonodaje o farmakovigilanci v letu 2012 in povečanja prihodkov iz pristojbin zaradi pričakovanega povečanja delovne obremenitve.
English: • A meeting with the medical device authorities.
Slovenian: • srečanje z organi za medicinske pripomočke;
English: The Board noted that the number of new chemical entities and the number of opinions were lower than those received in the previous three years.
Slovenian: Odbor je ugotovil, da je bilo število novih kemičnih sestavin in število mnenj manjše v primerjavi s številom kemičnih sestavin in mnenj, prejetih v preteklih treh letih.
English: With regard to the transparency of application dossiers, the Board repeated the need to reach an agreement at the EU level among the stakeholders as to what information is considered commercially confidential or constitutes personal data.
Slovenian: Glede preglednosti dokumentacije vlog je odbor ponovno poudaril potrebo po sporazumu med zainteresiranimi stranmi na ravni EU o tem, katere informacije se štejejo za poslovno zaupne ali vsebujejo osebne podatke.
English: Management Board consultation procedure for CHMP and CVMP nominations: follow-up from December 2010 discussion
Slovenian: Postopek posvetovanja v upravnem odboru za imenovanja v odbora CHMP in CVMP: nadaljevanje razprave iz decembra 2010
English: The discussion was held behind closed doors and focused on two areas of potential conflict of interests: firstly, whether any activity risked the misuse of confidential or privileged information gained during his leadership of the Agency; and secondly, whether any activity risked improper influence on decisions taken by the Agency.
Slovenian: Razprava je bila zaprta za javnost, v njej pa sta bili izpostavljeni dve morebitni področji navzkrižja interesov: prvič, ali bi se pri opravljanju katere koli dejavnosti pojavilo tveganje za zlorabo zaupnih ali zaščitenih informacij, pridobljenih med njegovim vodenjem agencije; in drugič, ali bi katera koli dejavnost lahko pomenila tveganje za neprimerno vplivanje na sprejete odločitve agencije.
English: Agenda for 17 March 2011 meeting
Slovenian: Dnevni red za sejo dne 17. marca 2011
English: The Board also supported the proposals for maintaining the EudraVigilance system until the new functionalities are implemented (in relation to data-quality management, support of EVDAS and the revised implementation of the EudraVigilance Access Policy).
Slovenian: Odbor je podprl tudi predloge za ohranitev sistema EudraVigilance, dokler ne bodo uvedene vse funkcionalnosti (v zvezi z upravljanjem kakovosti podatkov, podporo sistemu EVDAS in pregledanim izvajanjem politike dostopa do sistema EudraVigilance).
English: • Plans for limited and targeted amendement to the Penalties Regulation (focusing on the scope of the Regulation; a public consultation will be launched in spring 2011).
Slovenian: • načrti za omejeno in ciljno usmerjeno spremembo uredbe o kaznih (s poudarkom na področju uporabe uredbe; javna razprava se bo začela spomladi leta 2011);
English: At the last meeting, the EMA Chair handed over the chairmanship for the group to the Chair of EFSA.
Slovenian: Na zadnji seji je predsednik agencije EMA predsedovanje skupine predal predsedniku agencije EFSA.
English: The Chair invited the Board members to volunteer as topic coordinators for the analysis and assessment of the Acting Executive Director's Annual Activity Report 2010.
Slovenian: Predsedujoči je člane odbora pozval, naj prostovoljno prevzamejo mesta tematskih koordinatorjev za analizo in oceno Letnega poročila o dejavnostih za leto 2010 vršilca dolžnosti izvršnega direktorja.
English: The European Commission drew the attention of the Board to the fact that the EU contribution is still under discussion in the Commission, and that any increase in budget or staff needs to be duly substantiated, particularly in crisis periods.
Slovenian: Evropska komisija je odbor opozorila, da v Komisiji še vedno poteka razprava o prispevku EU ter da je treba zahteve po povečanju proračunskih sredstev ali števila zaposlenih ustrezno utemeljiti, še posebno v obdobju krize.
English: The conditions set by the Board also require that Mr Lönngren should neither have contact with Agency staff or committee members in the context of his professional activities, nor represent or accompany third parties at meetings with the Agency.
Slovenian: Pogoji, ki jih je sprejel odbor, določajo tudi, da gospod Lönngren pri svojem poslovnem delovanju ne sme biti v stiku z zaposlenimi agencije ali člani odborov, prav tako pa ne sme predstavljati ali spremljati tretjih strank na srečanjih z agencijo.
English: Held in London on 16-17 March 2011
Slovenian: V Londonu, 16. in 17. marca 2011
English: The Board was informed that the Director-General for DG SANCO has written to remind the Agency that audit reports need to be provided to the Board.
Slovenian: Odbor je bil seznanjen, da je generalni direktor GD SANCO z dopisom opomnil agencijo, da je treba odboru predložiti revizijska poročila.
English: Budget 2011
Slovenian: Proračun za leto 2011
English: Following such a uniform position at the EU level, a proposal can be made at the level of te International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), with a view to changing the format of the dossier to enable automatic publication of application information without releasing information that is commercially confidential or contains personal data.
Slovenian: Po oblikovanju enotnega stališča na ravni EU se lahko pripravi predlog na ravni Mednarodne konference o usklajevanju tehničnih zahtev za registracijo zdravil za uporabo v humani medicini (ICH) z namenom, da se oblika dokumentacije spremeni tako, da bo mogoče samodejno objavljanje informacij o vlogi, ne da bi bile pri tem objavljene informacije, ki so poslovno zaupne ali vsebujejo osebne podatke.
English: With regard to the staffing for 2011, the Commissioner indicated that the Agency may receive some of the posts requested for 2011.
Slovenian: Komisar je glede zaposlovanja v letu 2011 dejal, da bodo agenciji morda odobrena nekatera delovna mesta, za katera je zaprosila za leto 2011.
English: The Board concluded that none of the activities as communicated presented a conflict of interests.
Slovenian: Odbor je sklenil, da nobena predstavljena dejavnost ne predstavlja možnega navzkrižja interesov.
English: The Management Board adopted the preliminary work programme and the preliminary draft budget 2012.
Slovenian: Upravni odbor je sprejel predhodni delovni program in predhodni predlog proračuna za leto 2012.
English: Following the appointment of Marcus Müllner as Heads of Medicines Agencies (HMA) representative to the Management Board Telematics Committee (MBTC), the Chair invited members to express their interest to represent the Management Board at the MBTC.
Slovenian: Po imenovanju Marcusa Müllnerja kot predstavnika vodij agencij za zdravila v Odbor za telematiko pri upravnem odboru (Management Board Telematics Committee, MBTC) je predsedujoči pozval člane, naj se prijavijo za mesto predstavnika upravnega odbora v odboru MBTC.
English: If five or more members express their reservations, the chair of the committee concerned will be approached and his/her views sought before finalising the procedure.
Slovenian: Če pet ali več članov izrazi zadržek, bo predsednik zadevnega odbora 1 naprošen, da pred zaključkom postopka izrazi svoje stališče.
English: The Board indicated that it expects the next Executive Director to inform it of their intentions before the end of their mandate.
Slovenian: Odbor je nakazal, da od prihodnjega izvršnega direktorja pričakuje, da ga bo o svojih namenih obvestil pravočasno in pred koncem mandata.
English: In case the review will be completed later than the implementation work is due, the Agency requested the European Commission to provide for additional financial resources in the interim period.
Slovenian: Če bo pregled zaključen kasneje, kot je predvideno dokončanje del za izvajanje zakonodaje, je agencija Evropsko komisijo zaprosila, da za vmesno obdobje zagotovi dodatna finančna sredstva.
English: With regard to financing the implementation of the new pharmacovigilance legislation, the Agency requires significant financial and human resources to accomplish the work.
Slovenian: Za financiranje izvajanja nove zakonodaje o farmakovigilanci agencija potrebuje znatna finančna sredstva in človeške vire za dokončanje dela.
English: Chair: Pat O'Mahony
Slovenian: Predsedujoči: Pat O'Mahony
English: The Board agreed on the following strategic steer, allowing for the preparation of the implementation to proceed without delay, while asking the Agency to monitor the situation on an ongoing basis as the implementation of the legislation progresses.
Slovenian: Odbor je potrdil naslednjo strateško usmeritev, ki omogoča, da priprave za izvajanje potekajo brez zamud, agencijo pa je zaprosil, da nenehno spremlja dogajanje med izvajanjem zakonodaje.
English: In adopting its decision, the Board imposed a set of limitations on these and any future activities for a period of two years after leaving the Agency, including prohibitions on taking managerial and executive positions in the pharmaceutical industry, and on providing product-related advice with regard to activities falling within the remit of the Agency.
Slovenian: Pri sprejemanju odločitev je odbor določil nekatere omejitve teh in morebitnih prihodnjih dejavnosti za obdobje dveh let po odhodu iz agencije, vključno s prepovedjo opravljanja menedžerskih ali izvršnih funkcij v farmacevtski industriji ter prepovedjo svetovanja v zvezi z zdravili na področjih, ki sodijo v pristojnosti delovanja agencije.
English: • The Mediator case (a stress test was conducted in the context of the new pharmacovigilance legislation).
Slovenian: • primer Mediator (v okviru nove zakonodaje o farmakovigilanci je bilo izvedeno testiranje izjemnih situacij);
English: The KPIs enable the performance of the newly established cooperation agreements with national competent authorities to be monitored.
Slovenian: Glavni kazalniki uspešnosti omogočajo nadzorovanje izvajanja novih veljavnih sporazumov o sodelovanju s pristojnimi nacionalnimi organi.
English: • Non-automatic carryover of appropriations from 2010 to 2011, finalised on 13 January 2011.
Slovenian: • Nesamodejni prenos proračunskih sredstev iz leta 2010 v leto 2011, zaključeno 13. januarja 2011.
English: Apology received
Slovenian: Opravičilo
English: • The revision of the clinical trials legislation (target for the proposal is the second quarter of 2012).
Slovenian: • pregled zakonodaje o kliničnih preskušanjih (cilj je predlog v drugem četrtletju leta 2012);
English: Giulia Del Brenna Lenita Lindström Stefaan Van Der Spiegel
Slovenian: Giulia Del Brenna Lenita Lindstrom Stefaan Van Der Spiegel
English: The Board supported that the EudraVigilance audit should take place by Q4 2014 at the latest.
Slovenian: Odbor se je strinjal, da je treba revizijo sistema EudraVigilance izvesti najkasneje do zadnjega četrtletja leta 2014.
English: Written procedures
Slovenian: Pisni postopki
English: No conflict of interests was declared.
Slovenian: Nihče ni navedel, da obstaja navzkrižje interesov.
English: The Management Board also suggested considering how the training needs of regulators can be reflected in the projects undertaken under the Innovative Medicines Initiative (IMI).
Slovenian: Upravni odbor je tudi predlagal, da se preučijo potrebe regulativnih organov po usposabljanju in se nato upoštevajo pri projektih, ki se izvajajo v okviru pobude za inovativna zdravila (IMI).
English: Amendments to the delegate reimbursement rules
Slovenian: Spremembe pravil o povračilu stroškov delegatom
English: As regards pharmacovigilance implementation, the Commission is starting a review of the Fee Regulation in order for the Agency to charge fees for pharmacovigilance activities as foreseen in the pharmacovigilance legislation.
Slovenian: Glede izvajanja zakonodaje o farmakovigilanci pa je Komisija začela pregled uredbe o pristojbinah, da bi agencija lahko začela zaračunavati pristojbine za farmakovigilančne dejavnosti, kot je predvideno v zakonodaji o farmakovigilanci.
English: • The next cycle of the Benchmarking of the European Medicines Agencies (BEMA) exercise (the BEMA cycle will follow the five-year period of the HMA strategy and the EMA road map).
Slovenian: • naslednji cikel vaj primerjalnih analiz Evropske agencije za zdravila (BEMA) (cikel BEMA poteka v skladu s petletnim obdobjem strategije vodij agencij za zdravila in časovnega načrta agencije EMA);
English: • The continued work to clarify the tasks of the EMA and ECDC in the area of substances of human origin (a concept paper is under development; a proposal will be made at the June Management Board meeting).
Slovenian: • Nadaljevanje dela za podrobnejšo pojasnitev nalog agencij EMA in ECDC na področju snovi človeškega izvora (oblikuje se koncept; predlog bo oblikovan na junijski seji upravnega odbora);
English: The members noted the update report from the European Commission on a range of topics, including the following:
Slovenian: Člani so se seznanili s posodobljenim poročilom Evropske komisije o različnih temah:
English: The minutes have been published on the Agency's website.
Slovenian: Zapisnik je objavljen na spletni strani agencije.
English: It attaches great importance to transparency, and, acting in the public interest, requested the Acting Executive Director to publish its decision, together with supporting documents on the EMA website.
Slovenian: Posebej je poudaril pomen preglednosti in zaradi varovanja javnega interesa zaprosil vršilca dolžnosti izvršnega direktorja, da na spletni strani agencije EMA objavi njegovo odločitev, skupaj s podporno dokumentacijo.
English: However, it remains to be seen whether this is a temporary increase or the level of activity will remain high for a longer period.
Slovenian: Sčasoma se bo pokazalo, ali gre le za začasno ali dolgotrajno povečan obseg delovanja na tem področju.
English: List of participants
Slovenian: Seznam udeležencev
English: Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway)
Slovenian: Brigitte Batliner (Lihtenštajn) Gro Ramsten Wesenberg (Norveška)
English: The Board supported the development of a subset of functionalities required for the EudraVigilance audit that would meet predefined high-level requirements.
Slovenian: Odbor je podprl razvoj podskupin funkcionalnosti, ki so potrebne za revizijo sistema EudraVigilance in bi bile v skladu s predhodno določenimi zahtevami na visoki ravni.
English: Audit reports
Slovenian: Revizijska poročila
English: The Agency also anticipates that the adoption of the legislation on falsified medicines and the conclusion of the discussions on substances of human origin will also impact on activities in the near future.
Slovenian: Agencija pričakuje, da bosta na njeno delovanje v bližnji prihodnosti vplivala tudi sprejetje zakonodaje o ponarejenih zdravilih in zaključek razprave o snoveh človeškega izvora.
English: • [EMA/MB/111120/2011] Summary of transfers of appropriations in the budget 2010.
Slovenian: • [EMA/MB/111120/2011] Povzetek prenosov dodeljenih sredstev v proračunu za leto 2010.
English: Rannveig Gunnarsdóttir (Iceland)
Slovenian: Rannveig Gunnarsdóttir (Islandija)
English: The Board also noted the high level of activity in the area of variations.
Slovenian: Odbor se je seznanil tudi z velikim obsegom delovanja na področju sprememb.
English: • [EMA/MB/62985/2011] Information technology.
Slovenian: • [EMA/MB/62985/2011] Informacijska tehnologija.
English: • The enquiry by MEPs into off-label use of medicines in the EU (the MEPs' letters will be included on the April HMA agenda).
Slovenian: • poizvedba evropskih poslancev o nenamenski uporabi zdravil v EU (dopisi evropskih poslancev bodo vključeni na dnevni red vodij agencij za zdravila v aprilu).
English: The Board also discussed that the training programme for regulators is an important element to ensure that high-quality assessors are available.
Slovenian: Odbor je razpravljal tudi o pomenu programa usposabljanja regulativnih organov za zagotavljanje visokokakovostnih ocenjevalcev.
English: Amendments to the Management Board implementing rules on the Agency's fees
Slovenian: Spremembe izvedbenih pravil upravnega odbora o pristojbinah, ki se plačujejo agenciji
English: The Board asked, therefore, to be informed of further details on pharmacovigilance implementation, requirements for IT expenditure and staffing needs.
Slovenian: Zato je odbor zaprosil, da ga obveščajo o nadaljnjih podrobnostih izvajanja zakonodaje o farmakovigilanci, stroških IT ter potrebah po zaposlovanju.
English: [EMA/MB/149825/2011] The Board adopted the amendments to the delegate reimbursement rules which allow flight tickets to be changed if a meeting ends two hours earlier or later than planned.
Slovenian: [EMA/MB/149825/2011] Odbor je sprejel spremembe pravil o povračilu stroškov delegatom, ki omogočajo zamenjavo letalskih kart v primeru, da se srečanje konča dve uri prej ali kasneje, kot je bilo načrtovano.
English: In this context, reference was made to the joint HMA/EMA training strategy.
Slovenian: V okviru tega je bila omenjena skupna strategija usposabljanja vodij agencij za zdravila in agencije EMA.
English: The Board discussion focused on the implementation of the new legislative provisions in relation to EudraVigilance and EU Telematics Controlled Terms.
Slovenian: Razprava v odboru je poseben poudarek dala izvajanju določil nove zakonodaje v zvezi s sistemom EudraVigilance in telematsko nadzorovanimi izrazi EU.
English: • [EMA/MB/66833/2011] Performance of the Agency's scientific procedures: Survey 2010 for medicinal products for human use.
Slovenian: • [EMA/MB/66833/2011] Uspešnost znanstvenih postopkov agencije: raziskava zdravil za humano uporabo 2010.
English: • [EMA/MB/105462/2011] Outcome of written procedures during the period from 17 October 2010 to
Slovenian: • [EMA/MB/105462/2011] Izid pisnih postopkov v obdobju od 17. oktobra 2010 do
English: • 69th Management Board minutes from 16 December 2010, finalised on 11 February 2011.
Slovenian: • Zapisnik 69. seje upravnega odbora z dne 16. decembra 2010, zaključeno 11. februarja 2011.
English: Guiseppe Nisticó Björn Lemmer
Slovenian: Giuseppe Nisticó Björn Lemmer
English: Minutes of the 70th meeting of the Management Board
Slovenian: Zapisnik 70. seje upravnega odbora
English: The revised procedure now foresees that unless five or more members expressed their reservations with regards to the nomination, the candidate is considered accepted and the procedure is closed.
Slovenian: Spremenjeni postopek zdaj predvideva, da je kandidat potrjen in se postopek zaključi, razen če pet ali več članov izrazi zadržek glede imenovanja.
English: [EMA/MB/218686/2011] The Management Board adopted a decision giving its approval for the currently declared activities of Thomas Lönngren, who stepped down as Executive Director of the Agency on 31 December 2010.
Slovenian: [EMA/MB/218686/2011] Upravni odbor je sprejel odločitev, s katero je odobril trenutno prijavljene dejavnosti Thomasa Lönngrena, ki je dne 31. decembra 2010 odstopil s položaja izvršnega direktorja agencije.
English: [EMA/MB/808316/2010] The Management Board noted the minutes adopted by written procedure on 7 February 2011.
Slovenian: [EMA/MB/808316/2010] Upravni odbor se je seznanil z zapisnikom, ki je bil sprejet s pisnim postopkom dne 7. februarja 2011.
English: The members noted the update report from the Heads of Medicines Agencies on a range of topics, including the following:
Slovenian: Člani so se seznanili s posodobljenim poročilom vodij agencij za zdravila o različnih temah:
English: • The process for the implementation of the strategy paper (the HMA meetings will be reorganised to facilitate the implementation of the strategy paper).
Slovenian: • postopek izvajanja strateškega dokumenta (seje vodij agencij za zdravila se bodo preoblikovale, tako da bo mogoče izvajanje strateškega dokumenta);
English: • The new legislation on falsified medicines (the text of the legislation is likely to be published in the
Slovenian: • nova zakonodaja o ponarejenih zdravilih (besedilo zakona bo verjetno objavljeno v Uradnem listu maja 2011);
English: The Acting Executive Director updated the Board on the issue of products containing benfluorex, saying that the Agency had provided a platform for discussion but had not had a mandate to deal with national products.
Slovenian: Vršilec dolžnosti izvršnega direktorja je odbor obvestil o odprtem vprašanju glede zdravil, ki vsebujejo benfluoreks, pri čemer agencija sicer zagotavlja prostor za razpravo, ni pa pooblaščena za obravnavo nacionalnih zdravil.
English: "We believe that Thomas Lönngren's advisory role regarding strategic development of the companies, as well as business plans and investment opportunities are strictly connected with privileged information and confidential data that he gained during his mandate as EMA Executive Director.
Slovenian: Predstavniki Evropskega parlamenta v odboru so zahtevali, da se v zapisnik seje vnese naslednja izjava: „Menimo, da je svetovalna vloga Thomasa Lönngrena pri strateškem razvoju družb ter poslovnih načrtov in naložbenih priložnosti tesno povezana z zaščitenimi informacijami in zaupnimi podatki, ki jih je pridobil med opravljanjem funkcije izvršnega direktorja agencije EMA.
English: [EMA/MB/80540/2011] The Management Board adopted the revised charter of the accounting officer, which clarifies the accounting officer's obligations and responsibilities in line with the Financial Regulation.
Slovenian: [EMA/MB/80540/2011] Upravni odbor je sprejel spremenjeno listino za računovodje, ki pojasnjuje njihove dolžnosti in odgovornosti v skladu s finančno uredbo.
English: Accommodation of the Agency
Slovenian: Prostori agencije
English: • [EMA/MB/784841/2011] Preliminary draft budget.
Slovenian: • [EMA/MB/784841/2011] Predhodni predlog proračuna.
English: • [EMA/807799/2010] Annual report 2010 of the Agency's Internal Audit.
Slovenian: • [EMA/807799/2010] Letno poročilo službe za notranjo revizijo pri agenciji za leto 2010.
English: European Medicines Agency attendees
Slovenian: Sodelujoči iz Evropske agencije za zdravila
English: • [EMA/MB/805742/2011] Preliminary work programme.
Slovenian: • [EMA/MB/805742/2011] Predhodni delovni program.
English: A formal letter can be issued to the IMI board as part of the process to improve prospects of obtaining funding.
Slovenian: Kot del postopka za izboljšanje možnosti za pridobivanje sredstev se lahko odboru IMI izda uraden dopis.
English: • [EMA/634206/2010] Minutes from the latest Management Board Telematics Committee meeting
Slovenian: • [EMA/634206/2010] Zapisnik zadnje seje Odbora za telematiko pri upravnem odboru 2010-11
English: • [EMA/MB/78578/2011] Update report on the Agency's implementation of the EU telematics strategy.
Slovenian: • [EMA/78578/2011] Dopolnjeno poročilo o izvajanju strategije EU za telematske projekte s strani agencije.